Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 488
Filter
1.
Acta Pharmaceutica Sinica B ; (6): 2701-2714, 2023.
Article in English | WPRIM | ID: wpr-982859

ABSTRACT

Parkinson's disease (PD) is the most common neurodegenerative movement disease. It is featured by abnormal alpha-synuclein (α-syn) aggregation in dopaminergic neurons in the substantia nigra. Macroautophagy (autophagy) is an evolutionarily conserved cellular process for degradation of cellular contents, including protein aggregates, to maintain cellular homeostasis. Corynoxine B (Cory B), a natural alkaloid isolated from Uncaria rhynchophylla (Miq.) Jacks., has been reported to promote the clearance of α-syn in cell models by inducing autophagy. However, the molecular mechanism by which Cory B induces autophagy is not known, and the α-syn-lowering activity of Cory B has not been verified in animal models. Here, we report that Cory B enhanced the activity of Beclin 1/VPS34 complex and increased autophagy by promoting the interaction between Beclin 1 and HMGB1/2. Depletion of HMGB1/2 impaired Cory B-induced autophagy. We showed for the first time that, similar to HMGB1, HMGB2 is also required for autophagy and depletion of HMGB2 decreased autophagy levels and phosphatidylinositol 3-kinase III activity both under basal and stimulated conditions. By applying cellular thermal shift assay, surface plasmon resonance, and molecular docking, we confirmed that Cory B directly binds to HMGB1/2 near the C106 site. Furthermore, in vivo studies with a wild-type α-syn transgenic drosophila model of PD and an A53T α-syn transgenic mouse model of PD, Cory B enhanced autophagy, promoted α-syn clearance and improved behavioral abnormalities. Taken together, the results of this study reveal that Cory B enhances phosphatidylinositol 3-kinase III activity/autophagy by binding to HMGB1/2 and that this enhancement is neuroprotective against PD.

2.
China Journal of Chinese Materia Medica ; (24): 3949-3964, 2023.
Article in Chinese | WPRIM | ID: wpr-981527

ABSTRACT

This study aimed to evaluate the efficacy of Qi-supplementing and Yin-nourishing Chinese patent medicine in the treatment of early diabetic nephropathy(DN) by network Meta-analysis to explore the Chinese patent medicine with optimal efficacy and provide references for preventing renal deterioration and delaying the progression of early DN. Eight databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, were searched for clinical randomized controlled trial(RCT) of Qi-supplementing and Yin-nourishing Chinese patent medicines in the treatment of early DN. After the literature mee-ting the inclusion criteria was screened, the quality of the literature was evaluated using the Cochrane risk-of-bias tool, and network Meta-analysis was performed using the BUGSnet package in R 4.2.1. Seventy-two research articles with a sample size of 6 344 cases were included, involving eight Chinese patent medicines and seven outcome indicators. The results of the network Meta-analysis showed that(1)in terms of improving urinary albumin excretion rate(UAER), Chinese patent medicines combined with conventional treatment were superior to conventional treatment, and Qiyao Xiaoke Capsules + conventional treatment was optimal.(2)In terms of reducing serum crea-tinine(Scr), Bailing Capsules + conventional treatment had superior efficacy.(3)In terms of reducing 24-hour urine total protein(24hUTP), Shenyan Kangfu Tablets + conventional treatment and Jinshuibao Capsules + conventional treatment had equivalent efficacy, and Shenyan Kangfu Tablets + conventional treatment was superior.(4)In terms of improving fasting blood glucose(FBG), Shenyan Kangfu Tablets + conventional treatment had superior efficacy.(5)In terms of improving total cholesterol(TC), Qiyao Xiaoke Capsules +conventional treatment had superior efficacy.(6)In terms of reducing triglyceride(TG), Bailing Capsules + conventional treatment had superior efficacy.(7)In terms of safety, the occurrence of adverse reactions was reported in seven interventions, but due to the large clinical heterogeneity, the quantitative analysis could not be performed. Overall, Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment were superior to conventional treatment alone in the treatment of early DN. The results showed that Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment had good clinical efficacy, and they could significantly reduce renal function indicators such as UAER, Scr, and 24hUTP, and reduce blood sugar and blood lipid, which can provide evidence-based support for the treatment of early DN. However, due to the differences in the quantity and quality of the included research articles, large-sample, multi-center, high-quality studies are still needed for further verification.


Subject(s)
Humans , Diabetic Nephropathies/drug therapy , Nonprescription Drugs/therapeutic use , Qi , Network Meta-Analysis , Capsules , Drugs, Chinese Herbal/therapeutic use , Tablets , Diabetes Mellitus/drug therapy
3.
China Journal of Chinese Materia Medica ; (24): 3386-3393, 2023.
Article in Chinese | WPRIM | ID: wpr-981474

ABSTRACT

The present study collected data on traditional Chinese medicine(TCM) compounds effective in relieving pain from the patent database of the State Intellectual Property Office(SIPO), sorted out the TCM compounds against pain in patents, and analyzed the medication rules to provide references for the research and development of new TCM drugs against pain. The data were subjected to frequency statistics, association rules, cluster analysis, and complex network analysis by IBM SPSS Modeler 18.3 and SPSS Statistical 26.0. The results showed that among the 101 oral prescriptions included in the statistics, the top 5 drugs were Glycyrrhizae Radix et Rhizoma, Angelicae Sinensis Radix, Paeoniae Radix Alba, Chuanxiong Rhizoma, and Salviae Miltiorrhizae Radix et Rhizoma, and among the 49 external prescriptions included in the statistics, the top 5 drugs were Myrrha, Olibanum, Angelicae Dahuricae Radix, Borneolum Syntheticum, and Chuanxiong Rhizoma. Whether oral or external prescriptions, the drugs were mainly warm in nature, and bitter, pungent, and sweet in flavor. According to TCM complex network analysis, the core drugs were Glycyrrhizae Radix et Rhizoma, Angelicae Sinensis Radix, Paeoniae Radix Alba, and Chuanxiong Rhizoma in oral prescriptions, and Olibanum, Myrrha, Glycyrrhizae Radix et Rhizoma, Chuanxiong Rhizoma, and Angelicae Sinensis Radix in external prescriptions. Overall, the therapeutic principles of oral prescriptions were mainly replenishing Qi, nourishing blood, and promoting Qi and blood circulation, while those of external prescriptions were activating blood, resolving stasis, promoting Qi flow, and relieving pain on the basis of the oral prescriptions. In the future research and development of TCM compounds against pain, the prescriptions should be modified with mind-tranquilizing and depression-relieving drugs. With the modernization of TCM, the development of new pain-relieving TCM compound patents based on ancient methods and clinical experience adhering to the guidance of TCM treatment based on syndrome differentiation can meet the new demand for pain treatment in the current society and give full play to the advantages of TCM in pain treatment.


Subject(s)
Animals , Medicine, Chinese Traditional , Frankincense , Pain , Paeonia , Coleoptera
4.
China Journal of Orthopaedics and Traumatology ; (12): 145-150, 2023.
Article in Chinese | WPRIM | ID: wpr-970836

ABSTRACT

OBJECTIVE@#To explore the characteristics of comorbidities in patients with osteoporosis(OP) and factors associated health-related quality of life, so as to provide decision-making reference for improving the ability of disease co-prevention and co-treatment and the patient's life-cycle quality of life.@*METHODS@#From November 2017 to July 2018, clinical information and biological samples from residents in 10 communities in Chaoyang District and Fengtai Distric of Beijing were collected, and bone density testing was conducted. Based on the Charlson comorbidity index (CCI), the comorbidity of the population was quantified, and grouped according to factors such as gender, age, and the differences between the groups were explored. Combined with the clinical information of patients, the difference characteristics of comorbidity and non-comorbidity population were analyzed. Pearson/Spearman correlation analysis and binary Logistic regression analysis were used to explore the factors affecting the health-related quality of life in patients with OP.@*RESULTS@#Among the 521 OP patients, 121 patients had no comorbidities, and there were 153, 106, 65, and 30 patients with one, two, three, and four comorbidities, respectively, 46 patients with 5 or more kinds of comorbidites. Hypertension was the most common comorbidity in OP patients, accounting for 21.60%;followed by hyperlipidemia, accounting for 13.51%. The most common combination of the two diseases was hypertension plus hyperlipidemia (64 cases, 12.28%). Through the analysis of differences between age groups, it was found that the older patients, showed higher the CCI, and the difference between groups was statistically significant(Z=1.93, P=0.05). There were significant differences in the total EQ-5D score and the dimensions of anxiety and depression between patients with comorbidities (CCI≠0) and non-comorbidities (CCI=0) (Z=-2.67, P=0.01;Z=-2.44, P=0.02). Correlation analysis found that CCI, history of fracture, history of falls, hip bone mineral density T value and parathyroid hormone were all related to the health-related quality of life in OP patients (P<0.05). Binary Logistic regression analysis suggested that the right hip bone mineral density T value (P=0.02), CCI (P=0.01), fracture history (P=0.03) and fall history (P=0.01) were the risk factors that affect the health-related quality of life in OP patients.@*CONCLUSION@#The burden of comorbidities among middle-aged and elderly OP populations in Beijing is relatively heavy, and the health management of such populations should be further strengthened, specifically the combination of multiple comorbidities should be given high priority. Comorbid factors are of great importance for the diagnosis and treatment strategy of OP patients, which could further improve the quality of life.


Subject(s)
Aged , Middle Aged , Humans , Quality of Life , Osteoporosis/epidemiology , Comorbidity , Risk Factors , Fractures, Bone , Hypertension/epidemiology
5.
Chinese Acupuncture & Moxibustion ; (12): 322-326, 2023.
Article in Chinese | WPRIM | ID: wpr-969992

ABSTRACT

OBJECTIVE@#To observe the clinical efficacy of Miao medicinal crossbow acupuncture therapy as adjuvant treatment for lung cancer pain based on oxycodone hydrochloride extended-release tablet.@*METHODS@#A total of 60 patients with lung cancer pain were randomized into an observation group (30 cases, 1 case dropped off) and a control group (30 cases). In the control group, oxycodone hydrochloride extended-release tablet was given orally, 10 mg a time, once every 12 hours. On the basis of the treatment in the control group, Miao medicinal crossbow acupuncture therapy was applied once every other day in the observation group. The treatment of 14 days was required in the two groups. Before and after treatment, the numerical rating scale (NRS) score, number of break-out pain and Karnofsky performance status (KPS) score were observed in the two groups. The equivalent oxycodone consumption and rate of adverse reactions were recorded, the analgesic effect was evaluated in the two groups.@*RESULTS@#Compared before treatment, the NRS scores and number of break-out pain were decreased while the KPS scores were increased after treatment in the two groups (P<0.01). After treatment, the NRS score and number of break-out pain in the observation group were lower than the control group (P<0.01), the KPS score in the observation group was higher than the control group (P<0.05). The equivalent oxycodone consumption of whole course and the rate of adverse reactions i.e. constipation, drowsiness, nausea and vomiting in the observation group were lower than the control group (P<0.05). The analgesic effect rate was 93.1% (27/29) in the observation group, which was superior to 63.3% (19/30) in the control group (P<0.05).@*CONCLUSION@#On the basis of oxycodone hydrochloride extended-release tablet, Miao medicinal crossbow acupuncture therapy as adjuvant treatment can effectively relieve the pain degree, reduce the number of break-out pain and improve the health status and quality of life in patients with lung cancer pain, enhance the efficacy of medication and reduce its adverse reactions.


Subject(s)
Humans , Cancer Pain , Oxycodone , Quality of Life , Lung Neoplasms , Pain , Acupuncture Therapy , Adjuvants, Immunologic , Lung , Analgesics
6.
Chinese Journal of Orthopaedic Trauma ; (12): 77-82, 2023.
Article in Chinese | WPRIM | ID: wpr-992684

ABSTRACT

Objective:To evaluate the efficacy of arthroscopic minimally invasive reduction in the treatment of talus posterior process fractures.Methods:The clinical data were retrospectively studied of the 42 patients with talus posterior process fracture who had been admitted to Department of Orthopedics, The Fourth Hospital of Wuhan from January 2010 to June 2021. There were 25 males and 17 females, aged from 21 to 60 years (average, 40.5 years). They were assigned into 2 groups according to their different treatments. In the arthroscopic group of 15 cases, arthroscopic reduction and internal fixation (ARIF) were conducted via the posteromedial and posterolateral approaches; in the open reduction group of 27 cases, open reduction and internal fixation (ORIF) were conducted via the posteromedial para-Achilles approach. The 2 groups were compared in terms of operation time, blood loss, hospital stay, fracture clinical healing time, postoperative complications, and the American Society for Foot and Ankle Surgery (AOFAS) ankle-hindfoot score at one year postoperation.Results:There was no significant difference in the preoperative general data between the 2 groups, showing comparability ( P> 0.05). The arthroscopic group incurred significantly less blood loss [(32.0±11.5) mL], hospital stay [(5.3±1.8) d], and fracture clinical healing time [(4.6±1.0) months], and a significantly lower incidence of postoperative complications [20.0% (3/15)] than the open reduction group did [(80.0±15.2) mL, (8.4±2.4) d, (6.3±2.2) months, and 29.6% (8/27)], but significantly longer operation time [(74.0±8.9) min] than the open reduction group [(62.9±5.1) min] ( P<0.05). The AOFAS ankle-hindfoot scores at one year postoperation in both groups were higher than those before operation. The AOFAS ankle-hindfoot scores in the arthroscopic group [(83.0±13.0) points] were significantly higher than those in the open reduction group [(72.3±16.0) points] ( P<0.05). Conclusion:ARIF is a preferred minimally invasive treatment for talus posterior process fractures, because it leads to a smaller incision, less blood loss, shorter hospital stay, quicker clinical healing, a lower incidence of postoperative complications, and better functional improvement of the ankle and hindfoot than ORIF.

7.
Chinese Journal of Orthopaedic Trauma ; (12): 624-628, 2022.
Article in Chinese | WPRIM | ID: wpr-956566

ABSTRACT

Objective:To investigate the effect of subfibular ossicle excision on the clinical efficacy of Brostr?m procedure for chronic lateral ankle instability (CLAI).Methods:From March 2014 to December 2018, 76 patients were treated by the modified Brostr?m procedure using the suture anchor technique for CLAI at Department of Foot & Ankle Surgery, Wuhan Fourth Hospital. Of them, 33 had subfibular ossicles (SFO group) and 43 did not (NSFO group). In the SFO group, there were 19 males and 14 females, aged (28.4±8.6) years; in the NSFO group, there were 21 males and 22 females, aged (27.8±7.4) years. Subfibular ossicles were excised in the SFO group. The 2 groups were compared in terms of American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot scores and visual analogue scale (VAS) pain scores at preoperation and the final follow-up.Results:The 2 groups were comparable due to insignificant differences between them in their preoperative general data ( P>0.05). All the patients were followed up for 24 to 72 months (average, 28 months). The AOFAS ankle-hindfoot scores improved significantly from 54.5±3.4 to 95.7±2.1 in the SFO group and significantly from 56.2±2.7 to 95.2±2.4 in the NSFO group at the final follow-up; the VAS scores reduced significantly from 5.7±1.8 to 1.6±1.4 in the SFO group and significantly from 5.7±1.6 to 1.7±1.2 in the NSFO group at the final follow-up (all P<0.05). No significant differences were found between the 2 groups in terms of AOFAS or VAS scores at the final follow-up ( P>0.05). Conclusion:Since the modified Brostr?m procedure plus subfibular ossicle excision may result in similar good clinical efficacy as merely the modified Brostr?m procedure may for the CLAI patients without subfibular ossicle, subfibular ossicle excision should be suggested for the CLAI patients with subfibular ossicle.

8.
Chinese Journal of Digestive Surgery ; (12): 1087-1092, 2022.
Article in Chinese | WPRIM | ID: wpr-955227

ABSTRACT

Objective:To investigate the influencing factors and management strategies of colonoscopy-associated colorectal perforation.Methods:The retrospective case-control study was conducted. The clinical data of 358 patients who underwent colonoscopy in the Affiliated Hospital of Zunyi Medical University from January 2011 to March 2021 were collected. There were 216 males and 142 females, aged (59±14)years. Patients underwent colonoscopy for diagnosis or treatment. Observation indicators: (1) situations of colonoscopy-associated colorectal perforation; (2) analysis of influencing factors of colonoscopy-associated colorectal perforation; (3) construction of prediction model of colonoscop-associated colorectal perforation; (4) management of colonoscopy-associated colorectal perforation. Measurement data with normal distribution were represented as Mean± SD. Measurement data with skewed distribution were represented as M( Q1, Q3), and comparison between groups was analyzed using the Wilcoxom rank sum test. Count data were discribed as absolute numbers, and comparison between groups was analyzed using the chi-square test. Multivariate ana-lysis was conducted using the binary Logistic regression model. The sensitivity and specificity of the prediction model were evaluated by the receiver operating characteristic (ROC) curve. Results:(1) Situations of colonoscopy-associated colorectal perforation. Of the 358 patients, 18 cases developed colorectal perforation, including 6 males and 12 females, with an age of 61(49,69) years. Of the 18 patients, there were 12 cases with colon perforation, including 10 cases of sigmoid colon perfora-tion or rectosigmoid junction perforation, 1 case of transverse colon perforation and 1 case of descending colon perforation, 6 cases with rectal perforation. There were 11 cases with diagnostic perforation and 7 cases with therapeutic perforation. (2) Analysis of influencing factors of colonoscopy-associated colorectal perforation. Results of univariate analysis showed that gender, age, colorectal ulcer, colorectal diverticulum, colorectal tumor, history of abdominal surgery, type of colonoscopy and the experience of operating physician were related factors for colonoscopy-associated colorectal perforation ( χ2=5.77, Z=?3.24, χ2=37.99, 97.34, 37.99, 10.31, 8.07, 6.73, P<0.05). Results of multi-variate analysis showed that colorectal diverticulum and abdominal surgery history were indepen-dent risk factors for colonoscopy-associated colorectal perforation ( odds ratios=287.79, 6.74, 95% confidence intervals as 23.14?3 579.11, 1.19?38.27, P<0.05). Therapeutic colonoscopy was an independent protective factor for colonoscopy-associated colorectal perforation ( odds ratio=0.11, 95% confidence interval as 0.23?0.52, P<0.05). (3) Construction of prediction model of colonoscopy-associated colorectal perforation. With the colonoscopy-associated colorectal perforation as depen-dent variable, colorectal diverticulum, abdominal surgery history and therapeutic colonoscopy as independent variables, a prediction model of colonoscopy-associated colorectal perforation was constructed. The ROC of model showed that the sensitivity was 0.56, the specificity was 1.00, and the area under curve was 0.78 (95% confidence interval as 0.63?0.92, P<0.05). (4) Management of colonoscopy-associated colorectal perforation. Of the 18 cases with colonoscopy-associated colorectal perforation, 15 cases underwent laparoscopic perforation repair surgery immediately, 2 cases under-went endoscopic suture, and 1 case received conservative treatment. All the patients with perfora-tion were cured and discharged from hospital, without death due to colonoscopy-associated colorectal perforation. Conclusions:Colonoscopy-associated colorectal perforation is easy to occur at sigmoid colon or rectosigmoid junction. Colorectal diverticulum and abdominal surgery history are indepen-dent risk factors for colonoscopy-associated colorectal perforation. Therapeutic enteroscopy is an independent protective factor for colonoscopy-associated colorectal perforation. Laparoscopic repair of colon perforation has good effects for patients with colorectal perforation.

9.
Chinese Journal of Digestive Surgery ; (12): 802-808, 2022.
Article in Chinese | WPRIM | ID: wpr-955196

ABSTRACT

Objective:To investigate the influence of nonylphenol (NP) on cytoactive and the expression of G protein-coupled estrogen receptor 30 (GPR30) in human colon cancer SW480 cells.Methods:The experimental study was conducted. The human colon cancer SW480 cells were cultured in vitro. The influence of NP on proliferation, cell cycle, apoptosis and the expression of GPR30 in human colon cancer SW480 cells were analyzed by cell proliferation, cell cycle detection, cell apoptosis and gene expression and protein expression experiments. Cell grouping: SW480 cells cultured with medium were set as the control group, cultured with medium+1×10 ?8 mol/L estradiol were set as the estradiol group, cultured with medium+1×10 ?8 mol/L NP were set as the NP group, cultured with medium+1×10 ?8 mol/L NP+1×10 ?7 mol/L GPR30 specific antagonist G15 were set as the NP+G15 group, respectively. Observation indicators: (1) proliferation index of human colon cancer SW480 cells in the 4 groups; (2) cycle proportion of human colon cancer SW480 cells in the 4 groups; (3) apoptosis index of human colon cancer SW480 cells in the 4 groups; (4) GPR30 messenger RNA(mRNA) expression of human colon cancer SW480 cells in the 4 groups; (5) GPR30 protein expression of human colon cancer SW480 cells in the 4 groups. Measurement data with normal distribution were represented as Mean± SD and one way ANOVA was used for comparison between groups. The least significant difference method was used to test the pairwise comparison. Results:(1) Proliferation index of human colon cancer SW480 cells in the 4 groups. Results of the cell proliferation experiments showed that the proliferation indexes of human colon cancer SW480 cells in the control group, the estradiol group, the NP group and the NP+G15 group were 100.00±0.00, 89.19±4.86, 148.96±6.04 and 120.40±3.39, respectively, showing a significant difference among the 4 groups ( F=21.45, P<0.05). There was a significant difference between the control group and the NP group ( P<0.05), and there was no significant difference between the control group and the estradiol group, between the control group and the NP+G15 group ( P>0.05). (2) Cycle proportion of human colon cancer SW480 cells in the 4 groups. Results of the cell cycle detection experiments showed that the proportions of human colon cancer SW480 cells in the S phase of the cell cycles in the control group, the estradiol group, the NP group and the NP+G15 group were 39.96%±2.02%, 36.67%±0.62%, 43.85%±1.02% and 38.29%±1.42%, respectively, showing a significant difference among the 4 groups ( F=10.08, P<0.05). There were significant differences between the control group and the estradiol group, between the control group and the NP group ( P<0.05), and there was no significant difference between the control group and the NP+G15 group ( P>0.05). (3) Apoptosis index of human colon cancer SW480 cells in the 4 groups. Results of the cell apoptosis experiments showed that the apoptosis indexes of human colon cancer SW480 cells in the control group, the estradiol group, the NP group and the NP+G15 group were 1.67±0.18, 4.80±0.31, 0.75±0.11 and 2.20±0.19, respectively, showing a significant difference among the 4 groups ( F=136.79, P<0.05). There were significant differences between the control group and the estradiol group, between the control group and the NP group ( P<0.05), and there was no significant difference between the control group and the NP+G15 group ( P>0.05). (4) GPR30 mRNA expression of human colon cancer SW480 cells in the 4 groups. Results of quantitative real-time polymerase chain reaction detection showed that the relative expression rates of GPR30 mRNA in human colon cancer SW480 cells of the control group, the estradiol group, the NP group and the NP+G15 group were 1.00±0.00, 0.86±0.05, 1.89±0.27 and 0.64±0.12, respectively, showing a significant difference among the 4 groups ( F=26.61, P<0.05). There were significant differences between the control group and the NP group, between the control group and the NP+G15 group ( P<0.05), and there was no significant difference between the control group and the estradiol group ( P>0.05). (5) GPR30 protein expression human colon cancer SW480 cells in the 4 groups. Results of Western blot detection showed that the relative expression rates of GPR30 protein in human colon cancer SW480 cells of the control group, the estradiol group, the NP group and the NP+G15 group were 1.83±0.16, 1.68±0.15, 3.10±0.30 and 1.26±0.11, respectively, showing a significant difference among the 4 groups ( F=34.05, P<0.05). There were significant differences between the control group and the NP group, between the control group and the NP+G15 group ( P<0.05), and there was no significant difference between the control group and the estradiol group ( P>0.05). Conclusion:Low dose of NP can increase the proliferation index and the proportion of cells in the S phase of the cell cycles, decrease the apoptosis index, and promote the mRNA and protein expression of GPR30 in human colon cancer SW480 cells.

10.
China Pharmacy ; (12): 1806-1809, 2022.
Article in Chinese | WPRIM | ID: wpr-936482

ABSTRACT

OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ,and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ,the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ; the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ,and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ,and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.

11.
Chinese journal of integrative medicine ; (12): 492-500, 2022.
Article in English | WPRIM | ID: wpr-928964

ABSTRACT

OBJECTIVE@#To delineate the onset and recurrence characteristics of noncardiogenic ischemic stroke patients in China.@*METHODS@#A prospective, multicenter and registry study was carried out in 2,558 patients at 7 representative clinical sub-centers during November 3, 2016 to February 17, 2019. A questionnaire was used to collect information of patients regarding CM syndromes and constitutions and associated risk factors. Additionally, stroke recurrence was defined as a primary outcome indicator.@*RESULTS@#A total of 327 (12.78 %) patients endured recurrence events, 1,681 (65.72%) were men, and the average age was 63.33 ± 9.45 years. Totally 1,741 (68.06%) patients suffered first-ever ischemic stroke, 1,772 (69.27%) patients reported to have hypertension, and 1,640 (64.11%) of them reported dyslipidemia, 1,595 (62.35%) patients exhibited small-artery occlusion by The Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification. Specifically, 1,271 (49.69%) patients were considered as qi-deficient constitution, and 1,227 (47.97%) patients were determined as stagnant blood constitution. There were 1,303 (50.94%) patients diagnosed as blood stasis syndrome, 1,280 (50.04%) patients exhibited phlegm and dampness syndrome and 1,012 (39.56%) patients demonstrated qi deficiency syndrome. And 1,033 (40.38%) patients declared intracranial artery stenosis, and 478 (18.69%) patients reported carotid artery stenosis. The plaque in 1,508 (41.36%) patients were of mixed. Particularly, 41.09% of them demonstrated abnormal levels of glycated hemoglobin levels.@*CONCLUSIONS@#Recurrence in minor and small-artery stroke cannot be ignored. Hypertension, dyslipidemia, abnormal HbA1c, intracranial artery stenosis and carotid plaque were more common in stroke patients. Particularly, phlegm-dampness and blood stasis syndromes, as well as qi deficiency and blood stasis constitutions, were still the main manifestations of stroke. (Trial registration at ClinicalTrials.gov No. NCT03174535).


Subject(s)
Aged , Female , Humans , Male , Middle Aged , Constriction, Pathologic , Hospitals , Hypertension , Ischemic Stroke , Medicine, Chinese Traditional , Prospective Studies , Stroke/epidemiology , Syndrome
12.
China Journal of Chinese Materia Medica ; (24): 1501-1508, 2022.
Article in Chinese | WPRIM | ID: wpr-928080

ABSTRACT

This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.


Subject(s)
Humans , Capsules , Liver , Medicine, Chinese Traditional , Migraine Disorders/drug therapy , Syndrome
13.
China Journal of Chinese Materia Medica ; (24): 1493-1500, 2022.
Article in Chinese | WPRIM | ID: wpr-928079

ABSTRACT

This clinical value-oriented comprehensive evaluation of drugs was carried out in accordance with Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), with the qualitative and quantitative evaluation methods adopted. Based on the evidence-based medicine, epidemiology, clinical medicine, pharmacoeconomics, mathematical statistics, and health technology evaluation(HTA), the clinical value of Ginkgolide Injection was evaluated from the "6+1" dimension by giving weight to the criterion level and index level and calculating with multi-criteria decision analysis(MCDA) model and CSC v2.0. After entering the market, Ginkgolide Injection has been subjected to phase Ⅳ clinical trial, spontaneous reporting system(SRS)-based data monitoring, systematic review and Meta-analysis, acute toxicity and long-term toxicity assays, active monitoring, and RCTs, and the evidence of safety was sufficient. The results of active monitoring showed that the incidence of adverse reactions was 0.09%(rare), mainly manifested as flushing, dizziness, rash, nausea, and vomiting. According to the nested case-control study, the adverse reactions of this drug had nothing to do with the product batch, implying that the drug quality was controllable. The adverse reactions mainly resulted from the pharmacodynamic reactions. Because the drug was effective in resisting platelet aggregation, the resulting adverse reactions such as flushing, dizziness, headache, and phlebitis were caused by vasodilation. Skin rash and gastrointestinal symptoms were mainly attributed to the patients' sensitivity to drugs and their own allergic constitution. According to the sufficiency of evidence and the incidence of adverse reactions in the safety research, the safety of Ginkgolide Injection was grade A. The results of Meta-analysis showed that Ginkgolide Injection combined with conventional western medicine was superior to conventional western medicine in improving the clinical effective rate, neurological function score, and activity of daily living score of patients with cerebral infarction. The validity evidence was evaluated according to the PICO principle to be high. According to the GREAD evaluation principle, the quality of such evidence as clinical effective rate, National Institute of Health stroke scale(NIHSS), and Barthel Index(BI) was evaluated, and the results demonstrated that the evidence quality of clinical effective rate and activity of daily living score was medium. The effectiveness of Ginkgolide Injection was grade A. According to the economic report of Ginkgolide Injection, it had short-term and long-term pharmacoeconomic advantages in the treatment of ischemic stroke, and the economic evidence value was good. According to the CASP economic evaluation checklist, the overall quality evaluation results of the economic report are basically clear. To be specific, the economic evidence quality was high. Based on the comprehensive economic evidence quality and economic value, the economy of this drug was grade A. The innovation of this product was evaluated from three aspects: clinical innovation, enterprise service system innovation, and industrial innovation. Ginkgolide Injection could be used 24 h after intravenous thrombolysis for improving patients' neurological function without increasing bleeding, indicating its important clinical innovation. There were many innovations in ensuring drug supply, especially at the grass roots, drug safety, effectiveness, and reasonable price, which has provided reference for establishing enterprise philosophy, managing drug resources, developing process and technology, and determining enterprise management and marketing. Therefore, its innovation was grade A. The drug had no special medication plan in use, exhibiting good suitability for doctors, nurses, and patients. The suitability was grade B. Compared with similar drugs, its price was at a medium level, meaning good affordability, sufficient production capacity, and easy accessibility. Its accessibility was therefore grade B. This drug belonged to Chinese medicinal injection. The large-sample real-world research revealed rich human use experience, so it was grade C for the traditional Chinese medicine characteristic. According to the comprehensive evaluation, the clinical value of Ginkgolide Injection in the treatment of cerebral infarction fell into class A. It is suggested that it can be transformed into the relevant policy results of basic clinical medication management according to the procedure.


Subject(s)
Humans , Case-Control Studies , Cerebral Infarction/drug therapy , Drugs, Chinese Herbal/therapeutic use , Ginkgolides/therapeutic use , Medicine, Chinese Traditional
14.
China Journal of Chinese Materia Medica ; (24): 1484-1492, 2022.
Article in Chinese | WPRIM | ID: wpr-928078

ABSTRACT

Based on Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), this study aims to sort out the clinical evidence of Huangkui Capsules(HC) in the treatment of chronic kidney diseases in aspects of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) from real-world data, secondary literature evaluations, questionnaires, and public data, with the methods in evidence-based medicine, epidemiology, pharmacoeconomics, and health technology. Furthermore, with multi-criteria decision analysis(MCDA) model and CSC v2.0, the clinical value of the medicine is comprehensively assessed. All the above are to highlight the advantages and characteristics of HC and lay a basis for scientific decision-making by the medical management department. The dimensions are graded A, B, C, or D. According to the conclusions from phase Ⅳ clinical trial, spontaneous reporting system(SRS), systematic review and Meta-analysis, acute toxicity and long-term toxicity tests, it mainly results in the adverse reactions of nausea, abdominal distension, vomiting, pruritus, rash, and good prognosis in patients. According to the available research, the safety evidence is sufficient and the risk is controllable, so the safety of this medicine is grade B. According to Meta-analysis, HC in combination with conventional drugs in the treatment of chronic kidney disease is superior to conventional drugs alone in reducing urinary protein, serum creatinine concentration, and blood urea nitrogen. In addition, HC combined angiotensin receptor blocker(ARB) or angiotensin converting enzyme inhibitor(ACEI) is outstanding in improving total clinical effective rate, reducing 24 h urinary protein quantity, urinary albumin excretion rate, serum creatinine concentration, triglyceride, and total cholesterol in the treatment of diabetic nephropathy as compared with ARB or ACEI alone. As for chronic nephritis, the application together with ARB or ACEI can raise the total effective rate, reduce 24 h urinary protein content, serum creatinine concentration, and blood urea nitrogen, and delay the progress of the disease. HC boasts high-quality evidence in treating chronic kidney disease, diabetic nephropathy, and chronic nephritis. It has obvious clinical significance in treating chronic kidney disease and thus its efficacy in this aspect is grade B. It has outstanding clinical significance for diabetic nephropathy and chronic nephritis and corresponding and the effectiveness is grade A. As for the pharmacoeconomic value, HC combined with ARB or ACEI is more economical in the treatment of chronic kidney disease than Bailing Capsules combined with ARB or ACEI, with high-quality evidence, and thus the economy of the formula is grade B. HC is a key solution to the high urinary protein in patients with hypotension and chronic kidney disease. The innovation is evidenced by the methods to ensuring drug supply, community-level supply, drug safety, effectiveness, and reasonable price, as wells as the aspects of enterprise philosophy, equipment management, research and development in process and technology, enterprise management and marketing. Thus, the prescription is grade A in innovation. The suitability, as evidenced in drug administration, technical management, drug storage, information service, and medication, is grade B. The course of the medicine is affordable, and it is accessible in a wide range of areas and hospitals. Thus, the accessibility is grade A. HC was developed from an in-hospital preparation, with application in numerous patients and thus large-scale real-world data. As a result, HC is grade B in terms of characteristics of traditional Chinese medicine. After comprehensive evaluation, the clinical value of HC in treating chronic kidney disease is class B, and that for diabetic nephropathy and chronic nephritis is class A. The result is of great reference value for the basic clinical medication management.


Subject(s)
Humans , Angiotensin Receptor Antagonists/adverse effects , Angiotensin-Converting Enzyme Inhibitors , Capsules , Diabetic Nephropathies/drug therapy , Renal Insufficiency, Chronic/drug therapy
15.
China Journal of Chinese Materia Medica ; (24): 1476-1483, 2022.
Article in Chinese | WPRIM | ID: wpr-928077

ABSTRACT

This study systematically sorted out the evidence data of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) with the qualitative and quantitative evaluation methods adopted. Based on evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, and health technology evalua-tion(HTA), the clinical value of Reyanning Mixture was evaluated using multi-criteria decision analysis(MCDA) model, Chinese patent medicine clinical evidence, and value evaluation software(CSC v2.0). The SRS monitoring data, Meta-analysis, and other safety evidence showed that the main adverse reactions of Reyanning Mixture were nausea, diarrhea, and rash, and no serious adverse reactions were found. The pharmacovigilance system was sound, and the system was perfect. There was no recall, notification, or interview for unqualified products. Based on the existing research, the evidence was sufficient, and the risk was controllable. Hence, its safety was grade A. Meta-analysis showed that in the treatment of acute upper respiratory tract infection, Reyanning Mixture combined with Amoxicillin Capsules was better than Amoxicillin Capsules alone in shortening the complete fever relief time and improving the cure rate. Besides, it was superior to Shuanghuanglian Granules in shortening the complete fever relief time, cough relief time, nasal congestion relief time, and pharyngeal congestion relief time. The Meta-analysis was conducted based on AMSTAR standard, and its ove-rall quality was proved good. The evidence quality in GRADE system evaluation was medium and low. The quality of evidence was medium, and the clinical value was obvious. Hence, its effectiveness was grade A. The results of pharmacoeconomic research showed that compared with Amoxicillin Capsules, Reyanning Mixture alone or in combination with Amoxicillin Capsules had cost-effectiveness advantages in the treatment of acute upper respiratory tract infection, and the results were stable in sensitivity analysis. According to the CASP economic evaluation checklist, the research problems were clear and the results were reliable. As revealed by the comprehensive evaluation, the evidence quality was sufficient and the result was clear. Its economy was grade B. Reyanning Mixture had multiple therapeutic targets like anti-virus, anti-bacteria, antipyresis, and anti-cough, with good clinical innovation. There were many innovative initiatives in ensuring drug supply, especially at the grass roots, drug safety, and effectiveness, and also multiple innovative contributions to production technology, quality control, scientific and technological research and development, and enterprise management and marketing. Therefore, its innovation was grade B. The dosage form of Reyanning was mixture, which made it convenient for storage and transportation. The usage was easy to be mastered and accepted by doctors and nurses, exhibiting good suitability for clinicians, nurses, pharmacists, and patients who received this drug and basically meeting the needs of clinical medication. The suitability was grade B. The average daily cost of this drug was 8.082 yuan, and the price was low. The treatment cost accounted for a small proportion of the annual disposable income of urban and rural residents, indicating that it was affordable. Reyanning Mixture was available in 31 provinces, cities and autonomous regions, covering 6 910 hospitals. The allocation of hospitals at all levels was more than 50%. There was no shortage or supply restriction of medicinal material resources. The annual production capacity was sufficient to meet the supply demand, so its accessibility was grade A. Reyanning Mixture, sourced from "pneumonia Ⅲ", has been subjected to a real-world study of its clinical application, with 4 367 cases involved, and the characteristic of TCM was grade B. The comprehensive evaluation results demonstrated that the clinical value score of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) was 0.80, making it rated class A. According to the Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), it is recommended to convert it into the relevant policy results of basic clinical medication management according to the procedures.


Subject(s)
Humans , Hot Temperature , Lung , Medicine, Chinese Traditional , Respiratory Tract Infections/drug therapy , Syndrome
16.
China Journal of Chinese Materia Medica ; (24): 1469-1475, 2022.
Article in Chinese | WPRIM | ID: wpr-928076

ABSTRACT

This study aims to comprehensively summarize articles on the treatment of coronary heart disease angina pectoris with heart blood stasis syndrome(CHD-AP-HBSS) by Guanxin Shutong Capsules(GSC), and comprehensively evaluate the evidence and value of the formula in "6+1" dimensions based on multi-criteria decision analysis(MCDA) model and Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021) with quantitative and qualitative methods, which is expected to highlight the clinical characteristics and advantages of the prescription and serve as a reference for medical and health departments. The dimensions are grade A, B, C, or D. In terms of safety, according to the reports from the spontaneous reporting system of National Center for ADR Monitoring, and literature analysis, GSC mainly results in the adverse reactions of mild or moderate nausea, diarrhea, rash, palpitation, and headache, with favorable prognosis in patients. Nevertheless, severe adverse reactions have been reported after marketing. Thus, additional evidence for its safety should be accumulated, and the current safety is grade B. Meta-analysis proves that GSC in combination with conventional treatment is superior to conventional treatment alone in alleviating AP and symptoms indicated by electrocardiogram(ECG). Therefore, the effectiveness of the medicine is grade A. As for the pharmacoeconomic value, based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold, it is more economical for CHD-AP patients to use GSC combined with conventional treatment than conventional treatment alone. However, as the currently available clinical parameters fail to support the difference in indirect cost between the two groups, the accuracy in the cost of intervention plan needs to be further improved. Therefore, the economy of the prescription is grade B. GSC has been awarded 13 national invention patents and 1 utility model patent, and won a lot of national and provincial patent awards, marking the enterprise service awareness and innovativeness. As a result, it is grade A in aspect of innovation. A questionnaire on the suitability of GSC suggests that publicity and promotion influence patients' choice and thus additional efforts should be made in this aspect. The suitability of this formula is grade B. Both rural and urban residents can afford the medicine for the whole course and the price is close to that of similar Chinese patent medicines. In addition, it is accessible regardless of season and place, so accessibility is grade A. As a Mongolian empirical formula destined to treat heart stabbing pain, it has the effects of activating blood and resolving stasis, dredging channels and activating collaterals, and moving Qi to relieve pain, and boasts the empirical evidence of more than 2 000 human cases. With prominent characteristics of traditional Chinese medicine, it is grade B. Based on the MCDA model and CSC v2.0, GSC is comprehensively class A in the treatment of CHD-AP-HBSS. The result can serve as a reference for basic clinical medication management.


Subject(s)
Humans , Angina Pectoris/drug therapy , Capsules , Coronary Disease/drug therapy , Drugs, Chinese Herbal/adverse effects
17.
China Journal of Chinese Materia Medica ; (24): 1459-1468, 2022.
Article in Chinese | WPRIM | ID: wpr-928075

ABSTRACT

The present study systematically sorted out the existing research on Qilong Capsules in the treatment of ischemic stroke with Qi deficiency and blood stasis syndrome and comprehensively evaluated its clinical evidence and value to highlight the advantages and characteristics of products and provide references for the decision-making of national pharmaceutical management departments. Based on the evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, and pharmacoeconomics, the qualitative and quantitative evaluation of "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, and accessibility, as well as characteristics of traditional Chinese medicine(TCM) was performed with multi-criteria decision analysis(MCDA) mo-del using the information, such as public data, literature data, pharmaceutical research, and questionnaire survey, and CSC v2.0 was used to calculate the clinical value of Qilong Capsules. The evaluation results were grade A, B, C, or D. Spontaneous reporting system(SRS) monitoring data, literature reports, clinical trials, and other multi-source safety evidence showed that the main adverse reactions of this drug included dry mouth, nausea, and rash, and no severe adverse reactions was found. The evidence was sufficient with small and controllable known risks, and the safety was grade A. Meta-analysis showed that Qilong Capsules combined with conventional western medicine in the treatment of acute ischemic stroke was superior to the control group in improving neurological deficits, clinical total response rate, patients' activities of daily living, and hemorheological indexes. The level of evidence was high with manifest clinical significance, and the effectiveness was grade A. The results of pharmacoeconomic research showed that Qilong Capsules combined with conventional western medicine in the treatment of ischemic stroke were advantageous in cost-effectiveness as compared with conventional western medicine alone, but the incremental effect was not significant. The quality evaluation results of the economic report were comparatively clear, and the economy was grade B. Aiming at major cerebrovascular diseases in the society and giving full play to the advantages of TCM, Qilong Capsules focused on the inheritance of classics and scientific and technological innovation, and innovation was grade B. The results of the questionnaire survey showed that the technical characteristics and drug application could meet the medication needs of clinical doctors and patients, and the suitability was grade B. The price level of this drug was comparatively high and the affordability was good since the treatment cost accounted for a small proportion of disposable income. The drug accessibility was good with a wide range of drug sales, sufficient production capacity, and sustainable medicinal materials resources, and was grade B. This drug was derived from the classic prescription Buyang Huanwu Decoction with rich experience of human application, which could regulate Qi and blood circulation, and the section of TCM characteristics was grade B. Based on the evidence evaluation results of "6+1" dimensions of Qilong Capsules, the comprehensive evaluation of clinical value was class A. It is suggested that it can be transformed into relevant policy results of basic clinical medication management according to procedures.


Subject(s)
Humans , Activities of Daily Living , Capsules , Ischemic Stroke , Medicine, Chinese Traditional , Qi
18.
China Journal of Chinese Materia Medica ; (24): 537-546, 2022.
Article in Chinese | WPRIM | ID: wpr-927998

ABSTRACT

The present study evaluated the efficacy and safety of Xiangju Capsules in the treatment of sinusitis. CNKI, Wanfang, VIP, CBM, Cochrane Library, PubMed, EMbase, Web of Science and ClinicalTrials.gov were systematically searched for randomized controlled trials(RCTs) of Xiangju Capsules in the treatment of sinusitis, and Meta-analysis was performed on the included articles using RevMan 5.3. Twenty-nine articles were included, involving 4 331 cases, including 2 196 cases in the experimental group and 2 135 cases in the control group. Meta-analysis results showed that the conventional therapy combined with Xiangju Capsules showed better significant efficiency(RR=1.30, 95%CI[1.15, 1.47], P<0.000 01), total response rate(RR=1.19, 95%CI[1.16, 1.23], P<0.000 01), and Lund-Mackay scores(MD=-1.23, 95%CI[-1.39,-1.07], P<0.000 01) than conventional therapy alone. The conventional therapy combined with Eucalyptol-limonene-pinene Enteric Soft Capsules and Xiangju Capsules showed better total response rate(RR=1.14, 95%CI[1.07, 1.21], P<0.000 1) and VAS scores than conventional therapy combined with Eucalyptol-limonene-pinene Enteric Soft Capsules(MD_(headache)=-1.29, 95%CI[-1.48,-1.10], P<0.000 01; MD_(congestion)=-1.08, 95%CI[-1.21,-0.95], P<0.000 01; MD_(olfactory dysfunction)=-1.05, 95%CI[-1.23,-0.87], P<0.000 01; MD_(facial disorder)=-1.38, 95%CI[-1.49,-1.27], P<0.000 01). The conventional therapy combined with clarithromycin and Xiangju Capsules displayed a better total response rate(RR=1.15, 95%CI[1.08, 1.21], P<0.000 01) than conventional therapy combined with clarithromycin, while no significant difference was observed in the significant efficiency(RR=1.27, 95%CI[0.98, 1.65], P=0.07). The significant efficiency(RR=2.16, 95%CI[1.47, 3.18], P<0.000 1) and total effective rate(RR=1.48, 95%CI[1.28, 1.72], P<0.000 01) of clarithromycin combined with Xiangju Capsules in patients with sinusitis and CT scores(MD=-1.87, 95%CI[-2.01,-1.74], P<0.000 01) was significantly better than clarithromycin alone. Trial sequential analysis(TSA) showed that the cumulative sample size of the main outcome indicators had met expectations. The main adverse reactions included drowsiness, diarrhea, and abdominal pain, which had no direct relationship with Xiangju Capsules. Based on the available data and methods, the combination of Xiangju Capsules with multiple treatments showed significant efficiency and total response rate in the treatment of sinusitis, and improved CT scores, VAS scores, and Lund-Mackay scores, without serious adverse reactions. The efficacy and safety of Xiangju Capsules in the treatment of sinusitis still need to be verified by a large-sample, well-designed, and internationally standardized clinical trial scheme.


Subject(s)
Humans , Capsules , Drugs, Chinese Herbal/therapeutic use , Randomized Controlled Trials as Topic , Sinusitis/drug therapy
19.
China Journal of Chinese Materia Medica ; (24): 829-835, 2022.
Article in Chinese | WPRIM | ID: wpr-927966

ABSTRACT

To evaluate the pharmacoeconomic value of Qidong Yixin Oral Liquid in the treatment of viral myocarditis(Qi-Yin deficiency syndrome) by supplementing Qi, nourishing the heart, calming the mind, and relieving palpitation, the present study performed the Meta-analysis based on the published papers on Qidong Yixin Oral Liquid by AMSTAR and carried out pharmacoeconomic evaluation using TreeAge Pro by the cost-effectiveness analysis. The results showed that the quality of the included papers was good. After four weeks of treatment, Qidong Yixin Oral Liquid combined with the conventional treatment regimen was superior to the conventional treatment in improving creatine kinase isoenzyme, and the difference was statistically significant. Furthermore, the treatment cost was also higher than that of conventional treatment, with an incremental cost-effectiveness ratio of CNY 95.89, accounting for 0.30% of per capita disposable income. The results of sensitivity analysis showed that the research results were robust. Therefore, based on the assumption that the per capita disposable income in 2020 was the threshold of patients' willingness to pay, it is more economical for patients with viral myocarditis to use Qidong Yixin Oral Liquid combined with conventional secondary prevention regimen than conventio-nal secondary prevention regimen alone. The economic evaluation of Qidong Yixin Oral Liquid in the treatment of viral myocarditis will help physicians and patients choose optimal treatment options, improve rational clinical medication, and provide references for the efficient allocation and utilization of medical resources in China.


Subject(s)
Humans , Cost-Benefit Analysis , Drugs, Chinese Herbal/therapeutic use , Economics, Pharmaceutical , Myocarditis/drug therapy , Qi , Yin Deficiency/drug therapy
20.
International Eye Science ; (12): 1069-1073, 2022.
Article in English | WPRIM | ID: wpr-929481

ABSTRACT

@# AIM: To evaluate the efficacy of modified folding intraocular lens(IOL)suspension surgery in treatment of traumatic dislocation of lens surgery technique.METHODS: Prospective randomized controlled study. A total of 15 patients underwent the modified folding IOL suspension surgery. Among them, 9 patients chose Akreos AO IOL, and polypropylene sutures were used to thread the haptics of IOL. After guided to puncture out through the sclera, the ends of sutures were thermal expanded and fixed in the sclera. And 6 patients chose Tecnis ZA9003 IOL and no sutures were used. After guided the haptics to puncture out through the sclera, the ends of haptics were thermal expanded and fixed in the sclera. The best corrected visual acuity(BCVA, LogMAR)of all patients and postoperative complication were observed. RESULTS: This study included 15 patients, among them, 7 were male and 8 were female, the mean age was 64.00±9.85 years old, the mean course of diseases was 5.80±3.17 wk. There were no significant differences between the demographic and baseline clinical characteristics. After underwent the modified folding IOL suspension surgery, visual acuity of all patients were obviously improved. After 3mo of the surgery, the BCVA(LogMAR)of patients were improved from 1.28±0.56 to 0.52±0.30. More specifically, the BCVA(LogMAR)of patients who chose Akreos AO IOL were improved from 1.39±0.62 to 0.59±0.25, and those who chose Tecnis ZA9003 IOL of the BCVA(LogMAR)were improved from 1.12±0.45 to 0.42±0.35. Furthermore, there was no severe postoperative complication observed in our study. Only one patient suffered IOL dislocation and the IOL optical surface was mild oblique.CONCLUSION: Modified folding IOL suspension surgery technique resulted in good visual and outcomes with no severe complication, making it an effective option for IOL suspension surgery.

SELECTION OF CITATIONS
SEARCH DETAIL