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1.
China Pharmacy ; (12): 891-896, 2022.
Article in Chinese | WPRIM | ID: wpr-923199

ABSTRACT

Enteric-soluble soft capsule is a kind of new preparation that does not disintegrate in the stomach ,but releases rapidly in the intestinal tract to play a pharmacodynamic role. It has the unique advantages of improving drug stability ,reducing drug irritation ,delivering drugs directionally to the intestinal tract ,and prolonging drug action time. In this paper ,the decomposition and release mechanism ,application advantages ,classification of enteric-soluble coating materials and preparation methods of enteric-soluble soft capsule are sorted and summarized ,in order to provide reference for further development of this type of preparation.

2.
Acta Pharmaceutica Sinica ; (12): 169-177, 2022.
Article in Chinese | WPRIM | ID: wpr-913161

ABSTRACT

During fluorescence-guided cancer surgery, ultra-pH sensitive (UPS) fluorescent nanoprobes has multiple advantages such as real-time imaging procedures, ultra-high imaging sensitivity as well as broad tumor detection specificity. UPS nanoprobes stay at "OFF" state at higher pH and turn into "ON" state at lower pH with emission of strong fluorescence. Moreover, the transition pH points (transition pH point, pHt) can be precisely controlled by structural-based strategy. One of the previously-reported UPS nanoprobes showed good imaging effect. However, it is still not clear about the effect of pHt on cancer imaging efficiency of UPS nanoprobes and to further identify the optimal UPS. In this study, we synthesized a series of UPS nanoprobes with pHt at 4.5, 6.2, 6.6, 7.8 by adjusting the hydrophobic blocks of UPS polymers. Each nanoprobe showed excellent stability in "OFF" state by dynamic light scattering and uniform morphology observed by transmission electron microscopy. In vitro imaging characterized the ultra-pH sensitive fluorescence transition of each probe. In vivo imaging results identified two UPS nanoprobes (NP-6.2 and NP-6.6) with superior tumor imaging effect. All animal experiments in this study were approved by the Animal Ethics Committee of Peking University Health Science Center and were strictly followed by the welfare regulations of laboratory animals of Peking University Health Science Center. Therefore, this study has explored the effect of pHt on the cancer imaging efficiency of UPS nanoprobes and provides a new idea for design of the other cancer microenvironment-responsive polymers.

3.
China Pharmacy ; (12): 332-337, 2022.
Article in Chinese | WPRIM | ID: wpr-913092

ABSTRACT

OBJECTIVE To study the content changes of ch emical constituents of processed products of Terminalia chebula at different temperatures ,and to compare its anti-ulcerative colitis effect. METHODS Processed products of T. chebula at different temperatures(160,180,200,220,240,260,280,300 ℃)were prepared by sand scalding technology. HPLC method was adopted to determine the contents of gallic acid ,chebulagic acid ,chebulinic acid and ellagic acid in crude drug and processed products of T. chebula at different temperatures. The mice were divided into blank group ,model group ,Mesalazin enteric-coated tablets group (positive control ,0.4 g/kg),crude drug and processed products groups of T. chebula at different temperatures (1.3 g/kg),with 10 mice in each group. Except for blank group ,other groups were given 6% acetic acid 0.1 mL via anus to induce ulcerative colitis model. After modeling ,blank group and model group were given water intragastrically ,and other groups were given relevant drug intragastrically ,20 mL/kg,once a day ,for consecutive 7 days. The general physical signs of mice in each group were observed and the body weight was recorded. The colorectal length and index ,serum levels of related inflammation indexes [superoxide dismutase (SOD),malondialdehyde (MDA),interleukin-10 (IL-10),IL-1 β ,tumor necrosis factor α (TNF-α)] were detected. The pathomorphological changes of colon and rectum were observed ,and the comprehensive score of pharmacodynamics was performed. RESULTS With the increase of processing temperature ,the contents of chebulagic acid and chebulinic acid decreased gradually ,the content of gallic acid increased first and then decreased ,and the content of ellagic acid increased. Compared with model group ,the general physical signs ,body weight ,colorectal length ,colorectal index and related inflammation indexes were all improved significantly in crude drug and processed products groups of T. chebula at different temperatures(P<0.05 or P<0.01). The glandular recess structure of colorectal tissue was repaired ,the infiltration of inflammatory cells was reduced ,and the comprehensive score of efficacy of processed products prepared at 260 ℃ was the highest. CONCLUSIONS The contents of chemical components in T. chebula processed at different temperatures change significantly and their anti-ulcerative colitis effects are different. The processed products of T. chebula prepared at 260 ℃ show the best anti-ulcerative colitis effect.

4.
China Pharmacy ; (12): 287-292, 2022.
Article in Chinese | WPRIM | ID: wpr-913085

ABSTRACT

OBJECTIVE To establish the ultra-high performance liquid chromatography-mass spectrometry/mass spectrometry method for simultaneous determination of liquiritin , naringin, hesperidin, neohesperidin, nobiletin, atractylenolide Ⅲ , imperatorin,honokiol,isoimperatorin and magnolol in Huoxiang zhengqi soft capsules. METHODS Twelve batches of Huoxiang zhengqi soft capsules were extracted by ultrasonic extraction with ethanol. The determination was performed on Ultimate XB-C 18 column with mobile phase consisted of acetonitrile - 0.1% formic acid solution for gradient elution at the flow rate of 0.4 mL/min. The column temperature was 30 ℃. The electrospray ionization source was applied to carry out the positive and negative ion scanning with multiple react ion monitoring mode. RESULTS The linear range of liquiritin ,naringin,hesperidin,neohesperidin, nobiletin,atractylenolide Ⅲ ,imperatorin,honokiol,isoimperatorin and magnolol were 1.64-52.40,1.73-55.20,1.54-49.20, 1.71-54.80,1.74-55.60,4.19-134.00,1.51-48.40,1.61-51.60,1.80-57.60,1.74-55.60 ng/mL(r≥0.999 5),respectively. The limits of quantitation were 0.41,0.43,0.19,0.43,0.11,1.05,0.19,0.40,0.45,0.11 ng/mL,respectively. RSDs of precision ,stability (24 h)and repeatability tests were all lower than 6%. Average recoveries were 102.42%,98.65%,98.34%,101.48%,96.74%, 100.40%,104.92%,98.53%,99.50%,105.40%(RSD=1.34%-5.44%,n=9). The contents of the above 10 constituents in 12 batches of Huoxiang zhengqi soft capsules were 201.21-287.89,5.03-20.37,1 465.56-1 988.35,5.35-9.01,217.09-306.44,1.91- 16.17,1 081.59-1 377.12,2 388.34-2 915.13,341.26-397.45 and 7 633.47-8 976.99 μg/g,respectively. CONCLUSIONS The established method for content determination is convenient ,sensitive and accurate ,which can be used for the quality control and evaluation of Huoxiang zhengqi related preparations.

5.
Acta Pharmaceutica Sinica B ; (6): 2396-2415, 2021.
Article in English | WPRIM | ID: wpr-888867

ABSTRACT

The need for long-term treatments of chronic diseases has motivated the widespread development of long-acting parenteral formulations (LAPFs) with the aim of improving drug pharmacokinetics and therapeutic efficacy. LAPFs have been proven to extend the half-life of therapeutics, as well as to improve patient adherence; consequently, this enhances the outcome of therapy positively. Over past decades, considerable progress has been made in designing effective LAPFs in both preclinical and clinical settings. Here we review the latest advances of LAPFs in preclinical and clinical stages, focusing on the strategies and underlying mechanisms for achieving long acting. Existing strategies are classified into manipulation of

6.
Article in Chinese | WPRIM | ID: wpr-888363

ABSTRACT

OBJECTIVE@#To explore the genetic basis of four children with congenital hyperinsulinemia (CHI).@*METHODS@#The four children were subjected to high-throughput whole exome sequencing (WES). Candidate variants were validated by Sanger sequencing.@*RESULTS@#WES analysis has identified 4 variants in the ABCC8 gene and 1 variant in GLUD1, including a ABCC8 c.382G>A variant in case 1, compound heterozygous c.698T>C and c.4213G>A variants of the ABCC8 gene concomitant with a de novo 14.9 Mb microduplication of chromosome 15 in case 2, and ABCC8 c.331G>A variant in case 3, and de novo c.955T>C variant of the GLUD1 gene in case 4. Of these, c.698T>C of the ABCC8 gene and c.955T>C of the GLUD1 gene were unreported previously. Based on the American College of Medical Genetics and Genomics guidelines, the c.382G>A(p.Glu128Lys), c.698T>C(p.Met233Thr) and c.4213G>A(p.Asp1405Asn) variants of ABCC8 gene and c.955T>C(p.Tyr319His) variant of GLUD1 gene were predicted to be likely pathogenic(PM1+PM2+PP3+PP4, PM1+PM2+PM5+PP3+PP4, PM1+PM2+PP3+PP4 and PS1+PM1+PM2+PP3), and the c.331G>A (p.Gly111Arg) variant of ABCC8 gene was predicted to be uncertain significance(PM1+PM2+PP4).@*CONCLUSION@#The variants of the ABCC8 and GLUD1 genes probably underlay the pathogenesis of CHI in the four patients. Above results have facilitated clinical diagnosis and genetic counseling for the affected families.


Subject(s)
Child , Genomics , High-Throughput Nucleotide Sequencing , Humans , Hyperinsulinism , Mutation , Whole Exome Sequencing
7.
Chinese Journal of Endemiology ; (12): 936-939, 2021.
Article in Chinese | WPRIM | ID: wpr-909129

ABSTRACT

Objective:To observe and evaluate the effect of health education on drinking brick-tea type fluorosis in Zhiduo County, Qinghai Province, so as to provide basis for further formulating health education strategies.Methods:From April 2019 to April 2020, according to the historical prevalence of drinking brick-tea type fluorosis in Zhiduo County, Qinghai Province, 3 townships (towns) were selected to carry out the health education activities on drinking brick-tea type fluorosis for students of grade 4 - 6, village doctors, adults and monks in each township (town). We carried out a one-year publicity on the prevention and treatment of drinking brick-tea type fluorosis, distributed health education materials and organized health education activities. Before and after the intervention, we conducted a questionnaire survey on health education among the target population (grade 4 - 6 students, village doctors, adults and monks), to evaluate the awareness rate and behavior formation rate of fluorosis prevention and control, and to evaluate the intervention effect.Results:A total of 86 students of grade 4 - 6, 40 village doctors, 42 adults and 20 monks were investigated, after the intervention, the awareness rates of prevention and treatment of drinking brick-tea type fluorosis in grade 4 - 6 students, village doctors, adults and monks were 87.98% (227/258), 96.67% (116/120), 81.75% (103/126), 83.33% (50/60), respectively, which were significantly higher than those before the intervention [38.38% (76/198), 83.33% (100/120), 15.45% (19/123), 28.89% (13/45), P < 0.05]. After the intervention, the behavior formation rates of prevention and treatment of the drinking brick-tea type fluorosis in grade 4 - 6 students, village doctors, adults and monks were 74.42% (128/172), 72.50% (58/80), 52.38% (44/84), 60.00% (24/40), respectively, which were significantly higher than those before the intervention [14.39% (19/132), 38.75% (31/80), 3.66% (3/82), 0(0/28), P < 0.05]. Conclusion:The comprehensive intervention measures based on health education can significantly improve the knowledge of local residents, and improve their bad drinking habits of drinking tea, which is of great significance to the prevention and treatment of drinking brick-tea type fluorosis.

8.
Article in Chinese | WPRIM | ID: wpr-907533

ABSTRACT

Extensive stage small cell lung cancer (ES-SCLC) has a poor prognosis and short survival. Although platinum based combined with etoposide regimens and prophylactic craniocerebral irradiation have become the treatment regimens for ES-SCLC, it still faces the challenges of low local control rate and overall survival rate. As a local treatment, radiotherapy has a wide range of applications, which can not only be used for the radical treatment of local lesions, but also for the selective palliative treatment of advanced patients. Thoracic radiotherapy can improve the local control of ES-SCLC, among them, patients with residual intrathoracic lesions after chemotherapy benefit the most. There is still no unified standard for the appropriate population, optimal dose and segmentation of thoracic radiotherapy, and further research is needed.

9.
International Journal of Surgery ; (12): 655-659,F3, 2021.
Article in Chinese | WPRIM | ID: wpr-907499

ABSTRACT

Objective:To introduce the usefulness and advantages of needle-type choledochotomy in laparoscopic common bile duct exploration.Methods:A retrospective analysis for the data of 1 107 patients who successfully implemented laparoscopic common bile duct exploration in Subei People′s Hospital of Jiangsu Province from January 1, 2013 to December 31, 2020 were applied. All cases were divided into the study group 662 cases with needle-type choledochotomy) and the control group (445 cases with non-needle-type choledochotomy) according to the manipulation of common bile duct incision. The time-cost, incidences of bleeding and bile leakage, as well as the recurrence rate of bile duct stone and the incidence of bile duct stenosis were observed and compared between the two groups. Normally distributed data were expressed as mean±standard deviation ( Mean± SD) and compared by t test while count data were expressed as frequency or percentage and compared by chi-square test or Fisher′s exact test. Results:The bile duct incision time and bleeding rate were (14.45±2.46) s and 25.1% in the study group, (104.48±15.32) s and 68.1% in the control group, respectively. The differences between the two groups were statistically significant ( P<0.001). The incidence of stone recurrence, biliary leakage, and bile duct stricture were 3.0%, 3.6% and 0.3% in the study group, 4.9%, 5.6% and 0.4% in the control group, respectively. There were no statistically significant differences between the two groups ( P>0.05). Conclusion:Needle-type bile duct incision can be used as a routine manipulation in laparoscopic common bile duct exploration for its time-saving, less bleeding, safe and easy to handling.

10.
Article in Chinese | WPRIM | ID: wpr-905924

ABSTRACT

Objective:To observe and compare the protective effects of Tongqiao Huoxue decoction (TQHX) prepared by three methods against cerebral ischemia-reperfusion injury (CIRI), and to explore its mechanism through the glutamate (Glu) metabolic pathway in astrocytes. Method:The male SD rats of SPF grade were subjected to CIRI model induction by the modified middle cerebral artery occlusion method. The model rats were randomly divided into a model group, a sham operation group, and water-decocted, wine-decocted, and alcohol-extracted TQHX (6.3 g·kg<sup>-1</sup>·d<sup>-1</sup>) groups. The rats were treated correspondingly for 7 days. Those in the sham operation group and the model group were treated with an equal volume of normal saline by gavage. After the final treatment, the neurological function of rats was assessed by the modified neurological severity score (mNSS). Hematoxylin-eosin (HE) staining was used to observe the morphological changes of ischemic brain tissues in rats. High-performance liquid chromatography (HPLC) was used to detect glutamate (Glu) in ischemic brain tissues. The expression of glutamate transporter-1 (GLT-1) and glial fibrillary acidic protein (GFAP) and co-expression of glutamine synthetase (GS) and GFAP in ischemic brain tissues were detected by immunofluorescence assay. Western blot was used to detect the protein expression of GFAP, GLT-1, and GS. Result:Compared with the sham operation group, the model group showed increased mNSS (<italic>P</italic><0.01), large necrosis of cerebral cortex in ischemic brain tissues with disordered cell arrangement, obscure boundary, intracellular edema, and inflammatory infiltration, elevated Glu in ischemic brain tissues (<italic>P</italic><0.01), declining GLT-1-GFAP co-expression and GS-GFAP co-expression (<italic>P</italic><0.01), up-regulated expression of GFAP protein, and reduced protein expression of GLT-1 and GS(<italic>P<</italic>0.05,<italic>P<</italic>0.01). Compared with the model group, the TQHX groups showed decreased mNSS (<italic>P<</italic>0.01), relieved injury in the cerebral cortex and hippocampal nerve cells in ischemic brain tissues, reduced Glu expression(<italic>P<</italic>0.05,<italic>P<</italic>0.01), elevated co-expression of GLT-1 and GFAP (<italic>P<</italic>0.05,<italic>P<</italic>0.01), and up-regulated protein expression of GFAP and GLT-1(<italic>P<</italic>0.05,<italic>P<</italic>0.01). The co-expression of GS and GFAP (<italic>P<</italic>0.05,<italic>P<</italic>0.01)and the expression of GS (<italic>P<</italic>0.01)were increased in the wine-decocted and alcohol-extracted TQHX groups. Compared with the water-decocted TQHX group, the alcohol-extracted group showed increased GLT-1-GFAP and GS-GFAP co-expression(<italic>P<</italic>0.05); the wine-decocted and alcohol-extracted TQHX groups exhibited elevated GS protein expression (<italic>P<</italic>0.05); the alcohol-extracted TQHX group displayed declining Glu content (<italic>P</italic><0.01) and increased protein expression of GFAP and GLT-1 (<italic>P<</italic>0.05, <italic>P<</italic>0.01). Compared with the wine-decocted TQHX group, the alcohol-extracted TQHX group showed increased protein expression of GFAP and GLT-1(<italic>P<</italic>0.05,<italic>P<</italic>0.01). Conclusion:TQHX prepared by three methods can improve neurological deficits in CIRI rats. The effect is presumedly achieved by promoting the further activation of astrocytes, increasing the expression of GLT-1 and GS, promoting the clearance of Glu accumulated in the synaptic cleft by astrocytes through the Glu-glutamine (Gln) circulation, and reducing the excitotoxicity of Glu. The alcohol-extracted TQHX group was superior to the water-decocted and wine-decocted TQHX groups in reducing the content of Glu in ischemic brain tissues, promoting the activation of astrocytes, and enhancing the protein expression of GLT-1 and GS.

11.
Article in Chinese | WPRIM | ID: wpr-905234

ABSTRACT

Objective:To explore the effect of individualized occupational therapy on occupational performance of schizophrenic patients. Methods:From 2016 to 2018, 30 schizophrenic patients hospitalized over one year in Beijing Anding Hospital were randomly divided into control group (n = 15) and experimental group (n = 15). The control group was given routine group work activities, and the experimental group was given individualized occupational therapy, 30 minutes a time, once a day, five days a week for four weeks. The Comprehensive Occupational Therapy Evaluation Scale (COTE) was used to evaluate the occupational performance of schizophrenic patients before and after treatment。 Results:The difference value of COTE score was higher in the experimental group than in the control group (t = 3.842, P < 0.01), especially for interpersonal communication behavior and task behavior (t > 3.106, P < 0.01). Conclusion:Individualized occupational therapy could improve the occupational performance of patients with schizophrenia.

12.
Chinese Journal of Lung Cancer ; (12): 756-763, 2021.
Article in Chinese | WPRIM | ID: wpr-922143

ABSTRACT

BACKGROUND@#Segmentectomy has gradually become one of the standard surgical methods for small pulmonary nodules with early lung cancer on imaging. This study aimed to investigate the perioperative outcomes of patients who underwent uniport video-assisted thoracoscopic surgery (VATS) segmentectomy for identifying the intersegmental boundary line (IBL) by the near-infrared fluorescence imaging with intravenous indocyanine green (ICG) method or the modified inflation-deflation (MID) method and assess the feasibility and effectiveness of the ICG fluorescence (ICGF)-based method.@*METHODS@#We retrospectively analyzed the perioperative data in total 198 consecutive patients who underwent uniport VATS segmentectomy between February 2018 and August 2020. With the guidance of preoperative intelligent/interactive qualitative and quantitative analysis-three dimensional (IQQA-3D), the targeted segment structures could be precisely identified and dissected, and then the IBL was confirmed by ICGF-based method or MID method. Clinical effectiveness and postoperative complications of the two methods were evaluated.@*RESULTS@#An IBL was visible in 98% of patients by the ICGF-based group, even with the low-doses of ICG. The ICGF-based group was significantly associated with the shorter IBL clear presentation time [(23.59±4.47) s vs (1,026.80±318.34) s] (P0.05).@*CONCLUSIONS@#The ICGF-based method could highly accurately identify the IBL and make anatomical segmentectomy easier and faster, and therefore has the potential to be a feasible and effective technique to facilitate the quality of uniport VATS segmentectomy.


Subject(s)
Feasibility Studies , Humans , Indocyanine Green , Ion Transport , Lung Neoplasms/surgery , Pneumonectomy , Postoperative Complications , Retrospective Studies , Thoracic Surgery, Video-Assisted
13.
Article in English | WPRIM | ID: wpr-922106

ABSTRACT

OBJECTIVE@#To determine the effects of Chinese medicine (CM) involving triple rehabilitation therapy on the progression of knee osteoarthritis (KOA).@*METHODS@#A total of 722 patients recruited from 38 community health service centers located in China from March 2013 to March 2017 were randomly divided into treatment and control groups equally, using a cluster randomization design. Health education combined with CM involving triple rehabilitation therapy for KOA (electro-acupuncture, Chinese medicinal herb fumigating-washing, and traditional exercises) was administered in the treatment group while conventional rehabilitation therapy (physical factor therapy, joint movement training, and muscle strength training) was administered in the control group. Patients with a visual analog scale (VAS) scores ≽4 were treated with dispersible meloxicam tablets (7.5 mg, once daily). The Lequesne index scores, VAS scores, range of motion (ROM), lower limb muscle strength, knee joint circumference, quantitative scores of KOA symptoms, and the short-form 36 item health survey questionnaire (SF-36) scores were measured for each patient at 5 checkpoints (before treatment, at the 2nd week and the 4th week during the 4-week treatment period, at 1 month and 3 months after end of treatment), and adverse reactions were observed also.@*RESULTS@#A total of 696 patients completed the entire process, with 351 in the treatment group and 345 in the control group. At all treatment checkpoints, the treatment group demonstrated better outcomes than the control group with regard to the total Lequesne index scores, effective rate and improvement rate of the total Lequesne index scores, VAS scores, lower limb muscle strength, knee circumference, quantitative scores of KOA symptoms, and SF-36 scores as well (P<0.05 or P<0.01). No adverse reactions were encountered in this study.@*CONCLUSIONS@#CM involving triple rehabilitation therapy can alleviate KOA-related pain and swelling, improve lower limb muscle strength, promote flexion and activity of the knee and improve the quality of life in patients undergoing KOA. It is suitable for patients with early or mid-stage KOA. (Registration No. ChiCTR-TRC-12002538).


Subject(s)
Humans , Medicine, Chinese Traditional , Osteoarthritis, Knee/therapy , Outpatients , Quality of Life , Treatment Outcome
14.
Article in English | WPRIM | ID: wpr-921873

ABSTRACT

Objective This study aimed to assess the protective value of adiponectin (APN) in pancreatic islet injury induced by chronic intermittent hypoxia (CIH). Methods Sixty rats were randomly divided into three groups: normal control (NC) group, CIH group, and CIH with APN supplement (CIH+APN) group. After 5 weeks of CIH exposure, we conducted oral glucose tolerance tests (OGTT) and insulin released test (IRT), examined and compared the adenosine triphosphate (ATP) levels, mitochondrial membrane potential (MMP) levels, reactive oxygen species (ROS) levels, enzymes gene expression levels of


Subject(s)
Adiponectin/genetics , Animals , Hypoxia , Islets of Langerhans , Mitochondrial Dynamics , Rats , Rats, Wistar
15.
Article in Chinese | WPRIM | ID: wpr-921817

ABSTRACT

Tongsaimai Tablets/Capsules are composed of Lonicerae Japonicae Flos, Angelicae Sinensis Radix, Achyranthis Bidentatae Radix, Codonopsis Radix, Dendrobii Caulis, Astragali Radix, Scrophulariae Radix, and Glycyrrhizae Radix et Rhizoma, and are effective in promoting blood circulation, removing blood stasis, supplementing Qi, and nourishing Yin. It is widely used in the treatment of peripheral vascular diseases. With 40 years of clinical application, it has accumulated substantial research data and application experience. Its good clinical efficacy and pharmacoeconomic benefits in improving the clinical symptoms of peripheral vascular diseases have been confirmed by relevant research. Meanwhile, this drug has also been recommended by many expert consensus, guidelines, and teaching materials, serving as one of the most commonly used Chinese patent medicines in clinical practice. To further improve the understanding of the drug among clinicians and properly guide its clinical medication, the China Association of Chinese Medicine took the lead and organized experts to jointly formulate this expert consensus. Based on the questionnaire survey of clinicians and the systematic review of research literature on Tongsaimai Tablets/Capsules with clinical problems in the PICO framework, the consensus, combined with expert experience, concludes recommendations or consensus suggestions by GRADE system with the optimal evidence available through the nominal group technique. This consensus defines the indications, usage, dosage, course of treatment, medication time, combined medication, and precautions of Tongsaimai Tablets/Capsules in the treatment of peripheral vascular diseases, and explains the safety of its clinical application. It is recommended for clinicians and pharmacists in the peripheral vascular department(vascular surgery), traditional Chinese medicine surgery(general surgery), and endocrinology department of hospitals at all levels in China.


Subject(s)
Capsules , Consensus , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Peripheral Vascular Diseases , Tablets
16.
Article in Chinese | WPRIM | ID: wpr-921769

ABSTRACT

Clinical comprehensive evaluation was conducted in "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing~® Kudiezi Injection. The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs) have been carried out after the listing of Diemailing~® Kudiezi Injection. Since the total incidence of adverse reactions is 0.099% and the incidence of adverse drug reactions(ADR) is rare, the safety evaluation is grade A. The evidence value of effectiveness demonstrated that Diemailing~® Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction, which is superior to that in the conventional western medicine treatment group, and the level of evidence is high. Therefore, its efficacy is assessed as grade A. According to the results of economic research, when Diemailing~® Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment, the Diemailing~® Kudiezi Injection group has a greater incremental effect, but the cost is affordable. Given the overall quality evaluation results of economic report is clear, it is evaluated as grade B. The innovation is grade A. The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements. Since the drug exhibits good suitability for clinicians, nurses, pharmacists, and patients, it is evaluated as grade B. Considering its moderate price among similar drugs and good affordability and availability, it is evaluated as grade B. Diemailing~® Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction, and this medicine belongs to ethnic medicine. Large-sample active monitoring research has been conducted with rich experience in human use. Therefore, the characteristics of traditional Chinese medicine are evaluated as grade A. The comprehensive clinical evaluation of Diemailing~® Kudiezi Injection is class A. We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.


Subject(s)
Cerebral Infarction/drug therapy , Drugs, Chinese Herbal/therapeutic use , Humans , Injections , Medicine, Chinese Traditional
17.
Article in Chinese | WPRIM | ID: wpr-921768

ABSTRACT

This study systematically reviewed the existing research on Danhong Injection in the treatment of stroke with blood stasis syndrome. The methods of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, drug economics, mathematical statistics, and health technology assessment(HTA) were employed to qualitatively and quantitatively evaluate the "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) of Danhong Injection through questionnaire survey, public information, real world data, and secondary evaluation of literature. With the weights given by experts, the multi-criteria decision analysis(MCDA) model was employed to measure each dimension and highlight the clinical value of Danhong Injection. Multi-source safety evidence showed that Danhong Injection had been fully monitored and studied. The severity of adverse reactions was mostly moderate or mild, and the prognosis was good. So it was rated as grade A for safety. Compared with Ligustrazine Injection, Fufang Danshen Injection and conventional treatment of western medicine, Danhong Injection had obvious advantages in clinical response rate and NIHSS score improvement in the treatment of stroke with blood stasis syndrome. So it was rated as grade A for effectiveness. Compared with Ligustrazine Injection and Yinxing Damo Injection, Danhong Injection had a cost-effectiveness advantage in the treatment of stroke with blood stasis syndrome, and the economic results were good. According to the existing evidence, the Danhong Injection was rated as grade B for economy. Danhong Injection had won a number of national patents, which was rated as grade A for its good innovation in guaranteeing supply measures, scalability of production capacity, and production process. It had good suitability for clinicians, nurses, pharmacists, and patients using the drug, and met the needs of clinical medication, so it was rated as grade B for suitability. Danhong Injection is rich in medicinal materials, stable in price, and sustainable. However, its availability needed to be further improved due to the limitation of prescription use, so it was rated as grade B for accessibility. Danhong Injection can promote blood circulation, resolve blood stasis, warm vessels, and smooth collaterals. It had accumulated more than 30 000 pieces of empirical evidence for human use in the real world. It had prominent characteristics of traditional Chinese medicine and was rated as grade B. CSC v2.0 was used for calculation, and the clinical value of Danhong Injection was comprehensively evaluated as class A, which could be directly translated into relevant policy results of basic clinical medication management according to the Guidelines for the Management Clinical Comprehensive Evaluation of Drugs(trial version 2021).


Subject(s)
Drugs, Chinese Herbal , Humans , Injections , Medicine, Chinese Traditional , Stroke/drug therapy
18.
Article in Chinese | WPRIM | ID: wpr-921766

ABSTRACT

This study explored the clinical comprehensive evaluation of Mudan Granules, aiming to promote the safe, effective and rational use of Mudan Granules, reflect its clinical value and provide a basis for medical decision-making. The safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Mudan Granules were combed, and the multi-criteria decision analysis(MCDA) model was used to carry out comprehensive evaluation on each dimension. In terms of safety, multiple sources of evidence showed that the adverse reactions of Mudan Granules mainly involved gastrointestinal system, with controllable safety risk rated as grade B. In terms of effectiveness, Mudan Granules can significantly alleviate the diabetic peripheral neuropathy(Qi-deficiency and collateral stagnation syndrome), limb and trunk numbness, pain and sensory abnormalities and other clinical symptoms, exhibiting positive curative effect rated as grade A. In terms of economy, Mudan Granules combined with Mecobalamin and other conventional western medicines is economical compared with the western medicine alone group, which is supported by sufficient evidence and clear results, rated as grade B. In terms of innovation, Mudan Granules is the only Chinese patent medicine with the indication of benefiting Qi for activating blood circulation and dredging collaterals in the Medicine Catalogue for National Basic Medical Insurance, Industrial Injury Insurance, and Maternity Insurance. It has important clinical innovation and is evaluated as grade A. In the aspect of suitability, Mudan Granules has good suitability in ADR treatment, drug characteristics and usage, and is rated as grade B. In terms of accessibility, Mudan Granules has the price level comparable to that of similar drugs, with good affordability. The resources of medicinal materials for the preparation of Mudan Granules are abundant and available, which is rated grade B. Moreover, Mudan Granules, as a hospital preparation with both functions of tonification and purgation, reflects the combination between syndrome differentiation and disease differentiation as well as the combination between overall and local characteristics, and has prominent Chinese medicine features. According to the above dimensions, we suggest to classify Mudan Granules as a class A preparation which can be directly included the policy results of basic clinical drug administration.


Subject(s)
Diabetes Mellitus , Diabetic Neuropathies , Drugs, Chinese Herbal/therapeutic use , Female , Humans , Medicine, Chinese Traditional , Pregnancy , Qi , Syndrome
19.
Article in Chinese | WPRIM | ID: wpr-921765

ABSTRACT

This study evaluated the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Wenxin Granules in the treatment of arrhythmia(ventricular premature beat and atrial premature beat) with deficiency of Qi and Yin. The multi-criteria decision analysis(MCDA) model was adopted, and the criterion layer and index layer were weighted by experts. CSC v2.0 was used for clinical comprehensive evaluation. This study embodies the clinical value of Wenxin Granules, promotes its safe, effective and rational use, and provides a basis for national medical decision-making. The multi-source evidence shows that the major adverse reaction of Wenxin Granules is gastrointestinal damage. According to the available studies, Wenxin Granules has controllable risk and thus is rated as grade B in terms of safety. The systematic evaluation of effectiveness shows that compared with antiarrhythmic western medicine, Wenxin Granules demonstrates improved clinical efficacy and electrocardiogram efficacy, which is supported by high-quality evidence, and thus the effectiveness of Wenxin Granules is evaluated as grade A. Economic research shows that Wenxin Granules is more economical than antiarrhythmic western medicine, which is supported by sufficient evidence and clear results, and thus the economy of this preparation is rated as grade B. The indications and contraindications of Wenxin Granules are clear and detailed to different types of arrhythmia, which, together with the precise positioning and prominent clinical innovation and industrial innovation, rates it as grade A in terms of innovation. The suitability of drug storage, prescription circulation, dosage form and course of treatment basically meet the clinical medication needs of doctors and patients, and thus the suitability of Wenxin Granules is evaluated as grade B. Because of the few restrictions and the sustainable resources of medicinal materials, the accessibility of Wenxin Granules is evaluated as grade A. The prescription compatibility focuses on the pathogenesis characteristics of deficiency of Qi and Yin, and there are more than 3 000 cases studied. Therefore, the characteristics of traditional Chinese medicine of Wenxin Granules are evaluated as grade B. Based on the evidence from all the above dimensions, Wenxin Granules has the clinical comprehensive value of class A and prominent characteristics of traditional Chinese medicine. It is suggested to include Wenxin Granules into the policy results related to basic clinical medication management according to the procedure.


Subject(s)
Anti-Arrhythmia Agents , Humans , Medicine, Chinese Traditional , Qi , Treatment Outcome , Ventricular Premature Complexes , Yin Deficiency
20.
Article in Chinese | WPRIM | ID: wpr-921764

ABSTRACT

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.


Subject(s)
China , Drugs, Chinese Herbal , Information Storage and Retrieval , Medicine, Chinese Traditional , Nonprescription Drugs , Quality Control
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