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1.
Acta Pharmaceutica Sinica B ; (6): 3337-3363, 2021.
Article in English | WPRIM | ID: wpr-922739

ABSTRACT

COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread across the globe, posing an enormous threat to public health and safety. Traditional Chinese medicine (TCM), in combination with Western medicine (WM), has made important and lasting contributions in the battle against COVID-19. In this review, updated clinical effects and potential mechanisms of TCM, presented in newly recognized three distinct phases of the disease, are summarized and discussed. By integrating the available clinical and preclinical evidence, the efficacies and underlying mechanisms of TCM on COVID-19, including the highly recommended three Chinese patent medicines and three Chinese medicine formulas, are described in a panorama. We hope that this comprehensive review not only provides a reference for health care professionals and the public to recognize the significant contributions of TCM for COVID-19, but also serves as an evidence-based in-depth summary and analysis to facilitate understanding the true scientific value of TCM.

2.
Journal of Central South University(Medical Sciences) ; (12): 525-529, 2020.
Article in English | WPRIM | ID: wpr-827391

ABSTRACT

OBJECTIVES@#To explore the significance of coagulation and immune function indicators in clinical diagnosis and treatment of coronavirus disease 2019 (COVID-19).@*METHODS@#All patients with COVID-19 diagnosed and treated in First People's Hospital of Yueyang from January to March 2020 were enrolled. The general data of patients were collected. The patients were assigned into a light group (=20), an ordinary group (=33), a severe group (=23), and a critically severe group (=7) according to the severity of the disease. Coagulation and immune function indicators of each group were compared, and the relevance of coagulation and immune function indicators was analyzed.@*RESULTS@#The age of COVID-19 patients in Yueyang City was mainly between 45 and 65 years old. There was a significant difference in the coagulation function and immune-related indicators in each group of patients (all <0.05).@*CONCLUSIONS@#There are some abnormalities in coagulation and immune function in patients with COVID-19, which possess significance for clinical diagnosis and treatment of the disease.


Subject(s)
Aged , Humans , Middle Aged , Betacoronavirus , Blood Coagulation , China , Coronavirus Infections , Diagnosis , Allergy and Immunology , Immune System , Pandemics , Pneumonia, Viral , Diagnosis , Allergy and Immunology
3.
Chinese Critical Care Medicine ; (12): 897-899, 2020.
Article in Chinese | WPRIM | ID: wpr-866939

ABSTRACT

Traditional Chinese medicine (TCM) has a long history in treating infectious diseases, and the form of intervention varies with different medical conditions and disease types. "The battle field of Chinese doctor for anti-epidemic" was formed in fighting against severe acute respiratory syndrome (SARS) epidemics in China, and from the battle, valuable experiences of using TCM for prevention and treatment had been obtained. During responding to coronavirus disease 2019 (COVID-19) epidemics, we followed the principle of keeping summary and perfection while treament. And a whole process of TCM pattern or a model was organized, including early prevention in communities, cluster intervention in isolated places, comprehensive intervention in mobile cabin hospitals, centralized treatment in designated hospitals and rehabilitation support in rehabilitation posts. Thus, the innovation of whole process of TCM intervention was involved in the "trench warfare" strategy and platform system for prevention and treatment of new infectious COVID-19 epidemics. At different stages or conditions, different TCMs were used to play advantageous roles to solve various problems and elevate the effects of prevention and treatment of the disease. The construction of TCM mobile cabin hospitals was an innovation of organization form that might offset the constraints in technology and scale of simple community isolation or simple hospital treatment, exploring a new way for TCM to cope with public health emergencies.

4.
Clinical Medicine of China ; (12): 498-502, 2019.
Article in Chinese | WPRIM | ID: wpr-791187

ABSTRACT

Objective To analyze the correlation between the clinical characteristics and the incidence of postoperative hepatic encephalopathy in patients with cirrhosis who received transjugular intrahepatic portosystemic shunt ( TIPS) . Methods The clinical data of 80 patients with liver cirrhosis hospitalized in the Fifth Medical Center of PLA General Hospital from March 2015 to March 2017 were retrospectively analyzed. The related factors of hepatic encephalopathy complications after TIPS treatment were analyzed. Results The cumulative incidence of hepatic encephalopathy was about 23. 75%(19/80) in one year after TIPS operation. Through single factor analysis and multi factor Logistic regression analysis,it was found that the two factors of preoperative platelet level and the location of tips blood shunt were closely related to the occurrence of hepatic encephalopathy after TIPS operation. The ROC curve suggested that the AUC of preoperative platelet level and the location of tips blood shunt were 0. 657 and 0. 668, respectively. The sensitivity and specificity of the former were 70. 0%,52. 6% and the cutoff value was 51 ×109/L, respectively, while those of the latter were 70. 5% and 63. 2%, respectively. Conclusion Preoperative platelets level>51×109/L or shunting of the left branches of the portal vein may indicate a lower incidence of hepatic encephalopathy.

5.
Chinese Journal of School Health ; (12): 1828-1830, 2019.
Article in Chinese | WPRIM | ID: wpr-815625

ABSTRACT

Objective@#To understand the smoking of college students in Guizhou Province and to explore associated factors for better prevention and control of smoking behavior.@*Methods@#A multi-stage stratified random sampling method was used to describe the current smoking situation of college students. And 2 451 college students of different majors and grades from three cities with high, medium and low economic development levels were selected. Besides, we used multivariate logistic regression analysis to analyze the major factors affecting current smoking.@*Results@#Ever smoking rate of college students in Guizhou Province was 50.8%, the peak age of first smoking attempt was 8-13(35.2%); current smoking rate of college students in Guizhou Province was 20.8%. Logistic regression analysis showed that male, upper grade, monthly living expenses of not less than 1 000 yuan, single parents, family smoking and peer smoking were the main risk factors affecting college students’ smoking(OR=5.52,1.44,1.48,1.69,1.47,1.88,P<0.05).@*Conclusion@#College students in Guizhou Province have a higher rate of smoking attempt and low rate of current smoking, as well as low tobacco dependence which is determined by multiple factors. Tobacco hazard education, mental health education and living environment intervention for college students may help reduce the probabitity for tobacco use.

6.
Chinese Journal of Epidemiology ; (12): 1222-1227, 2018.
Article in Chinese | WPRIM | ID: wpr-738127

ABSTRACT

Objective To investigate the prevalence of diphenoxylate abuse and related factors of forced drug abstainer in Gansu province.Methods By using a self-designed questionnaire,an epidemiologic investigation was carried out among 2 108 forced drug abstainer selected from the compulsory isolation detoxification center of Gansu province.A case-control study was conducted to analyze the factors related with diphenoxylate abuse.Results The diphenoxylate abuse rate among forced drug abstainer in Gansu was 19.8% (406/2 046),ranking first in medical drug abuse.Multiple logistic regression analysis showed that factors as relieving withdrawal symptoms (OR=2.08,95%CI:1.01-4.32),ways to obtain diphenoxylate (other ways:OR=1.00;regular clinic:OR=27.67,95%CI:2.64-289.82;friend:OR=0.01,95%CI:0.01-0.03),degree of euphoria (high:OR=1.00;medium:OR=3.36,95%CI:1.18-9.55;low:OR=26.16,95%CI:10.30-66.42),years of drug abuse (<5 years:OR=-1.00;10-15 years:OR=2.48,95%CI:1.02-6.04),abuse at home or in friend's house (OR=3.04,95%CI:1.08-8.68),abuse in car (OR=0.05,95%CI:0.00-0.68) and detoxification for the first time (OR=0.61,95% CI:0.43-0.86) were the possible influencing factors for diphenoxylate abuse.Conclusions The prevalence of diphenoxylate abuse in forced drug abstainer in Gansu was relatively high.Reasons of abusing,the way to obtain diphenoxylate,whether using drug together with friends,degree of euphoria,years of abuse,abuse place and times for detoxification were related factors influencing the abuse of diphenoxylate.

7.
Chinese Journal of Oncology ; (12): 52-56, 2018.
Article in Chinese | WPRIM | ID: wpr-809803

ABSTRACT

Objective@#To verify the safety and efficacy of IONTRIS particle therapy system (IONTRIS) in clinical implementation.@*Methods@#Between 6.2014 and 8.2014, a total of 35 patients were enrolled into this trial: 31 males and 4 females with a median age of 69 yrs (range 39-80). Ten patients had locally recurrent head and neck tumors after surgery, 4 cases with thoracic malignancies, 1 case with hepatocellular carcinoma, 1 case with retroperitoneal sarcoma, and 19 cases with non-metastatic prostate carcinomas. Phantom dose verification was mandatory for each field before the start of radiation.@*Results@#Twenty-two patients received carbon ion and 13 had proton irradiation. With a median follow-up time of 1 year, all patients were alive. Among the 16 patients with head and neck, thoracic, and abdominal/pelvic tumors, 2, 1, 12, and 1 cases developed complete response, partial response, stable disease, or disease progression, respectively. Progression-free survival rate was 93.8% (15/16). Among the 19 patients with prostate cancer, biological-recurrence free survival was 100%. Particle therapy was well tolerated in all 35 patients. Twenty-five patients (71.4%) experienced 33 grade 1 acute adverse effects, which subsided at 1 year follow-up. Six (17.1%) patients developed grade 1 late adverse effects. No significant change in ECOG or body weight was observed.@*Conclusions@#IONTRIS is safe and effective for clinical use. However, long term follow-up is needed to observe the late toxicity and long term result.

8.
Chinese Journal of Dermatology ; (12): 189-193, 2018.
Article in Chinese | WPRIM | ID: wpr-710356

ABSTRACT

Objective To evaluate the effect of Notch 1 signaling pathway on the differentiation and function of Th17 cells in peripheral blood of patients with psoriasis.Methods Peripheral blood samples were obtained from 35 patients with psoriasis and 32 healthy controls.Flow cytometry was performed to determine the proportion of Th17 cells in CD4+ T cells in peripheral blood mononuclear cells (PBMCs),real-time RT-PCR to measure the mRNA expression of retinoic acid receptor-related orphan receptor γt (RORγt),interleukin (IL)-17,Notch 1 and hairy-and-enhancer-of-split-1 (Hes-1),and enzymelinked immunosorbent assay (ELISA) to detect levels of IL-17 in the serum and culture supernatant of PBMCs stimulated with phorbol ester,calcium ionophore and brefeldin A.The correlation of Notch 1 mRNA expression with psoriasis area and severity index (PASI) was analyzed,so were its correlation with the proportion of Th17 cells,mRNA expression of RORγt,and mRNA and protein expression of IL-17.PBMCs isolated from the patients with psoriasis were divided into 5 groups to be treated with γ-secretase inhibitor N-[N-(3,5-difluorophenacetyl)-1-alanyl]-S-phenylglycine t-butyl ester (DAPT) at different concentrations of 0(control group),2.5,5.0,10.0 and 20.0μmol/L,respectively,so as to evaluate the effects of blocking the Notch1 signaling pathway by DAPT on the proportion of Th17 cells in PBMCs,levels of RORγt and IL-17.Results Compared with the healthy controls,patients with psoriasis showed a significant increase in the proportion of Th17 cells in CD4+ T cells in PBMCs (2.863% ± 0.969% vs.0.604% ± 0.124%,P < 0.01),mRNA expression of RORγt (5.255 ± 0.998 vs.1.530-± 0.485,P < 0.01),Notch1 (6.743 ± 1.756 vs.1.731 ± 0.456,P < 0.01),Hes-1 (6.384 ± 1.665 vs.1.627 ± 0.485,P < 0.01) and IL-17 (6.944 ± 1.626 vs.1.698 ± 0.329,P < 0.01),and serum level of IL-17 ([36.444 ± 5.936] ng/L vs.[11.762 ± 2.260] ng/L,P < 0.01).Among the patients with psoriasis,the mRNA expression of Notch1 was positively correlated with PASI scores,proportion of Th17 cells,mRNA expression of RORγt and IL-17,and serum level of IL-17 (r =0.584,0.544,0.518,0.549 and 0.511,respectively,all P < 0.05).There were significant differences in the proportion of Th17 cells,mRNA expression of RORγt and IL-17,and level of IL-17 in the culture supematant among the control group,2.5-,5.0-,10.0-and 20.0-μmol/L DAPT groups (F =79.527,82.239,78.086 and 80.558,respectively,all P < 0.01).The above indices were significantly lower in the 2.5-,5.0-,10.0-and 20.0-μmol/L DAPT groups than in the control group (all P < 0.05),and decreased along with the increase of DAPT concentrations.Conclusion Notch1 signaling pathway can promote the differentiation of Th17 cells and the expression of RORγt,IL-17 and Hes-1 in the peripheral blood of patients with psoriasis.

9.
Chinese Journal of Epidemiology ; (12): 1222-1227, 2018.
Article in Chinese | WPRIM | ID: wpr-736659

ABSTRACT

Objective To investigate the prevalence of diphenoxylate abuse and related factors of forced drug abstainer in Gansu province.Methods By using a self-designed questionnaire,an epidemiologic investigation was carried out among 2 108 forced drug abstainer selected from the compulsory isolation detoxification center of Gansu province.A case-control study was conducted to analyze the factors related with diphenoxylate abuse.Results The diphenoxylate abuse rate among forced drug abstainer in Gansu was 19.8% (406/2 046),ranking first in medical drug abuse.Multiple logistic regression analysis showed that factors as relieving withdrawal symptoms (OR=2.08,95%CI:1.01-4.32),ways to obtain diphenoxylate (other ways:OR=1.00;regular clinic:OR=27.67,95%CI:2.64-289.82;friend:OR=0.01,95%CI:0.01-0.03),degree of euphoria (high:OR=1.00;medium:OR=3.36,95%CI:1.18-9.55;low:OR=26.16,95%CI:10.30-66.42),years of drug abuse (<5 years:OR=-1.00;10-15 years:OR=2.48,95%CI:1.02-6.04),abuse at home or in friend's house (OR=3.04,95%CI:1.08-8.68),abuse in car (OR=0.05,95%CI:0.00-0.68) and detoxification for the first time (OR=0.61,95% CI:0.43-0.86) were the possible influencing factors for diphenoxylate abuse.Conclusions The prevalence of diphenoxylate abuse in forced drug abstainer in Gansu was relatively high.Reasons of abusing,the way to obtain diphenoxylate,whether using drug together with friends,degree of euphoria,years of abuse,abuse place and times for detoxification were related factors influencing the abuse of diphenoxylate.

10.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 161-165, 2017.
Article in Chinese | WPRIM | ID: wpr-513161

ABSTRACT

The safety of TCM injection triggered attentions and hotspots in recent years in China.The centralized monitoring of TCM injection provided important evidence for analyzing the safety risk of TCM injections,recognizing adverse reactions and contraindications and perfecting the instructions.This study aimed at exploring the ethical problems on centralized monitoring.In this paper,we retrieved and screened the ethical issues of TCM injections over hospital centralized monitoring in China National Knowledge Infrastructure (CNKI,1979-Ju1.,2016).Issues over it were put forward and addressed.It is found that the current ethical issues related to hospital centralized monitoring lacks sufficient attentions,corresponding norms and requirements.Based on the ethical issues reflected from the literatures,suggestions should be pressed ahead with the ethical review of centralized surveillance,signing of informed consents,registration of research programs,data statistics and reporting stages,for the better protection of the rights and interests of subjects and improvement of research quality.

11.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 166-170, 2017.
Article in Chinese | WPRIM | ID: wpr-513160

ABSTRACT

Safety hospital centralized monitoring is one of the important methods for evaluating the medication safety of TCM injections in clinic.It is critical to warrant research quality by reasonable statistical analysis.However,universally accepted standards and guidelines for the statistical analysis of hospital centralized monitoring of TCM injections have not been issued so far,which would probably reduce the research quality of safety hospital centralized monitoring of TCM injections since the unreasonable use of statistical analysis methods.Combined with previous practical experience and understanding,we put forward the problems of statistical analysis of hospital centralized monitoring of TCM injections with the provision of some advice in this paper based on the analysis of the preceding studies,laying a foundation for the same kind of researches.

12.
China Oncology ; (12): 128-134, 2017.
Article in Chinese | WPRIM | ID: wpr-509440

ABSTRACT

Background and purpose:Radiomics is an emerging field that generates large amounts of valuable clinical information through extracting quantitative imaging features. The purpose of this study was to use the radiomics approach to assess the value of features captured from PET and CT in predicting the therapeutic effect in stageⅠ non-small cell lung cancer (NSCLC) after stereotactic ablative radiotherapy (SABR).Methods:Patients with stageⅠ NSCLC conifrmed by pathology and treated with SABR were included retrospectively. The gross tumor volume (GTV) was deifned by two radiologists. PET and CT scan images were collected, and radiomic features were further extracted and analyzed. Non-negative matrix factorization was used to distinguish patients with or without local control.Results:Sixteen patients were eligible for analysis. This study identiifed two PET features (LL_GLCM_Maximal_Correlation_Coeffcient and HL_GLRMS_LRE) captured from PET/CT as having signiifcance in classifying patients with or without disease development. This study not ifnd similar results in CT scans.Conclusion:It seems feasible to use radiomics information effects from PET/CT to predict therapeutic effects of SABR in stageⅠ NSCLC. Further investigation is needed.

13.
Biomedical Engineering Letters ; (4): 245-251, 2017.
Article in English | WPRIM | ID: wpr-645178

ABSTRACT

Surgical planning for scoliosis relies on the classification of the spinal curve pattern. To improve the reliability of the Peking Union Medical College (PUMC) classification system for scoliotic spinal curves, a computer-aided system is proposed and its reliability is evaluated. First, the reliability of curve measurements was improved by the computer-aided Cobb measurement approach. Second, judgmental errors were reduced by the computer program through the automation of the PUMC classification procedure. Four observers divided into an expert group and a resident group participated in the experiments. The kappa statistic was used to evaluate the variability. Classifications of 65 scoliotic cases by the four observers showed that with the computer's aid, the average intraobserver and interobserver kappa values were improved from 0.86 to 0.93 and from 0.75 to 0.86, respectively. The results indicate that the proposed computerized system can assist a surgeon in the PUMC classification of scoliosis and is especially useful for inexperienced surgeons.


Subject(s)
Automation , Beijing , Classification , Judgment , Scoliosis , Surgeons
14.
China Oncology ; (12): 926-931, 2016.
Article in Chinese | WPRIM | ID: wpr-508379

ABSTRACT

Background and purpose:Concurrent radiochemotherapy is the standard modality for locally advanced esophageal squamous cell carcinoma (ESCC) patients. This clinical trial aimed to assess the effectiveness and toxicity of continuous infusion of 5-lfuorouracil (5-FU) and weekly paclitaxel combined with radiotherapy in ESCC patients. Methods:Patients with locally advanced (T2-4N0-1M0-1a) esophageal squamous cell carcinoma were enrolled in a prospective, single-institutional, single-arm study of deifnitive chemoradiotherapy. Patients received 61.2 Gy with IMRT in 34 fractions. Patients had a Karnofsky performance status of 70 or greater, and normal liver, renal, and bone marrow functions. Patients were recommended to receive concurrent 5-FU (300 mg/m2 civ 96 h) for 5 days a week for 5 weeks, plus paclitaxel (50 mg/m2) given during 3 hours every week for 5 weeks. Patients were recommended to receive 2 courses of consolidation chemotherapy after concurrent radio (chemo) therapy (5-FU 1 800 mg/m2 civ 72 h, plus paclitaxel 175 mg/m2 every 28 days). The primary endpoints of the study were 5 year overall survival and acute toxicity. Results:Fifty patients were enrolled in this study, including 38 male patients and 12 female patients;median age:58 years (ranged 26 to 75 years). 72%patients completed all the chemotherapy and 98%patients received the full dose of radiotherapy. 1-, 2-, 3-, and 5-year survival were 75%, 56%, 42%and 28%respectively. Among haematological toxicities, grade 3 leukopenia (16%) was recorded, and no patients experienced any≥grade 2 thrombocytopenia or anaemia. Among non-haematological toxicities, the rates of grade 2 peripheral neurotoxicity, arthralgias and myalgias, nausea, vomiting, and fatigue were 8%, 4%, 4%, 2%and 6%respectively. The rates of≥grade 2 acute radiation-induced esophageal toxicity, radiation pneumonitis and skin toxicity were 32%, 44% and 14% respectively. No treatment-related deaths occurred and no patients experienced any ≥ grade 4 toxicities. Conclusion: Continuous infusion of 5-FU plus paclitaxel given concurrently with radiotherapy may be an effective and tolerable treatment option for ESCC patients.

15.
Chinese Journal of Rehabilitation Theory and Practice ; (12): 1485-1488, 2016.
Article in Chinese | WPRIM | ID: wpr-506775

ABSTRACT

Objective To apply Skin Care Record List of Operation Patients in skin rehabilitation after surgery. Methods From January to June, 2015, 2438 patients of scheduled operation were chosen as control. Conventional skin care was performed in the control group. Op-eration nurses checked and recorded skin pressure sores and skin integrity together with operation surgeons, who told these to ward nurses. From July to December, 2015, 2358 patients of scheduled operation were chosen as intervention group. The intervention group were also ap-plied self-designed Skin Care Record List of Operation Patients, which included patients' basic information, operative skin pressure area, the recorded location and size of pressure of fade of postoperative patients skin, and postoperative follow-up of operation nurses. Perioperative skin safety was managed by both operation nurse and ward nurse. Results There were 23 patients with pressure sores in the control group and 6 in the intervention group within 6 days after operation (χ2=9.471, P=0.002). Conclusion The application of Skin Care Record List of Operation Patients could effectively reduce the rate of operating pressure sores.

16.
Tianjin Medical Journal ; (12): 1048-1052, 2016.
Article in Chinese | WPRIM | ID: wpr-496367

ABSTRACT

Objective To assess the clinical effectiveness and safety of relinqing pharmaceutical preparations for the treatment of uncomplicated urinary tract infection(UTI). Methods The genitourinary infection, urinary tract infection, pyelonephritis, cystitis, stranguria and urethritis were used as key words to search at CNKI,VIP,SinoMed,PubMed,Wan Fang and Cochrane Library Databases up to April 2015. Data of randomised controlled trials (RCTs) comparing treatments using relinqing were included in this study. The quality of the literature was evaluated by the method of Cochrane handbook 5.1.0. Data extraction was carried out independently by two authors. RevMan 5.2 software was used for Meta-analysis. Results Five RCTs were included that involved a total of 471 uncomplicated UTIs. Analysis of four studies showed a higher rates of effectiveness for uncomplicated UTI in the treatment with relinqing plus antibiotics than those of antibiotics alone [RR and 95%CI:1.15 (1.08-1.23), P<0.001]. Analysis of two studies showed a higher rates of bacterial clearance for uncomplicated UTI in the treatment with relinqing plus antibiotics than those of antibiotics alone [RR and 95% CI: 4.04 (1.78-9.16)]. Conclusion Data from five small studies suggest that relinqing as an independent intervention or in conjunction with antibiotics may be beneficial for treating uncomplicated UTIs. However, the small number and poor quality of the included studies meant that it is not possible to formulate robust conclusion on the use of relinqing for uncomplicated UTI either alone or as an adjunct to antibiotics.

17.
Chinese Journal of Practical Nursing ; (36): 1502-1504, 2016.
Article in Chinese | WPRIM | ID: wpr-495831

ABSTRACT

Objective To explore the effects ofDoctor-nurse Integratingmode on the operation room nursing quality improvement. Methods From July 2014 to Dec. 2014,11 423 operations in our hospital were chosen as control group,while 10 897 operations from Jan. 2015 to June 2015 as intervention group.An administrating group of Doctor-nurse Integrating mode was formed, with both doctors and nurses acting as quality controllers. A144 Regular Meetings System was also formed. The author retrospected and analyzed 11 423 negative accidents which occurred during operation. Management details and responsibilities were specified, and training was enhanced. All these were monitored, controlled, implemented and improved by operation doctors, anaesthesia doctors and operation room nurses. Results The rate of negative accidents dropped from 1.226%(140/11 423) to 0.340%(37/10 897) since the implementation of Doctor-nurse Integrating mode of operation quality control. Conclusions Doctor-nurse Integrating mode of operation quality control has positive effects on the improvement of operation nursing quality.

18.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 2088-2092, 2016.
Article in Chinese | WPRIM | ID: wpr-670453

ABSTRACT

At present,the various levels of safety evaluations of traditional Chinese medical (TCM) injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.

19.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 2101-2104, 2016.
Article in Chinese | WPRIM | ID: wpr-670452

ABSTRACT

The implementation process management plays a important role for the quality of centralized safety monitoring study of post-marketing Chinese medical injections.One of the critical link is hospital.Currently,there is no principle or specification for hospital choosing,number of monitoring points,data collection responsible part and forms of data collection as well.These issues caused uneven quality,huge differences in results and questioned conclusion.Based on the previous research experience,this paper focused on discussing the link of hospital where research data may be influenced,and proposed some suggestions.

20.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 2093-2096, 2016.
Article in Chinese | WPRIM | ID: wpr-670423

ABSTRACT

Safety is a critical link restricting the development of TCM injections.Hospital centralized monitoring is of importance in the safety evaluation of TCM injections.However,the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality.Our research team have completed several projects over centralized monitoring in recent years.Based on the previous research experience,this paper mainly discussed the current statuation,the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections,in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.

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