Re-evaluation of systematic reviews of acupuncture and moxibustion for childhood autism / 中国针灸

OBJECTIVE@#To re-evaluate the systematic review/Meta-analysis of acupuncture and moxibustion for childhood autism (CA), aiming to provide decision-making basis for clinical diagnosis and treatment.@*METHODS@#The systematic review and/or Meta-analysis of acupuncture and moxibustion for CA were searched in PubMed, EMbase, Cochrane Library, SinoMed, CNKI and Wanfang databases. The retrieval time was from the database establishment to May 5th, 2022. PRISMA (preferred reporting items for systematic reviews and Meta-analyses) was used to evaluate the report quality, and AMSTAR 2 (a measurement tool to assess systematic reviews 2) was used to evaluate the methodological quality, bubble map was used to construct the evidence map and GRADE was used to evaluate the quality of evidence.@*RESULTS@#A total of 9 systematic reviews were included. The PRISMA scores ranged from 13 to 26. The report quality was low, and there was a serious lack in the aspects of program and registration, search, other analysis and funding. The main problems in methodology included not making prespecified protocol, incomplete retrieval strategy, not providing a list of excluded literatures, and incomplete explanation on heterogeneity analysis and bias risk. The evidence map showed that 6 conclusions were valid, 2 conclusions were possible valid and 1 conclusion was uncertain valid. The overall quality of evidence was low, and the main factors leading to the downgrade were limitations, followed by inconsistency, imprecision and publication bias.@*CONCLUSION@#Acupuncture and moxibustion has a certain effect for CA, but the quality of reporting, methodology and evidence in included literature need to be improved. It is suggested to perform high-quality and standardized research in the future to provide evidence-based basis.

Overview of systematic review on TCM for functional dyspepsia / 国际中医中药杂志

Objective:To re-evaluate the reliability of the conclusions of the systematic reviews (SR)/meta-analysis (MA) of Traditional Chinese Medicine (TCM) in the treatment of functional dyspepsia (FD).Methods:CNKI, CBM, WanFang Data, VIP, PubMed, Cochrane Library, and Embase were searched from the establishment of the database to March 30, 2022. Two researchers independently screened literature and extracted data, and included SRs/MAs in the treatment of FD with TCM. The AMSTAR 2 and GRADE tools were used to evaluate the included the study carried out methodological quality evaluation, outcome evidence quality grading, and descriptive analysis of the main outcome.Results:A total of 28 SRs/MAs were included, with 34 outcome indicators. According to the AMSTAR 2 evaluation results, 21 SRs/MAs were of medium quality, and 7 SRs/MAs were of low quality. The GRADE quality of evidence grading results showed that of the 100 evidence bodies, 13 were of high quality, 58 were of moderate quality, 24 were of low quality, and 5 were of very low quality.Conclusion:TCM in the treatment of FD can improve the clinical efficiency, improve the cure rate, reduce the recurrence rate, and improve the clinical symptoms, but the methodological quality and evidence quality of related SRs/MAs have certain defects, so this conclusion should be treated with caution.

Re-evaluation of systematic reviews of acupuncture and moxibustion for children with cerebral palsy / 中国针灸

OBJECTIVE@#To assess the methodological quality, report quality and evidence quality of the Meta-analysis and systematic reviews of acupuncture and moxibustion for children with cerebral palsy, aiming to provide decision-making basis for clinical treatment.@*METHODS@#The systematic reviews and Meta-analysis of acupuncture and moxibustion for children with cerebral palsy were searched in CNKI, Wanfang, VIP, SinoMed, Cochrane Library, PubMed and EMbase. The retrieval time was from the database establishment to June 30th, 2022. AMSTAR 2 (a measurement tool to assess systematic reviews) was used to evaluate the methodological quality， and PRISMA (preferred reporting items for systematic reviews and Meta-analyses) was used to evaluate the report quality, and GRADE was used to evaluate the quality of evidence.@*RESULTS@#A total of 14 systematic reviews were included, including 37 primary outcome indexes. According to AMSTAR 2 evaluation results, there were 4 low quality studies, 10 very low quality studies, and low scores on items 2, 4, 7, 10 and 16. PRISMA scores ranged from 15 to 25, and the main reporting problems reflected in structured abstracts, program and registration, retrieval, and funding sources, etc. According to the GRADE classification results, there were 3 high quality evidences, 7 medium quality evidences, 10 low quality evidences and 17 very low quality evidences. The main downgrading factors were limitations, imprecision and publication bias.@*CONCLUSION@#Acupuncture and moxibustion has a certain effect for cerebral palsy in children, but the quality of methodology, reporting and evidence in the included literature is poor, and the comparison of curative effect between different acupuncture and moxibustion methods is unclear.

Categorización y revisión de reevaluaciones en tomografía computada en una unidad de telerradiología de urgencia / Categorization and review of reevaluations in computed tomography in an emergency teleradiology unit

INTRODUCCIÓN La telerradiología se basa en el despliegue de radiólogos a distancia para evaluar estudios de dicha especialidad. Actualmente hay evidencia limitada sobre las tasas de error de evaluaciones en telerradiología. Este estudio corresponde a una revisión de las discrepancias entre los informes preliminares y finales de tomografía computada (TC) de una unidad de urgencia telerradiológica. OBJETIVO Determinar las discrepancias de las reevaluaciones (addendum) en los informes radiológicos de TC en una unidad de telerradiología de urgencia. MATERIALES Y MÉTODOS La recolección de datos se planificó a modo de tabla de cotejo, en la cual se tabularon casos de reevaluaciones de urgencia desde el mes de enero hasta mayo del año 2021, en base a la categorización Agrawal. RESULTADOS De una total de 111.599, 836 informes presentaron addendum, que corresponden al 0,74% del total informado, La categoría Agrawal 0 agrupó la mayor cantidad de casos y los exámenes de TC especialidad de cuerpo se encuentran los segmentos con mayores requerimientos de reevaluación. Discusión: Los valores obtenidos permiten establecer una baja incidencia de reevaluaciones y de la gravedad de estas, apuntando a errores asociados a canales de comunicación, redacción y elaboración de informes con especial énfasis en estudios TC Tórax y Abdomen/Pelvis. CONCLUSIÓN El porcentaje de cumplimiento de un 99,26% de exactitud en los informes permite concluir la alta confiabilidad y la calidad del servicio de telerradiología de la empresa en cuestión durante el periodo evaluado y el empleo de medidas correctivas basadas en organización, gestión e instrumentalización tecnológica

Clinical efficacy and modeling evaluation of He-wei-zhi-xie capsules in treating diarrhea patients / 中国临床药理学与治疗学

AIM: To evaluate the clinical efficacy and safety of He-wei-zhi-xie (HWZX) capsules in diarrhea patients. METHODS: The clinical study was conducted in 35 clinical trials centers from October 2015 to December 2017 by multicenter, prospective, open and uncontrolled design methods. The primary efficacy endpoint is the effective rate of diarrhea, the secondary endpoints include recovery rate of diarrhea, recovery time of diarrhea, number of irregular stools and Leeds dyspepsia questionnaire. The pharmacodynamics model of time course was established by nonlinear mixed effect model, and the effect of covariates on pharmacodynamic parameters was investigated. The safety measures were the incidence of adverse events, adverse reactions and the laboratory test indicators. RESULTS: A total of 2 285 cases were included in full analysis set. The effective rate of diarrhea was 90.8%, and the diarrhea recovery rate was 77.3%. The median time of recovery was 3 days, and the Leeds score was reduced by 3.6 points. It is found that baseline has a significant effect on model parameter E

Reevaluation of systematic evaluation of gemcitabine combined with cisplatin in the treatment of advanced non- small cell lung cancer / 中国药房

OBJECTIVE To reevaluate the system atic evaluation of g emcitabine combined with cisplatin in the treatment of advanced non-small cell lung cancer （NSCLC），in order to provide evidence-based evidence for the treatment of NSCLC. METHODS Retrieved from Wanfang database ，CNKI，VIP，PubMed，Embase，systematic evaluation of gemcitabine combined with cisplatin versus pemetrexed/vinorelbine combined with cisplatin in the treatment of advanced NSCLC was included from the inception to Dec. 2021. RevMan 5.3 system evaluation software was used for meta-analysis of various outcome indicators ； AMSTAR2 scale was used for methodological quality evaluation ，and GRADE tool was used for evidence quality evaluation. RESULTS A total of 9 literatures were included. Meta-analysis showed that the effective rate of gemcitabine combined with cisplatin was significantly lower than pemetrexed combined with cisplatin ，but was similar to vinorelbine combined with cisplatin. The 1-year survival rate of gemcitabine combined with cisplatin was equivalent to that of pemetrexed combined with cisplatin ，but was superior to vinorelbine combined with cisplatin. There was no significant difference in the incidence of nausea and vomiting between gemcitabine combined with cisplatin and pemetrexed/vinorelbine combined with cisplatin. Gemcitabine combined with cisplatin had a higher incidence of thrombocytopenia than pemetrexed/vinorelbine combined with cisplatin. The incidence of neutropenia and leukopenia in gemcitabine combined with cisplatin were higher than pemetrexed combined with cisplatin ，but were significantly lower than vinorelbine combined with cisplatin. The evaluation results of AMSTAR 2 scale showed that 6 systematic evaluation were of low quality in methodology and 3 were of very low quality. The results of the GRADE tool showed that 31％ of the outcome indicators were of medium quality （14 items），27％ were of low quality （12 items），and 42％ were of very low quality（19 items）. Research limitations and publication bias were the most frequently downgraded factors. CONCLUSIONS Gemcitabine combined with cisplatin has advantages over 154854280@qq.com vinorelbine combined with cisplatin in the efficacy and safety of ad vanced NSCLC ，especially in the 1-year survival rate ，the incidence of neutropenia and leucopenia. The efficacy and safety of gemcitabine combined with cisplatin are inferior to those of pemetrexed combined with cisplatin. However ，the methodological quality and evidence level of systematic evaluation are not high on the whole ，and the overall quality of research needs to be improved.

Efficacy and Safety of Selegiline for Parkinson ’s Disease ：A Reevaluation of Systematic Reviews / 中国药房

OBJECTIVE：To conduct reevaluation of systematic review/Meta-ana lysis on the efficacy and safety of selegiline in the treatment of Parkinson ’s disease （PD）. METHODS ：Retrieved from PubMed ，Embase，Cochrane L ibrary，CNKI，Wanfang database as well as official websites of domestic and foreign health technology assessment institutions ，based on manual retrieval and review of references ，systematic review/Meta-analysis on selegiline alone or combined with other anti-PD drugs （trial group ） versus placebo or blank control or other anti-PD drugs （control group ）were collected. The time limit was from database inception to November 2020. After literature screening and data extraction ，PRISMA statement was adopted to evaluate the quality of the included reports. AMSTAR 2 scale was used to evaluate the methodological quality ，and GRADE method was adopted to evaluate the evidence quality ，the outcome indicators of the included studies were summarised and analyzed. RESULTS ：A total of 12 systematic reviews/Meta-analysis were included ，involving 4 systematic reviews and 8 Meta-analysis；there were 31 outcome indexes in total. PRISMA scores of them ranged from 16.5 to 27.0，including 15.0 to 21.0 for 2 literatures（16.67％）and 22.0 to 27.0 for 10 literatures（83.33％）. Results of AMSTAR 2 scale showed that the methodological qualities of 2 literatures were classed as high quality ，3 as low quality and 7 as very low quality. Results of GRADE evidence quality evaluation showed that 1 evidence quality was high-level ，3 were medium-level ，5 were low-level ，21 were very low-level ，and 1 was no evaluable . The main factors leading to the degradation were bias risk （87.10％），publication bias （77.42％），inaccuracy （51.61％）and incon sistency（41.94％）. In terms of therapeutic efficacy ，compared with control group ，selegiline could improve the total score of UPDRS ，UPDRS Ⅰ score，UPDRS Ⅱ score，UPDRS Ⅲ score and Webster score in patients with Parkinson ’s disease，either monotherapy or in combination with other anti-PD drugs （P＜0.05）. In terms of safety ，there was no significant difference in the incidence of adverse events or mortality between 2 groups（P＞0.05），but the rate of withdrawal due to adverse events was higher（P＜0.05）. CONCLUSIONS ：Selegiline is effective and safe in the treatment of Parkinson ’s disease ，but current methodological quality and evidence quality of included systematic reviews /Meta-analysis are low，which requires further standardization of research methods.

Efficacy and Safety of Eplerenone in the Treatment of Essential Hypertension ：Reevaluation of Systematic Review/Meta-analysis / 中国药房

OBJECTIVE：To reeval uate the systematic review/Meta-analy sis of efficacy and safety of eplerenone in the treatment of essential hypertension. METHODS ：Retrieved from PubMed ，Embase，Cochrane Library ，Web of Science ，Wanfang database，CNKI，VIP，systematic review/Meta-analysis about eplerenone in the treatment of essential hypertension were collected from the inception to June 24th，2021. After literature screening and data extraction ，the quality of included literatures were evaluated with PRISMA statement ；methodology quality of included literatures were evaluated with AMSTAR 2 scale；GRADE method was adopted to evaluate the evidence quality of outcome measures. Efficacy and safety index evaluation of included literatures were summeried. RESULTS ：A total of 8 systematic reviews/Meta-analyses were included ，involving 5 systematic reviews and 3 Meta-analysis，including 73 outcome indicators. PRISMA scores ranged from 7.5 to 23.5，including 6 literatures （75.0％）with≤15 points，1（12.5％）with ＞15-＜21 points and 1（12.5％）with ≥21 points. The results of AMSTAR 2 evaluation indicated that the methodological quality of 2 studies was low ，and that of 6 studies was very low . GRADE quality evaluation results showed that there were 3 high quality indicators ，24 medium quality indicators and 46 low or very low quality indicators；the factors contributed to downgrading evidence quality were limitation ，inconsistency，imprecision and publication bias. In terms of efficacy ，compared with placebo ，eplerenone could significantly reduce clinical blood pressure （CBP）and 24-hour ambulatory blood pressure （ABP）. Its effect in reducing CBP was significantly better than other antihypertensive drugs or equivalent to other antihypertensive drugs. The effects of eplerenone on reducing clinical systolic blood pressure was not as good as spironolactone and enalapril ，or bett er than calcium channel blocker ，enalapril and angiotensin receptor antag onist，or equivalent to calcium channel blocker and enalapril ；the effect of eplerenone on reducing clinical diastolic blood pressure was not as good com as spironolactone ，calcium c hannel blocker and enalapril ，or as good as enalapril ，but better than angiotensin receptor antagonist. In terms of safety ，there was no significant difference in the incidence of ADR ，serious ADR or hyperkalemia caused by eplerenone ，compared with placebo ，or the incidence of ADR was higher than that of placebo. There was no statistical significance in the incidence of ADR or serious ADR ，compared with other antihypertensive drugs. CONCLUSIONS ：Efficacy and safety of eplerenone in the treatment of essential hypertension was good ，but in view of the poor methodological quality of systematic reviews or Meta-analysis and the low or very low level of outcome indicator evidence ，the authenticity and effectiveness of the conclusion will be reduced ，so that those indcaters should be interpreted carefully.

Research progress on adverse reactions and pseudo-allergic reactions of traditional Chinese medicine injections / 中国中药杂志

Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.

Study on Methodology Re-evaluation for Systematic Review/Meta-analysis of Antidepressants in the Treatment of Post-stroke Depression / 中国药房

OBJECTIVE： To re-evaluate t he methodology quality of published systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression. METHODS ：Retrieved from Cochrane Library ，PubMed，Embase， SinoMed，CNKI，Wanfang database ，VIP，CBM and other databases ，systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression were collected during the inception to Dec. 2019. After literature screening and data extraction ， methodology quality of included literatures were evaluated by using the AMSTAR scale. RESULTS ：A total of 33 systematic reviews/Meta-analysis were included ，involving 523 RCTs and 41 020 patients. Average score of AMSTAR methodological quality evaluation was 6.76. Citalopram ，duloxetine and paroxetine were effective for the therapy of post-stroke depression ，but the conclusions about the effectiveness among antide-pressants were not consistents. The ADR incidence of Paroxetine was low. It was not clear that sertraline and citalopram may improve the neurological function of patients. CONCLUSIONS ：The methodological quality of systematic review/Meta-analysis of antidepressants in the treatment of post-stroke depression is medium ，and the conclusions about the effectiveness of antidepressants ，improvement of daily life ability and the recovery of neurological function are still controversial.

Re-evaluation of Shuanghuanglian series preparations based on pharmacodynamics action value / 中草药

Objective: To re-evaluate the pharmacodynamics of Shuanghuanglian Oral Liquid, Shuanghuanglian Tablet, and Shuanghuanglian Granules with the index of pharmacodynamics action value. Methods: The pharmacodynamics action values of Shuanghuanglian Oral Liquid, Shuanghuanglian Tablet, and Shuanghuanglian Granules were determined and calculated. And the classical models of anti-inflammatory, antipyretic and antibacterial in vitro were used to verify the effect of these three preparations. Results: The pharmacodynamics action values of anti-inflammatory effect of Shuanghuanglian Oral Liquid, Shuanghuanglian Tablet, and Shuanghuanglian Granules were 2.80, 3.57, and 2.66 mg, respectively; The pharmacodynamics action values of antipyretic effect were 9.59, 14.86, and 13.42 mg respectively; The pharmacodynamics action values of antibacterial effect were 996.72, 2 011.64, and 1 691.98 mg respectively, which indicated that Shuanghuanglian Tablet had the strongest anti-inflammatory, antipyretic, and antibacterial effect, and the results of pharmacodynamics in vivo and in vitro studies also showed that Shuanghuanglian Tablet had better anti-inflammatory, antipyretic, and antibacterial effects than the other two preparations. Conclusion: In this study, the pharmacodynamic test verification results of these three preparations were consistent with the predicted results of pharmacodynamics action value. Therefore, the pharmacodynamics action value can be used as an index to re-evaluate the effect of Shuanghuanglian series preparations.

Reevaluation of the significance of fetal movement monitoring / 中国实用妇科与产科杂志

Fetal movement counting is one of the common methods for fetal prenatal monitoring. The changes of the normal pattern of fetal movements(FM)indicate abnormal fetal status in uterus.Studies have found that reduced fetal movement is the primary sign of fetal distress,which is associated with adverse pregnancy outcomes such as stillbirth,placental insufficiency,and fetal growth restriction.Increased fetal movement after 32 week's gestation is regular,but a single episode of vigorous FM increases risk of stillbirth.Clinically,fetal safety is preliminarily evaluated by counting numbers of FM to find abnormalities of fetus early and decrease adverse pregnancy outcomes,which is economical,convenient,and simple.However,this method is subjective,due to the different sensitiveness of pregnant women.

Study on the Legal System of Drug Reevaluation in America，European Union ，Japan and the Enlightenment to China / 中国药房

OBJECTIVE： To provide reference for the establishment and improvement of drug reevaluation system in China. METHODS： The design and relevant laws of drug reevaluation system in America， European Union and Japan were reviewed and summarized. The shortcomings of drug evaluation in China were analyzed and suggestions for improvement were put forward. RESULTS & CONCLUSIONS： America， European Union and Japan have formulated relevant laws and systems for post-marketing reappraisal of drugs， as well as specific implementation norms and technical support plans. The legal system of drug reevaluation in America can be divided into ADR monitoring and reporting system， post-marketing drug research system and active drug safety risk monitoring system. The European Union mainly has a monitoring and evaluation system for conventionally marketed drugs， drugs licensed under exceptional circumstances or conditions， and a re-registration system for drugs. Japan’s legal system of reevaluation mainly consists of reexamination system， reevaluation system and other systems. However， there are still some shortcomings in the drug reevaluation in our country， such as weak system， weak legislation， inadequate operability and deterrence， ineffective links between the implementation and application of drug evaluation results， and ineffective allocation of resources. It is suggested that we should integrate the existing reevaluation system to improve the legal system of drug reevaluation in China，starting from the systematic construction of the legal system of drug reevaluation， the construction and standardization of the legislative level， the connection of the legal system of drug reevaluation and the allocation of resources.

Study on the Implementation of American Post-marketing Re-evaluation of Drugs Legal System and Its Enlightenment to China / 中国药房

OBJECTIVE： To provide reference for the establishment and improvement of the post-marketing re-evaluation of drugs （shorted for re-evaluation） legal system in China. METHODS： Through sorting out American re-evaluation system， this paper focused on the current situation and procedures of the implementation of American re-evaluation system and put forward the suggestions for improving drug re-evaluation system in China. RESULTS & CONCLUSIONS： American re-evaluation system takes enterprises as the main body of execution and the government as the main body of supervision. It has the characteristics of highly informatized and transparent process. The work includes the report of ADR implementation of monitoring systems， the periodic reporting system and the post-listing clinical trials and research systems. The implementation process is to find clues， FDA preliminary review and notification， enterprise further self-examination and review， corporate actions and accept FDA supervision. It is suggested that when establishing the legal system of re-evaluation system in China， the main role of patients should be highlighted， and risk communication should be guided by the public. For example， the Medwatch voluntary reporting system of FDA can be imitated. The unified data collection， storage system and scientific data processing methods can be established. Continuously strengthen the main responsibility consciousness of pharmaceutical enterprises in testing and reporting， and constantly reduce the risk of drug use of patients.

Anti-TNF-α Monoclonal Antibody for Ulcerative Colitis：Methodology/Reporting Quality Reevaluation of Meta-analysis/ Systematic Evaluation / 中国药房

OBJECTIVE： To conduct methodology/reporting quality reevaluation for Meta-analysis/systematic evaluation of anti-TNF-α monoclonal antibody in the treatment of ulcerative colitis. METHODS： Retrieved from the Cochrane library， PubMed， Embase， CBM， Wanfang database and CNKI during data base establishment to Nov. 2018， Meta-analysis/systematic evaluations of anti-TNF-αmonoclonal antibody in the treatment of ulcerative colitis were collected. After data extraction of literatures that meet the inclusion criteria， methodological quality and reporting quality of included studies were evaluated by using AMSTAR scale and the PRISMA statement. RESULTS： Fourteen literatures of Meta-analysis/systematic evaluation were included. The average score of AMSTAR methodology quality （full score of 11 points） was 6.89， with medium methodological quality. PRISMA score （full score of 27 points） ranged from 15 to 26.5. CONCLUSIONS： Meta-analysis/systematic evaluations of anti-TNF-α monoclonal antibody for ulcerative colitis have poor methodological and reporting quality.

Safety evaluation of Xianling Gubao Capsule based on real-world study / 中草药

Objective To explore the characteristics of Xianling Gubao Capsule (XGC) induced adverse reactions, especially drug-induced liver injury, and the occurrence and prognosis of ADR, aiming to provide a reference for clinical rational drug use, and ideas for after-marketing re-evaluation of Chinese materia medica. Methods A total of 788 patients were enrolled in one tertiary hospital to observe the clinical application safety of XGC based on real-word study. Results Compared with the conventional treatment group, the incidence of ADR in the treatment group showed no significant difference (P > 0.05) in XGC group. XGC group had the highest incidence of adverse gastrointestinal reactions (83.0%), and a higher incidence of abdominal distension (P 0.05). Pre-drug liver abnormalities or patients with underlying liver disease were more likely to have drug induced liver injury (30.4%). Conclusion Monitoring adverse reactions of XGC should be enhanced in order to promote the rational use and ensure the safety in clinic.

Technical specification for re-evaluation of post-marketing clinical effectiveness of traditional Chinese medicine (first draft) / 中国中药杂志

The post-marketing re-evaluation of traditional Chinese medicine (TCM) is a crucial stage for drug evaluation. Due to the particularity of TCM, it is necessary to re-evaluate the effectiveness of certain Chinese medicines by studying and collecting the studies on safety of long-term/extensive populations under actual clinical application, in order to verify the effectiveness of post-marketing TCM. However, there is an absence in technical specifications for relevant clinical trials on re-evaluation of effectiveness at present. As a consequence, the preliminary technical specifications were drafted in this article, focusing on several perspectives related to the re-evaluation of post-marketing clinical effectiveness of TCM, including ethical protection, research plan formulation, real-world research methods, randomized controlled trial methods, research methods of clinical pharmacological mechanism, sublimation method of TCM theory and so on. The objective of writing this article is to provide general methodological guidance for the re-evaluation of TCM post-marketing effectiveness, so that the process and results of post-marketing re-evaluation of TCM can be more scientific and reasonable.

Re-evaluation for quality standard of Compound Lumbrical Capsule based on enzyme activity / 中草药

Objective: The quality standard of Compound Lumbrical Capsule (CLC) was re-evaluated using blood and anti-coagulation intensity as indexes. Methods: Fibrin plate method was used to determine the strength of promoting blood circulation and anti-coagulation for CLC by selecting urokinase and thrombin as reference substances. Results: The results of urokinase concentration and transparent circle area showed a good linear relationship in 200-1 000 U/mL, r = 0.999; The results of thrombin concentration and precipitation circle area showed a good linear relationship in 8-40 U/mL, r = 0.997. The blood anti-coagulant activity of compound earthworm capsule of temporary regulations were not less than 12 840 U/g and 113 822 U/g. Conclusion: The method is rapid, simple, and accurate for determining the activity of promoting blood circulation and anticoagulation for compound lumbrical capsule, thus it can be used for the quality control of CLC.

Post-marketing study on clinical safety of ginkgo diterpene lactone meglumine injection in 6 300 patients with ischemic stroke / 中国中药杂志

To further evaluate the safety of ginkgo diterpene lactone meglumine injection in the clinical use in ischemic stroke patients. Clinical safety study was conducted in 82 clinical units and 6 300 cases were completed and included from June 2013 to December 2014 by using multicenter, prospective, open and uncontrolled design methods for clinical research. A total of 29 cases of adverse reactions were observed in the experiment. Adverse reaction ratio (ADR) was 0.46%, and about 86.21% (25 cases) of them was mild with transient response which could be alleviated or disappeared without intervention; about 13.79% (4 cases) was moderate, including 2 cases of headache, 1 case of dizziness and 1 case of rash; no serious adverse reactions were found. The adverse reactions occurred in this study were pre-known adverse reactions or common adverse reactions of Chinese medicine injection. The overall incidence of adverse reactions was low, and the risk was controllable.

Discussion about re-evaluation of compound preparation of Chinese-Western medicine on post-marketing drug / 药物评价研究

In this paper,the management process of Chinese-Western medicine compound preparation is briefly reviewed.the existing problems were analyzed from the perspective of registration supervision and quality control.It is pointed out that there are still some types of management in the registration of supervision,such as the weak basic research,approval number of multiple pecifications,not uniform name,and not standardized specification.In the area of quality control,correlation analysis between the lack of key items (such as related substances,uniformity of contents,and dissolution test items) and the hidden dangers in medical security of preparations was performed.To explore the need for reevaluation,and put forward some suggestions for improvement in order to provide a useful reference for the scientific supervision of Chinese-Western medicine compound preparation.