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.

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

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.

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.

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.

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.

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.

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.

Locally advanced rectal cancer:an MRI radiomics study on lymph node re-evaluation after neoadjuvant chemoradiotherapy / 中华放射学杂志

Objective To develop and validate one optimal MR radiomics model for lymph node (LN) re-evaluation of locally advanced rectal cancer (LARC) after neoadjuvant chemoradiotheray (NCRT). Methods Four hundred and seven patients with clinicopathologically confirmed LARC in Beijing Cancer Hospital were included in this study from July 2010 to June 2015. All patients received NCRT before surgery,and underwent T2WI and DWI before and after NCRT.These patients were chronologically divided in the primary cohort(300 patients)and independent validation cohort(107 patients).The predicting model was trained and validated using postoperative pathological findings as truth values. By using radiomics method, we extracted the features of the tumor and the largest LN before and after neoadjuvant therapy, combined different features of the tumor and/or the largest LN before and/or after neoadjuvant therapy,and constructed 4 different prediction models,compared the performance of four predicting models.The optimal model with the highest accuracy was validated in the independent cohort. Decision curve analysis was conducted to determine the clinical usefulness of the radiomics nomograms by quantifying the net benefits at different threshold probabilities in the validation dataset. Results In the primary cohort, the radiomics signatures from 4 models provided an AUC of 0.637, 0.709, 0.753, 0.835, respectively in LN re-evaluation after chemoradiotheray. The diagnostic efficacy of model 4 was much better than that of 1, 2 and 3 model. In the validation cohort, the radiomics signatures provided an AUC of 0.795 for LN re-evaluation after chemoradiotheray. The sensitivity, specificity, positive predictive value, negative predictive value were 0.813, 0.693, 0.531, 0.897, respectively (95% CI: 0.694 to 0.896, 0.647 to 0.911, 0.582 to 0.786, 0.361 to 0.621, 0.792 to 0.952). While the probability of predicting N+ ranges from 17% to 80%, using the proposed radiomics model to predict N+ shows a greater advantage than either the scheme in which all patients were assumed to N+ or the scheme in which all patients are N-. Decision curve analysis demonstrated that the radiomics nomograms were clinically useful. Conclusion With a systematic analysis and comparison of both pre-and post-NCRT MRI data, we constructed an optimal individualized LN re-evaluation model based on MR radiomics, combing primary tumor and the largest LN features, compared with other models (only with pre/post tumor or pre/post largest LN features).

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.

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-market Re-evaluation on Safety of Yuxingcao (Houttuyniae Herba) Preparations / 医药导报

Objective To retrospectively analyze adverse drug reaction ( ADR ) of Yuxingcao ( Houttuyniae Herba ) preparations, thus provide reference for post-market re-evaluation of traditional Chinese medicine injections. Methods The ADR from Chinese ADR spontaneous reporting system database from 2006 to 2008 were analyzed by descriptive statistic method. Results A total of 2 282 reports on ADR induced by Yuxingcao preparations were concluded in this study, and 98.07% ADR of the total cases ( 2 238 case ) were due to vein injection. The main ADR were anaphylactic reactions which injure multiple systems and organs.The most frequent symptoms were respiratory system damage, such as expiratory dyspnea (with the incidence rate of 27.25%).Skin and mucous membrane were the secondly susceptible (with the incidence rate of 21.35%).The ratio of serious ADR in the total case was 13.50% (308 case), rate of allergic shock was 8.37% (191 case), and 22 cases were dead. Conclusion By strengthening the ADR reporting and monitoring, the risk of traditional Chinese medicine injection could be controlled.Safety re-evaluation should be performed to overall enhance safety, effectiveness and quality control of these kinds of medicine.

Review and reflection on re-evaluation system of Chinese patent medicine / 中草药

There has been more than 60000 approval numbers of Chinese patent medicines (CPM), among which a large portion were approved by provincial agencies before the Ministry of Health promulgated and implemented them in 1985. One drug was produced by many companies and the available drugs' quality varied among different producers. Drugs with low quality and low price have been flooded into the medicinal market, which has resulted the drugs in high quality are closed outside the market. The benign competition in CPM market has been influenced. Many measures to improve the quality of the marketed drugs have been taken by State Food and Drug Administration, including checking the approval numbers, re-registration, and quality improving actions, so as to strengthen the listed medicine value promotion, effectively promote the CPM listed in the market after the re-evaluation system construction and perfect. But there are still the disconnect between improving the quality standard and enhancing the clinical value of the quality and efficiency; The market is still filled with a large number of low quality and low cost of proprietary CPM, the re-evaluation work of CPM and other issues need to be improved. Nonetheless, to put forward the suggestion on that the approval numbers should be held by payment, the comprehensive evaluation system on drug safety, effectiveness, quality, and the economic value should be improved, the evaluation by the third party should be intervened, and the re-evaluation of CPM and GAP adminstration of genuine medicinal materials should be effectively linked up. We expect the improvement of industrial level of CPM and the cultivation with a large variety of CPM through the re-evaluation and re-study.

Systematic review of the effect of coenzyme Q10 on antioxidant capacity while focused on evaluation of claims for health functional food / 한국영양학회지

Although the functional ingredient has been evaluated by the Korea Food and Drug Administration (KFDA) based on scientific evidence, the levels of scientific evidence and consistency of the results might vary according to emerging data. Therefore, periodic re-evaluation may be needed for some functional ingredients. In this study, we re-evaluated scientific evidence for the antioxidant activity of coenzyme Q10 as a functional ingredient in health functional food. Literature searches were conducted using the Medline and Cochrane, KISS, and IBIDS databases for the years 1955-2010 with the search term of coenzyme Q10 in combination with antioxidant. The search was limited to human studies published in Korean, English, and Japanese. Using the KFDA's evidence based evaluation system for scientific evaluation of health claims, 33 human studies were identified and reviewed in order to evaluate the strength of the evidence supporting a relation between coenzyme Q10 and antioxidant activity. Among 33 studies, significant effects for antioxidant activities were reported in 22 studies and their daily intake amount was 60 to 300 mg. Based on this systematic review, we concluded that there was possible evidence to support a relation between coenzyme Q10 intake and antioxidant activities. However, because inconsistent results have recently been reported, future studies should be monitored.

Systematic review of the effect of omega-3 fatty acids on improvement of blood flow while focused on evaluation of claims for health functional food / 한국영양학회지

Omega-3 polyunsaturated fatty acids are essential fatty acids because humans cannot synthesize them de novo and must obtain them in their diet. Fish and fish oil are rich sources of omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Significant evidence of the beneficial role of dietary intake of omega-3 fatty acids in blood flow has been reported and putative mechanisms for improvement of blood flow include anti-thrombotic effects, lowered blood pressure, improved endothelial function, and anti-atherogenic effects. Edible oils containing omega-3 fatty acids were registered as functional ingredients in the Korea Health Functional Food Code. Although omega-3 fatty acids have been evaluated by the Korea Food and Drug Administration (KFDA) based on scientific evidence, periodic re-evaluation may be needed because emerging data related to omega-3 fatty acids have accumulated. Therefore, in this study, we re-evaluated scientific evidence for the effect of omega-3 fatty acids as a functional ingredient in health functional food on improvement of blood flow. A comprehensive literature search was conducted for collection of relevant human studies using the Medline and Cochrane, KISS, and IBIDS databases for the years 1955-2012. Search keywords were used by combination of terms related to omega-3 fatty acids and blood flow. The search was limited to human studies published in Korean, English, and Japanese. Using the KFDA's evidence based evaluation system for scientific evaluation of health claims, 112 human studies were identified and reviewed in order to evaluate the strength of the evidence supporting a relation between omega-3 fatty acids and blood flow. Among 112 studies, significant effects on improvement of blood flow were reported in 84 studies and the daily intake amount was ranged from 0.1 to 15 g. According to this methodology of systematic review, we concluded that there was possible evidence to support a relation between omega-3 fatty acid intake and blood flow. However, because inconsistent results have recently been reported, future studies should be monitored.

Implementation of Quality by Design in the Program of Safety Re-evaluation of TCM Injections / 世界科学技术-中医药现代化

It has been widely accepted in modern pharmaceutical industry that quality cannot be tested into products , instead quality should be built-in by design . However , the implementation of Quality by Design ( QbD ) in development , manufacture and supervision of traditional Chinese medicine ( TCM ) still remains to be a challenge . The program of safety re-evaluation of TCM injections provides an opportunity to practice QbD approach in TCM industry . This paper discussed some potential ways that improve the quality of TCM injec-tions base on QbD related tools , including identification of critical quality attributes , critical process parameters and critical material attributes, development of design space and control strategy.

Post-market re-evaluation on safety of Danhong injection / 国际中医中药杂志

Objective To study the safety of Danhong injection in application for providing reference to clinical drug usage.Methods 942 patients using Danhong injection from June 2010 to October 2011 in our hospital were chosen and asked to fill in the monitoring sheet of Danhong injection post-market re-evaluation.The data in these sheets were analyzed.Results Among the 942 selected cases,454 were male and 488 were female.The youngest patient was 15 years and the oldest was 102 years.The average age of the patients was 64.5 years.799 cases of patients were over the age of 50,accounting for 84.82％.20 cases had a history of allergy.815 cases took the injection for 7 to 14 days.150 cases used 5％ GS as solvent,while 792 cases used 0.9％ NS as solvent.4 cases of adverse drug reaction were discovered in 942 cases,and the incidence rate was 0.42％.Conclusion The incidence rate of adverse drug reaction is low.The incidence of adverse reaction has no relationship with diseases,age and gender of patients,solvent and dose.Adverse reaction of Danhong injection is mainly related to the patient's individual differences.