1.Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version).
Wei-An YUAN ; Jun-Hua ZHANG ; Jian-Ping LIU ; Zhong-Qi YANG ; Jun-Ling CAO ; Xing LIAO ; Xiao-Yu XI ; Mei HAN ; Wen-Yuan LI ; Zhen-Wen QIU ; Shi-Yin FENG ; Yuan-Yuan GUO ; Lu-Jia CAO ; Xiao-Hong LIAO ; Yan-Ling AI ; Ju HUANG ; Lu-Lu JIA ; Xiang-Fei SU ; Xue WU ; Ze-Qi DAI ; Ji-Hua GUO ; Bing-Qing LU ; Xiao-Xiao ZHANG ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2023;48(1):256-264
Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional
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Nonprescription Drugs
;
Consensus
;
China
;
Reference Standards
;
Drugs, Chinese Herbal
2.Evaluation of Dominant Diseases of Traditional Chinese Medicine: A Case Study of Ischemic Stroke
Wen-ran QIU ; Zhen-min XU ; Wei SHEN ; Guo-jing FU ; Liu-ding WANG ; Shao-jiao LIU ; Hong-xi LIU ; Yue LIU ; Ye-fei WANG ; Ling-ling DAI ; Chun-yan GUO ; Wei-wei JIAO ; Xing LIAO ; Yu LIU ; Xiao LIANG ; Yun-ling ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(12):225-232
The present study explored the effective approaches to realize the leading role of traditional Chinese medicine (TCM) in preventing diseases, the synergistic role in treating serious diseases, the core role in the rehabilitation of diseases and summarized the experience to provide feasible plans for the evaluation of other dominant diseases of TCM. To evaluate the effectiveness, safety, and economy of TCM in the treatment of ischemic stroke, encephalopathy project team of the China Center for Evidence-based Traditional Chinese Medicine(CCEBTCM) established an evaluation group to determine the work plan and complete the evaluation work. The concepts of the evaluation involved high-quality evidence, expert opinion survey, expert interview, and drug catalog. Under the guidance of clinical experts and methodologists, the evaluation work was completed in accordance with four steps, i.e., plan making, data collection and data extraction, evidence synthesis and evaluation, and report writing with the rapid review method. Through the review of TCM and western medicine experts, the advantage of TCM in the treatment of ischemic stroke was positioned in the convalescence period with the predominant effects of improving the neurological function defect and improving the daily living ability. In the convalescence period of stroke, TCM treatment could improve post-stroke motor dysfunction, post-stroke cognitive impairment, consciousness disorder, swallowing disorder, aphasia, constipation, urinary function, diplopia, etc., and the advantages of acupuncture, Chinese medicine, and traditional exercise were more prominent. In terms of safety, TCM treatment of ischemic stroke showed lower incidence of adverse reactions, fewer adverse events, and a milder degree of related symptoms. In terms of economic performance, the combined treatment of TCM and western medicine played a synergistic role and made the treatment cost more reasonable. Compared with conventional intervention, the integrated TCM and western medicine rehabilitation program showed more economic and social benefits.
3.Factors associated with death and attrition in HIV-infected children under initial antiretroviral therapy in Guangxi Zhuang Autonomous Region, 2004 - 2019.
Ye Sheng ZHOU ; Liu Hong LUO ; Mei LIN ; Hong Li CHEN ; Jing Hua HUANG ; Qiu Ying ZHU ; Huan Huan CHEN ; Zhi Yong SHEN ; Jian Jun LI ; Yi FENG ; Dan LI ; Ling Jie LIAO ; Hui XING ; Yi Ming SHAO ; Yu Hua RUAN ; Guanghua LAN
Chinese Journal of Epidemiology 2022;43(9):1430-1435
Objective: To investigate death and attrition in HIV-infected children under initial antiretroviral therapy (ART) and associated factors in Guangxi Zhuang autonomous region. Methods: This retrospective cohort study was conducted in HIV-infected children under initial ART in Guangxi from 2004 to 2019, data from ART information system of National comprehensive AIDS prevention and treatment information system. Cox proportional hazards models were used to assess factors associated with the death and attrition. Results: In 943 HIV-infected children, the overall mortality and attrition rates were 1.00/100 person-years and 0.77/100 person-years, respectively. The mortality and attrition rates within the first year of ART were 3.90/100 person-years and 1.67/100 person-years, respectively. The cumulative survival rate during the first, second, fifth and tenth year after ART was 96.14%, 95.80%, 93.68% and 91.54%, respectively. Multivariate Cox proportional hazards models results showed that being female (aHR=2.00, 95%CI: 1.17-3.40), CD4+T lymphocytes (CD4) counts before ART <200 cells/μl (aHR=2.79, 95%CI: 1.54-5.06), weight-for-age Z score before ART <-2 (aHR=2.38, 95%CI: 1.32-4.26), hemoglobin before ART <80 g/L (aHR=2.47, 95%CI: 1.24-4.92), initial ART with LPV/r (aHR=5.05, 95%CI: 1.15-22.12) were significantly associated with death; being female (aHR=2.23, 95%CI: 1.22-4.07) and initial ART with LPV/r (aHR=2.02, 95%CI: 1.07-3.79) were significantly associated with attrition. Conclusions: The effect of ART in HIV-infected children in Guangxi was better, but the mortality and attrition rates were high within the first year of treatment. It is necessary to strengthen the training in medical staff and health education in HIV-infected children and their parents in order to improve the treatment effect.
Anti-HIV Agents/therapeutic use*
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Child
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China/epidemiology*
;
Female
;
HIV Infections/drug therapy*
;
Humans
;
Male
;
Proportional Hazards Models
;
Retrospective Studies
4.Evidence of clinical randomized controlled trial study in treatment of acute cerebral infarction with traditional Chinese medicine in recent five years.
Zhen-Min XU ; Xiao LIANG ; Ling-Ling DAI ; Ye-Fei WANG ; Shao-Jiao LIU ; Liu-Ding WANG ; Wen-Ran QIU ; Chun-Yan GUO ; Rui-Xue HU ; Yun-Ling ZHANG ; Xing LIAO
China Journal of Chinese Materia Medica 2021;46(12):2942-2948
To systematically search and sort out the clinical randomized controlled trial(RCT) on the prevention and treatment of acute cerebral infarction with traditional Chinese medicine(TCM) by using the method of evidence map, and to understand the evidence distribution of related studies. CNKI, Wanfang, VIP, CBM, PubMed, EMbase, Cochrane Library and Web of Science were retrieved from January 2016 to September 2020, and literatures related to the prevention and treatment of acute cerebral infarction with traditional Chinese medicine were included. Text description combined with table and bubble chart were used to analyze the distribution characteristics of evidence. A total of 1 102 clinical articles in recent five years were retrieved. The annual trend of clinical study publication, study size, TCM therapy category and main scheme, and study literature quality were analyzed. We find that TCM treatment of acute cerebral infarction has become a hot topic of clinical research, the number of literature showed a trend of increased year by year, various means of intervention of TCM in the treatment of the advantages of increasingly highlight. Follow-up clinical research should highlight the characteristics of TCM: in the analysis of outcome indicators; increase the neuropsychological patients after stroke and cognitive ability, and the theory of combined treatment of TCM disease when thoughts; At the same time, the quality of clinical research needs to be improved. At present, there is still a lack of unified standards for the production of evidence map. This study is the first to explore the application of evidence map to summarize and display the clinical research status of TCM treatment of acute cerebral infarction, and combine it with the setting of priority areas of TCM clinical research, so as to provide a reference basis for determining the priority topic selection of TCM treatment optimization research.
Brain Ischemia
;
Cerebral Infarction/drug therapy*
;
Drugs, Chinese Herbal/therapeutic use*
;
Humans
;
Medicine, Chinese Traditional
;
Stroke/drug therapy*
5.Analysis of status quo of outcome indicators of randomized controlled trials in treatment of acute ischemic stroke with acupuncture in recent three years.
Ling-Ling DAI ; Zhen-Min XU ; Xiao LIANG ; Wen-Ran QIU ; Shao-Jiao LIU ; Liu-Ding WANG ; Chun-Yan GUO ; Ye-Fei WANG ; Xiang-Lan JIN ; Xing LIAO
China Journal of Chinese Materia Medica 2021;46(12):2949-2962
To analyze the use of outcome indicators of randomized controlled trial(RCT) of acupuncture in the treatment of acute ischemic stroke in recent three years, so as to provide a basis for building a study on the core outcome indicators for the treatment of acute ischemic stroke with acupuncture. The RCTs of acupuncture treatment for acute ischemic stroke in recent three years were collec-ted through computer retrieval of eight Chinese and English databases and two clinical trial registries at home and abroad. Literature was screened out, and data was extracted. Risk of assessment bias tool Cochrane 6.1 was used for bias risk assessment, outcome indicators were summarized and analyzed. A total of 47 RCTs were included, and 3 studies were trials registration scheme. Outcome indicators were divided into 6 categories according to functional attributes, namely physical symptoms/signs, physical and chemical examination, quality of life, traditional Chinese medicine symptoms/syndromes, safety events and long-term prognosis. The study found that in addition to the common problems in previous studies covered by the status quo of outcome indicators selection of RCT of acupuncture in the treatment of acute ischemic stroke, there were also the other problems as follows: emphasis on macroscopic efficacy indicators but neglect of acupuncture specific indicators, lack of characteristic indicators and economic indicators of traditional Chinese medicine therapy, and unification of indicators measurement tool and measurement time point. In the future, the outcome indicators set for the treatment of acute ischemic stroke with acupuncture shall be established, and the core outcome indicators set shall be in line with the characteristics of traditional Chinese medicine treatment.
Acupuncture Therapy
;
Brain Ischemia/therapy*
;
Humans
;
Ischemic Stroke
;
Quality of Life
;
Randomized Controlled Trials as Topic
;
Stroke/therapy*
;
Treatment Outcome
6.Overview of systematic reviews of Panax notoginseng saponins in treatment of acute cerebral infarction.
Liu-Ding WANG ; Zhen-Min XU ; Xiao LIANG ; Wen-Ran QIU ; Shao-Jiao LIU ; Ling-Ling DAI ; Ye-Fei WANG ; Chun-Yan GUO ; Xiang-Hua QI ; Jian WANG ; Yan-Bing DING ; Yun-Ling ZHANG ; Xing LIAO
China Journal of Chinese Materia Medica 2021;46(12):2963-2971
To overview the systematic reviews of Panax notoginseng saponins in the treatment of acute cerebral infarction. CNKI, CBM, Wanfang, VIP, PubMed, Cochrane Library and EMbase databases were retrieved to collect the systematic reviews of the efficacy of P. notoginseng saponins in the treatment of acute cerebral infarction. The retrieval time was from the time of database establishment to January 2021. After two researchers independently screened out the literature and extracted the data, AMSTAR-2 scale was used to evaluate the methodological quality of the included systematic reviews, GRADE system was used to grade the quality of evidences of the outcome indicators, and the efficacy evaluation was summarized. A total of 5 systematic reviews were included. AMSTAR-2 evaluation results showed that 3 items were relatively complete, while 4 items had a poor overall quality. P. notoginseng saponins combined with conventional Western medicine therapy was superior to single conventional therapy in the recovery of neurological function, enhancement of the total effective rate in clinic, and improvement of activities of daily living. GRADE evaluation results showed that the quality of evidence was from low quality to very low quality. In conclusion, in the treatment of acute cerebral infarction, P. notoginseng saponins can improve the clinical efficacy, with a good safety but a not high methodological quality and a low evidence quality. It is suggested that high-quality clinical studies shall be further carried out to provide evidence-based basis for the application of P. notoginseng saponins in the treatment of acute cerebral infarction.
Activities of Daily Living
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Cerebral Infarction/drug therapy*
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Humans
;
Panax notoginseng
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Saponins
;
Systematic Reviews as Topic
7.Overview of systematic reviews/Meta-analysis of Xingnaojing Injection in treatment of cerebral ischaemic stroke.
Ye-Fei WANG ; Zhen-Min XU ; Shao-Jiao LIU ; Ling-Ling DAI ; Chun-Yan GUO ; Liu-Ding WANG ; Wen-Ran QIU ; Xiao LIANG ; Ming-Hua WU ; Xiang-Lan JIN ; Xing LIAO
China Journal of Chinese Materia Medica 2021;46(12):2972-2983
There have been many clinical trials, systematic reviews/Meta-analysis proving that Xingnaojing Injection has a good clinical efficacy in treatment of cerebral ischaemic stroke, but with fewer comprehensive descriptions. In this study, an overview of systematic reviews/Meta-analysis of Xingnaojing Injection in treating cerebral ischaemic stroke was performed to provide current situation of evidences and basis for clinical practice. CNKI, Wanfang, VIP, CBM, EMbase, PubMed, Cochrane Library, Web of Science were retrieved through computers. A total of 6 literatures were included in this study. By AMSTAR-2 checklist and GRADE, the quality of included systematic reviews and the efficacy of Xingnaojing Injection were evaluated. The results of AMSTAR-2 checklist showed an extremely low quality for all of the 6 systematic reviews. According to the results of GRADE evaluation, among 55 outcomes, there were 2 outcomes with a medium quality, 4 outcomes with a low quality and 49 outcomes with an extremely low quality. The 6 systematic reviews reached a consistent conclusion that Xingnaojing Injection was effective in the treatment of cerebral ischaemic stroke. This therapy could improve the total efficacy, neurological deficit scores, hemodynamic and hemodynamic parameters. However, the methodolo-gical quality of all literatures was extremely low. The evidence levels of outcomes were between extremely low to medium. The effectiveness of Xingnaojing Injection in the treatment of cerebral ischaemic stroke still needs to be further verified by more high-quality studies. In the future, relevant clinical studies and systematic reviews/Meta-analysis shall be carried out in a strict accordance with relevant regulations.
Brain Ischemia/drug therapy*
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Drugs, Chinese Herbal
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Humans
;
Ischemic Stroke
;
Stroke/drug therapy*
;
Systematic Reviews as Topic
8.Advances in color stability of resin cements and its influence on all-ceramics restorations
Zixuan LIAO ; Wei ZHOU ; Ling ZHANG ; Biying QIU ; Haohan YU ; Lina NIU ; Jihua CHEN
Chinese Journal of Stomatology 2021;56(2):216-220
Resin cements have been widely employed for bonding all-ceramic restorations in clinical practice, its color stability is directly related to long-term prosthetic effect of restorations. Discoloration of resin cements can be attributed to two causes: endogenous factors are generally related to material compositions and initiation mechanism of polymerization; exogenous factors are mainly related to stimulation of local oral environment. Color stability of resin cements has close relationship with esthetic effect of all-ceramic restorations. The aim of this literature review was to make a presentation and discussion systematically about color stability of resin cements commonly used clinically, its influence factors and influence on all-ceramic restorations, so as to provide a reference for the application of all-ceramic restorations.
9.A new antimicrobial isobenzoisofuran compound from Cassia pumila.
Ling-Min LIAO ; Qian GAO ; Yin-Ke LI ; Jing LI ; Xin LIU ; Xue-Mei LI ; Guang-Yu YANG ; Yan-Qing YE ; Qiu-Fen HU ; Jian-Gang LI ; Miao DONG
China Journal of Chinese Materia Medica 2020;45(4):896-898
A new isobenzoisofuran(1) has been isolated from the whole plant of Cassia pumila using various chromatographic techniques, including silica gel, Sephadex, MCI-gel resin, and RP-HPLC, and its structure was determined as 9-(2-hydroxyethyl)-2,2-dimethyl-2H-furo[3,4-g]chromen-6(8H)-one. This compound was also evaluated for its antibacterial activity. The results showed that it had prominent antibacterial activity with MIC_(90) value of(45.2±4.2) μg·mL~(-1) for methicillin resistant Staphylococcus aureus(MRSA) strain. This value was closed to that of levofloxacin [with MIC_(90) value(48.5±4.3) μg·mL~(-1)].
Anti-Bacterial Agents/pharmacology*
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Benzofurans/pharmacology*
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Cassia/chemistry*
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Levofloxacin
;
Methicillin-Resistant Staphylococcus aureus/drug effects*
;
Microbial Sensitivity Tests
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Phytochemicals/pharmacology*
;
Plants, Medicinal/chemistry*
10.A new antiviral isoquinoline alkaloid from Thalictrum glandulosissimum.
Dian LUO ; Na LYU ; Ling-Min LIAO ; Qian GAO ; Yin-Ke LI ; Jing LI ; Xin LIU ; Xue-Mei LI ; Guang-Yu YANG ; Yan-Qing YE ; Qiu-Fen HU ; Miao DONG
China Journal of Chinese Materia Medica 2020;45(11):2568-2570
A new isoquinoline alkaloid(1) has been isolated from the whole plant of Thalictrum glandulosissimum by using various chromatographic techniques, including silica gel, sephadex, MCI-gel resin, and RP-HPLC, and its structure was determined as 1-(6-hydroxy-7-methylisoquinolin-1-yl) ethantone by physicochemical properties and spectroscopic data. This compound was evaluated for anti-tobacco mosaic virus(TMV) activity. The results showed that it had prominent anti-TMV activity with inhibition rates of 28.4%. This rate was closed to that of positive control.
Alkaloids
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Antiviral Agents
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Isoquinolines
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Thalictrum
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Tobacco Mosaic Virus

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