Current research situation of nephrotoxicity of Chinese herbal medicine / 中国中药杂志

To provide the basis for the future research on the nephrotoxicity of Chinese herbal medicine through systematic and comprehensive summary of all the Chinese herbal medicines which may lead to nephrotoxicity. Foreign resources included PubMed and Cochrane library， and domestic research resources was China Food and Drug Administration(CDFA) Adverse Drug Reaction Monitoring Center database. The databases were searched from establishment to January 1， 2017. There was no limitation on research type. 28 English studies were found， including 97 Chinese herbs or prescriptions with the risk of nephrotoxicity. The following six Chinese herbal medicines with the risk of nephrotoxicity had a large number of studies： aristolochic acid(5 studies)， Tripterygium wilfordii(4 studies)， Erycibe obtusifolia(2 studies)， Rheum palmatum(2 studies)， Ephedra sinica(2 studies)， and Atractylodes lances(2 studies). The remaining 91 Chinese medicines were reported with risk of nephrotoxicity in only 1 study respectively. CDFA reported 16 Chinese herbal medicines with the risk of nephrotoxicity， including Ganmaoqing Pian(capsule)， Zhenju Jiangya Pian， T. wilfordii preparation， Vc-Yinqiao Pian， Chuanhuning injection， Shuanghuanglian injection， Qingkailing injection， Lianbizhi injection， herbal decoction containing Aristolochiae Radix， Guanxin Suhe Wan， Shugan Liqi Wan， Ershiwuwei Songshi Wan， herbal decoction containing Aristolochia Fangchi， herbal granules containing root of Kaempfer Dutchmanspipe， Ganmaotong(tablets)， and Longdan Xiegan Wan. Currently， in addition to aristolochic acids， the most reported Chinese herbal medicine with the risk of nephrotoxicity is T. wilfordii preparation.

Evidence-based evaluation on safety of Tripterygium wilfordii preparations / 中国中药杂志

The study was aimed to conduct an evidence-based evaluation on the safety of Tripterygium wilfordii(TW) preparations through a method combined bibliometrics research with evidence-based evaluation research， to provide evidence-based safety information of the TW preparations(nephrotoxicity) for the government decision-making and clinical application， and to provides methods and suggestions for evaluating nephrotoxicity of Chinese herbal medicine(CHM) in the future. We searched relevant databases at home and abroad systematically， and six Chinese and English databases including CNKI， SinoMed， VIP， WanFang， PubMed， and Cochrane library were comprehensively searched. All types of research documents about the safety of TW preparations. Literature were screened and extracted based on inclusion and exclusion criteria. The methodology quality of all included studies were assessed by internationally recognized evaluation tools or standards. The incidence rate was analyzed by using R software. Subgroup analysis were conducted according to the type of disease treated， drug delivery way， medication time， and study types.

Evaluation of reporting quality of RCT on nephrotoxicity of Tripterygium wilfordii preparations according to CONSORT HARMs statement / 中国中药杂志

To evaluate the quality of randomized controlled trials(RCT) on nephrotoxicity of Tripterygium wilfordii preparations according to the CONSORT HARMs statement. The report quality of each included study was evaluated according to the CONSORT HARMs statement， and the number of entries that comply with CONSORT HARMs statement was calculated in each study to evaluate the report quality on nephrotoxicity-related adverse reactions of T. wilfordii preparations and summarize the problems in domestic studies on nephrotoxicity-related adverse reactions. A total of 16 RCTs were included， with an average of 7 entries complying with CONSORT HARMs statement per study. The report of the nephrotoxic-associated RCT of T. wilfordii preparations was of poor quality and the most non-repeating entries included the following ones： using validated tools to report adverse effects， standards for coding of the adverse reactions， describing how and when to collect data on adverse reactions in Method， describing how adverse reactions are attributed to T. wilfordii， clearly stating who has reported the adverse reactions， describing the analysis method of adverse reactions， describing the method of collecting recurrent adverse reaction data， describing any subgroup analysis and exploratory analysis associated with the hazard. We suggest that the studies on adverse reactions of traditional Chinese medicine should strictly report the entries according to the CONSORT HARMs statement， and take the characteristics of traditional Chinese medicine into account to report the details of the Chinese medicine like compositions， dose， taking time， combined medication and the dialectical typology of research objects.

Application of evidence-based rapid review in studying nephrotoxicity of Tripterygium wilfordii preparation / 中国中药杂志

To investigate the feasibility of applying the evidence-based rapid review in studying the nephrotoxicity of Tripterygium wilfordii preparation. We used four methods in relevant studies on the nephrotoxicity of T. wilfordii preparation. The first method had no limitation on any search terms， which was a traditional approach to retrieve systematic reviews. The second method limited the relevant search terms of T. wilfordii preparation to "all of CHMs containing T. wilfordii preparation approved by CFDA". The third method was to limit the relevant retrieval terms of nephrotoxicity as the "most frequently reported terms related to nephrotoxicity found in the study literature screening process in the early stage of systematic review". The fourth method was to limit the search terms relating to both T. wilfordii preparation and nephrotoxicity. Finally， the results of the last three search methods were compared with those of the first search method， and the feasibility of the rapid review method in the study for the nephrotoxicity of CHM was discussed. For the total number of literatures searched， the fourth method had the smallest number of literatures. For the number of articles in line with the inclusion criteria， the second method had the largest number of eligible literatures. For the type of literatures included， the forth method had a higher coincidence degree. The forth method was the best one， because it was not only consistent with the results， but also could minimize the workload. Rapid review is feasible in the study of nephrotoxicity of T. wilfordii.

Manual for the clinical experts consensus of Chinese patent medicine / 中国中药杂志

Chinese patent medicine is widely used in clinical practice, but improper use will not only weaken the efficacy of drugs, but even cause adverse consequences. Evidence-based medicine provides guidance for clinical practice based on the best available evidence, experience of experts and needs of patients. However, considering the situation of "insufficient evidence" or "very low quality" in Chinese medicine research, experts consensus is the main basis for clinical decision-making, but expert opinions on which the consensus depends are susceptible to various subjective biases. Therefore, a reliable and scientific consensus-making process is needed to maximally avoid bias on consensus. Unlike the clinical practice guidelines, there is no unified formulating process for consensus in the world today. This article learns from a set of formulating processes from some international consensus formulating institutions/associations, combined with the characteristics and current situation of traditional Chinese medicine, and draws up a set of standard process that is suitable for the clinical experts consensus on Chinese patent medicine, with the expect of providing evidence and reference for consensus makers, and then bringing evidence-based assistance for the clinical standardized application of Chinese patent medicines.

Discussion on issues related to clinical experts consensus of Chinese patent medicine / 中国中药杂志

The promulgation of standardized documents on traditional Chinese medicine has promoted the formulation of industrial standards of traditional Chinese medicine, including clinical practice guidelines and clinical expert consensus. In order to adapt to the current research situation of "insufficient evidence" or "very low quality" when developing clinical practice guideline in the field of traditional Chinese medicine, the author has made a retrospective study on the development of guidelines and consensus, and found that the consensus is more suitable for the current research status of Chinese patent medicine, as the stage of lack of high-quality clinical evidence will remain for a long time. However, unlike clinical practice guidelines, domestic scholars and consensus makers have insufficient understanding of the clinical experts consensus. This article will introduce the origin and status of the clinical experts consensus, the differences between clinical experts consensus and the clinical practice guidelines, and the basic principles that should be followed in the formulation of the clinical experts consensus of Chinese patent medicine, expecting to provide theory basis and reference for the normative formulation of clinical experts consensus.

Reporting criteria for clinical experts consensus of Chinese medicine / 中国中药杂志

Due to its own characteristics and research status, traditional Chinese medicine research often faces the reality of "insufficient evidence" or "very low quality" when making clinical practice guidelines. Therefore, in many cases, clinical decision-making of traditional Chinese medicine should rely mainly on expert consensus to achieve. A clear and detailed list of expert consensus report specifications will provide a good reporting tool for Chinese clinical expert consensus makers, which is very important for promoting the quality of consensus production and the promotion and application of consensus results. The author consulted the internationally published authoritative expert consensus, summarized the main points of the reports, combined with the formulation process of the clinical experts consensus of Chinese medicine, and the demonstration of clinical experts and methodologists, and then formulated the list of items for clinical expert consensus reports adapt to the field of Chinese medicine. This article introduces the entire list of items and elaborates on the key parts. It is expected to provide reference for the standardization of future clinical expert consensus reports.