Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions / 中国中药杂志

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

Technical specification for Instructions for Clinical Application of Chinese Patent Medicines in China Association of Chinese Medicine / 中国中药杂志

In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.

Pre-searching during formulation of expert consensus on clinical application of Chinese patent medicines:Yanshen Jianwei Capsules as example / 中国中药杂志

The formulation of expert consensus on clinical application of Chinese patent medicines, in means of exploring the effective combination of experience and evidence to form a research method in line with the characteristics of Chinese patent medicines, is an important transitional stage for clinical researches on Chinese patent medicines. Pre-searching is a new step in the formulation of expert consensus on clinical application of Chinese patent medicines. Before steps of interview and investigation on clinical application, pre-searching is conducted to collect publications and literature on certain variety and similar Chinese patent medicines; the publications on related medical classics and formulas of this variety; the recommendation condition of this variety in clinical practice guidelines and expert consensus; and the medication regimens recommended in disease-specific guidelines. Pre-searching is designed to know about the advantages of certain variety of Chinese patent medicine as well as its potential problems recorded in the literature, which is helpful to find out the clinical positioning of Chinese patent medicines, develop reasonable clinical questions and provide ideas for formal literature searching. However, it is not the direct basis for developing clinical questions. Moreover, interviews and investigations are still needed to further clarify the clinical positioning of Chinese patent medicines and develop reasonable questions. This paper took expert consensus on clinical application of Yanshen Jianwei Capsules as an example to introduce the pre-searching process and methods used during formulation of expert consensus on clinical application of Chinese patent medicines, and to further discuss the role of pre-searching to facilitate the formulation of clinical questions on selection of participants, interventions, controls and outcomes.

Analysis of Programs and Guidelines on Traditional Chinese Medicine (TCM) for COVID-19 to Provide Suggestions for Future Development of TCM Clinical Practice Guidelines / 中国实验方剂学杂志

Objective:To comprehensively analyze the diagnosis and treatment programs and prevention and treatment programs on tratidional Chinese medicine (TCM) for coronavirus disease-2019 (COVID-19), and to provide suggestions for further development of TCM clinical guidelines. Method:Diagnosis and treatment programs on TCM for COVID-19 pneumonia, as well as prevention and treatment programs, clinical practice guidelines and expert consensus, were retrieved till Feb 19, 2020. The information about TCM syndrome differentiation, state of disease, and TCM treatments (decoction and Chinese patent medicines) were extracted and analyzed. Result:A total of 24 TCM programs/guidelines were included containing 23 diagnosis and treatment programs or prevention and treatment programs and one rapid advice guideline. Of the 23 TCM programs, 14 programs described the classification of TCM syndromes and the stages of disease，22 programs described the composition of the TCM decoction; seven programs described how to add and subtract the herbs according to different TCM syndromes,17 programs described the weight/volume of the herbs of TCM decoctions, three programs described the decoction method，six programs described the usage and dosage of TCM decoction， two programs clarified the course of treatment; none of the 23 programs indicated the source of evidence. The TCM treatment within the rapid advice guideline was in reference to the fourth edition of the COVID-19 pneumonia TCM diagnosis and treatment program issued by the National Health Commission. A total of 41 Chinese patent medicines were recommended in 23 programs, of which 12 Chinese patent medicines were off-label recommended. Conclusion:In most TCM programs, TCM decoction and Chinese patent medicines are recommended based on TCM syndrome differentiation in combination with the state of disease, and the dosage of the TCM decoctions are clearly described. Some Chinese patent medicines in the TCM programs are off-label recommended. Expert experience and opinions are valued when developing TCM programs/ guidelines. All of these provide reference for developing TCM programs/guidelines in future.

Reporting standards for expert consensus on clinical practice of Chinese patent medicines of China Association of Chinese Medicine / 中国中药杂志

In 2018,Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine to discuss and draft a series of standards for expert consensus on clinical practice of Chinese patent medicines. These standards have been made by reference to the published standards for developing expert consensus and clinical practice guidelines. These standards were made based on full consideration of the current evidence status and the history of clinical practice of Chinese patent medicines. These standards were composed of four parts,namely information summary items,normative general items,normative technical items and information supplementary items,including cover,content,preface,introduction,title,scope,basic Information of Chinese patent medicine,suggestions for clinical application,safety,conflict of interest,appendix,and references,so as to provides reference for improving the quality of expert consensus-based compilation and enhancing the applicability of expert consensus.

Guidance of instructions for compiling expert consensus on clinical practice of Chinese patent medicine of China Association of Chinese Medicine / 中国中药杂志

The expert consensus on clinical practice of Chinese patent medicines shall be regarded as the same with clinical practice guidelines,which shall be concise,readable and applicable. Therefore,a formal expert consensus is unable to contain the whole compilation process and the content of its important process documents. It is necessary to write instructions for continuation,expansion and publicity. In 2018 Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine drafted a series of standards for expert consensus on clinical practice of Chinese patent medicines,including the guidance for compilation the instructions. It will be useful for readers of expert consensus to understand the work behind the compilation,so as to make the compilation process more transparent and standardized. We proposed nine requirements for compilation the instructions,namely content and requirements,work overview,main technical content,compilation process,process and basis for handling major disagreements,expert consensus implementation requirements and measure suggestions,other issues need to be explained,appendix and format for instructions.

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.

How to draft editorial explanation for transparent and concise guideline on clinical practice--Case analysis / 中国中药杂志

Clinical practice guideline (CPG) should be concise and readability, which can be possible to implement CPG into practice smoothly. A formal published CPG can't load its developing process and details. An editorial explanation of CPG is much useful to show details and logic process of developing CPG. Although there are many different standards for developing CPG, being nothing to do with process management of CPG. By referring to editorial explanation on international standards, a request for CPG was investigated in this study. An editorial explanation for clinical practice guideline should be transparency, logic and traceable. A good editorial explanation could make users or readers to learn what goes on behind the scenes. A standardized editorial explanation could supervise the GCP developing and improve the quality of GCP.

Research progress on effects and their mechanism of Ligustri Lucidi Fructus in treatment of osteoporosis / 中草药

Ligustri Lucidi Fructus (LLF), which could nourish the liver and kidney, was used for the treatment of bone atrophy in ancient times. The current basic and clinical studies have shown that LLF had a broad application prospect in the treatment of osteoporosis. In this paper, by reviewing the related literature of home and abroad, we summarize the related experimental and clinical research progress of LLF and its compound on the treatment of osteoporosis, and clear their function mechanism, hoping to lay a theoretical foundation for further experimental study and clinical research.

Effects of water extract from Ligustri Lucidi Fructus on bone structure and metabolism in ovariectomized rats / 中草药

Objective: To investigate the protecting and regulatory effects of water extract from Fructus Ligustri Lucidi (FLL) on bone structure and bone metabolism in osteoporosis rats. Methods: SD female rats were bilaterally ovariectomized to establish osteoporosis model, and Sham operated rats only cut the fat around the ovary. Experimental rats were divided into four groups: Sham operation (SHAM) group, model (OVX) group, alendronic acid sodium (ALN) group, and Fructus Ligustri Lucidi (FLL) group, with nine rats in each group. The rats in FLL group were given FLL water extract (3.5 g/kg) and rats in ALL group were given ALN suspension (0.12 g/kg) by ig administration for 12 weeks. At the end of the experiments, the contents of serum and urine calcium (S-Ca) and phosphorus (S-P), urine creatinine (U-Ca/Cr and U-P/Cr), serum high density lipoprotein (HDL-C) cholesterol, low density lipoprotein (LDL-C) cholesterol, total cholesterol (TC), and triglyceride (TG) were measured by biochemical methods. The levels of collagen I amino terminal peptide (PINP), collagen I carboxyl terminal peptide (CTX-I), osteocalcin (OCN), and urine deoxypyridinoline (DPD) were measured with ELISA. The determination of alkaline phosphatase (ALP) was by radioimmunoassay method. To evaluate the change of bone tissue structure, the bone density instrument, VivaCT, and a universal testing machine were used. Results: FLL could inhibit the increased body weight of ovariectomy (OVX) rats, increase S-Ca, S-P, serum HDL and PINP contents, reduce urinary U-Ca/Cr and U-P/Cr ratios, reduce serum LDL-C, TC, TG, ALP, OCN, CTX, and reduce urinary DPD content (P < 0.05 or 0.01) in OVX rats. Meanwhile, FLL can elevate the femur head and vertebral bone mineral density, bone micro-structure and bone strength in OVX rats. Conclusion: FLL can improve the bone density and bone strength in OVX rats by regulating Ca and P metabolism, collagen and non-collagen metabolism.