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Objective: To describe the treatment patterns and survival status of advanced gastric cancer (AGC) in China in the past two decades, and objectively evaluate the impact of standardized Chinese medicine (CM) treatment on the survival of AGC patients., Methods: This multicenter registry designed and propensity score analysis study described the diagnosis characteristics, treatment-pattern development and survival status of AGC from 10 hospitals in China between January 1, 2000 and July 31, 2021. Overall survival (OS) was evaluated between non-CM cohort (standard medical treatment) and CM cohort (integrated standard CM treatment ≥3 months). Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were performed to adjust any difference in average outcomes for bias., Results: A total of 2,001 patients histologically confirmed locally advanced and/or metastasis stomach and gastroesophageal junction adenocarcinoma were enrolled. Among them, 1,607 received systemic chemotherapy, 215 (10.74%) accepted molecular targeted therapy, 44 (2.2%) received checkpoint inhibitor therapy, and 769 (38.43%) received CM. Two-drug regimen was the main choice for first-line treatment, with fluoropyrimidine plus platinum as the most common regimen (530 cases, 60.09%). While 45.71% (16 cases) of patients with HER2 amplification received trastuzumab in first-line. The application of apatinib increased (33.33%) in third-line. The application of checkpoint inhibitors has increased since 2020. COX analysis showed that Lauren mixed type (P=0.017), cycles of first-line treatment >6 (P=0.000), CM (P=0.000), palliative gastrectomy (P=0.000), trastuzumab (P=0.011), and apatinib (P=0.008) were independent prognostic factors for the OS of AGC. After PSM and IPTW, the median OS of CM cohort and non-CM cohort was 18.17 and 12.45 months, respectively (P<0.001)., Conclusions: In real-world practice for AGC in China, therapy choices consisted with guidelines. Two-drug regimen was the main first-line choice. Standardized CM treatment was an independent prognostic factor and could prolong the OS of Chinese patients with AGC. (Registration No. NCT02781285)., (© 2024. The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature.)

The development of the guidelines should not only meet the rigorous methodological requirements, but also ensure the credibility or enforceability of the guideline recommendations when they are applied in clinical practice. Based on the idea of establi-shing a perfect guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believed that a complete evaluation system of clinical practice guidelines in the field of TCM shall be divided into three parts: quality evaluation, applicability evaluation and clinical application investigation. Among them, applicability evaluation refers to the evaluation of the degree of fit between the guideline and clinical practice, that is, whether the guidelines have good readability and clinical applicability to promote clinical application. The evaluators are clinical experts in the related fields of TCM. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. Based on the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM. In this paper, the author introduces the whole list of quality evaluation, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

Based on the idea of establishing a complete guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believes that a complete guideline evaluation system of traditional Chinese medicine clinical practice should be divided into three parts: quality evaluation, clinical applicability evaluation and clinical application investigation. According to the different purposes, different evaluators, different evaluation methods and different evaluation time points in the guideline evaluation, the quality evaluation recommendation list, the clinical applicability evaluation recommendation list and the clinical application questionnaire were formed. Among them, the purpose of quality evaluation is to evaluate the methodological quality in the guideline development process, in order to measure whether the entire guideline development process is scientifically rigorous. The evaluators must be the methodologists with an evidence-based medicine background. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. By referring to the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM by considering the characteristics of TCM field. In this paper, the author introduces the whole list of quality evaluation recommendations, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

Standardization is the technical support for the development of traditional Chinese medicine(TCM), and the guidelines have become the main component of the core standards of TCM technology. With the rise and development of evidence-based medicine in China, more than 500 guidelines have been issued in China, and the number is still increasing, but the quality of guidelines still lags far behind the international level. Similarly, the formulation of evidence-based clinical practice guidelines for TCM has gradually attracted the attention of the industry, but the quality is not so good, and most guidelines are not really evidence-based guidelines. Only reliable guidelines can fully and effectively play the role of clinical guidance. In order to comprehensively improve the scientificity and credibility of the guidelines, guideline evaluation can be used as a means to improve the quality of the guidelines. For the development of traditional Chinese medicine, it has become an urgent task to establish a complete evaluation standard system of guidelines, especially the evaluation standard system that conforms to the technical characteristics of traditional Chinese medicine. In this paper, the advantages and limitations of a series of domestic and foreign guideline evaluation tools were systematically analyzed, and the thinking and difficulties to establish the evaluation system of TCM guidelines were put forward, with a purpose to further improve the quality of TCM clinical practice guidelines, so that they can be better applied in clinical practice to enhance the clinical efficacy of TCM and ensure the quality of medical services.

At present,China has issued a series of standards relating to traditional Chinese medicine(TCM). The standard system has already taken shape,but there are still some problems,such as incomplete standard system,low standard quality,inadequate application,insufficient study strength and lack of talent. This paper makes a detailed analysis of current management and development of standardization of traditional Chinese medicine in the aspects of " management mechanism and system construction" and " standards".The problems existing in the standardization of TCM are analyzed in three aspects: quality and popularization,standard research and talent reserve. At the same time,some suggestions are put forward to solve the problems. First,we shall strengthen the management of top-level design; second,we shall guide the transformation of high-quality scientific and technological achievements to standards;third,we shall consolidate the basic research of standardization of TCM; fourth,we shall focus on cultivating standardized technical talents; and fifth,we shall strengthen the standard research and development work in key fields.

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.

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.

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., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

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., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

Aim: To investigate the protective effect of medical ozone (O(3)) combined with Traditional Chinese Medicine (TCM) Yigan Fuzheng Paidu Capsules (YC) against carbon tetrachloride (CCl(4))-induced hepatic injury in dogs., Methods: Thirty healthy dogs were divided randomly into five groups (n = 6 in each group), namely control, oleanolic acid tablet (OAT), O(3), YC and O(3) + YC, given either no particular pre-treatment, oral OAT, medical ozone rectal insulfflation every other day, oral YC, or oral YC plus medical ozone rectal insulfflation every other day, respectively, for 30 consecutive days. After pre-treatment, acute hepatic injury was induced in all dogs with a single-dose intraperitoneal injection of CCl(4). General condition and survival time were recorded. The biochemical and hematological indexes of alanine aminotransferase (ALT), aspartate aminotransferase/alanine aminotransferase (AST/ALT), serum total bilirubin (TBIL), prothrombin time (PT), blood ammonia (AMMO), and blood urea nitrogen (BUN) were measured after CCl(4) injection. Hepatic pathological changes were also observed., Results: Compared to the other four groups, the changes of group O(3) + YC dogs' general conditions (motoricity, mental state, eating, urination and defecation) could be better controlled. In group O(3) + YC the survival rates were higher (P < 0.05 vs group control). AST/ALT values were kept within a normal level in group O(3) + YC. Hepatic histopathology showed that hepatic injury in group O(3) + YC was less serious than those in the other four groups., Conclusion: Medical ozone combined with TCM YC could exert a protective effect on acute liver injury induced by CCl(4).

Objective: To investigate the protective effect of Yigan Fuzheng Paidu Capsules (YC) combined with medical ozone against hepatic injury in dogs induced by hepatotoxic drug., Methods: Twenty-four dogs were randomized equally into 4 groups (n=6), namely the model group, oleanolic acid tablet (OAT) group, YC group and YC+O(3) group, given either no particular treatment, oral OAT at 10 mg/day, oral YC at 0.2 g/day, or YC at 0.2 g/day plus 150 ml medical ozone transrectal insufflation every other day, respectively, for totally 30 consecutive days. Acute hepatic injury was induced after the treatment in the dogs with a sing-dose intraperitoneal injection of 0.9 ml/kg CCl(4) and peanut oil mixture (1:1, W/W). The general condition, survival time, alanine aminotransferase (ALT), aspartate aminotransferase/alanine aminotransferase (AST/ALT), serum total bilirubin (TBIL), prothrombin time (PT), blood ammonia (AMMO), and blood urea nitrogen (BUN) were recorded or measured. The hepatic pathological changes were observed upon death or on day 15 following CCl(4) injection., Results: Compared with the other 3 treatment protocols, YC plus O(3) showed favorable effects on the activity, mental state, diet, urination and defecation of the dogs, which had significantly higher survival rate and higher levels of ALT, TBIL, PT, and AMMO than the model and OAT groups (P<0.05). AST/ALT remained normal in YC+O(3) group, which had also milder hepatic injury than the other 3 groups., Conclusions: YC combined with medical ozone may decrease transaminase and blood ammonia levels, relieve jaundice, prolong the survival time of dogs with CCl(4)-induced hepatic injury.