Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine（Part 1）： Development Status and Characteristics / 中医杂志

The irrational use of Chinese patent medicines （CPM） is becoming more and more prominent， which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines， and promote its development， this paper introduced the concept of CPM guidelines， summarized the characteristics of the two development modes， namely “taking CPM as the key” and “taking disease/syndrome as the key”， and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems， three suggestions have been put forward to optimize the quality of CPM guidelines， which were clarifying the target users and scope of CPM guidelines， establishing an open and transparent mechanism of the personnel involvement and process steps， and formulating implementable and operable recommendations for the use of CPM.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine： 2.Establishment of Guideline Working Group and Management of Conflict of Interests / 中医杂志

This paper summarized the key points and methods in terms of the establishment of the guideline working group and the management of conflict of interests， trying to provide reference for the development of clinical practice guidelines for Chinese patent medicine （CPM）. The establishment of the working group is the first important step for developing CPM guidelines. Considering the characteristics of the clinical practice guidelines for CPM， this study suggests that the three key elements of ‘multidisciplinarity’， ‘clinical relevance’ and ‘geographical representativeness’ should be put focus on when forming the working group. The guideline advisory committee， clinical expert group， evidence systematic evaluation group， secretary group and the external review group should be established. All group members should clarify the conflict of interest， and the process and management method of the conflict of interest should be clearly reported.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine（Part 3）： Identification of Clinical Questions / 中医杂志

The identification of clinical questions for clinical practice guidelines of Chinese patent medicine （CPM） is important for subsequent evidence retrieval， evaluation of evidence quality， formation of recommendations. This paper described a methodological proposal for the identification of clinical questions for CPM guidelines to highlight the characteristics of Chinese patent medicine and reflect its effect in specific stage of the disease. Considering four aspects， namely， the drug of Chinese patent medicine （D）， the specific disease stage （S）， comparison （C）， and specific outcome （O）， DSCO framework has been proposed to formulate the clinical questions. Multi-source information through scientific research， policy or standard documents， and clinical data are suggested for collecting clinical questions， and clear selection criteria should be set to finalize the clinical questions to be addressed by the guideline. In addition， the above process needs to be transparently and publicly reported in order to ensure the clarity and completeness of the guidelines.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine（Part 4）： Evidence Retrieval and Evaluation / 中医杂志

The retrieval and evaluation of evidence is the basis for the development of clinical practice guidelines for Chinese patent medicine. As traditional Chinese medicine has a different development trajectory and utilization characteristics from modern medicine， there is certain differences in terms of evidence composition， retrieval and integration.This paper discussed multi-source body of evidence on Chinese patent medicine based on modern evidence-based medicine and ancient medical literature， and summarized the retrieval strategy as well as the possible problems and solving methods. For different types of evidence on Chinese patent medicine， the corresponding evaluation tools have been recommended， and the order to integrate the evidence based on the quality of the evidence from high to low is suggested. Finally， a multi-source based evidence retrieval-evaluation-integration scheme for Chinese patent medicine has been formed， which will provide a methodological reference for practitioners in the development of clinical practice guidelines for Chinese patent medicine.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine（Part 5）： Retrieval and Synthesis of Key Information on Rational Drug Use / 中医杂志

Recommendations for Chinese patent medicine （CPM） based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study， we discussed in detail of the key information on the rational use of CPM in five aspects， which are dosage， drug discontinuation， drug-drug and drug-food interactions， safety and economy. Following the process of multi-source search， synthesis and prioritization， it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions， policy documents， literature， and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally， methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine （Part 6）： Formation and Presentation of Recommendations / 中医杂志

Recommendation formation is a key component of clinical practice guidelines for Chinese patent medicine （CPM）， and should encompass the determination of the strength and direction of the recommendation， the rationale for the recommendation， and the methodology for implementing the recommendation. Recommendations can be formed through formal consensus and informal consensus. The strength and direction of recommendations for CPM guidelines should be determined by considering the quality of evidence for CPMs， the priority of the clinical questions， the pros and cons of efficacy and adverse effects， patient acceptance， the feasibility of the recommendation and the availability of resources， social fairness， economic benefits， and other influencing factors. In order to better guide guideline developers to consider these factors more rationally， this article provideed a detailed explanation of each factor in the context of the characteristics of TCM.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine （Part 7）： Introduction and Interpretation of the Guideline Reporting Checklist / 中医杂志

The systematic and comprehensive introduction and interpretation of the Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 is conducive to the presentation of high-quality clinical practice guidelines for Chinese patent medicines （CPMs）， thus improving their dissemination and use. The Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 specifies the requirements for clear， complete and transparent reporting of the whole process of developing CPMs guidelines， containing 4 domains， 17 topics and 43 items， and involving the basic information， recommendations and methods of guideline development. Especially， it details the items related to the rules and regulations of the use of CPMs in the recommendations， which is helpful for improving the completeness， scientificity and practicality of the reporting of CPMs guideline.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine （Part 8）： Quality Evaluation with AGREE Ⅱ and RIGHT / 中医杂志

ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine （CPM） with internationally recognized tools the appraisal of guidelines for research and evaluation （AGEREE） Ⅱ and reporting items for practice guidelines in healthcare （RIGHT）， thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI， VIP， Wanfang and Sinomed were searched for CPM guidelines， as well as medlive.cn， websites of China Association of Chinese Medicine and Chinese Medical Association， and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools， and consistency tests were performed using Interclass Correlation Coefficient， and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally， 140 CPM guidelines were included， of which 51 were disease-oriented and 89 were drug-oriented， all of which were issued by China. For 51 disease-oriented CPM guidelines， the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity， and the lowest was 26.80% for application； for 89 drug-oriented CPM guidelines， the highest average score was 55.62% for scope and purpose， and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist， the highest reporting rate was 68.26% for background， and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines； the highest reporting rate was 61.31% for background， and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ （rigour of development， clarity of presentation， editorial independence）， as well as four domains of RIGHT checklist （basic information， evidence， funding and declaration and management of interests， and other areas）. ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist， and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines， thereby guiding the clinical use of CPM in a better way.

Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine （RALIG-TCM） （Part 1）：Concept and Current Practice / 中医杂志

Rapid and living guidelines are those developed in response to public health emergencies in a short period of time using a scientific and standardized approach. Subsequently， they provide timely and credible recommendations for decision makers through regular and frequent updates of clinical evidence and recommendations. In this paper， we introduced the definition of rapid and living guideline as well as analyzed the basic characteristics of eight rapid and living guidelines in the field of traditional Chinese medicine （TCM） published till 2023 June， summarizing three core methodological issues in relation to how to rapidly develop guidelines， how to formulate recommendations when there is lack of evidence， and how to ensure the timeliness of guidelines. Based on the analysis of current rapid and living guidelines， it is implicated that there is necessity to carry out rapid and living guideline in the field of TCM， and the methodology of rapid integration of multivariate evidence in the field of TCM needs to be further explored； furthermore， it is necessary to further explore the obstacles of implementation of guidelines and promote timely updating， all of which provide certain theoretical references for relevant guideline developers and researchers.

Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine （RALIG-TCM） （Part 2）： Development Process and Key Steps during Preparation Stage / 中医杂志

It is necessary to develop rapid and living guidelines in order to improve the evidence translation and guidance for clinical practice in emergency situations， and to enhance the participation of traditional Chinese medicine （TCM） in management of emergencies. This paper introduced the process of developing rapid and living guidelines of TCM and divided it into three stages， that is preparation， rapid development and dynamic updating， which highlights the features of rapid development， high quality， and dynamic updating and the integration with the predominance of TCM. By comparing with general guidelines on composition， personnel number， timing to formulate and communication patterns of the guideline working groups， as well as the content and number of clinical questions， this paper mainly gave suggestions on how to formulate a concise but authoritative team during the preparation stage， how to efficiently manage the guideline team and promote the development process from conflict of interest management， working and communication mode adjustment， and how to formulate and update the important and prioritized clinical questions， all of which may provide reference for the development of TCM rapid and living guidelines.

Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine （RALIG-TCM） （Part 3）： Rapid Evidence Collection， Integration and Recommendation Formation / 中医杂志

The lack of direct evidence is an important problem faced in the formation of recommendations in rapid living guidelines of traditional Chinese medicine under public health emergencies， and the supplementation of indirect evidence can be a key method to solve this problem. For the collection of evidence， the type of evidence required， including direct and indirect evidence， should be clarified， and ‘direct first’ principle for selecting evidence can be set to standardize and accelerate the guideline development. When integrating evidence， recommendations can be formed directly if there is sufficient direct evidence， while regarding insufficient direct evidence， recommendations need to be supplemented and improved by integrating indirect evidence. In addition， when the body of evidence contains evidence from multiple sources， it is suggested to rate the evidence according to “higher rather than lower” principle. Finally， when forming recommendations， the level of evidence， safety and economic efficiency should be taken into consideration to determine the strength of the recommendation.

Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine （RALIG-TCM） （Part 4）： Evidence Monitoring and Dynamic Updates / 中医杂志

In developing rapid and living guidelines of traditional Chinese medicine （TCM） in response to public health emergencies， it is important that evidence continue to be reviewed， and clinical questions and recommendations updated if necessary， due to the rapid changes in disease progression and the continuous generation of relevant research evidence. This paper proposed that the updating scope in dynamic mode should first be identified； then evidence monitoring should be carried out in four aspects， including clinical research， related guidelines or laws and regulations， disease progression， as well as clinical use of recommendations and clinical needs； finally， based on the results of the evidence monitoring， different options should be made， including revising the clinical questions， updating the evidence and recommendations， and withdrawing the guideline.

Interpretation of the Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine：weighting of evaluation indicators / 中国药房

OBJECTIVE To provide a detailed report and interpretation of the method and results for determining the weights of the technical indicators from the “multi-dimensional and multi-criteria comprehensive evaluation index system （first edition）” stated in Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine. METHODS Normalization calculations were performed on the comprehensive weight values calculated by the analytic hierarchy process and expert weighting method to obtain the objective weights of the indicators. RESULTS The weight results of the six primary dimensions in the current comprehensive evaluation indicator system of Chinese patent medicine showed effectiveness dimension＞ safety dimension＞standard dimension＞application dimension＞scientific dimension＞economic dimension， with weight values of 0.281 0， 0.268 5， 0.195 8， 0.107 3， 0.096 1 and 0.051 3 respectively， consistent with the results of most researches currently. CONCLUSIONS The process of weight determination in this indicator system is scientifically reasonable， with clear methods and clear interpretations， and is worthy of further optimization and widespread application.

The mechanism of "Trichosanthis Fructus-Allii Macrostemonis Bulbus" on phlegm and blood stasis syndrome-related cardiovascular diseases based on network pharmacology and experimental verification / 药学学报

This study aimed to investigate the mechanism of "Trichosanthis Fructus-Allii Macrostemonis Bulbus" (GX) on phlegm and blood stasis syndrome (PBSS) rats combining the methods of network pharmacology and experimental verification. Animal experiment ethical requirements were approved by the Ethical Committee Experimental Animal Center of Anhui University of Chinese Medicine (grant number: AHUCM-rats-2021070). Based on the HPLC-Q-TOF-MS analysis and database, 69 chemical constituents of GX and 163 targets of GX for the treatment of phlegm and blood stasis-related cardiovascular diseases were obtained. Then, key targets such as serine/threonine kinase 1 (Akt1), tumor necrosis factor (TNF), interleukin 6 (IL6), vascular endothelial growth factor A (VEGFA), cellular tumor antigen p53 (Tp53) were screened. Pathway analysis showed that the targets of GX in the treatment of phlegm and blood stasis-relate cardiovascular diseases were mainly involved in PI3K/Akt signaling pathway, sphingolipid metabolism, platelet activation, hypoxia inducible factor-1 (HIF-1), ras-proximate-1 (rap1) and other signaling pathways. In addition, molecular docking analysis showed that apigenin, cucurbitacin D, linolenic acid and kaempferol and other key components had potential binding ability with Akt1, TNF, IL6, VEGFA and Tp53. In the animal experiments, compared to the phlegm and blood stasis syndrome group, GX could significantly improve the traditional Chinese medicine syndrome score, blood lipid, vascular endothelial structure disorders and reduce serum endothelin-1 (ET-1) level, increase serum nitric oxide (NO) and endothelial nitric oxide synthase (eNOS) levels, which could restore aortic endothelial function. In addition, the expression of intercellular cell adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) in aorta could be significantly reduced, which could improve the vascular endothelial injury of aorta. Western blot revealed that GX could significantly decrease the phosphorylation levels of phosphoinositide 3-kinase (PI3K) and Akt in aorta. This study revealed the mechanism of GX in treatment of phlegm and blood stasis-relate cardiovascular diseases is consistent with the characteristics of multiple ingredients, multiple targets and multiple pathways. In addition, this study also clarified that the reversal of pathological of phlegm and blood stasis syndrome rats may be related to GX inhibiting PI3K/Akt signaling pathway, which could improve vascular inflammation and vascular endothelial function injury.

Application and Enlightenment of WHO Drug Pricing Method in Medical Insurance Pricing of Proprietary Chinese Medicine in China / 中国卫生经济

WHO Guideline on Country Pharmaceutical Pricing Policies,published in 2020,outlines 10 commonly used pricing methods internationally.However,due to the unique composition of costs for traditional Chinese medicine(TCM),directly applying pricing methods designed for chemical and biological drugs may lead to discrepancies.Currently,in China,drug pricing primarily in-volves internal reference pricing,tender negotiation pricing,promoting the use of quality-assured generic and biosimilar drugs,and centralized procurement.It systematically analyzes various pricing methods and identifies their applicability and underlying reasons concerning the pricing of TCMwithin the medical insurance system.The method of value-based pricing and increasing price transparency has advantages for the pricing regulation of traditional Chinese medicine under medical insurance.

Development of Traditional Chinese Medicine in South Africa / 国际中医中药杂志

South Africa is an ethnically and culturally diverse presidential republic country. The medical and health system consists of public and private medical care. AIDS, lower respiratory infections, neonatal diseases, and interpersonal violence and road injuries are the leading causes of adult death. South Africa has rich herbal resources, and a long history of traditional medicine, which is mainly black African traditional medicine. Until the establishment of diplomatic relations between China and South Africa in 1998, the development of TCM was significantly improved, and legislation of TCM was adopted by the government in 2000. Chinese herbal medicine has not yet formed industrial standardization, the TCM application and TCM education are insufficient. Therefore, it is suggested to accelerate the standardization of TCM, to strengthen the TCM education for professional TCM practitioners, and to form a large-scale, industrial and standardized development model. Only in these ways can TCM provide good medical services for residents in South African.

The development status and analysis of Traditional Chinese Medicine in Turkey / 国际中医中药杂志

Turkey is a presidential republic country located in the Eurasian continent, which has a universal health coverage since the health reform in 2003. The leading causes of death in this country are ischemic heart disease, stroke, and lung cancer. Besides, lower respiratory infections, chronic kidney disease, and hypertensive heart disease are the diseases which have a fastest growing rate. Chinese acupuncture was officially recognized by Turkey in 1991 with the promulgation of Acupuncture Treatment Legislation. At present, only trained practitioners and dentist could conduct acupuncture treatment, which was stated in Regulation of Tradition and Complementary Medicine Practice. The application of Turkish acupuncture and moxibustion is still applied in a simplified way that lack of TCM theory. Moreover, Chinese herbal medicine is still not officially recognized and still under control of the Ministry of Agriculture. Therefore, it is suggested to introduce TCM theory in the spread of acupuncture, to promote acupuncture research and clinical practice, to clarify the different standards between the two countries, and to cooperate in Chinese medicine researches, especially those related to the local high incidence and refractory disease so as to promote the development of TCM in Turkey and provide medical services for local residents.

The development status and analysis of Traditional Chinese Medicine in USA / 国际中医中药杂志

American medical insurance is mainly composed of public medical insurance borne by the government and private medical insurance. The main cause of death in this country are ischemic heart disease, Alzheimer’s disease, and lung cancer. The motality rate mainly caused by drug use disorders, chronic kidney disease and Alzheimer’s disease. The development of Chinese herbal medicine is relatively slow and difficult. The education system has covered Traditional Chinese Medicine (TCM). However, there still exist certain challenges of the development of TCM acupuncture faces the challenge of localization; Chinese herbal medicine still lacks standardization and TCM education needs to be standardized. Based on the current situation, it is suggested to focus on the development of acupuncture and moxibustion, to promote the registration and declaration of Chinese herbal medicine products for treating difficult diseases, and to strengthen the international exchange of TCM education, so as to promote the development and spread of TCM in the United States.

The development status and analysis of Traditional Chinese Medicine in Thailand / 国际中医中药杂志

Thailand is a constitutional monarchy located in the central and southern part in Southeast Asia. It mainly implements the civil service insurance plan, the social insurance plan and the "Thai 30" plan, and the government bears the main health expenditures. The Thai traditional and alternative medicine system includes Thai traditional medicine, indigenous medicine and alternative medicine. Traditional Chinese Medicine (TCM) belongs to the category of alternative medicine. Currently, Thai traditional medicine and Chinese acupuncture have been included in medical insurance. With Thailand’s approval of doctors to use Chinese medicine to treat diseases published (Notification No.1 of BE 2543), a series of activities such as the establishment of national TCM center, the certification of TCM doctors, and the set of TCM courses and training have promoted TCM development in Thailand. However, the application of Chinese herbal medicine is restricted by Thai medicine laws; the practical skills of acupuncture and moxibustion is insufficient; and the TCM education is not systematic and complete. Therefore, it is recommended to carry out extensive and continuous publicity in the future to promote policy and legislative support; to strengthen research and development of Chinese patent medicine on popular diseases in Thailand and promote localization; to establish a special practice training center to improve acupuncture clinical operation capacity; to add and refine the content of TCM regarding university education system as well as short-term training; and to encourage cooperation between China and Thailand in talent exchanges and scientific researches, promoting the development of TCM in Thailand.

The development status and analysis of Traditional Chinese Medicine in Philippine / 国际中医中药杂志

The Philippines’ medical system is mainly based on the provincial responsibility system and the limited hierarchical. The Philippine government implement Philhealth program which can provide medical insurance for most people. The top 10 fatal diseases in this country includes ischemic heart disease, stroke, lower respiratory tract infection and so on. Of these diseases, the increasing rate of hypertensive heart disease, chronic kidney disease and diabetes are fast. Bone setting, massage and herbal medicine are the major form of traditional medicine in the Philippines. The acceptance of acupuncture and moxibustion by the government and local people is relatively high acupuncture and moxibustion therapy has been included in its medical insurance. There are many limitations on the development of Traditional Chinese Medicine (TCM) theory and Chinese herbal medicine in the Philippines, and the clinical application of acupuncture and Chinese herbal medicine is still limited. TCM education in the Philippines is still not systematic. Therefore, it is suggested to improve the education system of TCM, strengthen the promotion of acupuncture and moxibustion, give full play of the advantages of TCM for native high-risk diseases, and to make use of modern technologies such as telemedicine.