1.Internal rib fixation combined with external chest fixation and mechanical ventilation for traumatic flail chest with pulmonary contusion
Ziteng ZHANG ; Zhiliang HU ; Ling ZONG ; Ming MA ; Chunyang MENG
Chinese Journal of Trauma 2015;31(10):895-898
Objective To analyze the clinical efficacy of internal rib fixation combined with external chest fixation and mechanical ventilation for traumatic flail chest with pulmonary contusion.Methods Sixty cases of traumatic flail chest with pulmonary contusion treated from January 2011 to December 2014 were assigned to experimental group (30 cases) and control group (30 cases) according to the random number table.Patients in control group received thoracic external fixation combined with mechanical ventilation.In experimental group the patients received the same care but in addition they had rib fixation.The two groups were compared with regard to general condition, arterial blood gas as well as vital signs before treatment and 24 hours after treatment, lung function 3 months after discharge, complication rate and mortality.Results ICU stay [(6.8 ± 1.0) d], hospital stay [(15.0 ± 1.8) d] and duration of mechanical ventilation [(4.8 ± 1.0) d] in experimental group were significantly lower than these in control group [(13.6 ± 2.5) d, (21.4 ± 2.6) d, (10.3 ± 1.3) d, respectively] (P < 0.01).After treatment for 24 hours in either group, the pH value, PaO2, oxygenation index and systolic pressure (SBP) were significantly increased, and partial pressure of carbon dioxide (PaCO2), heart rate (HR) and respiratory rate (RR) were significantly lowered as compared to these before treatment (P <0.05).After treatment for 24 hours, experimental group demonstrated significantly enhanced levels in pH value,PaO2, oxygenation index and SBP but lowered levels in PaCO2, HR and RR as compared to control group (P < 0.05).Three months after discharge, forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), 75% forced expiratory flow (FEF75%) and total lung capacity (TLC) in experimental group were (81.7 ±2.6)%, (75.4 ±4.1)%, (83.2 ±4.6)%,(69.1 ±2.3)%, and (88.7 ±3.4)% respectively, significantly higher than (69.0 ±3.6)%, (71.3 ± 3.9) %, (78.9 ± 4.3) %, (62.3 ± 3.3) %, and (79.0 ± 4.6) % respectively in control group (P <0.01).In experimental group, there were four cases of pulmonary infection (13%), three pulmonary atelectasis(10%) and one intercostal neuralgia (3%).In control group, there were six cases of pulmonary infection (20%), five pulmonary atelectasis (17%), four intercostal neuralgia (13%) and four thoracocyllosis(13%)(P <0.05).There was no significant difference in mortality between the two groups.Conclusion Treatment effect of internal rib fixation for flail chest with pulmonary contusion is improved in combination with mechanical ventilation and external chest fixation.
2.Application and Enlightenment of WHO Drug Pricing Method in Medical Insurance Pricing of Proprietary Chinese Medicine in China
Yijiu YANG ; Bin LIU ; Haili ZHANG ; Ning LIANG ; Tian SONG ; Wenjie CAO ; Huizhen LI ; Xingyu ZONG ; Weili WANG ; Dingyi WANG ; Ziteng HU ; Yanping WANG ; Sheng HAN ; Nannan SHI
Chinese Health Economics 2023;42(12):53-56
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.
3.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 3): Identification of Clinical Questions
Ziteng HU ; Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Zhao CHEN ; Yin JIANG ; Cuicui CHENG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):55-59
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.
4.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 7): Introduction and Interpretation of the Guideline Reporting Checklist
Yujing ZHANG ; Fuqiang ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Haili ZHANG ; Huizhen LI ; Qianzi CHE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):178-184
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.
5.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT
Fuqiang ZHANG ; Ziteng HU ; Yujing ZHANG ; Lijiao YAN ; Juyi WANG ; Cehan ZHANG ; Jiaqi CHEN ; Mengyi WANG ; Shuoming LIU ; Xinyi XIE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):185-191
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.
6.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 1):Concept and Current Practice
Lijiao YAN ; Ning LIANG ; Ziteng HU ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Xiaoling LI ; Wenjie CAO ; Chen ZHAO ; Cheng LYU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):269-274
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.
7.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 2): Development Process and Key Steps during Preparation Stage
Yujing ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Xiaoling LI ; Qianzi CHE ; Jingya WANG ; An LI ; Nannan SHI ; Yanping WANG ; Ning LIANG
Journal of Traditional Chinese Medicine 2024;65(3):275-280
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.
8.Interpretation of the Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine:weighting of evaluation indicators
Haili ZHANG ; Bin LIU ; Weili WANG ; Wenjie CAO ; Yijiu YANG ; Ziteng HU ; Yaxin CHEN ; Ning LIANG ; Huizhen LI ; Qianzi CHE ; Xingyu ZONG ; Zhao CHEN ; Yanping WANG ; Nannan SHI
China Pharmacy 2024;35(7):773-777
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.
9.Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine(Part 1): Development Status and Characteristics
Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Ziteng HU ; Yaxin CHEN ; Huizhen LI ; Haili ZHANG ; Zhao CHEN ; Yin JIANG ; Bin LIU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):44-49
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.
10.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine: 2.Establishment of Guideline Working Group and Management of Conflict of Interests
Yaxin CHEN ; Ning LIANG ; Lijiao YAN ; Ziteng HU ; Yujing ZHANG ; Fuqiang ZHANG ; Haili ZHANG ; Huizhen LI ; Yijiu YANG ; Jing GUO ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):50-54
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.