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Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese medicine and Western medicine

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Military Medical Research 2024年第3期11卷 313-322页

作者： Ying-Hui Jin Yan-Ping Wang Ying-Lan Xie Gui-Hua Tian Xiao-Yu Zhang Nan-Nan Shi Ke-Hu Yang Xin Sun Yao-Long Chen Da-Rong Wu Xin-Feng Guo Long Ge Chen Zhao Cheng Lu Yin Jiang Jing Guo Si-Yu Yan Yong-Bo Wang Qiao Huang Xiang-Ying Ren Ying-Yue Rao Yun-Yun Wang Meng-Qian Yuan Xian-Tao Zeng Hong-Cai Shang center for evidence-based and Translational Medicine Zhongnan Hospital of Wuhan UniversityWuhan 430071China Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical SciencesBeijing 100700China China center for evidence based Traditional Chinese Medicine Beijing 100029China Hubei Provincial Hospital of Traditional Chinese Medicine Wuhan 430074China Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China evidence-based Medicine center School of Basic Medical SciencesLanzhou UniversityLanzhou 730000China China center for evidence-based Medicine West China Hospital of Sichuan UniversityChengdu 610041China State Key Laboratory of Dampness Syndrome of Chinese Medicine the Second Affliated Hospital of Guangzhou University of Chinese MedicineGuangzhou 510120China evidence-based Medicine Team Guangdong Provincial Hospital of Traditional Chinese MedicineGuangzhou 510120China Nanjing University of Chinese Medicine Nanjing 210023China Jiangsu Province Hospital of Chinese Medicine Nanjing 210029China

Integrated traditional Chinese medicine(TCM)and Western medicine(WM)is a new medical science grounded in the knowledge bases of both TCM and WM,which then forms a unique modern medical system in China.Integrated TCM and WM has a long history in China,and has made important achievements in the process of clinical diagnosis and treatment.However,the methodological defects in currently published clinical practice guidelines(CPGs)limit its development.The organic integration of TCM and WM is a deeper integration of TCM and WM.To realize the progression of"integration"to"organic integration",a targeted and standardized guideline development methodology is needed.Therefore,the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

关键词： Methodology Traditional Chinese medicine Western medicine Organic integration Clinical practice guidelines(CPGs)

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Formulation of international standards of Chinese medicine technology:clinical practice guide of Chinese medicine for cough

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Journal of Traditional Chinese Medicine 2024年第2期44卷 396-402页

作者： FANG Hanyu HONG Zheng LI Deming ZHANG Hongchun SHI Yihang LI Xiaojuan SUN Zengtao CHEN Wei ZHANG Chuchu ZU Yaqi Beijing University of Chinese medicine Beijing 100029China Department of Traditional Chinese Medicine for Pulmonary Diseases Center of Respiratory MedicineChina-Japan Friendship HospitalBeijing 100029 National center for Respiratory Medicine Beijing 100029China Department of Traditional Chinese Medicine for Pulmonary Diseases Center of Respiratory MedicineChina-Japan Friendship HospitalBeijing 100029China Tianjin University of Traditional Chinese Medicine Tianjin 301617China Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300250China center for evidence-based Medicine Beijing University of Chinese MedicineBeijing 100029China Institute of Information on Traditional Chinese Medicine China Academy of Chinese Medical SciencesBeijing 100700China

OBJECTIVE:To formulate the first clinical practice guideline for the treatment of cough using Chinese medicine based on the grading of recommendations assessment,development,and evaluation(GRADE)systematic approach,including clinical evidence,evaluation of ancient literature,and expert consensus.METHODS:In the process of development,the regulation of"evidence-based,consensus-assisted,and empirical"was followed,and a comprehensive systematic approach of recommendation assessment,GRADE,evidence-based evaluation,expert consensus,and the Delphi method was used.In the process of guideline development,evidence-based evaluation of ancient literature was included for the first time,and clinical evidence was fully integrated with clinical expert consensus.RESULTS:The clinical practice guidelines for the treatment of cough with Chinese herbal medicine were developed after a comprehensive consideration of evidence-based evaluation and expert opinions.The guideline recommendations focused on recommending herbal compound decoctions and Chinese patent medicines for cough in different conditions.based on the GRADE systematic approach,we conducted an evidence-based evaluation of the recommended Chinese patent medicines one by one;meanwhile,the expert consensus method was used to unify the recommendations of both.CONCLUSION:based on clinical evidence,ancient literature evaluation,and expert consensus,a clinical practice guideline for Traditional Chinese Medicine(TCM)in the treatment of cough was developed,providing the first current clinical practice guideline for domestic and foreign TCM and Western medicine practitioners,especially respiratory professionals at home and abroad.

关键词： Medicine Chinese Traditional clinical practice cough practice guide international standard

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Epidemiology of insertional and midportion Achilles tendinopathy in runners:A prospective cohort study

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Journal of Sport and Health Science 2024年第2期13卷 256-263页

作者： Wenbo Chen Kyra L.A.Cloosterman Sita M.A.Bierma-Zeinstra Marienke van Middelkoop Robert-Jan de Vos Department of Orthopaedic Surgery and Sports Medicine Erasmus MC University Medical CenterRotterdam 3015GDthe Netherlands Department of General practice Erasmus MC University Medical CenterRotterdam 3015GDthe Netherlands Department of Sports Medicine Huashan HospitalFudan UniversityShanghai 200040China

Background:Achilles tendinopathy(AT)is a common problem among runners.There is only limited evidence for risk factors for AT,and most studies have not defined the AT subcategories.No study has compared the incidence and risk factors between insertional AT and midportion AT,though they are considered distinct.This study aimed to assess incidence and risk factors of AT based on data from a large prospective cohort.The secondary aim was to explore differences in risk factors between insertional and midportion AT.Methods:Participants were recruited from among registered runners at registration for running events.Questionnaires were completed at baseline,1 month before the event,1 week before the event,and 1 month after the event.Information concerning demographics,training load,registered events,and running-related injuries were collected at baseline.The follow-up questionnaires collected information about new injuries.A pain map was used to diagnose midportion and insertional AT.The primary outcome was the incidence of AT.Multivariable logistic regression analysis was applied to identify risk factors for the onset.Results:We included 3379 participants with a mean follow-up of 20.4 weeks.The incidence of AT was 4.2%.The proportion of insertional AT was 27.7%and of midportion AT was 63.8%;the remaining proportion was a combined type of insertional and midportion AT.Men had a significantly higher incidence(5%,95%confidence interval(95%CI):4.1%-6.0%)than women(2.8%,95%CI:2.0%-3.8%).AT in the past12 months was the most predominant risk factor for new-onset AT(odds ratio(OR)=6.47,95%CI:4.27-9.81).This was similar for both subcategories of AT(insertional:OR=5.45,95%CI:2.51-11.81;midportion:OR=6.96,95%CI:4.24-11.40).Participants registering for an event with a distance of 10/10.55 km were less likely to develop a new-onset AT(OR=0.59,95%CI:0.36-0.97)or midportion AT(OR=0.47,95%CI:0.23-0.93).Higher age had a significant negative association with insertional AT(OR=0.97,95%CI:0.94-1.00).Conclusion:The incidence of new-onset AT

关键词： Achilles tendon injury Incidence Risk factor Running-related injury

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Organic Integration of Traditional Chinese and Western Medicines—Future of Clinical practice Guidelines of Integrated Traditional Chinese and Western Medicines

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Chinese Journal of Integrative Medicine 2024年第4期30卷 359-365页

作者： XIE Ying-lan HAN Fei JIN Ying-hui DING Yan-bing GUO Jing JI Dong-xiao ZHANG Teng CHENXiao-min SHANG Hong-cai Department of Traditional Chinese Medicine Encephalopathy Hubei Provincial Hospital of Traditional Chinese MedicineWuhan(430074)China Department of Traditional Chinese Medicine Encephalopathy Hubei Province Traditional Chinese Medicine Research InstituteWuhan(430074)China Xuanwu Hospital of Traditional Chinese Medicine Beijing(100000)China center for evidence-based and Translational Medicine Zhongnan Hospital of Wuhan UniversityWuhan(430074)China College of Acupuncture and Massage College of Health and RehabilitationNanjing University of Chinese MedicineNanjing(210023)China Department of Ophthalmology Huaihe Hospital of Henan UniversityKaifengHenan Province(475000)China Ministry of Education and Beijing Key Laboratory of Internal Medicine of Traditional Chinese Medicine Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine/Ministry of Education and Beijing Key Laboratory of Internal Medicine of Traditional Chinese MedicineBeijing(100700)China

The transformation and implementation of clinical practice guidelines for integrated traditional Chinese medicine(TCM)and Western medicine(WM)is crucial to the adoption of medical science and technological findings and is an important way for TCM to be made available to the world.First,clinical practice guidelines(CPGs)of TCM and WM integration in recent years was analyzed to clarify the current situation and problems in the existing guidelines according to the following four perspectives:(1)perspective of TCM and WM integration in guidelines,(2)diagnosis Using integrated TCM and WM,(3)integration of TCM and WM treatment,(4)promoting TCM and WM integration.Secondly,the information and quality evaluation of CPGs for integrated Chinese and Western medicine in 2020–2022 were analyzed to explore the degree and methods of integration of Chinese and Western medicine guidelines.And last this study aimed to lay a foundation for the further establishment of Chinese characteristic,repeatable,and calculable clinical practice guidelines of TCM and WM integration.

关键词： clinical practice guidelines integrated traditional Chinese and Western medicine organic integration

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Effects of exosomes from mesenchymal stem cells on functional recovery of a patient with total radial nerve injury: A pilot study

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World Journal of Stem Cells 2024年第1期16卷 19-32页

作者： ErdinçCivelek Serdar Kabatas Eyüp Can Savrunlu Furkan Diren Necati Kaplan Demet Ofluoğlu Erdal Karaöz Department of Neurosurgery University of Health SciencesGaziosmanpaşa Training and Research HospitalGaziosmanpaşa 34255IstanbulTurkey Department of Neurosurgery University of Health Sciences TurkeyGaziosmanpaşa Training and Research HospitalGaziosmanpaşa 34255IstanbulTurkey center for Stem Cell&Gene Therapy Research and practice University of Health Sciences TurkeyGaziosmanpaşa 34255IstanbulTurkey Department of Neurosurgery Nevşehir State HospitalNevşehir 50300Turkey Department of Neurosurgery Istanbul Rumeli UniversityÇorlu Reyap HospitalÇorlu 59860TekirdağTurkey Department of Physical Medicine and Rehabilitation Ofluoğlu KlinikGöztepe 34728IstanbulTurkey Liv Hospital Center for Regenerative Medicine and Stem Cell Research&Manufacturing(LivMedCell)Beşiktaş34340IstanbulTurkey Department of Histology and Embryology Istinye UniversityFaculty of MedicineZeytinburnu 34010IstanbulTurkey Istinye University Center for Stem Cell and Tissue Engineering Research and PracticeBeşiktaş34340IstanbulTurkey

BACKGROUND Peripheral nerve injury can result in significant clinical complications that have uncertain prognoses.Currently,there is a lack of effective pharmacological interventions for nerve damage,despite the existence of several small compounds,Despite the objective of achieving full functional restoration by surgical intervention,the persistent challenge of inadequate functional recovery remains a significant concern in the context of peripheral nerve injuries.AIM To examine the impact of exosomes on the process of functional recovery following a complete radial nerve damage.METHODS A male individual,aged 24,who is right-hand dominant and an immigrant,arrived with an injury caused by a knife assault.The cut is located on the left arm,specifically below the elbow.The neurological examination and electrodiagnostic testing reveal evidence of left radial nerve damage.The sural autograft was utilized for repair,followed by the application of 1 mL of mesenchymal stem cell-derived exosome,comprising 5 billion microvesicles.This exosome was split into four equal volumes of 0.25 mL each and delivered microsurgically to both the proximal and distal stumps using the subepineural pathway.The patient was subjected to a period of 180 d during which they had neurological examination and electrodiagnostic testing.RESULTS The duration of the patient’s follow-up period was 180 d.An increasing Tinel’s sign and sensory-motor recovery were detected even at the 10th wk following nerve grafting.Upon the conclusion of the 6-mo post-treatment period,an evaluation was conducted to measure the extent of improvement in motor and sensory functions of the nerve.This assessment was based on the British Medical Research Council scale and the Mackinnon-Dellon scale.The results indicated that the level of improvement in motor function was classified as M5,denoting an excellent outcome.Additionally,the level of improvement in sensory function was classified as S3+,indicating a good outcome.It is noteworthy that these assessments were conducte

关键词： Mesenchymal stem cell Exosomes Radial nerve Sural nerve

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Bloodletting puncture in the treatment of acute ischemic stroke:protocol for a mixed-method study of a multi-center randomized controlled trial and focus group

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Journal of Traditional Chinese Medicine 2023年第6期43卷 1259-1267页

作者： DAI Zeqi LIAO Xing GUAN Yueyue ZENG Zixiu TANG Jun HU Jing center for evidence based Chinese Medicine Institute of Basic Research in Clinical MedicineChina Academy of Chinese Medical SciencesBeijing 100700China Department of Encephalopathy Chongqing Hospital of Traditional Chinese MedicineChongqing 400021China evidence-based Medicine center Beijing Hospital of Traditional Chinese MedicineCapital Medical UniversityBeijing Institute of Traditional Chinese MedicineBeijing 100010China

This study is to investigate the effectiveness and safety of bloodletting puncture(BP)for acute ischemic stroke(AIS)when used in combination with standard treatment,as well as the patients'feelings and attitudes toward the treatment.This is a mixed method research which includes a multi-center,superiority,randomized controlled clinical trial,and focus group interview.A total of 360 AIS participants will be enrolled.They will be randomized into one of the following two groups for 7 d:(a)BP with standard treatment group(n=180);(b)standard treatment group(n=180).The primary outcome will be National Institute of Health stroke scale(NIHSS)score at day 7 after treatment.Secondary outcomes will be changes of Glasgow Coma Scale score,NIHSS score,mRS and Traditional Chinese Medicine syndrome score from baseline to 7,14,and 30 d after treatment,recurrence rate and all-cause mortality rate within 30 d,and the safety assessments.The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment.We designed a mixed method study to evaluate the effect of BP,an acupuncture therapy for patients with AIS.If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy,we believe this study will help the implementation of this therapy in clinical practice,and provide new evidence for the treatment of AIS.

关键词： bloodletting punctures ischemic stroke equivalence trial randomized controlled trial focus groups clinical protocols

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International standard of Traditional Chinese Medicine Techniques: Traditional Chinese Medicine guidelines for acute primary headache(2022)

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Journal of Traditional Chinese Medicine 2024年第4期 839-850页

作者： YAO Yuning CAO Kegang ZHANG Genming LIU Jianping CHEN Wei CAO Junling YANG Wenming YAN Yongmei GENG Chang JU Yi ZHAO Dexi QU Miao LI Xiaoli SUN Li HAN Zhenyun HE Liyun CUI Fangyuan FU Caihong ZHOU Bo LIAO Shuqin Department of Geriatrics Jilin Academy of Traditional Chinese Medicine Department of Neurology Shenzhen Hospital of Beijing University of Chinese Medicine Institute of Basic Research in Clinical Medicine China Academy Of Chinese Medical Sciences Department of Rehabilitation Shunyi HospitalBeijing Traditional Chinese Medicine Hospital Department of Neurology Xiyuan Hospital of China Academy of Chinese Medical Sciences Department of Neurology Dongzhimen Hospital of Beijing University of Chinese Medicine Centre for evidence-based Chinese Medicine Beijing University of Chinese Medicine Encephalopathy center First Affiliated Hospital of Anhui University of Chinese Medicine Department of Neurology Affiliated Hospital of Shaanxi University of Chinese Medicine Department of Neurology Beijing Changping District Hospital of Traditional Chinese Medicine Neurology center Beijing Tiantan HospitalCapital Medical University Department of Neurology Affiliated Hospital of Changchun University of Chinese Medicine Department of Neurology Xuanwu HospitalCapital Medical University Department of Neurology Beijing University of Chinese Medicine Third Affiliated Hospital

OBJECTIVE: To summarize the evidence from Traditional Chinese Medicine(TCM) practice in the treatment of acute primary headache and provide clinical practice guidance. METHODS: The guidelines were developed in accordance with the World Health Organization guideline development manual. After the establishment of steering committee, panel and the registration and protocol formulation, the evidence on TCM for acute primary headache from published guidelines, clinical evidence, and expert experience and consensus were collected. The grading of recommendations assessment, development and evaluation method was used to grade the evidence and make the recommendations. RESULTS: based on the available evidence, the guidelines recommended three TCM herbal decoctions, six Chinese patent medicines, and two kinds of external application of Chinese herbal medicines. Diagnostic recommendations based on the expert experience and consensus were also included in the guidelines. CONCLUSION: TCM diagnosis and treatment of decoction, Chinese patent medicine and external application for treating acute primary headache were recommended. We hope these guidelines will be helpful in standardize the TCM acute treatment of primary headache.

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Efficacy and safety of monoclonal antibodies in neuromyelitis optica spectrum disorders:A survival meta-analysis of randomized controlled trials

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Advances in Ophthalmology practice and Research 2022年第3期2卷 8-16页

作者： Xintong Xu Lindan Xie Lili Wei Meixuan Li Hao Wang Huanfen Zhou Mingming Sun Mo Yang Quangang Xu Kehu Yang Shihui Wei Medical School of Chinese PLA BeijingChina Department of Ophthalmology Chinese PLA General HospitalBeijingChina evidence-based Medicine center Lanzhou UniversityLanzhouChina Key Laboratory of evidence based Medicine and Knowledge Translation of Gansu Province LanzhouChina Gansu Medical Guideline Technology center Lanzhou UniversityLanzhouChina Department of Ophthalmology Lanzhou University Second HospitalLanzhouChina

Background Monoclonal antibodies such as rituximab(RTX),eculizumab,inebilizumab,satralizumab,and tocilizumab have been found to be effective therapies for neuromyelitis optica spectrum disease(NMOSD)in several clinical randomized controlled trials.Objective The purpose of this meta-analysis of randomized controlled trials was to assess the efficacy and safety of monoclonal antibodies in the treatment of NMOSD.Methods We searched the following databases for relevant English language literature from the establishment of the database to June 2021:PubMed,Embase,Cohorane Library,the Central Register of Controlled Trials(CENTRAL),and Web of Science.Randomized controlled trials of monoclonal antibodies were the targets of the review.Results We included seven trials containing 775 patients(485 in the monoclonal antibody group and 290 in the control group).Patients in the monoclonal group(HR 0.24,95%CI:0.14 to 0.40,P<0.00001),as well as patients with seropositive AQP4-IgG(HR 0.18,95%CI:0.11 to 0.29,P<0.00001),both had a higher free recurrence rate than that in the control group.In the first year(HR 0.25,95%CI:0.09 to 0.71,P=0.009)and the second year(HR 0.32,95%CI:0.13 to 0.81,P=0.02),no relapses were documented.The average changes of the expanded disability status scale(EDSS)score decreased by 0.29(95%CI:−0.09 to 0.51,P=0.005).Upper respiratory tract infection(OR 1.52,95%CI:0.76 to 3.04,P=0.24),urinary tract infection(OR 0.79,95%CI:0.51 to 1.21,P=0.27),and headache(OR 1.30,95%CI:0.78 to 2.17,P=0.31)were three most frequent adverse reactions.Conclusions Monoclonal antibodies are particularly effective treatments in avoiding recurrence for NMOSD patients,according to this meta-analysis.The associated adverse responses are not significantly different from those seen with traditional immunosuppressants.

关键词： NMOSD Randomized controlled trials Monoclonal antibody Meta-analysis Free-relapse Adverse events

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Meta-analysis with zero-event studies:a comparative study with application to COVID-19 data

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Military Medical Research 2022年第1期9卷 126-137页

作者： Jia-Jin Wei En-Xuan Lin Jian-Dong Shi Ke Yang Zong-Liang Hu Xian-Tao Zeng Tie-Jun Tong department of Mathematics Hong Kong Baptist UniversityHong KongChina Shenzhen Research Institute of Big Data ShenzhenChina College of Mathematics and Statistics Shenzhen UniversityShenzhenChina center for evidence-based and Translational Medicine Zhongnan Hospital of Wuhan UniversityWuhanChina.

Background:Meta-analysis is a statistical method to synthesize evidence from a number of independent studies,including those from clinical studies with binary outcomes.In practice,when there are zero events in one or both groups,it may cause statistical problems in the subsequent analysis.Methods:In this paper,by considering the relative risk as the effect size,we conduct a comparative study that consists of four continuity correction methods and another state-of-the-art method without the continuity correction,namely the generalized linear mixed models(GLMMs).To further advance the literature,we also introduce a new method of the continuity correction for estimating the relative risk.Results:From the simulation studies,the new method performs well in terms of mean squared error when there are few studies.In contrast,the generalized linear mixed model performs the best when the number of studies is large.In addition,by reanalyzing recent coronavirus disease 2019(COVID-19)data,it is evident that the double-zero-event studies impact the estimate of the mean effect size.Conclusions:We recommend the new method to handle the zero-event studies when there are few studies in a meta-analysis,or instead use the GLMM when the number of studies is large.The double-zero-event studies may be informative,and so we suggest not excluding them.

关键词： Continuity correction Coronavirus disease 2019 data Meta-analysis Relative risk Zero-event studies

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Methodological quality(risk of bias) assessment tools for primary and secondary medical studies: What are they and which is better?

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Military Medical Research 2020年第3期7卷 359-370页

作者： Lin-Lu Ma Yun-Yun Wang Zhi-Hua Yang Di Huang Hong Weng Xian-Tao Zeng center for evidence-based and Translational Medicine Zhongnan HospitalWuhan University169 Donghu RoadWuchang DistrictWuhan 430071HubeiChina Department of evidence-based Medicine and Clinical Epidemiology the Second Clinical CollegeWuhan UniversityWuhan 430071China center for evidence-based and Translational Medicine Wuhan UniversityWuhan 430071China Global Health Institute Wuhan UniversityWuhan 430072China

Methodological quality(risk of bias)assessment is an important step before study initiation usage.Therefore,accurately judging study type is the first priority,and the choosing proper tool is also important.In this review,we introduced methodological quality assessment tools for randomized controlled trial(including individual and cluster),animal study,non-randomized interventional studies(including follow-up study,controlled before-and-after study,before-after/pre-post study,uncontrolled longitudinal study,interrupted time series study),cohort study,case-control study,cross-sectional study(including analytical and descriptive),observational case series and case reports,comparative effectiveness research,diagnostic study,health economic evaluation,prediction study(including predictor finding study,prediction model impact study,prognostic prediction model study),qualitative study,outcome measurement instruments(including patient-reported outcome measure development,content validity,structural validity,internal consistency,cross-cultural validity/measurement invariance,reliability,measurement error,criterion validity,hypotheses testing for construct validity,and responsiveness),systematic review and meta-analysis,and clinical practice guideline.The readers of our review can distinguish the types of medical studies and choose appropriate tools.In one word,comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.

关键词： Methodological quality Risk of bias Quality assessment Critical appraisal Methodology checklist Appraisal tool Observational study Qualitative study Interventional study Outcome measurement instrument

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