目的:通过回顾分析古代医家针灸防治疫病的经验,结合针灸治疗相关呼吸道系统传染病的循证证据,挖掘针灸防治急性传染病的腧穴处方和诊疗思路,为针灸防治新型冠状病毒肺炎(Corona Virus Disease 2019,COVID-19)(简称新冠肺炎)提供间接临床证据.方法:检索古代中医针灸经典、现代研究证据和新型冠状病毒肺炎诊疗方案.提取并分析以下数据:证据来源、发表或发布的时间、作者、治疗手段、目标疾病、效果和不良反应.数据分析以定性描述的方法为主.采用Microsoft Excel 2010软件建立数据库并进行频数统计.结果:中医早在内经时代就系统地阐述了疫病的发生机制、治疗方法及预防措施,并将针灸疗法作为治疗疫病的主要方法.2项临床试验表明针灸治疗病毒性肺炎有效,2项实验证明针灸可抑制或调节相关炎性因子水平.结合《针灸干预新型冠状病毒肺炎指导意见》《新型冠状病毒肺炎恢复期中医康复指导建议(试行)》和《新型冠状病毒感染的肺炎诊疗方案(第6版)》辨证分型,提出了针灸干预新冠肺炎的诊疗思路.结论:针灸防治新冠肺炎切实可行性且具有巨大发展潜力,但是仍需大样本的临床试验证明其有效性、安全性.

腰痛患病率稳居全球第一,是人类致残的首要原因[1].我国慢性腰痛患病率为20.60％-41.54％[2],给个人及家庭生活、社会医疗系统均带来极大负担.功能障碍为腰痛临床试验的核心结局指标[3],Oswestry功能障碍指数(Oswestry dis-ability index,ODI)是功能障碍的测量工具[4].ODI量表基于中国腰痛人群的测量性能评价情况还未知.

Background The integrated traditional Chinese and Western medicine has proved to be significantly effective in low back pain. But the response rate, a key composite outcome index for assessing the efficacy, has not been unified and standardized in clinical research. Objective To perform a scoping review of the definition and contents of rate of chronic low back pain response to integrated traditional Chinese and Western medicine in clinical studies with response rate as a composite outcome indicator, offering a reference for appropriately selecting composite outcome indicators of this disease. Methods Databases including Web of Science, PubMed, EMBase, Cochrane Library, CNKI, CQVIP, Wanfang Data and SinoMed were searched for clinical studies of chronic low back pain treated by integrated traditional Chinese and Western medicine published from January 2015 to December 2019. Two researchers independently enrolled studies according to inclusion and exclusion criteria, extracted data according to the BPICOS principles, and reviewed and summarized the criteria for defining the response rate as a composite outcome indicator. Results Among 830 included studies, lumbar muscle degeneration had been studied the most 〔178 (21.4%) 〕, followed by the third lumbar transverse process syndrome〔103 (12.4%) 〕, lumbar disc herniation〔91 (11 .0%) 〕, low back pain〔89 (10.7%) 〕, lumbodorsal myofasciitis〔72 (8.7%) 〕, lumbar spinal stenosis〔69 (8.3%) 〕, and lumbar spondylolisthesis〔61 (7.3%) 〕. 808 studies (97.3%) described the reference for the definition of response rate or explained the definition of response rate developed by the author. Specifically, different versions of Criteria for the Diagnosis, Syndrome Differentiation, and Response Assessment of Diseases by Chinese Medicine was referred the most〔271 (32.7%) 〕. Clinical symptoms, level of daily life activities, pain, signs and work & living ability, these five indictors were used most frequently as composite outcome indicators, and 2-5 of them were often randomly used in combination as the third or fourth level of response criteria. In addition, common low back pain measurement tools were also used. Conclusion Due to the lack of unified standard, composite outcome indicators used for response assessment in clinical studies about chronic low back pain treated by traditional Chinese and Western medicine might have many problems, such as various definitions, division criteria, and assessment items. In view of this, it is suggested to standardize the composite outcome indicators for response assessment in accordance with the CORE Outcome Measurement and Evaluation Tool, and to improve their validity to be used in clinical studies regarding integrated traditional Chinese and Western medicine as unified indicators, thereby improving the quality and value of such studies.

Background Low back pain (LBP) is the leading cause of hypokinesia globally. Currently, the reporting of outcomes in clinical trials for LBP lacks consistency, utility, and standardization, and the results of studies in the same field cannot be combined for comparison. Thus, the homogeneity and utility of outcomes need to be enhanced. Objective To assess the quality of randomized controlled trials (RCTs) for LBP and their outcome reports, then to analyze the variations of reported outcomes and measurements among different interventions for LBP, and to explore homogeneous and practical outcome indices for LBP. Methods Four clinical trials registry platforms (Complementary Medicine Field Trials Register, Back and Neck Review Group Trials Register, ClinicalTrials.gov, WHO ICTRP) and seven databases (Cochrane Library, PubMed, Web of Science, CNKI, Wanfang Data, SinoMed, VIP) were searched for RCTs about LBP treated by traditional Chinese medicine (TCM) , western medicine (WM) and integrated traditional Chinese and western medicine (TCM-WM) published during 2017 to 2021. Information was extracted and analyzed descriptively. Results In total, 1 014 RCTs of LBP with WM treatment, 624 RCTs of LBP with TCM treatment, and 392 RCTs of LBP with integrated TCM-WM treatment were included. Overall, the quality of RCTs was low and the reporting of outcome in different interventions was deficient. Through our assessment, the total Jadad score was 2 (2, 4) for RCTs of LBP with WM treatment, 2 (2, 3) for RCTs of LBP with TCM treatment, and 2 (2, 2) for those of LBP with integrated TCM-WM treatment, with more than 50% of the RCTs having a total Jadad score of 2, and more than 10% having a Jadad score of 3. More than 80% of the RCTs had an outcome score of 1. The number of indices reported in RCTs about WM for LBP ranged from 1 to 8 (with a median value of 2) , and the top five outcome domains reported with frequency were pain level (28.2%) , physical function (28.0%) , hospital-related outcomes (8.0%) , economic indices (8.0%) , and adverse events/effects (8.0%) , and the top three scales used to evaluate outcomes were the Visual Analogue Scale (VAS) /Verbal Rating Scale (VRS) , the Oswestry Disability Index (ODI) , and Japanese Orthopaedic Association Score (JOA) . The number of indices reported in RCTs about TCM for LBP ranged from 1 to 6 (with a median value of 2) , and the top five outcome domains reported with frequency were pain level (45%) , physical function (27%) , others (14%) , overall quality of life (5%) , and musculoskeletal and connective tissue outcomes (2%) , and the main scales used included VAS/VRS, ODI, short-form McGill Pain Questionnaire (SF-MPQ) , the Numerical Rating Scale/ Numeric Pain Rating Scale (NRS/NPRS) , Roland-Morris Disability Questionnaire (RMDQ/RMD) , and 12-Item Short Form Health Survey/ 36-Item Short Form Health Survey (SF-12/SF-36) . The number of indices reported in RCTs for LBP with integrated TCM-WM treatment was 1-12 (with a median value of 2) , and the top five outcome domains reported with high frequency were physical function (39%) , pain level (34%) , others (9%) , overall quality of life (5%) , and musculoskeletal and connective tissue outcomes (4%) , and the scales used with high frequency were VAS/VRS, ODI, JOA, SF-12/SF-36, RMDQ, and NRS/NPRS. The evaluation dimensions of outcomes for three interventions were all mainly based on pain level and physical function, and the measurements were focused on the VAS/VRS scale (WM: 22.16%, TCM: 32.97%, integrated TCM-WM: 30.94%) and the ODI/CODI scale (WM: 15.88%, TCM: 18.74%, integrated TCM-WM: 20.07%) , and the common outcome indices with corresponding measurements were pain level (VAS/VRS) , physical function (ODI/RMD) , overall quality of life (SF-12/SF-36) and imaging results (X-ray/CT/MRI) . Conclusion By means of quality evaluation and data analysis, the result showed that all RCTs for LBP and their outcome reports had low-quality. The main outcome assessments among three interventions were pain level and physical function, and the main measurements were the VAS/VRS scale and the ODI/CODI scale. Pain level, physical function, quality of life, and imaging results were commonly reported through varied interventions. In brief, the results provide a basis for the future construction of Core Outcome Sets (COS) and Intervention-related Specific Outcome Sets (In-SOS) for LBP.

退行性腰椎管狭窄症(DLSS)是老年人运动系统常见病,严重影响患者生活质量.刘长信在明确DLSS西医诊断分类和中医辨证分型的基础上,研制了针对DLSS各证型的专用方,并研发了刺络中药竹罐疗法,应用于临床,疗效肯定.本文详述该疗法的技术方案,分析方药组成和用量,探讨组方思路及效验机制,以期为DLSS的治疗提供新方法和新思路.

核心结局指标集(COS)研制过程中,由于默认COS对结局指标的选择受到干预措施的影响,出现了“在特定健康状态下,根据干预措施的不同而制定不同COS的情况”.针对建立具有中医药特色的结局指标的观点,本课题组认为:结局指标的本质是反映受试者的健康状态或状态变化,特定人群中评价结局指标测量工具优劣的指标是信度、效度,结局指标的差异是中国与国外文化差异,而不是中医与西医的差别,因此结局指标的选择应该根据患者需求设立而不是干预措施.针对建立具有中医药COS的观点,本课题组认为:COS的概念中体现“核心”“所有临床研究”“最小集合”等关键词,要求不同干预下建立相同的COS,以方便横向比较;COS提出“特定健康状态”说明了特定患者群体认为重要或者期望的结局是核心结局,而且COS制定时要求限制干预制造商的参与比例以避免COS研究中的利益冲突和偏倚.据此,否定了建立中医药COS的假设.经过分析结局指标的分类后,课题组提出建立与患者特定健康状态相关的核心结局指标集(Pa-COS)和与干预措施相关的特色结局指标集(In-SOS)的新体系,以解决当前核心结局指标集研究的困境,并为COS的发展寻找新途径,建立新方法学体系.

目的 基于结局指标框架主题综合慢性腰背痛(CBP)患者的生活体验、期望等质性研究,从患者价值观角度,为CBP结局指标评估提供更广泛视角.方法 电子检索数据库PubMed、EMbase、CINAHL、PsyclNFO、Web of Science、SinoMed、中国期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)、万方数据库,时间为建库至2020年3月,使用澳大利亚JBI循证卫生保健中心质性研究质量评价的标准进行文献质量评价后,采用主题综合方法对研究结果进行分析,并对照COMET网站推荐的结局指标概念框架进行归类.结果 综合所纳入的23个研究,确定了4个主题和14个分主题:生理或临床(肌肉骨骼和结缔组织结局、一般结局),生活影响(身体功能、社会功能、角色功能、情感功能、认知功能、整体生活质量、护理提供),资源利用(经济性、进一步干预需要、社会/护理人员负担)、不良事件(药物副作用、手术有效性和安全性).结论 慢性腰背痛对患者的生理、心理、社会层面均有消极影响,在结局指标测量领域和CBP管理过程中需要全面考虑患者的真实期望.

基于患者或其疾病状态的核心结局指标集(Pa-COS)的概念,提出从体现中医药干预特点出发,构建体现中医药干预特色的结局指标集(TCM-SOS).TCM-SOS是反映中医药某一类干预(如针刺、推拿、中药等)特色的结局指标集.从方法论角度,Pa-COS与TCM-SOS的关系体现共性与个性的辩证观,Pa-COS强调特定健康状态下结局指标的共性特征,而TCM-SOS突出某类干预措施对特定健康状态下的特异性效果.研究方法上,前者强调结局指标对特定健康状态的重要性、可行性,后者强调结局指标反映措施干预后效果的特异性、显著性.以慢性腰背痛为例,阐述如何根据"反映干预措施特点"的研究目标,采用混合研究方法构建TCM-SOS的研究方法、流程及结果,从而建立一个以人群状态核心结局指标集为核心模块和能体现中医药干预特色为特异模块的模型.该模型既可以满足最小报告结局指标的要求,又可以体现中医药干预特点结局指标的诉求.

辨证论治疗效评价从评价人到评价方药,突出了评价"医者"辨证论治效果的思路和方法,据此本课题组构建辨证论治疗效评价阶梯递进式模型,阐述辨证论治阶梯递进式模型的具体内容、评价流程与步骤,探讨混合研究方法在中医辨证论治疗效评价中的应用及意义,提高辨证论治疗效评价研究的证据等级,优化中医辨证论治诊疗方案,为中医药辨证论治等复杂干预疗效评价提供方法学借鉴,促进中医药发展.

中医疗效评价指标体系由患者健康状态相关的核心结局指标集和干预措施相关的特色结局指标集构成,前者是针对特定健康领域的所有临床研究中应当报告的最小集合,后者是针对具有代表性中医干预措施的特色结局指标集合.中医疗效评价指标体系的核心基础是结局指标及其测量工具,满足测量学性能是构建中医疗效评价指标体系的前提条件.混合方法研究是一种将定性研究与定量研究有机地结合在一起的研究范式,符合中医疗效评价指标体系关于目标人群主观选择与临床客观测量的研究内容,让研究者从不同角度去分析问题,丰富研究证据以深入诠释研究问题,提高体系中结局指标的普遍性和特异性.运用混合方法研究构建国际公认、临床可行、反映中医特色结局指标的中医疗效评价指标体系,有利于为临床试验或实践提供结局指标,突出中医干预措施的特色,提高患者参与循证决策的能力,增强中医疗效评价指标体系的全面性、科学性,并为其提供新的方法学思路.

患者报告结局测量工具(PROMs)是评价与量化患者报告结局的工具,而良好的测量性能是应用PROMs的基本前提条件,但PROMs数量众多,测量性能评价欠规范、不全面,因此如何选择合适的PROMs成为临床研究中亟待解决的问题之一.基于共识健康测量工具的选择标准(COSMIN)旨在帮助临床研究人员和医务工作者选择最合适的PROMs,本研究参考COSMIN并以中国腰痛患者日常生活活动能力量表的选择为例,探讨PROMs选择路径,发现PROMs选择路径主要包含以下5项主要内容:全面检索判断是否已有工具、研制/译制工具、工具测量性能研究、系统评价、改编工具,其中系统评价是PROMs选择路径中的关键;同时,PROMs的选择并非"一蹴而就",而是一个循环向前的过程.

目的 比较肺炎相关呼吸道感染性疾病的结局指标的异同.方法 检索Comet(Core Outcome Measures in Effectiveness Trials,有效性试验核心结局指标测量)数据库肺炎相关疾病的核心结局指标集研究和Cochrane图书馆的肺炎相关Cochrane系统评价,提取不同疾病结局指标进行比较,并对照Comet推荐的结局指标概念框架进行归类.结果 综合所纳入的18个研究,涉及流感、肺炎、SARS(Severe Acute Respiratory Syndrome,严重急性呼吸综合征)、COVID-19(Coronavirus Disease 2019,新型冠状病毒肺炎)4种疾病,进行归纳合并后共获得24个结局指标,标准化分类得到5个核心域和8个结局类别:死亡(死亡率或生存率)、资源利用(住院)、生理或临床(呼吸、胸和纵膈,一般结局,传染和感染性疾病)、生活影响(生活质量,护理提供)、不良事件(不良事件).结论 具有相同生理、病理基础的不同疾病之间其结局指标存在共性和特异性,共性结局指标与疾病生理病理基础相关,特异性结局指标与疾病特异性和干预措施相关.

目的:总结膝关节疼痛患者敏化穴、激痛点、筋结点、软外压痛点的分布特征,探讨敏化穴与激痛点、筋结点、软外压痛点的相关性.方法:检索The Cochrane Library、PubMed、Web of Science、中国期刊全文数据库(CNKI)、万方数据库(WanFang)、维普数据库(VIP)、中国生物医学文献数据库(CBM),收集有关通过敏化穴和体表压痛点治疗膝关节疼痛的临床研究,提取敏化穴位与体表压痛点位置、频数、频率等,绘制敏化穴与体表压痛点分布图,计算敏化穴与体表压痛点重合率,分析敏化穴与体表压痛点相关性.结果:12篇文献3 585例膝关节敏化穴与激痛点的重合率为6.21％;敏化穴与筋结点的重合率为68.35％;敏化穴与软外压痛点的重合率为21.87％;与3类体表压痛点总重合率为96.40％.结论:穴位敏化与激痛点、筋结点、软外压痛点有一定的相关性,穴位敏化的产生机制可能不止一种,依据其解剖位置、病理改变、敏化形式等因素,其敏化发生机制各不相同.

中医临床疗效评价指标体系的建立是中医药现代化研究领域的关键问题.结局指标作为疗效评价指标体系的基础单元,首先必须满足作为一种结局评判尺度的基本功能,其次才是体现中医的特色性、代表性.所谓的中医、西医的结局指标差异源于中国与国外人群对健康状态的认知等文化差异,而非中医与西医干预措施的本身.因此,西医的某些结局指标同样适用于评价中医药疗法的特色.除此之外,证候疗效是中医的特色结局指标,指通过辨证论治、针对证候进行疾病防治所产生的效果,通过患者结局报告、健康相关生活质量量表及医生结局报告等指标构建体现辨证论治效果的特色结局指标集.中医疗效评价指标体系的层次结构上,既往研究关注中医、西医的差异进而区分结局指标归属问题,本研究则根据结局指标重要性和反映中医药特色代表性方面,提出新观点:中医疗效评价指标体系由患者健康状态相关的核心结局指标集和干预措施相关的特色结局指标集构成.前者针对特定健康领域的所有临床研究中应当报告的最小集合,包括所有的干预措施;后者针对具有代表性干预措施类别的特色指标集合.

目的 探讨以督脉大椎、百会为主穴,采用针刺疗法治疗血管性轻度认知损害的临床效果.方法 选取2017年1月～2020年1月就诊于门头沟区中医院的60例血管性轻度认知损害的患者作为研究对象,采用随机数字表法将其分为针刺组和药物组,每组各30例.两组患者均采用脑血管病二级预防及重复经颅磁刺激的治疗方法,针刺组选取督脉的大椎和百会为主穴,结合辩证选取配穴,治疗频率为3次/周.药物组予盐酸多奈哌齐5 mg口服,1次/d.按照试验要求完成为期12周的治疗后,观察两组患者的蒙特利尔认知评估量表(MoCA)、简明精神状态量表(MMSE)、画钟试验(CDT)评分变化,比较两组患者的治疗效果.结果 治疗后,两组患者的MoCA、MMSE、CDT评分均高于治疗前,差异有统计学意义(P<0.05).治疗后,针刺组患者的MoCA、MMSE、CDT评分均高于药物组,差异有统计学意义(P<0.05);治疗后,针刺组患者的总有效率为93.33％,药物组患者的总有效率为60.00％,针刺组患者的总有效率高于药物组,差异有统计学意义(P<0.05).结论 以督脉的大椎、百会为主穴,配合辩证取穴,可以有效改善血管性轻度认知损害患者的认知功能,值得推广.

目的 探讨马氏温灸法治疗寒凝血瘀型原发性痛经的临床效果.方法 选取2020年1-11月于门头沟区中医院就诊的40例寒凝血瘀型原发性痛经患者作为研究对象,采用随机数字表法将其分为对照组与观察组,每组各20例.两组患者均于月经来潮前1周开始治疗,对照组患者采用艾灸盒艾灸八髎穴,观察组患者采用马氏温灸法,均为1次/d,每个月经周期连续治疗7d,共治疗3个月经周期.比较两组患者治疗前后的视觉模拟评分法(VAS)评分及治疗效果.结果 治疗前,两组患者的VAS评分比较,差异无统计学意义(JP＞0.05);治疗3次后,两组患者的VAS评分低于治疗前,差异有统计学意义(P＜0.05);治疗后,观察组患者的VAS评分低于对照组,差异有统计学意义(P＜0.05).观察组患者的疗效优于对照组,差异有统计学意义(P＜0.05).结论 马氏温灸法治疗寒凝血瘀型原发性痛经的临床效果较好,值得推广.

目的:探索宫廷理筋术改良手法治疗慢性非特异性腰痛(CNLBP)的有效性及安全性.方法:将68例CNLBP患者随机分为针刺组和推拿组,针刺组予针刺联合红外光照射治疗,推拿组予宫廷理筋术改良手法治疗.两组均治疗6次,在4周内完成.比较两组治疗前,第1、6次治疗结束后,治疗结束1个月后疼痛数字评分(NRS)、中文版Oswestry功能障碍指数(ODI)、自拟功能障碍评分.对所收集数据进行统计分析.结果:两组在治疗后各时间点的NRS评分、ODI指数、自拟功能障碍评分较治疗前均显著降低(P＜0.05);推拿组在第1次治疗结束后、治疗结束1个月后的NRS评分显著低于针刺组(P＜0.05),两组在其他时点的NRS评分以及各时点的ODI指数和自拟功能障碍评分差异均无统计学意义.两组治疗过程中均未发生不良事件.结论:宫廷理筋术改良手法治疗CNLBP安全、有效,值得临床推广.

临床结局指标在临床实践和临床试验中具有重要地位.分析叙事医学和循证医学对于在临床活动中践行患者价值观的异同,提出医患不同的价值观导致临床结局指标评价存在差异性,认为目前的结局指标体系间接忽略了患者认为重要的结局指标,一定程度上误导了临床实践.因此,提出在叙事医学理念下,建立医患共建临床结局指标体系,阐述叙事医学理念指导下医患共建临床结局指标体系对中医临床的意义,以期为中医临床结局指标研究提供新思路、新方法.

Objective:To explore the clinical effect of the Ozone-Acupuncture therapy on chronic pain.Methods:A total of 33 patients with chronic pain, who were treated in the Department of Massage and Pain of Dongzhimen Hospital from January 2019 to October 2019, were selected. All patients were treated with the Ozone-Acupuncture, once a week, five times for one course of treatment. After one course, the Numberal Rating Scale (NRS) was used to evaluate the movement function and pain severity. The adverse events were recorded during the treatment.Results:After treatment, the pain NRS scores of 33 patients decreased to 2.0 (2.0) from 7.0 (3.0), which the difference was statistically significant ( P<0.01) , and the patients with lumbar disc herniation, knee osteoarthritis, lumbar muscle strain and other chronic pain improved significantly ( P values were 0.005, 0.011, 0.041, 0.026), but no significant among the patients with herpes zoster neuralgia ( P=0.066). The dysfunction NRS scores decreased to 2.0 (2.0) from 6.0 (4.0), which the difference was statistically significant ( P<0.01), and the patients with lumbar disc herniation, knee osteoarthritis, lumbar muscle strain and other chronic pain was more obvious ( P values were 0.007, 0.026, 0.039, 0.028), but no significant among the patients with herpes zoster neuralgia ( P=0.102). During the follow-up period of all patients, no adverse events were found. Conclusion:The Ozone-Acupuncture therapy can relieve pain, improve functional activity safely. However, multi-center, high-quality randomized controlled trials will be warranted in future.

根据证候疗效应回归其本来定位的观点——证候疗效是指通过辨证论治、针对证候进行疾病防治所产生的效果,是从干预措施的角度对临床结局及其评价指标的一种分类,突出干预措施的治疗特点,可以通过构建证候疗效特色结局指标集来体现辨证论治的效果特点.体现辨证论治干预效果的结局指标集合具有整体性、个体化、动态化的特点.由于辨证论治产生的效果可以根据其治疗的不同阶段进行分层表达,在整体层次的效果可以用患者结局报告及中医医生结局报告来评价.对于微观层次或疾病层次的效果则可以借鉴目前已经被广泛使用的指标与方法来评价.两个层次的评价指标和方法,相互联系但不可替代,具体选择哪一层次的方法与指标则要根据临床实践或研究目的来确定.