Core outcome set for stable angina pectoris in traditional Chinese medicine(COS-SAP-TCM)

Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.

Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.

Prescription and treatment rules for the prescriptions containing Poria cocos and Atractylodes macrocephala couplet medicine based on traditional Chinese Medicine inheritance support platform

Objectives:To provide a theoretical basis for the development of the new products of Poria cocos-Atractylodes macrocephala couplet medicine.Methods:All prescription preparations containing Poria cocos and Atractylodes macrocephala were collected from the Drug Standards of the Ministry of Public Health Drug Standard·Traditional Chinese Medicine Set Prescription Preparation(called Traditional Chinese Medicine Set Prescription Preparation for short).After standardization,the information of each prescription preparation was input into the Chinese Traditional Medicine Inheritance Support Platform(V2.5),and the relevant rules of the software were adopted.Data mining methods were used to analyze the frequency of drugs,main symptoms and diseases in prescriptions,and to analyze the regularity of prescriptions.The prescription rules of top 2 high frequency attending syndromes and diseases were analyzed.Results:There were total of 337 prescription preparations containing couplet medicine of Poria cocos and Atractylodes macrocephala,107 kinds of main symptoms and 66 kinds of diseases.The high frequency syndromes were deficiency of Qi and blood and weakness of spleen and stomach,and the high frequency syndromes were anorexia and irregular menstruation.Conclusion:The couplet medicine of Poria cocos-atractylodes macrocephala prescription is mainly used to treat digestive tract diseases and gynecological diseases;it mostly takes tonifying deficiency efficat.It can treat different diseases being compatible with different medicinal materials.The study can provide theoretical basis for clinical application and new drug development of the couplet medicine of Poria cocos-atractylodes macrocephala.

中医药治疗中风后失语临床研究核心指标集的构建

该研究基于核心指标集(core outcome set,COS)原理,参考目前国内外构建COS的流程,结合中风后失语疾病特点,构建中医药干预中风后失语有循证证据支持的COS。首先,全面检索四大中文数据库、三大英文数据库及三大临床注册中心,近五年中医药治疗中风后失语的相关文献,进行分析和归纳,形成中医药干预中风后失语临床研究核心结局清单的主要部分。其次,对临床医生及相关护理人员进行访谈,补充临床诊疗过程中认为重要的结局指标,形成核心结局指标条目池。采用2轮德尔菲问卷调查,对条目池中的核心结局指标进行重要性评分。最后,通过专家共识会议建立中医药干预中风后失语临床研究COS。最终纳入268篇研究(236篇RCTs,21篇Meta分析,11篇临床注册方案)和20份开放性问卷调查结果。经过两轮德尔菲专家调查,共14个结局指标及其对应的测量工具进入专家共识会议,最终专家共识会议确定了中风后失语COS,包含9个指标域和12个结局指标。

基于中医证候与精液质量相关参数构建精子DNA碎片预测模型与验证

背景:中医证候与精液质量相关参数相结合,共同预测精子DNA碎片指数(DNA fragmentation index,DFI)异常增高的发生并绘制列线图,能显著提高临床的实操性与应用效能,为临床全面评估精液质量,采取积极干预措施以改善临床结局及制定个体化医疗方案提供依据。目的:探讨基于中医证候与精液质量相关参数构建精子DNA碎片的预测模型与验证。方法:回顾性分析2019年7月至2021年7月在广西壮族自治区南溪山医院中医男科接受中医证候诊断及精子DNA碎片率检查的不育患者共420例,据《人类精液检查与处理实验室手册》(第6版),将其中137例精子DFI>30%患者纳入精子DFI异常增高组,将283例精子DFI≤30%作为对照组;首先采用单因素分析筛选精子DFI异常增高的影响因素,然后采用套索算法(LASSO)校正因子共线性问题并筛选出最佳匹配因子后,将其纳入多因素向前逐步Logistic回归找出其独立影响因素并绘制列线图,最后采用受试者工作曲线、校准曲线、临床决策曲线、临床影响曲线对该预测模型进行区分度与准确度及临床应用效能验证。结果与结论:①单因素分析结果显示,年龄、体质量指数、前向运动率、精子总活率、精子浓度、精子形态学、肾阳虚衰证、湿热下注证、肾精不足证为引发精子DFI异常增高的影响因子(P<0.05);②通过LASSO回归进一步筛选出的最佳匹配因素为年龄、体质量指数、精子总活率、精子浓度、精子形态学、肾阳虚衰证、湿热下注证、肾精不足证(P<0.05);③多因素向前逐步Logistic回归结果显示年龄、体质量指数、精子浓度、精子总活率、湿热下注证、肾阳虚衰证共6项为引发精子DFI异常增高的独立影响因素;④受试者工作曲线显示,模型组曲线下面积为0.760(0.713,0.806),验证组曲线下面积为0.745(0.714,0.776),说明该预测模型具有较好的区分度;⑤校准曲线平均绝对误差0.040,Hosmer-Lemeshow检验P>0.05,表明该模型预测发生精子DFI异常增高的概率与实际发生精子DFI异常增高的概率无显著统计学差异,证实该模型具有较好的准确度;⑥临床决策曲线与临床影响曲线显示,模型组与验证组分别在阈概率值为0.08-0.84与0.09-0.78时具有临床最大净获益,且在该阈概率范围内具有较好的临床应用效能;⑦结果表明,年龄、体质量指数、精子浓度、精子总活率、湿热下注证、肾阳虚衰证为引发精子DFI异常增高的独立影响因素,通过其构建的临床预测模型列线图具有较好的临床预测价值与临床应用效能,可为临床全面评估精液质量、预后与干预及个体化医疗服务提供依据。

中医药治疗孤独症谱系障碍随机对照试验结局指标分析

[目的]整理中医药治疗孤独症谱系障碍(ASD)的随机对照试验(RCTs)结局指标,分析中存在的问题,为其临床试验设计及构建核心结局指标集提供依据。[方法]计算机检索2018年1月1日至2023年12月31日中国知网(CNKI)、万方数据知识服务平台(WanFang Database)、中国生物医学文献服务系统(SinoMed)、维普中文期刊服务平台(VIP)、PubMed、Web of Science、Embase、The Cochrane Library数据库中医药治疗ASD的RCTs文献,通过文献筛选和资料提取汇总结局指标及其测量工具并进行整理和分析。[结果]共纳入72项研究,总样本量为5207例,单项研究样本量为18~169例,治疗周期为30 d~10个月;12项研究报告了ASD的中医辨证分型,64项研究报告了ASD的西医诊断标准,17项研究报告了中医诊断标准;有41项研究进行了疗效评价,共使用了13种有效率测量工具。所有研究一共涉及54个结局指标,归类进入8个指标域:临床有效率1项;中医病证类1项;症状/体征类共有35项;理化检测类13项,生活质量类3项,安全性事件类1项,远期预后和经济学评估未评估。单项RCT报告指标最少有1个,最多达8个,所有54个结局指标共应用259次,结局指标应用最多的是儿童孤独症评定量表评分(CARS),共计50次,其次是孤独症行为量表评分(ABC)共报道了45次,临床有效率指标共报道了41次。[结论]中医药治疗ASD的RCTs结局指标应用现状在临床研究中存在着试验设计方法学的不足,结局指标数量、选择的差异性大、疗效指标设计要素多,忽视不良结局指标、中医药特色指标不足等问题。研究者在遴选结局指标时,应对各种量表和临床疗效参考标准的质量及其适用性进行合理评估,注重中医病证特点,并选用权威可靠工具,助力构建中医药治疗ASD的核心指标集。

滇南正骨名医苏采臣正骨学术思想及其特色正骨手法

滇南苏氏正骨流派为中医骨伤科流派之一,滇南正骨名医苏采臣为滇南苏氏正骨流派承上启下的关键人物。该文系统总结了苏采臣的“顺”“合”“归”的正骨学术思想及其“原始创腔”“治血先治脉,复脉先复骨;整骨兼顺筋,瘀去骨自生”的正骨核心理念,并详述了5种治疗常见上肢骨折的正骨手法,即摇推法治疗桡骨远端骨折、漂浮法治疗尺桡骨双骨折、五步法治疗肱骨髁上骨折、分时段法治疗肱骨干骨折、脱套法治疗肱骨近端骨折合并肩关节脱位。苏采臣的正骨学术思想、正骨核心理念及其特色中医正骨手法,构建了滇南苏氏正骨学术思想及理论体系,可为中医治疗骨伤疾病提供治疗思路,将对中医骨伤的特色流派传承发展起到促进作用。

A real-world study of the differences in Traditional Chinese Medicine diagnosis and treatment rules for coronavirus disease 2019 between Northern and Southern China

OBJECTIVE:To explore the differences in Traditional Chinese Medicine(TCM)diagnosis and treatment rules for coronavirus disease 2019(COVID-19)between Northern and Southern China based on the real-world data from 982 COVID-19 patients.METHODS:All consecutive cases of COVID-19 admitted to the TCM department of designated COVID-19 hospitals in eight provinces and cities were retrospectively analyzed.Patients were divided into a Northern and a Southern group according to the location of the admitting hospital.The symptoms,syndrome elements,syndrome distribution and herbal treatments were analyzed.The core prescriptions were extracted using the multiscale backbone-based network comparison algorithm(msbNC).RESULTS:The distribution of syndrome elements showed that dampness was common in Northern and Southern China,wind and heat were more often present in the South,while fire toxin and spleen deficiency were more often encountered in the North.The distribution of syndromes showed that the South was dominated by heat dampness accumulating in the lung(55.69%),while the North was dominated by dampness-toxin stagnating in the lung(44.90%).The results of core prescription mining showed that dispelling dampness,dispersing wind,clearing heat and strengthening spleen were the common treatment methods in Northern and Southern China.For mild cases,Jinyinhua(Flos Lonicerae)and Lianqiao(Fructus Forsythiae Suspensae)were often used in the South to clear heat and relieve exterior symptoms,while Chaihu(Radix Bupleuri Chinensis)and Huangqin(Radix Scutellariae Baicalensis)were often used in the North to relieve muscles by expelling heat.For moderate cases,Chaihu(Radix Bupleuri Chinensis),Qinghao(Herba Artemisiae Annuae),and Shigao(Gypsum Fibrosum)were often used to clear heat of Tri-jiao Channel and stomach in the South,while Fuling(Poria),Chenpi(Pericarpium Citri Reticulatae),and Dangshen(Radix Codonopsis)were often used to invigorate spleen and remove dampness in the North.For severe cases,spleen invigoration and dampness removal as well as relaxing the bowels and discharging heat were often used in the North.CONCLUSION:There were certain North-South differences in terms of symptoms,syndrome elements and syndrome distribution of COVID-19,as well as differences in core prescriptions during different periods of the disease.The regional differences in the rules of TCM diagnosis and treatment for COVID-19 should be further considered in the process of optimization and revision of relevant treatment guidance.

健脾除湿汤联合卤米松乳膏治疗慢性湿疹临床研究

目的:观察健脾除湿汤联合卤米松乳膏治疗慢性湿疹的疗效。方法:选取2021年10月—2023年12月湖州市第一人民医院收治的80例慢性湿疹患者,按随机数字表法分为观察组与对照组各40例。对照组予以卤米松乳膏治疗,观察组在对照组基础上联合健脾除湿汤治疗。比较2组临床疗效及不良反应发生情况,比较2组治疗前后中医证候积分、湿疹面积和严重程度指数(EASI)、疼痛视觉模拟评分法(VAS)评分、白三烯B4(LTB4)、白三烯C4(LTC4)水平的变化。结果:观察组临床疗效总有效率为92.50%(37/40),对照组75.00%(30/40),2组比较,差异有统计学意义(P<0.05)。治疗后,2组中医证候主症、次症积分均较治疗前下降(P<0.05),观察组中医证候主症、次症积分均低于对照组(P<0.05)。治疗后,2组EASI、VAS评分均较治疗前下降(P<0.05),观察组EASI、VAS评分均低于对照组(P<0.05)。治疗后,2组LTB4、LTC4水平均较治疗前下降(P<0.05),观察组LTB4、LTC4水平均低于对照组(P<0.05)。观察组不良反应发生率为20.00%(8/40),对照组为25.00%(10/40),2组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:健脾除湿汤联合卤米松乳膏治疗慢性湿疹可有效抑制炎症反应,缓解湿疹严重程度及瘙痒程度,改善临床症状,疗效确切。

补阳还五汤加减联合针刺、低频重复经颅磁刺激治疗脑卒中后认知障碍临床研究

目的:观察补阳还五汤加减联合针刺、低频重复经颅磁刺激(rTMS)治疗脑卒中后认知障碍的临床疗效。方法:选取2022年7月—2023年7月于杭州市上城区人民医院治疗的脑卒中后认知障碍患者96例,按随机数字表法分为对照组和观察组各48例。对照组采用rTMS治疗,观察组在对照组基础上采用补阳还五汤加减联合针刺治疗,2组均治疗6周。比较2组临床疗效、中医证候评分、认知功能、血液流变学指标及不良反应发生率。结果:观察组总有效率为95.83%(46/48),高于对照组81.25%(39/48)(P<0.05)。治疗后,2组各项中医证候评分较治疗前降低(P<0.05),且观察组各项中医证候评分低于对照组(P<0.05)。治疗后,2组蒙特利尔认知评估量表(MoCA)评分较治疗前升高(P<0.05),且观察组MoCA评分高于对照组(P<0.05)。治疗后,2组纤维蛋白原(Fib)、血浆黏度及红细胞比容(HCT)水平较治疗前降低(P<0.05),且观察组Fib、血浆黏度及HCT水平低于对照组(P<0.05)。2组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:补阳还五汤加减联合针刺、rTMS治疗脑卒中后认知障碍效果较好,可改善患者临床症状,提高认知功能,改善血液循环,安全性较高。

探讨基于核心指标集构建中医特色的射血分数保留心力衰竭1+N模式疗效评价体系

核心指标集是就某一特定研究领域达成的所有临床研究都应该测量和报告的最少的临床结局,核心指标集可以提高临床疗效评价的规范性和可比性,是循证医学发展的必然、是中医药临床疗效评价的重要抓手、是推动中医药疗效评价与国际接轨的关键。如何运用核心指标集实现临床疗效国际化、标准化的同时,又能遵循中医诊疗特点体现自身优势是中医临床疗效评价的难点。针对这一难点,项目组创新性地提出了1+N模式的射血分数保留心衰(heart failure with preserved ejection fraction, HFpEF)疗效评价体系,即通用的核心指标集“1”+个性化指标集“N”,以满足循证医学和中医学疗效评价的双重需求。本文初探HFpEF疗效评价构建模式,主张在规范化基础上体现多样化和个性化的研究目的需求。结合HFpEF临床疗效评价的现状,综合业内专家意见,探讨了HFpEF 1+N模式疗效评价构建中核心指标集“1”的取舍以及“N”体系的构建思路,以期最大程度的形成符合中医药特色的临床评价体系新范式,推动中医药国际化进程。

“调督安神”针刺联合四逆散治疗老年顽固性失眠患者的临床观察

目的观察“调督安神”针刺联合四逆散治疗老年顽固性失眠患者的疗效,为其治疗提供方法。方法纳入2021年6月—2023年6月在遂宁市第三人民医院治疗的中医辨证为心脾两虚证的老年顽固性失眠患者102例,采用随机数字表法分为对照组和观察组,每组51例。对照组口服右佐匹克隆片,观察组在与对照组相同治疗的基础上加用“调督安神”针刺联合四逆散治疗,2组患者均持续治疗2周。比较2组临床疗效、中医证候评分和匹兹堡睡眠质量指数量表(PSQI)评分。结果观察组治疗有效率高于对照组(94.12%vs 78.43%,P<0.05)。治疗1周后,观察组患者神疲乏力、多梦易醒、头晕目眩、心悸易惊及注意力不集中评分均低于同组治疗前(P<0.05),而对照组上述各项评分与治疗前差异均无统计学意义(P>0.05);治疗2周后,两组的神疲乏力、多梦易醒、头晕目眩、心悸易惊及注意力不集中评分均低于同组治疗前,且观察组上述评分低于对照组(均P<0.05)。治疗1周后,观察组患者PSQI评分明显低于同组治疗前和对照组(均P<0.05);治疗2周后,观察组和对照组患者PSQI评分明显低于同组治疗前,且观察组PSQI评分低于对照组(均P<0.05)。结论西药右佐匹克隆片联合“调督安神”针刺与四逆散加味方治疗老年顽固性失眠患者,疗效确切,可显著改善患者的临床症状,具有一定的应用价值。

中药治疗再生障碍性贫血随机对照试验结局指标现状分析

目的:分析中药治疗再生障碍性贫血随机对照试验(RCTs)结局指标的使用现状,为构建中药治疗再生障碍性贫血的核心指标集研究提供参考。方法:检索中国知网(CNKI)、万方(Wanfang Data)、PubMed、Cochrane Library和Embase数据库,同时检索中国临床试验注册中心(ChiCTR)和Clinical Trials.gov收录的中药治疗再生障碍性贫血的研究,根据纳入标准筛选文献,评价纳入研究的偏倚风险,统计各结局指标的使用情况。结果:共纳入326项RCTs,样本量5~1 222例,共报告198个结局指标,应用总频数为2 020。结局指标按照功能属性可归到7个指标域中,包括中医病证、症状体征、理化检测、生活质量、远期预后、经济学评估和安全性事件,其中有效率、中医证候积分作为高频结局指标(分别报告了302次和52次),是中药治疗再生障碍性贫血核心结局指标的首要选择,其次应重点考虑的是中医证候有效率、不良反应、生活质量评分、生存质量。结论:中药治疗再生障碍性贫血RCTs在结局指标的使用方面存在着中医证型的诊断标准欠规范、临床疗效的评价标准不统一、指标种类多、指标数量及应用频数差异大、中医特色指标不足等诸多问题,尽快构建中药治疗再生障碍性贫血的核心指标集对推动中药治疗再生障碍性贫血临床研究具有深远的影响。

中医专业临床中药炮制学课程核心能力评价指标体系构建

目的构建中医专业临床中药炮制学课程核心能力评价指标体系,以期更加客观、全面地培养和评价学生的核心能力。方法研究小组基于教学内容和教学目标,并结合文献研究,拟订调查问卷,采用德尔菲法(Delphi)进行专家函询,形成中医专业的临床中药炮制学课程核心能力评价指标体系。结果专家函询问卷回收率为100%,各级指标的变异系数为0.067~0.481,协调系数为0.223~0.330。最终确立本轮采纳的评价指标体系:一级指标2项,二级指标9项,三级指标21项。结论中医专业临床中药炮制学课程核心能力评价指标体系科学可靠,能够客观、全面地为培养和评价中医专业本科生学习该课程的效果提供量化参考依据。

黄连温胆汤加减治疗痰热内扰型冠心病稳定型心绞痛合并慢性失眠的疗效观察

[目的]评价黄连温胆汤加减方对痰热内扰型冠心病稳定型心绞痛合并慢性失眠患者的临床疗效。[方法]收集2023年1月—2024年2月在中国中医科学院广安门医院南区心内科病房住院及门诊就诊的痰热内扰型冠心病稳定型心绞痛合并慢性失眠患者150例,试验组给予黄连温胆汤加减治疗,对照组给予佐匹克隆片治疗,疗程4周,对治疗前后匹兹堡睡眠质量指数(PSQI)、心率变异性(HRV)及中医证候积分的变化进行评价。[结果]最终138例纳入统计分析,试验组70例,对照组68例。两组治疗前后PSQI得分指标均有下降,试验组优于对照组(P<0.05),试验组有效率为88.5%,对照组有效率为76.4%。试验组优于对照组(P<0.05)。试验组在胸痛、胸闷、入睡困难、多梦、易醒、脘腹痞闷方面有所改善,在心悸、头晕、烦躁、口干口苦方面有明显疗效,在头痛、纳差方面无明显疗效。对照组在入睡困难方面具有明显疗效,在头晕方面有所改善,其余方面无明显疗效。比较两组治疗前后中医证候总积分试验组优于对照组(P<0.05)。比较两组治疗前后HRV,窦性心搏间标准差(SDNN),相邻正常心动周期差值的均方根(RMSSD),全部窦性心搏RR间期的标准差(SDANN)试验组优于对照组(P<0.05)。[结论]黄连温胆汤加减方对痰热内扰型冠心病稳定型心绞痛合并慢性失眠患者的中医证候、HRV以及失眠改善具有良好效果。

中医药治疗功能性消化不良随机对照试验结局指标现状分析

目的分析中医药治疗功能性消化不良(Functional dyspepsia,FD)的随机对照试验(Randomized controlled trial,RCT)结局指标研究现状,为中医药治疗功能性消化不良核心指标集的构建奠定基础。方法计算机检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、EMbase、PubMed、Cochrane Library数据库收录的中医药治疗FD的RCT,检索时限为2017年1月1日—2022年1月1日,2名研究者根据纳入、排除标准独立进行文献筛选与资料提取。结果共纳入了285项RCTs,28061例患者,涉及117个结局指标及28种中医证型,单项RCT指标数最多12个,最少1个,平均5个。各指标共计使用1275次,结局指标使用频次排列前5位的指标为临床总有效率(81.40%),中医症候积分(54.04%),不良反应(47.02%)、胃动素(MTL)(30.18%),症状积分(23.1%)。根据结局指标的功能属性将其分为6大指标域,其中,症状/体征(38.51%)及理化检测(28.94%)类指标应用较多。结论目前中医药治疗FD的RCT中结局指标存在指标选择差异过大、结局指标主次不分、中医疗效评价指标不一致、总有效率指标缺乏规范、指标测量时点差异大、缺乏远期预后指标、指标测量工具种类偏多且适用性差、未纳入经济学评价指标及安全性事件报告简单化等问题,亟须构建规范、标准的中医药治疗功能性消化不良核心指标集研究,解决结局指标存在的诸多问题。

中医药治疗脓毒症性急性肺损伤/急性呼吸窘迫综合征临床试验结局指标分析与思考

背景中医药治疗脓毒症性急性肺损伤(ALI)/急性呼吸窘迫综合征(ARDS)的疗效确切,但大多数已发表的临床试验设计中缺乏标准、统一的结局指标,造成同类研究结果难以合并、对比,无法产生高质量的循证证据指导临床决策。目的分析2017—2022年中医药治疗脓毒症性ALI/ARDS临床试验结局指标的使用情况。方法检索中国知网(CNKI)、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Web of Science、Embase、Cochrane Library数据库中有关脓毒症性ALI或ARDS的随机对照试验,其中干预组措施为中医药联合其他药物或常规治疗方案,对照组不做限制。采用Cochrane研发的ROB.2工具进行文献质量评价并总结结局指标分类情况。结果经筛选后纳入39篇文献,其中文献偏倚风险评估为低风险1篇(2.56%),高风险3篇(7.69%),可能存在风险35篇(89.74%)。5篇(12.82%)文献结局指标报告质量评分≥5分,为结局指标报告完整。共报告106种结局指标,累计使用443次,包括理化检测(55种,51.89%)、中医症状/证候(2种,1.89%)、症状/体征(13种,12.26%)、远期预后(19种,17.92%)、生活质量(7种,6.60%)、安全性事件(8种,7.55%)和经济学评估(2种,1.89%)。使用率>50%的结局指标有4个,分别是氧合指数(82.05%)、急性生理与慢性健康状况评分系统Ⅱ(58.97%)、机械通气时间(51.28%)和白介素6(51.28%)。21篇文献使用有效率和/或中医证候疗效的复合结局指标,包括总有效率12次,中医证候积分8次和中医症状疗效6次。由于各结局指标差异较大,对106种指标进行合并和依次归类,最终总结出3个大类,分别为:整体评价指标(36种,33.96%)、共性指标(36种,33.96%)及不同关注重点指标(34种,32.08%)。结论目前中医药治疗脓毒症性ALI/ARDS临床试验结局指标的选择尚不规范,主要表现为主次结局指标区分不明确、复合结局指标标准不统一、轻视终点指标、缺少随访数据和中医特色指标等。未来应构建脓毒症性ALI/ARDS的中医药核心结局指标集,推动中医药的高质量发展。

脾虚证动物模型研究述评

中医界运用现代科学方法进行相关研究已有多年历史,在病证动物模型上颇有收获。本文对脾虚证动物模型发展历程进行回顾,对动物选择、造模方法、评价指标、消化系统病证结合模型进行总结和评论。模型动物多选用以大鼠为代表的小型啮齿类。目前,多基于病因病机造模,而较少使用化学药物与物理因素造模,复合因素造模法最常见。评价指标则分为中医证型指标、与“脾”功能和特性有关量化指标,以及方剂反证。功能性腹泻/消化不良为代表的脾虚证病证结合模型是目前研究的重心。脾虚证动物模型研究成绩斐然的同时仍存在许多不足,如缺乏脾虚证模型行业标准和共识,评价指标缺乏系统性和整体性,脾虚理论的现代阐释缺乏统一,学界亟需解决上述问题以促进发展。

肥胖患者代谢手术前后糖脂代谢与中医证素的相关性分析

目的探讨肥胖患者代谢手术前后糖脂代谢与中医证素的相关性。方法选取2023年2月至2024年3月在中日友好医院住院行代谢手术并且术后1、3个月在门诊随访复查的肥胖患者,分别采集患者术前、术后1个月和术后3个月的血生化指标和中医证素特点,并分析二者的相关性。结果共纳入95例肥胖患者,术后1个月复查的患者共85例,术后3个月复查的患者共60例。术后1、3个月男性和女性体重、体重指数及腰围均低于术前(均P<0.05)。术后1、3个月,重度肥胖组总体体重减轻百分比均高于轻度、中度肥胖组(均P<0.001)。肥胖患者术后1、3个月空腹血糖、糖化血红蛋白、空腹胰岛素及稳态模型胰岛素抵抗指数(HOMA-IR)水平均低于术前(均P<0.05)。肥胖合并糖尿病患者热证素组空腹胰岛素、HOMA-IR水平均高于非热证素组[37.4(17.0,55.4)mIU/L比19.8(14.4,32.6)mIU/L、12.3(11.0,21.8)比6.6(5.6,11.2)](均P<0.05),且热证素与空腹胰岛素和HOMA-IR水平均呈正相关(风险比=0.371,P=0.030;风险比=0.415,P=0.026)。结论代谢手术能迅速且有效降低肥胖患者体重,改善肥胖患者的糖脂代谢。肥胖合并糖尿病患者术前热证素越明显,空腹胰岛素和HOMA-IR水平越高。