Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review

Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,Sino Med,Pub Med,Web of Science,Embase,Cochrane library,JBI,CINAHL,Psyc INFO,Clinical Trials Registry Platform portal,Clinical Trials Registry,Australian New Zealand Clinical Trials Registry,Center Watch Registry from inception to May 15,2022 to find randomized controlled trials,non-randomized controlled trials,case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage,with search terms of mastitis,acute mastitis,lactation mastitis,puerperal mastitis,breast problem,breast engorgement,milk stasis,blocked ducked,breast pain,breast massage,and acupoint massage.Outcomes and the measurement schemes(measurement methods,timing of assessing outcome,frequency of assessing outcome,measurers)were extracted from the included studies.We used the Management of Otitis Media with Effusion in Children with Cleft Palate(MOMENT)to assess the quality of each study,then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials(OMERACT)Filter 2.1 framework.Results We identified 85 clinical trials,in which 54 different outcomes were reported.A total of 81.2%(69/85)of studies were assessed as medium quality with a mean score of 2.6,and 18.8%(16/85)as low quality with a mean score of 0.9.These outcomes were organized in three core areas.Lump size(89.4%,76/85)was the most frequently reported outcome,followed by breast pain(69.4%,59/85)and milk excretion(68.2%,58/85).Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous.Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.

Effects of Chiropractic and Traditional Chinese Medicine in Treating Patients with Acute Postpartum Pubis Symphysis Pelvic Girdle Pain

[Objectives]To analyze and study the effects of chiropractic and traditional Chinese medicine on pain score and functional ambyiation category scale rating in patients with cervical spondylosis.[Methods]41 postpartum patients with acute pubic symphysis pelvic girdle pain were treated by Xiao Huoluodan Granules(orally taking one bag of Xiao Huoluodan Granules 20 g three times daily with 120-150 mL warm water after each meal),and combined with sacroiliac joint manipulation,muscle posture relaxation and muscle energy technique.[Results]After treatment,the pain score(VAS)was decreased and Holden walking function rating was improved(all P<0.001).[Conclusions]Chiropractic and traditional Chinese medicine therapy has a significant effect on the treatment of postpartum acute pubic symphysis pelvic girdle pain,and it can effectively relieve pain,improve postpartum quality of life and prevent postpartum complications.Due to its benefits,it is worthy of clinical promotion and application.

Feasibility and simulation model of a pilot scale membrane bioreactor for wastewater treatment and reuse from Chinese traditional medicine

The lack and pollution of water resource make wastewater reuse necessary. The pilot scale long-term tests for submerged membrane bioreactor were conducted to treat the effluents of anaerobic or aerobic treatment process for the high-strength Chinese traditional medicine wastewater. This article was focused on the feasibility of the wastewater treatment and reuse at shorter hydraulic retention time （HRT） of 5.0, 3.2 and 2.13 h. MLSS growth, membrane flux, vacuum values and chemical cleaning periods were also investigated. The experimental results of treating two-phase anaerobic treatment effluent demonstrated that the CODfilt was less than 100 mg/L when the influent COD was between 500-10000 mg/L at HRT of 5.0 h, which could satisfy the normal discharged standard in China. The experimental results to treat cross flow aerobic reactor effluent demonstrated that the average value of CODfilt was 17.28 mg/L when the average value of influent COD was 192.84 mg/L at HRT of 2.13 h during 106 d, which could completely meet the normal standard for water reuse. The maximum MLSS and MLVSS reached 24000 and 14500 mg/L at HRT of 3.2 h respectively. Membrane flux had maximal resume degrees of 94.7% at vacuum value of 0.02 MPa after cleaning. Chemical cleaning periods of membrane module were 150 d. A simulation model of operational parameters was also established based on the theory of back propagation neural network and linear regression of traditional mathematical model. The simulation model showed that the optimum operational parameters were suggested as follows： HRT was 5.0 h, SRT was 100 d, the range of COD loading rate was between 10.664-20.451 kg/（m3.d）, the range of MLSS was between 7543-13694 mg/L.

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.

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.

Similarity measurement of Chinese medicine ingredients for cold-hot nature identification

Objective:Nature theory of Chinese medicine (CM) is the core basic theory of Traditional Chinese Medicine (TCM), in which cold-hot nature is the focus of research. Studies have found that CM ingredients are the material basis for the production of medicine natures. Therefore, it is speculated that CMs with similar composition of substances should have similar medicinal nature. Modern work studies cold-hot medicine of CMs with chemical fingerprinting technology because the chemical fingerprint data of CM can reflect the whole composition of CM ingredients. Methods:To verify the hypothesis above, in this work, we study quantifying the similarity of CM ingredients to fingerprint similarity, and explore the relationship between the composition of CMs and cold-hot nature. Firstly, we utilize ultraviolet (UV) spectrum technology to analyze 61 CMs, which have clear cold-hot nature (including 30 ‘cold’ CMs and 31 ‘hot’ CMs). Secondly, with the constructed fingerprint database of CMs, a distance metric learning algorithm is studied to metric the similarity of UV fingerprints. Finally, a retrieval scheme is proposed to build a predictive identification model to identify cold-hot nature of CMs. Results:By means of numerous experiment analyses, ultraviolet spectrum data of petroleum ether solvent can better represent CMs to distinguish between cold and hot natures. Comparing with existing classical models, the proposed identification scheme has better predictive performance. Conclusion:The experimental results prove our inference that CMs with similar composition of substances should have similar medicinal nature. The proposed prediction model is proved to be effective and feasible.

“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。

不同中药炮制措施对中药饮片治疗效果的影响探讨

目的 分析不同中药炮制措施对中药饮片治疗效果的影响。方法 80例接受中药饮片治疗的患者,随机分为对照组与观察组,各40例。对照组在水处理前分档,观察组在水处理前分档联合炮制前分档。对比两组治疗效果及不良反应发生情况。结果 观察组治疗总有效率97.50%高于对照组的82.50%,差异有统计学意义(P<0.05)。观察组不良反应发生率5.00%显著低于对照组的20.00%,差异有统计学意义(P<0.05)。结论 不同的中药炮制措施会对中药饮片的治疗效果产生影响,水处理前分档联合炮制前分档的方式,可以使整体的治疗效果得到提升,并降低不良反应的发生率。

中医药防治射血分数保留心力衰竭的研究范式思考

射血分数保留的心力衰竭(heart failure with preserved ejection fraction,HFpEF)发病率逐年递增,患病人数庞大,如何发挥中医药防治HFpEF优势、提升中医药防治HFpEF能力成为关键。针对HFpEF自身发病特点和目前存在的问题,本文对中医药防治HFpEF的研究范式进行了探讨:(1)建立HFpEF病名、诊断、疗效评价于一体的标准化体系,从顶层设计确保研究的可比性,促进中医药研究走向国际化;(2)立足于规模化群防群治,在病证结合思路指导下分疾病阶段、抓核心病机形成核心方进行序贯治疗,在规模化防治中总结和提升疗效;(3)多学科交叉合作,对不同亚型的HFpEF诊治方案和临床转归做出精准决策;(4)在健康中国战略思维指导下,着眼长期可持续性发展,从“以预防为主,防治结合,中西医并重”的治疗理念逐渐发展到“以健康为中心”的治未病理念,从治疗HFpEF到关注HFpEF患者,再到从全局关注全生命周期的健康逐步转变。

男性情志问题与肝的相关性研究

目的:通过调查男性人群生活习惯、抑郁情绪、焦虑情绪、自尊水平等,分析男性情志问题与肝的关系,为制定男性情志问题干预策略提供依据。方法:共纳入2023年3—5月符合标准的男238例,通过问卷调查方式采集基本信息、中医肝脏象情绪量表、自尊量表等资料。结果:基本信息显示,调查对象以中青年男性为主,超重及肥胖者占59.7%,喜咸、喜辛辣和喜炙烤者偏多,47.1%有胃肠问题,17.6%有心脏问题,47.9%有睡眠问题,42.9%的男性基本不运动,男性疾病情况显示前列腺炎者14.3%、前列腺增生者4.6%、早泄者10.1%。中医肝脏象情绪量表总分异常者有169例(71.0%),抑郁情绪异常者173例(72.7%),焦虑情绪异常者152例(63.9%),肝经证候异常者134例(56.3%)。在年龄、寒热、喜咸、喜炙烤、睡眠、运动、心脏问题、胃肠问题、前列腺炎、前列腺增生、阳痿等维度,中医肝脏象情绪量表得分差异有统计学意义(P<0.05);抑郁情绪、焦虑情绪与肝经证候因子正相关;自尊水平与中医肝脏象情绪量表总分、抑郁情绪、焦虑情绪、肝经证候因子负相关。结论:男性情志问题与肝的关系密切,调节男性情志应以改善生活习惯、疏肝解郁为主要方法。

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。

门诊中药房中药饮片调剂差错原因分析及防范措施研究

分析门诊中药房中药饮片调剂差错的发生原因及防范措施。选取2022年8月—2023年8月盐城市中医院门诊中药房出现的82例中药饮片调剂差错事件,对差错原因进行分析,并提出防范对策。结果显示,82例门诊中药房中药饮片调剂差错事件中包含处方审方差错1例,药品漏配46例,药品错配11例,药品多配两例,剂量误差20例,药品发错两例。研究发现,门诊中药房中药饮片调剂差错出现的原因比较复杂,医院应加大对门诊中药房调剂人员的培训力度,提高处方开具规范性,加强处方监督,合理排班,从而降低门诊中药房中药饮片调剂差错率。

杭州市基层医疗卫生机构慢性颈肩痛患者社区中医师信任度调查

目的:了解杭州市基层医疗卫生机构慢性颈肩痛患者对社区中医师的信任度及影响因素。方法:采用自制基线调查表、维克森林医师信任度量表中文版、自制满意度量表和长海痛尺表对杭州市3家社区中的244名慢性颈肩痛患者开展信任度调查。用t检验和方差分析比较差异,采用多元线性逐步回归分析信任度得分的影响因素。结果:社区中医师平均信任度得分为(39.59±3.23)分,仁爱维度、技术能力维度得分分别为(19.32±1.96)分、(20.27±1.61分)。多因素分析结果显示,随访是否有效、文化程度、自我健康状况评分、满意度评价、中医体质以及长海痛尺评分影响对医生的信任度。结论:杭州市基层卫生机构慢性颈肩痛患者对社区中医师总体信任度处于较高水平。社区中医师要加强医学人文关怀,积极引导患者参与到诊疗过程中,重视和提高慢性病患者随访时的技术水平和关怀程度。基层医疗卫生机构应当进一步完善诊后随访流程,加大慢性病中医健康管理优势的宣传,树立分级诊疗意识,完善诊疗环境建设,形成医患信任关系的良好循环。

手足综合征的中西医防治概况

手足综合征是肿瘤患者接受化疗或分子靶向治疗后出现的特异性皮肤毒性反应,以手足皮肤红肿、疼痛、脱屑、溃疡,伴麻木、疼痛等感觉异常为特点。手足综合征的中医疗法以口服汤药、中药浸洗为主,辅以针灸等非药物手段;西医疗法则以药物对症处理为主,如控制炎症、改善血供,同时配合健康宣教、剂量控制等综合措施。研究发现,中西医防治手足综合征存在相似的作用机制,中西医联合治疗手足综合征有望成为一种可靠选择。参考文献69篇。

中医药治疗类风湿关节炎临床研究结局指标文献研究

[目的]分析中医药治疗类风湿关节炎临床试验的结局指标,为构建类风湿关节炎临床试验的核心指标集奠定基础。[方法]计算机检索中国期刊全文数据库(CNKI)、万方数据知识服务平台(WANFANG DATA)、中国生物医学文献数据库(SinoMed)、维普数据库(VIP)、PubMed、The Cochrane Library和EMbase数据库,收集中医药治疗类风湿关节炎的临床研究,检索时限设定为2020年。由两名研究者按照纳入与排除标准独立进行文献筛选和资料提取。[结果]纳入69项研究(随机对照试验56项,非随机同期对照研究3项,病例对照研究9项,自身前后对照研究1项),共计4077例患者,37个(类)结局指标。单篇文章使用指标数量差异大,为3~29个,平均为11个。使用频数排前10位的指标依次为:红细胞沉降率(73.91%)、C-反应蛋白(71.01%)、有效率(71.01%)、类风湿因子(66.67%)、不良反应(60.87%)、28个关节疾病活动度(DAS28)评分(46.38%)、视觉模拟评分法(VAS)评分(40.58%)、关节压痛数(40.58%)、晨僵持续时间(40.58%)、肿胀关节数(39.13%)。以指标功能属性为依据进行分类,所纳入研究指标域的设置比例由高到低依次为理化检测(92.75%)、疾病整体评价(91.30%)、症状/体征(73.91%)、安全性事件(60.87%)、中医病证(34.78%)、生活质量(4.35%),未涉及经济学评估及远期预后。[结论]类风湿关节炎临床试验的结局指标存在差异大、不规范、缺乏中医特色指标、缺乏远期预后与经济学评价等共性问题,亟需建立类风湿关节炎核心指标和中医药特色指标。

慢性心力衰竭伴轻度认知障碍中医证素与认知功能的相关性研究

目的:探讨慢性心力衰竭(CHF)患者中医证候要素与认知功能的相关性。方法:选取2021年5月至2022年3月北京中医药大学东方医院收治的94例CHF伴轻度认知功能障碍(MCI)患者作为研究对象,进行中医证候要素辨证,记录患者的一般资料,采用蒙特利尔认知评估量表(MoCA)对患者的认知功能进行评估,最后对中医证候要素与各项认知功能进行比较。结果:气虚证患者的视空间与执行能力评分更低,血瘀证患者的MoCA总分、注意与计算能力评分更低,痰浊证患者的MoCA总分、延迟回忆力以及抽象思维评分更低。结论:气虚证患者更容易出现视空间与执行能力的下降,血瘀证患者更容易出现注意与计算能力的下降,痰浊证患者更容易出现延迟回忆力和抽象思维能力的下降。

基于文献分析和德尔菲法的《痰湿质干预效果评价量表》条目筛选研究

[目的]初步筛选并确定痰湿质干预效果评价量表的条目。[方法]基于文献研究分析,构建痰湿质干预效果评价量表条目池,根据条目出现的频数、小组讨论及临床经验,确定初步条目并形成专家咨询问卷;采用德尔菲法,遴选19名相关研究且经验丰富的专家进行专家咨询,统计学分析并筛选条目。[结果]两轮咨询专家积极系数均为100%,专家权威系数(Cr)为0.935。经过第1轮专家咨询,11项条目修改1项,增加1项,共12项条目进行第2轮咨询;经过第2轮专家咨询,12项条目均值(MV)>3.5,满分比(FSR)>0.2。[结论]联合应用文献调研与德尔菲法筛选出痰湿质干预效果评价量表条目12项,均具有良好的代表性与可靠性,可作为评价痰湿质干预效果的条目。

中西医防控儿童轻中度近视的研究进展

随着近视日趋低龄化发展,防控工作的重点应前移至低龄儿童。本文通过回顾近年来中、西医防控低龄儿童(<11岁)轻、中度近视的研究,发现西医防控手段可一定程度上控制近视进展,但效果不够理想,且存在微生物性角膜炎、角膜溃疡等安全问题。以推拿、针灸、中药等为代表的中医适宜技术具有绿色安全、远期疗效相对稳定的特点,有利于弥补西医防控效果的不足,增强儿童近视防控的疗效与安全。

中医药创新人才智慧课堂教学评价量表构建研究

目的构建基于中医药创新人才视角的智慧课堂教学评价量表,科学评价中医药智慧课堂教学实践中的优缺点,提高教学质量。方法基于改革后的课堂教学观察评价协议量表的框架与内容,结合中医药创新人才特征构建符合智慧课堂教学特点的量表。2022年4月选取18位在中医药教育相关领域具有资深背景的专家,采用两轮德尔菲专家咨询法对量表进行修订。结果两轮函询问卷回收率均为100%,专家参与积极程度高;两轮函询专家权威系数均>0.70,专家咨询权威性较高;专家之间具有一致性;最终形成包含6项一级维度、15项二级维度、48个条目的智慧课堂教学评价量表。结论本研究编制了涵盖中医药创新人才及智慧课堂教学特点的条目内容,能综合且较全面地评价中医药创新人才视角下的智慧课堂教学,但量表还需进一步的实证研究。

重骨颗粒对膝骨关节炎患者免疫炎症水平的影响

目的观察重骨颗粒对膝骨关节炎(knee osteoarthritis,KOA)患者临床症状及相关实验室指标的影响。方法纳入60例KOA患者并分为治疗组和对照组,每组各30例。对照组予以口服盐酸氨基葡萄糖片,治疗组在对照组基础上口服重骨颗粒,两组均治疗12周。观察治疗前后疗效性评价量表和中医症状评分的变化,检测治疗前后C反应蛋白(CRP)、血沉(ESR)、IL-6、IFN-γ、骨代谢生化指标(尿Ca、尿P、BALP、TRACP-5b、IGF-1)、基质金属蛋白酶指标(MMP-1、MMP-13)、血清OPG、RANKL水平及OPG/RANKL比值。结果两组均无脱落病例,与治疗前比较,两组治疗后临床疗效指标较前均有所改善。治疗后观察组的疗效性评价量表、中医症状评分、CRP、ESR、IL-6、IFN-γ、尿Ca、尿P、TRACP-5b、MMP-1、MMP-13、RANKL水平均显著低于对照组(P<0.05或P<0.01),BALP、IGF-1、OPG水平显著高于对照组(P<0.05或P<0.01)。观察期间两组均未见明显不良反应。结论重骨颗粒可改善KOA患者临床症状,改善炎症因子及骨代谢水平,其机制可能与影响OPG/RANKL/RANK信号通路的表达有关。