针刺辅助治疗难治性肠易激综合征临床试验方案关键点设计的思考＊

肠易激综合征（Irritable bowel syndrome，IBS）是临床常见病、多发病，其治疗方法丰富，但部分患者疗效欠佳，发展成难治性IBS。目前国内外关于针灸治疗难治性IBS的临床随机对照试验尚不多见。本文立足试验方案设计的“PICOS”原则，从研究对象及诊断标准、干预措施、对照措施、结局指标四个方面入手，重点探讨针刺辅助治疗难治性肠易激综合征临床试验设计的关键要点。从选择特色优势病种、明确诊断标准、制定符合临床实际的干预方案、运用符合目标的安慰针刺、结合研究设计和目的选定结局指标几个角度，阐述试验相关环节设计的原因和思考。     

基于复杂网络的《新针灸学》与《经络腧穴学》比较分析研究（英文）

提取《新针灸学》《经络腧穴学》中穴位名称、主治病症信息,基于复杂网络建立穴-症网络,分析两者穴位数量、相互关联程度及主治规律变化,借助拓扑学数据解释变化原因,为传统针灸知识体系的结构化、标准化研究提供具体思路和方法。共纳入《新针灸学》386穴、773种症状、形成152163个穴位配伍对,《经络腧穴学》403穴、253种症状、28755个穴位配伍对。两本教材的穴-症网络存在丰富的差异性,其所载的病症结构化程度随医学知识的更新而提升。《新针灸学》模型具有更加典型的小世界效应,或因其以病症为主要分类手段的优势体现。两本教材穴位定位与主治方面发生许多变化,学科发展、时代背景等方面是变化的主要原因。     

Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine

Clinical trial outcome reporting differs between studies integrating traditional Chinese medicine (TCM) and Western medicine, so that some clinical trials are not eligible for inclusion in a systematic review. The excluded studies are therefore less widely disseminated, and even valid studies are less likely to yield impact. This problem may be addressed by developing core outcome sets (COSs) for integrative medicine in specific healthcare areas. The first stage of development is to define the scope of the COS for integrative medicine, the second stage is to establish the need for such a COS, and the third stage is to develop a protocol and register the COS. The final stage involves three steps: (i) development of a comprehensive list of outcomes (including efficacy outcomes and safety outcomes and TCM syndromes) using systematic review, qualitative or cross-sectional research, and reviews of package inserts and medical records; (ii) merging and grouping of outcomes within domains; (iii) conducting two rounds of Delphi survey and consensus meetings with a range of stakeholders. The final COS will include a general COS and core TCM syndrome- set. Development of COSs for clinical trials of integrative medicine may help to standardize outcome reporting and reduce publication bias in the future.     

不同产地丹参中隐丹参酮、丹参酮Ⅰ和丹参酮Ⅱ_A的含量比较

目的:建立测定不同产地丹参中隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA含量的方法。方法:采用反相高效液相色谱法。色谱柱为KromasilTMC18(250mm×4.6mm,5μm),流动相为甲醇-水(75∶25),流速为1mL·min-1,检测波长为270nm,柱温为30℃,进样量为10μL。结果:隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA进样量的线性范围分别为1.45～10.19、2.16～15.12、3.15～22.06μg(r分别为0.9998、0.9996、0.9997);平均回收率分别为99.44%、99.48%、99.34%,RSD分别为0.2%、0.1%、0.1%(n均为6)。不同产地丹参中隐丹参酮、丹参酮Ⅰ和丹参酮ⅡA含量差别较大。结论:本方法稳定、可靠、重复性好,可用于丹参的质量控制。     

皮下注射肾上腺素复制气滞血瘀模型的血流动力学初探

[目的]探讨皮下注射肾上腺素所致气滞血瘀模型的血流动力学变化。[方法]将24只大鼠分成肾上腺素组、生理盐水组、正常组,对各组大鼠连续2 h监测血流速度、心率、平均动脉压等血流动力学变化。[结果]皮下注射肾上腺素后,大鼠颈总动脉(CCA)血流速度下降(P<0.05),心率随时间无明显变化(P>0.05),CCA120 min平均动脉压较40 min降低(P<0.05)。肾上腺素组血流速度在60、80、100、120 min等时间点较正常组或生理盐水组均降低(P<0.05)。肾上腺素组心率较生理盐水组在60、80、100 min等时间点有所加快(P<0.05)。生理盐水组和肾上腺素组平均动脉压在0 min较正常组降低(P<0.05)。[结论]血流速度可作为肾上腺素所致气滞血瘀模型的量化评价指标,皮下注射肾上腺素后1 h是运用该模型进行活血化瘀药筛选与评价的较佳时间。     

BMSCs“归巢”在AMI后心肌重塑中的作用及活血化瘀药的干预研究

[目的]通过研究祛瘀生新中药对骨髓间充质干细胞(BMSCs)"归巢"的影响,探讨活血化瘀法对急性心肌梗死(AMI)后心肌重塑的效应机制。[方法]清洁级Wistar大鼠80只随机分为5组,分别为正常组、模型组、假手术组、中药组、西药组,每组16只。中药组大鼠术前3 d给药,1次/d。7 d后,检测外周血BMSCs含量,分析各组非梗死区心肌胶原含量,硝基四氮唑蓝(N-BT)染色评价梗死面积,并观察心肌组织苏木-伊红(H-E)染色结果及免疫组化检测心肌c-kit细胞数。[结果]药物组较模型组c-kit细胞数均明显增多,中药组与西药组相比较差异无统计学意义(P>0.05)。并能减轻心肌组织的病理损伤及降低心肌胶原含量和梗死面积。[结论]活血化瘀法可能通过对BMSCs"归巢"的动员作用,从而有效的抑制AMI后心肌重塑。     

利用德尔菲法确立乳癖辨证分型标准的研究

目的:运用德尔菲法对中医乳癖辨证分型及各证型诊断标准进行专家调研分析,制定乳癖中医诊断的行业标准。方法:共对全国42位专家进行两轮问卷调查,利用SPSS软件,对问卷反馈的数据进行专家意见的集中程度、协调程度及问卷信度进行统计与评价。结果:第一轮专家咨询共23名,专家积极系数为95.65%;第二轮专家咨询共20名,专家积极系数为100%。第一轮专家调查的内部一致信度值0.35,第二轮信度值0.734。结论:最终讨论出符合临床实际的乳癖中医辨证分型:冲任失调证、肝郁痰凝证。     

2000年—2011年针刺治疗原发性痛经临床研究的对照设置概况

合理的对照设置在针灸临床研究中具有重要作用,笔者通过对2000年—2011年间国内外发表的针刺治疗原发性痛经临床研究的对照设置情况进行分析总结,发现国内文献(111篇)中近半数未设置对照组,对照研究则主要采用西药对照;国外文献(13篇)均设置了对照组,主要采用空白及安慰对照。笔者认为国内研究者可借鉴国外常用对照设置方法,根据研究目的选择合理的对照措施,从整体上进一步提高针刺治疗原发性痛经的临床研究水平。     

中西医结合治疗小儿肱骨髁上骨折54例

目的探讨中西医结合治疗小儿肱骨髁上骨折的疗效。方法采用手法复位小夹板外固定结合手术治疗小儿肱骨髁上骨折54例,并进行临床统计。结果优40例,良8例,可5例,差1例,优良率为88．9％。结论中西医结合治疗小儿肱骨髁上骨折疗效肯定,术后并发症少。     

Clinical Practice Guideline of Acupuncture for Bell’s Palsy

Backgroud: Acupuncture is common used for Bell’s palsy in clinic, however, recent systematic reviews all shows that there is no sufficient evidence to support the effectiveness of acupuncture for Bell’s palsy because ofthe poor quality and heterogeneity. It’s urgently necessary to develop a guideline of acupuncture for Bell’s palsy based on principles of evidence-based medicine to optimize acupuncture treating, standardize outcomes evaluating and to improve the quality of acupuncture for patients with Bell’s palsy under general circumstances. Objective: To improve the accuracy of diagnosing and managing Bell’s palsy, optimize acupuncture treating and outcomes evaluating for patients with Bell’s palsy, and to improve the quality of acupuncture for patients with Bell’s palsy in most instances. Methods: This guideline was developed using an explicit and transparent a priori protocol based on supporting evidences and experts’ consensus. The guideline developing Group followed the protocol through all stages of the development process: proposed clinical questions, searched clinical evidences, evaluated levels of evidences, developed recommendations, peer reviewed and consummated, and finally formed the draft of this guideline. Results: (1)The guideline development group made a Grade A recommendation that ①With a course of Bell’s palsy within 3 months, the patients with mild facial palsy may be treated with any one of acupuncture, western drugs, or acupuncture combing with western drugs, whereas the patients with severe facial palsy may be treated with acupuncture or acupuncture combing with western drugs. With a course of more than 3 months, acupuncture is more suitable. ②Acupuncture should be applied as early as possible for Bell’s palsy. ③The principle of selecting acupoints for Bell’s palsy is to select local points, points of corresponding meridians and those according to differentiation. Generally, the points of yangming meridians are the main ones. ④The various methods of acupuncture and moxibustion are adopted for Bell’s palsy, including filiform needling, moxibustion, electro-acupuncture, etc. Two or more methods are usually used together in clinical practice. (2) The development group formed expert consensus on the principles of acupuncture treatment for Bell’ palsy. Bell’s palsy is suitably treated according to the stages, differentiation and symptoms.