针刺治疗慢性疲劳综合征随机对照试验的系统评价

发布时间：2018-05-02 22:44

本文选题：针刺 + 慢性疲劳综合征　；参考：《黑龙江中医药大学》2017年硕士论文

【摘要】：目的:通过循证医学系统评价与Meta分析的方法,以既往文献为检索对象,对针刺治疗慢性疲劳综合征的治疗效果和安全性进行评价,为临床针刺治疗慢性疲劳综合征提供循证医学依据。同时,对针刺治疗慢性疲劳综合征随机对照试验的设计及在方法学方面存在的问题进行探讨,以初步探索影响针刺治疗慢性疲劳综合征疗效评价的相关因素,提高临床研究质量,为今后针刺治疗慢性疲劳综合征随机对照试验的方案设计、数据总结及研究评价提供参考意见。方法:根据考科兰(Cochrane)提供的系统综述研究方法,制定科学的、有效的检索策略,对所有文献进行检索并纳入符合标准的研究,对其进行资料数据提取、方法学质量评价及结局指标报告与讨论。检索方法与筛选方法:采用计算机、手工等方式对电子数据库和杂志中的期刊文献、学位论文以及灰色文献等进行检索,计算机检索电子数据库分别为 Web of Science、Medline、Cochrane Library、Embase、Psycinfo、ICTRP、Clinical Trails、中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普数据库(VIP)、万方数据库(WANFANG);手工检索期刊杂志分别为《中国针灸》、《针刺研究》、《针灸临床杂志》和《上海针灸杂志》;另外,通过科技论文在线和Open Grey实现灰色文献或会议论文检索。检索日期均从建库到2016年12月30日。检索内容为同时包含"针刺"、"慢性疲劳综合征"的随机对照试验,首先,利用EndNoteX7文献管理软件除重,其次,根据文献的纳入、排除标准,通过阅读标题、摘要及全文,最终筛选出符合纳入标准的研究。数据提取与质量评价:资料的数据提取与质量评价,均由两名评价员独立完成,后交叉核对,如判断不一,可通过讨论或第三方裁定,所有数据结果以表格形式呈现。对于纳入的文献研究的方法学质量评价,我们采用偏倚风险评价工具(risk of bias tool)。对异质性的评估,我们不仅采用I2统计量检验,还进行χ2和它的P值检验;报告偏倚,若纳入的文献数量多于10个,则制作漏斗图对偏倚风险进行评估,由于目测漏斗图主观性较强,对偏倚风险的检验效能较低,所以我们使用Stata进行客观化较强的Egger检验;在数据合并上,当I2低于50%时,采用固定效应模型,当I2大于50%时,采用随机效应模型。结局指标:主要结局指标包括疲劳评价指标,疲劳评价采用FS-14、FSS、FAI量表。次要结局指标主要包括生活质量评价指标,采用SF-36、SF-20、SF-12量表,以及SAS量表。结果:通过计算机、手工方式对期刊文献、学位论文及灰色文献进行检索,获取文献题目、摘要2656篇。利用EndNoteX7软件剔除重复文献810篇后,将1846篇文献纳入到初筛流程,根据文献的纳入、排除标准,通过阅读标题、摘要,227篇文献进入到二次复筛流程,获取并阅读全文,最终纳入文献14篇,包括英文文献2篇,中文期刊论文12篇,共计患者1033例。1.在5个针刺对比空白对照的随机对照试验中,以FS-14作为终点指标,针刺对比空白对照能显著改善疲劳的状况,中度异质性,发表偏倚较低。在5个针刺对比假针刺治疗慢性疲劳综合征的随机对照试验中,以疲劳评定作为终点指标,针刺较假针刺能明显改善受试者的疲劳程度,异质性较高,发表偏倚较低。在4个针刺对比安慰针刺治疗慢性疲劳综合征的随机对照试验中,以疲劳评定作为终点指标,针刺较安慰针刺能明显改善受试者的疲劳程度,异质性较高,发表偏倚较低。2.纳入的研究中4个研究未报告不良反应事件,9个研究报告纳入的参与者在治疗和随访过程中均未观察到不良反应事件,1个研究报告2例不良反应事件与针刺直接相关,但症状轻微;2例严重的不良反应事件与针刺无关。结论:1.针刺在改善慢性疲劳综合征部分症状方面疗效确切。2.针刺对慢性疲劳综合征的治疗具有一定安全性,并在临床应用上有一定优势。
[Abstract]:Objective: To evaluate the therapeutic effect and safety of acupuncture in the treatment of chronic fatigue syndrome by using the methods of EBM system evaluation and Meta analysis, and to evaluate the efficacy and safety of acupuncture in the treatment of chronic fatigue syndrome, and provide evidence based medical basis for clinical acupuncture treatment of chronic fatigue syndrome. The design and the problems in methodology are discussed in order to preliminarily explore the related factors affecting the therapeutic evaluation of acupuncture for the treatment of chronic fatigue syndrome, improve the quality of clinical research, and provide a reference for the design of the randomized controlled trial of the acupuncture treatment of chronic fatigue syndrome in the future, the total data and the evaluation of the research. Cochrane (Cochrane) provides a systematic review and research method, formulating scientific and effective retrieval strategies, retrieving all documents and incorporating standard research, extracting data data, evaluating methodological quality and reporting and discussion of outcome indicators. Retrieval method and screening methods: using computer, manual and other methods Web of Science, Medline, Cochrane Library, Embase, Psycinfo, ICTRP, Clinical Trails, Chinese knowledge network (CNKI), Chinese raw material medical literature database, VP database, and Wanfang database, respectively. WANFANG); the manual retrieval journal magazines are "Chinese acupuncture >," Acupuncture Research > "," Acupuncture Clinical Journal > "and" Shanghai acupuncture magazine > "; in addition, grey literature or conference papers are retrieved through scientific papers online and Open Grey. The retrieval dates are from the building to December 30, 2016. The contents of the retrieval are including" acupuncture "and" chronic fatigue synthesis ". First, use EndNoteX7 document management software to remove weight, and secondly, according to the inclusion of the literature, the exclusion criteria, through reading the title, summary and full text, the final screening of the inclusion criteria of the study. Data extraction and quality evaluation: data extraction and quality evaluation, all of the two assessors are completed independently, then hand in Cross check, such as different judgments, can be presented in tabular form by discussion or third party adjudication. For the methodological quality evaluation of the included literature research, we use the bias risk assessment tool (risk of bias tool). To evaluate heterogeneity, we do not only use I2 statistics test, but we also carry out x 2 and its P value test. Reporting bias, if more than 10 documents are included, the funnel map is made to evaluate the bias risk. Because the visual funnel graph is more subjective and has a lower test efficiency for the bias risk, we use Stata to objectively test the Egger. When the data merge is less than 50%, the fixed effect model is used when the I2 is large. At 50%, the random effect model was used. The outcome index included the fatigue evaluation index, and the fatigue evaluation used FS-14, FSS, FAI scale. The secondary outcome indexes mainly included quality of life evaluation index, SF-36, SF-20, SF-12 scale, and SAS scale. Results: by computer, periodical literature, dissertations and ash were handmade by computer. 2656 articles were retrieved and 2656 articles were retrieved in the color literature. After 810 articles were eliminated by EndNoteX7 software, 1846 papers were incorporated into the initial screening process. According to the inclusion of the literature, the criteria were excluded, and the reading headlines, abstracts, and 227 documents were entered into the two rescreening flow, and the full text was obtained and included in the literature 14, Bao Kuoying. 2 articles and 12 articles in Chinese Journal, 1033 patients with.1. in a randomized controlled trial with 5 needles compared to blank control, with FS-14 as the end target, acupuncture compared to blank control could significantly improve the status of fatigue, moderate heterogeneity, and low publication bias. 5 needles contrast false acupuncture treatment of chronic fatigue syndrome at random. In the control experiment, with fatigue evaluation as the end point, acupuncture compared with the false acupuncture can obviously improve the fatigue degree of the subjects, the heterogeneity is higher, the publication bias is lower. In the randomized controlled trial of 4 acupuncture contrastive acupuncture and consolation acupuncture treatment for chronic fatigue syndrome, the fatigue evaluation as the terminal target, acupuncture compared with the comfort acupuncture can obviously improve the subject. The degree of fatigue and heterogeneity of the subjects were high, and 4 studies in the lower.2. had not reported adverse events. 9 of the participants had not observed adverse events during the treatment and follow-up, and the 1 studies reported that 2 cases of adverse reactions were directly related to acupuncture, but the symptoms were mild; 2 cases were serious. Adverse events have nothing to do with acupuncture. Conclusion: 1. acupuncture is effective in improving the partial symptoms of chronic fatigue syndrome..2. acupuncture has certain safety in the treatment of chronic fatigue syndrome, and has some advantages in clinical application.

【学位授予单位】：黑龙江中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R246

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