中医药治疗失血性休克的系统评价

发布时间：2018-02-12 02:44

本文关键词： 失血性休克中医药系统评价 meta分析　出处：《大连医科大学》2016年硕士论文　论文类型：学位论文

【摘要】：背景在中国中医药作为辅助疗法已经被广泛应用于失血性休克患者的治疗中,大量的随机对照试验已经对其疗效进行了研究。目的对中医药(Traditional Chinese Medicine,TCM)联合西医常规疗法(Conventional Therapy)治疗失血性休克(Hemorrhagic Shock,HS)患者的有效性和安全性进行荟萃分析(Meta-analysis)。为将来中医药治疗失血性休克的临床推广提供可靠的循证证据。方法用计算机对中国生物医学文献数据库(China biomedical database web,CBM)、中国学术期刊全文数据库(China national knowledge infrastructure databases,CNKI)、美国国立图书馆因特网检索系统(Pub Med)、科学指引数据库(Science Direct database)、荷兰医学文摘(EMBASE)、考克兰图书馆(Cochrane Library)、万方(Wang Fang data)、维普(VIP)等数据库进行全面的检索,检索的起始时间为数据库的建立时间,截止时间为2015年12月。符合中医药联合常规西医治疗与单独使用西医常规治疗失血性休克相比较的临床随机对照试验(randomized clinical trials,RTCs)将会被纳入,由2名评价员根据Cochrane系统评价手册5.1.0版本对纳入研究的偏倚风险以及文献质量独立进行评价,并对纳入研究的详细信息进行提取。利用Rev Man5.2软件对纳入文献的主要终点指标及次要终点指标进行合并统计分析,利用风险比(risk ratio,RR)、均数差(mean difference,MD)以及95%可信区间(95%CI)对效应值进行评估,利用STATA 12.0软件对发表偏倚进行评估。结果共有15篇随机对照试验符合我们的标准被纳入,共包含了1076名受试者,且均为中文发表。本次的Meta分析结果显示:(1)在降低死亡率层面,中医药联合西医常规治疗治疗失血性休克的疗效要优于单纯西医常规治疗(RR=0.24,95%CI:0.13-0.46,P0.0001);(2)在减少多器官功能障碍综合征(multiple organ dysfunction syndrome,MODS)的发生率方面,中医药联合西医常规治疗失血性休克要优于单纯的西医常规治疗(RR=0.47,95%CI:0.34-0.66,P0.00001);(3)在增强心功能,稳定心率方面,联合治疗组具有明显优势(MD=-7.6,95%CI:-9.17—-6.02,P0.00001);(4)失血性休克复苏时期,联合治疗组在升压、稳压方面要优于单纯西医常规治疗(MD=8.83,95%CI:6.82-10.84,P0.00001);(5)在改善肾脏血流灌注、增加尿量输出方面,联合治疗组优于单纯西医常规治疗(MD=7.26,95%CI:5.00-9.53,P0.00001)。用STATA 12.0软件检测发表偏倚时,漏斗图和Egger检验结果提示各研究间没有潜在发表偏倚。所有纳入的研究都未对不良反应进行报道。结论中医药联合西医常规治疗失血性休克比单纯的西医常规治疗更具优势。但是,中医药治疗失血性休克的机制目前尚不清楚,未来需要进行更多的动物实验和临床试验来探索其具体机制。此外,本次meta分析也存在一定的局限性,一方面是纳入文献的方法学质量问题:纳入文献都说明是随机分组,但是大部分研究都没有详细描述随机分配序列的产生方法,而且都没有描述随机序列的隐藏方法,所有试验都没有说明盲法的具体实施过程;另一方面联合治疗组中使用干预药物的组方(单品、复方或注射液)、剂量和疗程的差异也是导致我们不能得出一个明确结论的原因。未来需要更多的经过严格设计的、多中心的、大规模的前瞻性随机对照试验来增加中医药治疗HS临床疗效的可靠性与确切性。
[Abstract]:The background as adjuvant therapy has been widely used in the treatment of hemorrhagic shock patients in China Chinese medicine, a large number of randomized controlled trials have been carried out to study the effect of traditional Chinese medicine. (Traditional Chinese, Medicine, TCM) combined with conventional western medicine therapy (Conventional Therapy) in the treatment of hemorrhagic shock (Hemorrhagic, Shock, HS) effective the safety of patients for meta-analysis (Meta-analysis). To provide reliable evidence for clinical future promotion of Chinese medicine in the treatment of hemorrhagic shock. The database method for computer Chinese biological medical literature (China biomedical database web, CBM), Chinese Academic Journal Full-text Database (China National Knowledge infrastructure databases, CNKI). The National Library of Internet retrieval system (Pub Med), scientific guidelines (Science Direct database) database, Holland Medical Abstracts (EMB ASE), the Cochrane Library (Cochrane Library), Wanfang (Wang Fang data), VIP database (VIP) to conduct a comprehensive search, the starting time for the establishment of the database retrieval time, the deadline for December 2015. In line with the clinical randomized controlled trials of traditional Chinese medicine combined with conventional Western Medicine alone and conventional western medicine treatment of hemorrhagic shock compared to the (randomized clinical trials, RTCs) will be included, by 2 reviewers according to the manual evaluation of Cochrane system 5.1.0 version of the risk of bias of included studies and literature quality in independent evaluation, and the detailed information included in the study were extracted. Combined with statistical analysis of the main indicators of indicators included in the literature and the secondary end point end point using Rev Man5.2 software, using the risk ratio (risk ratio RR), mean difference (mean difference, MD) and 95% confidence intervals (95%CI) to evaluate effect value, Use STATA 12 software to assess the publication bias. Results a total of 15 randomized controlled trials met our criteria were enrolled, included 1076 subjects, which were published Chinese. The results of Meta analysis showed that the (1) in reducing mortality level, is superior to the conventional western medicine treatment of traditional Chinese medicine combined with conventional Western medicine therapy efficacy in the treatment of hemorrhagic shock (RR=0.24,95%CI:0.13-0.46, P0.0001); (2) reduction in multiple organ dysfunction syndrome (MODS multiple organ dysfunction syndrome) the incidence of traditional Chinese medicine, combined with conventional western medicine in the treatment of hemorrhagic shock is better than pure Western conventional treatment (RR=0.47,95%CI:0.34-0.66, P0.00001); (3) to improve cardiac function and stabilize heart rate, the combined treatment group has obvious advantages (MD=-7.6,95%CI:-9.17, -6.02, P0.00001); (4) hemorrhagic shock and resuscitation period, the combined treatment group in boost, Regulator is superior to the conventional western medicine treatment (MD=8.83,95%CI:6.82-10.84, P0.00001); (5) in renal perfusion, increase urine output, the combined treatment group is better than routine western medicine (MD=7.26,95%CI:5.00-9.53, P0.00001). Using STATA 12 software to detect publication bias, funnel plots and Egger test results indicate that the study did not the potential publication bias. All included studies were not adverse reactions were reported. Conclusion the traditional Chinese medicine combined with conventional western medicine in the treatment of hemorrhagic shock has more advantage than simple routine western medicine. However, traditional Chinese medicine treatment mechanism of hemorrhagic shock is not clear, the future need to explore the mechanism of animal experiment more and in clinical trials. In addition, the meta analysis has some limitations, one is the methodological quality of included literature shows that: It is randomized, but most of them are not a detailed description of the random sequence method, and can not describe the hidden method of random sequence, all the tests did not explain the specific implementation of the blind method; the use of prescription drug intervention combined treatment group (on the other hand, in a single product, compound or injection), and dose difference the course is also the cause we cannot draw a definite conclusion. The future need for more rigorous design, multi center, large prospective randomized placebo-controlled trials to increase the reliability of the clinical curative effect of the TCM treatment of HS with certainty.

【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R278

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