本文關(guān)鍵詞： 失血性休克 中醫(yī)藥 系統(tǒng)評(píng)價(jià) meta分析　出處：《大連醫(yī)科大學(xué)》2016年碩士論文　論文類型：學(xué)位論文

【摘要】：背景在中國中醫(yī)藥作為輔助療法已經(jīng)被廣泛應(yīng)用于失血性休克患者的治療中,大量的隨機(jī)對(duì)照試驗(yàn)已經(jīng)對(duì)其療效進(jìn)行了研究。目的對(duì)中醫(yī)藥(Traditional Chinese Medicine,TCM)聯(lián)合西醫(yī)常規(guī)療法(Conventional Therapy)治療失血性休克(Hemorrhagic Shock,HS)患者的有效性和安全性進(jìn)行薈萃分析(Meta-analysis)。為將來中醫(yī)藥治療失血性休克的臨床推廣提供可靠的循證證據(jù)。方法用計(jì)算機(jī)對(duì)中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(China biomedical database web,CBM)、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫(China national knowledge infrastructure databases,CNKI)、美國國立圖書館因特網(wǎng)檢索系統(tǒng)(Pub Med)、科學(xué)指引數(shù)據(jù)庫(Science Direct database)、荷蘭醫(yī)學(xué)文摘(EMBASE)、考克蘭圖書館(Cochrane Library)、萬方(Wang Fang data)、維普(VIP)等數(shù)據(jù)庫進(jìn)行全面的檢索,檢索的起始時(shí)間為數(shù)據(jù)庫的建立時(shí)間,截止時(shí)間為2015年12月。符合中醫(yī)藥聯(lián)合常規(guī)西醫(yī)治療與單獨(dú)使用西醫(yī)常規(guī)治療失血性休克相比較的臨床隨機(jī)對(duì)照試驗(yàn)(randomized clinical trials,RTCs)將會(huì)被納入,由2名評(píng)價(jià)員根據(jù)Cochrane系統(tǒng)評(píng)價(jià)手冊(cè)5.1.0版本對(duì)納入研究的偏倚風(fēng)險(xiǎn)以及文獻(xiàn)質(zhì)量獨(dú)立進(jìn)行評(píng)價(jià),并對(duì)納入研究的詳細(xì)信息進(jìn)行提取。利用Rev Man5.2軟件對(duì)納入文獻(xiàn)的主要終點(diǎn)指標(biāo)及次要終點(diǎn)指標(biāo)進(jìn)行合并統(tǒng)計(jì)分析,利用風(fēng)險(xiǎn)比(risk ratio,RR)、均數(shù)差(mean difference,MD)以及95%可信區(qū)間(95%CI)對(duì)效應(yīng)值進(jìn)行評(píng)估,利用STATA 12.0軟件對(duì)發(fā)表偏倚進(jìn)行評(píng)估。結(jié)果共有15篇隨機(jī)對(duì)照試驗(yàn)符合我們的標(biāo)準(zhǔn)被納入,共包含了1076名受試者,且均為中文發(fā)表。本次的Meta分析結(jié)果顯示:(1)在降低死亡率層面,中醫(yī)藥聯(lián)合西醫(yī)常規(guī)治療治療失血性休克的療效要優(yōu)于單純西醫(yī)常規(guī)治療(RR=0.24,95%CI:0.13-0.46,P0.0001);(2)在減少多器官功能障礙綜合征(multiple organ dysfunction syndrome,MODS)的發(fā)生率方面,中醫(yī)藥聯(lián)合西醫(yī)常規(guī)治療失血性休克要優(yōu)于單純的西醫(yī)常規(guī)治療(RR=0.47,95%CI:0.34-0.66,P0.00001);(3)在增強(qiáng)心功能,穩(wěn)定心率方面,聯(lián)合治療組具有明顯優(yōu)勢(shì)(MD=-7.6,95%CI:-9.17—-6.02,P0.00001);(4)失血性休克復(fù)蘇時(shí)期,聯(lián)合治療組在升壓、穩(wěn)壓方面要優(yōu)于單純西醫(yī)常規(guī)治療(MD=8.83,95%CI:6.82-10.84,P0.00001);(5)在改善腎臟血流灌注、增加尿量輸出方面,聯(lián)合治療組優(yōu)于單純西醫(yī)常規(guī)治療(MD=7.26,95%CI:5.00-9.53,P0.00001)。用STATA 12.0軟件檢測(cè)發(fā)表偏倚時(shí),漏斗圖和Egger檢驗(yàn)結(jié)果提示各研究間沒有潛在發(fā)表偏倚。所有納入的研究都未對(duì)不良反應(yīng)進(jìn)行報(bào)道。結(jié)論中醫(yī)藥聯(lián)合西醫(yī)常規(guī)治療失血性休克比單純的西醫(yī)常規(guī)治療更具優(yōu)勢(shì)。但是,中醫(yī)藥治療失血性休克的機(jī)制目前尚不清楚,未來需要進(jìn)行更多的動(dòng)物實(shí)驗(yàn)和臨床試驗(yàn)來探索其具體機(jī)制。此外,本次meta分析也存在一定的局限性,一方面是納入文獻(xiàn)的方法學(xué)質(zhì)量問題:納入文獻(xiàn)都說明是隨機(jī)分組,但是大部分研究都沒有詳細(xì)描述隨機(jī)分配序列的產(chǎn)生方法,而且都沒有描述隨機(jī)序列的隱藏方法,所有試驗(yàn)都沒有說明盲法的具體實(shí)施過程;另一方面聯(lián)合治療組中使用干預(yù)藥物的組方(單品、復(fù)方或注射液)、劑量和療程的差異也是導(dǎo)致我們不能得出一個(gè)明確結(jié)論的原因。未來需要更多的經(jīng)過嚴(yán)格設(shè)計(jì)的、多中心的、大規(guī)模的前瞻性隨機(jī)對(duì)照試驗(yàn)來增加中醫(yī)藥治療HS臨床療效的可靠性與確切性。
[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.

【學(xué)位授予單位】：大連醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R278

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