血必净对严重烧伤患者临床疗效的Meta分析

发布时间：2018-06-27 12:14

本文选题：血必净 + 严重烧伤　；参考：《广西医科大学》2013年硕士论文

【摘要】：背景：近年来国内外对严重烧伤后应用血必净治疗的临床报道较多,作为一种纯中药制剂,其临床疗效如何备受关注,目前关于血必净在严重烧伤方面应用的临床研究大多数为小样本的随机试验,缺乏循证医学方面的依据和说服力,故本文通过收纳相关文献进行Meta分析,旨在为血必净在临床上的使用提供参考。目的：对血必净在严重烧伤方面应用的临床疗效进行系统评价。方法：应用计算机检索中国生物医学文献数据库(CBM,1979/2013.3)、重庆维普中文科技期刊全文数据库(VIP,1989/2013.3)、清华同方数据库(CNKI,1979/2013.3)、万方数据库(1982/2013.3)、Pubmed、 EMBASE和Cochrane图书馆(1948-2013.3),以“血必净”和“烧伤”为中文检索词,英文检索词包括"Xuebijing"和"Burn",并辅以手工检索,收集血必净对严重烧伤患者临床治疗的随机对照试验(RCTs),同时查阅纳入文献的参考文献,以补充可能遗漏的研究,主要评价指标为(1)凝血酶原时间(PT)；(2)血液内毒素水平；(3)炎症因子白细胞介素-6(IL-6)、肿瘤坏死因子-a(TNF-a)水平和全身炎症反应综合征(SIRS)发生率；(4)反映心功能的肌酸激酶(CK)、肝功能的丙氨酸转氨酶(ALT)及肾功能的肌酐(Cr)水平；(5)多器官功能衰竭综合征(MODS)发生率。评价纳入研究的方法学质量并进行资料提取后,对符合纳入标准的文献采用RevMan5.1软件进行Meta分析,首先对纳入研究进行异质性分析,经检验无异质性的研究结果采用固定效应模型合并分析,存在异质性的则采用随机效应模型合并分析。分析结果如果是连续变量采用均数差(mean difference, MD)或标准均数差(standard mean difference,SMD)表示,分类变量则采用相对危险度(relative risk, RR)表示,结果均给出95%可信区间(95%CI),发表偏倚采用漏斗图显示。结果：共纳入10个随机对照试验,包括532例严重烧伤患者。Meta分析结果显示：与对照组比较,血必净治疗组患者的凝血酶原时间(PT)异常明显改善(SMD=-1.35,95％CI=-1.95～-O.76,P0.00001)；治疗后血液内毒素水平与对照组相比降低(MD=-10.37,95％CI=-13.58～-7.16,P0.00001);与对照组比较,血必净能减少炎症因子IL-6和TNF-a的释放,降低SIRS发生率,两组差异均有统计学意义(IL-6:SMD=-O.82,95％CI=-1.28～-O.36,P=0.0005； TNF-a:SMD=-1.89,95％CI=-2.95～-0.82,P=0.0005；SIRS发生率：SMD=0.58,95％CI=0.45～0.75,P0.0001)；对心、肝及肾功能保护的方面,血必净治疗组均优于对照组,统计学结果分别为(SMD=-0.35,95％CI=-O.64～-0.07,P=O.02).(SMD=-5.00,95％CI=-7.59～-2.41,P=0.0002).(SMD=-2.15,95％CI=-4.03～-0.27,P=0.03)；在减少MODS发生率方面,两组差异无统计学意义(RR=0.58,95%CI=0.32-1.07,P-0.08)。结论：上述结果表明严重烧伤后应用血必净能有效保护患者的凝血功能,有助于清除血中的内毒素和炎症因子以减少它们对患者的全身性损害,并且对严重烧伤后患者的心、肝和肾功能具有良好的保护作用,但与常规治疗组相比,血必净治疗组在降低MODS的发生率方面的作用尚不能得到有效的证据支持。由于本研究纳入的原始文献质量的局限性,有待于更多高质量研究的开展以进一步证实血必净在严重烧伤方面的临床疗效。
[Abstract]:Background: in recent years, there are many clinical reports on the application of Xuebijing treatment after severe burns. As a pure Chinese medicine preparation, its clinical efficacy has been paid much attention. At present, most clinical studies on Xuebijing in severe burns are randomized trials of small samples, and lack of evidence and persuasion in evidence-based medicine. This article aims to provide reference for clinical application of Xuebijing by collecting relevant literature for Meta analysis.
Objective: to systematically evaluate the clinical efficacy of Xuebijing in the treatment of severe burns.
Methods: CBM, 1979/2013.3, VIP, 1989/2013.3, VIP, 1989/2013.3, CNKI, 1979/2013.3, 1982/2013.3, Pubmed, EMBASE and Cochrane Library (1948-2013.3), "Xuebijing" and "burn" were used by the computer. Chinese retrieval words, including "Xuebijing" and "Burn", combined with manual retrieval, collect the randomized controlled trial (RCTs) of Xuebijing's clinical treatment for severely burned patients, and refer to the references in the literature to supplement the possible missing studies. The main target is (1) the prothrombin time (PT); (2) the blood endotoxin water. (3) the incidence of inflammatory factor interleukin -6 (IL-6), tumor necrosis factor -a (TNF-a) and systemic inflammatory response syndrome (SIRS); (4) the cardiac function of creatine kinase (CK), alanine aminotransferase (ALT) and creatinine (Cr) level of liver function; (5) the incidence of multiple organ failure syndrome (MODS). After studying the quality of the methodology and extracting the data, the RevMan5.1 software is used for the Meta analysis of the documents which conform to the inclusion criteria. First, the heterogeneity analysis is carried out on the included research. The results of the study on the non heterogeneity are combined with the fixed effect model, and the heterogeneity is combined with the stochastic effect model. If mean difference, MD or standard mean difference, SMD) is used as a continuous variable, the relative risk degree (relative risk, RR) is used for the classification variables, and the results all give 95% confidence interval (95%CI), and the publication bias is displayed by the funnel graph.
Results: a total of 10 randomized controlled trials were included, including 532 cases of severe burn patients with.Meta analysis. Compared with the control group, the abnormality of prothrombin time (PT) in the patients with Xuebijing treatment group was significantly improved (SMD=-1.35,95%CI=-1.95 to -O.76, P0.00001), and the level of endotoxin in blood liquid was lower than that of the control group (MD=-10.37,95% CI=-13.58 ~ -7.16, P0.00001); compared with the control group, Xuebijing could reduce the release of inflammatory factors IL-6 and TNF-a, and reduce the incidence of SIRS (IL-6:SMD=-O.82,95%CI=-1.28 to -O.36, P=0.0005; TNF-a:SMD=-1.89,95%CI=-2.95 to -0.82, P= 0.0005); occurrence rate of 0.75. 0001); for the protection of heart, liver and kidney function, Xuebijing group was superior to the control group, and the statistical results were (SMD=-0.35,95%CI=-O.64 to -0.07, P=O.02). (SMD=-5.00,95%CI=-7.59 to -2.41, P=0.0002). (SMD=-2.15,95%CI=-4.03 to -0.27, P=0.03), and there was no statistical significance in reducing the incidence of MODS (RR=0.) (RR=0.). 58,95%CI=0.32-1.07, P-0.08).
Conclusion: the above results suggest that Xuebijing can effectively protect the patients' coagulation function after severe burns, help to remove endotoxin and inflammatory factors in blood to reduce their systemic damage to the patients, and have a good protective effect on the heart, liver and kidney function of patients after severe burns, but blood must be compared with the conventional treatment group. The role of the net treatment group in reducing the incidence of MODS has not yet been supported by effective evidence. Due to the limitations of the quality of the original literature included in this study, more high quality studies have been needed to further confirm the clinical efficacy of Xuebijing in severe burns.
【学位授予单位】：广西医科大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R644

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