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血必净治疗MODS患者疗效的Meta分析

Effectiveness of Xuebijing in treatment of multiple organ dysfunction syndrome: a Meta analysis

摘要:

目的 系统评价血必净注射液治疗多器官功能障碍综合征(MODS)的疗效.方法 以血必净、多器官功能障碍综合征、多器官功能障碍、多器官功能不全综合征、多器官功能衰竭等为关键词,在美国国立医学图书馆PubMed数据库、Cochrane Library、荷兰医学文摘Embase数据库、中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普数据库(VIP)及万方数据库中,系统检索从建库至2018年3月4日公开发表的有关比较血必净注射液与常规西医治疗MODS疗效的随机对照临床试验(RCT).对照组给予常规西医治疗,包括病因治疗、抗菌药物治疗、机械通气、营养支持以及维持水、电解质、酸碱平衡等综合治疗;试验组给予常规西医治疗联合血必净注射液.结局指标包括7 d和28 d病死率、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)、Marshall评分、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)、血小板、活化部分凝血活酶时间(APTT)及凝血酶原时间(PT).由2位评价者按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量.采用RevMan 5.3软件进行Meta分析;采用漏斗图分析各项研究发表偏倚情况.结果 最终纳入35项RCT、共2131例患者,其中试验组1076例,对照组1055例.Meta分析结果显示,与对照组相比,试验组可明显降低MODS患者病死率〔7 d病死率:优势比(OR)=0.42,99%可信区间(99%CI)=0.26~0.69,P<0.00001;28 d病死率:OR=0.31,99%CI=0.21~0.45,P<0.00001〕,并可明显降低APACHEⅡ、Marshall评分〔APACHEⅡ:均数差(MD)=3.24,99%CI=2.00~4.49,P<0.00001;Marshall评分:MD=1.95,99%CI=0.50~3.40,P=0.0005〕;同时试验组清除IL-6和TNF-α、提升血小板及改善PT的效果均较对照组更好(IL-6:MD=5.56,99%CI=1.44~9.68,P=0.0005;TNF-α:MD=4.97,99%CI=3.44~6.50,P<0.00001;血小板:MD=-50.79,99%CI=-74.84~-26.74,P<0.0001;PT:MD=4.55,99%CI=3.96~5.14,P<0.00001),但在改善APTT方面未显示出明显优势(MD=0.96,99%CI=-5.08~7.00,P=0.68).漏斗图分析显示,各项研究的效应点大致以合并效应量为中心,大体呈对称分布的"倒漏斗"型,但由于纳入研究数量偏少,尚不能完全排除文献发表偏倚.结论 血必净可能通过其较强的清除细胞因子、提升血小板和改善凝血功能的能力来实现对MODS患者器官功能的保护作用,从而降低病死率,改善预后.

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abstracts:

Objective To systematical evaluate the effect of Xuebijing injection in the treatment of multiple organ dysfunction syndrome (MODS).Methods With the keywords including Xuebijing, multiple organ dysfunction syndrome, multiple organ dysfunction and multiple organ failure, PubMed, the Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), China Biology Medicine (CBM), VIP and Wanfang Data from the database start until March 4th, 2018 were searched for relevant randomized controlled trials (RCTs) related to Xuebijing injection combined conventional treatment versus conventional treatment alone for MODS. The control group received conventional western medicine treatment, including etiological treatment, antibiotics, mechanical ventilation, nutritional support, and comprehensive treatment to maintain fluid, electrolyte, acid and alkali balance. The experimental group was given traditional western medicine combined with Xuebijing injection. The observation parameters included 7-day and 28-day mortality, acute physiology and chronic health evaluationⅡ (APACHEⅡ) and Marshall score, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), the number of platelets, activated partial thromboplastin time (APTT) and prothrombin time (PT). According to the inclusion and exclusion criteria, two evaluators independently screened the literature, extracted data and evaluated the methodological quality of the included studies. RevMan 5.3 software was used for Meta analysis. Funnel plot was used to analyze publication bias.Results A total of 35 RCTs and 2131 patients were enrolled, including 1076 in the experimental group and 1055 in the control group. The results of Meta analysis showed that compared with control group, Xuebijing combined conventional treatment was in favor to decrease the mortality of patients with MODS [7-day mortality: odds ratio (OR) = 0.42, 99% confidence interval (99%CI) = 0.26-0.69,P < 0.00001; 28-day mortality:OR= 0.31, 99%CI= 0.21-0.45,P < 0.00001], also could obviously reduce critical condition degree of APACHE Ⅱ score and the organ function of Marshall score [APACHEⅡ: mean difference (MD) =3.24, 99%CI = 2.00-4.49,P < 0.00001; Marshall score:MD = 1.95, 99%CI = 0.50-3.40,P = 0.0005]. Meanwhile, the results of conventional western medicine combined with Xuebijing in the removal of IL-6 and TNF-α, platelets increase and improvement of PT were better than those of conventional western medicine (IL-6:MD = 5.56, 99%CI = 1.44-9.68, P = 0.0005; TNF-α:MD = 4.97, 99%CI = 3.44-6.50,P < 0.00001; platelets:MD = -50.79, 99%CI = -74.84 to -26.74, P < 0.0001; PT:MD = 4.55, 99%CI = 3.96-5.14,P < 0.00001), however, there was no obvious advantage in improving APTT (MD = 0.96, 99%CI = -5.08-7.00,P = 0.68). The analysis of funnel map showed that the effect points of various studies were mainly centered on the amount of combined effect, and the "inverted funnel" type was generally symmetrical distribution. However, because the number of the included studies was less, the literature bias could not be completely eliminated.Conclusion Xuebijing injection may through its strong cytokines clearance, platelet increase and blood coagulation improvement to protect the organ function in patients with MODS, so as to reduce the mortality and improve the prognosis.

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