清热解毒和凉血散瘀法对脓毒症疗效的Meta分析  

A Meta-analysis of Qingre Jiedu and Liangxue Sanyu method in the treatment of sepsis

作　　者：程璐 蒋华 陈明祺 陈秋华 王醒 鲁俊 Cheng Lu;Jiang Hua;Chen Mingqi;Chen Qiuhua;Wang Xing;Lu Jun(Department of Intensive Care Unit,Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing 210029, Jiangsu,China)

机构地区：[1]南京中医药大学附属医院重症医学科,江苏南京210029

出　　处：《中华危重病急救医学》2019年第1期73-80,共8页Chinese Critical Care Medicine

基　　金：国家自然科学基金(81704048);江苏省中医药管理局科研项目(YB2017015).

摘　　要：目的针对清热解毒、凉血散瘀法对脓毒症患者的疗效进行系统评价,探讨其在脓毒症治疗中的作用。方法检索美国国立医学图书馆PubMed数据库、荷兰医学文摘Embase数据库、科学网(Web of Science)、中国知网(CNKI)、万方数据库从建库至2017年12月31日发表的关于清热解毒、凉血散瘀法治疗脓毒症患者效果的随机对照临床试验(RCT)。对照组采用脓毒症的常规治疗措施,如液体复苏、维持血流动力学稳定、抗感染、改善组织灌注、维持器官功能及营养支持等;试验组在对照组的基础上,应用清热解毒、凉血散瘀法为基础的中医药治疗,包括中成药或中药草。主要观察指标为28d病死率;次要观察指标为急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)、凝血功能、炎性因子、降钙素原(PCT)、血乳酸(Lac)及重症加强治疗病房(ICU)住院时间。由2位研究者分别独立检索文献、收集数据及评估偏倚风险;应用RevMan 5.3和STATA 13.0软件完成统计分析;采用漏斗图和Egger检验分别定性、定量评价主要观察指标的潜在发表偏倚。结果共20项RCT被纳入本次Meta分析,包含1347例患者,对照组667例,试验组680例。偏倚风险评估结果显示:11项RCT为风险未知,9项RCT为高风险。Meta分析结果显示:与对照组比较,试验组28d病死率明显降低〔相对危险度(RR)=0.54,95%可信区间(95%CI)=0.45~0.65,P<0.00001〕,7d APACHE Ⅱ评分明显降低〔均数差(MD)=-3.86,95%CI=-4.82^-2.90,P<0.00001〕,7d凝血酶原时间(PT)和活化部分凝血活酶时间(APTT)均明显缩短(PT:MD=-1.72,95%CI=-2.29^-1.14,P<0.00001;APTT:MD=-4.36,95%CI=-5.81^-2.91,P<0.00001),7dD-二聚体略有改善(MD=-0.13,95%CI=-0.37~0.11,P=0.29),10d白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)明显下降(IL-6:MD=-40.33,95%CI=-59.55^-21.11,P<0.0001;TNF-α:MD=-7.26,95%CI=-11.31^-3.21,P=0.0004),7dLac明显下降(MD=-1.30,95%CI=-1.91^-0.68,P<0.0001);而PCT(MD=-1.57,95%CI=-3.25~0.11,PObjective To systematically review the effect of Qingre Jiedu and Liangxue Sanyu method in patients with sepsis, and to discuss its effect in the treatment of sepsis. Methods The randomized controlled trials (RCTs) on the treatment of Qingre Jiedu and Liangxue Sanyu method for sepsis published on PubMed, Embase, Web of Science, CNKI and Wanfang database from the construction to December 31st, 2017 were searched by electronical way. Conventional treatment measures for sepsis, such as fluid resuscitation, maintenance of hemodynamic stability, anti-infection, improvement of tissue perfusion, maintenance of organ function and nutritional support were used in the control group. While traditional Chinese medicine treatment based on Qingre Jiedu and Liangxue Sanyu method were applied in the experimental group besides the conventional treatment, including Chinese patent medicine or Chinese herbal medicine. The main outcome was 28-day mortality, and the second outcome was acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ), coagulation function, inflammatory mediators, procalcitonin (PCT), lactic acid (Lac), and the length of intensive care unit (ICU) stay. Two researchers independently searched literatures, collected data and evaluated risk bias. The statistical analysis was completed by RevMan 5.3 and STATA 13.0 software. The funnel plot and Egger test were used to evaluate the potential publication bias of the main outcomes. Results A total of 20 RCTs were enrolled in this Meta-analysis, including 1347 patients, with 667 patients in the control group and 680 patients in the experimental group. Comprehensive risk bias assessment showed that the risk bias of 11 RCT items was unknown, and the risk bias of 9 RCT items was high. Meta-analysis results showed that compared with the control group, the 28-day mortality of the experimental group was significantly lowered [relative risk (RR) = 0.54, 95% confidence interval (95%CI) = 0.45-0.65, P < 0.00001], the 7-day APACHE Ⅱ score was significantly lowered [mean di

关 键 词：脓毒症 脓毒性休克 清热解毒 凉血散瘀 炎性介质 凝血功能 

分 类 号：R278[医药卫生—中医学]