四种药物辅助治疗老年重症肺炎有效性和安全性的系统评价——基于网络Meta分析

Systematic review on the efficacy and safety of four drugs in adjuvant treatment of elderly patients with severe pneumonia:a network-based meta-analysis

目的常规治疗基础上加用血必净、乌司他丁、胸腺肽-α1、胸腺五肽治疗老年重症肺炎相关报道日渐增多,但药物疗间效及安全性差异均不清楚,现基于循证医学的网络Meta方法对4种药物组成的5种方案治疗老年重症肺炎患者的有效性和安全性进行评价。方法检索WanFang、CNKI、VIP、Pubmed、EMbase、Medline、Cochrance Library数据库中四种药物治疗老年重症肺炎的随机对照临床试验(Randomized Controlled Trial,RCT)的文献,根据纳入、排除标准筛选文献,对文献进行质量评价,并提取文献中的数据,分析四种药物治疗老年重症肺炎的有效性和安全性。结果纳入11篇RCT文献,4种药物组成的五种联合治疗方案分别为血必净组(XBJ)、乌司他丁组(UTI)、血必净联合胸腺五肽组(XBJ+TH-5)、血必净联合乌司他丁组(XBJ+UTI)、血必净联合胸腺肽-α1(XBJ+TH-α1),与单用常规治疗组共6种治疗方案间共有15种两两干预措施的比较,有效率方面,与常规治疗组比较,XBJ组OR=3.36(2.13,5.29),XBJ+TH-5组OR=22.15(3.94,124.68),XBJ+UTI组OR=7.79(2.41,25.16);与XBJ组比较,XBJ+TH-5组OR=6.60(1.25,34.95);与XBJ+TH-α1组比较,XBJ+TH-5组的OR=8.31(1.14,60.74);干预措施疗效排序(SUCRA:累计排序曲线下面积):XBJ+TH-5组、XBJ+UTI组、UTI组、XBJ组、TH-α1组和常规治疗组依次降低。治疗7d后氧合指数(PaO2/FiO2)方面,与常规治疗组比较,XBJ组、XBJ+TH-α1组、XBJ+UTI组的MD分别为34.33(5.63,63.02)、138.40(91.74,185.06)、73.43(17.5,129.32),差异均具有统计学意义;与XBJ组比较,XBJ+TH-α1组MD为104.07(49.29,158.86),差异有统计学意义;XBJ+UTI组与XBJ+TH-α1组比较差异则无统计学差异;SUCRA大小排序分别为XBJ+TH-α1组、XBJ+UTI组、XBJ组和对照组。副作用/不良反应方面,XBJ+TH-5组出现1例恶心、呕吐,1例皮肤瘙痒,XBJ组出现1例恶心、呕吐。结论初步论证了四种药物组成的5种用法与常规治疗组比较是安全、有效的。

Objective An increasing number of reports have described the use of Xuebijing,Ulinastatin,thymosin-a1 and thymopentin adding on to conventional treatment on elderly patients with severe pneumonia,though differences in efficacy and safety between drug treatments were not clear.Based on the network meta-analysis method of evidence-based medicine,the efficacy and safety of five regimens composed of the four drugs in the treatment of elderly patients with severe pneumonia were evaluated.Methods The randomized controlled clinical trials(RCTs)of four drugs in the treatment of severe pneumonia in the elderly were retrieved from Wanfang,CNKI,VIP,PubMed,EMBASE,MEDLINE and Cochrane Library.According to the inclusion and exclusion criteria,the quality of the literature was evaluated and the data involved were extracted to analyze the effectiveness and safety of the four drugs in the treatment of elderly severe pneumonia.Results Eleven RCT literatures were included.The five therapeutic regimens were Xuebijing group(XBJ),Ulinastatin group(UTI),Xuebijing combined with thymopentin group(XBJ+Th-5),Xuebijing combined with Ulinastatin group(XBJ+UTI),Xuebijing combined with ulinastatin group(XBJ+TH-α1).There were 15 kinds of intervention measures comparing with the conventional treatment group.From effectiveness perspective:compared with conventional treatment group,XBJ group or=3.36(2.13,5.29),XBJ+Th-5 group or=22.15(3.94,124.68),XBJ+UTI group or=7.79(2.41,25.16);compared with XBJ group,XBJ+Th-5 group or=6.60(1.25,34.95);compared with XBJ+TH-α1 group,XBJ+Th-5 group or=8.31(1.14,60.74).The ranking of intervention effect(SUCRA:surface under the cumulative ranking curve):XBJ+Th-5 group,XBJ+UTI group,UTI group,XBJ group,TH-α1 group and conventional treatment group decreased sequentially.In terms of PaO2/FiO2 after seven days of treatment,the MD of XBJ group,XBJ+thymosin-α1 group and XBJ+UTI group were 34.91(5.73,64.09)、138.40(91.74,185.06)、73.43(17.5,129.32)respectively,and the differences were statistically significant;compared with XBJ group,the MD of XBJ+TH-α1 group was 104.07(49.29,158.86)(P<0.05),and the difference was statistically significant;there was no significant difference between XBJ+UTI group and XBJ+TH-α1 group;the ranking of SUCRA was XBJ+TH-α1 group,XBJ+UTI group,XBJ group and control group.In terms of side effects/adverse reactions,there was 1 case of nausea and vomiting,1 case of skin pruritus in XBJ+Th-5 group,and 1 case of nausea and vomiting in XBJ group.Conclusion It is preliminarily demonstrated that the five regimens composed of the four drugs are safe and effective compared with the conventional treatment group.