参麦注射液治疗慢性阻塞性肺疾病合并呼吸衰竭的Meta分析

Application of Shenmai Injection in Chronic Obstructive Pulmonary Disease with Respiratory Failure:a meta-analysis

目的对参麦注射液应用于慢性阻塞性肺疾病(COPD)伴呼吸衰竭的有效性及安全性进行Meta分析。方法检索中国知网、万方数据库、维普资讯、中国生物医学文献数据库、PubMed、Cochrane Library、Web of Science、Embase医学文献数据库,由2位研究者根据纳入、排除标准独立筛选文献,提取相应研究信息并交叉核对,筛选出参麦注射液治疗COPD伴呼吸衰竭的随机对照试验,使用RevMan5.4软件对纳入研究进行Meta分析,并使用GRADE评价系统对结局指标质量进行分级。结果本研究纳入16项临床研究,共1313例患者,观察组667例,对照组646例;参麦注射液联合西医常规治疗COPD伴呼吸衰竭患者,在临床总有效率[OR=3.10,95%CI(2.05~4.70),P<0.00001]、氧分压[MD=7.98,95%CI(4.97~11.00),P<0.00001]、二氧化碳分压[MD=-8.31,95%CI(-11.11~-5.51),P<0.00001]、C反应蛋白(CRP)[SMD=-1.64,95%CI(-2.37~-0.91),P<0.00001]、第一秒用力呼气容积(FEV1)[MD=0.38,95%CI(0.33~0.42),P<0.00001]方面,相较对照组差异有统计学意义(P<0.01);用力肺活量(FVC)两组间差异无统计学意义(P>0.05)。GRADE证据分级结果提示,总有效率、动脉血气氧分压、动脉血气二氧化碳分压、CRP、FVC、FEV1为极低级质量证据。结论西医常规结合参麦注射液治疗COPD合并呼吸衰竭可以提高临床治疗总有效率,改善低氧血症和(或)二氧化碳潴留,减轻炎症,安全性较好。

Objective:To conduct a systematic evaluation and meta-analysis on the efficacy and safety of Shen⁃mai Injection in treating chronic obstructive pulmonary disease(COPD)and respiratory failure.Methods:Databas⁃es of China National Knowledge Infrastructure,China Science Periodical Database,Chinese Citation Database,Chi⁃na Biomedical Literature Database,PubMed,Cochrane Library,Web of Science,and Embase were searched to screen out randomized controlled trials of Shenmai Injection in the treatment of COPD and respiratory failure.Rev⁃Man5.4 software was used for systematic evaluation and meta-analysis of the included studies,and GRADE system was used to estimate the quality of outcome indicators.Results:16 clinical studies were included in this study,with a total of 1313 patients,667 in the experimental group and 646 in the control group.Shenmai Injection com⁃bined with conventional western medicine in the treatment of COPD patients with respiratory failure.In the clini⁃cal total effective rate[OR=3.10,95%CI(2.05~4.70),P<0.00001],arterial partial pressure of oxygen[MD=7.98,95%CI(4.97~11.00),P<0.00001],arterial partial pressure of carbon dioxide[MD=-8.31,95%CI(-11.11~-5.51),P<0.00001],CRP[SMD=-1.64,95%CI(-2.37~-0.91),P<0.00001],FEV1[MD=0.38,95%CI(0.33~0.42),P<0.00001]of the Shenmai Injection combination group,the differences were statistically significant com⁃pared with control group(P<0.01);there was no significant difference in FVC between the two groups.GRADE ev⁃idence classification indicated that the clinical total effective rate,arterial partial pressure of oxygen,arterial par⁃tial pressure of carbon dioxide,FVC,FEV1 and CRP had low quality evidence.Conclusion:Conventional western medicine combined with Shenmai Injection the treatment of COPD and respiratory failure can improve the total effective rate of clinical treatment,improve hypoxemia or/and carbon dioxide retention,reduce inflammation,with good safety,which is worthy of promotion and application.