艾易舒注射液对恶性胸腔积液真实临床疗效的Meta分析

Clinical efficacy of Aiyishu injection for malignant pleural effusion: A Meta- analysis

目的系统评价艾易舒注射液治疗恶性胸腔积液的真实疗效,为临床治疗策略提供依据。方法系统检索Cochrane图书馆、Embase、Pubmed、ISI、CNKI、维普、CBM及万方数据库,采用Cochrane协作网随机对照试验(randomised controlled trial,RCT)质量评价标准评价纳入研究质量,Meta分析提取数据。结果 1纳入8个RCT,恶性胸腔积液484例,纳入研究质量一般;2Meta分析合并客观有效率(ORR)、骨髓抑制、胃肠道反应及艾易舒单独用药与化疗比较的生活质量的RR值及95%CI分别为1.47(1.28,1.68)、0.07(0.02,0.23)、0.36(0.20,0.65)、1.98(1.33,2.94),在两组间有统计学差异;3Meta分析合并胸痛、发热、艾易舒联合化疗与化疗组比较的胃肠道反应及生活质量的RR值及95%CI分别为0.80(0.57,1.12)、1.03(0.74,1.45)、0.71(0.33,1.52)、1.20(0.96,1.50),在两组间无统计学差异。结论艾易舒单独或联合用药能改善恶性胸腔积液近期疗效,具有协同增效作用,单用艾易舒组胃肠道反应及骨髓抑制率低,具有较好安全性,但不能肯定其降低化疗药物毒性作用。

Objective To review the studies about Aiyishu injection for the malignant pleural effusion and analyze the clinical efficacy. Methods All related studies in CBM,CNKI,VIP,Wanfang,ISI,Pubmed and Embase were retrieved. The quality was evaluated by Cochrane evaluation handbook of RCTs and all data were analyzed by Meta- analysis. Results（ 1） Eight RCTs involving 484 malignant pleural effusion patients were included with general methodological quality in most trials;（ 2） The merged RR values and their 95% CI of Meta- analysis for ORR,myelosuppression,gastrointestinal reactions and quality of life between Aiyishu alone and chemotherapy were as follows： 1. 47（ 1. 28,1. 68）,0. 07（ 0. 02,0. 23）,0. 36（ 0. 20,0. 65） and 1. 98（ 1. 33,2. 94） and these data were statistically significant;（ 3） The merged RR values and their 95% CI of Meta- analysis for chest pain,fever and the gastrointestinal reactions and quality of life between Aiyishu with chemotherapy and chemotherapy alone were as follows： 0. 80（ 0. 57,1. 12）,1. 03（ 0. 74,1. 45）,0. 71（ 0. 33,1. 52） and 1. 20（ 0. 96,1. 50）and these data were no statistically significant. Conclusion Aiyishu injection alone or with other drugs could significantly improve the clinical efficacy for malignant pleural effusion with synergistic effects. It has better security than chemotherapy. But it is not sure that Aiyishu could reduce the toxicity of chemotherapy drugs.