喘可治注射液治疗慢性阻塞性肺疾病的系统评价

Systematic Evaluation on Chuankezhi Injection for Treating Chronic Obstructive Pulmonary Disease

目的系统评价喘可治注射液治疗慢性阻塞性肺疾病(CODP)的疗效和安全性。方法搜集使用喘可治注射液治疗CODP的随机对照试验(RCT),根据纳入与排除标准选择试验、评价质量和提取有效数据,用RevMan5.14软件进行Meta分析。结果共纳入14个RCT,包括968例患者。Meta分析结果显示,喘可治试验组与对照组相比,有效率[RR=1.22,95%CI(1.13,1.32),P<0.000 01]、动脉血氧分压(PaO2)[MD=6.33,95%CI(5.38,7.29),P<0.000 01]、二氧化碳分压(PaCO2)[MD=-6.01,95%CI(-8.42,-3.60),P<0.000 01]、第1秒用力呼气容积(FEV1)[MD=0.24,95%CI(0.13,0.34),P<0.000 1]、用力肺活量(FVC)[MD=0.35,95%CI(0.09,0.60),P=0.008]、第1秒用力呼气容积与用力肺活量比值(FEV1/FVC)[MD=4.83,95%CI(2.79,6.87),P<0.000 1],差异有统计学意义。未报道与喘可治注射液临床应用相关的严重不良反应。结论现有研究表明,在常规对症治疗基础上加喘可治注射液治疗COPD,可明显提高临床疗效,有助于改善肺功能,安全性好。该评价受纳入研究质量所限,尚需更多高质量的研究进一步验证。

Objective To assess the efficacy and safety of Chuankezhi Injection for treating chronic obstructive pulmonary disease （COPD）. Methods The randomized controlledl trials（RCTs） of Chuankezhi injection in treating COPD were collected. RCTs were se- lected according to the inclusion and exclusion criteria, their quality evaluation was performed, the effective data were extracted and the meta analysis was performed by RevMan 5. 14 software. Results Fourteen RCTs involving 968 patients were included. The meta analysis showed that in the comparison of the Chuankezhi Injection treatment group with the control group, the effective rate [ RR = 1.22, 95% （21（ 1.13, 1.32）, P 〈 O. 000 O1 ], PaO~ [ MD = 6. 33, 95% CI（5.38, 7.29）, P 〈 O. 000 01 ], PaCO2 [ MD = - 6. 01, 95% CI（ - 8.42, - 3.60）, P〈 0.000 01], FEVI[ MD =0. 24, 95% CI（O. 13, 0. 34）, P〈 0.000 1], FVC[ MD =0.35, 95% CI（0.09, 0. 60）, P =0. 008], FEVI/FVC [ MD = 4, 83, 95% CI（2.79, 6. 87）, P 〈 0. 000 1 ], the differences had statistical significance. No serious adverse reactions related with the clinical practice of Chuankezhi Injection were reported. Conclusion The existing researches show that on the basis of the routine symptomatic treatment, adding Chuankezhi Injection for treating COPD can significantly increase the clinical therapeutic effect and con- duce to the improvement of the lung function with good safety. But this evaluation is restricted by the included RCTs quality, which needs more high quality trials to be further verified.