基于Meta分析的清开灵注射剂治疗慢性阻塞性肺疾病临床评价研究被引量：2

Meta-analysis of Qingkailing Injection in the Treatment of Chronic Obstructive Pulmonary Disease

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摘要目的:采用Meta分析的方法评价清开灵注射剂治疗慢性阻塞性肺疾病(COPD)的临床疗效和安全性。方法:计算机检索CNKI、VIP、万方数据库、SinoMed、PubMed、Cochrane Library、Embase数据库中关于清开灵注射剂治疗COPD的随机对照试验,检索时间界定为各数据库建库至2017年6月10日,采用Cochrane风险评价表评价纳入研究的偏倚风险,提取资料并通过RevMan 5.3和Stata 12.0软件进行数据分析。结果:共纳入10篇文献,6篇清开灵注射剂给药方式为静脉滴注,4篇为雾化吸入,累计患者836例。Meta分析结果显示,对比仅用西医常规疗法,清开灵注射剂静脉滴注联合西医常规疗法治疗COPD可以更好地提高临床总有效率(RR=1.20,95%CI:1.11~1.30,P<0.000 1),改善患者FEV_1(MD=0.33,95%CI:0.09~0.58,P=0.008)、FVC(MD=0.27,95%CI:0.15~0.40,P<0.000 1)、FEV_1/FVC(MD=7.99,95%CI:2.88~13.10,P=0.002)、PaCO_2(MD=-11.50,95%CI:-16.22^-6.78,P<0.000 01)、PaO_2(MD=12.31,95%CI:8.36~16.25,P<0.000 01)和IL-8(MD=-12.80,95%CI:-16.52^-9.08,P<0.000 1);对比仅用西医常规疗法,清开灵雾化吸入联合西医常规疗法治疗COPD可以更好地提高临床总有效率(RR=1.26,95%CI:1.14~1.39,P<0.000 01)。纳入文献中,2篇明确未发生严重不良反应,4篇对发生的不良反应/事件进行了报道。结论:根据当前纳入研究证据表明,对比仅用西医常规疗法,清开灵注射剂联合西医常规疗法治疗COPD有较好的疗效。在清开灵注射剂的使用过程中应严格监测用药反应,一旦出现不良反应,及时采取有效措施。 Objective： To systematically evaluate the clinical efficacy and safety of Qingkailing injection（ QKL）in treatment of chronic obstructive pulmonary disease（ COPD）. Methods： Retrieved randomized controlled trials（ RCTs）regarding QKL in the treatment of COPD in CNKI,VIP,Wanfang database,Sino Med,Pub Med,Cochrane Library and Embase up to June 10 th,2017. Two researchers searched and selected the RCTs and extracted information independently.Risk bias of included RCTs was evaluated by the Cochrane Risk of Bias Assessment Tool,and then the required information was extracted and Meta-analyzed by Rev Man 5. 3 and Stata 12. 0 software. Results： A total of 10 RCTs with 836 patients were included. 6 of them were treated by intravenous drip of QKL,and 4 of them were treated by aerosol inhalation. In the Meta analysis,intravenous drip of QKL with routine western medicine（ WM） can achieve a better effect than WM in respect of total effective rate（ RR = 1. 20,95% CI： 1. 11-1. 30,P 0. 000 1）,FEV_1（ MD = 0. 33,95% CI： 0. 09-0. 58,P= 0. 008）,FVC（ MD = 0. 27,95% CI： 0. 15-0. 40,P 0. 000 1）,FEV_1/FVC（ MD = 7. 99,95% CI： 2. 88-13. 10,P =0. 002）,PaCO_2（ MD =-11. 50,95% CI：-16. 22--6. 78,P 0. 000 01）,PaO_2（ MD = 12. 31,95% CI： 8. 36-16. 25,P 0. 000 01） and IL-8（ MD =-12. 80,95% CI：-16. 52--9. 08,P 0. 000 1）. Aerosol inhalation of QKL with WM can improve total effective rate（ RR = 1. 26,95% CI： 1. 14-1. 39,P 0. 000 01）. Two articles cleared that there was no ADRs/ADEs in the studies. Four articles reported the detail of ADRs. Conclusion： QKL with WM is more effective in treating of COPD than WM. However,the adverse drug reactions should be strictly observed during the use of QKL.