灯盏花素注射液联合常规治疗用于AECOPD有效性和安全性的Meta分析

Efficacy and Safety of Breviscapine Injection Combined with Routine Treatment of AECOPD: A Meta-analysis

目的:系统评价灯盏花素注射液联合常规治疗用于慢性阻塞性肺疾病急性加重期(AECOPD)的疗效和安全性,为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国生物医学文献数据库、中国知网、维普数据库和万方数字化期刊全文数据库,收集灯盏花素注射液联合常规治疗(试验组)对比常规治疗(对照组)用于AECOPD的随机对照试验(RCT)。筛选文献、提取资料并按改良Jadad量表评价文献质量后,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入19项RCT,合计1 930例患者。Meta分析结果显示,试验组患者总有效率[OR=2.80,95%CI(1.96,4.01),P<0.000 01]、第1秒用力呼气容积(FEV1)[MD=0.65,95%CI(0.57,0.72),P<0.000 01]、FEV1占预计值百分比[MD=5.33,95%CI(0.31,10.35),P=0.04]、用力肺活量(FVC)[MD=0.69,95%CI(0.23,1.16),P=0.004]、FEV1/FVC比值[MD=4.83,95%CI(0.98,8.67),P=0.01]、呼气峰流速[MD=0.95,95%CI(0.57,1.33),P<0.001]、氧分压[MD=4.70,95%CI(2.02,7.37),P<0.001]、CD3^+水平[MD=5.11,95%CI(3.04,7.18),P<0.001]、CD4^+水平[MD=2.62,95%CI(1.78,3.47),P<0.001]均显著高于对照组,二氧化碳分压[MD=-3.33,95%CI(-5.02,-1.65),P<0.001]、CD8^+水平[MD=-2.55,95%CI(-4.28,-0.82),P<0.004]、咳嗽缓解时间[MD=-1.93,95%CI(-2.24,-1.63),P<0.001]、咳痰缓解时间[MD=-2.19,95%CI(-2.48,-1.89),P<0.001]、哮鸣音缓解时间[MD=-1.59,95%CI(-1.86,-1.32),P<0.001]、住院时间[MD=-1.73,95%CI(-2.06,-1.39),P<0.001]均显著低于或短于对照组,两组患者CD4^+/CD8^+比值比较,差异无统计学意义[MD=-0.11,95%CI(-0.23,0.01),P=0.06]。安全性方面,有3项研究报告了不良反应发生情况,均未见严重不良反应发生。结论:灯盏花素注射液可提高AECOPD患者疗效、改善肺功能、增强免疫力,且安全性较高。

OBJECTIVE:To systematically evaluate therapeutic efficacy and safety of Breviscapine injection combined with routine treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD),and to provide evidence-based reference for clinical drug use. METHODS:Retrieved from Cochrane Library,PubMed,Embase,CBMdisc,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about Breviscapine injection combined with routine treatment(trial group)versus routine treatment(control group)in the treatment of AECOPD were collected. After literature screening and data extraction,the qualities of literatures were evaluated with modified Jadad scale;Meta-analysis was performed by using Rev Man 5.2 statistical software. RESULTS:A total of 19 RCTs were included,involving 1 930 patients. Results of Meta-analysis showed that total response rate [OR=2.80, 95% CI(1.96, 4.01), P<0.000 01], FEV1[MD=0.65, 95% CI(0.57, 0.72), P<0.000 01],FEV1%[MD=5.33,95%CI(0.31,10.35), P=0.04],FVC[MD=0.69,95%CI(0.23,1.16),P=0.004], FEV1/FVC [MD=4.83,95%CI(0.98,8.67),P=0.01],PEF [MD=0.95,95%CI(0.57,1.33),P<0.001],PaO2[MD=4.70,95% CI(2.02,7.37),P<0.001],CD3^+level [MD=5.11,95% CI(3.04,7.18),P<0.001] and CD4^+level [MD=2.62,95%CI(1.78,3.47),P<0.001] of trial group were significantly higher than those of control group;Pa CO2[MD=-3.33,95%CI(-5.02,-1.65),P<0.001],CD8^+level [MD=-2.55,95%CI(-4.28,-0.82),P<0.004],cough relief time [MD=-1.93,95%CI(-2.24,-1.63),P<0.001],sputum remission time [MD=-2.19,95%CI(-2.48,-1.89),P<0.001],wheezing remission time [MD=-1.59,95%CI(-1.86,-1.32),P<0.001] and hospital stay [MD=-1.73,95%CI(-2.06,-1.39),P<0.001]of trial groups were significantly lower or shorter than those of control group;there was no statistical significance in CD4^+/CD8^+between 2 groups [MD=-0.11,95%CI(-0.23,0.01),P=0.06]. In terms of safety,3 studies reported the occurrence of ADR,and no serious ADR occurred. CONCLUSIONS:Breviscapine injection can improve clinical efficacy and lung function,enhance immunity in patients with AECOPD with good safety.