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[摘要]
系统评价丹参川芎嗪注射液治疗慢性阻塞性肺病(COPD)的有效性与安全性。计算机检索PubMed、EMBase、ClinicalTrials、Cochrane图书馆、中国期刊全文数据库(CNKI)、中国生物医学文献数据(CBM)、万方数据库、中文科技期刊数据库(VIP)。纳入丹参川芎嗪注射液联合西医疗法(试验组)对比常规疗法(对照组)治疗慢性阻塞性肺病的随机对照试验(RCTs),检索时限为建库起至2018年2月,提取资料并按照Cochrane系统评价员手册5.3评价质量后,采用Revman 5.3对数据进行Meta分析。通过对入选的文献进行质量评价与筛选,共纳入16篇RCTs,合计1 259例患者。Meta分析结果显示,试验组患者的总有效率显著优于对照组[OR=4.67,95% CI(3.03,7.19),P<0.000 01],第1秒用力呼气容积(FEV1)改善情况显著优于对照组[SMD=1.43,95% CI(1.14,1.72),P<0.000 01],用力肺活量(FVC)恢复程度显著优于对照组[SMD=1.53,95% CI(1.17,1.90),P<0.000 01],FEV1/FVC显著高于对照组[SMD=1.12,95% CI(0.90,1.34),P<0.000 01],FEV1占预计值显著优于对照组[SMD=0.62,95% CI(0.31,0.93),P<0.000 1],血氧分压(PaO2)水平明显高于对照组[MD=9.7,95% CI(7.92,11.65),P<0.000 01],血二氧化碳分压(PaCO2)显著低于对照组[SMD=-1.51,95% CI(-1.90,-1.12),P<0.000 01],动脉血氧饱和度(SaO2)显著高于对照组[SMD=0.94,95% CI(0.48,1.40),P<0.000 1]。对于治疗慢性阻塞性肺疾病,在常规西医疗法的基础上加用丹参川芎嗪注射液患者能明显改善患者的肺功能,但该研究结论仍需更多高质量的临床试验支持。
[Key word]
[Abstract]
To evaluate therapeutic efficacy and safety of Salviae Miltiorrhizae and Ligustrazine Hydrochloride Injection in the treatment of chronic obstructive pulmonary diseases (COPD). All clinical trial databases were retrieved from PubMed, EMBase, ClinicalTrials, Cochrane Library, CNKI, CBM, VIP, and Wanfang. Data were searched from inception to February 2018, randomized controlled trials (RCTs) by Salviae Miltiorrhizae and Ligustrazine Hydrochloride Injection combined with chemotherapy (experimental group) compared with conventional therapy (control group) in the treatment of COPD were included. All included studies were critically appraised by two independent reviewers according to the cochrane systematic review method and using Revman 5.3 Software and State 12.0 for Meta-analysis. There were 16 RCTs were included in the evaluation and screening of selected articles with a total of 1 259 patients. The Meta-analysis showed that the total clinical efficacy of the patients in the experimental group after treatment was significantly better than that in the control group[OR=4.67, 95% CI (3.03, 7.19), P < 0.000 01]; The improvement of forced expiratory volume in one second (FEV1) was significantly better than control group[SMD=1.43, 95% CI (1.14, 1.72), P < 0.000 01]; Forced vital capacity (FVC) was significantly better than control group[SMD=1.53, 95% CI (1.17, 1.90), P < 0.000 01]; FEV1/FVC was significantly better than control group[SMD=1.12, 95% CI (0.90, 1.34), P < 0.000 01]; FEV1 in the percentage of the predicted value forced vital capacity (FVC) was significantly better than control group[SMD=0.62, 95% CI (0.31, 0.93), P < 0.000 1] and the blood gas index of PaO2 was significantly higher than control group[MD=9.7, 95% CI (7.92, 11.65), P < 0.000 01]; PaCO2 was significantly lower than control group[SMD=−1.51, 95% CI (−1.90, −1.12), P < 0.000 01]; SaO2 was significantly higher than control group[SMD=0.94, 95% CI (0.48, 1.40), P < 0.000 1]. For the treatment of chronic obstructive pulmonary disease, Salviae Miltiorrhizae and Ligustrazine Hydrochloride Injection combined with chemotherapy can significantly improve the lung function of patients, but the conclusions of the study still need to be confirmed by more high-quality clinical trials.
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