丹红注射液治疗特发性肺纤维化临床疗效及安全性的Meta分析

Efficacy and safety of Danhong injection for idiopathic pulmonary fibrosis: Meta-analysis

计算机检索Pubmed,EMbase,Web of Science,Cochrane Library,CNKI,CBM,万方数据库,VIP,检索时限均从建库至2016年5月,同时补充互联网及手检相关杂志的文献,纳入有关丹红注射液治疗特发性肺纤维化的随机对照试验(RCT)和半随机对照试验(quasi-RCT),并追溯纳入文献的参考文献。由2名研究者按纳入与排除标准独立筛选文献、提取资料并评价质量后,使用Rev Man 5.3进行Meta分析,系统评价丹红注射液治疗特发性肺纤维化的疗效和安全性。共纳入12个RCT,包括844例患者,试验组423例,对照组421例。Meta分析结果显示:与对照组比较,丹红注射液组对临床有效率[RR=1.36,95%CI(1.25,1.49),P<0.000 01],DLCO提高值[MD=4.25,95%CI(3.32,5.18),P<0.000 01],Pa O2提高值[MD=14.51,95%CI(12.35,16.68),P<0.000 01]的改善作用更显著,差异具有统计学意义。描述性分析结果显示丹红注射液能显著降低血清TGF-β1含量。试验组不良反应症状较轻、发生率低,提示丹红注射液治疗特发性肺纤维化的近期安全性较高,耐受性良好。现有证据表明,短期内(<12周)使用丹红注射液可改善特发性肺纤维化患者的临床情况、提高DLCO及Pa O2、降低血清TGF-β1含量,且不良反应少,安全性较高。但由于纳入研究的局限性,急需高质量RCT更深入更全面地探究丹红注射液对特发性肺纤维化的短期及长期有效性及安全性。

To systematically review the efficacy and safety of Danhong injection for patients with idiopathic pulmonary fibrosis（ IPF）,two researchers electronically searched Pub Med,EMbase,Web of Science,Cochrane Library,CNKI,CBM,Wan Fang Data and VIP databases from the date of establishment to May 2016 for all randomized controlled trials（ RCTs） and quasi-RCTs on the use of Danhong injection in patients with IPF. Manual search in relevant journals and search of relevant literature on other websites were also performed. The data extraction and quality assessment of included RCTs and quasi-RCT were conducted by two reviewers independently. Then,Meta-analysis was conducted by using Rev Man 5. 3 software. A total of 12 RCTs involving 844 patients were included,423 cases in experiment group and 421 cases in control group. The results of meta-analysis indicated that the Danhong injection group was superior than the control group in clinical effectiveness（ RR = 1. 36,95% CI 1. 25 to 1. 49,P〈0. 000 01）,increased DLCO value（ MD = 4. 25,95% CI 3. 32 to 5. 18,P〈0. 000 01）,and increased Pa O2 value（ MD = 14. 51,95% CI 12. 35 to 16. 68,P〈0. 000 01）. The analysis results showed that Danhong injection could significantly reduce the level of TGF-β1 in serum. There were no serious or frequently happened adverse effects in the Danhong injection group,indicating high safety and good tolerance of Danhong injection in treatment of IPF. The current evidences suggested that Danhong injection in short term use（ 12 weeks） could increase clinical effectiveness,improve DLCO and Pa O2,and decrease the level of TGF-β1 in serum of IPF patients,with less adverse effects. However,these results should be carefully interpreted due to the low methodology quality and small sample size of trials,and this conclusion had to be further verified by high quality,large scale and double blinded RCTs.