吡非尼酮治疗特发性肺纤维化疗效与安全性的系统评价  

The effectiveness and safety of pirfenidone for idiopathic pulmonary fibrosis in Chinese patients:a systematic review

作　　者：朱晓燕 徐晓涵[2] 翟所迪[2] ZHU Xiao-yan;XU Xiao-han;ZHAI Suo-di(Department of Pharmacy,Beijing Water Conservancy Hospital,Beijing 100036,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京水利医院药剂科,北京100036 [2]北京大学第三医院药剂科,北京100191

出　　处：《临床药物治疗杂志》2020年第9期22-26,共5页Clinical Medication Journal

摘　　要：目的系统评价吡非尼酮治疗特发性肺纤维化的疗效与安全性,为临床提供循证参考和用药建议。方法检索中国期刊全文数据库、万方数据库和中国生物医学文献数据库2020年4月30日前发表的吡非尼酮在中国治疗特发性肺纤维化的临床随机对照研究,采用Cochrane偏倚评价量表进行质量评价,对主要研究指标进行汇总分析。结果共纳入6个临床随机对照研究,涉及393例患者。与对照组患者相比,观察组患者在接受吡非尼酮治疗后,1秒用力呼气容积(FEV1)、用力肺活量(FVC)、FEV1/FVC、一氧化碳弥散量(DLco)、动脉氧分压(PaO2)、最大呼气流量(PEF)等均有改善,差异有统计学意义(P<0.05);与治疗前相比,观察组患者在接受吡非尼酮治疗后,上述有效性指标均有改善,差异有统计学意义(P<0.05)。观察组不良反应发生率为8.90%(35/393),主要为胃肠道反应、过敏反应、转氨酶升高,程度多为轻至中度,患者均可耐受。结论吡非尼酮在中国治疗特发性肺纤维化患者的疗效和安全性良好。Objective To evaluate systematically the efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis(IPF)in China,and to provide reference and medication advice for clinical practice. Methods Objective to search the China National Knowledge Infrastructure,Wanfang and China biomedical literature database for randomized controlled trials of pirfenidone in the treatment of Chinese IPF patients before April 30,2020. The data of the studies meeting the inclusion and exclusion criteria were extracted,and the quality evaluation was conducted by using the Cochrane bias rating scale,and the main research indicators were summarized and analyzed. Results Six randomized controlled studies involving393 patients were included. Compared with the control group,the outcomes of FEV1,FVC,FEV1/FVC,DLco,PaO2,PEF were improved in the experimental group after treatment. The difference was statistically significant(P<0. 05). Compared with before,the above outcomes were improved after treatment with pirfenidone in the experimental group. The difference was statistically significant(P<0. 05). The incidence of adverse reactions in the experimental group was 8. 90%(35/393),mainly gastrointestinal reactions,allergic reactions and elevated transaminase,and the degree,mostly mild to moderate and could be tolerated by patients. Conclusion Pirfenidone has good efficacy and safety in treatment of Chinese patients with idiopathic pulmonary fibrosis.

关 键 词：吡非尼酮 特发性肺纤维化 系统评价 合理给药 

分 类 号：R563.1[医药卫生—呼吸系统]