吡非尼酮治疗特发性肺纤维化的快速卫生技术评估

Pirfenidone for the treatment of idiopathic pulmonary fibrosis:a rapid health technology assessment

目的:基于快速卫生技术评估(health technology assessment,HTA)方法,评价吡非尼酮治疗特发性肺纤维化(idiopathic pulmonary fibrosis, IPF)的有效性、安全性和经济性,相对高效、快捷地为临床合理用药和医疗机构药物遴选提供一定的参考。方法:系统检索PubMed和Cochrane Library等英文数据库及中国知网(CNKI)、万方数据等中文数据库。由2位评价者根据纳入与排除标准独立筛选文献、提取资科和评价质量后,对结果进行定性分析。结果:共纳入14篇Meta分析(4篇中文10篇英文)、4篇经济学研究和1篇HTA。在治疗IPF时,吡非尼酮对用力肺活量(forced vital capacity, FVC),肺活量(vital capacity, VC)有显著作用,对6 min步行试验无显著作用,可能对急性恶化有效,可能降低死亡率,吡非尼酮的安全性较好,最常见的不良反应为恶心、疲劳、腹泻和皮疹,一般为轻到中度,光敏反应须引起注意。整体有效性和经济性良好。吡非尼酮的经济性证据尚不充分。结论:吡非尼酮的有效性和安全性良好,经济性尚待进一步评估。

Objective: To access the efficacy, safety and economy of Pirfenidone for the treatment of idiopathic pulmonary fibrosis based on Health Technology Assessment(HTA) method, and to efficiently and quickly provide reference for reasonable clinical application and selection of the drug. Methods: PubMed, Cochrane Library, CNKI and Wanfang databases were searched for system review, Meta-analysis, HTA and researches of pharmacoeconomics. Two reviewers independently identified studies, extracted data and accessed the quality of included studies. Qualitative analysis was performed. Results: 11 Meta-analysis, 4 pharmacoeconomic studies and 1 HTA were included. Pirfenidone had a significant effect on forced vital capacity(FVC) and vital capacity(VC), while no significant effect of 6-minute walk test was observed. It was probably effective on acute exacerbations and death rate. The most frequent adverse events were nausea, fatigue, diarrhea and rash, all mild to moderate in severity, indicating a good safety. Photosensitized reactions should be carefully treated. The efficacy and safety of pirfenidone is good while the economy was unknown because of insufficient evidence. Conclusion: The efficacy and safety of pirfenidone is good while the economy needs further evaluation.