布地奈德雾化吸入治疗特发性肺纤维化临床研究的系统评价

Budesonide Inhalation for Patients with Idiopathic Pulmonary Fibrosis:a systematic review

目的:探讨布地奈德雾化吸入治疗特发性肺纤维化的有效性和安全性。方法:检索包括中国生物医学文献数据库,中国期刊全文数据库,中文科技期刊数据库和万方数据资源系统。收集2009年4月以前发表的布地奈德雾化吸入治疗特发性肺纤维化的随机对照研究。纳入研究的质量评价参考Cochrane干预性研究系统评价员手册,采用RevMan4.2分析数据。结果:6个关于布地奈德雾化吸入治疗特发性肺纤维化的随机对照研究纳入评价,纳入特发性肺纤维化患者260例(试验组/对照组:132/128),纳入研究质量较低。对同质性好的数据进行meta分析,结果表明布地奈德雾化吸入治疗特发性肺纤维化能改善患者的呼吸困难等症状,改善肺功能,氧分压,疗效与口服泼尼松(龙)组相当。且布地奈德雾化吸入方式不良反应较少,表现为口腔炎及血糖高,其不良反应明显低于口服泼尼松(龙)组,患者依从性较好。结论:纳入研究的方法学质量普遍较低,存在多种偏倚,影响了结果的可靠性。有必要开展设计严谨、管理规范的临床研究以进一步证实布地奈德雾化吸入治疗特发性肺纤维化的有效性和安全性,为临床决策提供高质量的疗效证据。

Objective：To investigate the efficacy and safety of budesonide inhalation in the treatment of idiopathic pulmonary fibrosis.Methods：Literature associated with randomized controlled trials（RCT）of budesonide inhalation in treating patients with idiopathic pulmonary,which were published before April 2009,were retrieved by computerized searching from Chinese Biological Medicine Database（CBM）,CNKI,Chinese scientific and technical journals and WANFANG Databases.They were evaluated by method recommended in Cochrane Reviewer＇s Handbook,and statistical analysis was performed by the Cochrane Collaborati-on＇s Rev Man 4.2 software.Results：6 RCT,involving 260 patients（test group/control group：132/128）with idiopathic pulmonary fibrosis meeting the inclusion criteria were identified.Quality of the RCTs included was lower.The results of meta-analysis indicated that budesonide inhalation could improve dyspnea,lung function,oxygen partial pressure etc.Budesonide inhalation in test group had same efficacy with oral prednisone in control group,and had better compliance.The adverse reaction,sch as stomatitis and high blood sugar,was significantly lower than that of oral prednisone group.Conclusion：Methodological quality of RCTs included was generally low.A wide range of bias affect the reliability of the results.Well-structured,standardized clinical studies are required to further confirm the efficacy and safety of budesonide inhalation in treating idiopathic pulmonary fibrosis and provide high-quality evidence for clinical decision-making.