摘要
目的:快速评估甲磺司特治疗支气管哮喘的有效性、安全性和经济性,为临床合理用药提供循证证据。方法:系统检索PubMed、EMBase、the Cochrane Library、中国知网、万方数据库、维普数据库和国内外卫生技术评估(health technology assessment,HTA)机构官方网站,纳入甲磺司特治疗支气管哮喘的HTA报告、系统评价/文献荟萃分析(Meta分析)、随机对照试验(randomized controlled trial,RCT)和药物经济学研究,采用定性描述的方法汇总纳入研究的结论,并对其方法学质量进行评价。结果:共纳入11篇文献,均为RCT,其中7项研究针对成人支气管哮喘患者、4项研究针对儿童支气管哮喘患者,未检索到HTA报告、系统评价/Meta分析和药物经济学研究。结果显示,对于成人支气管哮喘患者,甲磺司特能通过减少嗜酸性粒细胞气道炎症抑制患者的气道高反应,有效缓解支气管哮喘患者(包括激素依赖性哮喘、咳嗽变异性哮喘)的临床症状,改善肺功能、提高临床治疗效果;其疗效显著优于安慰剂,与氟替卡松、曲尼司特及丙酸倍氯米松的疗效相当甚至更优;同时,其不良反应发生率低,安全性好。对于儿童支气管哮喘患者,甲磺司特同样疗效确切且安全可靠,与美喹他嗪、孟鲁司特钠疗效相当。本次纳入的各项研究结论的一致性较好。结论:甲磺司特治疗成人和儿童支气管哮喘均具有良好的有效性和安全性,可减少激素用量。未来可考虑对其开展药物经济学研究,补充其治疗支气管哮喘的经济性评价证据。
OBJECTIVE:To rapidly evaluate the efficacy,safety and economical efficiency of suplatast tosilate in the treatment of bronchial asthma,so as to provide evidence-based evidence for clinical rational drug use.METHODS:PubMed,Embase,the Cochrane Library,CNKI,WanFang database,VIP and health technology assessment (HTA) organization websites were searched systematically.HTA reports,systematic reviews/meta-analysis,randomized controlled trials (RCT) and pharmacoeconomic studies related to suplatast tosilate in the treatment of bronchial asthma were included.Qualitative and descriptive analysis as well as methodological quality assessment were performed on the included studies.RESULTS:A total of 11 RCT were included.Among them,7 studies were conducted on adults with bronchial asthma and 4 studies were conducted on children with bronchial asthma.No HTA reports,systematic reviews/meta-analysis and pharmacoeconomic studies were found.The results showed that in adult patients with bronchial asthma,methorprost could effectively relieve the clinical symptoms of bronchial asthma (including steroid-dependent asthma and cough variant asthma),improve lung function and improve clinical treatment effects by reducing eosinophilic airway inflammation and inhibiting airway hypersensitivity.The efficacy was significantly better than placebo,and the efficacy was equal to or better than fluticasone,trimester and beclomethasone propionate.At the same time,suplatast tosilate was safe with a lower incidence of adverse drug reactions.For children with bronchial asthma,suplatast tosilate was also effective and safe,which was comparable to mequitazine and montelukast.The conclusions of the studies included in this assessment were consistent.CONCLUSIONS:Suplatast tosilate has favorable efficacy and safety in the treatment of bronchial asthma in adults as well as in children,and can reduce the dosage of glucocorticoid.In the future,pharmacoeconomics research on suplatast tosilate can be considered to supplement the evidence of economic evaluation.
作者
李婷
裴艺芳
赵紫楠
李可欣
杨蕾
倪倩
李超
谭玲
LI Ting;PEI Yifang;ZHAO Zinan;LI Kexin;YANG Lei;NI Qian;LI Chao;TAN Ling(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Assessment of Clinical Drugs Risk and Individual Application Key Laboratory,Beijing 100730,China;Clinical Trial Center,Beijing Hospital,National Center of Gerontology,Beijing 100730,China)
出处
《中国医院用药评价与分析》
2019年第9期1114-1117,1122,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
“国家重大新药创制”科技重大专项(No.2017zx09101001002002)
关键词
甲磺司特
快速卫生技术评估
支气管哮喘
Suplatast tosilate
Rapid health technology assessment
Bronchial asthma
