汉防己甲素片治疗尘肺病的药物临床综合评价

Drug clinical comprehensive evaluation of tetrandrine in the treatment of pneumoconiosis

目的探讨汉防己甲素片治疗尘肺病的安全性、有效性、经济性、创新性、适宜性和可及性,为卫生政策决策和临床实践提供证据。方法于2022年7月,系统检索PubMed、Embase、the Cochrane Library、中国知网、万方数据库和中国生物医学文献服务系统等数据库(检索时间为建库至2022年6月30日),筛选符合标准的文献并进行数据提取与评估,使用国际卫生技术评估组织协会(INAHTA)制定的《HTA checklist》对健康卫生技术评价(HTA)报告进行评价;使用《AMSTAR-2量表》评价系统评价/Meta分析的质量;使用《CHEERS量表》评价药物经济学研究的质量;对纳入的队列研究或病例对照研究,使用《纽卡斯尔-渥太华量表》进行评价;对纳入的随机对照试验(RCT)研究用Cochrane风险偏倚评估工具(Cochrane RCT)质量评价标准进行评价。根据纳入研究的数据特征进行综合比较与分析。结果初筛检出相关文献882篇,根据相关标准纳入8篇RCT研究。与尘肺病基础治疗组比较,汉防己甲素+基础治疗组患者的第1秒用力呼气容积(FEV1)提高(MD=0.13,95%CI:0.06~0.20,P<0.001),一秒率(FEV1/FVC)提高(MD=4.48,95%CI:0.61~8.35,P=0.02)。药物不良反应一般为轻度。汉防己甲素片可负担系数为0.295~0.492。结论汉防己甲素能改善尘肺病患者的临床症状和肺通气功能,不良反应多为轻度,临床应用安全性良好。

Objective To analyze the safety,effectiveness,economics,innovation,suitability and accessibility of tetrandrine in the treatment of pneumoconiosis,and provide evidence-based basis for health policy decision-making and clinical practice.Methods In July 2022,the system searched PubMed,Embase,the Cochrane Library,CNKI,Wanfang,SinoMed databases(the retrieval time was from the establishment of the database to June 30,2022),screened the documents that meet the standards,extracted and evaluated the data,and used the"HTA checklist"developed by the International Network of Agencies for Health Technology Assessment(INAHTA)to evaluate the HTA report.AMSTAR-2 Scale was used to evaluate the quality of systematic evaluation/Meta analysis.CHEERS Scale was used to evaluate the quality of pharmacoeconomics research.The included cohort study or case-control study was evaluated with the Newcastle-Ottawa Scale.The included randomized controlled trial(RCT)studies were evaluated using the Cochrane Risk Bias Assessment Tool(Cochrane RCT)quality evaluation criteria.Comprehensive comparison and analysis based on the characteristics of the data included in the study.Results A total of 882 related literatures were detected from the initial screening.According to relevant standards,8 RCT studies were finally selected for analysis.Statistical results showed that basic treatment with tetrandrine could better improve FEV1(MD=0.13,95%CI:0.06-0.20,P<0.001),FEV1/FVC(MD=4.48,95%CI:0.61-8.35,P=0.02)and clinical treatment efficiency.Tetrandrine had a low incidence of adverse reactions.The affordability coefficient of tetrandrine tablets was 0.295-0.492.Conclusion Tetrandrine can improve the clinical symptoms and pulmonary ventilation function of pneumoconiosis patients,most of the adverse reactions are mild,and the clinical application is safe.