痰热清注射液治疗急性呼吸系统感染及其并发症的快速卫生技术评估  

Tanreqing injection for acute respiratory infections and complications:a rapid health technology assessment

作　　者：李潇潇[1,2] 门鹏 周燊[1,3] 江华 赵荣生 史录文[2] 杨毅恒 LI Xiao-xiao;MEN Peng;ZHOU Shen;JIANG Hua;ZHAO Rong-sheng;SHI Lu-wen;YANG Yi-heng(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Department of Pharmacy Administration&Clinical Pharmacy,School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Peking Pharmaceutical Quality Control&Improvement Center,Beijing 100191,China)

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京大学药学院药事管理与临床药学系,北京100191 [3]北京大学医学部药物评价中心,北京100191 [4]北京市药学质量控制和改进中心,北京100191

出　　处：《中国医院药学杂志》2021年第9期959-965,共7页Chinese Journal of Hospital Pharmacy

基　　金：北京市卫生健康委员会药械处快速药物经济学评价与医院新药遴选专项工作;北京大学第三医院临床重点项目孵育项目(编号:BYSY2018035)。

摘　　要：目的:通过快速卫生技术评估,评价痰热清注射液用于急性呼吸系统感染及其并发症的有效性、安全性及经济性,为临床实践与决策者提供循证依据。方法:系统检索主要的中英文数据库,由2名评价者分别根据预设的纳入排除标准和数据提取表筛选文献和提取数据,并对结果进行综合分析。结果:共纳入13篇系统评价/Meta分析,以中等质量文献为主。与抗菌药物/抗病毒药/常规治疗单药治疗相比,联合应用痰热清注射液可改善成人肺炎、支气管炎、全身炎性反应综合征、H1N1的临床总有效率等相关指标,差异有统计学意义(P<0.05)。痰热清注射液与抗菌药物在肺炎、支气管炎的临床总有效率相当(P>0.05),但可缩短退热时间和咳嗽消失时间,差异有统计学意义(P<0.05)。与抗菌药单药应用相比,联合痰热清注射液不增加药品不良反应发生风险(P>0.05)。与左氧氟沙星单药用于社区获得性肺炎相比,痰热清注射液联用左氧氟沙星具有成本效果优势。结论:与抗菌药物/抗病毒药/常规治疗等治疗急性呼吸系统感染及其并发症相比,联合使用痰热清注射液具有较好疗效与经济性,且不增加安全性风险。有必要进一步开展大样本、高质量的临床试验进行验证。OBJECTIVE To provide evidences to healthcare providers and decision makers through a rapid health technology assessment of clinical effectiveness,safety and economy of Tanreqing Injection for acute respiratory infections and complications.METHODS Several major Chinese and English databases were systematically searched.After independent study selection,data extraction and quality assessment,included studies were comprehensively analyzed.RESULTS A total of 13 systematic reviews/Meta-analyses with fair average quality were included.As compared with antibiotics/antiviral agents/conventional therapy for pneumonia,bronchitis,systemic inflammatory response syndrome and H1 N1 alone,combined treatment of Tanreqing Injection could improve the overall effective rate.And the difference was statistically significant(P<0.05).No significant difference existed in overall effective rate between Tanreqing Injection and antibiotics in the treatment of either pneumonia or bronchitis(P>0.05).However,fever clearance time and cough disappearance time benefited from Tanreqing Injection.And the difference was statistically significant(P<0.05).As compared with antibiotics alone,co-using Tanreqing Injection showed no increased risk of adverse drug reaction(P>0.05).As compared with levofloxacin alone for community-acquired pneumonia,Tanreqing Injection plus levofloxacin demonstrated a cost-effective advantage.CONCLUSION Tanreqing Injection plus antibiotics/antiviral agents/conventional therapy offer better effectiveness and economy for acute respiratory infections and complications while safety risk remains the same.Large samples and high-quality validation studies are still required.

关 键 词：痰热清 循证评价 急性呼吸系统感染 有效性 安全性 经济性 

分 类 号：R969.3[医药卫生—药理学]