注射用七叶皂苷钠的药品临床综合评价

Comprehensive Clinical Evaluation of Sodium Aescinate for Injection

目的:从有效性、安全性、经济性、创新性、适宜性和可及性6个维度对注射用七叶皂苷钠进行药品综合评价。方法:系统检索PubMed、the Cochrane Library、Embase、中国生物医学文献数据库、中国知网、万方数据库和WebCRD等数据库,通过快速卫生技术评估(HTA)的方法,对注射用七叶皂苷钠的有效性、安全性和经济性进行分析。检索国家药品监督管理局、国家药品监督管理局药品审评中心等专业网站以及各国药典、药品说明书,对注射用七叶皂苷钠的创新型、适宜性和可及性进行分析。结果:(1)有效性与安全性方面,研究人群包括脑出血致脑水肿、脑缺血致脑水肿、手术致肿胀和创伤致肿胀;研究方案为注射用七叶皂苷钠对比甘露醇、注射用七叶皂苷钠对比其他阳性药物和注射用七叶皂苷钠对比空白对照,注射用七叶皂苷钠联合甘露醇对比甘露醇、注射用七叶皂苷钠联合依达拉奉对比依达拉奉、注射用七叶皂苷钠联合依达拉奉对比注射用七叶皂苷钠和注射用七叶皂苷钠联合依达拉奉对比空白对照,研究组与对照组均予以常规治疗。结果显示,注射用七叶皂苷钠单药或与甘露醇等阳性药物联合应用能显著提高治疗有效率、降低药品不良反应发生率。(2)经济学方面,注射用七叶皂苷钠联合甘露醇在创伤致肿胀人群中的应用具有最佳的增量成本-效果比,在脑梗死患者中使用的增量成本-效果比仅次于低分子肝素钠。注射用七叶皂苷钠属于医保乙类药品,存在报销限制。(3)创新性方面,注射用七叶皂苷钠在分析检测方法和制备方法上具有2项专利。(4)适宜性方面,注射用七叶皂苷钠的质量标准为国家标准,注射剂型对药品的使用适宜性具有一定影响。(5)可及性方面,注射用七叶皂苷钠的注册生产企业所在地涉及11个省、直辖市,供应可及性良好。结论:注射用七叶皂苷钠在出血性脑卒中致脑水肿、缺血性脑卒中致脑水肿、手术致肿胀和创伤体肿胀患者中应用,具有较好的临床效果和安全性;单药应用于缺血性脑卒中致脑水肿和创伤致肿胀患者的经济性居中;尚无针对该药在手术致肿胀患者中应用的经济学研究。

OBJECTIVE:To comprehensively evaluate sodium aescinate for injection from effectiveness,safety,economy,innovation,suitability and accessibility.METHODS:PubMed,the Cochrane Library,Embase,CBM,CNKI,Wanfang Data and WebCRD were systematically retrieved.The rapid health technology assessment(HTA)was used to analyze the effectiveness,safety and economy of sodium aescinate for injection.National Medical Products Administration,Center for Drug Evaluation of National Medical Products Administration and other professional websites,pharmacopoeia and drug instructions of various countries were retrieved to analyze the innovation,suitability and accessibility of sodium aescinate for injection.RESULTS:(1)In terms of effectiveness and safety,the study population included cerebral edema induced by cerebral hemorrhage,cerebral edema induced by cerebral ischemia,swelling induced by surgery and swelling induced by trauma.The study protocol was sodium aescinate for injection versus mannitol,sodium aescinate for injection versus other positive drugs,sodium aescinate for injection versus blank control,sodium aescinate for injection combined with mannitol versus mannitol,sodium aescinate for injection combined with edaravone versus edaravone,sodium aescinate for injection combined with edaravone versus sodium aescinate for injection,sodium aescinate for injection combined with edaravone versus blank control,the study group and the control group were given routine treatment.Sodium aescinate for injection alone or in combination with positive drugs such as mannitol could significantly improve the treatment efficiency and reduce the incidence of adverse drug reactions.(2)In terms of economics,the application of sodium aescinate for injection combined with mannitol in trauma-induced swelling had the best incremental cost-effectiveness ratio,and the incremental cost-effectiveness ratio in patients with cerebral infarction was inferior to low molecular weight heparin sodium.Sodium aescinate for injection was the class B drug under medical insurance,which had limitations on reimbursement.(3)In terms of innovation,sodium aescinate for injection had two patents in analysis and detection methods and preparation methods.(4)In terms of suitability,the quality standard of sodium aescinate for injection was the national standard,and the injection dosage form had a certain influence on the suitability of drug use.(5)In terms of accessibility,the registered production enterprises of sodium aescinate for injection were located in 11 provinces and municipalities directly under the central government,and the supply of sodium aescinate for injection was well accessible.CONCLUSIONS:The clinical effectiveness and safety of sodium aescinate for injection in patients with cerebral edema induced by hemorrhagic stroke,cerebral edema induced by ischemic stroke,swelling induced by surgery and swelling of traumatic body are significant.The economy of single drug in patients with cerebral edema induced by ischemic stroke and swelling induced by trauma is medium.There are no economic studies on the use of sodium aescinate for injection in patients with surgical swelling.