肺动脉高压治疗药物5型磷酸二酯酶抑制剂的Mini卫生技术评估

Mini health technology assessment of phosphodiesterase-5 inhibitors for the treatment of pulmonary arterial hypertension

目的对肺动脉高压治疗药物5型磷酸二酯酶抑制剂西地那非、伐地那非、他达拉非进行Mini卫生技术评估,为医疗机构的药品遴选提供依据。方法通过检索中国知网、万方、维普数据库、PubMed、the Cochrane Library等中外文数据库及相关政府网站,获取药品适应证、价格、药理作用、指南推荐情况等信息,按照药学特性、有效性、安全性、经济性、医保属性、基药属性、贮藏条件、有效期、药品使用情况及生产企业状况10项《中国医疗机构药品评价与遴选快速指南》评估细则对西地那非、伐地那非、他达拉非进行药品遴选量化评价,汇总得分并根据评分结果划分推荐级别。结果最终得分西地那非77.3分,伐地那非69.6分,他达拉非71.8分。西地那非为原研药品,在儿童患者中的循证依据最为充分,为此类患者的首选用药;伐地那非和他达拉非日均治疗费用相当,但他达拉非给药频次较少,且在联合用药方面循证证据充足,较伐地那非有明显优势。结论西地那非和他达拉非可作为强推荐,伐地那非可作为弱推荐药品进入医疗机构目录用于肺动脉高压的治疗。

Objective This study was designed to provide references for medical institutions to select phosphodiesterase-5inhibitors Sildenafil,Vardenafil,Tadalafil for the treatment of pulmonary arterial hypertension through mini health technology assessment.Methods Indications,pharmacological effects,guideline recommendations,prices of drugs and other information of drugs were selected by searching Chinese and foreign databases such as CNKI,Wanfang,VIP,PubMed,the Cochrane Library and related government websites.Quantitative evaluation of drug selection for Sildenafil,Vardenafil,Tadalafil according to the 10 medical institutions of a Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions based on pharmaceutical characteristics,effectiveness,safety,economics,medical insurance attributes,base medicine attributes,original research attributes,storage conditions,drug validity,global usage status and status of the production enterprise.Then the scores were summarized and combined.The recommendation level was divided according to the scoring results.Results Sildenafil and Vardenafil and Tadalafil’s final scores were 77.3 and 69.6 and 71.8 respectively.Sildenafil is the original research drug,which has the most sufficient evidence-based evidence in pediatric patients and could be the first choice for children.The average daily treatment cost of Vardenafil was similar to Tadalafil,but the frequency of Tadalafil administration was less,and there was sufficient evidence-based evidence in combination medication,showing obvious advantages over Vardenafil.Conclusion Sildenafil and Tadalafil are strongly recommended and Vardenafil is weakly recommended to enter the catalog of medical institutions for the treatment of pulmonary arterial hypertension.