黄莪胶囊临床综合评价

Clinical comprehensive evaluation of Huang'e Capsules

目的对黄莪胶囊进行临床综合评价,探索其临床优势,以推进临床合理用药。方法采用文献研究及问卷调研的方式,全面收集黄莪胶囊在安全性、有效性、经济性、创新性、适宜性和可及性的证据及相关资料,利用多准则决策分析对黄莪胶囊的临床价值进行综合评价。结果近5年有8部临床指南、专家共识或专著中收录了黄莪胶囊,推荐用于气虚血瘀证、湿热阻滞证患者。文献研究显示,单用或与其他阳性药物联用,均可有效提高良性前列腺增生症患者的临床总有效率、最大尿流率,降低国际前列腺症状评分(I-PSS),减少夜尿次数,有效性评定为A级。不良反应发生率为0~12.7%,多为一般不良反应,未见严重不良反应报道,安全性评为A级。相比于安慰剂治疗,使用黄莪胶囊每提高1%有效率,需多花费33.04元,经济性评为A级;具有很好的临床创新性和服务创新性,创新性评为A级;无特殊保存条件、药材成分和其他限制条件,临床使用符合用药指南规范,适宜性评为A级;黄莪胶囊与同西医适应症的中成药相比,价格相对偏高,日费用为39.3元,可及性评为B级。结论综合定量与定性2种方法,以循证医学证据为主,结合调查问卷、官网数据信息、人用经验、药物经济学评价等研究方法,对黄莪胶囊进行综合评估:可及性评定为B级,有效性、安全性、经济性、创新性及适宜性均为A级。

Objective To evaluate the clinical effectiveness of Huang'e Capsules,aiming to clarify its clinical advantages and promote rational drug use.Methods Based on literature and questionnaire research,comprehensive evidence and related data on shexiang tongxin were collected in the dimensions of safety,effectiveness,economy,innovation,suitability and accessibility.And multi-criteria decision analysis(MCDA)was used to comprehensively evaluate the clinical value of Huang'e Capsules.Results Based on the eight clinical guidelines,expert consensus or monographs publishd in the past five years,Huang'e Capsules are recommended for patients with qi deficiency,blood stasis and damp heat blockade.Alone,or combination with other positive drugs,Huang'e Capsules can effectively improve the total clinical response rate,maximum urine flow rate,reduce I-PSS score,reduce the frequency of nocturia,and rate the effectiveness as A.Adverse reactions are mostly general adverse reactions and the incidence of adverse reactions was 0—12.7%.No serious adverse reactions have been reported,the risk is known to be small,and the safety is rated A.Compared with placebo,increase 1%effective rate would extra cost 33.04 yuan for Huang'e capsule,economic rating of grade A.It has good clinical innovation and service innovation,and innovation is rated as A.There are no special storage conditions,medicinal material ingredients and other restrictions,and the clinical use meets the specifications of the medication guidelines,and the suitability is rated as A;Compared with proprietary Chinese medicines with Western medical indications,the price of Huang'e Capsules are relatively highwith the daily cost of 39.3 yuan,and the accessibility is rated as B.Conclusion A comprehensive evaluation of Huang'e Capsules was conducted using two methods,quantitative and qualitative,with evidence-based medicine as the main method.Research methods such as survey questionnaires,official website data,user experience,and pharmacoeconomic evaluation were combined to evaluate the accessibility of Huange Capsules.The accessibility was rated as B level,while the effectiveness,safety,economy,innovation,and suitability were all rated as A.