便通胶囊/片治疗便秘临床综合评价

Clinical Comprehensive Evaluation of Biantong Capsules and Biantong Tablets in Treatment of Constipation

目的:以药品临床价值为导向,对便通胶囊/片治疗便秘开展临床综合评价,为便通胶囊/片的合理定价、合理用药及药品目录遴选提供科学依据。方法:基于当前可获得数据及调研数据,围绕便通胶囊/片与3种对照药治疗便秘的有效性、安全性、经济性、创新性、适宜性和可及性6个维度开展临床综合评价。结果:有效性方面,便通胶囊/片可提高临床有效率,药理作用机制明确。安全性方面,未见不良反应,预后良好。经济性方面,日均费用在对照药中最低,并具有一定成本效果优势。创新性方面,获得国内专利,并作为三类中药新药/中药9新药上市。适宜性方面,便于储存、方便服用,在药物技术特性和药品使用方面都具有较好的适宜性。可及性方面,医院覆盖较广,产能充足,患者负担较低,药品目录收录广泛,长期应用无较大环境风险。4种中成药的综合价值分数从高到低依次为对照药B(84.27分)、便通胶囊/片(82.47分)、对照药A(70.47分)、对照药C(59.46分)。专家组推荐意见为A类(18/18),建议可直接转化为决策使用。结论:便通胶囊/片治疗便秘的临床综合价值较高,可为药品合理定价、合理用药及药品目录遴选提供参考依据。

Objective:To carry out the clinical comprehensive evaluation of Biantong capsules and Biantong tablets in the treatment of constipation guided by the clinical value of drugs,and to provide a scientific basis for the rational pricing,rational use,and cataloging of Biantong capsules/tablets.Method:The available evidence and survey data were used for the clinical comprehensive evaluation of Biantong capsules/tablets and three control drugs in the treatment of constipation in terms of the six dimensions including effectiveness,safety,economics,innovation,suitability,and accessibility.Result:In terms of effectiveness,Biantong capsules/tablets can improve the response rate,with clear pharmacological mechanism.In terms of safety,the absence of toxic reaction,the mild adverse reactions,and the favorable prognosis indicate high safety.In terms of economics,the average daily cost of Biantong capsules/tablets is the lowest among the tested drugs,which indicates a cost-effectiveness advantage.In terms of innovation,Biantong capsules/tablets have been authorized patents in China and listed as members in the third category of new drugs of traditional Chinese medicine/ninth new drugs of traditional Chinese medicine.In terms of suitability,Biantong capsules/tablets are convenient to store and take and have good suitability in terms of drug technical characteristics and drug usage.In terms of accessibility,Biantong capsules/tablets have a wide coverage in hospitals,sufficient capacity,low patient burden,extensive drug catalogue coverage,and no major environmental risk for long-term application.The comprehensive values of the tested drugs follow a descending order of control drug B(84.27 score),Biantong capsules/tablets(82.47 score),control drug A(70.47 score),and control drug C(59.46 score).The recommendations of the expert panel are Class A(18/18),which can be directly converted into decision-making.Conclusion:Biantong capsules/tablets demonstrate a high clinical comprehensive value in the treatment of constipation,providing a reference for the rational pricing,rational use,and cataloging of drugs.