目的 通过整理夏荔芪胶囊治疗前列腺增生(本虚标实证)的研究文献,对其进行临床综合评价,明确其优势和特点及临床精准定位,为决策部门提供参考。方法 采用定性与定量相结合的评价方法,从安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色的"6+1"维度构建评价体系,通过专家对准则层、指标层赋予权重,运用多准则决策分析模型、中成药临床证据和价值评估软件对各维度进行计算后进一步转化为A~D 4个等级。结果 基于现有研究,(1)夏荔芪胶囊说明书对不良反应的说明、国家药品不良反应监测中心自发呈报系统、临床安全性系统评价与Meta分析等多源数据表明,该药品不良反应主要有胃部不适、腹胀、腹泻等,未观察到严重不良反应。风险可控,安全性好,安全性评为A级。(2)临床有效性系统评价与Meta分析表明,夏荔芪胶囊单用或联合常规治疗后,对国际前列腺评分、最大尿流率等的改善均优于对照组或单用常规治疗组。有效性较好,临床意义较大,有效性评为B级。(3)对夏荔芪胶囊联合常规治疗vs常规治疗进行成本-效果分析,说明其相对经济性。证据报告比较充分、结果较明确,经济性评为B级。(4)夏荔芪胶囊自2004年起先后获得8项国家专利,在临床创新性、服务体系创新性及产业创新性方面均可体现企业的创新性。创新性好,评为A级。(5)基于问卷调查结果,夏荔芪胶囊可基本满足临床用药需求。适宜性较好,评为B级。(6)从药品价格水平、可获得性和可负担性3方面得出夏荔芪胶囊可及性较好,评为B级。(7)夏荔芪胶囊是在络病理论的基础上化裁自李东垣的"通关丸"。中医药特色较突出,评为B级。综合"6+1"维度证据评价结果,夏荔芪胶囊治疗前列腺增生(本虚标实证)的临床价值综合评为B类。结论 夏荔芪胶囊治疗前列腺增生(本虚标实证)临床价值较好,创新性较为突出,据国家卫生健康委员会发布的《药品临床综合评价管理指南(2021年版试行)》,建议可按程序转化为基本临床用药管理的相关政策结果。

Objective According to existing research of Xialiqi Capsules (夏荔芪胶囊) in the treatment of prostatic hyperplasia (deficiency in origin and excess in superficiality), the clinical comprehensive evaluation was carried out to clarify advantages, characteristics, precise clinical positioning and provide reference for the decision-making of the national pharmaceutical administrative department. Method Using evaluation method of qualitative and quantitative combination, evaluation system from dimension of safety, effectiveness, economy, innovation, suitability, accessibility and specific features of TCM was established. Then experts give weight to the criteria layer and index layer, and the model of multiple criteria decision analysis and clinical evidence and value evaluation software of Chinese patent medicine were used to calculate each dimension before further transformed into A-D four levels. ResultsBased on the existing research, (1) the description of adverse reactions,national adverse drug reaction monitoring center spontaneous reporting system (SRS) and multiple data of clinical safety systematic evaluation and Meta-analysis in the instruction of Xialiqi Capsules showed that the adverse reactions mainly includes stomach discomfort, abdominal distension, diarrhea, and so on, no serious adverse reaction was observed. Xialiqi Capsules has controllable risk and better safety, and the safety rate is A. (2) Clinical effectiveness systematic evaluation and Meta-analysis showed that the improvement of international prostate score scale and maximum urinary flow rate in Xialiqi Capsules alone or combined with conventional treatment were better than the control group or conventional treatment group alone. The effectiveness is good, the clinical significance is great, and the effectiveness is rated as B. (3) By means of analyzing the cost-effectiveness of Xialiqi Capsules combined with conventional treatment vs conventional treatment, the relative economy of Xialiqi Capsules was confirmed. The evidential report is sufficient, the results is clear, and economy rate is B. (4) Xialiqi Capsules has obtained eight national patents since 2004 and innovation also reflect on clinical innovation, service system innovation and industrial innovation. Xialiqi Capsules has better innovation, and innovation rate is A. (5) Xialiqi Capsules can basically meet the clinical drug needs based on the result of questionnaire survey. Xialiqi Capsules has good suitability and suitability rate is B. (6) Xialiqi Capsules has good accessibility based on the drug price level, availability and affordability. Accessibility rate is B. (7) Xialiqi Capsules comes from "Tongguan Pill" created by Li Dong-yuan on the basis of Luo disease theory. Xialiqi Capsules has prominent TCM characteristic. Specific features of TCM is B. Based on the results of "6+1" dimensional evidence evaluation, the clinical value of Xialiqi Capsules in the treatment of prostatic hyperplasia (deficiency in origin and excess in superficies syndrome) is rated as Class B comprehensively. Conclusion Xialiqi Capsules has good clinical value and outstanding innovation in the treatment of prostatic hyperplasia (deficiency in origin and excess in superficies syndrome). According to the Guideline for Comprehensive Clinical Evaluation of Drugs (2021 edition) issued by the National Health Commission, it is recommended that Xialiqi Capsules can be transformed into the relevant policy results of basic clinical drug management procedurally.

R285.64

国家重点研发计划“中医药现代化研究”项目：十种中成药大品种和经典名方上市后治疗重大疾病的循证评价及其效应机制的示范研究（2018YFC1707400）；首都卫生发展科研专项“中成药高价值专利评价标准与培育策略研究”（首发 2022-1-4291）；国家自然科学基金面上项目：“区块链”融合深度学习的中药上市后肾损伤预警模型研究（81973982）；全国中医药创新骨干人才培养项目“中药药物警戒平台构建及中医药创新骨干人才培养”（Z0687）