目的 对鸡骨草胶囊治疗乙型肝炎、胆囊炎（肝胆湿热证）的临床价值进行综合评价，明确临床精准定位。方法 全面系统检索和收集鸡骨草胶囊研究文献和信息，定性研究与定量研究方法相结合，对药品安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色的证据及质量进行评价，利用多准则层决策分析模型及中成药临床证据和价值评估软件，综合评价其临床价值。结果 多源安全性证据表明，鸡骨草胶囊不良反应（adverse drug reaction，ADR）主要累及胃肠道，ADR发生率约为0.001 4%，安全性评为A级。随机对照试验及其Meta分析表明，鸡骨草胶囊联合恩替卡韦片治疗慢性乙型肝炎能够提高患者血清乙型肝炎e抗原（hepatitis B e antigen，HBeAg）转阴率，降低乙肝病毒DNA、谷丙转氨酶、谷草转氨酶、总胆红素水平；治疗胆囊炎可改善临床症状和体征、胆囊壁及收缩功能；有效性评为B级。预算影响分析表明，鸡骨草胶囊纳入医保报销范围，能够减轻医保基金的支出压力，减少患者经济负担，有利于患者的规范治疗以及基金的可持续发展，经济性评为B级。对肝胆湿热证肝胆同治，具有保肝降酶、抗炎镇痛、退黄疸、抗肝纤维化等功效，适用于急性、慢性肝炎的早期和中期，胆囊炎的轻、中症，尤其适用于肝炎合并胆囊炎者，具有临床创新性，有良好的服务创新性和产业创新性，获得8项国家发明专利；创新性评为B级。鸡骨草胶囊便于供应、储运、配制及给药，药品特性与用法适宜个体化治疗，适宜性评为B级。日治疗费用占城镇/农村居民人均可支配日收入的1.21%/3.22%，可负担性良好；全国28个省市在售，涵盖16 292家终端，可获得性良好；可及性评为A级。采用广西特色药材毛鸡骨草等10种中药组方，临床应用近50年，肝胆同治，异病同治，体现了中医药特色。基于现有研究，鸡骨草胶囊临床综合评价为B级，中医药特色＋。结论 鸡骨草胶囊临床价值较好，建议按程序有条件转化为基本临床用药管理的相关政策结果。

objective To comprehensively evaluate the clinical value of Jigucao Capsule (鸡骨草胶囊) in the treatment of hepatitis B and cholecystitis (liver and gallbladder dampness and heat syndrome) and clarify the precise clinical positioning. Methods Comprehensively and systematically search and collect the research literature and information of Jigucao Capsule, combine qualitative research with quantitative research methods, evaluate the evidence and quality of the safety, effectiveness, economy, innovation, suitability, accessibility and characteristics of traditional Chinese medicine, and evaluate the clinical value of the medicine by using the multi criteria layer decision analysis model (MCDA) and the Chinese patent medicine clinical evidence and value evaluation software. Results Multi source safety evidence showed that adverse drug reaction (ADR) of this drug mainly involveed the gastrointestinal tract. The incidence of ADR was about 0.0014%, and the safety rating was A. RCT and Meta-analysis showed that Jigucao Capsule combined with entecavir tablets could improve the negative rate of serum hepatitis B e antigen (HBeAg) and reduce the levels of HBV DNA, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBIL) in patients with chronic hepatitis B; Treatment of cholecystitis can improve clinical symptoms and signs, gallbladder wall and contractile function; The effectiveness was rated as B. The budget impact analysis showed that the drug was included in the scope of medical insurance reimbursement, which can reduce the expenditure pressure of medical insurance fund, reduce the economic burden of patients, and was conducive to the standardized treatment of patients and the sustainable development of the fund. The economic evaluation was B. Aiming at the liver and gallbladder damp heat syndrome, it had the effects of protecting liver and reducing enzymes, anti inflammation and analgesia, reducing jaundice, and anti liver fibrosis. It was suitable for the early and middle stage of acute and chronic hepatitis, and for the mild and moderate symptoms of cholecystitis, especially for the patients with hepatitis and cholecystitis, with clinical innovation; It had service innovation in terms of supply guarantee and capacity expansion; The industrial innovation was better reflected in the enterprise concept, information feedback and communication; It had obtained eight national invention patents; Innovation was rated as B. The suitability of the drug was evaluated as good in terms of convenience of preparation and administration, difficulty in treatment of adverse reactions, individualized treatment, drug characteristics and usage, convenience of supply, storage and transportation, and the suitability was evaluated as B. The daily treatment cost accounts for 1.21%/3.22% of the per capita disposable daily income of urban/rural residents, which was well affordable; It was sold in 28 provinces and cities nationwide, covering 16292 terminals, with good availability; Accessibility was rated as A. It was composed of 10 kinds of traditional Chinese medicines, such as Maojigucao (Herba Abri Mollis), which had been used in clinical practice for nearly 50 years. The liver and gallbladder were treated together and different diseases were treated together, reflecting the characteristics of traditional Chinese medicine. Based on the existing research, the comprehensive clinical evaluation was grade B, with characteristic of traditional Chinese medicine +. Conclusion Jigucao Capsule has good clinical value. It is suggested that it can be converted into relevant policy results of basic clinical medication management according to the procedure.

R285.64

中国中医科学院科技创新工程重大攻关项目（CI2021A00702）；国家重点研发计划“中医药现代化研究”项目（2018YFC1707400）