降脂通络软胶囊治疗高脂血症(血瘀气滞证)的临床综合评价  

Clinical comprehensive evaluation of Jiangzhi Tongluo Soft Capsules for treating hyperlipidemia(syndrome of blood stasis and Qi stagnation)

作　　者：路振凯 刘福梅[1] 张旭明 王雅星 谢雁鸣[1] LU Zhen-kai;LIU Fu-mei;ZHANG Xu-ming;WANG Ya-xing;XIE Yan-ming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国中药杂志》2024年第20期5627-5634,共8页China Journal of Chinese Materia Medica

基　　金：国家中医药管理局2021岐黄学者支持项目(国家中医药人教函[2022]6);谢雁鸣全国名老中医药专家传承工作室建设项目(国家中医药人教函[2022]75)。

摘　　要：该研究全面梳理降脂通络软胶囊治疗高脂血症(血瘀气滞证)的现有证据,基于《药品临床证据和价值评估管理指南》标准,结合问卷调查、循证医学证据、药物经济学评价等定性与定量相结合的方法,利用多准则决策分析(MCDA)模型,针对安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色“6+1”维度进行临床证据和临床价值的综合评估。安全性证据充分性和已知风险评价显示,降脂通络软胶囊风险可控,安全性证据充足、结果确定。有效性基于Meta分析结果,降脂通络软胶囊能够显著改善患者甘油三酯水平(RR=-0.25,95%CI[-0.41,-0.10],P=0.001),降脂通络软胶囊vs辛伐他汀片在治疗血脂有效率方面疗效相当(RR=1.11,95%CI[0.96,1.27],P=0.15),降脂通络软胶囊vs脂必妥片在治疗血脂有效率方面疗效相当(RR=1.07,95%CI[0.99,1.16],P=0.10),降脂通络软胶囊vs血脂康胶囊在治疗血脂有效率方面效果更佳(RR=1.44,95%CI[1.17,1.76],P=0.0006);GRADE证据均为C级,综合证据质量和证据价值评价结果,认为该品种有效性证据较充足。通过构建Markov经济模型提示,降脂通络软胶囊vs蒲参胶囊治疗方案更具有经济性,综合增量效应水平和干预方案成本水平,认为该药经济性较好。从3个一级指标,18个二级指标进行创新性评价,认为其创新性证据较充足。该药信息服务齐全,问卷调查显示其对临床医生、护士、药师以及患者适宜,综合评价适宜性证据较充足。药品可及性主要涉及药品价格水平、可获得性和可负担性3个方面,降脂通络软胶囊中标价0.72元/粒,报销后治疗费用占城镇居民可支配收入中位数的0.08%,占农村居民可支配收入中位数的0.31%,可及性证据较充足。基于中医药特色评定原则,降脂通络软胶囊中医药特色较突出。综合“6+1”维度,运用CSC v2.0软件计算得出综合衡量价值为0.69,该药临床综合价值证据�This study provides a systematic review of existing evidence concerning the efficacy of Jiangzhi Tongluo Soft Capsules(JTSC)in treating hyperlipidemia(syndrome of blood stasis and Qi stagnation),following the Guidelines for clinical evidence and value assessment of drugs.The qualitative and quantitative methods were integrated,including questionnaire surveys,evidence-based medicine,and pharmacoeconomic evaluation.Multi-criteria decision analysis(MCDA)model was used for comprehensive assessment of the clinical evidence and value of JTSC for hyperlipidemia in"6+1"dimensions:safety,effectiveness,cost-effectiveness,innovation,suitability,accessibility,and traditional Chinese medicine(TCM)characteristics.The safety evidence was sufficient and the results of the known risk assessment indicated that JTSC was safe and had a sufficient safety profile.Meta-analysis showed that JTSC recovered patients'triglyceride levels(RR=-0.25,95%CI[-0.41,-0.10],P=0.001).JTSC had similar efficacy to simvastatin Tablets(RR=1.11,95%CI[0.96,1.27],P=0.15)and Zhibituo Tablets(RR=1.07,95%CI[0.99,1.16],P=0.10)in restoring blood lipid levels.JTSC outperformed Xuezhikang Capsules in recovering blood lipid levels(RR=1.44,95%CI[1.17,1.76],P=0.0006).According to the Grading of Recommendations Assessment,Development and Evaluation(GRADE)system,the evidence was rated as grade C,and the overall evaluation of the quality and value of the evidence indicated that the effectiveness evidence of this product was fairly sufficient.Markov economic model was established,and the results suggested that JTSC was more economical than Pushen Capsules.Considering the incremental effect and the cost of the intervention scheme,JTSC had good cost effectiveness.The innovation of JTSC was evaluated based on three primary indicators and eighteen secondary indicators,which suggested the evidence of innovation for JTSC was abundant.The information of Chinese patent medicines of JTSC was complete,and the survey results showed that the drug was suitable for clinicians,nurses,p

关 键 词：降脂通络软胶囊 高脂血症 血瘀气滞证 临床综合评价 

分 类 号：R259[医药卫生—中西医结合]