摘要
目的:系统梳理痛泻宁颗粒治疗腹泻型肠易激综合征(IBS-D)肝气犯脾证的现有证据,从“6+1”维度进行临床综合价值评估,为国家医疗决策、药品临床应用、药事服务等提供参考。方法:依据《药品临床证据和价值评估管理指南》相关标准,基于循证医学证据、问卷调查、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模型(MCDA),从有效性、安全性、经济性、创新性、适宜性、可及性、中医药特色“6+1”维度对痛泻宁颗粒治疗IBS-D肝气犯脾证的临床证据和临床价值进行综合评估。结果:(1)安全性:根据安全性证据的已知风险和证据充分性两方面评价结果,认为痛泻宁颗粒风险可控,安全性证据充足。(2)有效性:基于Meta分析,痛泻宁颗粒联合益生菌可以降低IBS-D患者肠道症状积分水平[均数差(MD)=-2.29,95%置信区间(95%CI)(-3.20,-1.38),P<0.01],痛泻宁颗粒联合常规治疗(双歧杆菌三联活菌片/匹维溴铵片/马来酸曲美布汀片)有效提高IBS-D患者的综合改善率[相对危险度(RR)=1.19,95%CI(1.14,1.25),P<0.01],痛泻宁颗粒能够显著提高IBS-D患者腹痛[RR=1.99,95%CI(1.62,2.44),P<0.01]及腹泻有效率[RR=1.56,95%CI(1.07,2.25),P<0.05],痛泻宁颗粒与匹维溴铵片在降低IBS-D患者HAMA评分[MD=0.29,95%CI(-0.30,0.88),P=0.34]、HAMD评分[MD=0.35,95%CI(-0.31,1.00),P=0.30],改善IBS-QOL评分[MD=0.28,95%CI(-1.70,2.26),P=0.78]方面疗效相当。根据有效性的证据质量和证据价值评价结果,认为该品种有效性证据充足。(3)经济性:痛泻宁颗粒为全国医保乙类产品,经过5年3种Markov模型模拟后,认为痛泻宁颗粒为优势治疗方案,且结果稳定,经济性较好。(4)创新性:痛泻宁颗粒守正创新,从临床应用、产品组分和生产工艺上进行研发,获得国家中药新药证书、中华中医药学会科学技术一等奖、中国专利优秀奖等,在临床、企业、产业三方面创新性证据充�
Objective:To systematically review the existing evidence of Tongxiening(TXN)Granules in the treatment of diarrhea-predominant irritable bowel syndrome(IBS-D)with liver Qi invading spleen syndrome,and evaluate the clinical comprehensive value from the 6+1 dimension,providing references for national medical decision-making,drug clinical application promotion,pharmaceutical services,etc.Method:Following the relevant standards of the"Guidelines for the Management of Clinical Evidence and Value Evaluation of Drugs",a combination of qualitative and quantitative approaches based on evidence-based medicine,questionnaire surveys,pharmacoeconomic evaluation,etc.,was employed.Multi-criteria decision analysis(MCDA)model was employed to comprehensively evaluate the clinical evidence and value of TXN Granules in the treatment of IBS-D with liver Qi invading spleen syndrome from the"6+1"dimensions of effectiveness,safety,economy,innovation,suitability,accessibility,and traditional Chinese medicine(TCM)characteristics Result:①Safety:Based on the evaluation of known risks and adequacy of safety evidence,TXN granules were considered to have controllable risks with sufficient safety evidence.②Effectiveness:Metaanalysis showed that TXN granules combined with probiotics could reduce the intestinal symptom score level of IBS-D patients[mean difference(MD)=-2.29,95%confidence interval(CI)(-3.20,-1.38),P<0.01],and TXN granules combined with conventional treatments(such as Bifidobacterium triple viable capsules,pinaverium bromide tablets,or trimebutine maleate tablets)effectively improved the comprehensive improvement rate of IBS-D patients[relative risk(RR)=1.19,95%CI(1.14,1.25),P<0.01].TXN granules significantly improved abdominal pain[RR=1.99,95%CI(1.62,2.44),P<0.01]and diarrhea efficacy rate[RR=1.56,95%CI(1.07,2.25),P<0.05]in IBS-D patients.TXN granules were comparable to pinaverium bromide tablets in reducing HAMA score[MD=0.29,95%CI(-0.30,0.88),P=0.34],HAMD score[MD=0.35,95%CI(-0.31,1.00),P=0.30],and improving IBS-QOL score[MD=
作者
路振凯
谢雁鸣
LU Zhenkai;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2024年第11期139-149,共11页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家中医药管理局2021歧黄学者支持项目(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)。
关键词
痛泻宁颗粒
腹泻型肠易激综合征(IBS-D)
肝气犯脾证
临床综合评价
Tongxiening Granules
diarrhea-predominant irritable bowel syndrome
liver Qi invading spleen syndrome
clinical comprehensive evaluation
