摘要
目的:评价双歧杆菌四联活菌片联用莫沙必利治疗功能性便秘的临床疗效与经济性。方法:检索CNKI、万方、PubMed、Embase、ClinicalTrials.gov等数据库(建库至2024年6月),按标准筛选随机对照试验,通过Meta分析评估联合用药的有效性与安全性。基于中国卫生体系角度构建决策树模型,通过成本-效用分析评价双歧杆菌四联活菌片联用莫沙必利(研究组)相比于莫沙必利(对照组)治疗功能性便秘的经济性。采用单因素敏感性分析与概率敏感性分析检验模型稳健性。结果:Meta分析显示,研究组总有效率及复发率显著优于对照组,安全性差异无统计学意义。经济性分析显示,研究组3个月治疗成本为385.55元,较对照组高246.63元;研究组较对照组增加0.0039单位QALYs,ICER为62491元/QALY。敏感性分析中复发率、药品单价和效用值对研究结果影响较大,概率敏感性分析显示,在2024年1倍人均GDP(95749元)阈值下,研究组具有经济性的概率为81.0%。结论:双歧杆菌四联活菌片联用莫沙必利治疗功能性便秘临床疗效更优,且具有经济性。
Objective:To evaluate the clinical efficacy and cost-effectiveness of Bifidobacterium quadruple viable tablets combined with mosapride for functional constipation.Methods:Databases including CNKI,Wanfang,PubMed,Embase,and ClinicalTrials.gov were searched from inception to June 2024.RCTs were selected for Meta-analysis.A decision tree model was constructed from the perspective of the Chinese healthcare system to evaluate the cost-utility of Live Combined Bifidobacterium and Lactobacillus Tablets combined with mosapride(study group)versus mosapride alone(control group)in the treatment of functional constipation.Sensitivity analyses were performed to test robustness.Results:Meta-analysis showed superior total effectiveness and lower recurrence in the combination group,with similar safety.The combination group cost 385.55 yuan over 3 months,246.63 yuan higher than the control,and gained an additional 0.0039 QALYs,yielding an ICER of 62491 yuan/QALY.Sensitivity analyses showed that the recurrence rate,drug unit price,and utility values had notable impacts on the results,and the probability of being cost-effective was 81.0%at a willingness-to-pay threshold of 1×GDP per capita(95749 yuan).Conclusion:The combination therapy is clinically and economically favorable for functional constipation.
作者
代露露
薛景
李洪超
DAI Lulu;XUE Jing;LI Hongchao(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China;Center for Pharmacoeconomics and Outcomes Research,China Pharmaceutical University,Nanjing 211198,China)
出处
《药学与临床研究》
2026年第1期39-44,共6页
Pharmaceutical and Clinical Research
关键词
功能性便秘
双歧杆菌四联活菌片
莫沙必利
系统评价
药物经济学评价
Functional constipation
Bifidobacterium quadruple viable tablets
Mosapride
Systematic review
Pharmacoeconomic evaluation
