世界中医药

目的：通过成本-效果和成本-效用分析评价小金胶囊与对照药小金丸相比治疗甲状腺结节的经济学优劣，为甲状腺结节的临床治疗和相关医药政策的制订提供参考。方法：采用前瞻性队列研究设计，选择全国各地13家医院中，从统一约定的同一时点开始，研究者选用2种研究药物进行治疗的全部符合纳排标准的病例，以周为单位竞争性纳入，计划小金胶囊队列纳入前300例，小金丸队列纳入前100例患者，进行为期6个月的随访调查。以中医证候疗效、结节体积缩小为主要效果指标，质量调整生命年为效用指标，进行成本-效果和成本-效用分析。结果：共纳入454例病例，因调查表格填写不完整而剔除1例，完成随访的病例小金胶囊队列共353例、小金丸队列共100例，基线时有3个关键变量在2个队列间比较，差异有统计学意义（P>0.05），因此根据这3个变量进行分层分析。中医证候疗效方面，分层1中小金胶囊的有效性和经济性均优于对照药，分层2中小金胶囊相对于对照药更具经济性，分层3中小金胶囊经济性虽然稍差，但有效性明显要优于对照药，为了达到较好的有效性，选用小金胶囊是值得的；结节体积缩小方面，小金胶囊各分层成本-效果比较与中医证候疗效结果基本一致，且治疗效果相对于对照药的优势更加突出。成本-效用分析结果表明，小金胶囊在各分层人群中相对于对照药均更具经济性。结论：小金胶囊在甲状腺结节的治疗中与对照药相比具有一定的有效性和经济性优势。

English Summary:

To evaluate the economics of Xiaojin capsule compared with Xiaojin pill control in the treatment of thyroid nodule,using cost-effectiveness and cost-utility analysis and to provide references for the clinical treatment of thyroid nodules and the formulation of relevant medical policies.Methods:The prospective cohort study design was used,353 cases (Xiaojin capsule group) and 100 cases (control) from 13 hospitals were selected.From the time and place of agreement,the investigators selected all the two research drugs for treatment to meet the criteria for nasopharyngeal exclusion.They were competitively included on a weekly basis and included the first 300 patients in the Jinjin capsule cohort and the first 100 patients in the Xiaojinwan Cohort.Patients were followed up for 6 months.Three layers were designed in accordance with the key variables that affected the curative effect of Xiaojin capsule.Cost-effectiveness and cost-utility analysis were carried out based of the curative effect of TCM syndrome and the reduction of nodule volume as effect indicators,and quality adjusted life years as utility indicators.Results:A total of 454 cases were included.One case was filled out due to incomplete questionnaires.A total of 353 cases of Xiaojin capsules were completed for follow-up and 100 cases of Xiaojinwan cohort.There were three key variables at the baseline between the two groups.P>0.05),so stratified by these three variables.effect on TCM syndrome:the effectiveness and economical efficiency of Xiaojin capsule in Layer 1 were both superior to control.Xiaojin capsule was more economical compared with control in Layer 2.the effectiveness of Xiaojin capsule in Layer 3 was significantly superior to control,though its economy was a bit poor.So it was worthy to choose Xiaojin capsule in order to achieve a better effectiveness.Effect on nodule size Reduction:Cost-effectiveness analysis results of all layers were in accordance with that of TCM syndrome effect.Furthermore,the effectiveness of Xiaojin capsule was more prominent to control.cost-utility analysis:Xiaojin capsule was more economical compared with control in all layers.Conclusion:Xiaojin capsule presented highly effective and economical advantage in the treatment of thyroid nodule compared with control.

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