| 引用本文:肖飞1，张宇2，张玉杰3，张春霞4，钟华5，徐旭东6，盛盼7，裴学军1，赵刚1，李和林8.小金胶囊治疗乳腺增生病药物经济学研究[J].世界中医药,2018,(11):. |
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| 小金胶囊治疗乳腺增生病药物经济学研究 |
| Pharmacoeconomic Research of Xiaojin Capsule in the Treatment of Breast Hyperplasia |
| 投稿时间：2018-10-26 |
| DOI：10.3969/j.issn.1673-7202.2018.11.056 |
| 中文关键词: 小金胶囊 小金丸 乳腺增生病 药物经济学 |
| English Keywords:Xiaojin Capsule Xiaojin Pill Breast hyperplasia Pharmacoeconomics |
| 基金项目:国家中药标准化项目(ZYBZH-C-HUB-20) |
| 作者 | 单位 | | 肖飞1，张宇2，张玉杰3，张春霞4，钟华5，徐旭东6，盛盼7，裴学军1，赵刚1，李和林8 | 1 健民药业集团股份有限公司药物研究院,武汉,430052
2 上海中医药大学附属市中医院外二科,上海,200071
3 中国中医科学院广安门医院普通外科,北京,102600
4 北京市顺义区医院乳腺甲状腺科,北京,101300
5 清华大学附属华信医院普外科,北京,100016
6 武汉市第五医院肿瘤综合科，武汉430050
7 武汉市东西湖人民医院乳腺甲状腺科,武汉,430040
8 中国中药协会中药药物经济学专业委员会,北京,100101 |
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| 中文摘要: |
| 目的:通过成本-效果和成本-效用分析评价小金胶囊(0.35 g/粒)与对照药小金丸比较治疗乳腺增生病的经济学优劣,为乳腺增生病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,选取2014年5月至2016年8月全国各地14家医院,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500例,小金丸队列纳入前100例患者,进行为期3个月的随访调查。以乳房疼痛疗效、增生体积缩小疗效为主要效果指标,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600例病例,其中小金胶囊队列共498例、小金丸队列共102例,基线时有2个关键变量(年龄和生育次数)在2个队列间存在显著差异(P>0.05),因此根据这2个变量进行分层分析。在乳房疼痛症状方面,2个队列疗效相当,其中,小金胶囊在生育次数大于1次的女性更具有经济性,为优势方案。在乳腺增生体积缩小方面,小金胶囊治疗大于30岁的患者时疗效更具有疗效优势,年龄小于30岁并生育次数≥1、年龄>30岁人群中小金胶囊更具有经济性,为优势方案。改善生命质量方面,小金胶囊能更好的提高年龄不超过30岁未生育的女性患者人群的健康状况,小金胶囊为优势方案,更具有经济性,值得临床推荐。此外,研究未观察到小金胶囊的不良反应。结论:在部分人群小金胶囊治疗乳腺增生病与对照药比较具有一定的有效性和经济性优势。 |
| English Summary: |
| To evaluate the economics of Xiaojin Capsule (0.35 g/capsule) compared with Xiaojin Pill (the control drug) in the treatment of breast hyperplasia，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:This study was designed using the prospective cohort study.As from May 2014 to August 2016 in 14 hospitals in China，all cases that conformed to the inclusion & exclusion standard were competitively included in weekly from the same agreed time.The first 500 Xiaojin Capsule-treated cases and first 100 control-treated cases were selected to join a three-month follow-up investigation.Cost-effectiveness and cost-utility analysis were carried out based on the curative effect of breast pain and the reduction of hyperplasia volume as effect indicators and quality adjusted life years as utility indicators.Results:A total of 600 cases completed the study with 498 Xiaojin Capsule-treated cases and 102 control-treated cases.There was obvious difference of two key variables between age and fertility in the two queues (P>0.05)，so stratification analysis was selected based on two variables.Effects on breast pain：the effectiveness of Xiaojin Capsule was equivalent to control drug.The use of Xiaojin Capsule was more economical for women that were greater than or equal to 1 fertility.Effects on hyperplasia volume reduction：the effectiveness of Xiaojin Capsule was more prominent to control drug for women over 30 years.The use of Xiaojin Capsule was more economical for women under 30 years who were greater than or equal to 1 fertility and women above 30 years.Life quality improving：It was worthy of clinical recommendation to use Xiaojin Capsule for women under 30 years with no fertility.Furthermore，no adverse drug reaction was observed.Conclusion:Xiaojin Capsule presents highly effective and economical advantage in the treatment of breast hyperplasia compared with control drug (Xiaojin Pill) in some people. |
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