| 引用本文:肖飞1，丁全如1，裴学军1，方洋1，张学斌2，赵刚1.不同剂量小金胶囊治疗甲状腺结节与乳腺增生病临床疗效研究[J].世界中医药,2018,(10):. |
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| 不同剂量小金胶囊治疗甲状腺结节与乳腺增生病临床疗效研究 |
| Clinical Efficacy of Different Dosages of Xiaojin Capsule in the Treatment of Thyroid Nodule and Breast Hyperplasia |
| 投稿时间：2018-09-12 |
| DOI：10.3969/j.issn.1673-7202.2018.10.022 |
| 中文关键词: 小金胶囊 甲状腺结节 乳腺增生病 剂量 疗效 |
| English Keywords:Xiaojin Capsule Thyroid nodule Breast hyperplasia Dosage Curative effect |
| 基金项目:国家中药标准化项目（ZYBZH-C-HUB-20） |
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| 中文摘要: |
| 目的：比较分析不同剂量的小金胶囊（0.35 g/粒）治疗甲状腺结节与乳腺增生病的疗效。方法：采用前瞻性研究设计，选取2014年5月至2016年8月全国各地三级乙等以上医院15家，从统一约定的同一时点开始，采用小金胶囊（0.35 g/粒）治疗的全部符合入排标准的病例竞争性纳入，计划纳入甲状腺结节病例300例，进行为期6个月的随访调查，以中医证候改善和结节缩小为主要疗效指标；计划纳入乳腺增生病例500例，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疗效指标。结果：共纳入病例851例，其中甲状腺结节353例，乳腺增生498例。甲状腺结节患者根据重要变量性别、年龄和吸烟量等因素分为3个分层，乳腺增生病患者根据重要变量年龄和生育次数因素分为4个分层。甲状腺结节患者中，小金胶囊用量为5～6粒/次可取得100%有效率，4粒/次为88%以上有效率；乳腺增生病患者中，小金胶囊用量5～6粒/次可取得100%疼痛症状有效率，4粒/次为85%以上有效率。结论：小金胶囊（0.35 g/粒）不论用于甲状腺结节还是乳腺增生病的治疗，服用量采用4粒/次可取得较好疗效，且相对较为经济，在该用量基础上进一步增加每次服用量可适当增加疗效，且未见不良反应发生。 |
| English Summary: |
| To compare the clinical efficacy of different dosages of Xiaojin Capsule (0.35 g/capsule) in the treatment of thyroid nodule and breast hyperplasia.Methods:This study was designed using the prospective study.All cases that conformed to the inclusion and exclusion standard were competitively included from the same agreed time.The 300 thyroid nodule cases (six-month follow-up,main indicators were TCM symptom improvement and nodule narrowing) and 500 breast hyperplasia cases (three-month follow-up,main indicators were breast pain relief and hyperplasia shrinking) from 15 hospitals of grade B class 3 and over from May 2014 to August 2016 were selected to join the investigation.Results:A total of 353 thyroid nodule cases and a total of 498 breast hyperplasia cases completed the study.The thyroid nodule cases were divided into three layers based on gender,age,and smoking amount factors.The breast hyperplasia cases were divided into four layers based on age and fertility number factors.In thyroid nodule cases,dosage of 5-6 capsules per time achieved 100% efficient,and dosage of 4 capsules per time achieved >88% efficient.In breast hyperplasia cases,dosage of 5-6 capsules per time achieved 100% pain symptom efficient,and dosage of 4 capsules per time achieved >85% efficient.Conclusion:Dosage of 4 capsules per time of Xiaojin Capsule may obtain good curative effect and is relatively economic for both thyroid nodule and breast hyperplasia treatment.Furthermore,dosage increase may appropriately increase the curative effect with no adverse drug reaction. |
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