世界中医药

目的：探索小金胶囊（0.35 g/粒）治疗乳腺囊性增生病的临床疗效及安全性。方法：选取2015年11月至2017年1月湖北省妇幼保健院收治的行Mammotome病检证实为乳腺囊性增生病的患者330例作为研究对象，按照随机数字表法随机分为A、B、C 3组，每组110例，分别给予小金胶囊（0.35 g）、他莫昔芬片、乳癖消片治疗，疗程为3个月，治疗结束后对3组进行疗效评估。结果：治疗12周后，A组的总有效率显著高于C组（90.9% VS 69.1%，P<0.05)，与B组比较差异无统计学意义（90.9% VS 89.1%，P>0.05)；A组乳房VAS评分及肿块大小评分显著高于C组（P<0.05)，与B组比较差异无统计学意义（P>0.05)；A组不良反应发生率显著低于B组（1.8% VS 24.5%，P<0.05)，与C组比较差异无统计学意义(1.8% VS 4.5%，P>0.05)。结论：小金胶囊治疗乳腺囊性增生病疗效确切，不良反应少，应用安全，值得临床推广。

English Summary:

To explore clinical efficacy and safety of Xiaojin Capsules(0.35 g/piece)in the treatment of breast cystic hyperplasia.Methods:A total of 330 patients with cystic hyperplasia of breast admitted in Maternal and Child Health Hospital of Hubei Province from November 2015 to January 2017 and confirmed by Mammotome examination were selected as study objects, and they were randomly divided into groups A, B and C, with 110 patients in each group.They were treated with Xiaojin Capsules(0.35 g), Tamoxifen Tablets and Rupixiao Tablets for 3 months, respectively.After the treatment, the efficacy of the 3 groups was evaluated.Results:After 12 weeks of the treatment, the total effective rate in the group A was significantly higher than that in the group C(90.9% VS 69.1%, P<0.05), but there was no significant difference between the group A and the group B(90.9% VS 89.1%, P>0.05).The breast VAS score and mass size score in the group A were significantly higher than those in the group C(P<0.05), but there was no significant difference between the group A and the group B(P>0.05).In the group A, the incidence of adverse reactions was significantly lower than that in the group B(1.8% VS 24.5%, P<0.05), but there was no significant difference with the group A and the group C(1.8% VS 4.5%, P>0.05).Conclusion:Xiaojin Capsules' efficacy in breast cystic hyperplasia is exact, with less adverse reactions, which is worthy of clinical promotion.

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