Objective: To observe clinical effects of RuPi decoction and mammary gland package for external application in treating hyperplasia of mammary glands. Methods: All 240 patients were randomized into the groups of A, B, C and D. A group took RuPi decoction, one dose each day, mammary gland package for external application fomenting, twice each day; B group took Tamoxifen tablet orally, 10 mg each time, twice each day; and C group RuPi decoction, one dose each day; D group mammary gland package for external application fomenting, twice each day, the course was seven days, for 12 courses consecutively, followed for half a year, clinical effects of the patients in four groups were observed, and the levels of estradiol and progesterone of four groups were compared before and after treating. Results: Total effective rate of A group was 85.0％ (51/60), B 81.7％ (49/60), C 55.0％ (33/60) and D58.3％ (35/60). Total effective rates of A and B were higher than these of C and D (P＜0.05), the difference had no statistical meaning in the comparisons between A and B (P＞0.05). The difference had no statistical meaning in the comparisons of the levels of estradiol and progesterone among four groups before treating, and the levels of hormones of four groups after treating improved, and the levels of hormones of A and B improved obviously (P＜0.05), the difference had no statistical meaning in the comparisons of the levels of hormones between both groups after treating (P＞0.05), No obvious adverse reaction happened during therapeutic period in four groups. Conclusion: Oral administration of RuPi decoction and mammary gland package for external application are superior to single RuPi decoction and mammary gland package for external application, equivalent to clinical effects of Tamoxifen tablet.%目的:观察乳癖汤与乳腺热敷包治疗乳腺增生的临床疗效.方法:将女性乳腺增生患者240例随机分为A、B、C及D组.A组患者口服乳癖汤每日1剂,同时热敷乳腺外敷包每日2次;B组口服三苯氧胺片10 mg/次,2次/d;C组口服乳癖汤每日1剂;D组热敷乳腺外敷包每日2次,疗程均为7天,连续治疗12个疗程,随访半年,观察4组患者临床疗效,并比较4组患者治疗前后雌二醇、孕酮激素水平.结果:总有效率A组为85.0％(51/60),B为81.7％(49/60),C组为55.0％(33/60),D组为58.3％(35/60).总有效率A、B组高于C、D组(P＜0.05),A组与B组比较差异无统计学意义(P＞0.05).治疗前4组患者雌二醇、孕酮水平比较差异无统计学意义(P＞0.05),治疗后4组患者激素水平改善,其中A、B组激素水平改善明显(P＜0.05),但A、B2组间患者激素水平比较差异无统计学意义(P＞0.05),4组患者治疗期间未发生明显不良反应.结论:口服乳癖汤联合乳腺外敷包治疗乳腺增生效果优于单纯口服乳癖汤或乳腺外敷包治疗,与三苯氧胺片治疗相当.
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