法乐通治疗乳腺囊性增生症的前瞻性临床研究

Therapeutic Effect of Toremifene on Cystic Hyperplasia of Breast

目的研究法乐通(TOR)对乳腺囊性增生症的疗效和副反应。方法前瞻性随机对照研究分别应用法乐通(TOR)和三苯氧胺(TAM)共治疗156例临床症状明显的乳腺囊性增生症患者,疗程为三个月。并随诊三个月。结果TOR治疗组:治愈17例(21.5%),显效49例(62%),有效10例(12.7%),总有效率96.2%。无效3例(3.8%)。副反应总发生率16.4%,主要不良反应为消化道症状及抗雌激素反应;未发现继发深静脉血栓形成或子宫内膜癌。TAM治疗组:治愈14例(18.2%),显效42例(54.5%),有效11例(14.3%),总有效率87%。无效10例(13%)。副反应总发生率为46.8%。结论法乐通对乳腺囊性增生症有较好疗效,副作用小,临床应用安全性高。

Objective To investigate the therapeutic effect and side affe ct of toremifene on cystic hyperplasia of breast. Methods The trial based on fo reseeing randomized paired was proceeded to study 156 patients with cystic hyper plasia of breast showing clinical symptoms. They were treated with either TOR or TAM for a course of three months and followed up for 3 months. Results TOR gro up: 17 cases recovered(21.5%), 49 had excellent result(62%), 10 had fair result( 12.7%), and only 3 cases failed(3.8%). The total rates of effective treatment an d having side effect were 96.2% and 16.4% respectively. The main adverse effect s were anti-estrogen and showing digestive symptoms. No secondary deep vein thr ombosis or uterus endometritic carcinoma were found. TAM group: 14 cases recover ed(18.2%), 42 had excellent result(54.5%), 11 had fair result(14.3%) and 10 case s failed(13%). The total rate of effective treatment and having side effect wer e 87% and 46.8% respectively. Conclusions TOR is effective in treating cystic hy perplasia of breast and showing little side affect. Therefore TOR is fairly safe in clinical application.