托瑞米芬治疗绝经前妇女周期性乳痛症的安全性和有效性临床研究

Safety and effectiveness of toremifene therapy for premenopausal woman with cyclical mastalgia

目的评价托瑞米芬治疗绝经前妇女周期性乳痛症的安全性和有效性。方法北京协和医院乳腺外科于2008年3月至2010年1月期间应用托瑞米芬治疗中、重度绝经前周期性乳痛症患者共106例。患者接受每日托瑞米芬40mg治疗共3个月经周期,治疗前后检查血常规、肝肾功能、血脂、雌二醇(E2)、孕酮(P)、促黄体生成素(LH)、促卵泡激素(FSH)和乳腺、盆腔超声,每个周期记录视觉模拟疼痛评分(VAS)和不良反应事件。治疗后VAS评分较基线降低50%被认定为有效。计量资料采用t检验,计数资料采用χ2检验或连续性校正χ2检验。结果 106例患者完成了3个月经周期的托瑞米芬治疗,治疗前后血常规、肝肾功能及血脂变化不明显,血清性激素水平差异无统计学意义(P>0.050),超声检查亦无明显改变。主要不良反应为:潮红多汗20.8%(22/106),阴道分泌物增加5.7%(6/106),轻度恶心2.8%(3/106)。经过3个周期托瑞米芬治疗后,疼痛临床缓解率为73.6%(78/106),乳痛评分较治疗前平均降低59.7%。结论应用托瑞米芬治疗绝经前妇女周期性中重度乳痛症是安全有效的。

Objective To evaluate the safety and effectiveness of toremifene therapy for premenopausal woman with cyclical mastalgia. Methods From March 2008 to January 2010, 106 premenopausal women with moderate or severe cyclical mastalgia were administered with 40 mg toremifene daily for three menstrual cycles. Visual analogue scale （VAS）and adverse events were recorded in each menstrual cycle and blood routine, liver and renal function, blood fat, estradiol （E2）, progestone （P）, follicle stimulating hormone （FSH）, luteotrophic hormone （LH） were detected. The bilateral breast and uterine ultrasound were performed before and after toremifene therapy. If VAS scores had 50%o decrease from baseline, the treatment was identified as effective. The measurement data were processed using t test, count data using X2 test or continuity correction X2 test. Results Totally 106 premenopansal women completed toremifene therapy for three menstrual cycles. The blood routine, liver and renal function, blood-fat and serum sexual hormones showed no significant changes after treatment. The major adverse events included sweat and hot flush （20. 8% ） , vaginal discharge （5.7%） , mild nausea （2. 8% ）. After toremifene therapy for three menstrual cycles, 73.6%o （78 cases） women had good response to the treatment, and the mean pain scores were decreased by 59. 7%. Conclusion It is safe and effective to treat premenopausal woman with moderate or severe cyclical mastalgia with toremifene.