坤泰胶囊对绝经早期妇女生活质量及乳房胀痛、阴道流血的影响

Effects of Kuntai Capsule on Quality of Life,Breast Distending Pain and Vaginal Bleeding in Women at Early Stage of Menopause

目的研究中药坤泰胶囊对绝经早期妇女生活质量以及乳腺、阴道流血的影响。方法绝经早期妇女104例,其中有子宫者54例,按随机表分为坤泰组和激素组各27例;无子宫者50例,按随机表分为坤泰组和激素组各25例。坤泰组予口服坤泰胶囊4粒,每日2次;激素组予口服倍美力(结合雌激素片,premarin)每日0.45mg,有子宫者加用安宫黄体酮每日2mg。治疗时间为1年。每3个月随访1次,受试者每日记录乳房胀痛和阴道流血情况,随访时完成绝经期生活质量量表,用药前后分别行盆腔超声、乳房超声检查及血清雌二醇(E2)、卵泡刺激素(FSH)测定。结果在生活质量方面,除有子宫两组心理状态从用药6个月开始起效外,坤泰组效果与激素组相似,均在治疗3个月起均显著改善了绝经妇女的血管舒缩症状、心理状态和生理状态,组间比较差异无统计学意义。坤泰胶囊对有子宫者性生活的改善从用药后9个月开始起效,无子宫者性生活无改善;激素组有无子宫性生活皆从3个月起效。两组在治疗各时间点的乳房胀痛发生率无明显差别,但在用药1～3个月时有子宫激素组乳房胀痛的程度显著高于有子宫坤泰组。用药1～3个月有子宫坤泰组阴道流血的发生率和累计天数均显著低于激素组,两组用药前后子宫内膜均在正常范围内。坤泰组治疗前后E2、FSH差异无统计学意义;有子宫激素组治疗结束后E2较治疗前显著升高,FSH显著性降低(P<0.05)。结论坤泰胶囊能显著改善绝经早期妇女的生活质量,且引起乳房胀痛与阴道流血的不良反应相对较少,对性激素影响不大。

Objective To study the effects of Kuntai Capsule （KTC） , a Chinese herbal preparation, on the quality of life （QOL） , breast distending pain and vaginal bleeding in women at early stage of menopause. Methods A total of 104 women at early stage of menopause, 54 had their uterus existed （Ue） and 50 in-existed （ Ui）, were enrolled, and they were randomized to the KTC group and the control group, with equal cases of Ue and Ui in each. The KTC group was treated with KTC 4 capsules twice a day; the control group treated with premarin 0.45 mg per day and for those of Ue 2 mg medroxyprogesterone additionally, with the remedies medicated orally for 1 year. All the testees were asked to record everyday their own condition of breast pain and vaginal bleeding and followed-up every 3 months to fulfill the Menopause Specific Quality of Life questionnaire. Ultrasonic examination on pelvis and breast as well as endocrine hormone assays of estradiol （ E2） and follicle-stimulating hormone （FSH） were performed before and after the medication term. Results Effects of treatment in the two groups were different insignificantly in terms of QOL. The women were benefited in vasomotor and physical domains from the 3rd month of medication, and the psyehosocial domain was also improved （for Ui initiating from the 3rd month and for Ue from the 6th month）. In the domain of sexual life, KTC showed its favorable effect only on Ue beginning from the 9th month, but not on Ui; while all subjects in the control group had their sexual life improved from the 3rd month. In domain of breast pain, the occurrence at various time points between the two groups was insignificantly different, only that the severity in Ue of the control group was more significant from the 1st to 3rd month than that in the KTC group. As for the domain of vaginal bleeding, the uterine membrane was basically normal in both groups either before or after medication, but the ineidence and lasting days from the 1st to 3rd month in Ue of the KTC group were significantly lower than those of the control group. Levels of E2 and FSH were not significantly changed after medication in the KTC group, while in the control group, E2 significantly increased and FSH signifieantly decreased in the women of Ue （P 〈 0.05）. Conclusion KTC could evidently improve the QOL of women at the early stage of menopause, and is of high safety, with less adverse reaction of breast pain and vaginal bleeding, and shows few impact on sexual hormones.