Zhang Jing, Gong Li-Li, Zhang Shao-Fen
Obstetrics and Gynecology Hospital of Fudan University, Shanghai.
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2008 Nov;28(11):972-6.
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.
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.
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 psychosocial 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 incidence 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 significantly decreased in the women of Ue (P <0.05).
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.
研究中药制剂坤泰胶囊（KTC）对绝经早期女性生活质量（QOL）、乳房胀痛及阴道出血的影响。
纳入104例绝经早期女性，其中有子宫者（Ue）54例，无子宫者（Ui）50例，随机分为KTC组和对照组，每组Ue和Ui例数相等。KTC组给予KTC 4粒，每日2次；对照组给予倍美力0.45 mg/d，有子宫者加用甲羟孕酮2 mg，均口服给药1年。所有受试对象每日记录自身乳房疼痛及阴道出血情况，每3个月随访1次，填写绝经特异性生活质量问卷。用药前后进行盆腔及乳房超声检查以及雌二醇（E2）和促卵泡生成素（FSH）内分泌激素测定。
两组治疗后生活质量方面差异无统计学意义。用药第3个月起，两组女性在血管舒缩和身体领域均有获益，心理社会领域也得到改善（Ui从第3个月起，Ue从第6个月起）。在性生活领域，KTC仅从第9个月起对有子宫者有良好效果，对无子宫者无效果；而对照组所有受试者从第3个月起性生活均得到改善。在乳房疼痛领域，两组各时间点发生率差异无统计学意义，仅对照组有子宫者第1至3个月疼痛程度较KTC组明显。至于阴道出血领域，两组用药前后子宫内膜基本正常，但KTC组有子宫者第1至3个月发生率及持续天数均明显低于对照组。KTC组用药后E2和FSH水平无明显变化，而对照组有子宫者E2明显升高，FSH明显降低（P<0.05）。
坤泰胶囊可明显改善绝经早期女性的生活质量，安全性高，乳房疼痛及阴道出血不良反应少，对性激素影响小。
