Chen Ranran, Song Dianrong, Zhang Wei, Fan Guanwei, Zhao Yingqiang, Gao Xiumei
Tianjin University of Traditional Chinese Medicine, China.
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, China.
Evid Based Complement Alternat Med. 2018 Oct 14;2018:6452709. doi: 10.1155/2018/6452709. eCollection 2018.
To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA).
This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events.
At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (>0.05). Serum E and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed.
MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.
评估改良二至颗粒（MEG）治疗绝经相关外阴阴道萎缩（VVA）患者的临床疗效及安全性。
本随机、双盲、安慰剂对照研究分为治疗组和对照组。患者分别接受MEG和安慰剂治疗12周。采用阴道健康评分（VHS）、阴道炎评分、阴道成熟指数（VMI）、女性性功能指数（FSFI）及改良Kupperman指数（改良KI）作为疗效终点指标，于给药前、给药第4、8、12周及停药后4周进行评估。于基线期和第12周测定血清雌二醇（E）、促卵泡生成素（FSH）、盆腔超声、乳腺超声等安全性指标，并记录不良事件。
与基线期及对照组相比，治疗12周时，VHS、阴道上皮表层细胞百分比及FSFI显著升高，阴道炎评分、阴道上皮基底细胞百分比及改良KI显著降低（均P<0.05）；停药后4周这些差异仍持续存在。安慰剂组治疗期间与基线值相比无显著变化（>0.05）。所有患者治疗前后血清E、FSH水平、子宫内膜厚度及乳腺厚度均在正常范围内，未观察到严重不良反应。
MEG可显著缓解绝经相关外阴阴道萎缩，对子宫内膜、乳腺、肝肾功能无明显不良影响。
