Kitanohara M, Yamamoto T, Masunaga S, Ohishi M, Komatsu Y, Nagase M
a Kitanohara Women's Clinic , Sendai-shi , Miyagi , Japan.
b Yamamoto Clinic , Kyoto-shi , Kyoto , Japan.
Climacteric. 2017 Apr;20(2):144-150. doi: 10.1080/13697137.2017.1279140. Epub 2017 Jan 23.
This study assessed the effects of oral porcine placental extract (PPE) on the mild menopausal symptoms of climacteric women.
In this 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, 50 climacteric Japanese women were randomized 1 : 1 to oral PPE (300 mg/day) or placebo. Menopausal symptoms were evaluated by using the Simplified Menopausal Index (SMI), as were serum estradiol (E2) and follicle stimulating hormone (FSH) levels. Blood biochemical and cellular and urinary tests were done to evaluate safety aspects of repeated oral administration of PPE.
The total SMI score of the PPE group was significantly more improved after 12 weeks than that of the placebo group (p = 0.031). This score and three subscores (vasomotor, psychological, and somatic symptoms) were significantly improved at 8 and/or 12 weeks compared with the initial values in the PPE group (p < 0.05). E2 and FSH levels were not improved in either group. No adverse events were observed.
Oral PPE at 300 mg/day improved the mild menopausal symptoms of climacteric women. Since oral PPE did not improve serum E2 and FSH levels, PPE is thought not to ameliorate hormonal balance itself but to improve subjective feelings of climacteric women.
本研究评估口服猪胎盘提取物（PPE）对更年期女性轻度更年期症状的影响。
在这项为期12周的多中心、随机、双盲、安慰剂对照平行组研究中，50名更年期日本女性按1∶1随机分为口服PPE组（300毫克/天）或安慰剂组。使用简化更年期指数（SMI）评估更年期症状，同时检测血清雌二醇（E2）和卵泡刺激素（FSH）水平。进行血液生化、细胞及尿液检测以评估重复口服PPE的安全性。
12周后，PPE组的SMI总分较安慰剂组有显著改善（p = 0.031）。与初始值相比，PPE组在第8周和/或第12周时该总分及三个子分数（血管舒缩症状、心理症状和躯体症状）均有显著改善（p < 0.05）。两组的E2和FSH水平均未改善。未观察到不良事件。
每天口服300毫克PPE可改善更年期女性的轻度更年期症状。由于口服PPE未改善血清E2和FSH水平，推测PPE并非改善激素平衡本身，而是改善更年期女性的主观感受。
