Short-term urogenital effects of raloxifene, tamoxifen, and estrogen
Short-term urogenital effects of raloxifene, tamoxifen, and estrogen
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DOI：
10.1067/mob.2003.374
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发表时间：
2003-07-01
影响因子：
9.8
通讯作者：
Cosman, F
中科院分区：
文献类型：
--
作者：
Vardy, MD;Lindsay, R;Cosman, F
目的：本研究的目的是评估雷洛昔芬、他莫昔芬、结合马雌激素和安慰剂对健康绝经后妇女泌尿生殖系统的影响。研究设计：这项随机、双盲、安慰剂对照研究比较了0.625 mg共轭马雌激素（n = 15名女性）、20 mg他莫昔芬（n = 14名女性）、60 mg雷洛昔芬（n = 15名女性）和安慰剂（n = 13名女性）对泌尿生殖系统的影响。基线和用药20周后的评估包括盆腔检查，阴道和尿道细胞学评估，盆腔器官脱垂定量，棉签试验尿道轴偏斜（仅限尿失禁患者[33%]）。结果：马结合雌激素提高了尿道和阴道细胞学状况的成熟值（P = 0.002, P = 0.032）。雷洛昔芬组阴道成熟值降低（无统计学意义）。结合马雌激素组8名妇女中有2名通过盆腔器官脱垂定量显示脱垂加重的证据；8名妇女中有2名的情况有所改善。在雷洛昔芬，他莫昔芬和安慰剂组中，12名妇女中有8名，13名妇女中有4名，11名妇女中有2名脱垂评分加重，而没有一名妇女有改善。雷洛昔芬组5名妇女中有3名，他莫昔芬组8名妇女中有5名，安慰剂组4名妇女中有0名，结合马雌激素组2名妇女中有0名，棉签偏转增加。75%接受雷洛昔芬治疗的患者和60%接受他莫昔芬治疗的患者通过任何测量（即盆腔器官脱垂定量或棉擦或临床评估）出现脱垂增加，而安慰剂组为18%，结合马雌激素组为22% (P = 0.015)，尽管症状在组间没有差异。结论：雷洛昔芬和他莫昔芬均不能改善阴道和尿道的细胞激素效应，而马结合雌激素有改善作用。与结合马雌激素和安慰剂相比，雷洛昔芬和他莫昔芬似乎表现出更严重的脱垂。这些影响的临床相关性尚不清楚，需要进一步研究。
OBJECTIVE: The purpose of this study was to assess the urogenital effects of raloxifene, tamoxifen, conjugated equine estrogen, and placebo in healthy postmenopausal women.STUDY DESIGN: This randomized, double-blind, placebo-controlled study compared the urogenital effects of 0.625 mg of conjugated equine estrogen (n = 15 women), 20 mg of tamoxifen (n = 14 women), 60 mg of raloxifene, (n = 15 women), and placebo (n = 13 women). Evaluations at baseline and evaluations after 20 weeks receiving the drug included a pelvic examination with cytologic evaluation of vagina and urethra, pelvic organ prolapse quantitation, and urethral axis deflection by cotton swab test (only in patients with incontinence [33%]).RESULTS: Conjugated equine estrogen increased the maturation value of both urethral and vaginal cytologic condition (P = .002, P = .032, respectively). There was a decrease in vaginal maturation value in the raloxifene group (not significant). Two of 8 women in the conjugated equine estrogen group showed evidence of worsening prolapse by pelvic organ prolapse quantitation; the condition of 2 of 8 women improved. In the raloxifene, tamoxifen, and placebo groups 8 of 12 women, 4 of 13 women, and 2 of 11 women had worsening in prolapse scores, respectively, whereas none of the women had improvement. Increased cotton swab deflection was found in 3 of 5 women in the raloxifene group, in 5 of 8 women in the tamoxifen group, in 0 of 4 women in the placebo group, and in 0 of 2 women in the conjugated equine estrogen group. Seventy-five percent of the patients who received raloxifene and 60% of the patients who received tamoxifen had increases in prolapse by any measure (ie, pelvic organ prolapse quantitation or cotton swab or clinical assessment) compared with 18% of the patients in the placebo group and 22% of the patients in the conjugated equine estrogen group (P = .015), although symptoms did not differ among groups.CONCLUSION: Neither raloxifene nor tamoxifen improve cytohormonal effects in the vagina or urethra, whereas conjugated equine estrogen does. Raloxifene and tamoxifen appear to show worsening prolapse compared with conjugated equine estrogen and placebo. The clinical relevance of these effects is unknown and requires investigation.