Suckling J, Lethaby A, Kennedy R
University of Auckland, Department of Obstetrics and Gynaecology, National Women's Hospital, Claude Rd, Epsom, Auckland, New Zealand.
Cochrane Database Syst Rev. 2006 Oct 18(4):CD001500. doi: 10.1002/14651858.CD001500.pub2.
Vaginal atrophy is a frequent complaint of postmenopausal women; symptoms include vaginal dryness, itching, discomfort and painful intercourse. Systemic treatment for these symptoms in the form of oral hormone replacement therapy is not always necessary. An alternative choice is oestrogenic preparations administered vaginally (in the form of creams, pessaries, tablets and the oestradiol-releasing ring).
The objective of this review was to compare the effectiveness, safety and acceptability of oestrogenic preparations for women who suffer from vaginal atrophy.
We searched the Cochrane Menstrual Disorders and Subfertility Group Register of trials (searched January 2006), The Cochrane Library (2006,Issue 2), MEDLINE (1966 to January 2006), EMBASE (1980 to January 2006), Current Contents (1993 to January 2006, Biological Abstracts (1969 to 2006), Social Sciences Index (1980 to January 2006), PsycINFO (1972 to February 2006), CINAHL (1982 to January 2006) and reference list of articles. We also contacted manufacturers and researchers in the field.
The inclusion criteria were randomised comparisons of oestrogenic preparations administered intravaginally in postmenopausal women for the treatment of symptoms resulting from vaginal atrophy or vaginitis.
Thirty-seven trials were identified: of these 18 were excluded. Included trials were assessed for quality and two reviewer authors extracted data independently. The ratios for dichotomous outcomes and means for continuous outcomes were calculated. The outcomes analysed were categorised under the headings of: efficacy, safety and acceptability.
Nineteen trials with 4162 women were included in this review. The overall quality of the studies was good, although not all trials measured the same outcomes. All trials measured efficacy, with various outcome measures. When comparing the efficacy of different oestrogenic preparations (in the form of creams, pessaries, tablets and the oestradiol-releasing vaginal ring) in relieving the symptoms of vaginal atrophy, results indicated significant findings favouring the cream, ring, and tablets when compared to placebo and non-hormonal gel. Fourteen trials compared safety. Four looked at hyperplasia, four looked at endometrial overstimulation and seven looked at adverse effects. One trial showed significant adverse effects of the cream (conjugated equine oestrogen) when compared to tablets (oestradiol) which included uterine bleeding, breast pain and perineal pain (1 RCT; OR 0.18, 95% CI 0.07 to 0.50). Two trials showed significant endometrial overstimulation as evaluated by a progestagen challenge test with the cream (conjugated equine oestrogen) group when compared to the ring (OR 0.29, 95% CI 0.11 to 0.78). Although not statistically significant there was a 2% incidence of simple hyperplasia in the ring group when compared to the cream (conjugated equine oestrogen) and 4% incidence of hyperplasia (one simple, one complex) in the cream group (conjugated equine oestrogen) when compared to the tablet (oestradiol). Eleven studies compared acceptability to the participants by comparing: comfort of product use, ease of use, overall product rating, delivery system and satisfaction. Results showed a significant preference for the oestradiol-releasing vaginal ring.
AUTHORS' CONCLUSIONS: Creams, pessaries, tablets and the oestradiol vaginal ring appeared to be equally effective for the symptoms of vaginal atrophy. One trial found significant side effects following cream (conjugated equine oestrogen) administration when compared to tablets causing uterine bleeding, breast pain and perineal pain. Another trial found significant endometrial overstimulation following use of the cream (conjugated equine oestrogen) when compared to the ring. As a treatment choice women appeared to favour the oestradiol-releasing vaginal ring for ease of use, comfort of product and overall satisfaction.
阴道萎缩是绝经后女性常见的问题；症状包括阴道干燥、瘙痒、不适及性交疼痛。对于这些症状，口服激素替代疗法这种全身治疗并非总是必要的。另一种选择是经阴道给予雌激素制剂（乳膏、阴道栓剂、片剂及释放雌二醇的阴道环）。
本综述的目的是比较雌激素制剂对患有阴道萎缩的女性的有效性、安全性和可接受性。
我们检索了Cochrane月经紊乱与生育力低下小组试验注册库（2006年1月检索）、Cochrane图书馆（2006年第2期）、MEDLINE（1966年至2006年1月）、EMBASE（1980年至2006年1月）、《现刊目次》（1993年至2006年1月）、《生物学文摘》（1969年至2006年）、《社会科学索引》（1980年至2006年1月）、PsycINFO（1972年至2006年2月）、CINAHL（1982年至2006年1月）以及文章的参考文献列表。我们还联系了该领域的制造商和研究人员。
纳入标准为绝经后女性经阴道给予雌激素制剂治疗阴道萎缩或阴道炎所致症状的随机对照试验。
共识别出37项试验：其中排除18项。对纳入试验进行质量评估，两位综述作者独立提取数据。计算二分法结局的比值和连续结局的均值。分析的结局分为以下几类：疗效、安全性和可接受性。
本综述纳入了19项试验，共4162名女性。研究的总体质量良好，尽管并非所有试验测量的结局都相同。所有试验均测量了疗效，采用了各种结局指标。在比较不同雌激素制剂（乳膏、阴道栓剂、片剂及释放雌二醇的阴道环）缓解阴道萎缩症状的疗效时，结果表明与安慰剂和非激素凝胶相比，乳膏、阴道环和片剂有显著效果。14项试验比较了安全性。4项观察了增生情况，4项观察了子宫内膜过度刺激情况，7项观察了不良反应。一项试验显示，与片剂（雌二醇）相比，乳膏（结合马雌激素）有显著不良反应，包括子宫出血、乳房疼痛和会阴疼痛（1项随机对照试验；比值比0.18，95%可信区间0.07至0.50）。两项试验显示，与阴道环相比，乳膏（结合马雌激素）组经孕激素激发试验评估有显著的子宫内膜过度刺激（比值比0.29，95%可信区间0.11至0.78）。与乳膏（结合马雌激素）组相比，阴道环组单纯增生的发生率为2%，与片剂（雌二醇）相比，乳膏（结合马雌激素）组增生（1例单纯性、1例复杂性）的发生率为4%，尽管差异无统计学意义。11项研究通过比较产品使用舒适度、易用性、总体产品评分、给药系统和满意度来比较参与者的可接受性。结果显示对释放雌二醇的阴道环有显著偏好。
乳膏、阴道栓剂、片剂及雌二醇阴道环对阴道萎缩症状似乎同样有效。一项试验发现，与片剂相比，乳膏（结合马雌激素）给药后有显著副作用，导致子宫出血、乳房疼痛和会阴疼痛。另一项试验发现，与阴道环相比，使用乳膏（结合马雌激素）后有显著的子宫内膜过度刺激。作为一种治疗选择，女性似乎更青睐释放雌二醇的阴道环，因其使用方便、产品舒适度高且总体满意度高。
