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复方激素阴道环与低剂量复方口服激素避孕药治疗特发性慢性盆腔疼痛的比较:一项随机试验

Comparison of combined hormonal vaginal ring and low dose combined oral hormonal pill for the treatment of idiopathic chronic pelvic pain: a randomised trial.

作者信息

Priya Khushboo, Rajaram Shalini, Goel Neerja

机构信息

Department Of Obstetrics & Gynecology, UCMS & GTB Hospital, New Delhi, India.

Department Of Obstetrics & Gynecology, UCMS & GTB Hospital, New Delhi, India.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2016 Dec;207:141-146. doi: 10.1016/j.ejogrb.2016.10.026. Epub 2016 Nov 8.

Abstract

OBJECTIVE

To compare the efficacy and acceptability of combined hormonal vaginal ring with combined oral hormonal pill in women with idiopathic chronic pelvic pain.

STUDY DESIGN

Randomised prospective interventional trial conducted in 60 women with idiopathic chronic pelvic pain. Women were randomised into two groups of 30 each. In each group, treatment was given for 84 days using either combined vaginal ring or combined oral hormonal pill. Hormonal vaginal ring releases 15mcg of ethinyl estradiol and 120mcg of the etonogestrel per day while the hormonal pill contained 30mcg of ethinyl estradiol and 150mcg of levonorgestrel. There was no ring or pill free week. After every 28 days, pain relief was measured using visual analogue scale (VAS), and verbal rating score (VRS) calculated by summing dysmenorrhea, non-cyclic pelvic pain (NCCP) and deep dyspareunia scores. Side effects, compliance, satisfaction, and user acceptability were also measured. Data was analyzed using various parametric and non-parametric tests.

RESULTS

Reduction in mean VAS score at end of treatment in ring group was 6.23 (95% confidence interval [CI], 5.45-7.01; p<0.001) as compared to 5.53 in pill group (95% CI, 4.83-6.23; p<0.001). Reduction in mean VRS score was 5.63 in ring users (95% CI, 4.84-6.42; p<0.001) versus 4.36 in pill users (95% CI, 3.63-5.10; p<0.001). A significantly higher persistent relief in NCPP score was observed in vaginal ring group as compared to oral pill group at end of one month after stopping treatment. Compliance, satisfaction, and user acceptability were higher in ring users (80%) than pill users (70%) and a higher incidence of nausea was seen in pill group.

CONCLUSION

Present study demonstrates for first time that both vaginal and oral hormonal therapy are effective in treatment of idiopathic chronic pelvic pain and vaginal ring may be a better choice with higher satisfaction rate and fewer side effects.

摘要

目的

比较复方激素阴道环与复方口服激素避孕药治疗特发性慢性盆腔疼痛女性的疗效和可接受性。

研究设计

对60例特发性慢性盆腔疼痛女性进行随机前瞻性干预试验。将女性随机分为两组,每组30例。每组使用复方阴道环或复方口服激素避孕药进行84天的治疗。激素阴道环每天释放15微克乙炔雌二醇和120微克依托孕烯,而激素避孕药含有30微克乙炔雌二醇和150微克左炔诺孕酮。没有无环或无药周。每28天后,使用视觉模拟评分法(VAS)测量疼痛缓解情况,并通过将痛经、非周期性盆腔疼痛(NCCP)和深部性交困难评分相加计算言语评分(VRS)。还测量了副作用、依从性、满意度和使用者可接受性。使用各种参数和非参数检验分析数据。

结果

治疗结束时,环组的平均VAS评分降低了6.23(95%置信区间[CI],5.45 - 7.01;p<0.001),而药丸组为5.53(95%CI,4.83 - 6.23;p<0.001)。环使用者的平均VRS评分降低了5.63(95%CI,4.84 - 6.42;p<0.001),而药丸使用者为4.36(95%CI,3.63 - 5.10;p<0.001)。停药后1个月结束时,与口服避孕药组相比,阴道环组的NCCP评分持续缓解明显更高。环使用者的依从性、满意度和使用者可接受性(80%)高于药丸使用者(70%),药丸组恶心发生率更高。

结论

本研究首次表明,阴道和口服激素疗法均对特发性慢性盆腔疼痛有效,阴道环可能是更好的选择,满意度更高且副作用更少。

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