Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial
Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial
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DOI：
10.1016/j.fertnstert.2011.02.045
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发表时间：
2011-05-01
影响因子：
6.7
通讯作者：
Hoshiai, Hiroshi
中科院分区：
文献类型：
--
作者：
Harada, Tasuku;Momoeda, Mikio;Hoshiai, Hiroshi
目的：评价低剂量口服避孕药的有效性和安全性（IKH-01; 0.035 mg炔雌醇和1 mg炔诺酮）治疗原发性痛经患者。设计：安慰剂对照、双盲、随机试验。设置：日本的临床试验地点。患者：115例原发性痛经患者。干预：患者被随机分配接受IKH-01或安慰剂治疗四个周期。主要结果测量：总痛经评分，根据工作能力受限和镇痛药需求定义疼痛的口头评定量表，以及视觉模拟量表（VAS）。结果：IKH-01组治疗前后总痛经评分和VAS评分的降低显著高于安慰剂组。IKH-01组的总痛经评分和VAS从第2周期至第5周期显著降低。IKH-01组不良事件的总体发生率显著较高。IKH-01组的发生率随时间推移而降低;安慰剂组不变。结论：IKH-01可作为单药或与镇痛药联合治疗原发性痛经。（Fertil Steril（R）2011; 95：1928-31.（C）2011年由美国生殖医学协会。
Objective: To evaluate the efficacy and safety of low-dose oral contraceptives (IKH-01; 0.035 mg ethinyl estradiol and 1 mg norethisterone) for patients with primary dysmenorrhea.Design: Placebo-controlled, double-blind, randomized trial.Setting: Clinical trial sites in Japan.Patient(s): One hundred fifteen patients with primary dysmenorrhea.Intervention(s): Patients randomly assigned to receive IKH-01 or placebo for four cycles.Main Outcome Measure(s): Total dysmenorrhea score, verbal rating scale defining pain according to limited ability to work and need for analgesics, and visual analog scale (VAS).Result(s): Reduction in total dysmenorrhea score and VAS before and after treatment was significantly higher in the IKH-01 group than in the placebo group. Total dysmenorrhea score and VAS in the IKH-01 group significantly decreased from cycles 2 to 5. Overall incidence of adverse events was significantly higher in the IKH-01 group. Incidence decreased over time in the IKH-01 group; it was invariable in the placebo group. No serious adverse events occurred.Conclusion(s): IKH-01 could be used as a single agent or in combination with analgesics for treatment of primary dysmenorrhea. (Fertil Steril (R) 2011; 95: 1928-31. (C)2011 by American Society for Reproductive Medicine.)