塞来昔布治疗原发性痛经:结果从两个随机,双盲,活跃,安慰剂对照,交叉研究。

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丹尼尔斯,罗宾斯J,西CR, Nemeth MA

塞来昔布治疗原发性痛经:结果从两个随机,双盲,活跃,安慰剂对照,交叉研究。

其他。2009年6月,31 (6):1192 - 208。doi: 10.1016 / j.clinthera.2009.06.003。

PubMed ID
19695387 (在PubMed
]
文摘

背景:塞来昔布,cyclooxygenase-2抑制剂,建立了镇痛功效治疗急性疼痛产生的各种原因。目的:本文描述了2研究旨在评估疗效和耐受性的塞来昔布在原发性痛经患者。方法:两个相同的,为期3天,multiple-dose,随机、双盲、活跃,安慰剂对照,交叉研究进行了年龄在18岁到44岁的女性与原发性痛经(研究1和2)。研究采用6-sequence,三期,完整的块交叉设计3个月经周期。患者接受塞来昔布400毫克,紧随其后的是塞来昔布第一剂量200毫克不早于12小时后(第一天),然后根据需要塞来昔布200毫克q12h(天2和3);萘普生钠550毫克其次是萘普生钠550毫克不早于12小时后第一剂量(1天),然后萘普生钠550毫克q12h必要(2和3);或安慰剂。时间加权之和总疗效措施缓解疼痛和痛苦的时间和强度差异后8小时的第一剂量研究药物(TOTPAR[8]和SPID[8],分别)。耐受性是评估使用常规体格检查,包括生命体征的测量和年底筛查和临床实验室分析研究。结果:总体而言,149年,154名患者被随机分配到1 6处理序列的研究1和2,分别。在序列治疗,平均年龄范围是23.4到26.9年(研究1)和28.3 - 34.1年(研究2)。平均重量范围是62.7到74.5公斤(研究1)和69.2到86.7公斤(研究2)。大多数病人(96.6%在研究1中,80.5%在研究2)是白人。 Mean TOTPAR[8] values with celecoxib (study 1/study 2, 18.28/17.98) and naproxen sodium (20.59/21.27) were significantly greater than with placebo (12.82/12.98) (all, P < 0.001). Mean SPID[8] values were significantly greater with celecoxib (10.06/9.60) and naproxen sodium (11.48/11.71) than with placebo (5.96/6.41) (all, P < 0.001). Naproxen sodium was significantly different from celecoxib in TOTPAR[8] (study 2 only) and SPID[8] (both studies) (all, P < 0.001). In both studies, the adverse-events (AEs) profile was not significantly different between treatments, with the majority of AEs being related to primary dysmenorrhea and not medication. Less than 10% of patients experienced severe AEs in any treatment period. CONCLUSIONS: In these 2 identically designed studies in women aged 18 to 44 years, celecoxib 400 mg (followed by 200 mg q12h) was more effective, as measured using pain scores, in the treatment of primary dysmenorrhea compared with placebo. In each study, the primary efficacy measures-TOTPAR[8] and SPID[8] scores-were significantly improved with celecoxib and naproxen sodium compared with placebo. SPID[8] in both studies and TOTPAR[8] in study 2 were significantly improved with naproxen sodium compared with celecoxib. Both celecoxib and naproxen sodium were well tolerated and provided relief from menstrual pain within 1 hour of administration.

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