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去氨加压素鼻喷雾剂治疗遗传性出血性疾病女性月经过多:一项随机安慰剂对照交叉研究。

DDAVP nasal spray for treatment of menorrhagia in women with inherited bleeding disorders: a randomized placebo-controlled crossover study.

作者信息

Kadir R A, Lee C A, Sabin C A, Pollard D, Economides D L

机构信息

University Department of Obstetrics and Gynecology, The Royal Free Hospital, London, UK.

出版信息

Haemophilia. 2002 Nov;8(6):787-93. doi: 10.1046/j.1365-2516.2002.00678.x.

DOI:10.1046/j.1365-2516.2002.00678.x
PMID:12410648
Abstract

To assess DDAVP (1-deamino-8-d-arginine vasopressin; desmopressin) nasal spray in the management of menorrhagia in patients with inherited bleeding disorders, 39 women (aged 18-50 years) with menorrhagia were recruited and were randomized to start 2 months' therapy with placebo or DDAVP (300 micro g) spray in a double-blind crossover study. Twenty-eight and 24 completed first and second period of treatment, respectively. Menstrual loss was assessed using the pictorial blood assessment chart (PBAC) during each treatment period. The main outcome measure was comparison of PBAC scores following DDAVP and placebo treatments. The safety of DDAVP spray was also assessed by monitoring side-effects. Overall, PBAC scores were significantly lower in the second treatment period than the first (P = 0.01). After adjusting for this differences, mean PBAC scores were slightly lower (mean difference 8; 95% confidence interval of - 15.5 to 31.6) in women receiving DDAVP than when receiving placebo, although this difference was not statistically significant (P = 0.51). In conclusion, although there was an indication that menstrual bleeding was less heavy when women received DDAVP than when receiving placebo, the small sample size meant that this difference was not significant.

摘要

为评估去氨加压素(1-去氨基-8-D-精氨酸加压素;弥凝)鼻喷雾剂对遗传性出血性疾病患者月经过多的治疗效果,39名年龄在18至50岁之间、患有月经过多的女性被纳入一项双盲交叉研究,并随机分为两组,分别开始为期2个月的安慰剂或去氨加压素(300μg)喷雾剂治疗。分别有28名和24名患者完成了第一个和第二个治疗周期。在每个治疗周期中,使用图片式失血评估图(PBAC)评估失血量。主要观察指标是比较去氨加压素和安慰剂治疗后的PBAC评分。还通过监测副作用来评估去氨加压素喷雾剂的安全性。总体而言,第二个治疗周期的PBAC评分显著低于第一个周期(P = 0.01)。在对这一差异进行校正后,接受去氨加压素治疗的女性的平均PBAC评分略低于接受安慰剂治疗的女性(平均差值为8;95%置信区间为-15.5至31.6),尽管这一差异无统计学意义(P = 0.51)。总之,尽管有迹象表明女性接受去氨加压素治疗时的月经量比接受安慰剂治疗时少,但样本量较小意味着这一差异不显著。

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