Zotter Zsuzsanna, Veszeli Nóra, Csuka Dorottya, Varga Lilian, Farkas Henriette
3rd Department of Internal Medicine, Semmelweis University, Kútvölgyi út 4, Budapest, H-1125, Hungary.
Orphanet J Rare Dis. 2014 Dec 5;9:205. doi: 10.1186/s13023-014-0205-6.
Danazol, a drug extensively used in the management of hereditary angioedema due to C1 inhibitor deficiency (C1-INH-HAE), has various side effects. This study investigated the virilizing actions of this drug in 31 danazol-treated female patients with HAE-C1-INH. We compared our findings with those of healthy controls and with literature data.
The patients were interviewed individually about the type and severity of the virilizing effects, as well as about their satisfaction with danazol therapy.
The average duration of danazol treatment was 10.31 years [2 to 23] and its mean daily dose was 131.7 mg [33 to 200]. The most common adverse effects were hirsutism (n=14), weight gain (n=13), and menstrual disturbances (n=8). The severity of danazol adverse effects did not differ by duration of treatment or by daily drug dose. The mean level of patient satisfaction with the treatment was high. The comparison of age-matched healthy controls and of HAE-C1-INH patients receiving danazol did not demonstrate a statistically higher incidence of any of the monitored symptoms in the danazol group.
Our findings indicate that long-term danazol treatment - using the lowest effective dose - has only a mild virilizing effect.
达那唑是一种广泛用于治疗因C1抑制剂缺乏所致遗传性血管性水肿(C1-INH-HAE)的药物,有多种副作用。本研究调查了31例接受达那唑治疗的女性HAE-C1-INH患者中该药物的男性化作用。我们将研究结果与健康对照者以及文献数据进行了比较。
就男性化效应的类型和严重程度以及她们对达那唑治疗的满意度对患者进行了个体访谈。
达那唑治疗的平均持续时间为10.31年[2至23年],平均每日剂量为131.7毫克[33至200毫克]。最常见的不良反应是多毛症(n = 14)、体重增加(n = 13)和月经紊乱(n = 8)。达那唑不良反应的严重程度在治疗持续时间或每日药物剂量方面并无差异。患者对治疗的平均满意度较高。年龄匹配的健康对照者与接受达那唑治疗的HAE-C1-INH患者之间的比较未显示达那唑组中任何监测症状的发生率在统计学上更高。
我们的研究结果表明,长期使用最低有效剂量的达那唑治疗仅有轻微的男性化作用。