哮喘联盟

   摘要
   背景：有关磷酸二酯酶4抑制剂罗氟司特治疗慢性阻塞性肺疾病(COPD)的安全性已有深入的研究。已报告的不良事件(AEs)包括头痛、腹泻以及体重减轻。然而，罗氟司特治疗支气管哮喘的安全性如何，尚不清楚。
   目的：本研究通过运用完成于1997-2005年的一项开放标签和十项汇总的安慰剂对照Ⅱ期、Ⅲ期临床试验的安全性数据，旨在评估罗氟司特的安全性与耐受性。
   对象与方法：研究实施于欧洲、北美洲和南美洲、非洲、大洋洲及亚洲，研究时间为4-40周。纳入了5,169例12-70岁的患者，并对其中2,851例接受罗氟司特125μg、250μg、500μg治疗的患者进行了分析。随机分组时患者的用力呼气流速在45-100%之间。
   结果：头痛是最常见的不良事件，罗氟司特500μg治疗组和安慰剂组的发生率分别为50/100病人年和29.2/100病人年。胃肠道不良事件常见。罗氟司特500μg治疗组和安慰剂组恶心、腹泻的发生率分别为28.7/100病人年和28.3/100病人年。使用罗氟司特治疗的患者，体重下降的幅度较小。在为期4周开放性标签的随访研究中，有465例患者出现不良事件，这一发现也反应了汇总研究的结果。
   结论：本项有关罗氟司特安全性的汇总分析，阐述了其不良事件的严重程度和发生率，证实了罗氟司特用于哮喘患者的总体耐受性良好。这也反应了既往报道的罗氟司特用于COPD患者的总体安全性。
 

（杨冬 审校）
PulmPharmacolTher. 2015Nov20.pii:S1094-5539(15)30014-6.doi:10.1016/j.pupt.2015.11.003. [Epub ahead of print]

 

Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies.
 

Chervinsky P1, Meltzer EO2, Busse W3, Ohta K4, Bardin P5, Bredenbröker D6, Bateman ED7.

 

Abstract
BACKGROUND:The safety profile of roflumilast, a phosphodiesterase 4 inhibitor, has been extensively researched in patients with chronic obstructive pulmonary disease (COPD). Adverse events (AEs) including headache, diarrhoea and weight loss have been reported. Much less is known about the safety of roflumilast treatment in patients with bronchial asthma.
AIM:To evaluate the safety and tolerability of roflumilast using safety data from one open-label and ten pooled placebo-controlled phase II and III clinical studies completed between 1997 and 2005.
SUBJECTS AND METHODS:The studies were conducted at sites in Europe, North and South America, Africa, Australasia and Asia and study length varied from 4-40 weeks. Data for 5,169 patients between 12-70 years of age, of whom 2,851 received roflumilast at doses of 125, 250 and 500μg, were analyzed. At randomization patients had a forced expiratory flow of 45-100%.
RESULTS:Headache was the most frequent AE with an incidence rate of 50 and 29.2 per 100 patient-years in the 500μg roflumilast and placebo groups, respectively. Gastrointestinal AEs were common. Nausea and diarrhoea occurred in 28.7 and 28.3 per 100 patient-years in the 500μg roflumilast and placebo groups, respectively. The extent of weight loss in roflumilast-treated patients was small. AEs reported in 465 patients in the 4-week open-label follow-up study reflected those of the pooled studies.
CONCLUSIONS:The severity and incidence of AEs reported from this pooled safety analysis confirm that roflumilast is generally well tolerated by patients with asthma. This reflects the general safety profile reported previously in patients with COPD.
 

PulmPharmacolTher. 2015Nov20.pii:S1094-5539(15)30014-6.doi:10.1016/j.pupt.2015.11.003. [Epub ahead of print]