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噻托溴铵治疗标准联合疗法控制不佳的哮喘
Tiotropium in Asthma Poorly Controlled with Standard Combination Therapy


Huib A.M. Kerstjens ... 呼吸系统疾病 • 2012.09.27
相关阅读
• 长效β2受体激动剂治疗哮喘的安全性试验汇总分析 • 成人重度和难治性哮喘 • tezepelumab治疗哮喘未得到控制的成人患者 • 长期大环内酯疗法治疗未控制的哮喘 • 噻托溴铵能倍乐吸入器和在COPD中的死亡危险 • 白三烯拮抗剂作为哮喘控制的一线或添加疗法研究

摘要


背景

一些哮喘患者尽管接受了吸入型糖皮质激素和长效β受体激动剂(LABA)治疗,仍有频繁的病情加重和持续气流阻塞。

 

方法

在两项纳入912例正在接受吸入型糖皮质激素和LABA治疗的哮喘患者的重复、随机、对照试验中,我们比较了加用噻托溴铵(总剂量为5 μg)或安慰剂对肺功能和病情加重的效果,噻托溴铵及安慰剂均通过软雾吸入器每日给药1次,持续48周。所有患者均有症状,支气管扩张剂使用后第1秒用力呼气量(FEV1)≤预期值的80%,并且在过去一年中有至少1次重度加重史。

 

结果

患者平均基线FEV1为预期值的62%,平均年龄为53岁。24周时,在两项试验中噻托溴铵组FEV1峰值相对于基线的平均(±SE)变化均大于安慰剂组:在试验1中差异为86 mL±34 mL(P=0.01),在试验2中为154 mL±32 mL(P<0.001)。试验1和试验2中噻托溴铵组给药前(谷值)FEV1与安慰剂组相比也有所改善:差异分别为88 mL±31 mL(P=0.01)和111 mL±30 mL(P<0.001)。加用噻托溴铵延长了至首次重度加重时间(282日对226日),重度加重风险总体降低21%(风险比为0.79;P=0.03)。两组均无死亡发生,不良事件相似。

 

结论

在使用吸入型糖皮质激素和LABA后哮喘仍控制不佳的患者中,加用噻托溴铵显著延长了至首次重度加重时间,并且产生了一定程度持续的支气管扩张作用(由勃林格殷格翰和辉瑞公司资助;在ClinicalTrials.gov注册号为NCT00772538和NCT00776984)。





作者信息

Huib A.M. Kerstjens, M.D., Michael Engel, M.D., Ronald Dahl, M.D., Pierluigi Paggiaro, M.D., Ekkehard Beck, M.D., Mark Vandewalker, M.D., Ralf Sigmund, Dipl.Math., Wolfgang Seibold, M.D., Petra Moroni-Zentgraf, M.D., and Eric D. Bateman, M.D.
From the University of Groningen and the Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD — all in Groningen, the Netherlands (H.A.M.K.); Therapeutic Area Respiratory Diseases, Boehringer Ingelheim Pharma, Ingelheim am Rhein (M.E., P.M.-Z.), the Medical Department, Institut für Gesundheitsförderung, Rüdersdorf Brandenburg (E.B.), and Biostatistics (R.S.) and Clinical Research (W.S.), Boehringer Ingelheim Pharma, Biberach an der Riss — all in Germany; the Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark (R.D.); CardioThoracic Department, Pulmonary Unit, University Hospital of Pisa, Pisa, Italy (P.P.); Clinical Trials, Clinical Research of the Ozarks, Columbia, MO (M.V.); and the Department of Medicine, University of Cape Town, Cape Town, South Africa (E.D.B.).Address reprint requests to Dr. Kerstjens at the University of Groningen, Department of Pulmonology, University Medical Center Groningen, P.O. Box 30.001, 9700 RB Groningen, the Netherlands, or ath.a.m.kerstjens@umcg.nl.

 

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