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额外增加吸入糖皮质激素的患者a a基于时间点之前的6周 % 布地奈德 参考DB 参考 OL 基线 1/4 1 2 3 4 5 年 额外增加的哮喘药物治疗 布地奈德组与参考治疗组的差异 双盲期 开放标签期 吸入性糖皮质激素 p0.001 p0.001 口服/全身使用糖皮质激素 p=0.009 NS (p=0.79) 短效 ?2-激动剂 p0.001 NS (p=0.17) 长效 ?2-激动剂 p0.001 p0.001 黄嘌呤 p=0.02 NS (p=1.00) 色甘酸 NS (p=0.28) p=0.003 白三烯调节剂 NS (p=0.78) NS (p=0.90) 其他哮喘治疗药物 NS (p=0.25) NS (p=1.00) START - 哮喘管理的里程碑 患者满意度 不良反应 症状 肺功能 急性发作 临床状况 改善 明显延缓肺功能下降速度 无症状天数明显增多 不良反应与安慰剂组类似: 11岁的儿童中,生长速度有显著性,但小幅、短暂的下降 明显降低至首次SARE的风险 明显减少对糖皮质激素的需求 每日一次治疗,可良好耐受 START - 哮喘管理的里程碑 这项研究采用“真实世界”设计,研究结果适用于临床实践 总结 START 是一项具有里程碑意义的研究,证实了轻度持续性哮喘患者早期使用吸入性糖皮质激素的疗效。 这些发现强调了哮喘管理目标中以前不太了解的重要方面(患者的肺功能下降加快)。 这些发现改变了哮喘的管理方式,构成了我们今天使用的指南的基础。 START - 哮喘管理的里程碑 * Mean Annual Increase in FEV1 During ICS Therapy ? In a controlled prospective study, Agertoft and Pedersen1 assessed lung function in 216 children every 6 months for 1-2 years without ICS therapy (布地奈德) followed by 3-6 years with ICS therapy. “There was a significant (P=0.01) relationship between the duration of asthma at the start of 布地奈德 and the annual increase in FEV1 during 布地奈德 therapy.” Reference: 1. Agertoft L, Pedersen S: Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med. 1994;88:373-381. Slide 16 * * * * * * 19 * 21 * Percentage of patients on leukotriene modifiers Leukotriene modifiers were introduced into the treatment market during the course of the START study. A very low percentage of subjects received the leukotriene modifiers during the course of the study, and there was little difference in use between the two treatment arms. Reference therapy = 安慰剂 + usual asthma therapy布地奈德 therapy = 布地奈德 Turbuhaler + usual asthma therapy * Classification of concomitant asthma medication Concomitant asthma medications were divided into a number of sub-categories. It should be clarified that the class ”inhaled corticosteroids” did not include the study drug. * Click to edit Master title style Click to edit
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