TY - JOUR T1 -低剂量皮质类固醇和茶碱对COPD急性加重风险的影响:tasc随机对照试验JF -欧洲呼吸杂志》乔和J - 10.1183/13993003.03338 -2020欧元六世- 57 - 6 SP - 2003338 AU -詹金斯,克里斯汀·r . AU -温Fu-Qiang AU -马丁、埃里森AU -巴恩斯,Peter J . AU -切利,Bartolome盟——钟,南山AU -郑,《金瓶梅盟——Scaria西班牙盟迪坦拿,慢性阻塞性肺病(COPD)的最高负担发生在低收入和中等收入国家。如果有效，低成本的口服药物可以使负担得起的、可获得的COPD治疗成为可能。方法在中国37个研究中心开展的一项随机、三组、双盲、双假、安慰剂对照研究中，有症状的中至极重度COPD患者被随机分为每日2次安慰剂+每日1次安慰剂。低剂量茶碱100mg，每日2次+安慰剂，每日1次或低剂量茶碱100mg，每日2次+低剂量强的松5mg，每日1次，持续48周。主要终点为年加重率。结果1670名受试者被随机分组，1242名受试者完成了研究(1142名受试者在第48周数据可接受)。受试者(75.7%为男性)的平均年龄为64.4岁，支气管扩张剂后1秒用力呼气量(FEV1)为1.1±0.4 L(预测值42.2%)，St George’s Respiratory Questionnaire (SGRQ)得分为45.8±20.1。三种治疗方法的年恶化率差异可以忽略不计:茶碱加泼尼松组为0.89 (95% CI 0.78-1.02)，茶碱加安慰剂组为0.86 (95% CI 0.75-0.99)，安慰剂组为1.00 (95% CI 0.87-1.14)。 The rate ratio for theophylline plus prednisone versus pooled theophylline plus placebo and placebo was 0.96 (95% CI 0.83–1.12), for theophylline plus placebo versus placebo was 0.87 (95% CI 0.73–1.03; p=0.101) and for theophylline plus prednisone versus placebo was 0.90 (95% CI 0.76–1.06; p=0.201). Secondary outcomes of hospitalisations, FEV1, SGRQ and COPD Assessment Test score showed no statistically significant difference between treatment arms. Serious adverse events other than exacerbations were <2% and did not differ between treatment arms.Conclusions Low-dose theophylline alone or in combination with prednisone did not reduce exacerbation rates or clinically important secondary end-points compared with placebo.This large, rigorously conducted RCT showed that the combination of low-dose theophylline and prednisone did not affect exacerbation rate in patients with moderate to severe COPD in China https://bit.ly/2KSQ2BK ER -