TY - JOUR T1 -低剂量糖皮质激素和茶碱对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,慢性阻塞性肺疾病(COPD)的最高负担发生在低收入和中等收入国家。低成本的口服药物如果有效,可以使负担得起的、可获得的慢性阻塞性肺病治疗成为可能。在中国37个中心进行的一项随机、三臂、双盲、双假、安慰剂对照研究中,有症状的中度至极重度COPD患者按1:1:1随机分组,安慰剂每日2次,安慰剂每日1次。小剂量茶碱100mg每日2次加安慰剂每日1次或小剂量茶碱100mg每日2次加低剂量口服强的松5mg每日1次,连续48周。主要终点是年化恶化率。结果随机抽取1670名受试者,1242人完成了研究(1142人在48周时获得了可接受的数据)。受试者(75.7%男性)平均年龄64.4岁,平均±sd基线1 s后用力呼气容积(FEV1) 1.1±0.4 L(预测42.2%),圣乔治呼吸问卷(SGRQ)评分45.8±20.1。三种治疗的年恶化率之间的差异可以忽略不计: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 -