SEREVENT NATIONWIDE SURVEILLANCE STUDY - COMPARISON OF SALMETEROL WITH SALBUTAMOL IN ASTHMATIC-PATIENTS WHO REQUIRE REGULAR BRONCHODILATOR TREATMENT
SEREVENT NATIONWIDE SURVEILLANCE STUDY - COMPARISON OF SALMETEROL WITH SALBUTAMOL IN ASTHMATIC-PATIENTS WHO REQUIRE REGULAR BRONCHODILATOR TREATMENT
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DOI：
10.1136/bmj.306.6884.1034
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发表时间：
1993-04-17
影响因子：
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通讯作者：
PALMER, J
中科院分区：
文献类型：
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作者：
CASTLE, W;FULLER, R;PALMER, J
目的：比较沙美特罗与沙丁胺醇治疗哮喘的安全性。在16周内进行的平行组随机临床试验。背景-英国各地的一般实践。受试者-25180名哮喘患者被认为需要定期使用支气管扩张剂治疗，由他们的全科医生招募（n=3516）。干预-沙美特罗（Serevent）（50 μ g，每日两次）或沙丁胺醇（200 μ g，每日四次），按两名患者服用沙美特罗与一名患者服用沙丁胺醇的比例随机分配。所有其他药物包括预防哮喘的药物在整个研究中持续使用。主要结果测量-所有严重事件和退出原因结果：服用沙美特罗的患者比服用沙丁胺醇的患者因哮喘而停药的人数少（2.91%v3.79%，chi 2 =13.6，p=0.0002）。死亡率和住院率符合预期。在服用沙美特罗的组中有一个小的但不显著的死亡率增加，哮喘事件显著增加，包括严重哮喘患者的死亡。每月使用两罐以上的支气管扩张剂与不良哮喘事件的发生特别相关。结论：使用沙美特罗或沙丁胺醇治疗超过16周与哮喘相关死亡的发生率超过预测值无关。沙美特罗组患者的哮喘总体控制更好。严重不良事件发生在入组时风险最高的患者中，可能是由于疾病而不是治疗所致。
Objective-To compare safety of salmeterol and salbutamol in treating asthma.Design-Double blind, randomised clinical trial in parallel groups over 16 weeks.Setting-General practices throughout the United Kingdom.Subjects-25180 patients with asthma considered to require regular treatment with bronchodilators who were recruited by their general practitioner (n=3516).Interventions-Salmeterol (Serevent) (50 mug twice daily) or salbutamol (200 mug four times a day) randomised in the ratio of two patients taking salmeterol to one taking salbutamol. All other drugs including prophylaxis against asthma were continued throughout the study.Main outcome measures-All serious events and reasons for withdrawals (medical and non-medical) whether or not they were considered to be related to the drugs.Results-Fewer medical withdrawals due to asthma occurred in patients taking salmeterol than in those taking salbutamol (2.91% v 3.79%; chi2=13.6, p=0.0002). Mortality and admissions to hospital were as expected. There was a small but nonsignificant excess mortality in the group taking salmeterol and a significant excess of asthma events including deaths in patients with severe asthma on entry. Use of more than two canisters of bronchodilator a month was particularly associated with the occurrence of an adverse asthma event.Conclusions-Treatment over 16 weeks with either salmeterol or salbutamol was not associated with an incidence of deaths related to asthma in excess of that predicted. Overall control of asthma was better in patients allocated to salmeterol. Serious adverse events occurred in patients most at risk on entry and were probably due to the disease rather than treatment.