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Báo cáo y học: " Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue: an integrated analysis of 2 randomised clinical trials using computed "

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học 'Respiratory Research cung cấp cho các bạn kiến thức về ngành y đề tài: Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue: an integrated analysis of 2 randomised clinical trials using computed. | Stockley et al. Respiratory Research 2010 11 136 http respiratory-research.eom content 11 1 136 RESPIRATORY RESEARCH RESEARCH Open Access Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue an integrated analysis of 2 randomised clinical trials using computed tomography densitometry PrsHdrt A Ctrrr Hrv rhv. iH rt Parr2 Piifi ilainon3 err Qtr Jlz4 Roroncl Stool4 Amor nirbeem5 RUUeli. A Stockley David G rail Leva riitulainen Jan Stolk DelellU C Stoel Asger UllkseM Abstract Background Two randomised double-blind placebo-controlled trials have investigated the efficacy of IV alpha-1 antitrypsin AAT augmentation therapy on emphysema progression using CT densitometry. Methods Data from these similar trials a 2-center Danish-Dutch study n 54 and the 3-center EXAcerbations and CT scan as Lung Endpoints EXACTLE study n 65 were pooled to increase the statistical power. The change in 15th percentile of lung density PD15 measured by CT scan was obtained from both trials. All subjects had 1 CT scan at baseline and at least 1 CT scan after treatment. Densitometric data from 119 patients AAT Alfalastin or Prolastin n 60 placebo n 59 were analysed by a statistical endpoint analysis method. To adjust for lung volume volume correction was made by including the change in log-transformed total lung volume as a covariate in the statistical model. Results Mean follow-up was approximately 2.5 years. The mean change in lung density from baseline to last CT scan was -4.082 g L for AAT and -6.379 g L for placebo with a treatment difference of 2.297 95 CI 0.669 to 3.926 p 0.006 . The corresponding annual declines were -1.73 and -2.74 g L yr respectively. Conclusions The overall results of the combined analysis of 2 separate trials of comparable design and the only 2 controlled clinical trials completed to date has confirmed that IV AAT augmentation therapy significantly reduces the decline in lung density and may therefore reduce the future risk of .