Antoniou K M, Nicholson A G, Dimadi M, Malagari K, Latsi P, Rapti A, Tzanakis N, Trigidou R, Polychronopoulos V, Bouros D
Dept of Pneumonology, Medical School, University of Crete, Iráklion, Greece.
Eur Respir J. 2006 Sep;28(3):496-504. doi: 10.1183/09031936.06.00032605. Epub 2006 Apr 12.
Idiopathic pulmonary fibrosis (IPF)/usual interstitial pneumonia is a deadly disease with no effective treatment. The purpose of this randomised prospective multicentric study was to characterise the clinical effects of interferon gamma (IFN-gamma) 1b administered subcutaneously thrice weekly versus colchicine for 2 yrs. This study had no pre-specified end-points. Fifty consecutive IPF patients were randomised. Patients with mild-to-moderate IPF were eligible for the study if they had histologically proven IPF, or, in the absence of surgical biopsy, fulfilled the European Respiratory Society/American Thoracic Society criteria. In the intent-to-treat population, five out of 32 (15.6%) IFN-gamma-1b patients and seven out of 18 (38.8%) colchicine patients died after a median follow-up period of 25 months Patients treated with IFN-gamma 1b showed a better outcome after 2 yrs of therapy, and fewer symptoms, as assessed using the St George's Respiratory Questionnaire, after 12 months of therapy. Also, the IFN-gamma-1b group exhibited a higher forced vital capacity (percentage of the predicted value) after 24 months of treatment. No significant differences were detected in resting arterial oxygen tension, total lung capacity (% pred), transfer factor of the lung for carbon monoxide (% pred) and high-resolution computed tomographic scoring between the two treatment groups. These data suggest that long-term treatment with interferon gamma 1b may improve survival and outcome in patients with mild-to-moderate idiopathic pulmonary fibrosis. Further studies are needed to verify these results.
特发性肺纤维化（IPF）/普通型间质性肺炎是一种致命疾病，目前尚无有效治疗方法。这项随机前瞻性多中心研究的目的是比较每周皮下注射三次干扰素γ（IFN-γ）1b与秋水仙碱治疗2年的临床效果。本研究没有预先设定的终点。连续纳入50例IPF患者并进行随机分组。轻度至中度IPF患者，若经组织学证实为IPF，或在未进行手术活检的情况下符合欧洲呼吸学会/美国胸科学会标准，即可纳入本研究。在意向性治疗人群中，32例接受IFN-γ 1b治疗的患者中有5例（15.6%）、18例接受秋水仙碱治疗的患者中有7例（38.8%）在中位随访期25个月后死亡。接受IFN-γ 1b治疗的患者在治疗2年后显示出更好的预后，并且在治疗12个月后，根据圣乔治呼吸问卷评估，症状更少。此外，在治疗24个月后，IFN-γ 1b组的用力肺活量（预测值百分比）更高。两个治疗组在静息动脉血氧张力、肺总量（%预测值）、肺一氧化碳弥散量（%预测值）和高分辨率计算机断层扫描评分方面未检测到显著差异。这些数据表明，长期使用干扰素γ 1b治疗可能改善轻度至中度特发性肺纤维化患者的生存率和预后。需要进一步研究来验证这些结果。
