Nierop G, Gijzel W P, Bel E H, Zwinderman A H, Dijkman J H
Department of Pulmonology, University Hospital, Leiden, The Netherlands.
Thorax. 1992 May;47(5):349-54. doi: 10.1136/thx.47.5.349.
Long term administration of oral corticosteroids in patients with asthma may be associated with serious side effects. Non-steroidal anti-inflammatory drugs, including gold salts, have been shown to reduce the need for systemic corticosteroid treatment in uncontrolled studies. The effect of oral gold (auranofin) on asthma symptoms, lung function, and the need for oral prednisone treatment was investigated.
A 26 week randomised, double blind, placebo controlled, parallel group trial of auranofin was performed in 32 patients with moderately severe chronic asthma who required an oral corticosteroid dose of at least 5 mg prednisone a day (or equivalent) or 2.5 mg/day prednisone plus more than 800 micrograms/day inhaled corticosteroids. Auranofin was given orally in a dose of 3 mg twice daily. Asthma symptoms, lung function, and adverse effects were assessed at regular intervals. After 12 weeks of treatment prednisone dosage was tapered down by 2.5 mg every two weeks if the patient was clinically stable. Asthma exacerbations were treated with short courses of high doses of oral steroids.
Twenty eight of the 32 patients, 13 in the placebo group and 15 in the auranofin group, completed the study. The total corticosteroid reduction achieved after 26 weeks of treatment was significantly greater (4 mg) in the auranofin group than in the placebo group (0.3 mg). The number of exacerbations requiring an increase of steroids was greater in the placebo group (2.1) than in the active group (0.9). A significant increase in FEV1 of 6.4% predicted occurred in the auranofin group during the study and there was a reduction of asthma symptoms such as wheezing and cough. There was no difference between the groups in peak flow measurements or in the number of asthma attacks. The incidence of side effects of auranofin was low, but exacerbations of constitutional eczema were noticeable.
Auranofin provides an effective adjunct to treatment for steroid dependent asthma, leading to a reduction of oral steroid dose.
哮喘患者长期口服皮质类固醇可能会伴有严重的副作用。在非对照研究中，包括金盐在内的非甾体抗炎药已显示可减少全身性皮质类固醇治疗的需求。本研究调查了口服金制剂（金诺芬）对哮喘症状、肺功能以及口服泼尼松治疗需求的影响。
对32例中度严重慢性哮喘患者进行了一项为期26周的随机、双盲、安慰剂对照平行组试验，这些患者每天需要口服至少5毫克泼尼松（或等效剂量）或2.5毫克/天泼尼松加超过800微克/天吸入性皮质类固醇。金诺芬口服给药，剂量为每日两次，每次3毫克。定期评估哮喘症状、肺功能和不良反应。治疗12周后，如果患者临床稳定，泼尼松剂量每两周减少2.5毫克。哮喘急性发作采用短期高剂量口服类固醇治疗。
32例患者中的28例，安慰剂组13例，金诺芬组15例，完成了研究。治疗26周后，金诺芬组实现的皮质类固醇总减量（4毫克）显著大于安慰剂组（0.3毫克）。需要增加类固醇治疗的急性发作次数在安慰剂组（2.1次）多于活性药物组（0.9次）。研究期间，金诺芬组的预测第一秒用力呼气容积（FEV1）显著增加了6.4%，哮喘症状如喘息和咳嗽有所减轻。两组在峰值流量测量或哮喘发作次数方面没有差异。金诺芬的副作用发生率较低，但全身性湿疹的加重较为明显。
金诺芬为依赖类固醇的哮喘治疗提供了一种有效的辅助治疗方法，可减少口服类固醇剂量。
