Boman G, Bäcker U, Larsson S, Melander B, Wåhlander L
Eur J Respir Dis. 1983 Aug;64(6):405-15.
This multicentre trial was undertaken to confirm previous results indicating that long-term treatment with oral acetylcysteine reduces the exacerbation rate in patients with chronic bronchitis. Two hundred and eighty-five patients, smokers or ex-smokers, with chronic bronchitis started a pre-trial placebo-period of 1 month. After this run-in period 259 patients were included in the trial and randomized into two parallel groups. The patients were treated in a double-blind way either with acetylcysteine 200 mg b.i.d. or placebo b.i.d. for 6 months. The trial was completed by 98 patients in the acetylcysteine group and by 105 patients in the placebo group. Initially, there were no significant differences between the groups. Twice weekly, the patients filled in a diary card concerning symptoms. The number of exacerbations was assessed from these cards and at visits 2, 4 and 6 months after institution of therapy. The exacerbation rate was significantly lower in the acetylcysteine group in which 40% of the patients remained free from exacerbations compared to 19% in the placebo group. Sick-leave due to acute exacerbation was significantly less common in the acetylcysteine group. The drug was well tolerated.
这项多中心试验旨在证实先前的研究结果，即口服乙酰半胱氨酸长期治疗可降低慢性支气管炎患者的急性加重率。285名患有慢性支气管炎的吸烟者或曾经吸烟者开始了为期1个月的试验前安慰剂期。在这个导入期之后，259名患者被纳入试验并随机分为两个平行组。患者以双盲方式接受治疗，一组服用200毫克乙酰半胱氨酸，每日两次，另一组服用安慰剂，每日两次，为期6个月。乙酰半胱氨酸组有98名患者完成试验，安慰剂组有105名患者完成试验。最初，两组之间没有显著差异。患者每周两次填写关于症状的日记卡。根据这些卡片以及治疗开始后2个月、4个月和6个月的就诊情况评估急性加重的次数。乙酰半胱氨酸组的急性加重率显著较低，该组40%的患者未出现急性加重，而安慰剂组这一比例为19%。乙酰半胱氨酸组因急性加重导致的病假明显较少。该药物耐受性良好。
