Tang Hao, Fang Zheng, Saborío Gabriela P, Xiu Qingyu
Department of Respiratory Medicine, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.
Lung. 2015 Aug;193(4):513-9. doi: 10.1007/s00408-015-9737-3. Epub 2015 Jun 5.
Recurrent acute exacerbations are generally associated with accelerated decline of lung function and characterized by reduced physical activity and worsening of clinical status in patients with chronic obstructive pulmonary disease (COPD). Effective practices and therapies aimed at preventing acute exacerbations are continuously under investigation by healthcare providers. This double-blind, placebo-control, randomized clinical trial sought to evaluate the preventive effect of a bacterial lysate (OM-85) on acute exacerbations in patients with COPD or chronic bronchitis in China.
A total of 428 patients were randomly assigned either to OM-85 treatment or to placebo. Patients received study drug or placebo for 10 days per month over 3 consecutive months, with a 10-week follow-up. Three hundred and eighty-four (384) patients completed the study (192 in the OM-85 group and 192 in the placebo group) and were included in the full analysis set (FAS). Thirty (30) patients, 21 in the OM-85 and 9 in the placebo groups, were excluded due to protocol violations and drop-outs, and the remaining 354 patients (171 in the OM-85 and 183 in the placebo groups) were included in the per protocol set (PPS).
The proportion of patients with recurrent acute exacerbations in the OM-85 group was significantly lower than in the placebo group at the end of the treatment period, both, in the FAS (23.4 % vs. 33.3 %, p = 0.0311) and in the PPS (17.0 % vs. 31.2 %, p < 0.05). Throughout the entire 22-week study period, the proportion of patients with recurrent acute exacerbations in the OM-85 group was lower than in the placebo group in the FAS (32.8 % vs. 38.0 %, p = 0.277), while the difference is statistically significant in the PPS (26.3 % vs. 36.1 %, p < 0.05).
OM-85 significantly reduced the proportion of patients with acute exacerbation after 12 weeks of therapy and the benefit appeared to be maintained up to 22 weeks, and showed a favorable tolerability profile.
反复急性加重通常与慢性阻塞性肺疾病（COPD）患者肺功能加速下降相关，其特征为身体活动减少和临床状况恶化。医疗服务提供者一直在研究旨在预防急性加重的有效措施和疗法。这项双盲、安慰剂对照、随机临床试验旨在评估细菌溶解产物（OM-85）对中国COPD或慢性支气管炎患者急性加重的预防效果。
总共428例患者被随机分配接受OM-85治疗或安慰剂治疗。患者连续3个月每月接受研究药物或安慰剂治疗10天，并进行10周的随访。384例患者完成了研究（OM-85组192例，安慰剂组192例）并被纳入全分析集（FAS）。30例患者（OM-85组21例，安慰剂组9例）因违反方案和退出研究而被排除，其余354例患者（OM-85组171例，安慰剂组183例）被纳入符合方案集（PPS）。
在治疗期结束时，OM-85组反复急性加重患者的比例在FAS（23.4%对33.3%，p = 0.0311）和PPS（17.0%对31.2%，p < 0.05）中均显著低于安慰剂组。在整个22周的研究期间，OM-85组反复急性加重患者的比例在FAS中低于安慰剂组（32.8%对38.0%，p = 0.277），而在PPS中差异具有统计学意义（26.3%对36.1%，p < 0.05）。
OM-85在治疗12周后显著降低了急性加重患者的比例，且这种益处似乎维持到22周，并显示出良好的耐受性。
