一种由灭活菌体构成的免疫刺激剂（*）在预防气道感染发作中的临床疗效和耐受性：一项双盲、安慰剂对照、随机、多中心研究。
Clinical efficacy and tolerability of an immune-stimulant(*) constituted by inactivated bacterial bodies in the prophylaxis of infectious episodes of airways: a double blind, placebo-controlled, randomized, multicentre study.
作者信息
Carlone Stefano, Minenna Michele, Morlino Paride, Mosca Luigi, Pasqua Franco, Pela Riccardo, Schino Pietro, Tubaldi Alberto, Tupputi Emmanuele, De Benedetto Fernando
机构信息
Pulmonary Department of San Giovanni-Addolorata General Hospital, Respiratory Diseases I, Via dell'Amba Aradan 9, Rome, 00184 Italy.
Pneumology, Civile di Bitonto Hospital, Via Gomes 32, Bitonto, BA 70032 Italy.
出版信息
Multidiscip Respir Med. 2014 Nov 19;9(1):58. doi: 10.1186/2049-6958-9-58. eCollection 2014.
BACKGROUND
(Buccalin ®) is a Bacterial Lysates (BL) that belongs to a family of immune-stimulators, developed more than 30 years ago and it still has a role in the prophylaxis of Recurrent Respiratory Tract Infections (RRTI). However, original studies were conducted with an approach that does not seem to be aligned with the present methodologies. In addition, concomitant therapies substantially improved in the last decades. These two reasons strongly suggested to update our knowledge on the capacity of this bacterial lysate (Buccalin ®) to reduce the number of days with infectious episodes in patients with RRTI.
METHODS
A double blind, placebo-controlled, randomized, multicentre study was programmed (EudraCT code: 2011-005187-25). The reduction of the number of days with infectious episodes (IE) was the primary endpoint. Secondary endpoints were the number of IE, the use of concomitant drugs, the efficacy on signs and symptoms of RRTI and the safety of the drug. Patients were treated according to the registered schedule and were followed up for a period of 6 months.
RESULTS
From a cohort of 188 patients eligible for the study, 90 were included in the active group and 88 in the placebo group. The study was completed in 170 patients. A significant reduction of the number of days with IE was observed (6.57 days in the active group and 7.47 in the placebo group). Secondary endpoints were only partially achieved. No virtual adverse events related to the treatment were recorded.
CONCLUSION
The administration of bacterial lysate (Buccalin ®) in patients with RRTI had the capacity to significantly reduce the number of days with IE in a multicentre, randomized, placebo controlled, clinical study. The treatment was safe. Of note, all patients were free to be treated with the best concomitant therapies. In these conditions, the positive results observed demonstrated that this bacterial lysate has maintained its capacity of reducing the days with infections in patients with RRTI, also in association to the concomitant therapies available nowadays.
背景
（泛福舒®）是一种细菌溶解产物（BL），属于免疫刺激剂家族，30多年前研发，至今仍在预防反复呼吸道感染（RRTI）中发挥作用。然而，最初的研究采用的方法似乎与当前的方法不一致。此外，在过去几十年中，伴随治疗有了显著改善。这两个原因强烈表明，我们需要更新关于这种细菌溶解产物（泛福舒®）减少RRTI患者感染发作天数能力的认识。
方法
计划进行一项双盲、安慰剂对照、随机、多中心研究（欧盟临床试验编号：2011-005187-25）。减少感染发作天数（IE）是主要终点。次要终点包括IE的次数、伴随药物的使用、对RRTI体征和症状的疗效以及药物的安全性。患者按照注册方案进行治疗，并随访6个月。
结果
在188名符合研究条件的患者队列中，90名被纳入活性组，88名被纳入安慰剂组。170名患者完成了研究。观察到IE天数显著减少（活性组为6.57天，安慰剂组为7.47天）。次要终点仅部分实现。未记录到与治疗相关的实际不良事件发生。
结论
在一项多中心、随机、安慰剂对照的临床研究中，对RRTI患者给予细菌溶解产物（泛福舒®）能够显著减少IE天数。该治疗是安全的。值得注意的是，所有患者都可以自由接受最佳的伴随治疗。在这些条件下，观察到的阳性结果表明，这种细菌溶解产物在RRTI患者中仍保持减少感染天数的能力，即使与目前可用的伴随治疗联合使用也是如此。
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