细菌裂解物Lantigen B可减少呼吸道反复感染患者的急性发作次数：一项双盲、安慰剂对照、多中心临床试验的结果。
The bacterial lysate Lantigen B reduces the number of acute episodes in patients with recurrent infections of the respiratory tract: the results of a double blind, placebo controlled, multicenter clinical trial.
作者信息
Braido Fulvio, Melioli Giovanni, Candoli Piero, Cavalot Andrea, Di Gioacchino Mario, Ferrero Vittorio, Incorvaia Cristoforo, Mereu Carlo, Ridolo Erminia, Rolla Giovanni, Rossi Oliviero, Savi Eleonora, Tubino Libero, Reggiardo Giorgio, Baiardini Ilaria, di Marco Eddi, Rinaldi Gilberto, Canonica Giorgio Walter, Accorsi Carlo, Bossilino Claudia, Bonzano Laura, DiLizia Michela, Fedrighini Barbara, Garelli Valentina, Gerace Vincenzo, Maniscalco Sara, Massaro Ilaria, Messi Alessandro, Milanese Manlio, Peveri Silvia, Penno Arminio, Pizzimenti Stefano, Pozzo Tiziana, Raie Alberto, Regina Sergio, Sclifò Francesca
机构信息
Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy.
Allergy & Respiratory Diseases Department, University of Genoa, IRCCS A.O.U. San Martino - IST, Lg. Benzi, 10, 16132 Genova, Italy.
出版信息
Immunol Lett. 2014 Dec;162(2 Pt B):185-93. doi: 10.1016/j.imlet.2014.10.026. Epub 2014 Nov 3.
Studies in the 1970s and 1980s reported that bacterial lysates (BL) had a prophylactic effect on recurrent respiratory tract infections (RRTI). However, controlled clinical study procedures have evolved substantially since then. We performed a trial using updated methods to evaluate the efficacy of Lantigen B®, a chemical BL. This double blind, placebo controlled, multi-center clinical trial had the primary objective of assessing the capacity of Lantigen B to significantly reduce the total number of infectious episodes in patients with RRTI. Secondary aims were the RRTI duration, the frequency and the severity of the acute episodes, the use of drugs and the number of missed workdays. In the subgroup of allergic patients with RRTI, the number of allergic episodes (AE) and the use of anti-allergic drugs were also evaluated. One hundred and sixty patients, 79 allocated to the treated group (TG) and 81 to the placebo group (PG), were enrolled; 30 were lost during the study and 120 (79 females and 38 males) were evaluated. The PG had 1.43 episodes in the 8-months of follow-up while the TG had 0.86 episodes (p=0.036). A similar result was observed in the allergic patients (1.80 and 0.86 episodes for the PG and the TG, respectively, p=0.047). The use of antibiotics was reduced (mean 1.24 and 2.83 days of treatment for the TG and the PG). Logistic regression analysis indicated that the estimated risk of needing antibiotics and NSAIDs was reduced by 52.1 and 30.6%, respectively. With regard to the number of AE, no significant difference was observed between the two groups, but bronchodilators, antihistamines and local corticosteroids were reduced by 25.7%, 56.2% and 41.6%, respectively, in the TG. Lantigen B significantly reduced the number of infectious episodes in patients with RRTI. This finding suggests a first line use of this drug for the prophylaxis of infectious episodes in these patients.
20世纪70年代和80年代的研究报告称，细菌溶解产物（BL）对复发性呼吸道感染（RRTI）有预防作用。然而，从那时起，对照临床研究程序有了很大发展。我们采用更新的方法进行了一项试验，以评估化学性细菌溶解产物兰菌净（Lantigen B®）的疗效。这项双盲、安慰剂对照、多中心临床试验的主要目的是评估兰菌净显著减少RRTI患者感染发作总数的能力。次要目标包括RRTI的持续时间、急性发作的频率和严重程度、药物使用情况以及误工天数。在患有RRTI的过敏患者亚组中，还评估了过敏发作次数（AE）和抗过敏药物的使用情况。招募了160名患者，其中79名分配到治疗组（TG），81名分配到安慰剂组（PG）；研究期间有30名失访，对120名患者（79名女性和38名男性）进行了评估。安慰剂组在8个月的随访中有1.43次发作，而治疗组有0.86次发作（p = 0.036）。在过敏患者中也观察到了类似结果（安慰剂组和治疗组分别为1.80次和0.86次发作，p = 0.047）。抗生素的使用减少了（治疗组和安慰剂组的平均治疗天数分别为1.24天和2.83天）。逻辑回归分析表明，需要使用抗生素和非甾体抗炎药的估计风险分别降低了52.1%和30.6%。关于AE的数量，两组之间未观察到显著差异，但治疗组中支气管扩张剂、抗组胺药和局部皮质类固醇的使用分别减少了25.7%、56.2%和41.6%。兰菌净显著减少了RRTI患者的感染发作次数。这一发现表明该药物可作为这些患者预防感染发作的一线用药。
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