Macchi Alberto, Vecchia Laura Della
Head and Neck Otorhinolaryngology Operative Unit, Ospedale di Circolo e Fondazione Macchi, Varese, Italy.
Arzneimittelforschung. 2005;55(5):276-81. doi: 10.1055/s-0031-1296857.
One hundred and fourteen patients with a medical history of recurrent upper respiratory tract infections (at least four episodes in the year preceding this open comparative study) were randomly assigned to three groups of 38 patients each. The first group received, by sublingual route, Ismigen, a new immunostimulating lysate (Polivalent Mechanical Bacterial Lysate, PMBL) obtained by mechanical lysis of 48 billion bacteria commonly responsible for upper respiratory tract infections; the second group received an oral immunostimulating lysate (CLBL) obtained by chemical lysis of 36 billion bacteria. A third group served as control and did not receive any immunostimulating treatment (Control NT). One tablet a day of PMBL was given to the first group for the first ten days during three consecutive months; the patients of the second group received one capsule a day of CLBL with the same treatment schedule. At the end of the treatment period the patients of the 3 groups were followed up for 3 months. The primary end point was the number of acute upper respiratory tract infections (URTIs) that occurred during the three months of treatment and three months of follow-up. Secondary endpoints were: the number of patients free from disease, the duration of infectious episodes, the number of working days lost because of disease, the need for a concomitant antibiotic treatment, and the safety of the two treatments. During the treatment period the mean number (+/- SD) of URTIs per patient was 0.34 (0.48) in the PMBL group, 1.0 (0.83) and 1.23 (0.77) in the CLBL and Control NT groups, respectively. Results of PMBL treatment were significantly better (p < 0.05) than the results in the other two groups; CLBL was not significantly different from the control group. In the three months of follow-up, the mean number (+/- SD) of URTIs per patient was: 0.42 (0.55) in the PMBL group, 0.92 (0.67) in the CLBL group, and 1.55 (0.88) in the Control NT group. The PMBL group was significantly better than the other two (p < 0.05). During the 6-month study, significantly more patients of the PMBL group remained free from respiratory infections in comparison to the other two groups. As regards other secondary end points (duration of infectious episodes and number of working days lost), the mean values of the PMBL group were statistically significantly lower than those of the other two groups, in both the treatment and follow-up periods. No PMBL treated patient needed concomitant administration of an antibiotic, while 9 patients of the CLBL group received such treatment (p < 0.05). No patient reported adverse events.
114例有复发性上呼吸道感染病史（在本开放性对照研究前一年至少发作4次）的患者被随机分为3组，每组38例。第一组通过舌下途径给予伊斯米根（Ismigen），这是一种新的免疫刺激裂解物（多价机械细菌裂解物，PMBL），由对引起上呼吸道感染的480亿个常见细菌进行机械裂解获得；第二组给予通过对360亿个细菌进行化学裂解获得的口服免疫刺激裂解物（CLBL）。第三组作为对照组，未接受任何免疫刺激治疗（对照NT）。第一组在连续3个月的前10天每天服用1片PMBL；第二组患者按照相同治疗方案每天服用1粒CLBL胶囊。在治疗期结束后，对3组患者进行3个月的随访。主要终点是在治疗的3个月和随访的3个月期间发生的急性上呼吸道感染（URTI）的数量。次要终点包括：无疾病患者的数量、感染发作的持续时间、因病损失的工作日数量、是否需要联合抗生素治疗以及两种治疗方法的安全性。在治疗期间，PMBL组每位患者URTI的平均数量（±标准差）为0.34（0.48），CLBL组为1.0（0.83），对照NT组为1.23（0.77）。PMBL治疗的结果明显优于其他两组（p<0.05）；CLBL组与对照组无显著差异。在随访的3个月中，PMBL组每位患者URTI的平均数量（±标准差）为：0.42（0.55），CLBL组为0.92（0.67），对照NT组为1.55（0.88）。PMBL组明显优于其他两组（p<0.05）。在为期6个月的研究中，与其他两组相比，PMBL组中更多患者未发生呼吸道感染。关于其他次要终点（感染发作的持续时间和因病损失的工作日数量），在治疗期和随访期，PMBL组的平均值均显著低于其他两组。接受PMBL治疗的患者均无需联合使用抗生素，而CLBL组有9例患者接受了此类治疗（p<0.05）。没有患者报告不良事件。
