Department of Internal Medicine, Unit of Respiratory Clinical Pharmacology, University of Rome Tor Vergata, Rome, Italy.
Pulm Pharmacol Ther. 2012 Feb;25(1):62-8. doi: 10.1016/j.pupt.2011.11.002. Epub 2011 Nov 27.
Respiratory tract infections are common and remain a major source of morbidity, mortality and economic cost worldwide, despite advances in modern medicine. One treatment approach is to non-specifically increase the immune response or augment innate defense mechanisms through the use of bacterial lysates. Polyvalent Mechanical Bacterial Lysate (PMBL) is a bacterial lysate made from a wide range of pathogenic bacteria, including all of the most commonly occurring pathogens of the upper and lower respiratory tract obtained by mechanical lysis.
To test the available evidence that PMBL is able to prevent respiratory tract infections.
A number of studies investigating randomized comparisons of PMBL (active) with placebo or no treatment (control) were selected for analysis. The primary outcome measure was the prevention of exacerbations or acute respiratory tract infection. The results were expressed as relative risk (RR) and the number of patients needed to treat for one to benefit (NNTB).
Data from 2557 patients from 15 randomized clinical trials (RCTs) was investigated. PMBL induced a significant reduction of infections vs placebo (RR -0.513; 95% CI; -0.722 - -0.303; p = 0.00). The NNTB was 1.15. The RR was always in favor of PMBL (in recurrent respiratory infections other than COPD, chronic bronchitis and tuberculosis, RR -0.502; 95% CI -0.824 - -0.181; in children RR -2.204; 95% CI -3.260 - -1.147; in COPD or chronic bronchitis, RR -0.404; 95% CI -0.864-0.057; in tuberculosis, RR -0.502; 95% CI -0.890 - -0.114).
The results of the present meta-analysis suggest that PBML is effective in both in children and in adults in preventing respiratory tract infections. Our current meta-analysis shows that there is a trend with PBML toward clinically significant results in patients with COPD but it did not quite achieve statistical significance due to the small number of COPD studies.
尽管现代医学取得了进步，但呼吸道感染仍然是全球发病率、死亡率和经济成本的主要来源。一种治疗方法是通过使用细菌裂解物来非特异性地增加免疫反应或增强先天防御机制。多价机械细菌裂解物（PMBL）是一种由广泛的致病菌制成的细菌裂解物，包括通过机械裂解获得的上呼吸道和下呼吸道最常见的病原体。
检验 PMBL 能够预防呼吸道感染的现有证据。
选择了一些研究，这些研究调查了 PMBL（活性）与安慰剂或无治疗（对照）的随机比较。主要结局测量是预防恶化或急性呼吸道感染。结果表示为相对风险（RR）和需要治疗一个患者以获益的患者数（NNTB）。
对来自 15 项随机临床试验（RCT）的 2557 名患者的数据进行了研究。PMBL 与安慰剂相比，感染发生率显著降低（RR-0.513；95%CI-0.722-0.303；p=0.00）。NNTB 为 1.15。RR 始终有利于 PMBL（除 COPD、慢性支气管炎和肺结核以外的复发性呼吸道感染，RR-0.502；95%CI-0.824-0.051；儿童，RR-2.204；95%CI-3.260-0.147；COPD 或慢性支气管炎，RR-0.404；95%CI-0.864-0.057；肺结核，RR-0.502；95%CI-0.890-0.114）。
本荟萃分析的结果表明，PMBL 对儿童和成人预防呼吸道感染均有效。我们目前的荟萃分析表明，PMBL 对 COPD 患者有临床意义的趋势，但由于 COPD 研究数量较少，因此并未达到统计学意义。
