1 CARE Program, 1702 College Plaza, 8215 112 St NW Edmonton, AB T6G 2C8, Canada.
2 Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, T6E 1R9, Canada.
Benef Microbes. 2017 Oct 13;8(5):739-754. doi: 10.3920/BM2017.0032. Epub 2017 Sep 8.
Our objective was to conduct a systematic review and meta-analysis for the use of modified (heat-killed or sonicated) probiotics for the efficacy and safety to prevent and treat various diseases. Recent clinical research has focused on living strains of probiotics, but use in high-risk patients and potential adverse reactions including bacteremia has focused interest on alternatives to the use of live probiotics. We searched MEDLINE/PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL, Alt Health Watch, Web of Science, Scopus, PubMed, from inception to February 14, 2017 for randomised controlled trials involving modified probiotic strains. The primary outcome was efficacy to prevent or treat disease and the secondary outcome was incidence of adverse events. A total of 40 trials were included (n=3,913): 14 trials (15 arms with modified probiotics and 20 control arms) for the prevention of diseases and 26 trials (29 arms with modified probiotics and 32 control arms) for treatment of various diseases. Modified microbes were compared to either placebo (44%), or the same living probiotic strain (39%) or to only standard therapies (17%). Modified microbes were not significantly more or less effective than the living probiotic in 86% of the preventive trials and 69% of the treatment trials. Modified probiotic strains were significantly more effective in 15% of the treatment trials. Incidence rates of adverse events were similar for modified and living probiotics and other control groups, but many trials did not collect adequate safety data. Although several types of modified probiotics showed significant efficacy over living strains of probiotics, firm conclusions could not be reached due to the limited number of trials using the same type of modified microbe (strain, daily dose and duration) for a specific disease indication. Further research may illuminate other strains of modified probiotics that may have potential as clinical biotherapeutics.
我们的目标是对使用改良（热灭活或超声处理）益生菌预防和治疗各种疾病的疗效和安全性进行系统评价和荟萃分析。最近的临床研究集中在活菌株的益生菌上，但在高危患者中的应用以及包括菌血症在内的潜在不良反应引起了人们对替代活益生菌的关注。我们检索了 MEDLINE/PubMed、Embase、Cochrane 对照试验中心注册库、CINAHL、Alt Health Watch、Web of Science、Scopus、PubMed，从建库至 2017 年 2 月 14 日，纳入涉及改良益生菌株的随机对照试验。主要结局是预防或治疗疾病的疗效，次要结局是不良事件的发生率。共纳入 40 项试验（n=3913）：14 项（15 个改良益生菌组和 20 个对照组）预防疾病，26 项（29 个改良益生菌组和 32 个对照组）治疗各种疾病。与安慰剂（44%）、相同的活益生菌株（39%）或仅标准治疗（17%）相比，改良微生物在 86%的预防试验和 69%的治疗试验中效果无显著差异。在 15%的治疗试验中，改良益生菌株的效果显著更优。改良益生菌株和活益生菌株以及其他对照组的不良事件发生率相似，但许多试验没有收集足够的安全性数据。虽然几种类型的改良益生菌在疗效上优于活益生菌株，但由于用于特定疾病适应证的同一类型改良微生物（菌株、每日剂量和持续时间）的试验数量有限，无法得出明确的结论。进一步的研究可能会揭示其他改良益生菌株作为临床生物治疗剂的潜力。
