Santana Porbén S
Escuela de Medicina de La Habana, La Habana, Cuba.
Nutr Hosp. 2010 Nov-Dec;25(6):971-83.
A quasi-experimental clinical assay was carried out to assess the tolerance, safety and usefulness of a 4 lactobacili + 1 bifidobacterium combination as adjuvant to the pharmacological treatment of UC Ulcerative colitis patients differing in mucosal change. The effectiveness of the probiotic treatment was assessed from changes in patient's stool pattern, body composition, and selected biochemical indicators of disease activity and nutritional status. Fifty patients entered consecutively in the trial between December 2005-June 2009 (CONTROL GROUP: 29; Treatment Group: 21). Twenty of them completed treatment with probiotics. Effectiveness of regular pharmacological treatment was recorded with 24 control patients. Thirty-six days of probiotic treatment per patient were accumulated. Probiotic treatment obedience rate was 99.3%. Five days of treatment were lost due to non-availability of the product. No adverse reactions were reported after probiotic treatment. Two deaths were recorded after completion of the study, one on each group. Improvement in the quality of the stools [RR Relative risk: 1.69; 95% IC: 0.87-3.27]; frequency [RR: 1.35; 95% IC: 0.15-11.90]; and volume [RR: 1.11; 95% IC: 0.16-7.63] was observed in treated patients, although biological variability prevented these trends to become statistically significant. Probiotic treatment also resulted in reduction of occurrence of nocturnal depositions [RR: 1.75; 95% IC: 0.53-5.73]. Probiotic treatment prevented the onset of undesirable changes in stool pattern of treated patients who presented free of symptoms, but observed effect was no superior to that of medication administered. Probiotic treatment did not influence upon presence of blood in stools. Probiotic treatment also resulted in reduction of disease activity and ESR Erythro-sedimentation rate, respectively [Change in the Clinical Activity Index:
-1.1 ± 3.2 vs. Treatment Group: -4.1 ± 3.3; p < 0.05; Change in ESR:
3.6 ± 16.4 vs. Treatment Group: -6.7 ± 15.6; p < 0.05]. Adjuvant probiotic treatment resulted in increase of body weight, at the expenses of increase of MAMC Mid-arm Muscle Circumference and sum of skinfolds. Probiotic effect upon body weight was not attributed to increased food intakes in treated patients. In spite of clinical heterogeneity associated to mucosal damage in UC, probiotic treatment might result in beneficial effects upon patient's stool pattern, body composition, and selected biochemical indicators of disease activity. Invariance of food intakes could imply that observed changes in response variables were not the result of a placebo effect of used probiotic combination.
进行了一项准实验性临床分析,以评估4种乳酸杆菌+1种双歧杆菌组合作为辅助药物治疗不同黏膜变化的溃疡性结肠炎(UC)患者的耐受性、安全性和有效性。从患者大便模式、身体成分以及疾病活动和营养状况的选定生化指标的变化来评估益生菌治疗的效果。2005年12月至2009年6月期间,50名患者连续进入试验(对照组:29名;治疗组:21名)。其中20名完成了益生菌治疗。24名对照患者记录了常规药物治疗的效果。每位患者积累了36天的益生菌治疗。益生菌治疗的依从率为99.3%。因产品无法获取而损失了5天的治疗时间。益生菌治疗后未报告不良反应。研究完成后记录到2例死亡,每组各1例。治疗患者的大便质量[相对危险度(RR):1.69;95%可信区间(IC):0.87 - 3.27]、频率[RR:1.35;95% IC:0.15 - 11.90]和体积[RR:1.11;95% IC:0.16 - 7.63]有所改善,尽管生物学变异性使这些趋势未达到统计学显著水平。益生菌治疗还导致夜间排便次数减少[RR:1.75;95% IC:0.53 - 5.73]。益生菌治疗预防了无症状治疗患者大便模式出现不良变化,但观察到的效果并不优于所给予的药物治疗。益生菌治疗对大便中血液的存在没有影响。益生菌治疗还分别导致疾病活动度和红细胞沉降率(ESR)降低[临床活动指数变化:对照组:-1.1±3.2 vs.治疗组:-4.1±3.3;p<0.05;ESR变化:对照组:3.6±16.4 vs.治疗组:-6.7±15.6;p<0.05]。辅助益生菌治疗导致体重增加,代价是中臂肌肉周长(MAMC)和皮褶厚度总和增加。益生菌对体重的影响并非归因于治疗患者食物摄入量的增加。尽管UC中黏膜损伤存在临床异质性,但益生菌治疗可能对患者的大便模式、身体成分以及疾病活动的选定生化指标产生有益影响。食物摄入量不变可能意味着观察到的反应变量变化不是所用益生菌组合安慰剂效应的结果。