Delia P, Sansotta G, Donato V, Frosina P, Messina G, De Renzis C, Famularo G
Institute of Radiology, Oncologic Radiotherapy Unit, Azienda Ospedaliera Universitaria, Messina, Italy.
World J Gastroenterol. 2007 Feb 14;13(6):912-5. doi: 10.3748/wjg.v13.i6.912.
To investigate the efficacy of a high-potency probiotic preparation on prevention of radiation-induced diarrhea in cancer patients.
This was a double-blind, placebo-controlled trial. Four hundred and ninety patients who underwent adjuvant postoperative radiation therapy after surgery for sigmoid, rectal, or cervical cancer were assigned to either the high-potency probiotic preparation VSL#3 (one sachet t.i.d.,) or placebo starting from the first day of radiation therapy. Efficacy endpoints were incidence and severity of radiation-induced diarrhea, daily number of bowel movements, and the time from the start of the study to the use of loperamide as rescue medication.
More placebo patients had radiation-induced diarrhea than VSL#3 patients (124 of 239 patients, 51.8%, and 77 of 243 patients, 31.6%; P<0.001) and more patients given placebo suffered grade 3 or 4 diarrhea compared with VSL#3 recipients (55.4% and 1.4%, P<0.001). Daily bowel movements were 14.7 +/- 6 and 5.1 +/- 3 among placebo and VSL#3 recipients (P<0.05), and the mean time to the use of loperamide was 86 +/- 6 h for placebo patients and 122 +/- 8 h for VSL#3 patients (P<0.001).
Probiotic lactic acid-producing bacteria are an easy, safe, and feasible approach to protect cancer patients against the risk of radiation-induced diarrhea.
探讨高效益生菌制剂预防癌症患者放射性腹泻的疗效。
这是一项双盲、安慰剂对照试验。490例乙状结肠癌、直肠癌或宫颈癌术后接受辅助放疗的患者,从放疗第一天起被分为高效益生菌制剂VSL#3组(每日3次,每次1袋)或安慰剂组。疗效终点包括放射性腹泻的发生率和严重程度、每日排便次数以及从研究开始到使用洛哌丁胺作为急救药物的时间。
安慰剂组发生放射性腹泻的患者比VSL#3组多(239例患者中有124例,占51.8%;243例患者中有77例,占31.6%;P<0.001),与VSL#3组相比,安慰剂组有更多患者出现3级或4级腹泻(分别为55.4%和1.4%,P<0.001)。安慰剂组和VSL#3组的每日排便次数分别为14.7±6次和5.1±3次(P<0.05),安慰剂组患者使用洛哌丁胺的平均时间为86±6小时,VSL#3组患者为122±8小时(P<0.001)。
益生菌乳酸菌是保护癌症患者免受放射性腹泻风险的一种简便、安全且可行的方法。