Garcia Compean D, Ramos Jimenez J, Guzman de la Garza F, Saenz C, Maldonado H, Barragan R F, Michel H
Department of Internal Medicine, University Hospital, Faculty of Medicine, Autonomous University of Nuevo Leon, Monterrey, Mexico.
AIDS. 1994 Nov;8(11):1563-7. doi: 10.1097/00002030-199411000-00007.
To compare the effect of octreotide (a long-acting somatostatin analog) to that of antidiarrheal therapy plus placebo on large-volume refractory AIDS-associated diarrhea.
A randomized controlled trial.
Referral-based clinic and hospital in a tertiary care center.
Twenty male patients with AIDS and refractory diarrhea, with stool volume > 1000 ml/day who failed to improve after initial supportive management. All patients finished the study.
Patients were randomly given either octreotide in doses of 100, 200 and 300 micrograms subcutaneously every 8 h, or high doses of loperamide and diphenoxylate orally plus placebo subcutaneously for 10 days.
Bowel movements and stool volume were registered before and every day after treatment by the patients themselves and the nursing personnel.
Patients from both groups were similar for age, time of AIDS diagnosis, duration of diarrhea and etiology. Baseline mean bowel movements per day (9.4 +/- 2.8 in the octreotide group versus 10 +/- 3.1 in controls) and baseline mean stool volume (2753 +/- 840 versus 2630 +/- 630 ml/day, respectively) were similar in both groups before therapy (P < 0.05). Mean bowel movements per day after 10 days of therapy was 2.1 +/- 1.6 in the octreotide group versus 7 +/- 3 in controls (P < 0.05). Mean stool volume after 10 days of therapy was 485 +/- 480 in the octreotide group versus 1080 +/- 420 ml/day in controls (P < 0.05). Complete response (stool volume < 250 ml/day) was observed in two patients from the octreotide group and none from controls; partial response (decrease > 50% in stool volume) in four and two; and no response (decrease < 50% or no change) in four and eight (P < 0.05), respectively. Side-effects occurred in eight out of 10 octreotide patients and three out of 10 controls (P < 0.05), but none were significant to result in discontinuation of medication.
Octreotide proved to be superior to conventional therapy in this short-term treatment of large-volume refractory AIDS-associated diarrhea.
比较奥曲肽（一种长效生长抑素类似物）与止泻疗法加安慰剂治疗大量难治性艾滋病相关腹泻的效果。
一项随机对照试验。
三级医疗中心的转诊诊所和医院。
20名患有艾滋病且腹泻难治的男性患者，粪便量>1000毫升/天，在初始支持治疗后未见改善。所有患者均完成了研究。
患者被随机给予每8小时皮下注射100、200和300微克剂量的奥曲肽，或口服高剂量洛哌丁胺和地芬诺酯加皮下注射安慰剂，持续10天。
患者本人及护理人员在治疗前及治疗后每天记录排便次数和粪便量。
两组患者在年龄、艾滋病诊断时间、腹泻持续时间和病因方面相似。治疗前两组的基线平均每日排便次数（奥曲肽组为9.4±2.8次，对照组为10±3.1次）和基线平均粪便量（分别为2753±840毫升/天和2630±630毫升/天）相似（P<0.05）。治疗10天后，奥曲肽组平均每日排便次数为2.1±偏倚1.6次，对照组为7±偏倚3次（P<0.05）。治疗10天后，奥曲肽组平均粪便量为485±偏倚480毫升/天，对照组为1080±偏倚420毫升/天（P<0.05）。奥曲肽组有2例患者出现完全缓解（粪便量<250毫升/天），对照组无；部分缓解（粪便量减少>50%）的患者分别为4例和2例；无缓解（粪便量减少<50%或无变化）的患者分别为4例和8例（P<0.05）。10名奥曲肽患者中有8例出现副作用，10名对照组患者中有3例出现副作用（P<0.05），但均未严重到导致停药。
在这种大量难治性艾滋病相关腹泻的短期治疗中，奥曲肽被证明优于传统疗法。
