School of Medicine and Surgery, Department of Experimental and Clinical Medicine, University Magna Graecia of Catanzaro, Mater Domini University Hospital, Catanzaro, Italy.
Eur J Clin Pharmacol. 2010 Feb;66(2):137-44. doi: 10.1007/s00228-009-0751-3. Epub 2009 Nov 10.
Our aim was to compare the efficacy and tolerability of loperamide and racecadotril in elderly patients with acute diarrhea.
We performed a randomized, prospective, double-blind, and parallel group design implemented in geriatric nursing homes in Catanzaro, Italy, from February 2008 to March 2009. Patients of both sexes were randomly allocated to receive either one tablet of racecadotril 100 mg every 8 h or two tablets of loperamide 2.0 mg followed by one tablet after each unformed stool, up to four tablets in any 24-h period. Patients were treated until recovery, defined as the production of two consecutive normal stools or no stool production for a period of 12 h.
Normal stools were collected 36 +/- 4 h after the beginning of racecadotril and in 63 +/- 6 h from the beginning of loperamide administration (P < 0.01). The median time of abdominal pain in the intent-to-treat (ITT) population was 14 h for racecadotril and 28 h for loperamide. In the per-protocol (PP) population, the median time of abdominal pain was 14 h for racecadotril and 32 h for loperamide (P < 0.01). About the 50% of patients experienced at least one adverse event during the study: 12% in the racecadotril group and 60% in the loperamide group. The most frequently occurring adverse events were nausea and constipation. Genetic analysis did not report the presence of rapid or poor metabolizers. Pharmacoeconomic analysis performed at the end of our study documented an increase in costs in the loperamide group with respect to the racecadotril group (P < 0.01).
Racecadotril is more effective than loperamide-probably due to drug interaction with loperamide-and it is not related to pharmacogenetic susceptibility. Racecadotril is also more cost effective than loperamide.
比较洛哌丁胺和瑞巴派特在老年急性腹泻患者中的疗效和耐受性。
我们在意大利卡坦扎罗的老年护理院进行了一项随机、前瞻性、双盲、平行组设计的研究，时间为 2008 年 2 月至 2009 年 3 月。所有患者均接受洛哌丁胺 2.0mg 每 8 小时 1 片或瑞巴派特 100mg 每 8 小时 1 片治疗，不成形便后加用 1 片，24 小时内最多用 4 片。患者治疗至痊愈，即连续 2 次排成形便或 12 小时无便为止。
瑞巴派特治疗后 36 ± 4 小时、洛哌丁胺治疗后 63 ± 6 小时患者排便正常（P < 0.01）。意向治疗（ITT）人群中腹痛中位时间为瑞巴派特 14 小时，洛哌丁胺 28 小时。在方案人群中，腹痛中位时间为瑞巴派特 14 小时，洛哌丁胺 32 小时（P < 0.01）。研究期间约 50%的患者发生至少 1 次不良反应：瑞巴派特组 12%，洛哌丁胺组 60%。最常见的不良反应为恶心和便秘。遗传分析未报告存在快速或代谢不良者。研究结束时进行的药物经济学分析表明，洛哌丁胺组的费用增加（P < 0.01）。
瑞巴派特比洛哌丁胺更有效，可能与药物与洛哌丁胺的相互作用有关，而与药物遗传易感性无关。瑞巴派特也比洛哌丁胺更具成本效益。
