Pece H
Arzneimittelforschung. 1979;29(5):849-51.
In an open clinical study symptomatic treatment was given to 93 children aged 16 days to 24 months who suffered from acute diarrhea. All the patients received antidiarrheal diet suited to their age. If indicated, the children were rehydrated with electrolyte and buffer solutions. In order to reduce the intestinal motility as well as the loss of water and electrolyte in the stool, but not to stop the stools, difenoxin hydrochloride (Lyspafen) in the commercial composition was prescribed. The dose was 1 drop/kg body weight/day administered in 3 single doses. The preparation was administered to the children for 4-6 days on the average. Regardless of the bacteriological findings in the stools, very good results were obtained in 59 patients (63.44%); sufficient results in 19 children (20.43%); and poor results in 15 children (16.13%). In the group with negative stool samples very good results were obtained in 74% of the patients. The therapeutic results were very good to sufficient in the majority of cases belonging to the group with facultative pathogenic germs and pathogenic coli in the stools. In 66.67% (4 cases) of the children infected by Salmonellae and Shigellae the treatment was insufficient. No undesirable adverse reactions were seen in the children treated. Summing-up of the results revealed that cure of or improvement in the diarrhea was obtained in 83.87% of the test population.
在一项开放性临床研究中，对93名年龄在16天至24个月之间患有急性腹泻的儿童进行了对症治疗。所有患者均接受适合其年龄的止泻饮食。如有必要，用电解质和缓冲溶液对儿童进行补液。为了减少肠道蠕动以及粪便中的水分和电解质流失，但又不阻止排便，开了市售复方的盐酸地芬诺酯（利舒芬）。剂量为1滴/千克体重/天，分3次单剂量给药。该制剂平均给儿童服用4至6天。无论粪便的细菌学检查结果如何，59例患者（63.44%）取得了非常好的效果；19名儿童（20.43%）取得了足够的效果；15名儿童（16.13%）效果不佳。在粪便样本阴性的组中，74%的患者取得了非常好的效果。在粪便中含有兼性病原菌和致病性大肠杆菌的大多数病例组中，治疗效果非常好至足够。在感染沙门氏菌和志贺氏菌的儿童中，66.67%（4例）的治疗效果不佳。在接受治疗的儿童中未观察到不良不良反应。结果总结显示，83.87%的受试人群腹泻得到治愈或改善。
