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[Treatment of diarrhea with difenoxin hydrochloride in children (author's transl)]
Insights
Difenoxin hydrochloride (Lyspafen) effectively treated acute diarrhea in infants and young children, with 83.87% experiencing improvement or cure. No adverse reactions were observed during the study.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
Context:
- Acute diarrhea is a common pediatric illness, posing risks of dehydration and electrolyte imbalance.
- Symptomatic treatment aims to reduce intestinal motility and fluid loss without completely halting stool passage.
Purpose:
- To evaluate the efficacy and safety of difenoxin hydrochloride (Lyspafen) in treating acute diarrhea in children aged 16 days to 24 months.
- To assess therapeutic outcomes based on bacteriological findings in stool samples.
Summary:
- A clinical study involving 93 children with acute diarrhea utilized difenoxin hydrochloride (Lyspafen) alongside age-appropriate diet and rehydration therapy.
- The medication was administered at a dose of 1 drop/kg body weight/day for an average of 4-6 days.
- Overall, 83.87% of patients showed improvement or cure, with very good results in 63.44% and sufficient results in 20.43%.
Impact:
- Difenoxin hydrochloride (Lyspafen) demonstrated a high success rate in managing acute pediatric diarrhea, with significant improvement observed in the majority of cases.
- The treatment was well-tolerated, with no adverse reactions reported, suggesting a favorable safety profile.
- Efficacy varied with etiology, showing less effectiveness in Salmonellae and Shigellae infections but good outcomes in cases with negative or less pathogenic bacterial findings.
Abstract:
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.