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Evaluation of efficacy of longer durations of therapy of fresh cases of kala-azar with sodium stibogluconate.
Indian J Med Res. 1991 Mar; 93:103-10.IJ

Abstract

The efficacy and safety of three regimens of treatment for kala-azar (visceral leishmaniasis) with sodium stibogluconate were evaluated in a randomised clinical trial to ascertain the optimal duration of treatment for Indian patients. The study included a total of 312 (226 male, 86 female) patients with fresh kala-azar, confirmed by demonstration of parasites in aspirates from bone marrow or spleen, who were randomly allocated into three treatment groups of 104 patients in each to receive sodium stibogluconate intramuscularly. The dose of the drug was 20 mg/kg/body weight/daily with a maximum of 8.5 ml for 20, 30 and 40 days (groups A, B, C respectively). The response of treatment was assessed under blind conditions and patients were followed up each month for a period of six months. The number of patients who were apparently cured (i.e., those whose temperature had returned to normal at the end of their respective regimen and aspirates were free of parasites) was 91 (87%) in group A, 98 (94%) in group B, and 102 (98%) in group C. The difference between groups A and C was significant (P less than 0.01). The number of patients who were ultimately cured at six months was 74 (71%) in group A, 86 (83%) in group B and 98 (94%) in group C. These patients had not relapsed and were cured as confirmed by a bone marrow aspirate which was free of parasites. The difference between groups A and C (P less than 0.001) and groups B and C (P less than 0.05) were significant. However, the difference between groups A and B was not statistically significant.(

ABSTRACT

TRUNCATED AT 250 WORDS)

Authors+Show Affiliations

Patna Medical College Hospital.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

1649790

Citation

Thakur, C P., et al. "Evaluation of Efficacy of Longer Durations of Therapy of Fresh Cases of Kala-azar With Sodium Stibogluconate." The Indian Journal of Medical Research, vol. 93, 1991, pp. 103-10.
Thakur CP, Kumar M, Pandey AK. Evaluation of efficacy of longer durations of therapy of fresh cases of kala-azar with sodium stibogluconate. Indian J Med Res. 1991;93:103-10.
Thakur, C. P., Kumar, M., & Pandey, A. K. (1991). Evaluation of efficacy of longer durations of therapy of fresh cases of kala-azar with sodium stibogluconate. The Indian Journal of Medical Research, 93, 103-10.
Thakur CP, Kumar M, Pandey AK. Evaluation of Efficacy of Longer Durations of Therapy of Fresh Cases of Kala-azar With Sodium Stibogluconate. Indian J Med Res. 1991;93:103-10. PubMed PMID: 1649790.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of efficacy of longer durations of therapy of fresh cases of kala-azar with sodium stibogluconate. AU - Thakur,C P, AU - Kumar,M, AU - Pandey,A K, PY - 1991/3/1/pubmed PY - 1991/3/1/medline PY - 1991/3/1/entrez SP - 103 EP - 10 JF - The Indian journal of medical research JO - Indian J Med Res VL - 93 N2 - The efficacy and safety of three regimens of treatment for kala-azar (visceral leishmaniasis) with sodium stibogluconate were evaluated in a randomised clinical trial to ascertain the optimal duration of treatment for Indian patients. The study included a total of 312 (226 male, 86 female) patients with fresh kala-azar, confirmed by demonstration of parasites in aspirates from bone marrow or spleen, who were randomly allocated into three treatment groups of 104 patients in each to receive sodium stibogluconate intramuscularly. The dose of the drug was 20 mg/kg/body weight/daily with a maximum of 8.5 ml for 20, 30 and 40 days (groups A, B, C respectively). The response of treatment was assessed under blind conditions and patients were followed up each month for a period of six months. The number of patients who were apparently cured (i.e., those whose temperature had returned to normal at the end of their respective regimen and aspirates were free of parasites) was 91 (87%) in group A, 98 (94%) in group B, and 102 (98%) in group C. The difference between groups A and C was significant (P less than 0.01). The number of patients who were ultimately cured at six months was 74 (71%) in group A, 86 (83%) in group B and 98 (94%) in group C. These patients had not relapsed and were cured as confirmed by a bone marrow aspirate which was free of parasites. The difference between groups A and C (P less than 0.001) and groups B and C (P less than 0.05) were significant. However, the difference between groups A and B was not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS) SN - 0971-5916 UR - https://www.unboundmedicine.com/medline/citation/1649790/Evaluation_of_efficacy_of_longer_durations_of_therapy_of_fresh_cases_of_kala_azar_with_sodium_stibogluconate_ DB - PRIME DP - Unbound Medicine ER -