A randomized clinical trial of low dosage combination of pentamidine and
allopurinol in the treatment of antimony unresponsive cases of visceral
leishmaniasis.
Author(s): Das VN, Ranjan A, Sinha AN, Verma N, Lal CS, Gupta AK, Siddiqui NA, Kar SK.
Affiliation(s): Rajendra Memorial Research Institute of Medical Sciences, Indian Council of
Medical Research, Agamkuan, Patna.
Publication date & source: 2001, J Assoc Physicians India. , 49:609-13
OBJECTIVES: A randomized clinical trial of low dosage combination of pentamidine
and allopurinol was carried out with objectives to assess the efficacy and
toxicity as compared to full dosage of pentamidine in antimony unresponsive
visceral leishmaniasis (VL) patients.
METHODS: Using a randomized control clinical trial, a total of 158 antimony
unresponsive patients of VL were randomly allocated into two treatment groups.
Patients in one group (n=80) received half the dosage of pentamidine i.e. 2 mg/kg
body weight by IM route on alternate day and allopurinol in dose of 15 mg/kg body
weight in three divided dosages for 30 days; patients in the second group (n=78)
received pentamidine in dose of 4 mg/kg body weight by IM route on alternate day
for 15 injections in 30 days. The efficacy and safety of the two regimens were
compared.
RESULTS: Apparent cure i.e. clinical and pathological cure at the end of therapy,
in 78 (97.5%) and 67 (86%), and ultimate cure i.e. clinical and parasitological
cure at the end of follow-up of six months, in 73 (91.25%) and 58 (74.35%)
patients was observed in the combination regimen and single regimen group
respectively. The difference of the ultimate cure between two groups of the
patients was statistically significant (p < 0.01). In single regimen group, 11
(14%) patients showed primary unresponsiveness (with no response during
treatment) and nine (13%) relapse (after six months of follow-up) respectively,
where as in combination regimen group, two (2.5%) patients showed primary
unresponsiveness and five (6.4%) relapse respectively. By the end of the
treatment, the incidence of injection-related toxicity, such as rigor and fever,
was same in both groups. No hyperglycemia was observed in combination therapy
probably due to reduced dose of pentamidine and three patients in single regimen
developed hyperglycemia and one of them developed irreversible hyperglycemia.
CONCLUSIONS: The study showed that the combination of pentamidine (half dose) and
allopurinol is more effective in achieving ultimate cure with an added advantage
of reduced toxicity in unresponsive cases as compared to full pentamidine dose.
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