UNLABELLED: One hundred thirty parasitologically confirmed cases of kala-azar were randomly divided in two equal treatment groups. Patients in group A were treated by infusion with amphotericin B deoxycholate (ABD), 1 mg/kg day on days 1-20 and the infusion was given in two hours. Patients in group B were treated by an escalating dose of ABD 0.05 mg/kg, 0.1 mg/kg, 0.25 mg/kg, 0.5 mg/kg, 1 mg/kg on days 1-5, respectively and then in the same dosage on alternate days. The infusion was completed in 6 hours. Total dose of 20 mg/kg remaining the same in both the groups, the treatment was completed in 20 days in group A and 43 days in group B. Clinical cure (subsidence of fever, improvement in general well being and regression in the size of the spleen) and parasitological cure (absence of parasites in splenic aspirates at the end of treatment) occurred in all patients in both the groups. Sixty four (99%) patients in each group had not relapsed clinically and parasitologically within 6 months of follow up and were ultimately cured. The two relapsed patients, one in each group were treated with a 20-day course of ABD and were cured. Leukocyte count, haemoglobin, serum albumin increased (P < 0.05) and ESR, spleen and liver size decreased (P < 0.05) at the end of treatment and follow up. Adverse events were similar in both the groups. The minimum cost of treatment estimated was Rs. 14,500 in group B and Rs. 10,000 in Group A. Thus the newer mode of administration was more cost effective. CONCLUSION: It was concluded that newer mode of administration of amphotericin B was as effective and tolerable as the classical mode of administration and was no more toxic. The newer mode of administration of amphotericin B is more cost effective and puts lesser burden on hospital staff and is recommended for use in kala-azar.
RCT Entities:
UNLABELLED: One hundred thirty parasitologically confirmed cases of kala-azar were randomly divided in two equal treatment groups. Patients in group A were treated by infusion with amphotericin Bdeoxycholate (ABD), 1 mg/kg day on days 1-20 and the infusion was given in two hours. Patients in group B were treated by an escalating dose of ABD 0.05 mg/kg, 0.1 mg/kg, 0.25 mg/kg, 0.5 mg/kg, 1 mg/kg on days 1-5, respectively and then in the same dosage on alternate days. The infusion was completed in 6 hours. Total dose of 20 mg/kg remaining the same in both the groups, the treatment was completed in 20 days in group A and 43 days in group B. Clinical cure (subsidence of fever, improvement in general well being and regression in the size of the spleen) and parasitological cure (absence of parasites in splenic aspirates at the end of treatment) occurred in all patients in both the groups. Sixty four (99%) patients in each group had not relapsed clinically and parasitologically within 6 months of follow up and were ultimately cured. The two relapsed patients, one in each group were treated with a 20-day course of ABD and were cured. Leukocyte count, haemoglobin, serum albumin increased (P < 0.05) and ESR, spleen and liver size decreased (P < 0.05) at the end of treatment and follow up. Adverse events were similar in both the groups. The minimum cost of treatment estimated was Rs. 14,500 in group B and Rs. 10,000 in Group A. Thus the newer mode of administration was more cost effective. CONCLUSION: It was concluded that newer mode of administration of amphotericin B was as effective and tolerable as the classical mode of administration and was no more toxic. The newer mode of administration of amphotericin B is more cost effective and puts lesser burden on hospital staff and is recommended for use in kala-azar.