PubMed Health⌕ Search

Biomedical subjects

U K Sheth

Publications and source records attributed to U K Sheth.

At least 19 recordsLinked to original sources
PubMed1987

A phase-III clinical trial of mefloquine in children with chloroquine-resistant falciparum malaria in Thailand.

Mefloquine is a highly effective drug for the treatment of falciparum malaria among adults, but studies of its effects on children are lacking. An open, noncomparative trial of mefloquine was therefore carried out among 84 children aged 5-12 years who were patients at the Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand. The drug was administered as a single dose of 18-29 mg base per kg body weight. Eighty-two of the 84 children completed a 42-day period of post-treatment observation. The drug was well tolerated also by 11 children with glucose-6-phosphate dehydrogenase deficiency, and all the children in the study cleared their parasitaemia initially (average clearance time, 65 hours). Furthermore, the clinical-chemical parameters measured exhibited no drug-related changes during the study. The radical cure rate of nearly 98% and high tolerance indicate that mefloquine can be used effectively and safely for the treatment of children aged 5-12 years who are suffering from uncomplicated falciparum malaria.

Child↗
PubMed1987

A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria.

Fansimef is a combination of 250 mg mefloquine (base), 500 mg sulfadoxine, and 25 mg pyrimethamine per tablet. One hundred and fifty adult male Brazilian patients at Belém (Pará), who had peripheral blood smears positive for Plasmodium falciparum, with or without clinical symptoms of falciparum malaria, were treated in a double-blind randomized fashion with either one, two or three tablets of Fansimef. Of those receiving one tablet (48 patients), 81% were cured and 19% exhibited RI recrudescences. All the patients receiving two or three tablets of Fansimef (49 patients in each group) were cured. The rates of initial clearance of parasitaemia and fever were similar in all treatment groups. Tolerance was good at all dose levels. The main side-effects included nausea, vomiting, dizziness, diarrhoea and abdominal pain, but these were mild and transient and required no specific treatment. The incidence of vomiting and nausea was highest in patients given the three-tablet dose. The results of various haematological, biochemical and urine analyses were not adversely altered by the administration of Fansimef.

Administration, Oral↗
PubMed1987

Mefloquine, sulfadoxine, and pyrimethamine in the treatment of symptomatic falciparum malaria: a double-blind trial for determining the most effective dose.

A total of 89 adult male Thai patients who had acute, uncomplicated falciparum malaria were treated in a double-blind randomized trial with a single oral dose of two or three tablets, each consisting of 250 mg mefloquine, 500 mg sulfadoxine, and 25 mg pyrimethamine (MSP). The two-tablet regimen produced a cure rate (S response) of 93%, the three-tablet regimen a cure rate of 98%. The mean duration of parasitaemia for the two- and three-tablet groups was 50 and 29 hours, respectively, while the mean duration of fever was 43 and 40 hours, respectively. Differences between the groups were not statistically significant. Tolerance was good at both dose levels. The main side-effects were abdominal discomfort, nausea, vomiting, dizziness, and diarrhoea, but these were mild, transient, and required no specific treatment. The results of haematological and biochemical investigations and of urinalysis revealed no drug-related changes following administration of MSP. The electrocardiograms of some patients revealed sinus bradycardia or sinus arrythmia, but these conditions were transient, symptomless, and clinically not significant.

Administration, Oral↗
PubMed1987

A double-blind trial of a fixed combination of mefloquine plus sulfadoxine-pyrimethamine compared with sulfadoxine-pyrimethamine alone in symptomatic falciparum malaria.

A total of 100 male Zambian patients with symptomatic falciparum malaria were treated with either two tablets of mefloquine plus sulfadoxine-pyrimethamine (Fansimef) or three tablets of sulfadoxine-pyrimethamine (Fansidar) as a single dose. The patients were kept under observation from day 0 (day of treatment) to day 28 and all were cured. An S-type of response was seen in all patients; one patient in the Fansimef group inexplicably remained positive for Plasmodium falciparum trophozoites until day 6. There were no cases of recrudescence.The rate of clearance of parasitaemia was similar in both groups. The rate of clearance of fever was marginally faster in the Fansimef group. Side-effects such as pruritus, diarrhoea and abdominal pain occurred after both drugs but were mild and transient; tolerance was slightly better with Fansimef. Severe orthostatic hypotension occurred in 20% of the Fansidar patients and in only 2% of the Fansimef patients; this was reversed by bed rest. Haematological and biochemical parameters were generally not modified in an undesirable manner by the administration of these drugs.

Administration, Oral↗
PubMed1985

A double-blind clinical trial of a combination of mefloquine, sulfadoxine and pyrimethamine in symptomatic falciparum malaria.

Fansimef is a combination of 250 mg of mefloquine, 500 mg of sulfadoxine, and 25 mg of pyrimethamine per tablet. A total of 150 adult male Zambian patients who had symptomatic Plasmodium falciparum parasitaemia were treated in a double-blind randomized fashion with either one, two or three tablets of Fansimef. All patients in the three treatment groups showed an S-type response. The rates of clearance of parasitaemia and fever were similar in all treatment groups. Tolerance was good at all dose levels. The main side-effects were abdominal discomfort, weakness and lassitude, dizziness, and pruritus, but these were mild, transient and required no specific treatment. Vomiting occurred only in 4% of patients given the highest dose of three tablets. The results of various haematological and biochemical investigations and urinalysis were not adversely altered by the administration of Fansimef.

Adolescent↗
PubMed1985

An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil.

The clinical and parasitological response of adult male patients to mefloquine and to a combination of quinine and sulfadoxine-pyrimethamine during the treatment of falciparum malaria was compared. These patients were from an area in Brazil where Plasmodium falciparum is showing increasing resistance to quinine and to sulfadoxine-pyrimethamine. The drugs were administered to 100 patients (50 in each group), based on a randomized study design.The rates of clearance of parasitaemia and fever were similar in both groups. However, the parasitological cure rate ("S" response) was 100% for mefloquine but only 92% for quinine plus sulfadoxine-pyrimethamine. Tolerance was good in both groups. The main side-effects (nausea, vomiting, abdominal pain, and dizziness) were mild, transient and required no specific treatment. Nausea and vomiting were more frequent in patients who received quinine plus sulfadoxine-pyrimethamine, while abdominal pain and loose stools or mild diarrhoea were more frequent in the mefloquine group. Tinnitus and hearing difficulty were observed following the administration of quinine plus sulfadoxine-pyrimethamine, but not after mefloquine treatment. Laboratory tests of various haematological and biochemical parameters were not adversely affected in either group after drug administration.It can be concluded that mefloquine, given in a single oral dose of 1000 mg, is highly effective, well tolerated, and safe for the treatment of falciparum malaria in adult males in Brazil.

Adolescent↗
PubMed1985

A phase I clinical trial of Fansimef (mefloquine plus sulfadoxine-pyrimethamine) in Brazilian male subjects.

A double-blind, randomized phase I clinical trial was carried out to compare Fansimef (a fixed-dose combination of mefloquine, sulfadoxine, and pyrimethamine) with sulfadoxine and pyrimethamine (Fansidar) for safety and tolerance. Twenty adult male Brazilian subjects from malaria endemic areas were studied for a period of 66 days, which included 2 days before and 63 days after drug administration.Both drugs were well tolerated and safe, as seen from the absence of drug-induced changes in the various laboratory, haematological, and biochemical parameters measured. Fansimef produced a complete clearance of parasites on day 3, with an "S" type response in one subject who had blood smears which were positive for Plasmodium falciparum on day 0. Two subjects in the sufladoxine-pyrimethamine group also had P. falciparum infections on day 0; the parasitaemia was cleared on day 2 in one of these subjects and on day 3 in the other, but an early RI response (recrudescence) was observed in the former case. Relapses due to P. vivax occurred in both groups.Side-effects due to Fansimef included mild dizziness, nausea, and vomiting. The incidence of dizziness and nausea was similar in the sulfadoxine-pyrimethamine group. In both groups, these side-effects were mild, short-lived and did not require specific treatment. Thus, Fansimef in an oral dose of three tablets (total of 750 mg mefloquine (base) plus 1500 mg sulfadoxine plus 75 mg pyrimethamine) was found to be well tolerated and safe.

Adult↗
PubMed1983

Phase 1 tolerability and antiamoebic activity studies with 1-methylsulphonyl-3-(1-methyl-5-nitro-2-imidazolyl)-2-imidazolidinone (Go.10213): a new antiprotozoal agent.

Go.10213, a new nitroimidazole, was studied in 12 male volunteers for tolerability and in 20 patients with intestinal amoebiasis for antiamoebic activity. Go.10213 was well-tolerated by volunteers up to a dose of 400 mg X 3. Patients also tolerated well the dose of 100-150 mg X 3 for 7 days. In two patients, there were mild and transient side-effects like headache, dizziness, fatigue, etc. No neurological side-effects were observed. There were no significant changes in blood pressure, pulse rate and ECG. The organ function tests did not show any adverse effects of Go.10213 on bone-marrow, kidney, liver, etc. Go.10213, at a dose of 150 mg X 3, showed potent antiamoebic activity in 10 patients with intestinal amoebiasis, as judged by the clinical relief, the eradication of the trophozoites and cysts of Entamoeba histolytica from stools and the healing of colonic ulcers. Go.10213, a novel nitroimidazole, may prove to be the most potent and safe agent against the protozoal infections, e.g. amoebiasis, giardiasis and trichomoniasis.

Adolescent↗
PubMed1983

A double-blind comparative clinical trial of mefloquine and chloroquine in symptomatic falciparum malaria.

A total of 99 male Zambian patients with symptomatic falciparum malaria were treated in a double-blind randomized manner with either mefloquine (1000 mg given in one day) or chloroquine (1500 mg given over 3 days). An S-type response was seen in all the chloroquine patients and 98% of the mefloquine group; one patient in the latter group (2%) showed an RI-type response, but the parasites obtained during the recrudescence were sensitive to both chloroquine and mefloquine in the in vitro microtest, and the patient responded satisfactorily to oral chloroquine. The rate of clearance of parasitaemia was marginally faster in the chloroquine-treated group. The rate of clearance of fever was similar in the two groups. Both drugs were well tolerated and side-effects such as nausea, vomiting, dizziness, loose stools, and pruritus were mild and transient. Pruritus was more common after chloroquine administration and dizziness more common in the mefloquine group. There were no drug-induced alterations in the haematological and biochemical profiles.

Adolescent↗
PubMed1981

Effect of muscimol, a central GABA receptor agonist, on the catalepsy, striatal homovanillic acid increase, and analgesia induced by pilocarpine in rats.

Muscimol, a structural analog of GABA, significantly potentiated pilocarpine-induced analgesia in rats, but failed to alter pilocarpine-induced catalepsy. It also failed to affect pilocarpine-elicited increase in homovanillic acid levels in the striatum. These findings suggest that the potentiation of pilocarpine-induced analgesia by muscimol is unrelated to an interaction of the GABAergic system with the striatal cholinergic or dopaminergic systems.

Analgesics↗
PubMed1981

Pharmacokinetics of ethynyloestradiol in women for different populations.

The pharmacokinetics of a dose of 50 microgram ethynyloestradiol administered orally was studied in fourteen centres. Absorption was rapid and the highest serum concentrations of total ethynyloestradiol were found in most subjects at 1 h and by 24 h concentrations were less than 250 pg/ml. Calculation of the half-lives for absorption, distribution and elimination showed wide variations between subjects, the half-life of elimination varying from 2.5 h to more than 30 h. Bioavailability as measured by the area under the serum ethynyloestradiol concentration-time curve also showed more than a ten-fold variation. Intra-centre differences in the various parameters measured were as large as the inter-centre differences.

Biological Availability↗