4 research outputs found
Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: Randomized controlled double blind clinical trial
Oropharynx is an important site of cancer in India. Global comparison
indicates higher incidences in India. Radiotherapy remains an important
treatment modality. Efforts to improve loco-regional treatment and
prolong survival are areas of focus. Radiosensitizers in hypoxic tumors
have shown promise. Aim: To study the safety and radiosensitizing
efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage
T2-4, N0-3, M0) as phase-II double blind controlled trial in patients
treated with conventional radiotherapy. SETTINGS AND DESIGN: Single
institutional, randomized, double-blind, placebo-controlled trial.
MATERIALS AND METHODS: Group 1 (control; n =23) received normal saline
infusion, group 2 (test; n =23) received sanazole biweekly 1.25 g
intravenous infusion 15 minutes before radiotherapy. Surrogate end
points of efficacy were tumor and nodal size; safety parameters were
mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia
and neurological deficit. Investigators blinded to the trial evaluated
patients, weekly during treatment for six weeks and thereafter monthly
for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi
square, Mann-Whitney U tests. RESULTS: In the test, 15 (65%) patients
had complete response, five (22%) partial/no response, two (9%) died,
one (4%) lost to follow up. In the control, five (22%) patients had
complete response, 16 (70%) partial/no response, one (4%) died, one
(4%) lost to follow up. Short-term loco-regional response was better in
the test ( DF = 3 , 95% Confidence Interval 0.418, 0.452, P=0.0048 ).
In the test group significant vomiting and one case of grade 3
neurological deficit was observed. CONCLUSION: The study validates the
usefulness of sanazole for initial loco-regional control in
oropharyngeal cancers
Effect of ethanolic leaf extract of Ocimum sanctum on haloperidol-induced catalepsy in albino mice
Neuroleptic drugs used in the treatment of schizophrenia and other
affective disorders are known to produce extrapyramidal side effects.
Catalepsy induced by these drugs in animals has been used as a model
for the extrapyramidal side effects associated with antipsychotic
agents in human beings. In the present study, we have attempted to
evaluate the protective effect of the ethanolic leaf extractof Ocimum
sanctum (OS) on haloperidol (1.0 mg/kg, intraperitoneal
administration)-induced catalepsy in mice by employing the standard bar
test. Mice were allocated to seven groups, each group containing six
animals. The effects of the test drug OS (at 1.75, 4.25 and 8.5 mg/kg
doses) and the standard drugs, scopolamine (1.0 mg/kg) and ondansetron
(0.5 and 1.0 mg/kg doses) were assessed after single and repeat dose
administration for seven days, 30 minutes prior to the haloperidol. The
results suggest that OS has a protective effect against
haloperidol-induced catalepsy, which is comparable to the standard
drugs used for the same purpose. Our study indicates that OS could be
used to prevent drug-induced extrapyramidal side effects
Do geriatrics require dose titration for antidiabetic agents?
Objective: To evaluate the antidiabetic drug dosage differences between geriatric and nongeriatric diabetics with reference to duration of disease and creatinine clearance (Crcl). Materials and Methods: Prospective study conducted for 6 months in a tertiary care hospital. Patients with type 2 diabetes mellitus were grouped into geriatric (age ≥60 years) and nongeriatric (age <60 years). Patients′ demographic data, duration of diabetes, medication, and serum creatinine were recorded. Crcl was calculated using Cockcroft-Gault formula. Doses of sulfonylureas (SU) were converted into equivalent doses, taking glibenclamide as standard. Univariate analysis was done for comparison of drug doses between groups. Result: A total of 320 geriatric and 157 nongeriatric diabetics completed the study. The duration of diabetes and Crcl adjusted dose reduction of glibenclamide (mean dose: Geriatrics 7.2±0.4 mg, nongeriatrics 9.6±0.7 mg; P=0.01) and gliclazide (mean dose: Geriatrics 85.5±11.5 mg, nongeriatrics 115.3±32.7 mg; P=0.42) was 25%, glimepiride (mean dose: Geriatrics 1.62±0.13 mg, nongeriatrics 2.1±0.18 mg; P=0.06) was 22%. Glipizide did not require dose reduction. Mean converted equivalent dose of sulfonylurea monotherapy was significantly lower in geriatrics than nongeriatrics (3.2±0.5 vs 6.4±1.02 mg; P=0.01) and showed 50% dose reduction. Mean dose of metformin was lower in geriatrics (901±32.2 mg vs 946.7±45.8 mg; P=0.45) and showed 5% reduction in dosage. There was no difference in the mean drug doses of thiazolidinediones and insulin between the groups. Conclusion: A substantial dose reduction of glibenclamide (25%), gliclazide (25%), glimepiride (22%), and metformin (5%) in geriatrics compared to nongeriatrics was observed. Smaller dosage formulations like 0.75 mg glibenclamide, 0.5 mg glimepiride, 20 mg gliclazide, and 250 mg metformin may be of value in geriatric diabetic practice