Effects of botropase on clotting factors in healthy human volunteers.

OBJECTIVE: To evaluate the effects of botropase on various clotting factors in human volunteers. MATERIALS AND METHODS: It was a prospective open label study conducted on human healthy volunteers. After the baseline screening, subjects fulfilling inclusion criteria were enrolled. On the study day, 1 ml of botropase was administered intravenously and after an hour same dose of botropase (1 ml) was given by intramuscular (IM) route. The efficacy and safety parameters were monitored up to 72 h from the time of intravenous (IV) administration. RESULTS: A total of 15 volunteers, belonging to 24-35 years of age were included in the study. Botropase significantly reduced the plasma level of fibrinogen and fibrin degradation products after 5 min of IV administration (P < 0.05). In addition, factor X was observed to reduce constantly by botropase administration suggesting enhanced turnover between 5 and 20 min of IV administration. Although botropase reduced clotting and bleeding time in all the volunteers, the data remains to be statistically insignificant. CONCLUSION: Present study demonstrated the safety and efficacy of botropase in human healthy volunteers. The study has shown that it is a factor X activator and reduces effectively clotting and bleeding time.

Acute toxicity and diuretic studies of the roots of Asparagus racemosus Willd in rats.

OBJECTIVE: Asparagus racemosus Willd has been used as diuretic in Ayurveda but has not been validated by a suitable experimental model. Hence the present study was undertaken. MATERIALS AND METHODS: The study was carried out with an aqueous extract of the roots of Asparagus racemosus utilizing three doses viz 800 mg/kg, 1600 mg/kg and 3200 mg/kg for its diuretic activity in comparison with standard drug (furosemide) and control (normal saline) rats after doing acute toxicity study. RESULTS: Acute toxicity study showed no fatality even with the highest dose and the diuretic study revealed significant diuretic activity (p < 0.05) in the dose of 3200 mg/kg. CONCLUSION: Asparagus racemosus showed diuretic activity at a 3200 mg/kg dose without acute toxicity.

Serum bicarbonate: can it be a marker of metformin induced acidosis in geriatrics?

Metformin is an oral antidiabetic agent, widely used in the treatment of type 2 diabetes mellitus. The serious side effect of metformin therapy is lactic acidosis. Contraindications for metformin therapy include renal insufficiency. A cut off value of 60 ml/min in creatinine clearance is suggested. Hundred type 2 diabetics receiving metformin as monotherapy or in combination with insulin/other oral antidiabetic agents, were enrolled in the study. Patients were on metformin for atleast one month prior to being enrolled. Patients' demographic data were taken. Baseline serum creatinine and bicarbonate were estimated. Creatinine clearance (Clcr ml/ min) was calculated. Patients were grouped into group 1-4 depending upon the doses of metformin they received. Patients were again grouped based on their Clcr as groupA (Clcr < 60 ml/min), group B (Clcr > 60.01 ml/min). Data was analysed using student's t test. Out of 100 patients 52 were males, 48 females. Mean age and SD of males and females were 69.92 +/- 6.95 and 66.85 +/- 5.72 respectively. Comparison of mean bicarbonate level in different doses of metformin did not show any statistical significance. But comparison of bicarbonate levels based on Clcr were highly statistically significant (p = 0.0084). In three patients whose bicarbonate level was very low (15, 16.4 and 19.2 mmol/L), doses of metformin was reduced and after one month their bicarbonate levels returned to normal (27.4, 25.6 and 26.2 mmol/L). Hence serum bicarbonate can be a marker to assess metformin induced acidosis in geriatrics patients with low creatinine clearance.