BIOAVAILABILITY STUDY OF ONDANSETRON GEL IN RABBITS AND HUMAN VOLUNTEERS APPLING UPLC AS ANALYTICAL TOOL AND EVALUATION OF THE ANTIEMETIC EFFECT OF ONDANSETRON GEL IN CISPLATIN-INDUCED EMESIS IN RATS

Objective: This study was undertaken to determine the bioavailability of ondansetron gel in experimental animals and humans applying UPLC as an analytical tool and evaluation of the antiemetic effect of ondansetron gel in cisplatin-induced emesis in rats. Methods: Ondansetron gel (F13: sodium alginate 7% w/w) was used, marketed I. V. ondansetron (Zofran) ® was chosen as reference. The bioavailability study in rabbits was selected as a parallel design using nine healthy rabbits divided into three groups whereas, bioavailability study in humans was an open-label, wherein 6 healthy subjects administered ondansetron gel. The potential effect of ondansetron gel was evaluated for the prevention of different phases of emesis motivated by exposure to antineoplastic drugs (cisplatin) by determination of body weight loss, water and food intake applying kaolin-pica model in rats using seventy-two rats divided into six groups. Results: Ondansetron gel (0.5%) showed detectable plasma concentration 22.833±2.17 ng/m1 after ¼ h and 419.55±2.17 ng/ml after 1-h post-treatment in rabbits and human respectively and concentration was maintained above-reported minimum effective concentration for more than 2.5 h for rabbits and 7 h for humans compared to 1.75 h after I. V. administration. The ondansetron gel significantly reduces all phases of cisplatin-induced emesis and a decrease in body weight, water, and food consumption was significantly attenuated. Conclusion: Based on the high efficacy of gel on emesis induced by cisplatin, and its high bioavailability, transdermal ondansetron gel could be a promising convenient system to prevent nausea and vomiting following administration of antineoplastic drugs

Carbetocin versus Oxytocin and Misoprostol in prevention of atonic post-partum hemorrhage in high risk patients planed for cesarean delivery

Background: Post-partum hemorrhage prevention (PPH) is considered a major issue due to its effect on maternal morbidity and mortality. The objective of this study was to compare efficacy of Carbetocin in prevention of atonic post-partum hemorrhage in high risk patients undergoing elective caesarean section in comparison to Oxytocin and Misoprostol.Methods: 150 pregnant women prepared for elective caesarean section were classified into 3 groups; Group I (50 patients received Carbetocin 100 mg I.V infusion), Group II (50 patients received 20 IU of Oxytocin infusion on 1000 ml of normal saline solution) and Group III (50 cases received Misoprostol 400 µg per rectum immediately before induction of anaesthesia). Assessment of PPH and its degree was determined according to amount of blood loss during and for first 24 hours of caesarean delivery, also further need for haemostatic measures were also assessed.Results: There was a statistically significant difference in PPH among the three groups 6, 14 and 12% for group I, II and III respectively (P <0.001), major PPH was 0, 4 and 6% for the same groups respectively (P <0.001). The need for additional uterotonic agents was significantly lesser in Group I compared to Group II and III (2% versus 8 and 12% respectively P = 0.02) also the need for additional surgical measures was significantly lesser among the three groups (P= 0.00). The drop in Hb level and haematocrit value was significantly lesser in group I compared to group II& III (P <0.05). The need for blood transfusion was significantly lesser in Group I compared to group II and III (0% versus 12% p <0.0001)Conclusions: Carbetocin was superior to Oxytocin and Misoprostol in prevention of atonic PPH in high risk patients underwent elective caesarean delivery. Carbetocin should be administered for all cases undergoing elective CS and carry a risk factor for postpartum hemorrhage.

Link between vitamin B12, type 2 diabetes mellitus, and bone mineral density in elderly patients

AbstractBackground/PurposeThere have been many conflicting reports on the effects of type 2 diabetes mellitus (DM) and the level of vitamin B12 on bone mineral density (BMD) in elderly patients. Moreover, conflicting data exists regarding the prevalence of vitamin B12 deficiency among elderly diabetics. The aim of this study was to investigate the link between vitamin B12 levels, type 2 DM, and BMD in elderly patients.MethodsA case–control study was conducted on 61 participants, ≥60 years of age, divided into 31 cases of patients with diabetes and 30 age-matched healthy controls. Patients receiving vitamin B12 supplements were excluded. The relationship between BMD and serum levels of vitamin B12 was examined.ResultsBorderline/deficient serum B12 status was more common in the control group; it was found in 53.33% of the controls and 25.80% of diabetic patients. The mean serum vitamin B12 concentration was 820.65 ± 544.77 pg/mL in patients with diabetes and 677.80 ± 619.89 pg/mL in healthy control participants (p = 0.34). Serum vitamin B12 concentration showed no significant difference between osteoporotic patients, osteopenic patients, and normal patients among the diabetic group.ConclusionThe prevalence of vitamin B12 deficiency was higher in the control group than the diabetic group who did not receive oral B12 supplementation. Low serum vitamin B12 is commonly overlooked in the elderly, with or without diabetes. The presence of diabetes mellitus did not affect BMD in the elderly. Furthermore, there is no significant relationship between serum vitamin B12 levels and BMD among diabetics

Carbetocin versus Oxytocin and Misoprostol in prevention of atonic post-partum hemorrhage in high risk patients planed for cesarean delivery

Background: Post-partum hemorrhage prevention (PPH) is considered a major issue due to its effect on maternal morbidity and mortality. The objective of this study was to compare efficacy of Carbetocin in prevention of atonic post-partum hemorrhage in high risk patients undergoing elective caesarean section in comparison to Oxytocin and Misoprostol.Methods: 150 pregnant women prepared for elective caesarean section were classified into 3 groups; Group I (50 patients received Carbetocin 100 mg I.V infusion), Group II (50 patients received 20 IU of Oxytocin infusion on 1000 ml of normal saline solution) and Group III (50 cases received Misoprostol 400 µg per rectum immediately before induction of anaesthesia). Assessment of PPH and its degree was determined according to amount of blood loss during and for first 24 hours of caesarean delivery, also further need for haemostatic measures were also assessed.Results: There was a statistically significant difference in PPH among the three groups 6, 14 and 12% for group I, II and III respectively (P &lt;0.001), major PPH was 0, 4 and 6% for the same groups respectively (P &lt;0.001). The need for additional uterotonic agents was significantly lesser in Group I compared to Group II and III (2% versus 8 and 12% respectively P = 0.02) also the need for additional surgical measures was significantly lesser among the three groups (P= 0.00). The drop in Hb level and haematocrit value was significantly lesser in group I compared to group II&amp; III (P &lt;0.05). The need for blood transfusion was significantly lesser in Group I compared to group II and III (0% versus 12% p &lt;0.0001)Conclusions: Carbetocin was superior to Oxytocin and Misoprostol in prevention of atonic PPH in high risk patients underwent elective caesarean delivery. Carbetocin should be administered for all cases undergoing elective CS and carry a risk factor for postpartum hemorrhage.