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Regimen B (regimen + b)

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Medical Sciences100%

Selected Abstracts

Addition of muramyl tripeptide to chemotherapy for patients with newly diagnosed metastatic osteosarcoma,

CANCER, Issue 22 2009
A report from the Children's Oncology Group
Abstract BACKGROUND: The addition of liposomal muramyl tripeptide phosphatidylethanolamine (MTP-PE) to chemotherapy has been shown to improve overall survival in patients with nonmetastatic osteosarcoma (OS). The authors report the results of addition of liposomal MTP-PE to chemotherapy for patients with metastatic OS. METHODS: Intergroup-0133 was a prospective randomized phase 3 trial for the treatment of newly diagnosed patients with OS. The authors compared 3-drug chemotherapy with cisplatin, doxorubicin, and high-dose methotrexate (Regimen A) to the same 3 drugs with the addition of ifosfamide (Regimen B). The addition of liposomal MTP-PE to chemotherapy was evaluated. RESULTS: Five-year event-free survival (EFS) for patients who received liposomal MTP-PE (n = 46) was 42% versus 26% for those who did not (n = 45) (relative risk for liposomal MTP-PE, 0.72; P = .23; 95% confidence interval [CI], 0.42-1.2). The 5-year overall survival for patients who received MTP-PE versus no MTP-PE was 53% and 40%, respectively (relative risk for liposomal MTP-PE, 0.72; P = 0.27; 95% CI, 0.40-1.3). The comparison of Regimen A with Regimen B did not suggest a difference for EFS (35% vs 34%, respectively; relative risk for Regimen B, 1.07; P = .79; 95% CI, 0.62-1.8) or overall survival (52% vs 43%, respectively; relative risk for Regimen B, 1.1, P = .75; 95% CI, 0.61-2.0). CONCLUSIONS: When the metastatic cohort was considered in isolation, the addition of liposomal MTP-PE to chemotherapy did not achieve a statistically significant improvement in outcome. However, the pattern of outcome is similar to the pattern in nonmetastatic patients. Cancer 2009. © 2009 American Cancer Society. [source]

Randomized clinical trial of the efficacy and safety of tropicamide and phenylephrine in preoperative mydriasis for phacoemulsification

CLINICAL & EXPERIMENTAL OPHTHALMOLOGY, Issue 1 2003
Philip TH Lam FRCOphth
Abstract Purpose: To compare the mydriatic effect and safety between different concentrations of tropicamide and phenyle­phrine in preoperative mydriasis for phaco­emulsification. Methods: Two hundred and seventeen consecutive eyes in the same number of Chinese patients undergoing phaco­emulsification under local or topical anaesthesia in a university-based eye hospital were analyzed. Patients were randomized into two groups by cluster randomization, each group receiving a different preoperative mydriatic regimen. Regimen A consisted of tropicamide 1.0% with phenylephrine 2.5%, and Regimen B consisted of tropicamide 0.5% with phenylephrine 0.5%. The main outcome measures were horizontal pupillary diameter, systolic, diastolic and pulse pressure and pulse rate. Results: The group who received Regimen A attained a mean horizontal pupillary diameter of 7.00 ± 1.06 mm. Their pupils were significantly larger than those receiving Regimen B (6.61 ± 1.03 mm, P = 0.007). No untoward cardiovascular effects were noted in either groups. Conclusion: Regimen A attained better preoperative mydriasis for phacoemulsification than Regimen B. Both regimens were safe with regard to their cardiovascular effects. The combination of tropicamide 1.0% and phenylephrine 2.5% is recommended as preoperative mydriatic for phacoemulsification in Chinese patients who have darkly pigmented irides. [source]

Effect of omeprazole on the pharmacokinetics of paricalcitol in healthy subjects

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 2 2007
Rameshraja Palaparthy
Abstract Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism in chronic kidney disease (CKD). Proton pump inhibitors are prescribed to CKD patients to treat gastroesophageal reflux. This was a single dose, crossover study evaluating the effect of omeprazole, change in gastric pH as a result thereof, on the pharmacokinetics (PK) of paricalcitol. Twenty-six healthy subjects were administered paricalcitol capsules (16 µg) alone (regimen A), and following a single dose of OMP (40 mg) (regimen B), with a washout of at least 7 days. Plasma samples for paricalcitol concentrations were collected for 48 h post-paricalcitol dose. The plasma paricalcitol concentrations were measured using an LC,MS/MS assay (LOQ=0.02 ng/ml) and paricalcitol pharmacokinetic parameters were estimated using non-compartmental methods. The point estimates and the corresponding 90% confidence intervals for Cmax and AUC0-, to evaluate paricalcitol,omeprazole interaction were 1.032 [0.920,1.158] and 1.041 [0.951,1.139], respectively. No significant differences in Tmax (regimen A: 2.9 h vs regimen B: 2.6 h) or t1/2 (6.83 h vs 6.6 h) between the regimens were observed. Hence, the co-administration of omeprazole does not affect the PK of paricalcitol. Both regimens were well tolerated and no apparent differences among the regimens with respect to safety were observed. Copyright © 2007 John Wiley & Sons, Ltd. [source]