The purpose of this research was to study the pharmacokinetics and the bioavailability of recombinant human parathyroid hormone [rhPTH (1-34)] in Rhesus monkeys after single and multiple subcutaneous administration....The purpose of this research was to study the pharmacokinetics and the bioavailability of recombinant human parathyroid hormone [rhPTH (1-34)] in Rhesus monkeys after single and multiple subcutaneous administration. An immunoradiometric assay (IRMA) was used to determine the plasma drug concentration of rhFFH (1-34) after giving single dose of 10, 20 and 40 ug/kg and daily dose of 40 ug/kg for 7 d by subcutaneous administration, and intravenous injection of 20 ug/kg in Rhesus monkeys. The pharmacokinetic parameters were calculated by noncompartmental analysis. The drug plasma level quantitation range was from 0.027 to 2.22 ng/mL. The intra- and inter-assay precision (CV) of analysis were less than 15%, and the average recovery was about 93.0% ± 8.6% - 116.5% ± 14.0%. After subcutaneous administration of rhPTH(1-34) at dose of 10, 20 and 40 ug/kg, the average Tmax was 0.67, 0.5 and 0.83 h, Cmax were 1.85 ± 0.05, 3.23 ± 0.25 and 7.15 ± 1.19 ng/mL, the AUC(0-∞) were 3.4 ± 0.6, 10.7 ± 1.3 and 12.6 ± 1.5 ng/h/mL, and terminal-phase elimination T1/2 were 0.72 ± 0.10, 1.15 ± 0.10 and 1.03 ± 0.06 h, respectively. The absolute bioavailability of rhPTH (1-34) was 46.96% after subcutaneous administration of 20 ug/kg. There was no evidence of accumulation during systemic exposure of rhPTH (1-34) upon multiple dosing in Rhesus monkeys. The IRMA assay method provide reasonable sensitivity and specificity for the pharrnacokinetic study of rhPTH (1-34) after subcutaneous or intravenous administration in Rhesus monkeys. The pharmacokinetic characteristic of rhPTH (1-34) in monkeys shows linear relationship with the dose administered subcutaneously.展开更多
Objective: To systematically analyze and summarize non-thyrogenous masses of the neck (NTMN) by consideration of new areas, a large sample size and multiple-aspect analysis. Methods: Our research involved 3125 NTM...Objective: To systematically analyze and summarize non-thyrogenous masses of the neck (NTMN) by consideration of new areas, a large sample size and multiple-aspect analysis. Methods: Our research involved 3125 NTMN cases. We summarized the proportion of various NTMN and the distribution of the neck diseases based on the new international classification. The clinical traits such as sexual proportion and age, etc, were analyzed along with the unknown primary cervical metastatic carcinomas (UPCMC), and built up a mathematical model based on the data above. Results: There were 68 different diseases identified. Among all the NTMN, the percentage of metastatic carcinomas was 63.3%. The neck masses with a focus above the clavicle comprised 62.3% of the metastatic carcinomas whose focuses were clear. Moreover, other results almost supported the "rule of 80%". There was an obvious distribution of traits at every sub level. For example, there were 23 different diseases in level Ⅲ, of which the most common was lymphoma. UPCMC made up 12.3% of all metastatic carcinomas. The clinic cases could be analyzed by our model even to form a primary diagnosis which showed a high coincident rate with clinic diagnosis. Conclusion: NTMN are complex and various, with a definite distribution in each neck level. Data relating component character, sex ratio and UPCMC et al to the clinical traits of NTMN will provide vigorous support for clinical applications. The mathematical model could be an efficient method to synthetically analyze complicate data of NTMN.展开更多
文摘The purpose of this research was to study the pharmacokinetics and the bioavailability of recombinant human parathyroid hormone [rhPTH (1-34)] in Rhesus monkeys after single and multiple subcutaneous administration. An immunoradiometric assay (IRMA) was used to determine the plasma drug concentration of rhFFH (1-34) after giving single dose of 10, 20 and 40 ug/kg and daily dose of 40 ug/kg for 7 d by subcutaneous administration, and intravenous injection of 20 ug/kg in Rhesus monkeys. The pharmacokinetic parameters were calculated by noncompartmental analysis. The drug plasma level quantitation range was from 0.027 to 2.22 ng/mL. The intra- and inter-assay precision (CV) of analysis were less than 15%, and the average recovery was about 93.0% ± 8.6% - 116.5% ± 14.0%. After subcutaneous administration of rhPTH(1-34) at dose of 10, 20 and 40 ug/kg, the average Tmax was 0.67, 0.5 and 0.83 h, Cmax were 1.85 ± 0.05, 3.23 ± 0.25 and 7.15 ± 1.19 ng/mL, the AUC(0-∞) were 3.4 ± 0.6, 10.7 ± 1.3 and 12.6 ± 1.5 ng/h/mL, and terminal-phase elimination T1/2 were 0.72 ± 0.10, 1.15 ± 0.10 and 1.03 ± 0.06 h, respectively. The absolute bioavailability of rhPTH (1-34) was 46.96% after subcutaneous administration of 20 ug/kg. There was no evidence of accumulation during systemic exposure of rhPTH (1-34) upon multiple dosing in Rhesus monkeys. The IRMA assay method provide reasonable sensitivity and specificity for the pharrnacokinetic study of rhPTH (1-34) after subcutaneous or intravenous administration in Rhesus monkeys. The pharmacokinetic characteristic of rhPTH (1-34) in monkeys shows linear relationship with the dose administered subcutaneously.
文摘Objective: To systematically analyze and summarize non-thyrogenous masses of the neck (NTMN) by consideration of new areas, a large sample size and multiple-aspect analysis. Methods: Our research involved 3125 NTMN cases. We summarized the proportion of various NTMN and the distribution of the neck diseases based on the new international classification. The clinical traits such as sexual proportion and age, etc, were analyzed along with the unknown primary cervical metastatic carcinomas (UPCMC), and built up a mathematical model based on the data above. Results: There were 68 different diseases identified. Among all the NTMN, the percentage of metastatic carcinomas was 63.3%. The neck masses with a focus above the clavicle comprised 62.3% of the metastatic carcinomas whose focuses were clear. Moreover, other results almost supported the "rule of 80%". There was an obvious distribution of traits at every sub level. For example, there were 23 different diseases in level Ⅲ, of which the most common was lymphoma. UPCMC made up 12.3% of all metastatic carcinomas. The clinic cases could be analyzed by our model even to form a primary diagnosis which showed a high coincident rate with clinic diagnosis. Conclusion: NTMN are complex and various, with a definite distribution in each neck level. Data relating component character, sex ratio and UPCMC et al to the clinical traits of NTMN will provide vigorous support for clinical applications. The mathematical model could be an efficient method to synthetically analyze complicate data of NTMN.