Procedures for application of the extended dosing after antitumor drug clinical trials / 中南大学学报(医学版)

New drug clinical trials have been considered as a positive way for treating cancer by cancer patients and doctors, and the extended dosing is a special way for patients' withdrawal from antitumor clinical trials to obtain investigational new drugs. However, neither the regulations of expanded dosing nor the detail documents for expanded dosing have been officially published in China. At present, expanded dosing of investigational drugs is still at the exploratory stage in various medical institutions, and a complete management system has not been established to meet patients' urgent needs for drug use. Based on the practical experience of extended dosing in Hunan Cancer Hospital, this paper preliminarily explored the application procedures and ethical review requirements of extended dosing for subjects in antitumor clinical trials. It is necessary to clarify the responsibilities of all patients in the procedure and establish a patient-medical institution-sponsor joint application system. In the process of ethical review, it is recommended that all parties fully consider the risks and benefits of extended dosing for patients, and then the ethics committee makes a comprehensive assessment to decide whether to approve extended dosing.

Bioequivalence of Nimesulide Granules in Healthy Volunteers / 中国药师

Objective:To evaluate the bioequivalence of two kinds of domestic nimesulide granules in healthy volunteers. Meth-ods:In self-control and two-way crossover design, 18 healthy male volunteers were divided into two groups randomly. Each subject was given 100 mg test or reference nimesulide granules with single dose. The concentration of nimesulide in plasma was determined by HPLC. The concentration of nimesulide in plasma was calculated and compared statistically to evaluate the bioequivalence between the two kinds of granules by DAS 2. 1 software. Results:The main pharmacokinetic parameters of test and reference preparations were as follows:Cmax was(9. 28 ± 2. 05) and(9. 41 ± 2. 31)μg·ml-1;Tmax was(3. 50 ± 1. 86)and(3. 56 ± 1. 65)h;T1/2 was (3. 43 ± 0. 85) and(3.38 ±0.68)h;AUC0-24 was(77.78 ±18.42)and(81.69 ±23.50)μg·ml·h-1;AUC(0-∞) was (79.07 ±19.21)and(82.92 ± 24. 11)μg·ml·h-1, respectively. The 90% confidential interval of ln(AUC0-24), ln(AUC0-∞) and ln(Cmax) of the test preparation was 90. 7%-107. 9%,90. 6%-111. 2% and 90. 7%-103. 0%, respectively. The relative bioavailability was (96. 7 ± 37. 6)%. Con-clusion:The two nimesulide granules are bioequivalent.

Clinical examination of olfactory and gustatory function / 临床耳鼻咽喉头颈外科杂志

OBJECTIVE@#To explore changes of olfactory and gustatory functions in patients with olfactory dysfunction.@*METHOD@#The 284 study subjects included 92 healthy volunteers, 92 with hyposmia and 100 with functional anosmia. Their olfactory and gustatory functions were examined using T&T olfactometer, olfactory event-related potentials (OERPs) and triple drop method, respectively.@*RESULT@#The T&T results showed that the difference between patients with hyposmia and functional anosmia and healthy subjects had statistical significance. The OERPs results showed that patients with olfactory dysfunction had N1 and P2 waves of prolonged latency and reduced amplitude when compared to healthy subjects with the difference of statistical significance. When compared to healthy subjects, patients with olfactory dysfunction had clear hypogeusia and the difference had statistical significance. There was no significant difference between female and male groups.@*CONCLUSION@#It is suggested that the apparently concomitant hypogeusia is in patients with olfactory dysfunction. Decreased of olfactory and gustatory function exhibited little or no relationship with gender. Combined examinations of OERPs, T&T and triple drop method, could make it possible to reflect the overall chemical sensory functions in subjects systematically and provide scientific evidence for clinical diagnosis and treatment early.

Determination of Enalapril in Human Plasma With HPLC-MS / 中国药房

OBJECTIVE:To estabilish a HPLC-MS method for determining enalapril in human plasma METHODS:Alprozalam was added into plasma sample as an internal standard,then supernate of the sample was extracted through solid-phase extration column,washed with methanol and detected by HPLC-MS method:column,ODS C18;mobile phase,methanol-0 01% formic acid(45∶55);flow rate,0 8ml/min;capillary voltage,3 81kV;cone voltage,39 0V The selected ion was determined by EST RESULTS:The calibration curve was linear within the range of 2 5～400ng/ml r=0 9 996,the recovery was 102 2%,RSDs of intra -day and inter-day were 4 0% and 5 4%,respectively CONCLUSION:The method is accurate and sensitive with no endogenous interference It can be applied to studying the pharmacokinetics and bioavailability of enalapril tablets in humans

Investigatin on Clinical Effects of Astragalus Injection on Preventing Cisplatin Induced Early Kidney Injury / 中成药

0.05). But the determined values in the above two dose groups of Astragalus Injection were obviously lower than that in cisplatin group. There were remarkable differences.( P