In order to ensure the science and rationality of the research , ethical review has been the general principles of the international community before biomedical research . Along with the development of Chinese medicine in China , the Chinese government has paid close attention to the construction of ethical review in re-cent years . Relying on the State Clinical Research Center of Chinese Trial Program Affiliated to State Adminis-tration of Traditional Chinese Medicine of the People's Republic of China , our hospital has some experiences in the construction of ethical review platform . The academic exchanges and strengthening of personnel training can increase the ethical review level in order to provide supports and insurance for the Chinese medicine clini-cal research .

ObjectiveTo investigate the pharmacokinetic characteristics of sofosbuvir tablets, and to evaluate the bioequivalence and safety of two preparations. MethodsHealthy volunteers were recruited through the platform of clinical trial recruitment in The Affiliated Hospital of Changchun University of Chinese Medicine. Screening physical examination was performed for fasting group on September 18, 2018 and for postprandial group on September 28, 2018, and the volunteers were enrolled after their physical examination results met the inclusion criteria. The fasting group and the postprandial group, with 40 volunteers in each group, were given oral administration of the test preparation sofosbuvir tablets or the reference preparation sofosbuvir tablets (SOVALDI, 400 mg). This was a randomized, open-label, two-sequence, four-cycle, single-dose, and completely repeated cross-over bioequivalence test in the fasting or postprandial state in the healthy population; in the fasting group, 20 volunteers each received oral administration of the test preparation and the reference preparation, and in the postprandial group, 20 volunteers each received oral administration of the test preparation and the reference preparation. Liquid chromatography-tandem mass spectrometry was used to measure the content of sofosbuvir and its major metabolite GS-331007 in human EDTA-K2 plasma; the plasma concentration of sofosbuvir was measured at 15 time points from 0 hour to 8 hours after administration, and that of GS-331007 was measured at 16 time points from 0 hour to 72 hours after administration. WinNonlin software was used to calculate pharmacokinetic parameters and evaluate bioequivalence. ResultsAfter the administration of the test preparation and the reference preparation in the fasting state, when the pharmacokinetic parameters of sofosbuvir was used to evaluate the bioequivalence of the test preparation and the reference preparation, the ratios of the geometric means of Cmax, AUC0-t, and AUC0-inf were 90.55%, 97.26%, and 94.62%, respectively; when the pharmacokinetic parameters of GS-331007 was used to evaluate the bioequivalence of the test preparation and the reference preparation, the ratios of the geometric means of Cmax, AUC0-t, and AUC0-inf were 98.91%, 98.98%, and 99.46%, respectively. All of the above values were within the range of 80.00%-125.00%. An analysis of variance was performed after the pharmacokinetic parameters of sofosbuvir Cmax, AUC0-t, and AUC0-inf were transformed by natural logarithm, and the results showed that sequence, cycle, and preparation had no marked influence on Cmax, AUC0-t, and AUC0-inf (all P＞0.05). ConclusionThe test preparation of sofosbuvir tablets is bioequivalent to the reference preparation in the fasting and postprandial states.

Objective:To investigate the urinary iodine and thyroid volume of children aged 8 to 10 years in Linhai City Zhejiang Province, and evaluate the iodine nutrition level of children so as to provide a basis for formulating intervention measures to eliminate iodine deficiency disorders.Methods:In 2019, a systematic sampling method was adopted to select 1 township (street) central primary school in each of the 5 areas in the east, west, south, north, and middle of Linhai City. At least 40 children aged 8 to 10 years were selected from each of the central primary schools in each township (street) to collect family edible salt samples and one-time urine samples during the day for salt iodine and urinary iodine testing, respectively, as well as thyroid B-ultrasound examination.Results:A total of 215 salt samples were collected. The median salt iodine was 21.0 mg/kg, the coverage rate of iodized salt was 57.2% (123/215), the qualified rate of iodized salt was 91.9% (113/123), and the consumption rate of qualified iodized salt was 52.6% (113/215). A total of 215 urine samples were collected. The median urinary iodine was 166.0 μg/L, and the proportion of urinary iodine < 50 μg/L accounted for 5.1% (11/215). A total of 215 children were examined, and the goiter rate was 4.7% (10/215).Conclusion:The overall iodine nutrition level of children aged 8 to 10 years in Linhai City is at an appropriate level (100-199 μg/L), and the goiter rate is within the standard limit for the elimination of iodine deficiency disorders (5%), but the coverage rate of iodized salt and the consumption rate of qualified iodized salt are seriously low.