Abstract: We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE)/gestodene (GSD) transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet ® ) were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS) assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration (C max ), extended time to reach the C max and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration–time curve (AUCs) of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations. Keywords: pharmacokinetics, safety, ethinylestradiol/gestodene, transdermal contraceptive patch
BACKGROUND The psychological status of volunteers was investigated to provide a theoretical method for Phase I clinical trial management and result analysis. MATERIAL AND METHODS The Symptom Checklist 90 (SCL-90) and Eysenck Personality Questionnaire (EPQ) were used to assess the psychological status 200 healthy Chinese volunteers. RESULTS SCL-90 results indicate that the average value of positive factors is 10.32±14.26 by self-assessment of healthy volunteers, somatization factor is 1.13±0.13, compulsive symptom factor is 1.29±0.27, interpersonal sensitivity factor is 1.31±0.21, depression factor is 1.26±0.33, anxiety factor is 1.21±0.21, hostility factor is 1.08±0.26, phobia factor is 1.05±0.18, paranoid factor is 1.12±0.23, and psychotic symptom factor is 1.17±0.26. CONCLUSIONS Compared to the norm in China, the score of each factor of healthy volunteers was relatively low, with a statistically significant difference (P<0.001). EPQ results show that P score was 4.59±2.33, E score is 13.13±4.32, N score was 6.89±5.26, and L score was 13.21±4.25 for the 200 healthy volunteers. Compared to the norm in China, the P and N scores were lower, and the E and L scores were higher, with a statistically significant difference (P<0.001).
Psychological health of Chinese healthy volunteers was investigated to provide a theoretical method for phase I clinical trial management and result analysis. Symptom checklist 90 (SCL-90) and Eysenck Personality Questionnaire (EPQ) were used to assess 200 healthy volunteers and to analyse the level of psychological health of Chinese healthy volunteers. SCL-90 result indicates that the average value of positive factors is 10.32 ± 14.26 by self-assessment of healthy volunteers, somatization factor is 1.13 ± 0.13, compulsive symptom factor is 1.29 ± 0.27, interpersonal sensitivity factor is 1.31 ± 0.21, depression factor is 1.26 ± 0.33, anxiety factor is 1.21 ± 0.21, hostility factor is 1.08 ± 0.26, phobia factor is 1.05 ± 0.18, paranoid factor is 1.12 ± 0.23, psychotic symptom factor is 1.17 ± 0.26. Comparing the norm in China, the score of each factor of healthy volunteers is relatively low with statistically significant difference (P<0.001). EPQ result shows that P score is 4.59 ± 2.33, E score is 13.13 ± 4.32, N score is 6.89 ± 5.26, and L score is 13.21 ± 4.25 for 200 healthy volunteers. Comparing the norm in China, the P and N scores are lower, and the E and L scores are higher, with statistically significant difference (P<0.001).
Single-cell RNA sequencing (scRNA-seq) is useful for exploring cell heterogeneity. For large animals, however, little is known regarding spermatogonial stem cell (SSC) self-renewal regulation, especially in dairy goats. In this study, we described a high-resolution scRNA-seq atlas derived from a dairy goat. We identified six somatic cell and five spermatogenic cell subtypes. During spermatogenesis, genes with significantly changed expression were mainly enriched in the Notch, TGF-β, and Hippo signaling pathways as well as the signaling pathway involved in the regulation of stem cell pluripotency. We detected and screened specific candidate marker genes ( TKTL1 and AES) for spermatogonia. Our study provides new insights into goat spermatogenesis and the development of testicular somatic cells.
An experimental realization of the Qi-Wu-Zhang model for the quantum anomalous Hall effect is achieved based on ultracold fermions with two-dimensional spin-orbit coupling. A robust experimental protocol of pump-probe quench measurement is developed to precisely determine, with minimal heating, the properties of topological quantum systems with a limited lifetime.
Abstract We report the experimental realization of quantum degenerate Fermi gases of 87 Sr atoms under controlled 10- and dual-nuclear-spin configurations. Based on laser cooling and evaporative cooling, we achieve an ultracold Fermi gas of 10 5 atoms equally distributed over 10 spin states, with a temperature of T/T F =0.21. We further prepare a dual-spin gas by optically pumping atoms to the m F =9/2 and m F =7/2 states and observe a slightly lower T/T F than that for a 10-spin gas under the same trapping condition, showing efficient evaporative cooling under a decreasing number N of spin states ( N≥2 ) despite the increasing importance of Pauli exclusion. Given that rethermalization becomes less efficient with N approaching unity, we evaporatively cool an almost polarized gas to 130 nK. The simple and efficient preparation of ultracold Fermi gases of 87 Sr with tunable spin configurations provides a first step towards engineering topological quantum systems .
Objective To investigate current status of behavior management of non-dipper hypertension patients and provide information for clinical health education. Methods From February to December 2009, 100 outpatients and inpatients with non-dipper hypertension in our hospital were randomly sampled and telephone interview was conducted. Analyzed the results of the survey. Results 44% of the patients had healthy balanced diet. 48% of patients were trying to control blood pressure through moderate physical exercise. 20% of the patients were intended to control body weight. The drug compliance rate was only 56%. The overall correct rate of behavior management was no more than 33%. Conclusions The compliance of behavior management of non dipper hypertension patients is low. Focusing on hypertension knowledge is the key to improve the compliance of behavior management of non-dipper hypertension patients.
Key words:
Non-dipper hypertension; Behavior management; Investigation
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