Pharmacokinetics and bioequivalence studies of fluvoxamine maleate tablets in healthy Chinese subjects.

Fluvoxamine is a selective serotonin reuptake inhibitor commonly used for various types of depression. The purpose of this study was to evaluate the pharmacokinetics and bioequivalence of fluvoxamine maleate tablets orally on an empty stomach and after a meal in healthy adult Chinese subjects and to preliminarily evaluate their safety. A single-center, randomized, open-label, two-drug, two-period, crossover, single-dose trial protocol was designed. Sixty healthy Chinese participants were enrolled and randomly classified into fasting (n = 30) and fed groups (n = 30). Each week, subjects took fluvoxamine maleate tablets 50 mg orally once as a test preparation or as a reference preparation on an empty stomach/after meals. To evaluate the bioequivalence of test and reference tables, the concentration of fluvoxamine maleate in the plasma of the subjects at different time points after administration was detected by liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters including the maximum plasma drug concentration (Cmax ), the time to reach maximum concentration (Tmax ), the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t ) and the area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞ ) were calculated. Our data revealed that the 90% confidence intervals of the geometric mean ratio of the test or reference drugs for the Cmax , AUC0-t and AUC0-∞ fell within the acceptance range for bioequivalence (92.30-102.77%). The absorption, measured by AUC, did not show a significant difference between the two groups. There were no suspected serious adverse reactions or serious adverse events over the entire trial. Our results demonstrated that the test and reference tablets were bioequivalent under fasting and fed conditions.

Expression and significance of matrix metalloproteinase and tissue inhibitor of metalloproteinase in nasal cavity squamous cell carcinoma / 中华耳鼻咽喉头颈外科杂志

<p><b>OBJECTIVE</b>To study the expression and significance of matrix metalloproteinase (MMP) 2, MMP-9, tissue inhibitor of metalloproteinase (TIMP)1 and TIMP-2 in nasal cavity squamous cell carcinoma and their signification.</p><p><b>METHODS</b>Fifty cases of epithelial carcinoma tissue and 50 cases of normal nasal tissue were detected for MMP-2, MMP-9, TIMP-1, TIMP-2 by immunohistochemistry technique (S-P), and their relationship between the expression of MMP-2, MMP-9, TIMP-1, TIMP-2 and some clinical symptoms were analyzed. The SPSS 12.0 software was used to analyze the data.</p><p><b>RESULTS</b>The positive ratio of expression of MMP-2 in 50 cases of epithelial carcinoma was 52.0% (26/50), which was significantly higher (χ(2) = 6.00, P < 0. 05) than those [28.0% (14/50)] in the normal nasal tissue. The positive ratio of expression of MMP-9 in 50 cases of epithelial carcinoma was 58.0% (29/50), which was significantly higher (χ(2) = 12.8, P < 0.05) than those [10.0% (5/50)] in the normal nasal tissue. The positive ratio of expression of TIMP-1 in two groups was 74.0% (37/50), 56.0% (28/50) respectively. There was no difference between two groups (χ(2) = 0.51, P > 0.05). The positive ratio of expression of TIMP-2 in two groups was 26.0% (13/50), 20% (10/50) respectively. There was no difference between two groups (χ(2) = 3.35, P > 0.05).</p><p><b>CONCLUSIONS</b>There was a close relationship between pathogenesis and development of nasal epithelial carcinoma and the expression of MMP-2, MMP-9 in the epithelial carcinoma tissues. Both MMP and TIMP, especially the unbalance of MMP and TIMP, have prognostic value in nasal cavity squamous cell carcinoma.</p>

Shang Ring circumcision versus conventional surgical procedures: comparison of clinical effectiveness / 中华男科学杂志

<p><b>OBJECTIVE</b>To compare the efficacy and complications of the Shang Ring circumcision with those of conventional surgical procedures.</p><p><b>METHODS</b>A total of 724 patients, 521 with redundant prepuce and 203 with phimosis, were randomly assigned to receive the Shang Ring circumcision (n = 402) and conventional surgical procedures (n = 322). Comparisons were made between the two groups in the surgical duration, blood loss, pain score, as well as postoperative complications, satisfaction with the penile appearance, and the quality of sexual life.</p><p><b>RESULTS</b>The surgical duration, blood loss, postoperative satisfaction and IIRF-5 score were (4.70 +/- 1.30) min, (2.60 +/- 1.80) ml, 99.50% (400/402) and 23.45 +/- 3.43, respectively, in the Shang Ring group as compared with (25.6 +/- 8.3) min, (11.20 +/- 3.50) ml, 69.57% (224/322) and 23.12 +/- 3.26 in the conventional surgery group, with statistically significant differences in the first three parameters (P < 0.01), but not in IIRF-5 score (P > 0.05).</p><p><b>CONCLUSION</b>Compared with the conventional surgical procedures, the Shang Ring circumcision has the advantages of shorter operation time, less blood loss, mild pain, fewer complications, better penile appearance, lower expenses, and higher satisfaction and acceptance of the patients.</p>