Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction: interim results of a multicenter, randomized, open-label trial / 亚洲男科学杂志(英文版)

Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.

Protective effect of lycopene on human spermatozoa during cryopreservation and its mechanism / 中华男科学杂志

<p><b>OBJECTIVE</b>To investigate the protective effect of lycopene against cryopreservation injury of post-thawing human sperm and its mechanism.</p><p><b>METHODS</b>Semen samples were collected from 25 volunteers, each sample equally divided into four parts to be cryopreserved with cryoprotectant only (Ly0 control) or cryoprotectant + lycopene at the concentrations of 2 (Ly2), 5 (Ly5), and 10 µmol/L (Ly10), respectively. Before and after thawing, the semen samples were subjected to computer-assisted semen analysis ( CASA) for sperm kinematics, flow cytometry for sperm apoptosis, thiobarbituric acid assay for malondialdehyde (MDA) concentration, and JC-1 fluorescent staining for the sperm mitochondrial membrane potential (MMP).</p><p><b>RESULTS</b>After cryopreservation, sperm motility was markedly decreased in all the groups (P < 0.01). The rate of sperm apoptosis was significantly lower in the Ly5 group than in the Ly0 control ([25.68 ± 4.36]% vs [33.26 ± 4.78]%, P < 0.05), while sperm MMP remarkably higher in the former than in the latter ([66.18 ± 14.23]% vs [55.24 ± 12.31]%, P < 0.05). The Ly2, Ly5 and Ly10 groups showed no statistically significance differences in the MDA level from the Ly0 control (P > 0.05).</p><p><b>CONCLUSION</b>Addition of lycopene at a proper concentration to cryoprotectant may reduce oxidative damage to sperm mitochondria in the freezing-thawing process, attenuate oxidative stress injury induced by reactive oxygen species to sperm plasma membrane, and improve the anti-apoptosis ability of sperm.</p>

Reliability and validity of the Chinese version of The Premature Ejaculation Diagnostic Tool / 中华男科学杂志

<p><b>OBJECTIVE</b>To translate the English version of The Premature Ejaculation Diagnostic Tool (PEDT) into Chinese, evaluate its reliability and validity, and analyze its feasibility in the diagnosis of premature ejaculation (PE).</p><p><b>METHODS</b>Following the forward-backward translation procedure, we developed the Chinese version of PEDT, which was then revised by andrologists and bilingual linguists. We enrolled subjects with or without PE from 15 urological or andrological clinics in China and obtained the information about their demographic characteristics, PEDT scores, and intra-vaginal ejaculation latency time (IELT). We evaluated the internal consistency of PEDT using Cronbach alpha, was examined its reliability and stability by test-retest analysis, analyzed its correlation with IELT by Spearman correlation analysis, and tested its sensitivity and specificity by receiver operating characteristic ( ROC) analysis.</p><p><b>RESULTS</b>Totally, 570 PE patients (aged [30.66 ± 7.11] years) and 226 non-PE men (aged [33.01 ± 5.41] years) were recruited, with the mean IELT of (1.34 ± 0.54) min in the former and (11.09 ± 7.5) min in the latter group. The Cronbach's alpha of the Chinese version of PEDT was 0.79, and the test-retest correlation coefficient was 0.75 (P < 0.01). The PEDT score was negatively correlated with IELT (Spearman's p = -0.52, P < 0.01). When the cutoff value of PE diagnosis was defined as 7.5, the sensitivity and specificity of PEDT were 0.80 and 0.78, and when as 8.5, they were 0.72 and 0.89, respectively.</p><p><b>CONCLUSION</b>The Chinese version of PEDT was demonstrated to have good internal consistency, reliability, and validity, as well as a high predictability for PE. It can be used as a reliable and convenient tool to screen PE among Chinese men.</p>

Yimusake Tablet: safe and efficacious for premature ejaculation / 中华男科学杂志

<p><b>OBJECTIVE</b>To objectively evaluate the efficacy and safety of Yimusake Tablet in the treatment of premature ejaculation (PE) through a multi-centered large-sample trial.</p><p><b>METHODS</b>We conducted a multi-centered, open, fixed-dose, and self-compared clinical trial among 300 patients with diagnosed PE. The trial lasted 12 weeks, including 4 weeks without any medication and 8 weeks of treatment with Yimusake Tablet, 2 pills (1 g) per night. We observed the intravaginal ejaculation latency time (IELT) before and after treatment, evaluated the safety of medication, and performed a questionnaire investigation on the patients' satisfaction.</p><p><b>RESULTS</b>Of the 300 PE patients, 288 accomplished the clinical trial. The patients ranged in age from 22 to 60 years, averaging at 31.6 years. The mean IELT of the patient was 62.5 seconds at baseline, 168.9 seconds after 4 weeks of treatment with Yimusake Tablet, and 222.2 seconds after 8 weeks of medication. Among the 157 patients with normal erectile function (IIEF >21), the mean IELT was 71.4 seconds before treatment, 147.4 seconds after 4 weeks of medication, and 172.5 seconds after 8 weeks of medication. The patients' satisfaction was significantly increased after treatment. Those complicated by mild to moderate erectile dysfunction achieved different degrees of improvement in the IIEF-5 score, with a mean increase of 3.8. Only a few patients experienced mild adverse events, including constipation, dry mouth, nose bleeding, abdominal pain, and lumbosacral pain, which were all relieved without drug withdrawal.</p><p><b>CONCLUSION</b>Yimusake Tablet is a safe and effective medicine for the treatment of PE.</p>

Expressions of differential proteins in the expressed prostatic secretion of patients with III A chronic prostatitis / 中华男科学杂志

<p><b>OBJECTIVE</b>To study the expressions of differential proteins in the expressed prostatic secretion (EPS) of patients with III A chronic prostatitis and healthy men.</p><p><b>METHODS</b>We collected EPS samples from 35 patients with III A chronic prostatitis and 18 age-matched healthy men, and detected the differentially expressed proteins in EPS by MALDI-TOF/MS. Based on the data obtained, we conducted a statistical analysis on the mass-to-charge (m/z) ratios of different proteins and a retrieval analysis on the relevant proteins using the protein database.</p><p><b>RESULTS</b>In the comparative studies of the III A chronic prostatitis patients and healthy men, 5 proteins were detected as at least 2-fold differentially expressed, which were probably brevinin-2Eg, big endothelin-1, alpha-defensin 15, beta-defensin 134 and prostatic steroid-binding protein C2. The m/z ratios were significantly up-regulated in 3 372, 3 487, 425 and 5 325 Da proteins (P < 0.01) and down-regulated in 10631Da (P < 0.01).</p><p><b>CONCLUSION</b>Proteins are differentially expressed in the EPS of III A chronic prostatitis patients and healthy men, and these proteins may be significantly correlated with the development and progression of III A chronic prostatitis.</p>

Clinical analysis of 87 cases of testicular tumor / 中华男科学杂志

<p><b>OBJECTIVE</b>To improve the diagnosis and treatment of testicular tumor.</p><p><b>METHODS</b>Eighty-seven cases of testicular tumor were retrospectively studied.</p><p><b>RESULTS</b>Of the total number, 79 cases were pathologically diagnosed as germ cell tumor (90.1%), among which there were 44 cases of seminoma (55.7%) and 7 cases of benign tumor (8.1%). Nonseminoma germ cell tumor (NSGCT) was found mainly among those under 5 and from 18 to 40 years of age, while seminoma chiefly among those beyond 17, and testis tumor was rare among those between 5 and 17 years old (1 case only). Three-year and 5-year survival rates of seminoma and NSGCT were 90.6% and 81.3%, and 83.3% and 56.7%, respectively.</p><p><b>CONCLUSION</b>(1) Testicular tumors are mostly germ cell tumors. (2) NSGCT develops mainly among those under the age of 5 and from 18 to 40. (3) Seminoma is rare in those under 18. (4) Testicular tumor rarely develops among those between 5 and 17 years old. (5)Three-year and 5-year survival rates for seminoma are higher than those for NSGCT.</p>