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.

Diagnosis and treatment of prostatic malignant mesenchymal tumors: Analysis of 20 cases / 中华男科学杂志

<p><b>OBJECTIVE</b>To explore the diagnosis, treatment, and prognosis of prostatic malignant mesenchymal tumors (PMMT).</p><p><b>METHODS</b>We retrospectively analyzed the clinical and follow-up data about 20 cases of PMMT and reviewed the literature relevant to the diagnosis, treatment, and prognosis of the disease.</p><p><b>RESULTS</b>Based on the results of pathology and immunohistochemistry, the 20 PMMT cases included leiomyosarcoma (n = 7), rhabdomyosarcoma (n = 5), prostatic stromal sarcoma (n = 3), chondrosarcoma (n = 1), and undifferentiated PMMT (n = 4). Twelve of the patients were treated by radical prostatectomy (3 concurrently by sigmoid colostomy and 1 by cystostomy), 2 by pelvic tumor resection following arterial embolization, 1 by total pelvic exenteration, 1 by colostomy with pelvic lymph node biopsy, and 4 by conservative therapy because of metastasis to the lung, pelvis and bone. Of the 20 patients, 9 died of systemic metastasis within 3 months after treatment, 3 died at 6, 7, and 14 months, respectively, 3 survived with tumor for 5, 11, and 12 months, respectively, 2 survived without tumor for 12 and 24 months so far, all subjected to periodic chemotherapy postoperatively, and 3 lost to follow-up.</p><p><b>CONCLUSION</b>PMMT is a tumor of high malignancy and rapid progression, for which transrectal ultrasound-guided biopsy remains the main diagnostic method. The clinical stage of the tumor is an important factor influencing its prognosis and the survival rate of the patients can be improved by early diagnosis and combined therapy dominated by radical prostatectomy.</p>

Comparison of ultrasound-guided transrectal and transperineal prostate biopsies in clinical application / 中华男科学杂志

<p><b>OBJECTIVE</b>To compare the positive rates and complications of ultrasound-guided transrectal and transperineal prostate biopsies.</p><p><b>METHODS</b>We retrospectively analyzed 156 cases of ultrasound-guided transrectal (n = 97) and transperineal (n = 59) prostate biopsy, and compared the positive rate and post-biopsy complications between the two approaches.</p><p><b>RESULTS</b>The positive rates in the transrectal and transperineal groups were 48.4% and 44.1%, respectively, with no significant difference between the two approaches according to different PSA levels (P >0.05). No statistically significant differences were observed between the transrectal and transperineal groups in the post-biopsy incidence rates of such complications as hematuria (54.6% vs 42.4%, P >0.05), lower urinary tract symptoms (17.5% vs 22.0%, P >0.05), dysuria (9.3% vs 6.8%, P >0.05), and acute urinary retention (7.2% vs 6.8%, P >0.05). However, the incidence rates of post-biopsy infection and rectal bleeding were remarkably higher (15.5% vs 3.4%, P<0.05 and 50.5% vs 3.4%, P >0.01) while that of perineal swelling markedly lower in the former than in the latter (3.1% vs 13.6%, P <0.05).</p><p><b>CONCLUSION</b>Transrectal and transperineal biopsies are both effective for the diagnosis of prostate cancer. Since their complications vary, the choice between the two methods depends on the specific condition of the patient.</p>

Expression of Nkx3.1 enhances 17beta-estradiol anti-tumor action in PC3 human prostate cancer cells / 亚洲男科学杂志(英文版)

<p><b>AIM</b>To explore whether the anti-tumor action of 17beta-estradiol is enhanced by re-expression of the homeodomain transcription factor Nkx3.1 in PC3 human prostate cancer cells.</p><p><b>METHODS</b>PC3 cells were stably transfected with pcDNA3.1-Nkx3.1-His vector, which carries a full-length cDNA of human Nkx3.1. The PC3 cells stably transfected with vector pcDNA3.1 were set as a control. The expression of Nkx3.1 protein in the cells was confirmed by Western blot analysis. The effect of Nkx3.1 on cell proliferation of PC3 cells was examined with MTT assay. The antiproliferative and apoptotic effects of 17beta-estradiol alone or in combination with Nkx3.1 were estimated on PC3 cells by using MTT growth tests and flow cytometric analyses. The expression of apoptosis-related proteins was analyzed using Western blotting.</p><p><b>RESULTS</b>The plasmid carrying Nkx3.1 gene induced high expression of Nkx3.1 protein in PC3 cells. The re-expression of exogenous Nkx3.1 did not cause a significant reduction in cellular proliferation, whereas the expression of Nkx3.1 enhanced the 17beta-estradiol anti-proliferative effect in PC3 cells. Nkx3.1 expression promoted 17beta-estradiol-induced apoptosis of PC3 cells, as shown by analysis of Bcl-2, Bax, Caspase-3 and poly (ADP-ribose) polymerase expression.</p><p><b>CONCLUSION</b>The present study demonstrates that re-expression of Nkx3.1 enhances 17beta-estradiol anti-tumor action in PC3 human prostate cancer cells. The in vitro study suggests that re-expression of Nkx3.1 is worthy of further consideration as an adjuvant treatment of androgen independent prostate cancer with estrogen anti-tumor therapies.</p>

Sexual-nerve-Sparing radical cystectomy: experience with 32 cases / 中华男科学杂志

<p><b>OBJECTIVE</b>To evaluate the effect of sexual-nerve-sparing radical cystectomy.</p><p><b>METHODS</b>Thirty-two male patients were treated with sexual-nerve-sparing radical cystectomy in our hospital in the past 5 years. The age of the patients ranged from 38 to 72 years, with the course of the disease ranging from 2 days to 20 years. All of them were potent preoperatively. Radical cystectomy was performed antegradely and retrogradely with the neurovascular bundle spared.</p><p><b>RESULTS</b>The patients were followed up for 6 to 54 months, 3 achieved sexual activity of Grade I, 6 Grade II and 23 Grade III after the operation. The recovery time of erectile function ranged from 2 to 14 months, averaging at 4. 5 months.</p><p><b>CONCLUSION</b>Whenever condition suits, sexual-nerve-sparing radical cystectomy is to be strongly recommended.</p>

Inverted urothelial papilloma: report of 151 cases / 中华外科杂志

<p><b>OBJECTIVE</b>To investigate the clinical features, pathology, diagnosis and treatment of inverted urothelial papilloma.</p><p><b>METHODS</b>A total of 151 cases of urothelial inverted papilloma were analysed retrospectively. Of the cases, 134 were male and 17 were female, with a mean age of 54 years old. Most patients complained of painless gross hematuria. The diagnosis could be established mainly by ultrasonic, intravenous urography, retrograde pyelography, cystoscope and pathology. Among them, 7 cases who had the papilloma at upper urinary tract underwent nephroureterectomy except one. One hundred and forty-four cases had the papilloma at low urinary tract, with 124 treated by transurethral bladder tumor resection (TURBT), among which 11 cases accompanying benign prostatic hyperplasia were treated by transurethral prostatic resection, 3 by transurethral resection of prostatic urethral tumor, 15 by partial cystectomy, 2 by total cystectomy.</p><p><b>RESULTS</b>One hundred and eighteen cases were followed up 1 year to 12.5 years (mean 6.3 years). Intravesical recurrence was found in 5 cases. Of them 2 cases developed malignance in 8 and 30 months postoperatively, and 1 case underwent total cystectomy.</p><p><b>CONCLUSIONS</b>Inverted urothelial papilloma is a benign tumor, which appears male predominant. Most of the lesions are found in the bladder. TURBT is the preferred treatment choice for inverted papilloma of the bladder. Although this disease has a good prognosis, regular follow-up observations are necessary.</p>