Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction / 中华男科学杂志

Objective@#To evaluate the safety, efficacy and tolerability of China-made sildenafil citrate (Jinge) in the treatment of ED.@*METHODS@#We conducted a multi-center, randomized, double-blind and placebo-controlled clinical trial among 222 ED patients in five urological or andrological clinics of China. The patients were randomly assigned to receive sildenafil citrate (SC, n = 111) or placebo (n = 111) for 8 weeks. We obtained and analyzed the demographic and clinical characteristics of the patients, the scores of International Index of Erectile Function (IIEF), the success rate of sexual intercourse, and the incidence of adverse events.@*RESULTS@#No statistically significant differences were found between the patients of the SC and those of the placebo group in the mean age (［47.2±11.32］ yr vs ［46.67±13.08］ yr, P>0.05), psychological etiology (27.93% vs 23.42%, P>0.05), organic etiology (21.62% vs 29.73%, P>0.05) or mixed etiology (50.45% vs 46.85%, P>0.05), nor in height, weight, nationality, or history of smoking, drinking or allergy. Compared with the placebo controls, the SC-treated patients showed significant increases in the excellence rate of effectiveness (29.91% vs 78.90%, P<0.01), success rate of sexual intercourse (29.16% vs 63.87%, P<0.01), and total effectiveness rate (34.58% vs 77.98%, P<0.01). The effectiveness rates on organic, psychogenic and mixed types ED were remarkably higher in the SC group (64.52%, 83.33%, and 82.14%) than in the placebo control (46.15%, 21.21%, and 25.00%) (P<0.01). Mild or temporary adverse events were observed in 32 cases in the SC group as compared with 13 in the placebo control.@*CONCLUSIONS@#China-made sildenafil citrate is an effective, safe and well-tolerated drug for ED of different etiologies in the Chinese population.

Clinical research on the correlations between type 2 diabetes mellitus and renal clear cell carcinoma / 中华外科杂志

<p><b>OBJECTIVE</b>To investigate the relationship between renal clear cell carcinoma and type 2 diabetes mellitus (DM).</p><p><b>METHODS</b>Two hundreds and sixty-four patients with renal clear cell carcinoma and four hundred controls who suffered from non-urinary system, non-neoplastic or non-hormone-related disorders, were enrolled from January 2008 to December 2012. The incidence of diabetes between the 2 groups and the relationship between renal clear cell carcinoma and duration of diabetes were compared, moreover, renal clear cell carcinoma patients with DM were compared with patients without DM for their clinical features, laboratory examinations and histological characteristics.</p><p><b>RESULTS</b>The comparison of renal clear cell carcinoma group and control group: the incidence of DM in the two groups were 19.7% and 12.8% respectively, and the difference was significant (χ(2) = 5.86, P < 0.05, OR = 1.68). In the renal clear cell carcinoma group, the proportion of patients with DM diagnosed within 2-4 years was 4.92%, which were significant higher than those in the control group 1.70% (χ(2) = 5.49, P < 0.05, OR = 2.91). And men with diabetes had high occurrence risk 86% of renal clear cell carcinoma (OR = 1.86, 95%CI: 1.09-3.15). The comparison of diabetes patients subgroup and non-diabetic patients subgroup in renal clear cell carcinoma group: in respect of clinical features, greatest tumor diameter in the two subgroups were (4.9 ± 2.3) cm and (4.2 ± 2.1) cm respectively, and the difference was significant (t = 1.96, P < 0.05). However, there was no significant difference in terms of age, gender and cancer location between the two subgroups (P > 0.05). In respect of laboratory examinations, serum creatinine in the two subgroups were (72 ± 20) µmol/L and (65 ± 17) µmol/L, and the difference was significant (t = 2.34, P < 0.05); serum urea nitrogen in the 2 subgroups were (7.1 ± 2.1) mmol/L and (6.0 ± 1.5) mmol/L respectively, and the difference was significant too (t = 1.47, P < 0.05). In respect of histological characteristics, the proportion of well differentiated clear cell carcinoma were 80.8% and 81.1% respectively, and the difference was significant (χ(2) = 4.23, P < 0.05). The proportion of stage II were 25.0% and 27.8% respectively and the difference was significant (χ(2) = 4.08, P < 0.05).</p><p><b>CONCLUSIONS</b>DM is closely related with renal clear cell carcinoma and DM may be a possible risk factor for the tumor. And for elderly patients with diabetes who appear waist discomfort or hematuria, a careful examination of kidney is important to make early diagnosis, give timely treatment and improve survival prognosis.</p>

Transurethral prostatectomy with the bipolar plasmakinetic technique for benign prostate hyperplasia: a report of 712 cases / 中华男科学杂志

<p><b>OBJECTIVE</b>To evaluate the effect and safety of transurethral prostatectomy with the bipolar plasmakinetic technique (PKRP) in the treatment of benign prostate hyperplasia (BPH).</p><p><b>METHODS</b>A total of 712 BPH patients underwent transurethral prostatectomy with the bipolar plasmakinetic technique. The patients averaged 70.6 years of age and 52 g (range 35-102 g) in estimated prostate weight preoperatively. Comparative analyses were made on the maximum urine flow rate (Qmax), residual urine volume and scores on IPSS and QOL obtained pre- and post-operatively.</p><p><b>RESULTS</b>The operations lasted 20-120 minutes (mean 51 min), the resected tissues weighed 15-96 g (mean 46 g), and no transurethral resection syndrome (TURS) occurred. The catheters were removed 4 -5 days after surgery. The patients were followed up for 1 -52 months (mean 27.6 mo). Obvious reduction was observed in the average Qmax from 4.7 ml/s preoperatively to 19. 1 ml/s postoperatively, in the mean IPSS score from 26.6 to 5. 8, and in the mean QOL score from 5.4 to 1.7, all with significant differences (P < 0.01).</p><p><b>CONCLUSION</b>Transurethral prostatectomy with the bipolar plasmakinetic technique is a safe and effective means for the treatment of BPH.</p>

Long-term outcomes of mini-margin nephron sparing surgery for renal cell carcinoma / 中华外科杂志

<p><b>OBJECTIVE</b>To study the safety and effects of mini-margin nephron sparing surgery (NSS) for renal cell carcinoma (RCC).</p><p><b>METHODS</b>From January 1998 to December 2006, 115 cases of RCC with diameter of 4 cm or less and stage of T1aN0M0 were treated with NSS using a margin of 5 mm or more. The mean diameter of the tumors was 3.3 cm (range 1.0-4.0 cm). Of the cases, 3 were with synchronous bilateral cancer while 112 cases were with normal opposite kidneys. The clinical results were followed and analyzed.</p><p><b>RESULTS</b>All of the operations were technically successful. The mean duration of surgical procedures was 90 min (ranged 80-120 min). The blood loss was 50 -200 ml. No patient needed blood transfusion. Renal arteries were occluded in 98 cases under hypothermic technique for a mean duration of 22 min (20-25 min). While in 17 cases, renal parenchyma squeezing was used for bleeding control. All of the 115 cases were of negative margin by weather frozen or routine pathologic study. The mean follow-up was 62 months (6-96 months). Local recurrence was found in 1 case during follow-up, with a local recurrence rate of 0.9%, while no distant metastasis was detected. All the patients were alive with no evidence of tumor bearing until last evaluation. Secondary gross hematuria occurred in 3 cases during hospital stay and cured by bed limitation. There were no major complications such as bleeding and urinary leakage or urinoma requiring re-operation.</p><p><b>CONCLUSIONS</b>Mini-margin nephron sparing surgery is likewise safe and effective in treating early localized renal cell carcinoma 4 cm or less. It provides excellent renal function preservation, favorable long-term progression-free survival, and is not associated with an increased risk of local recurrence.</p>

Significance of margin in nephron sparing surgery for renal cell carcinoma of 4 cm or less / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Current surgical practice for nephron sparing surgery allows at least 1 cm margin of normal tissue around the tumour. However, recent studies show that the width of the margin is not important, even simple enucleation is as effective as partial nephrectomy. We explored whether margin size has significant impacts on clinical outcomes in nephron sparing surgery for renal cell carcinoma of 4 cm or less.</p><p><b>METHODS</b>Between 1998 and 2006, 115 patients with sporadic, pathologically confirmed, renal cell carcinoma 4 cm or less (T1a) and normal contralateral kidney were treated by nephron sparing surgery using a margin less than 5 mm. The surgical margin status was evaluated from frozen and permanent paraffin sections.</p><p><b>RESULTS</b>Mean and median tumour diameter were 3.3 cm and 3.5 cm (range 1.0-4.0). The mean margin width was 2.2 mm (median 2.0, range 0-6). In addition, 114 cases had margins 5 mm or less (99.1%), 97 cases (84.3%) had margin 3 mm or less, and 26 cases had margin zero (22.6%). None of the patients had positive surgical margins. No patients died during follow-up (mean 65 months). There were no any major surgical complications and no distant metastasis was detected. Local recurrence was detected in one case (0.9%) at a different site of the kidney.</p><p><b>CONCLUSIONS</b>For early localized renal cell carcinoma of 4 cm or less, as long as tumour is completely excised, the size of margin in nephron sparing surgery is not important. Nephron sparing surgery with 5 mm margin is enough for tumour control. It provides excellent renal function preservation, favourable long term progression free survival and is not associated with an increased risk of local recurrence.</p>

Transurethral prostatectomy with the bipolar plasma kinetic technique for benign prostate hyperplasia: a report of 297 cases / 中华男科学杂志

<p><b>OBJECTIVE</b>To evaluate the effect and safety of transurethral prostatectomy with the bipolar plasma kinetic technique (PKRP) in the treatment of benign prostate hyperplasia(BPH).</p><p><b>METHODS</b>Two hundred and ninty-seven BPH patients underwent transurethral prostatectomy with the bipolar plasma kinetic technique. The preoperative estimated weight of the prostate ranged from 35 g to 102 g, averaging 52 g.</p><p><b>RESULTS</b>The operation lasted 40 approximately 65 min, averaging 51 min. The resected tissues weighed 40 approximately 80 g, averaging 46 g. During the operation no transurethral resection (TUR) syndrome occurred. The catheter was removed 4 approximately 5 days after the operation, all with fluent urination. The patients were followed up for 2 approximately 33 months. IPSS decreased from average 31.5 preoperatively to average 6.8 postoperatively (P < 0.001). Average maximum flow-rate (Q(max)) decreased from 6.3 ml/s preoperatively to 18.6 ml/ s postoperatively (P < 0.001). Preoperative average residual urine was 97 ml and reduced to average 9 ml after the operation. Temporary incontinence occurred in 4 cases, perioperative hemorrhage in 2, and urethral stricture in 1.</p><p><b>CONCLUSION</b>Transurethral prostatectomy with the bipolar plasma kinetic technique is a safe and effective means for the treatment of BPH.</p>

P53 expression and its clinical significance in prostatic carcinoma / 中华男科学杂志

<p><b>OBJECTIVE</b>To investigate the expression of P53 protein and its clinical significance in prostatic carcinoma.</p><p><b>METHODS</b>Formalin-fixed, paraffin-embedded tissue sections from 45 cases of prostatic carcinoma (PCa) and 10 cases of benign prostate hyperplasia (BPH) were analyzed retrospectively with immunohistochemical Elivision staining method. The relationship of P53 expression with prostate cancer stage, grade, PSA, endocrine therapeutic effect and prognosis was evaluated.</p><p><b>RESULTS</b>The positive staining rates of p53 protein expression were 51.1% and 10.0% respectively in patients with PCa and BPH (P < 0.05); 70.0% and 25.0% in PCa patients at pathological stage D and stages A approximately C respectively (P < 0.05); 14.3% and 56.7% in those with Gleason score < or = 7 and > 7 (P < 0.05); 20.0% and 60.0% in those with PSA < or = 10 microg/L and PSA > 10 micro/L (P > 0.05 ); 25.0% and 72.3% in those who responded to endocrine therapy and those who failed to respectively (P < 0.05). Log Rank analyses showed that the survival time of the PCa patients with negative P53 expression was obviously longer than those with the positive (P < 0.05 ).</p><p><b>CONCLUSION</b>There were correlations between P53 expression and tumor grade, tumor stage and survival time, so the expression of P53 could be regarded as a prognostic molecular marker and a predictor of endocrine therapeutic effect for prostate cancer.</p>

The combined therapy of intervention, operation and biology in patients with middle-advanced renal cell carcinoma / 中华外科杂志

<p><b>OBJECTIVE</b>To observe the effect of the combined therapy of intervention, operation and biology in patients with middle-advanced renal cell carcinoma.</p><p><b>METHODS</b>Combined therapy was used in 52 cases as combined care groups and the single operational therapy was used in 50 cases as control group. Compare their resection rates, surgical risks and 3, 5 years survival rates.</p><p><b>RESULTS</b>In the combined care group, the excision rate was 100%, the average amount of blood transfusion during the operation was 280 ml, the average operation time was 100 minutes, and the 3, 5 years survival rates were 73% and 50%; While in the control group, the results were 90%, 396 ml, 130 minutes, 55% and 27% respectively. There were significant differences between 2 groups (P < 0.05).</p><p><b>CONCLUSION</b>Combined therapy could elevate resection rates and 3, 5 years survival rates and decrease surgical risks.</p>