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Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.
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Objective To explore the clinical efficacy and safety of off-clamping in robotic-assisted partial nephrectomy (RAPN) for the treatment of renal tumors.Methods From January 2015 to March 2017,the data of 48 patients who underwent off-clamping RAPN were reviewed retrospectively.There were 31 males and 17 females,and the mean age was 57 years (range:23-84 years).The mean tumor size was 3.1 cm (range:1.2-6.4 cm),with the upper,middle,and lower polar tumors account for 35.4％,27.1％,and 37.5％,respectively.The clinical tumor stage was T1N0M0 in all 48 cases,according to the AJCC tumor staging system for renal cancer.Results RAPNs were performed successfully in all 48 cases,without conversion to open surgery.In those patients,the application of off-clamping in robotic-assisted partial nephrectomy was performed in 44 cases.The renal artery and vein was exposed,dissected,isolated and then clamped in 4 cases due to bleeding.The mean surgical time was 85 min (range:75-185 min).The mean estimated blood loss was 134 ml (range:60-270 ml),and no blood transfusion was needed.The wound surface was closed using interrupted suture with Hem-o-lok clips securing each needle point.The mean time for renorrhaphy was 22 min (rang:11-31 min).No intraoperative severe complications such as vascular injury,trauma of abdominal organ occurred.There were 5 complications,including 2 cases of hematuria,2 cases of delayed healing of incision,and 1 case of pneumohypoderma.The pathological diagnosis included 40 cases of renal clear cell carcinoma,3 cases of papillary renal cell carcinoma,and 5 cases of angiomyolipomas.No tumor recurrence or distant metastasis was observed during the average follow-up of 17 months (range 3-27 months).Conclusions Off-clamping RAPN is safe and feasible approach to excise certain kidney tumors.It carries the benefits of less complication,quick recovery,and less ischemia reperfusion renal injury.Off-clamping RAPN would be suitable for those patients with solitary kidneys,renal insufficiency,and bilateral tumors.
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Background and purpose:Rs10993994 at 10q11 was found to be associated with prostate cancer risk by genome-wide association studies. This study tried to reveal its mechanism and to explore the role of rs10993994 for the transcriptional activity of microseminoprotein beta (MSMB) gene in prostate cancer cell lines. Methods:Promoter fragments were generated by chemical synthesis. Due to the two possibility of rs10993994 (T/C) in the region, we generated two promoter fragments: MSMB promoter-T and MSMB promoter-C. The fragments were then cloned into pGL3-basic vectors, positive clones were transfected into prostate cancer cell lines PC-3 and LNCaP, ifnally, relative level of lfuorescence was detected by lfuoresce detector.Results:We generated two promoter fragments of MSMB, MSMB promoter-T and MSMB promoter-C. The two promoter fragments were cloned with pGL3-basic vectors to pGL3-MSMB promoter-T and pGL3-MSMB promoter-C. In PC-3, the relative level of lfuorescence of pGL3-MSMB promoter-C was signiifcant higher than that of pGL3-MSMB promoter-T(2.27±0.39vs 0.57±0.13,P<0.05); In LNCaP, the relative level of lfuorescence of pGL3-MSMB promoter-C was signiifcant higher than that of pGL3-MSMB promoter-T (1.70±0.32vs 0.37±0.09,P<0.05).Conclusion:The transcriptional activity of pGL3-MSMB promoter-C was stronger than that of pGL3-MSMB promoter-T. Rs10993994 could inlfuence the transcriptional activity ofMSMB gene promoter in prostate cancer cell lines PC-3 LNCaP, allele C in rs10993994 could facilitate transcription than T.
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Objective To investigate the relationship between non muscle-invasive bladder can-cer and polymorphisms of DNA repair genes among Han nationality in Shanghai. Methods From January 2006 to June 2008, 94 patients with non muscle-invasive bladder cancer and 304 controls were enrolled. Known single nucleotide polymorphism(SNP) in the XPC, XPG, XRCC1 genes were detec-ted by TaqMan real-time PCR. After adjusted for age, sex, and smoking, interaction effects of the genotypes and non muscle-invasive bladder cancer risk, genotypes and clinical and pathological features of bladder cancer were analyzed using unconditional Logistic regression. Results After adjusted for age, sex, and smoking, the XPC 939 Lys/Gln, XPC 939Gin/Gin genotype and XPG 1104 Asp/His, XPG 1104 His/His genotype were more frequent in patients with non muscle-invasive bladder cancer, adjusted OR=1.89, 95%CI 1.14-3. 23 and OR=1.07,95%CI 0.86-1.87, respectively. The XRCC1 Arg399Gln polymorphisms were not significantly associated with non muscle-invasive bladder cancer, adjusted OR= 1.15, 95% CI 0.55-2.40. There were no significant associations between tumor clinical and pathological features in patients who possessed either the XPC or XPG polymor-phisms (P>0.05). Conclusion XPC Lys939Gln and XPG Asp1104His may modulate non muscle-invasive bladder cancer risk among Han nationality in Shanghai.
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Objective To investigate the effect of tissue factor pathway inhibitor-2(TFPI-2)on invasiveness and apoptosis of renal cell carcinoma,to analysis the relationship between promoter methylation and expression of TFPI-2.Methods Immunohistochemistry,Western blot and real-time RT-PCR were performed to detect the expression of TFPI-2 in 37 renal cell carcinoma tissues and 11 normal kidney tissues.TUNEL was used tO study the apoptosis status of renal cell carcinoma.Real-time methylation specific PCR was performed to analysis the methylation status of TFPI-2 gene promoter.Results The optical density of Western-blot strip in renal cell carcinoma and normal kidnev was 0.92±0.36,1.6l±0.13.The relative expression of TFPI-2 mRNA in renal cell carcinoma and normal kidney was 0.0019±0.0011,0.0065±0.0008.Compared with normal kidney,lower expression of TFPI-2 was detected in renal cell carcinoma.The correlation between expression of TFPI-2 and stage of renal cell carcinoma was negative.Apoptosis index of renal cell carcinoma specimens was 2.41%(TFPI-2 expression:grade 1),3.90%(TFPI-2 expression:grade 2),6.78%(TFPI-2 expression:grade 3),9.57%(TFPI-2 expression:grade 4).The expression of TFPI-2 was positively correlated with the apoptosis index of renal cell carcinoma.The relative expression of TFPI-2 mRNA in methylated and unmethylated tumors was 0.0015±0.0011,0.0024±0.0009.The optical densitv of Western-blot strip in methylated and unmethylated tumors was 0.82±0.35,1.04±0.34.Expressions of TFPI-2 mRNA and protein were significantly lower in methylated tumors than those in unmethylated tumors.Conclusions The expression of TFPI-2 is negatively correlated with the invasiveness of renal cell carcinoma.Overexpression of TFPI-2 may induce tumor cell apoptosis in renal cell carcinoma.Lower expression of TFPI-2 in renal cell carcinoma is partially due to hypermethylation of gene promoter.
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Purpose：To evaluate the use of transrectal ultrasonography in diagnosis of prostate cancer.Methods：A high-frequency probe was used to examine 56 cases of prostate cancer transrectally and the sonographic features were analyzd. Results：On Trus image lesions were located in peripheral zone in 48(76.8%), transition zone in 8 (14.3%),and central zone in 5 (8.9%). 45 cases (80.4%) of the prostate cancer were hypoechoic,4(7.1%) were hyperechoic, 5(8.9%) had mixed echogenicity and 2 (3.6%)showed isoechoic appearance. Indirect signs represented prostatic asymmetry,intermittent capsular and dilation or disappear of the seminal vesicles.Conclusions：TRUS is imperative in the diagnosis and staging of prostate cancer.
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100 ml) in 14 cases (12.7%).Postoperative short-term (within 1 month) complications included dysuria in 9 cases (8.2%),urinary reten-tion in 1(0.9%), de novo urgency and frequency in 12(10.9%).Long-term (after 6 months) complica-tions consisted of suprapubic discomfort in 8 cases (7.3%),urinary difficulty in 2(1.8%), frequency andurgency in 3(2.7%).No tape erosion or pelvic hematoma was found. Only 1 patient underwent the secondprocedure to cut off the tape due to repeated urinary retention. Conclusions TVTprocedure is effective,safe, minimally invasive for the management of female stress urinary incontinence.
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Objective To study the diagnosis and treatment of coincident vesical transitional cell carcinoma and prostatic cancer. Methods 8 cases of coincident vesical transitional cell carcinoma and prostatic cancer were evaluated clinically. Results All the 8 were diagnosed as vesical transitional cell carcinoma on cystoscopy and biopsy.Whereas on needle biopsy of the prostate,prostatic cancer was diagnosed in 7 and BPH in 1 but turned to be prostatic cancer on pathological study after cystoprostatectomy.4 patients underwent transurethral resection of the bladder cancer and bilateral orchiectomy with bladder instillation of MMC or BCG and oral flutamide for prostatic cancer.1 patient underwent partial cystectomy,bilateral orchiectomy and external radiotherapy for prostatic cancer.3 underwent radical cystoprostatectomy.2 cases were lost to follow up.In the other 6,3 survived less than 1 year because of wide metastasis.The other 3 have been followed up for 1.5 to 4.0 years,remained well and tumor free. Conclusions PSA detection together with rectal palpation,biopsy,transrectal ultrasonography and cystoscopy played the important role in the diagnosis of coincident vesical transitional cell carcinoma and prostatic cancer.Radical cytoprostatectomy yields a better outcome.
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0.05 ).The detection rate of IRC by B-ultrasound accounted for 98.2%(108/110).The rate of surgical excision in IRC was 92.2%(107/116).Stage Ⅰ to Ⅱ lesions were found in 69.0% of the patients with IRC and in 49.3% with CRC.Stage Ⅲ to Ⅳ lesions were found in 31.0% of the patients with IRC and in 50.7% with CRC.Patients were followed up postoperatively for a mean of (45?40) months.The 3- and 5-year cancer specific survival rates were significantly higher in IRC than those in CRC (86.5% and 81.3% vs 70.8 % and 64.2%, P