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1.
R. Jeffrey Karnes Voleak Choeurng Ashley E. Ross Edward M. Schaeffer Eric A. Klein Stephen J. Freedland Nicholas Erho Kasra Yousefi Mandeep Takhar Elai Davicioni Matthew R. Cooperberg Bruce J. Trock 《European urology》2018,73(2):168-175
Background
Risk of prostate cancer-specific mortality (PCSM) is highly variable for men with adverse pathologic features at radical prostatectomy (RP); a majority will die of other causes. Accurately stratifying PCSM risk can improve therapy decisions.Objective
Validate the 22 gene Decipher genomic classifier (GC) to predict PCSM in men with adverse pathologic features after RP.Design, setting, and participants
Men with adverse pathologic features: pT3, pN1, positive margins, or Gleason score > 7 who underwent RP in 1987–2010 at Johns Hopkins, Cleveland Clinic, Mayo Clinic, and Durham Veteran's Affairs Hospital. We also analyzed subgroups at high risk (prostate-specific antigen > 20 ng/ml, RP Gleason score 8–10, or stage > pT3b), or very high risk of PCSM (biochemical recurrence in < 2 yr [BCR2], or men who developed metastasis after RP [MET]).Outcome measurements and statistical analysis
Logistic regression evaluated the association of GC with PCSM within 10 yr of RP (PCSM10), adjusted for the Cancer of the Prostate Risk Assessment Postsurgical Score (CAPRA-S). GC performance was evaluated with area under the receiver operating characteristic curve (AUC) and decision curves.Results and limitations
Five hundred and sixty-one men (112 with PCSM10), median follow-up 13.0 yr (patients without PCSM10). For high GC score (> 0.6) versus low-intermediate (≤ 0.6), the odds ratio for PCSM10 adjusted for CAPRA-S was 3.91 (95% confidence interval: 2.43–6.29), with AUC = 0.77, an increase of 0.04 compared with CAPRA-S. Subgroup odds ratios were 3.96, 3.06, and 1.95 for high risk, BCR2, or MET, respectively (all p < 0.05), with AUCs 0.64–0.72. GC stratified cumulative PCSM10 incidence from 2.8% to 30%. Combined use of case-control and cohort data is a potential limitation.Conclusions
In a large cohort with the longest follow-up to date, Decipher GC demonstrated clinically important prediction of PCSM at 10 yr, independent of CAPRA-S, in men with adverse pathologic features, BCR2, or MET after RP.Patient summary
Decipher genomic classifier may improve treatment decision-making for men with adverse or high risk pathology after radical prostatectomy. 相似文献2.
Zhangqun Ye Guohua Zeng Huan Yang Kun Tang Xiaochun Zhang Hong Li Weibing Li Zhong Wu Lingwu Chen Xingfa Chen Xiankui Liu Yaoliang Deng Tiejun Pan Jinchun Xing Shusheng Wang Yue Cheng Xiaojian Gu Wenxi Gao Hua Xu 《European urology》2018,73(3):385-391
Background
Recent large high-quality trials have questioned the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones.Objective
To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo.Design, setting, and participants
We conducted a double-blind, placebo-controlled study of 3296 patients with distal ureteral stones, across 30 centers, to evaluate the efficacy and safety of tamsulosin.Intervention
Participants were randomly assigned (1:1) into tamsulosin (0.4 mg) or placebo groups for 4 wk.Outcome measurements and statistical analysis
The primary end point of analysis was the overall stone expulsion rate, defined as stone expulsion, confirmed by negative findings on computed tomography, over a 28-d surveillance period. Secondary end points included time to stone expulsion, use of analgesics, and incidence of adverse events.Results and limitations
Among 3450 patients randomized between September 1, 2011, and August 31, 2013, 3296 (96%) were included in the primary analysis. Tamsulosin benefits from a higher stone expulsion rate than the placebo (86% vs 79%; p < 0.001) for distal ureteral stones. Subgroup analysis identified a specific benefit of tamsulosin for the treatment of large distal ureteral stones (>5 mm). Considering the secondary end points, tamsulosin-treated patients reported a shorter time to expulsion (p < 0.001), required lower use of analgesics compared with placebo (p < 0.001), and significantly relieved renal colic (p < 0.001). No differences in the incidence of adverse events were identified between the two groups.Conclusions
Our data suggest that tamsulosin use benefits distal ureteral stones in facilitating stone passage and relieving renal colic. Subgroup analyses find that tamsulosin provides a superior expulsion rate for stones >5 mm, but no effect for stones ≤5 mm.Patient summary
In this report, we looked at the efficacy and safety of tamsulosin for the treatment of distal ureteral stones. We find that tamsulosin significantly facilitates the passage of distal ureteral stones and relieves renal colic. 相似文献3.
Ilana Sebbag Raymond Tang Vit Gunka JagPaul Sahota Himat Vaghadia Andrew Sawka 《Brazilian Journal of Anesthesiology》2018,68(3):280-284
Study objective
The purpose of this study was to assess whether application of dorsal table tilt and body rotation to a parturient seated for neuraxial anesthesia increased the size of the paramedian target area for neuraxial needle insertion.Setting
Labor and Delivery Room.Patients
Thirty term pregnant women, ASA I–II, scheduled for an elective C‐section delivery.Interventions
Lumbar ultrasonography was performed in four seated positions: (F) lumbar flexion; (FR) as in position F with right shoulder rotation; (FT) as in position F with dorsal table‐tilt; (FTR) as in position F with dorsal table‐tilt combined with right shoulder rotation.Measurements
For each position, the size of the ‘target area’, defined as the visible length of the posterior longitudinal ligament was measured at the L3‐L4 interspace.Main results
The mean posterior longitudinal ligament was 18.4 ± 4 mm in position F, 18.9 ± 5.5 mm in FR, 19 ± 5.3 mm in FT, and 18 ± 5.2 mm in FTR. Mean posterior longitudinal ligament length was not significantly different in the four positions.Conclusions
These data show that the positions studied did not increase the target area as defined by the length of the posterior longitudinal ligament for the purpose of neuraxial needle insertion in obstetric patients. The maneuvers studied will have limited use in improving spinal needle access in pregnant women. 相似文献4.
Introduction
Tamsulosin is an α-1A-specific blocker inducing selective relaxation of ureteral smooth muscle and inhibition of ureteral spasms leading to ureteral dilatation that can facilitates retrograde ureterorenoscopy (URS).Objective
To assess the efficacy of tamsulosin in improving the outcome of URS management of lower ureteral stones.Patients and methods
This prospective, randomised, controlled, clinical trial was carried out between June 2011 and December 2014. It included 98 patients with lower ureteral stones scheduled for treatment with URS. Before URS, patients were randomly divided into 2 groups; study group including 51 patients, in which pre-URS daily oral dose of tamsulosin 0.4 mg tab, for 1 week, was given and control group including 47 patients who received no additional therapy rather than standard analgesic on demand. The URS outcomes were evaluated and compared between both groups.Results
The demographic and stone characteristics were comparable between both groups. The mean URS time was significantly shorter in study group than in control group (52.0 ± 14.9 min vs. 71.0 ± 17.3 min; p = 0.039). Of the 98 patients, 89 (90.81%) had a successful URS procedures. The success rate was 94.1% (98/51) in study group compared 89.2% (58/65) in the control group, with statistically significant difference (p = 0.045). The major complications occurred in 4.25% of patients in control group but in only 1.96% of those received tamsulosin (p = 0.034).Conclusion
Post-tamsulosin ureteroscopy was easier and safer; leading to significantly increased stone-free rates and fewer complications. 相似文献5.
Karl H. Pang Ruth Groves Suresh Venugopal Aidan P. Noon James W.F. Catto 《European urology》2018,73(3):363-371
Background
Multimodal enhanced recovery after surgery (ERAS) regimens have improved outcomes from colorectal surgery.Objective
We report the application of ERAS to patients undergoing radical cystectomy (RC).Design, setting, and participants
Prospective collection of outcomes from consecutive patients undergoing RC at a single institution.Intervention
Twenty-six components including prehabilitation exercise, same day admission, carbohydrate fluid loading, targeted intraoperative fluid resuscitation, regional local anaesthesia, cessation of nasogastric tubes, omitting oral bowel preparation, avoiding drain use, early mobilisation, chewing gum use, and audit.Outcome measurements and statistical analysis
Primary outcomes were length of stay and readmission rate. Secondary outcomes included intraoperative blood loss, transfusion rates, survival, and histopathological findings.Results and limitations
Four hundred and fifty-three consecutive patients underwent RC, including 393 (87%) with ERAS. Length of stay was shorter with ERAS (median [interquartile range]: 8 [6–13] d) than without (18 [13–25], p < 0.001). Patients with ERAS had lower blood loss (ERAS: 600 [383–969] ml vs 1050 [900–1575] ml for non-ERAS, p < 0.001), lower transfusion rates (ERAS: 8.1% vs 25%, chi-square test, p < 0.001), and fewer readmissions (ERAS: 15% vs 25%, chi-square test, p = 0.04) than those without. Histopathological parameters (eg, tumour stage, node count, and margin state) and survival outcomes did not differ with ERAS use (all p > 0.1). Multivariable analysis revealed ERAS use was (p = 0.002) independently associated with length of stay.Conclusions
The use of ERAS pathways was associated with lower intraoperative blood loss and faster discharge for patients undergoing RC. These changes did not increase readmission rates or alter oncological outcomes.Patient summary
Recovery after major bladder surgery can be improved by using enhanced recovery pathways. Patients managed by these pathways have shorter length of stays, lower blood loss, and lower transfusion rates. Their adoption should be encouraged. 相似文献6.
Massimiliano Spaliviero Nicholas E. Power Katie S. Murray Daniel D. Sjoberg Nicole E. Benfante Melanie L. Bernstein James Wren Paul Russo Jonathan A. Coleman 《European urology》2018,73(1):53-59
Background
Mannitol is currently used as a renal protective agent to mitigate the effects of renal ischemia during nephron-sparing surgery (NSS). This routine practice lacks rigorous methodological study.Objective
To assess the effect on renal function outcomes after surgery of mannitol infusion prior to renal ischemia during NSS.Design, setting, participants
This prospective, randomized, placebo-controlled, double-blind trial included 199 patients with a preoperative estimated glomerular filtration rate (eGFR) >45 ml/min/1.73m2 scheduled for NSS; the trial was conducted between July 2012 and July 2015.Intervention
Patients undergoing NSS were randomized to receive mannitol (12.5 g) or placebo intravenously within 30 min prior to renal vascular clamping.Outcome measurements and statistical analysis
The primary outcome was the difference in eGFR (renal function) between the two groups at 6 mo following surgery assessed with an analysis of covariance model using preoperative eGFR, treatment group, and surgical approach as covariates.Results and limitations
At baseline, the median age of the patients was 58 yr, and the median eGFR was 88 ml/min/1.73m2. Comparing placebo with mannitol infusion, the adjusted difference of 0.2 eGFR units at 6 mo was not significant (p = 0.9), with the upper bound of the 95% confidence interval (–3.1 to 3.5) excluding a clinically relevant effect of mannitol. Limitations include evaluation of a single mannitol dose and patients all had excellent preoperative renal function.Conclusions
Intraoperative 12.5 g mannitol infusion during NSS has no demonstrable clinical benefit when compared with standardized fluid hydration in patients with normal preoperative renal function, and its use in this setting is not warranted.Patient summary
In this randomized trial, patients with normal kidney function who received mannitol during surgery to remove part of their kidney had no better kidney function 6 mo after surgery than those who did not receive mannitol. We conclude that this routine practice should be discontinued. 相似文献7.
Brent K. Hollenbeck Samuel R. Kaufman Phyllis Yan Lindsey A. Herrel Tudor Borza Florian R. Schroeck Bruce L. Jacobs Ted A. Skolarus Vahakn B. Shahinian 《European urology》2018,73(4):491-498
Background
Prostate cancer treatment is a significant source of morbidity and spending. Some men with prostate cancer, particularly those with significant health problems, are unlikely to benefit from treatment.Objective
To assess relationships between financial incentives associated with urologist ownership of radiation facilities and treatment for prostate cancer.Design, setting, and participants
A retrospective cohort of Medicare beneficiaries with prostate cancer diagnosed between 2010 and 2012. Patients were further classified by their risk of dying from noncancer causes in the 10 yr following their cancer diagnosis by using a mortality model derived from comparable patients known to be cancer-free.Intervention
Urologists were categorized by their practice affiliation (single-specialty groups by size, multispecialty group) and ownership of a radiation facility.Outcome measurements and analysis
Use of intensity-modulated radiation therapy (IMRT) and use of any treatment within 1 yr of diagnosis. Generalized estimating equations were used to adjust for patient differences.Results
Among men with newly diagnosed prostate cancer, use of IMRT ranged from 24% in multispecialty groups to 37% in large urology groups (p < 0.001). Patients managed in groups with IMRT ownership (n = 5133) were more likely to receive IMRT than those managed by single-specialty groups without ownership (43% vs 30%, p < 0.001), regardless of group size. Among patients with a very high risk (> 75%) of noncancer mortality within 10 yr of diagnosis, both IMRT use (42% vs 26%, p < 0.001) and overall treatment (53% vs 44%, p < 0.001) were more likely in groups with ownership than in those without, respectively.Conclusions
Urologists practicing in single-specialty groups with an ownership interest in radiation therapy are more likely to treat men with prostate cancer, including those with a high risk of noncancer mortality.Patient summary
We assessed treatment for prostate cancer among urologists with varying levels of financial incentives favoring intervention. Those with stronger incentives, as determined by ownership interest in a radiation facility, were more likely to treat prostate cancer, even when treatment was unlikely to provide a survival benefit to the patient. 相似文献8.
9.
Sophie Maria Pierrette Nieuwendijk Iris Johanne de Korte Mereille Marren Pursad Monique van Dijk Heinz Rode 《Burns : journal of the International Society for Burn Injuries》2018,44(5):1151-1158
Background
Pruritus is a common problem seen in the healing process of a burn wound and gives great discomfort for the patient. Most research in this field has been done in the adult population, so evidence in the pediatric population is still lackingPurpose
The aims of this study were to assess the incidence and severity of post-burn pruritus, identify predictors for pruritus and evaluate the pharmacological treatments in a pediatric setting.Methods
Pruritus was assessed in this prospective observational study using a numeric rating scale and the Itch Man Scale applied by the patients’ caregiver. The predictive values of candidate predictors for pruritus were compared using Fisher exact tests and Kruskal–Wallis tests.Results
413 patients were included in this study. Pruritus was reported in 71.7% of the patients. Complete symptom relief was only achieved in 29.8% of the patients who used medication. Time since burn (p < 0.001), depth of the injury (p = 0.017), TBSA burned (p = 0.001) and skin grafting (p = 0.001) were found to be significant predictors for post-burn pruritus.Conclusion
Post-burn pruritus is still a highly prevalent problem in pediatric burn care. Its intensity and frequency are higher especially in the first three months or with a deeper wound or a higher TBSA. 相似文献10.
Sarah-Claude Provençal Suzie Bond Elie Rizkallah Ghassan El-Baalbaki 《Burns : journal of the International Society for Burn Injuries》2018,44(8):1870-1881
Background
Evidence from clinical trials suggests psychological interventions should be considered as an adjunct to medications.Objective
The purpose of this systematic review and meta-analysis was to evaluate the effectiveness of clinical hypnosis on pain, anxiety and medication needs during wound care in adults suffering from a burn injury.Data sources
Medline, PsychINFO, CINAHL, Embase, ISI, SCOPUS, Cochrane, and Proquest databases were searched for randomized controlled trials comparing hypnosis to other interventions during dressing change in adult patients.Data synthesis
Two independent reviewers extracted relevant articles and assessed their methodological quality. Only six studies met the inclusion criteria and were described in detail. Available data was pooled with Revman 5.3.Results
For the primary outcome, we found a statistically significant difference in pain intensity ratings favoring hypnosis (MD = ?8.90, 95% CI ?16.28, ?1.52). For the secondary outcomes, there was a statistically significant difference in anxiety ratings favoring hypnosis (MD = ?21.78, 95% CI ?35.64, ?7.93) and no difference in medication usage (MD = ?0.07, 95% CI ?0.32, 0.17).Conclusion
These results suggest that hypnosis reduces pain intensity and anxiety ratings in adults undergoing burn wound care. However, because of the limitations discussed, clinical recommendations are still premature. 相似文献11.
Sam J. Egger Ross J. Calopedos Dianne L. O’Connell Suzanne K. Chambers Henry H. Woo David P. Smith 《European urology》2018,73(6):859-867
Background
Long-term psychological well-being and quality-of-life are important considerations when deciding whether to undergo active treatment for low-risk localised prostate cancer.Objective
To assess the long-term effects of active surveillance (AS) and/or watchful waiting (WW) on psychological and quality-of-life outcomes for low-risk localised prostate cancer patients.Design, setting, and participants
The Prostate Cancer Care and Outcome Study is a population-based prospective cohort study in New South Wales, Australia. Participants for these analyses were low-risk localised prostate cancer patients aged <70 yr at diagnosis and participated in the 10-yr follow-up.Outcome measurements and statistical analysis
Validated instruments assessed outcomes relating to six health-related quality-of-life and nine psychological domains relevant to prostate cancer patients. Adjusted mean differences (AMDs) in outcome scores between prostate cancer treatment groups were estimated using linear regression.Results and limitations
At 9–11 yr after diagnosis, patients who started AS/WW initially had (1) higher levels of distress and hyperarousal than initial radiation/high-dose-rate brachytherapy patients (AMD = 5.9; 95% confidence interval or CI [0.5, 11.3] and AMD = 5.4; 95% CI [0.2, 10.5], respectively), (2) higher levels of distress and avoidance than initial low-dose-rate brachytherapy patients (AMD = 5.3; 95% CI [0.2, 10.3] and AMD = 7.0; 95% CI [0.5, 13.5], respectively), (3) better urinary incontinence scores than initial radical prostatectomy patients (AMD = –9.1; 95% CI [–16.3, –2.0]), and (4) less bowel bother than initial radiation/high-dose-rate brachytherapy patients (AMD = –16.8; 95% CI [–27.6, –6.0]). No other significant differences were found. Limitations include participant attrition, inability to assess urinary voiding and storage symptoms, and nonrandom treatment allocation.Conclusions
Notwithstanding some long-term differences between AS/WW and various active treatment groups in terms of distress, hyperarousal, avoidance, urinary incontinence, and bowel bother, most long-term outcomes were similar between these groups.Patient summary
This study assessed the long-term psychological and quality-of-life impacts of initially monitoring rather than actively treating low-risk prostate cancer. The results suggest that initial monitoring rather than active treatment has only a minor impact on subsequent long-term psychological and quality-of-life outcomes. 相似文献12.
Alejandra Bravo-Molina José Patricio Linares-Palomino Blanca Vera-Arroyo Luis Miguel Salmerón-Febres Eduardo Ros-Díe 《Foot and Ankle Surgery》2018,24(1):60-64
Background
The aim of this cohort study was to assess the inter-observer agreement of three diabetic foot classification systems: the Wagner, the University of Texas and the PEDIS.Methods
We included 250 consecutive patients diagnosed of diabetic foot syndrome in 2009–2013. Wound scores were recorded at admission and a reevaluation was performed simultaneously or 24 h later by a different evaluator. Demographical, laboratory data and associated risk factors were obtained from the patients’ medical records.Results
The Kappa coefficient showed a moderate inter-observer agreement between the first evaluation and the reevaluation for Wagner scale (Kappa = 0.55; 95% CI: 0.507–0.593), University of Texas scale (Kappa = 0.513; 95% CI: 0.463–0.563) and for PEDIS scale (Kappa = 0.574; 95% CI: 0.522–0.626).Conclusions
This moderate agreement shows that these scales should not be used alone for management decisions regarding diabetic foot syndrome and should, therefore, be integrated with other clinical data to ensure an adequate handover. 相似文献13.
Farrukh Aslam Khalid Usman Khalid Farooq Muhammad Saleem Jibran Rabbani Muhammad Amin Kamal Uddin Khan Younas Mehrose Moazzam N. Tarar 《Burns : journal of the International Society for Burn Injuries》2018,44(6):1489-1495
Background
The ear is the common site for keloid formation especially in women after ear piercing. Surgery is the main stay of treatment in these lesions but there are large numbers of treatment failures in surgery alone.Objective
The objective of this study was to compare the efficacy of post-excision intralesional 5-fluorouracil/triamcinolone acetonide (5-FU/TAC) and post-excision radiotherapy in the treatment of ear keloids.Study design
A randomized controlled trial.Setting
The study was conducted from May 2014 to January 2015 at Jinnah Burn and Reconstructive Surgery Centre, Allama Iqbal Medical College, Lahore.Subject & methodology
After approval from the hospital ethical committee, 60 patients presented in the outpatient department fulfilling the inclusion criteria were selected and randomly assigned in two groups with the help of the random number table. Patients in group A had excision followed by intralesional 5-FU/TAC injections while patients of group B had excision followed by radiotherapy.Patients were assessed at 6 months after completion of treatment for efficacy (no recurrence within 6 months of treatment).Results
In our study total of 60 patients completed the study, with 30 patients in each group. 7 patients (23.34%) in Group-A and 9 patients (30%) in Group-B were males while 23 patients (76.67%) in Group-A and 21 patients (70%) in Group-B were females i.e. male to female ratio is 1:2.75. Mean age was 31.8 + 6.48 years. The comparison of frequency of efficacy in both groups showed that 73.33% (n = 22) in Group-A and 43.33% (n = 13) in Group-B had efficacy, p value was calculated as 0.01, showing a significant statistical difference.Conclusion
Excision and intralesional 5-FU/TAC is an effective treatment for keloids on the ears. 相似文献14.
Background
Soft tissue release for hallux valgus correction is traditionally performed through a dorsal first web space incision. We performed a single surgeon series review of hallux valgus correction with Scarf ± Akin osteotomy and lateral release using a single medial incision.Methods
192 feet were included. Patient satisfaction survey was conducted at the time of study. Pre-operative and final post-operative radiographic data obtained.Results
All radiological parameters had statistically significant improvement [p < 0.05 for each variable]. Response rate was 71% (completely satisfied 69%, satisfied with minor reservation 14%, satisfied with major reservation 11%, dissatisfied 6%). There was no correlation of any preoperative or postoperative radiographic measure with satisfaction grade. No patient required revision procedure.Conclusions
Single medial incision surgery for hallux valgus correction is a simple, safe and effective technique with very high satisfaction. The results are comparable to traditional two-incision surgery. 相似文献15.
16.
Objective
The aim of this study was to investigate the clinical efficacy of superficial temporal artery-middle cerebral artery anastomosis (STA-MCA) + encephalo-duro-myo-synangiosis (EDMS) in treating ischemic Moyamoya disease (IMD) in adults.Methods
A total of 30 adult patients with IMD were selected to be included in the study; they underwent STA-MCA + EDMS and were followed up for 3 months to 2 years. The digital subtraction angiography findings, modified Rankin scale (mRs) score, and complications of all the patients were compared.Results
Thirty patients successfully completed the surgery. Three patients had postoperative complications (two patients with cerebral infarction on the surgical side and one patient with poor scalp healing). The postoperative morbidity rate was 10%. Angiography conducted at 3 to 6 months postoperatively showed 28 cases of anastomotic patency; the anastomotic patency rate was 93.3%. The mRs scores of the patients’ neurological function 3 months after surgery were lower than those before surgery.Conclusion
STA-MCA + EDMS is effective in treating Moyamoya disease. 相似文献17.
Raju Vaishya Vipul Vijay Kapil Mani K.C. Amit Kumar Agarwal 《Journal of Clinical Orthopaedics and Trauma》2018,9(2):107-111
Introduction
Considering the old age, uncertain life expectancy, co-morbidities and fear of postoperative complications, elderly patients often hesitate to undergo simultaneous bilateral total knee arthroplasty (SBTKA).Materials & methods
A retrospective study of SBTKA in 46 patients (92 knees) of age >70 years done between 2003 and 2012. Mean age was 80.13 ± 5.24 years (range ?70–93 years).Results
74 percent had 1 or more major medical problems. There was a significant improvement of KSS at six months (p value = 0.00).Conclusion
With expected benefits of surgery, SBTKA seems a safe, efficient, and viable procedure for carefully selected elderly patients. 相似文献18.
James T. Kearns Anna V. Faino Lisa F. Newcomb James D. Brooks Peter R. Carroll Atreya Dash William J. Ellis Michael Fabrizio Martin E. Gleave Todd M. Morgan Peter S. Nelson Ian M. Thompson Andrew A. Wagner Yingye Zheng Daniel W. Lin 《European urology》2018,73(5):706-712
Background
Many patients who are on active surveillance (AS) for prostate cancer will have surveillance prostate needle biopsies (PNBs) without any cancer evident.Objective
To define the association between negative surveillance PNBs and risk of reclassification on AS.Design, setting, and participants
All men were enrolled in the Canary Prostate Active Surveillance Study (PASS) between 2008 and 2016. Men were included if they had Gleason ≤3 + 4 prostate cancer and <34% core involvement ratio at diagnosis. Men were prescribed surveillance PNBs at 12 and 24 mo after diagnosis and then every 24 mo.Outcome measurements and statistical analysis
Reclassification was defined as an increase in Gleason grade and/or an increase in the ratio of biopsy cores to cancer to ≥34%. PNB outcomes were defined as follows: (1) no cancer on biopsy, (2) cancer without reclassification, or (3) reclassification. Kaplan–Meier and Cox proportional hazard models were performed to assess the risk of reclassification.Results and limitations
A total of 657 men met inclusion criteria. On first surveillance PNB, 214 (32%) had no cancer, 282 (43%) had cancer but no reclassification, and 161 (25%) reclassified. Among those who did not reclassify, 313 had a second PNB. On second PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no reclassification, and 54 (17%) reclassified. In a multivariable analysis, significant predictors of decreased future reclassification after the first PNB were no cancer on PNB (hazard ratio [HR] = 0.50, p = 0.008), lower serum prostate-specific antigen, larger prostate size, and lower body mass index. A finding of no cancer on the second PNB was also associated with significantly decreased future reclassification in a multivariable analysis (HR = 0.15, p = 0.003), regardless of the first PNB result. The major limitation of this study is a relatively small number of patients with long-term follow-up.Conclusions
Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These findings have implications for tailoring AS protocols.Patient summary
Men on active surveillance for prostate cancer who have a biopsy showing no cancer are at a decreased risk of having worse disease in the future. This may have an impact on how frequently biopsies are required to be performed in the future. 相似文献19.
Masaki Yoshida Masayuki Takeda Momokazu Gotoh Shinji Nagai Takafumi Kurose 《European urology》2018,73(5):783-790
Background
Vibegron is a novel, potent, and selective β3-adrenoreceptor agonist for the treatment of patients with overactive bladder (OAB).Objective
To evaluate the efficacy and safety of vibegron versus placebo in Japanese OAB patients.Design, setting, and participants
Patients with OAB entered a 2-wk placebo run-in phase. Once eligibility (≥8 micturition/d and either ≥1 urgency episodes/d or ≥1 urgency incontinence episodes/d) was confirmed, patients entered a 12-wk double-blind treatment phase. The anticholinergic imidafenacin was used as an active reference.Intervention
A total of 1232 patients were randomly assigned to one of the four 12-wk treatment groups: vibegron (50 mg or 100 mg once daily), placebo, or imidafenacin (0.1 mg twice daily).Outcome measurements and statistical analysis
The primary endpoint was change in the mean number of micturitions/d at wk 12 from baseline. The secondary endpoints were changes from baselines in OAB symptom variables (daily episodes of urgency, urgency incontinence, incontinence, and nocturia, and voided volume/micturition). Quality of life (QoL) and safety were assessed. A constrained longitudinal data analysis model was used for analysis of efficacy.Results and limitations
Patients taking vibegron 50 mg and 100 mg orally for 12 wk had significant improvements over the placebo in the primary and secondary endpoints. The proportions of patients with normalization of micturition, resolution of urgency, urgency incontinence, and incontinence were significantly greater than placebo. Vibegron significantly improved QoL, with high patient satisfaction. Incidences of drug-related adverse events with vibegron 50 mg and 100 mg were 7.6%, 5.4%, similar to placebo (5.1%), and less than imidafenacin (10.3%). Treatment was for just 12 wk and a long-term study is needed.Conclusions
The 12-wk treatment with vibegron is effective and well tolerated in patients with OAB.Patient summary
This randomized study demonstrated that vibegron is clinically useful for treatment of patients with OAB.Trial registration ?JapicCTI-152936. http://www.clinicaltrials.jp/user/cteDetail.jsp. 相似文献20.
Joaquin Mateo Heather H. Cheng Himisha Beltran David Dolling Wen Xu Colin C. Pritchard Helen Mossop Pasquale Rescigno Raquel Perez-Lopez Verena Sailer Michael Kolinsky Ada Balasopoulou Claudia Bertan David M. Nanus Scott T. Tagawa Heather Thorne Bruce Montgomery Suzanne Carreira Johann S. de Bono 《European urology》2018,73(5):687-693