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Objective: To verify the efficacy and safety of tamsulosin 0.4 mg and tamsulosin 0.2 mg compared with those of placebo in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).Methods: A total of 494 patients from multiple centers participated in this double-blind, randomized, phase 3 trial. Eligible patients were randomly assigned to the tamsulosin 0.4 mg group, tamsulosin 0.2 mg group or placebo group. The International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), post-void residual (PVR) urine volume, blood pressure, heart rate and adverse events were compared among the three groups at 4, 8 and 12 weeks.Results: A total of 494 BPH patients were analyzed. There were no differences in the baseline characteristics among the three groups. After 12 weeks of treatment, total IPSS was improved in the 0.2 mg and 0.4 mg tamsulosin groups; however, the extent of improvement was greater in the 0.4 mg group than in the 0.2 mg group (0.4 mg: -9.59 vs. 0.2 mg: -5.61; least-squares mean difference [95% confidence interval]: -3.95 [-5.01, -2.89], p < .0001). In addition, in the patients with severe symptoms (IPSS ≥20), total IPSS was improved the most in the 0.4 mg group (-11.27 ± 5.00, p < .0001). Qmax and PVR were improved in the 0.4 mg and 0.2 mg groups; however, the differences were not statistically significant between treatment groups. No patients experienced any serious adverse effects in any of the three groups.Conclusions: Tamsulosin 0.4 mg and 0.2 mg appear to be superior to placebo treatment, and tamsulosin 0.4 mg is more effective than 0.2 mg in terms of total IPSS improvement. Tamsulosin 0.4 mg has favorable efficacy and tolerability in Asian men with symptomatic BPH. ClinicalTrials.gov Identifier: NCT02390882. [ABSTRACT FROM AUTHOR]

A practical process that includes a simple four-step procedure for the preparation of gefitinib (1), a tyrosine kinase inhibitor that targets the epidermal growth factor receptor, is described. Dramatic improvements over previously reported conventional synthetic procedures were achieved. We found effective coupling conditions to minimize the inevitable production of anN-alkylated side product,N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)-N-(3-morpholinopropyl)-quinazoline-4-amine (3) using a transient trimethylsilyl protecting group. We synthesized gefitinib in an 81.1% overall yield from a commercially available starting material on a multigram scale using a route that did not require work-up of any of the reaction steps. [ABSTRACT FROM PUBLISHER]

Objective. Although endoscopic treatment for early gastric cancer (EGC) is an accepted therapy in South Korea and Japan, long-term outcomes remain unknown. We evaluated the clinical outcome of endoscopic submucosal dissection (ESD) for gastric dysplasia and EGC. Material and methods. A total of 402 patients with gastric dysplasia and EGC were treated with ESD at a single hospital from January 2004 to December 2007. The patients underwent ESD and then received periodic endoscopic follow-up and metastatic surveys for 9--49 months (median 30 months). Resectability (en bloc or piecemeal resection), curability (complete or incomplete), local recurrence, and disease-free survival rates were estimated. Results. There were 107 patients with low-grade dysplasia (LGD), 97 with high-grade dysplasia (HGD) and 198 with EGC. In EGC patients, en bloc resection was achieved in 89.7% (177/198), the complete resection rate was 87.9% (174/198), and the local recurrence rate was 5.1% (10/198). Tumor size >20 mm was significantly associated with local recurrence (odds ratio 6.45; 95% CI 1.20--20.11; p=0.001). There were significant correlations between the incidences of a piecemeal or incomplete resection and that of local recurrence (odds ratio 5.23; 95% CI 1.02--18.34; p=0.001; and odds ratio 6.99; 95% CI 1.22--21.65; p=0.002, respectively). The 3-year cancer-free survival rate was 94.9%. Conclusions. Curative treatment with successful en bloc resection can reduce the local recurrence of gastric neoplastic lesions after ESD. Clinical outcome may be excellent, although longer follow-up studies are warranted. [ABSTRACT FROM AUTHOR]

Objective. Endoscopic submucosal dissection (ESD) of gastric neoplasia has been reported to have a higher bleeding rate than conventional endoscopic mucosal resection (EMR). The aim of this study was to identify the risk factors for bleeding associated with ESD. Material and methods. The records of consecutive patients who underwent ESD for gastric adenoma/early gastric cancer were reviewed. Potential risk factors included patient age, lesion size, gross findings, location, and histology of the tumor. The primary end-point was the incidence of immediate or delayed bleeding related to ESD. Results. A total of 144 patients were studied; bleeding occurred in 32 cases (22.2%) with immediate bleeding in 29 cases. Delayed bleeding (3 cases) occurred at day 2 (2 patients) and at day 7 in 1 patient. In all cases of immediate bleeding, immediate hemostatic therapy was successful. The histology of tumor was the only factor that was statistically significantly associated with bleeding (adjusted hazard ratio 6.770, 95% confidence interval 1.830--25.048, p=0.004). Conclusions. The only factor that correlated with an increased risk of bleeding with ESD was the presence of gastric malignancy. We found no factor that would, prospectively, be amenable to prevention of bleeding. [ABSTRACT FROM AUTHOR]