[The design and baseline characteristics of a phase III study to evaluate the efficacy and safety of alogliptin versus placebo in type 2 diabetes mellitus in Mainland China].

OBJECTIVE: To assess the design and the Mainland China subgroup baseline characteristics of the study to evaluate the efficacy and safety of alogliptin versus placebo in subjects with type 2 diabetes (T2DM) as monotherapy, add-on to metformin or add-on to pioglitazone. METHODS: This was a multi-center, randomized, double-blind, placebo-controlled, 16-week study comparing alogliptin (ALO, 25 mg, 1/d) versus placebo (PLA) as monotherapy (A), add-on to metformin (B) or add-on to pioglitazone ± metformin (C). The T2DM subjects with glycosylated hemoglobin A1c(HbA1c) between 7% and 10% and aged between 18 years and 75 years were enrolled and randomized to the alogliptin group and the placebo group in 1: 1 ratio with 16 weeks treatment. All patients were followed up every 4 weeks. The safety endpoints consisted of the incidence of hypoglycemia and other adverse events. RESULTS: A total of 491 patients were enrolled in the Mainland China subgroup of the study (181 in group A, 186 in group B and 124 in group C). In each treatment group, the baseline characteristics including age, gender, body mass index, diabetes duration, HbA1c, fasting plasma glucose, body weight, daily dosage of metformin and daily dosage of pioglitazone were all well balanced. CONCLUSION: The demographic data, medical history, glycemic profile and treatment regimen at baseline in Mainland China subgroup are well balanced. The result of this study will provide the clinical evidence for the use of alogliptin in Chinese T2DM patients.

[Primary cutaneous T-cell lymphoma of the penis complicated by Fournier gangrene: a case report].

OBJECTIVE: To explore the clinical presentation, pathologic characteristics, diagnosis and treatment of cutaneous T-cell lymphoma of the penis. METHODS: A 49-year-old man presented with painful swelling and inflammation of the foreskin, failed to respond to antibiotic treatment and dorsal incision, and was instead complicated by Fournier gangrene. Then he underwent debridement and pathological examination. RESULTS: Pathological results indicated cutaneous T-cell lymphoma of the penis. Immunohistochemistry showed CD3 and CD45 RO to be positive, but CD30, CD79a, CD20 and HMB negative. The patient was treated by interferon alpha and ultraviolet B for 2 weeks, followed by total removal of the external genitalia because of necrosis of the corpus spongiosum, which involved the scrotum and right testis on pathological examination. CONCLUSION: Cutaneous T-cell lymphoma of the penis is a rare condition and easily mis diagnosed in the early phase. Definitive diagnosis depends on pathological study.

[Change of nerve growth factor mRNA in human detrusor in bladder outlet obstruction with benign prostatic hyperplasia and their implication].

OBJECTIVE: To investigate the change of nerve growth factor (NGF) mRNA in human detrusor in bladder outlet obstruction (BOO) with benign prostatic hyperplasia (BPH) and their implication. METHODS: Eight cases of bladder cancer and 40 patients with BPH were included in this study. All patients were divided into three groups, a control group, an obstructive detrusor stability group and an obstructive detrusor instability group. NGF mRNA in detrusor from all patients was measured using a RT-PCR. RESULTS: The RT-PCR study indicated that NGF mRNA was expressed in detrusor of three groups of patients. There were significant differences among the three groups (P < 0.01). The expression of NGF mRNA in the obstructive instability group was higher than that in the obstructive stability group and in the control group. The NGF mRNA level in the obstructive stability group was higher than that in the control group. CONCLUSION: The expression of NGF mRNA in detrusor was elevated in BOO with BPH. The elevated expression of NGF mRNA might be correlated with detrusor instability (DI) due to BOO.

[Association of uPA and uPAR expression with invasive behaviors of urinary transitional cell carcinoma].

BACKGROUND & OBJECTIVE: Urokinase-type plasminogen activator (uPA)/its receptor (uPAR), serine protease system, plays a key role in the degradation of extracellular matrix and basement membranes, and intensifying the tumor invasion. The study was designed to investigate the expression of uPA and uPAR in urinary transitional cell carcinoma. The correlation between their expression and tumor invasion was evaluated. METHODS: The expression and localization of uPA and uPAR were examined among 50 cases of renal pelvic and ureter carcinoma and 40 cases of bladder cancer using the PicTure(TM) current type of immunohistochemical two-step method. RESULTS: The normal pelvic, ureter, and bladder did not express uPA and uPAR. The positive expression of uPA and uPAR were concentrated in tumor tissues compared with that in the adjacent tissues. The positive rates of uPA and uPAR expressed the tissues were 33.33% and 50.00% in G1 grade; 88.47% and 96.15% in G3 grade; 37.50% and 50.00% in Ta-T1 tissues; 100.0% and 100.0% in T4 tissues, respectively. The positive rates of uPA and uPAR expression in tumor tissues with higher grade and stage were obviously increased (P< 0.05); meanwhile, there were close correlation between uPA and uPAR (rs=0.979). CONCLUSION: The co-expression of uPA and uPAR was one of the characteristics of urinary transitional cell carcinoma and significantly correlated with tumor stage and grade.

[The expression of urokinase-type plasminogen activator and its receptor in urinary transitional cell carcinoma].

OBJECTIVE: To probe into the expression and clinical significance of urokinase-type plasminogen activator (uPA) and its receptor (uPAR) in urinary transitional cell carcinoma. METHODS: Expression of uPA and uPAR were detected in 50 cases of renal pelvis and ureter carcinoma and 40 cases of bladder cancer immunohistochemically. RESULTS: The positive rates of uPA and uPAR were closely correlated to the grade and the stage of urinary transitional cell carcinoma (r = 0.979, P < 0.01), whereas uPA and uPAR were not detected in normal kidney, ureter and bladder tissue. CONCLUSION: uPA and uPAR are highly expressed in urinary transitional cell carcinoma and they may be responsible for the tumor invasion and metastasis.