ABSTRACT
Objective To evaluate the efficacy and safety of sorafenib in the treatment of Chi-nese patients with metastatic renal cell carcinoma. Methods This muhicenter phase Ⅱ clinical trial was performed from May 2006 to December 2006. Sixty-two patients with metastatic renal cell carci-noma not suitable for curative treatment were enrolled. All patients received oral sorafenib as single a-gent at the dose of 400 mg twice a day until disease progression or intolerable toxicities occurred. Re-salts Partial responses were recorded as best response in 11 patients, while complete remission was found in 1 patient and stable diseases were found in another 35 patients. According to the intents-to-treatment population, the overall response rate was 19.4% (12/62), and the disease control rate was 77.4%(48/62). The median progression free survival time was 9.6 months with 1-year progression-free survival rate of 41.9%. However, the median survival time had not reached due to the short fol-low-up. The most frequent adverse events included alopecia (66.1%), diarrhea (62.9%), hand-foot syndrome (58.1%), anorexia (40.3%), rash(37.1%), fatigue (37.1%), hypertension (35.5%), hoarseness(32.3%), joint pain (25.8%), hypophosphatemia (21.0%), fever (19.4%), nausea (19.4%), abnormal transeaminase( 11.3% ), elevated total bilirubicin( 16.1% ), leucopenia( 12.9% ), bleeding under nail(16.1%), and gum bleeding(11.3%). Grade 3 adverse events included hand-foot syndrome (16.1%), hypertension (12.9%), diarrhea(6.5%), hypophosphatemia (4.8%), joint pain (3.2%), and leucopenia(3.2%). Conclusions Sorafenib has prominent anti-tumor activity in Chi-nese metastatic renal cell cancer patients with most adverse events being grade 1 or 2. More attention should be paid to hypertension and cardio-cerebral vascular events during the application of sorafenib.
ABSTRACT
Objective To study the efficacy and safety of naftopidil,a new ? 1-adrenoceptor antagonist for treatment of benign prostatic hyperplasia(BPH). Methods A randomized,double-blind,double-simulant,parallel-controlled,multicentral clinical trial was conducted in 224 patients with BPH.Patients of treatment group received naftopidil (25 mg,once a day) and the controls received tamsulosin (0.2 mg,once a day). Results After 6-week therapy,IPSS,quality of life (QOL) score,maximum urinary flow rate (Qmax) and average urinary flow rate(Qave) were significantly improved both in naftopidil group and tamsulosin (control) group.In naftopidil group,IPSS was averagely decreased by 11.03 (P0.05).The clinical adverse event rate was 2.68% in naftopidil group, which was significantly lower than that in tamsulosin group (8.93%,P