丙型肝炎病毒（hepatitis C virus,HCV）为黄病毒属的单股正链RNA病毒,主要通过血液传播,慢性化程度高。目前的标准治疗是聚乙二醇干扰素（pegylated IFN-α）联合利巴韦林（ribavirin,RBV）。自1989年首次鉴定出HCV以来[1],HCV的干扰...丙型肝炎病毒（hepatitis C virus,HCV）为黄病毒属的单股正链RNA病毒,主要通过血液传播,慢性化程度高。目前的标准治疗是聚乙二醇干扰素（pegylated IFN-α）联合利巴韦林（ribavirin,RBV）。自1989年首次鉴定出HCV以来[1],HCV的干扰素治疗虽然有缓慢的进展,如长效干扰素的使用,但仍无法摆脱其不良反应多、持续病
毒学应答率（sustained virologic response，SVR）不够高及使用不便等缺点。近几年，丙型肝炎的抗病毒治疗研究突飞猛进。展开更多
Aim:This comparative,open design,phase III study was to assess the non-inferiority of the non-preserved T-Gel 0.1% single dose unit(SDU)versus its preserved multidose(MD)reference.Methods:175 patients with bilateral P...Aim:This comparative,open design,phase III study was to assess the non-inferiority of the non-preserved T-Gel 0.1% single dose unit(SDU)versus its preserved multidose(MD)reference.Methods:175 patients with bilateral POAG or OHT were randomised:87 patients were to receive one drop daily of T-Gel 0.1% MD and 88 patients were to receive one drop daily of T-Gel 0.1% SDU,for a treatment period of 12 weeks.The primary efficacy variable was the change in intraocular pressure(IOP)in the worse eye between the baseline and the last assessment.Subjective and objective ocular signs as well as adverse events were recorded for safety.Global tolerance was assessed by the investigator and by the patient.Results:The mean percentage reduction from baseline IOP was 24% for both treatments groups,which was consistent with previous studies.The safety results were comparable in both treatment groups.Because of gel formulation,mild short lasting episodes of blurred vision occurred for about 20% of patients.The global tolerance assessment reported that both treatments were well tolerated.Conclusion:The overall study results demonstrated that T-Gel 0.1% SDU is not inferior to T-Gel 0.1% MD.展开更多
文摘Aim:This comparative,open design,phase III study was to assess the non-inferiority of the non-preserved T-Gel 0.1% single dose unit(SDU)versus its preserved multidose(MD)reference.Methods:175 patients with bilateral POAG or OHT were randomised:87 patients were to receive one drop daily of T-Gel 0.1% MD and 88 patients were to receive one drop daily of T-Gel 0.1% SDU,for a treatment period of 12 weeks.The primary efficacy variable was the change in intraocular pressure(IOP)in the worse eye between the baseline and the last assessment.Subjective and objective ocular signs as well as adverse events were recorded for safety.Global tolerance was assessed by the investigator and by the patient.Results:The mean percentage reduction from baseline IOP was 24% for both treatments groups,which was consistent with previous studies.The safety results were comparable in both treatment groups.Because of gel formulation,mild short lasting episodes of blurred vision occurred for about 20% of patients.The global tolerance assessment reported that both treatments were well tolerated.Conclusion:The overall study results demonstrated that T-Gel 0.1% SDU is not inferior to T-Gel 0.1% MD.
