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应用恩卡他朋辅助左旋多巴治疗稳定性帕金森病的安慰剂对照双盲研究
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作者 Olanow C.W. Kieburtz K. +1 位作者 stern m. 郭俊 《世界核心医学期刊文摘(神经病学分册)》 2005年第2期61-62,共2页
Background: The catechol O methyltransferase inhibitor entacaponeacts by exte nding the elimination half life of levodopaand is currently approved as an adju nct to levodopa for thetreatment of patients with Parkinson... Background: The catechol O methyltransferase inhibitor entacaponeacts by exte nding the elimination half life of levodopaand is currently approved as an adju nct to levodopa for thetreatment of patients with Parkinson disease (PD) with mo torfluctuations. Objective: To determine if the addition of entacapone administr ation provides benefit to levodopa treated PD patients who have a stable respon se to levodopa and do notexperience motor complications. Design: Prospective, do ubleblind,placebo controlled trial. Setting: Outpatient multicenter study. Pati ents: Female and male patients 30 years or older with idiopathic PD receiving st able doses of levodopa or carbidopa with or without other dopaminergic therapies and who did not experience motor fluctuations were eligible for the study. Main Outcome Measures: Parkinsonian function and quality of life. Results: The addit ion of entacapone did not improve motor scores on the Unified Parkinsons Disea se Rating Scale in levodopa treated PD patients who did not experience motor fl uctuations. The mean ±SE adjusted change between baseline and final treatment v isitwas -0.9±0.35 in the entacapone group and -0.8 ±0.35 in the placebo grou p (P = .83). Significant improvement with entacapone treatment was detected in s everal quality of life measures, including the Parkinson Disease Questionnaire 39, the 36 item Short Form Health Survey, the Parkinsons Symptom Inventory, and investigator and subject Clinical Global Assessments. The drug was well tolerated by patients in this population . Conclusions: The catechol Omethyltransferase inhibitor entacapone, used as an adjunct to levodopa in PD patients who do not experience motor fluctuations, doe s not improve Unified Parkinsons Disease Rating Scale motor scores but does im prove a variety of quality of life measures. 展开更多
关键词 左旋多巴 帕金森病 卡他 安慰剂对照 双盲研究 多巴胺能药物 评分量表 辅助用药 运动功能评分 症状调查
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抗氧化剂治疗慢性丙型肝炎病毒感染:I期临床试验结果
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作者 melhem A. stern m. +2 位作者 Shibolet O. Y. Ilan 陈瑜 《世界核心医学期刊文摘(胃肠病学分册)》 2006年第1期49-50,共2页
Background: The pathogenesis of chronic hepatitis C virus (HCV) infection is associated with a defective host antiviral immune response and intrahepatic oxidative stress. Oxidative stress and lipid peroxidation play m... Background: The pathogenesis of chronic hepatitis C virus (HCV) infection is associated with a defective host antiviral immune response and intrahepatic oxidative stress. Oxidative stress and lipid peroxidation play major roles in the fatty liver accumulation (steatosis) that leads to necro-inflammation and necrosis of hepatic cells. Previous trials suggested that antioxidative therapy may have a beneficial effect on patients with chronic HCV infection. Aims: To determine the safety and efficacy of treatment of chronic HCV patients via a combination of antioxidants. Methods: Fifty chronic HCV patients were treated orally on a daily basis for 20 weeks with seven antioxidative oral preparations (glycyrrhizin, schisandra, silymarin, ascorbic acid, lipoic acid, L-glutathione, and alpha-tocopherol), along with four different intravenous preparations (glycyrrhizin, ascorbic acid, L-glutathione, B-complex) twice weekly for the first 10 weeks, and followed-up for an additional 20 weeks. Patients were monitored for HCV-RNA levels, liver enzymes, and liver histology. Assessment of quality of life was performed using the SF-36 questionnaire. Results: In one of the tested parameters (eg, liver enzymes, HCV PvNA levels, or liver biopsy score), a combination of antioxidants induced a favorable response in 48% of the patients (24). Normalization of liver enzymes occurred in 44% of patients who had elevated pretreatment ALT levels (15 of 34). ALT levels remained normal throughout follow-up period in 72.7% (8 of 11). A decrease in viral load (one log or more) was observed in 25% of the patients (12). Histologic improvement (2-point reduction in the HAI score) was noted in 36.1% of the patients. The SF-36 score improved in 26 of 45 patients throughout the course of the trial (58% of the patients). Treatment was well tolerated by all patients. No major adverse reactions were noted. Conclusions: These data suggest that multi antioxidative treatment in chronic HCV patients is well tolerated and may have a beneficial effect on necro-inflammatory variables. A combination of antiviral and antioxidative therapies may enhance the overall response rate of these patients. 展开更多
关键词 I期临床试验 临床试验结果 抗氧化剂 脂质过氧化反应 氧化应激 肝脏组织学 水飞蓟素 甘草皂苷 抗病
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