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谈生命伦理学在医学人体试验中应用的特殊性 被引量:1
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作者 陈玲 刘延 +1 位作者 刘珺 孙玮 《中国医药导报》 CAS 2011年第36期5-6,共2页
为探讨生命伦理学在医学人体试验中的具体应用有其特殊性,说明不能照搬医疗中的自主性原则。本文对临床盲试伦理进行具体分析,发现医学人体试验中的自主性原则应注重受试者的自主决定权而不是知情权;同时,鉴于医学人体试验旨在促进医学... 为探讨生命伦理学在医学人体试验中的具体应用有其特殊性,说明不能照搬医疗中的自主性原则。本文对临床盲试伦理进行具体分析,发现医学人体试验中的自主性原则应注重受试者的自主决定权而不是知情权;同时,鉴于医学人体试验旨在促进医学发展和社会进步,社会利益也是医学人体试验伦理应考虑的重要因素。因此,自主性原则与社会利益的兼顾才真正符合医学人体试验的伦理道德。 展开更多
关键词 生命伦理学 医学人体试验 临床盲试 自主性 社会利益
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A double-blind,placebo-controlled study of traditional Chinese medicine sarsasapogenin added to risperidone in patients with negative symptoms dominated schizophrenia 被引量:1
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作者 肖世富 薛海波 +4 位作者 李霞 陈超 李冠军 苑成梅 张明园 《Neuroscience Bulletin》 SCIE CAS CSCD 2011年第4期258-268,共11页
Objective To identify whether sarsasapogenin, a sapogenin from the Chinese medicinal herb Anemarrhena Asphodeloides Bunge, would augment the efficacy of risperidone and significantly improve cognitive functions in pat... Objective To identify whether sarsasapogenin, a sapogenin from the Chinese medicinal herb Anemarrhena Asphodeloides Bunge, would augment the efficacy of risperidone and significantly improve cognitive functions in patients with negative symptoms dominated schizophrenia. Methods The trial was a double-blind, placebo-controlled, parallel- group design. The eligible patients were randomized into 2 treatment groups: sarsasapogenin group (sarsasapogenin plus risperidone for 8 weeks, n = 41) and placebo group (risperidone only for 8 weeks, n = 39). At the baseline, as well as at weeks 2, 4 and 8 of treatment, the therapeutic response was measured by using scales including Positive and Nega- tive Symptoms Scale (PANSS), Wechsler Memory Scale (WMS), modified Chinese Wechsler Adult Intelligence Scale (mWAIS), Clinical Global Impression (CGI) and Brief Psychiatry Rating Scale (BPRS). The study period for each subject was 8 weeks and duration of overall trial was 2 years. Results Patients treated with sarsasapogenin plus risperidone demonstrated no statistically significant differences in changes in PANSS, WMS or mWAIS score at the end-point of the trial compared with patients treated with placebo plus risperidone. The incidence of treatment-emergent adverse events in patients treated with sarsasapogenin was not different from that observed in placebo group. Conclusion Sarsasapogenin did not augment the efficacy of risperidone in treating negative symptoms dominated schizophrenia. Sarsasapogenin at a dosage of 200 mg per day added to a flexible dosage of risperidone at 2-4 mg per day is safe and well tolerated by patients with negative symptoms dominated schizophrenia. 展开更多
关键词 SCHIZOPHRENIA SARSASAPOGENIN RISPERIDONE TRIAL DOUBLE-BLIND
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