目的调查影响我国临床试验质量的主要因素。方法随机选择从2016年3月15日至12月31日在中国临床试验注册中心注册的临床试验,对其中随机对照试验的研究计划书按照"临床随机对照试验计划书制订指南(SPIRIT)",包括对数据管理制...目的调查影响我国临床试验质量的主要因素。方法随机选择从2016年3月15日至12月31日在中国临床试验注册中心注册的临床试验,对其中随机对照试验的研究计划书按照"临床随机对照试验计划书制订指南(SPIRIT)",包括对数据管理制度、原始数据共享声明进行评估。结果从该时间段注册的2 205个试验中按1:4的比例随机抽取了457个试验,其中393个为治疗性的随机对照试验。国家药理基地实施的上市前临床试验研究计划书质量较好,其中4个试验为最高质量(1.02%),21个较好(5.34%)。129个试验(28.23%)描述了正确的数据管理制度,包括使用纸质病例记录表和电子数据收集与管理系统(electronic data capture,EDC);392个试验(85.77%)声明愿共享原始数据。结论临床研究计划书质量低、缺乏专业的数据管理制度是我国很多临床试验的共同问题。我们相信我国大多数临床研究者有很好的学习能力和愿望,这可从多数研究者愿意共享原始数据反映出来。我们建议从三方面为我国临床研究者提供知识教育和技术支撑:①推广普及SPIRIT;②提供标准化数据管理平台;③推广临床试验透明化包括共享原始数据是临床研究伦理要求的理念。展开更多
OBJECTIVE:To evaluate the effect of acupuncture on the quality of life in patients with depression by clinical randomized single-blind placebo-controlled study.METHODS:one hundred and sixty-three cases of depression a...OBJECTIVE:To evaluate the effect of acupuncture on the quality of life in patients with depression by clinical randomized single-blind placebo-controlled study.METHODS:one hundred and sixty-three cases of depression according with the inclusion criteria were randomly divided into a group of acupuncture dredging liver and regulating flow of theosophy(group 1),a group of acupoint shallow stab(group 2)and a group of non-acupoint shallow stab(group 3)at 1∶1∶1 ratio,and treated with acu-puncture,moxibustion,and intradermal embedding of needle,twice a week,for a total of 12 weeks.Scale of Quality of Life(SF-36)was used to measure the scores at four different time points and evaluate the effect of acupuncture on the quality of life of the patients with depression.RESULTS:At each time point after treatment,in scores of the 8 items,physical function,physical role,bodily pain,general physical condition,energy,social function,emotional function and mental health there were statistically significant differences among the 3 groups(P<0.0125).CONCLUSION:Acupuncture can effectively improve the quality of life of patients with depression.展开更多
文摘目的调查影响我国临床试验质量的主要因素。方法随机选择从2016年3月15日至12月31日在中国临床试验注册中心注册的临床试验,对其中随机对照试验的研究计划书按照"临床随机对照试验计划书制订指南(SPIRIT)",包括对数据管理制度、原始数据共享声明进行评估。结果从该时间段注册的2 205个试验中按1:4的比例随机抽取了457个试验,其中393个为治疗性的随机对照试验。国家药理基地实施的上市前临床试验研究计划书质量较好,其中4个试验为最高质量(1.02%),21个较好(5.34%)。129个试验(28.23%)描述了正确的数据管理制度,包括使用纸质病例记录表和电子数据收集与管理系统(electronic data capture,EDC);392个试验(85.77%)声明愿共享原始数据。结论临床研究计划书质量低、缺乏专业的数据管理制度是我国很多临床试验的共同问题。我们相信我国大多数临床研究者有很好的学习能力和愿望,这可从多数研究者愿意共享原始数据反映出来。我们建议从三方面为我国临床研究者提供知识教育和技术支撑:①推广普及SPIRIT;②提供标准化数据管理平台;③推广临床试验透明化包括共享原始数据是临床研究伦理要求的理念。
基金Supported by the Youth Fund Project of Natural Science Foundation of China(Antidepressant Mechanism of Acupuncture Based on Snare Proteins Modulating the Release of Glutamic Acid in Presynaptic NeuronsNo.81303041)+5 种基金the China Postdoctoral Science Foundation(Mechanism Research of Acupuncture on Hippocampal Tripartite Glutamatergic Synapses of Depressive Disorder RatsNo.2012M511784)the Outstanding Young Innovation Foundation of Guangdong Provincial Department of Education(Clinical Research of Acupuncture in the Treatment of Mild to Moderate Depression,No.2012LYM0043)Special Research Foundation of New Teacher Category for the Doctor-al Program of Higher School of National Ministry of Education(the Moderating Effects of Acupuncture for Hippocampal Tripartite Glutamatergic Synapses of Depressive Disorder rats,No.20124425120005)the Special Financial Grant from the China Postdoctoral Science Foundation(the Modulating Effects of Acupuncture for Glutamic Acid in Hippocampal Presynaptic Neurons of Depressive Disorder Rats,No.2013T60793)the Science Foundation of the Postdoctoral Researchers in Guangzhou University of Chinese Medicine from Guangdong Provincial Department of Human Resources and Social Security(Clinical Study on Acupuncture and Moxibustion for Treatment of Depression Based on Patient Reported Outcome Indicators,No.BBK429122K19)
文摘OBJECTIVE:To evaluate the effect of acupuncture on the quality of life in patients with depression by clinical randomized single-blind placebo-controlled study.METHODS:one hundred and sixty-three cases of depression according with the inclusion criteria were randomly divided into a group of acupuncture dredging liver and regulating flow of theosophy(group 1),a group of acupoint shallow stab(group 2)and a group of non-acupoint shallow stab(group 3)at 1∶1∶1 ratio,and treated with acu-puncture,moxibustion,and intradermal embedding of needle,twice a week,for a total of 12 weeks.Scale of Quality of Life(SF-36)was used to measure the scores at four different time points and evaluate the effect of acupuncture on the quality of life of the patients with depression.RESULTS:At each time point after treatment,in scores of the 8 items,physical function,physical role,bodily pain,general physical condition,energy,social function,emotional function and mental health there were statistically significant differences among the 3 groups(P<0.0125).CONCLUSION:Acupuncture can effectively improve the quality of life of patients with depression.
