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Cerebral mechanism of puncturing at He-Mu point combination for functional dyspepsia: study protocol for a randomized controlled parallel trial 被引量:9
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作者 Shuai Yin Yuan Chen +13 位作者 Du Lei Rui-rui Sun Ting-ting Ma Pei-min Feng Zhao-xuan He Xue-ling Suo Pei-hong Ma Yu-zhu Qu Ke Qiu Miao-miao Jing Qi-yong Gong Fan-rong Liang Jiao Chen Fang Zeng 《Neural Regeneration Research》 SCIE CAS CSCD 2017年第5期831-840,共10页
Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlyin... Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups: the low-He point group(puncturing at Zusanli(ST36)), Mu point group(puncturing at Zhongwan(CV12)), and He-Mu point combination group(puncturing at ST36 and CV12). Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensation and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the neuromechanism by which acupuncture at the He-Mu point combination for functional dyspepsia. Registration: Chinese Clinical Trial Registry, Chi CTR-IOR-15006402. 展开更多
关键词 nerve regeneration DYSPEPSIA acupoint combination acupuncture traditional Chinese medicine neuromechanism functional magnetic resonance imaging clinical trial protocol neural regeneration
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Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China:study protocol of a multicenter randomized controlled trial 被引量:15
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作者 Xue-qing Yu Jian-sheng Li +5 位作者 Su-yun Li Yang Xie Ming-hang Wang Hai-long Zhang Hai-feng Wang Zhi-wan Wang 《Journal of Integrative Medicine》 SCIE CAS CSCD 2013年第2期140-146,共7页
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major public health problem worldwide. Pulmonary rehabilitation (PR) is an established intervention for the management of patients with COPD. Exercise... BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major public health problem worldwide. Pulmonary rehabilitation (PR) is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN: A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline (month 0) and after the study period (month 3). DISCUSSION: It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000. 展开更多
关键词 chronic obstructive pulmonary disease DAOYIN randomized controlled trial study protocol
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Evaluation on the efficacy and safety of Chinese herbal medication Xifeng Dingchan Pill in treating Parkinson's disease: study protocol of a multicenter, open-label, randomized active-controlled trial 被引量:7
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作者 Jie Zhang Yun-zhi Ma Xiao-ming Shen 《Journal of Integrative Medicine》 SCIE CAS CSCD 2013年第4期285-290,共6页
BACKGROUND: Parkinson's disease (PD) is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its compl... BACKGROUND: Parkinson's disease (PD) is a complicated disease, commonly diagnosed among the elderly, which leads to degeneration of the central nervous system. It presently lacks an effective therapy for its complex pathogenesis. Adverse effects from Western drug-based medical intervention prevent long-term adherence to these therapies in many patients. Traditional Chinese medicine (TCM) has long been used to improve the treatment of PD by alleviating the toxic and adverse effects of Western drug-based intervention. Therefore, the aim of this study is to evaluate the efficacy and safety of Xifeng Dingchan Pill (XFDCP), a compound traditional Chinese herbal medicine, taken in conjunction with Western medicine in the treatment of PD patients at different stages in the progression of the disease. METHODS AND DESIGN: This is a multicenter, randomized controlled trial. In total, 320 patients with early- (n = 160) and middle-stage PD (n = 160) will be enrolled and divided evenly into control and trial groups. Of the 160 patients with early-stage PD, the trial group (n = 80) will be given XFDCP, and the control group (n = 80) will be given Madopar. Of the 160 patients with middle-stage PD, the trial group (n = 80) will be given XFDCP combined with Madopar and Piribedil, and the control group (n = 80) will be given Madopar and Piribedil. The Unified Parkinson's Disease Rating Scale scores, TCM symptoms scores, quality of life, change of Madopar's dosage and the toxic and adverse effects of Madopar will be observed during a 3-month treatment period and through a further 6-month follow-up period. DISCUSSION: It is hypothesized that XFDCP, combined with Madopar and Piribedil, will have beneficial effects on patients with PD. The results of this study will provide evidence for developing a comprehensive therapy regimen, which can delay the progress of the disease and improve the quality of life for PD patients in different stages. TRIAL REGISTRATION: This trial has been registered in the Chinese Clinical Trial Registry with the identifer ChiCTR-TRC-12002150. 展开更多
关键词 Parkinson disease LEVODOPA drugs Chinese herbal drug toxicity randomized controlled trial clinical protocols
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Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial 被引量:9
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作者 Jian Liu Chuan-bing Huang +5 位作者 Yuan Wang Gui-qin Xu Yuan-yuan Cheng Yun-xia Feng Lei Liu Ya-jun Qi 《Journal of Integrative Medicine》 SCIE CAS CSCD 2013年第6期428-434,共7页
BACKGROUND: Rheumatoid arthritis (RA), as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does... BACKGROUND: Rheumatoid arthritis (RA), as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN: This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1:1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo (imitation leflunomide). The control group will receive leflunomide and an herbal placebo (imitation Xinfeng Capsule). The American College of Rheumatology (ACR) Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate (ACR20), which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION: The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877. 展开更多
关键词 Xinfeng Capsule rheumatoid arthritis double-blind method PLACEBOS ACRcriteria quality of life randomized controlled trials clinical protocols
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Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial 被引量:9
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作者 Yang Yang Mao Pang +5 位作者 Yu-Yong Chen Liang-Ming Zhang Hao Liu Jun Tan Bin Liu Li-Min Rong 《Neural Regeneration Research》 SCIE CAS CSCD 2020年第8期1532-1538,共7页
Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin... Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019. 展开更多
关键词 clinical study early chronic phase efficacy human umbilical cord mesenchymal stem cell multicenter trial prospective study randomized controlled trial safety spinal cord injury study protocol
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医疗失效模式与效应分析在临床试验方案偏离管理中的应用
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作者 邱博 杨浩天 +5 位作者 杜润璇 宋浩静 孙雪 丁琮洋 白万军 董占军 《医药导报》 CAS 北大核心 2024年第10期1645-1650,共6页
目的规范临床试验的管理,降低方案偏离的发生率,为提高临床试验的质量提供参考。方法运用医疗失效模式与效应分析方法(HFMEA)确定目前方案偏离发生的潜在失效模式,量化并评估失效模式发生频率、严重程度及可探测度,计算风险优先数(RPN)... 目的规范临床试验的管理,降低方案偏离的发生率,为提高临床试验的质量提供参考。方法运用医疗失效模式与效应分析方法(HFMEA)确定目前方案偏离发生的潜在失效模式,量化并评估失效模式发生频率、严重程度及可探测度,计算风险优先数(RPN),提出相应的改进措施,统计分析HFMEA实施前后RPN值,评估改进效果。结果开展HFMEA活动后,14项潜在失效模式的RPN值明显下降(P<0.05);12项潜在失效模式的风险等级下降。HFMEA小组成员在发现问题和解决问题能力、沟通配合等方面得到了显著提高。结论HFMEA活动的实施有助于临床试验方案偏离的管理,可有效降低方案偏离的发生,为提高药物临床试验质量提供经验。 展开更多
关键词 临床试验 方案偏离 医疗失效模式与效应分析
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药物生物等效性临床试验中方案偏离的分析与改进
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作者 陈莹蓉 叶丽冰 +1 位作者 田孟丽 杨水新 《医院管理论坛》 2024年第1期71-73,70,共4页
目的 研究药物生物等效性临床试验实施中发生方案偏离的原因,并探讨解决对策,为提高临床试验质量提供依据。方法 以方案偏离的年度分布、发生率和类别为评价指标,分析造成方案偏离现象的原因,并提出解决对策。结果 2018年1月至2022年12... 目的 研究药物生物等效性临床试验实施中发生方案偏离的原因,并探讨解决对策,为提高临床试验质量提供依据。方法 以方案偏离的年度分布、发生率和类别为评价指标,分析造成方案偏离现象的原因,并提出解决对策。结果 2018年1月至2022年12月湖州市中心医院共开展生物等效性试验项目27个,发生方案偏离项目23个,共计229例次。发生方案偏离的类别主要为血样采集过程(59.40%)、违反试验流程(33.17%)和生物样本管理(7.43%)。结论 建议组建职业化的临床试验人才队伍,建立完善的质量管理体系;研究人员应持续学习和培训,严格遵循GCP原则及试验方案,减少方案偏离的发生。 展开更多
关键词 药物临床实验 生物等效性试验 方案偏离
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药物临床试验815例次方案违背的帕累托图分析
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作者 陈云艳 李晓晖 文娱 《现代医药卫生》 2024年第10期1700-1702,共3页
目的分析药物临床试验的方案违背情况,找出需重点关注的方案违背,并提出解决方案,以保证药物临床试验质量。方法收集2022年1-12月该院815例次药物临床试验方案违背报告数据,包括类别、例数等。采用Excel2007软件进行数据分析,绘制帕累托... 目的分析药物临床试验的方案违背情况,找出需重点关注的方案违背,并提出解决方案,以保证药物临床试验质量。方法收集2022年1-12月该院815例次药物临床试验方案违背报告数据,包括类别、例数等。采用Excel2007软件进行数据分析,绘制帕累托图,明确构成方案违背的主要因素。结果815例次药物临床试验中药物漏服/少服/多服、检查漏查、访视超窗是方案违背的主要因素。导致方案违背的责任主体中61.84%(504/815)为受试者,25.64%(209/815)为研究者。结论药物临床试验实施过程中,需重点关注药物服用情况,检查完整性及访视窗问题,加强研究者及受试者培训,规范药物临床试验管理,提高药物临床试验质量。 展开更多
关键词 方案违背 药物临床试验 帕累托图 质量控制
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药物临床试验中违背方案事件类型分析
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作者 张梦琦 梁欣 +2 位作者 夏瑞 裴宇盛 张亚同 《中国药业》 CAS 2024年第14期13-16,共4页
目的 促进药物临床试验质量的提升。方法 提取医院药物临床试验伦理委员会2019年5月至2023年5月接收的药物临床试验违背方案报告,分析违背方案事件的类型、责任主体、发生时间、产生的影响,并比较国内外申办项目违背方案事件的发生情况... 目的 促进药物临床试验质量的提升。方法 提取医院药物临床试验伦理委员会2019年5月至2023年5月接收的药物临床试验违背方案报告,分析违背方案事件的类型、责任主体、发生时间、产生的影响,并比较国内外申办项目违背方案事件的发生情况。结果 共纳入违背方案报告304份,涉及违背方案事件1 087例次,以受试者筛选入组及方案执行(597例次,54.92%),未按方案用药(305例次,28.06%),试验用药品管理(82例次,7.54%)违背方案事件发生较多,且主要发生于Ⅱ期及Ⅲ期药物临床试验阶段;责任主体主要为受试者(544例次,50.05%)和研究者(344例次,31.65%);产生影响的违背方案事件发生率较低,其中影响受试者安全15例次(1.38%),影响受试者权益和显著影响研究结果均为9例次(0.83%);共涉及108个申办项目,其中国内申办项目较多(97项),国外申办项目中发生知情同意签署、生物样本管理、受试者筛选入组及方案执行的违背方案事件数量均显著少于国内申办项目(P <0.05)。结论 建议机构及申办方加强对研究者《药物临床试验质量管理规范》和试验方案设计的培训,医院药物临床试验伦理委员会需加强对违背方案的监管,从而减少试验过程中违背方案事件的发生,保障受试者的安全和权益,提高药物临床试验质量。 展开更多
关键词 药物临床试验 违背方案事件 伦理审查 责任主体
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百地滋阴丸和参芪益肺丸辅助治疗敏感肺结核患者有效性和安全性:一项全国随机对照多中心临床研究
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作者 王雪钰 石文卉 +3 位作者 李琦 荆玮 初乃惠 聂文娟 《中国防痨杂志》 CAS CSCD 北大核心 2024年第11期1306-1312,共7页
背景:结核病多伴有咳嗽、咳痰、乏力、纳差、消瘦等症状,且一线抗结核药物治疗方案常伴肝肾损伤等不良反应。百地滋阴丸和参芪益肺丸具有减轻结核病症状、抗炎、增强细胞免疫功能和保肝的作用。目前尚无百地滋阴丸和参芪益肺丸辅助一线... 背景:结核病多伴有咳嗽、咳痰、乏力、纳差、消瘦等症状,且一线抗结核药物治疗方案常伴肝肾损伤等不良反应。百地滋阴丸和参芪益肺丸具有减轻结核病症状、抗炎、增强细胞免疫功能和保肝的作用。目前尚无百地滋阴丸和参芪益肺丸辅助一线抗结核治疗方案的研究。方法:本研究采用多中心随机对照临床试验,以新发敏感肺结核患者作为研究对象,随机分为试验组和对照组,两组均接受标准一线抗结核治疗方案,同时,试验组增加百地滋阴丸和参芪益肺丸辅助治疗,旨在通过对比两组患者的症状缓解情况,评估百地滋阴丸和参芪益肺丸作为辅助治疗药物,对接受一线抗结核治疗的新发敏感肺结核患者症状缓解及药物不良反应减轻的效果。讨论:尽管本研究未对两种药物的独立影响作用及长期治疗效应进行分析,但本研究期望通过优化新发敏感肺结核治疗方案以减轻结核病呼吸道和全身症状,以及抗结核化疗不良反应,改善肺结核患者生活质量,以期为临床医生提供更多的有关中药辅助治疗结核病的思路和策略。 展开更多
关键词 结核 临床治疗性研究 中药 临床对照试验 临床方案
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科学性审查视角下研究者发起的临床研究方案撰写问题及对策 被引量:1
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作者 孙健 翁学智 张捷迅 《现代医院》 2024年第2期311-313,316,共4页
研究者发起的临床研究(investigator initiate trial,IIT)项目日益增多,科学、可行、详尽、清晰的研究方案是保证临床试验能够顺利实施,并获得科学、准确和可靠结果的重要前提。文章以北京某三甲医院132项IIT项目科学性审查情况为研究对... 研究者发起的临床研究(investigator initiate trial,IIT)项目日益增多,科学、可行、详尽、清晰的研究方案是保证临床试验能够顺利实施,并获得科学、准确和可靠结果的重要前提。文章以北京某三甲医院132项IIT项目科学性审查情况为研究对象,汇总分析了研究方案撰写中的一些共性问题,涉及立项依据、研究设计类型、纳入排除标准、结局指标和样本量五个方面,同时探讨了以上问题的产生原因及解决对策,以期提高科学性审查的工作效率,促进IIT项目高质量运行。 展开更多
关键词 临床研究 科学性审查 研究方案 研究者发起的临床研究
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Possible effect of blonanserin on gambling disorder:A clinical study protocol and a case report 被引量:1
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作者 Akihiro Shiina Tadashi Hasegawa Masaomi Iyo 《World Journal of Clinical Cases》 SCIE 2021年第11期2469-2477,共9页
BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to t... BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder,new treatment strategies are needed.Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.AIM To investigate if blonanserin,a dopamine D3 receptor antagonist,would be effective in reducing gambling impulses in patients with gambling disorder.METHODS We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder,in which up to 12 mg/d of blonanserin was prescribed for 8 wk.RESULTS A 37-year-old female patient with gambling disorder,intellectual disability,and other physical diseases participated in the pilot study.The case showed improvement of gambling symptoms without any psychotherapy.However,blonanserin was discontinued owing to excessive saliva production.CONCLUSION This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies,but it also carries a risk of adverse effects. Further studies are needed to confirm the findings. 展开更多
关键词 BLONANSERIN Gambling disorder MEDICATION Clinical trial protocol D3 receptor Case report
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注册药物临床试验病理切片管理相关要求对比分析
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作者 潘辛梅 陈勇川 +4 位作者 马攀 谢江川 曹丽亚 张馨 谢林利 《中国药业》 CAS 2024年第15期1-4,共4页
目的 保障受试者的权益,确保临床试验的规范性。方法 收集某院临床试验机构2018年1月至2023年4月立项的肿瘤类临床试验项目,对申办方(外资企业和国有企业)在试验方案和知情同意书中病理切片质量要求、检测后及撤销知情后病理切片处置措... 目的 保障受试者的权益,确保临床试验的规范性。方法 收集某院临床试验机构2018年1月至2023年4月立项的肿瘤类临床试验项目,对申办方(外资企业和国有企业)在试验方案和知情同意书中病理切片质量要求、检测后及撤销知情后病理切片处置措施、知情同意书中未来使用切片的表述情况进行汇总、分析。结果 共35项临床试验项目寄送病理切片,主要集中于呼吸科(11项,31.43%),外资企业和国有企业分别为16项(45.71%)和19项(54.29%)。国有企业和外资企业试验方案中对病理切片质量要求未表述的分别为6项(31.58%)和8项(50.00%),差异无统计学意义(P> 0.05);申办方试验方案和知情同意书中病理切片检测后处置措施未表述的分别为26项(74.29%)和13项(37.14%);知情同意书中未表述未来使用病理切片数据的为20项(57.14%)。结论 试验方案和知情同意书中病理切片质量要求、检测后和撤销知情后处置措施,以及切片数据是否用于未来研究表述均不足,应在注册药物临床试验病理切片管理中明确。同时,加强系统风险管理和过程风险管理,保障病理切片质量,保护我国生物医学发展的战略资源。 展开更多
关键词 临床试验 人类遗传资源 病理切片 试验方案 知情同意书 风险管理
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抗肿瘤药物临床试验方案偏离的原因分析及管理对策探讨
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作者 蒋海静 黄贝贝 葛佳佳 《中国处方药》 2024年第10期59-61,共3页
目的分析抗肿瘤药物临床试验方案偏离的原因,并探讨相应的管理对策。方法选择2021年1月~2023年10月徐州医科大学附属医院进行的药物临床试验560项,回顾性分析抗肿瘤药物临床试验的方案偏离的原因,针对可能的原因制定相应的管理对策。结... 目的分析抗肿瘤药物临床试验方案偏离的原因,并探讨相应的管理对策。方法选择2021年1月~2023年10月徐州医科大学附属医院进行的药物临床试验560项,回顾性分析抗肿瘤药物临床试验的方案偏离的原因,针对可能的原因制定相应的管理对策。结果在560项临床试验方案中,抗肿瘤药物临床试验出现偏离方案231例次,占41.25%,前三位原因分别为:标准操作规程(SOP)不依从(31.60%),检验、检查方式及评估等超窗(27.27%),抗肿瘤药物用法及用量不依从(18.61%)。在抗肿瘤药物临床试验偏离方案危害性评估中,65.80%的试验存在持续违背方案的情况,虽然不属于重大方案违背,但是反复、多次违背方案;26.84%的试验对违规事件不予以纠正。在综合评估中,A级风险28项(占12.12%,需采取相应措施并持续关注)、B级风险140项(占60.61%,需密切关注)、C类风险63项(占27.27%,风险在可控范围内)。结论抗肿瘤药物临床试验中,标准操作规程不依从,检验、检查方式及评估等超窗,抗肿瘤药物用法及用量不依从是导致方案偏离的主要原因。方案偏离的主体包括申办者、研究者、受试者等,且具有诸多危害性,相关部门应引起重视,动态监测项目风险等级取向,提高抗肿瘤药物使用合理性。 展开更多
关键词 抗肿瘤药物 临床试验方案 方案偏离 原因分析 管理对策 风险等级
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口腔医疗器械临床试验方案设计要点的把控
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作者 邱楠 彭寒松 尚姝环 《口腔材料器械杂志》 2024年第2期120-123,共4页
基于口腔医学专业和口腔医疗器械的特点,探讨如何在口腔医疗器械临床试验方案的设计过程中把控纳排标准制定、对照设置、疗效评估、盲法设计、样本量计算等关键点。从口腔医疗器械临床试验起始阶段开始,理清思路,把控设计的要点,提升设... 基于口腔医学专业和口腔医疗器械的特点,探讨如何在口腔医疗器械临床试验方案的设计过程中把控纳排标准制定、对照设置、疗效评估、盲法设计、样本量计算等关键点。从口腔医疗器械临床试验起始阶段开始,理清思路,把控设计的要点,提升设计与实施的连贯性,以期防患于未然,提高临床试验质量。 展开更多
关键词 临床试验 医疗器械 方案设计 口腔医学
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自适应平台试验在临床研究中的应用
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作者 马艳 程千吉 +2 位作者 陆瑶 宁金铃 葛龙 《协和医学杂志》 CSCD 北大核心 2024年第5期1157-1164,共8页
适应性设计以动态调整试验设计、减少资源浪费、提高试验效率等优势突破了新药研发的竞争态势,逐渐满足临床需求。近年来,结合适应性设计的平台试验作为一种创新研究模式,为新药研发增添了动力。本文简要概述适应性设计的研究进展、内... 适应性设计以动态调整试验设计、减少资源浪费、提高试验效率等优势突破了新药研发的竞争态势,逐渐满足临床需求。近年来,结合适应性设计的平台试验作为一种创新研究模式,为新药研发增添了动力。本文简要概述适应性设计的研究进展、内容及特点、设计类型、统计分析方法和案例解读,介绍自适应平台试验的概念、类型及应用,以期为深入探索临床试验和新药研发提供科学参考。 展开更多
关键词 适应性设计 主方案设计 平台试验
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人工智能/机器学习在临床试验中的运用及监管挑战浅析——基于FDA讨论文件、EMA观点文件与利益攸关方视角
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作者 姚立新 吴天贺 《中国食品药品监管》 2024年第1期58-75,共18页
药品开发,必须符合相关法规要求,需要以监管机构制定的行业指南为指针,参考监管机构制定的相关用例。新药获批必须基于临床试验生成的证据。随着生物制药行业的不断发展,临床试验复杂程度增加。单纯依靠增加投入,难以改善临床试验效率,... 药品开发,必须符合相关法规要求,需要以监管机构制定的行业指南为指针,参考监管机构制定的相关用例。新药获批必须基于临床试验生成的证据。随着生物制药行业的不断发展,临床试验复杂程度增加。单纯依靠增加投入,难以改善临床试验效率,解决管线产出率低、成本高企的问题。本文通过解析FDA讨论文件、EMA观点文件中涉及的临床试验中人工智能/机器学习(AI/ML)运用内容,以及介绍利益攸关方对FDA讨论文件的反馈意见,初步探讨AI/ML在临床试验中的运用以及监管挑战。 展开更多
关键词 人工智能 机器学习 临床试验 方案设计 试验效率 管线产出率 透明度
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Contralateral needling at the foot of unaffected side combining with rehabilitation treatment for motor dysfunction of hand after ischemic stroke:study protocol for a randomized controlled pilot trial 被引量:1
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作者 LI Menghan YAN Yan +5 位作者 DENG Shizhe WANG Yu FU Yu SHI Lei YANG Jin ZHANG Chunhong 《Journal of Traditional Chinese Medicine》 SCIE CSCD 2023年第5期1034-1039,共6页
This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling,which is manipulated at the foot of the unaffected side,for the recovery of ... This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling,which is manipulated at the foot of the unaffected side,for the recovery of the paretic hand post-stroke.This prospective pilot clinical trial will recruit 72 stroke patients with paretic hands and a disease course of 14 to 90 d.Patients will be randomized into two groups:the control group will receive conventional Xingnao Kaiqiao acupuncture and basic treatment for the stroke;based on the control group,the observation group will receive the contralateral needling at the foot of the unaffected side combined with the rehabilitation movement of the paretic hand.12 sessions will be administrated for 2 weeks.The primary outcome,FuglMeyer Assessment,and the secondary outcomes,the handgrip strength,the range of motion,the modified Barthel index,and the Brunnstrom recovery stages,will be measured the recovery of the hand motor function during the 2 weeks'intervention.This study aims to investigate the instant effect of contralateral needling at the foot of the unaffected side combined with the rehabilitation treatment movement for patients with the paretic hand of Poststroke motor dysfunction and provide the previous evidence for the future large sample studies. 展开更多
关键词 acupuncture contralateral needing opposing needling REHABILITATION stroke clinical trial protocol
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基于风险的药物临床试验方案偏离管理模式探讨
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作者 邱博 杜润璇 +5 位作者 杨浩天 宋浩静 孙雪 丁琮洋 白万军 董占军 《中南药学》 2023年第9期2524-2528,共5页
目的分析药物临床试验实施中发生方案偏离的原因,探讨预防和改进措施,为提高临床试验的质量提供参考。方法参照新版《药物临床试验质量管理规范》、人用药品注册技术要求国际协调会议(ICH)GCP等法规对我院2019年3月至2021年9月结题的47... 目的分析药物临床试验实施中发生方案偏离的原因,探讨预防和改进措施,为提高临床试验的质量提供参考。方法参照新版《药物临床试验质量管理规范》、人用药品注册技术要求国际协调会议(ICH)GCP等法规对我院2019年3月至2021年9月结题的47项药物临床试验项目中出现的方案偏离进行统计分析,根据统计分析的结果探讨产生方案偏离的原因,并从研究者、申办者、受试者、机构和伦理监管等不同维度提出有效应对及预防措施。结果经统计,所有项目共计上报方案偏离458例,其中试验药物相关偏离188例,占比41.05%;检查/检验相关偏离150例,占比32.75%;访视相关偏离80例,占比17.47%;生物样本相关偏离35例,占比7.64%;入/排相关偏离5例,占比1.09%。结论本研究分析了我院药物临床试验常见的方案偏离,从不同维度提出了应对和预防措施来有效降低方案偏离的发生,为提高我院药物临床试验质量提供借鉴。 展开更多
关键词 药物临床试验 方案偏离 质量控制 改进措施
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降糖药临床试验不依从/违背方案事件的特点与管理策略
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作者 范华莹 吴明凤 +3 位作者 谢振伟 王瓅珏 宋超 饶慧瑛 《医院管理论坛》 2023年第9期22-25,75,共5页
目的分析降糖药临床试验中违背方案事件的特点,探讨违背方案事件的管理策略。方法采用根原因分析法,对某医院内分泌科近几年承接的降糖药临床试验进行回顾性分析,统计试验实施过程中违背方案事件的类别、发生率和影响因素。结果降糖药... 目的分析降糖药临床试验中违背方案事件的特点,探讨违背方案事件的管理策略。方法采用根原因分析法,对某医院内分泌科近几年承接的降糖药临床试验进行回顾性分析,统计试验实施过程中违背方案事件的类别、发生率和影响因素。结果降糖药临床试验发生的265例次违背方案事件,93.58%为轻度违背,重度违背仅占6.42%。所有违背中,以未按照中心实验室的要求管理生物样本、未执行已批准的研究程序和未按照试验方案用药发生率最高。结论申办者和研究团队可引入基于风险的质量管理体系,通过早期识别、定期监测和评估关键风险并制定防控措施加强降糖药临床试验的质量管理,减少临床试验不依从/违背方案事件的发生。 展开更多
关键词 临床试验 违背方案事件 降糖药 质量管理
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