背景口服中药在慢性阻塞性肺疾病急性加重(AECOPD)的治疗中应用广泛,但相关临床试验的结局指标尚未得到统一和规范。目的通过筛选已发表的以口服中药为AECOPD治疗措施的随机对照试验(RCT),总结其文献特征和选用的结局指标情况,为中医药...背景口服中药在慢性阻塞性肺疾病急性加重(AECOPD)的治疗中应用广泛,但相关临床试验的结局指标尚未得到统一和规范。目的通过筛选已发表的以口服中药为AECOPD治疗措施的随机对照试验(RCT),总结其文献特征和选用的结局指标情况,为中医药治疗AECOPD临床试验设计和结局指标选择提供参考。方法计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、PubMed、Embase、Web of Science、Cochrane Library、ClinicalTrials.gov、中国临床试验注册中心,获取口服中药治疗AECOPD的RCT和临床试验注册方案,检索时限为2018年1月—2022年10月。由2位评价员独立筛选文献、提取资料后,采用定性分析的方法,对纳入研究的结局指标选择情况进行描述。结果纳入578篇文献,包含574篇已报告试验结果的RCT及4个临床试验注册方案。574篇RCT共纳入51508例患者。88篇文献在纳入标准中限定了患者的疾病分级,361篇文献在纳入标准中限定了中医证型,6篇文献报告了盲法,6篇文献提及了随访。纳入文献共涉及4030个结局指标,单篇文献结局指标数量范围为1~24个。按照结局指标的功能属性,将其归为8个指标域:中医症状/证候、症状/体征、理化检测、生活质量、远期预后、经济学评估、安全性评价、其他,报告率最高的指标域是理化检测,报告频次排名前5位的结局指标项目是:有效率(11.5%)、第1秒用力呼气容积(7.5%)、中医症状/证候评分(7.0%)、第1秒用力呼气容积/用力肺活量(6.8%)、用力肺活量(4.6%)。445篇文献报告了有效率的组成,报告率排名前5位的研究指标依次为症状(423篇)、体征(281篇)、中医证候评分(203篇)、实验室检查(89篇)、肺功能(71篇)。结论口服中药治疗AECOPD的RCT涉及的结局指标数量多、范围广,纳入的文献在不同程度上关注了口服中药对AECOPD患者的症状体征、理化检测指标、生活质量、远期预后、经济学评价和安全性结局等方面的影响。但结局指标的选择仍存在多方面的问题:结局指标主次不清;主要关注替代终点,对临床终点的关注不足;对卫生经济学指标关注不足;有效性参考来源不一、判断标准不一。研究者可参考已发表的核心指标集,合理设计结局指标,以提高中医药临床研究的质量。展开更多
目的结合压力中心(COP)轨迹与康复评估量表,研究虚拟现实技术(VR)对脑卒中患者坐位平衡功能障碍的康复效果。方法招募2020年12月~2021年4月在上海市养志康复医院收治的脑卒中坐位平衡功能障碍患者16例,使用随机数字表法分为试验组(n=7)...目的结合压力中心(COP)轨迹与康复评估量表,研究虚拟现实技术(VR)对脑卒中患者坐位平衡功能障碍的康复效果。方法招募2020年12月~2021年4月在上海市养志康复医院收治的脑卒中坐位平衡功能障碍患者16例,使用随机数字表法分为试验组(n=7)和对照组(n=9)。两组患者均给予常规功能康复训练,另外对照组患者给予30 min传统坐位平衡训练,试验组患者进行30 min VR坐位平衡训练,持续4周。治疗前、后分别采用测力台测量坐姿下压力中心位移。展开更多
Context: Most older adults with dementia will be cared for by primary care physicians, but the primary care practice environment presents important challenges to providing quality care. Objective: To test the effectiv...Context: Most older adults with dementia will be cared for by primary care physicians, but the primary care practice environment presents important challenges to providing quality care. Objective: To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease. Design, Setting, and Patients: Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were randomized by physician to receive collaborative care management (n=84) or augmented usual care (n=69)-at primary care practices within 2 US university-affiliated health care systems from January 2002 through August 2004. Eligible patients (identified via screening or medical record) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver. Intervention: Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient’s family caregiver and integrated within primary care. The team used standard protocols to initiate treatment and identify, monitor, and treat behavioral and psychological symptoms of dementia, stressing nonpharmacological management. Main Outcome Measures: Neuropsychiatric Inventory (NPI)-administered at baseline and at 6, 12, and 18 months. Secondary outcomes included the Cornell Scale for Depression in Dementia (CSDD), cognition, activities of daily living, resource use, and caregiver’s depression severity. Results: Initiated by caregivers’reports, 89%of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocols. Intervention patients were more likely to receive cholinesterase inhibitors (79.8%vs 55.1%; P=.002) and antidepressants (45.2%vs 27.5%; P= .03). Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months (mean difference, -5.6; P= .01) and at 18 months (mean difference, -5.4; P=.01). Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months; at 18 months, caregivers showed improvement in depression as measured by the Patient Health Questionnaire-9. No group differences were found on the CSDD, cognition, activities of daily living, or on rates of hospitalization, nursing home placement, or death. Conclusions: Collaborative care for the treatment of Alzheimer disease resulted in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers. These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics. Trial Registration: clinicaltrials.gov Identifier: NCT00246896.展开更多
Context: Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences. Previous research has suggested beneficial outcomes of both psycholog...Context: Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences. Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments, but blinded placebo-controlled trials comparing the effects of these treatments are lacking. Objective: To examine short-and long-term clinical efficacy of cognitive behavioral therapy (CBT) and pharmacological treatment in older adults experiencing chronic primary insomnia. Design, Setting, and Participants: A randomized, double-blinded, placebo-controlled trial of 46 adults (mean age, 60.8 y; 22 women) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients. Intervention: CBT (sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation; n=18), sleep medication (7.5-mg zopiclone each night; n=16), or placebo medication (n=12). All treatment duration was 6 weeks, and the 2 active treatments were followed up at 6 months. Main Outcome Measures: Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time, total sleep time, sleep efficiency, and slow-wave sleep (only assessed using polysomnography) on all 3 assessment points. Results: CBT resulted in improved short-and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures. For most outcomes, zopiclone did not differ from placebo. Participants receiving CBT improved their sleep efficiency from 81.4%at pretreatment to 90.1%at 6-month follow-up compared with a decrease from 82.3%to 81.9%in the zopiclone group. Participants in the CBT group spent much more time in slow-wave sleep (stages 3 and 4) compared with those in other groups, and spent less time awake during the night. Total sleep time was similar in all 3 groups; at 6 months, patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone. Conclusion: These results suggest that interventions based on CBT are superior to zopiclone treatment both in short-and long-term management of insomnia in older adults.展开更多
Aims: We conducted a multi- centre, prospective, controlled, randomize d rial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation(AF) relapses in pat...Aims: We conducted a multi- centre, prospective, controlled, randomize d rial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation(AF) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed. Methods and results: One hundred and thirty seven patients were randomized to ablation and antiarrhythmic drug therapy(ablation group) or antiarrhythmic drug therapy alone(control group). In the ablation group, patients underwent cavo- tricuspid and left inferior pulmonary vein(PV)- mitral isthmus ablation plus circumferential PV ablation. The primary end- point of the study was the absence of any recurrence of atrial arrhythmia lasting >30s in the 1- year follow- up period, after 1- month blanking period. Three(4.4% ) major complications were related to ablation: one patient had a stroke during left atrium ablation, another suffered transient phrenic paralysis, and the third had a pericardial effusion which required pericardiocentesis. After 12 months of follow- up, 63/69(91.3% ) control group patients had at least one AF recurrence, whereas 30/68(44.1% )(P < 0001) ablation group patients had atrial arrhythmia recurrence(four patients had atrial flutter, 26 patients AF). Conclusion: Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed.展开更多
目的:评价健脾疏肝法治疗功能性消化不良脾虚气滞证的疗效和安全性,并采用了基于患者的结局评价从患者的角度考察其最关心的问题的变化情况。方法:采用多中心、随机、双盲、安慰剂对照的方法将来自5个分中心的160例脾虚气滞证功能性消...目的:评价健脾疏肝法治疗功能性消化不良脾虚气滞证的疗效和安全性,并采用了基于患者的结局评价从患者的角度考察其最关心的问题的变化情况。方法:采用多中心、随机、双盲、安慰剂对照的方法将来自5个分中心的160例脾虚气滞证功能性消化不良患者按2∶1的比例分为试验组和对照组,分别给予具有健脾疏肝作用的中药健脾理气方以及安慰剂治疗。中药及安慰剂均为配方颗粒,由70℃温水冲服,分早晚2次服用,每次150 m L。2组治疗疗程均为4周,治疗结束后4周进行随访。主要评价指标为基于患者评价的消化道症状积分,包括消化道总体症状积分和单项症状积分,分别在第0,1,2,3,4和8周观察记录。次要评价治疗为钡条胃排空试验,在第0和4周完成。结果:与安慰剂比较,治疗4周后及随访试验组患者消化道总体症状积分和单项症状积分改善优于对照组(P<0.01或P<0.05)钡条胃排空试验中药组对胃肠动力改善亦优于对照组(P<0.05)。临床试验期间未出现与药物相关的不良事件。结论:中药健脾疏肝法可改善功能性消化不良脾虚气滞证患者的临床症状,且安全性良好。展开更多
文摘背景口服中药在慢性阻塞性肺疾病急性加重(AECOPD)的治疗中应用广泛,但相关临床试验的结局指标尚未得到统一和规范。目的通过筛选已发表的以口服中药为AECOPD治疗措施的随机对照试验(RCT),总结其文献特征和选用的结局指标情况,为中医药治疗AECOPD临床试验设计和结局指标选择提供参考。方法计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库、PubMed、Embase、Web of Science、Cochrane Library、ClinicalTrials.gov、中国临床试验注册中心,获取口服中药治疗AECOPD的RCT和临床试验注册方案,检索时限为2018年1月—2022年10月。由2位评价员独立筛选文献、提取资料后,采用定性分析的方法,对纳入研究的结局指标选择情况进行描述。结果纳入578篇文献,包含574篇已报告试验结果的RCT及4个临床试验注册方案。574篇RCT共纳入51508例患者。88篇文献在纳入标准中限定了患者的疾病分级,361篇文献在纳入标准中限定了中医证型,6篇文献报告了盲法,6篇文献提及了随访。纳入文献共涉及4030个结局指标,单篇文献结局指标数量范围为1~24个。按照结局指标的功能属性,将其归为8个指标域:中医症状/证候、症状/体征、理化检测、生活质量、远期预后、经济学评估、安全性评价、其他,报告率最高的指标域是理化检测,报告频次排名前5位的结局指标项目是:有效率(11.5%)、第1秒用力呼气容积(7.5%)、中医症状/证候评分(7.0%)、第1秒用力呼气容积/用力肺活量(6.8%)、用力肺活量(4.6%)。445篇文献报告了有效率的组成,报告率排名前5位的研究指标依次为症状(423篇)、体征(281篇)、中医证候评分(203篇)、实验室检查(89篇)、肺功能(71篇)。结论口服中药治疗AECOPD的RCT涉及的结局指标数量多、范围广,纳入的文献在不同程度上关注了口服中药对AECOPD患者的症状体征、理化检测指标、生活质量、远期预后、经济学评价和安全性结局等方面的影响。但结局指标的选择仍存在多方面的问题:结局指标主次不清;主要关注替代终点,对临床终点的关注不足;对卫生经济学指标关注不足;有效性参考来源不一、判断标准不一。研究者可参考已发表的核心指标集,合理设计结局指标,以提高中医药临床研究的质量。
文摘目的结合压力中心(COP)轨迹与康复评估量表,研究虚拟现实技术(VR)对脑卒中患者坐位平衡功能障碍的康复效果。方法招募2020年12月~2021年4月在上海市养志康复医院收治的脑卒中坐位平衡功能障碍患者16例,使用随机数字表法分为试验组(n=7)和对照组(n=9)。两组患者均给予常规功能康复训练,另外对照组患者给予30 min传统坐位平衡训练,试验组患者进行30 min VR坐位平衡训练,持续4周。治疗前、后分别采用测力台测量坐姿下压力中心位移。
文摘Context: Most older adults with dementia will be cared for by primary care physicians, but the primary care practice environment presents important challenges to providing quality care. Objective: To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease. Design, Setting, and Patients: Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were randomized by physician to receive collaborative care management (n=84) or augmented usual care (n=69)-at primary care practices within 2 US university-affiliated health care systems from January 2002 through August 2004. Eligible patients (identified via screening or medical record) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver. Intervention: Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient’s family caregiver and integrated within primary care. The team used standard protocols to initiate treatment and identify, monitor, and treat behavioral and psychological symptoms of dementia, stressing nonpharmacological management. Main Outcome Measures: Neuropsychiatric Inventory (NPI)-administered at baseline and at 6, 12, and 18 months. Secondary outcomes included the Cornell Scale for Depression in Dementia (CSDD), cognition, activities of daily living, resource use, and caregiver’s depression severity. Results: Initiated by caregivers’reports, 89%of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocols. Intervention patients were more likely to receive cholinesterase inhibitors (79.8%vs 55.1%; P=.002) and antidepressants (45.2%vs 27.5%; P= .03). Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months (mean difference, -5.6; P= .01) and at 18 months (mean difference, -5.4; P=.01). Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months; at 18 months, caregivers showed improvement in depression as measured by the Patient Health Questionnaire-9. No group differences were found on the CSDD, cognition, activities of daily living, or on rates of hospitalization, nursing home placement, or death. Conclusions: Collaborative care for the treatment of Alzheimer disease resulted in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers. These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics. Trial Registration: clinicaltrials.gov Identifier: NCT00246896.
文摘Context: Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences. Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments, but blinded placebo-controlled trials comparing the effects of these treatments are lacking. Objective: To examine short-and long-term clinical efficacy of cognitive behavioral therapy (CBT) and pharmacological treatment in older adults experiencing chronic primary insomnia. Design, Setting, and Participants: A randomized, double-blinded, placebo-controlled trial of 46 adults (mean age, 60.8 y; 22 women) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients. Intervention: CBT (sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation; n=18), sleep medication (7.5-mg zopiclone each night; n=16), or placebo medication (n=12). All treatment duration was 6 weeks, and the 2 active treatments were followed up at 6 months. Main Outcome Measures: Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time, total sleep time, sleep efficiency, and slow-wave sleep (only assessed using polysomnography) on all 3 assessment points. Results: CBT resulted in improved short-and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures. For most outcomes, zopiclone did not differ from placebo. Participants receiving CBT improved their sleep efficiency from 81.4%at pretreatment to 90.1%at 6-month follow-up compared with a decrease from 82.3%to 81.9%in the zopiclone group. Participants in the CBT group spent much more time in slow-wave sleep (stages 3 and 4) compared with those in other groups, and spent less time awake during the night. Total sleep time was similar in all 3 groups; at 6 months, patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone. Conclusion: These results suggest that interventions based on CBT are superior to zopiclone treatment both in short-and long-term management of insomnia in older adults.
文摘Aims: We conducted a multi- centre, prospective, controlled, randomize d rial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation(AF) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed. Methods and results: One hundred and thirty seven patients were randomized to ablation and antiarrhythmic drug therapy(ablation group) or antiarrhythmic drug therapy alone(control group). In the ablation group, patients underwent cavo- tricuspid and left inferior pulmonary vein(PV)- mitral isthmus ablation plus circumferential PV ablation. The primary end- point of the study was the absence of any recurrence of atrial arrhythmia lasting >30s in the 1- year follow- up period, after 1- month blanking period. Three(4.4% ) major complications were related to ablation: one patient had a stroke during left atrium ablation, another suffered transient phrenic paralysis, and the third had a pericardial effusion which required pericardiocentesis. After 12 months of follow- up, 63/69(91.3% ) control group patients had at least one AF recurrence, whereas 30/68(44.1% )(P < 0001) ablation group patients had atrial arrhythmia recurrence(four patients had atrial flutter, 26 patients AF). Conclusion: Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed.
文摘目的:评价健脾疏肝法治疗功能性消化不良脾虚气滞证的疗效和安全性,并采用了基于患者的结局评价从患者的角度考察其最关心的问题的变化情况。方法:采用多中心、随机、双盲、安慰剂对照的方法将来自5个分中心的160例脾虚气滞证功能性消化不良患者按2∶1的比例分为试验组和对照组,分别给予具有健脾疏肝作用的中药健脾理气方以及安慰剂治疗。中药及安慰剂均为配方颗粒,由70℃温水冲服,分早晚2次服用,每次150 m L。2组治疗疗程均为4周,治疗结束后4周进行随访。主要评价指标为基于患者评价的消化道症状积分,包括消化道总体症状积分和单项症状积分,分别在第0,1,2,3,4和8周观察记录。次要评价治疗为钡条胃排空试验,在第0和4周完成。结果:与安慰剂比较,治疗4周后及随访试验组患者消化道总体症状积分和单项症状积分改善优于对照组(P<0.01或P<0.05)钡条胃排空试验中药组对胃肠动力改善亦优于对照组(P<0.05)。临床试验期间未出现与药物相关的不良事件。结论:中药健脾疏肝法可改善功能性消化不良脾虚气滞证患者的临床症状,且安全性良好。
