Shikiar R, Shakespeare A, Sagnier P P, Wilkinson D, McKeith I, Dartigues J F, Dubois B
MEDTAP International, Seattle, Washington, USA.
J Am Geriatr Soc. 2000 Mar;48(3):268-74. doi: 10.1111/j.1532-5415.2000.tb02645.x.
To assess the impact on burden reported by caregivers of patients with mild to moderate Alzheimer's disease (AD) who were treated with metrifonate during a randomized double blind clinical trial.
Randomized clinical trial, with a 2-week screening period and a 26-week double blind, placebo controlled, treatment phase. Caregivers were assessed at baseline, at 12 weeks, and at end of trial.
Caregivers were interviewed at clinics as part of the assessment of the patients.
Six hundred and three caregivers of AD patients who were enrolled in the MALT trial; 591 (98%) provided data suitable for analysis at baseline, and 546 (91%) provided data allowing for inclusion in the analysis of change scores.
The Caregiver Burden Assessment consisted of the Screen for Caregiver Burden, including both subjective (SCB-subj) and objective (SCB-obj) scores; the cognitive subscale of Poulshock and Deimling (PD); an abridged version of the Relatives Stress Scale (aRSS); assessments of time spent in providing care, including the Caregiver Activity Time Scale (CATS); and demographic and background variables on both the patient and caregiver.
Treatment of mild to moderate AD patients with metrifonate for a duration of 26 weeks significantly reduced the psychological burden of care to the caregivers, as measured by the SCB-subj, the PD, and the aRSS. There were no statistically significant differences on the measures assessing the time spent in caregiving, except for the caregiver's subjective impression of the change in time spent providing care during the trial. When comparing individual dose groups, most of the measures of burden showed the largest benefits in burden for the 60/80 mg group, followed by the 40/50 mg group, and then the placebo group. However, there was no statistically significant dose effect.
This study provides the first evidence from a randomized clinical trial of any acetylcholinesterase inhibitor used in the treatment of AD demonstrating a positive impact on the patient's caregiver as well as benefits to the patient. These results were shown consistently across several measurement scales and were observed after six months of treatment. These findings reinforce the clinical significance of research that has shown that metrifonate has beneficial impacts on the cognitive, behavioral, and functional abilities of AD patients. Because caregiver burden is a leading factor in the decision for institutional care placement, the ability to favorably impact that burden through pharmacological treatment of the patient is important.
评估在一项随机双盲临床试验中，接受敌百虫治疗的轻度至中度阿尔茨海默病（AD）患者的照料者报告的负担所受影响。
随机临床试验，有2周的筛查期和26周的双盲、安慰剂对照治疗阶段。在基线、12周和试验结束时对应照料者进行评估。
作为患者评估的一部分，在诊所对照料者进行访谈。
603名参加MALT试验的AD患者的照料者；591名（98%）在基线时提供了适合分析的数据，546名（91%）提供的数据可纳入变化分数分析。
照料者负担评估包括照料者负担筛查，包括主观（SCB - subj）和客观（SCB - obj）分数；Poulshock和Deimling的认知子量表（PD）；亲属压力量表简版（aRSS）；提供照料时间的评估，包括照料者活动时间量表（CATS）；以及患者和照料者的人口统计学和背景变量。
用敌百虫治疗轻度至中度AD患者26周，通过SCB - subj、PD和aRSS测量，显著减轻了照料者所承受的心理负担。在评估照料时间的测量指标上，除了照料者对试验期间提供照料时间变化的主观印象外，没有统计学上的显著差异。比较各个剂量组时，大多数负担测量指标显示60/80毫克组的负担减轻最大，其次是40/50毫克组，然后是安慰剂组。然而，没有统计学上的显著剂量效应。
本研究提供了来自任何用于治疗AD的乙酰胆碱酯酶抑制剂随机临床试验的首个证据，证明其对患者的照料者有积极影响，对患者也有益处。这些结果在多个测量量表上一致显示，且在治疗六个月后观察到。这些发现强化了研究的临床意义，该研究表明敌百虫对AD患者的认知、行为和功能能力有有益影响。由于照料者负担是决定是否安排机构照料的主要因素，通过对患者进行药物治疗来积极影响该负担的能力很重要。
