摘要
背景:血管性痴呆是继阿尔茨海默病后的第二大常见痴呆类型。随着人口的老龄化,其患病率逐步上升。但目前尚无证实有效的药物,因此寻求中医治疗是非常必要的。瘀阻脑络证是血管性痴呆的主要中医证候。目的:观察活血化瘀中药治疗轻中度血管性痴呆的临床疗效及安全性。设计、场所、对象和干预措施:这是一项随机、双盲、安慰剂平行对照临床试验。自2009年3月至2010年12月共纳入48例轻中度血管性痴呆患者,随机分为活血化瘀中药组(n=24)和安慰剂对照组(n=24),所有患者接受2周的洗脱期,其后分别接受为期12周的活血化瘀中药治疗或安慰剂。安慰剂气味和外观均与活血化瘀中药相同。主要结局指标:主要疗效指标是阿尔茨海默病评估量表(认知部分)(Alzheimer's Disease Assessment Scale-cognitive subscale,ADAS-cog);次要疗效指标是简易精神状态检查量表(Mini-Mental State Examination,MMSE)和日常生活能力量表(Activities of Daily Living,ADL)。结果:基线时两组人口学及神经心理学量表得分均无差异。活血化瘀中药组治疗12周后ADAS-cog得分较基线无显著变化(P>0.05),安慰剂组12周后ADAS-cog得分较基线显著升高2.35分,两组间ADAS-cog变化值的差异具有统计学意义(P=0.027)。两组间MMSE和ADL得分与基线比较差异无统计学意义。两组间不良反应的发生率均较低,且两组间差异无统计学意义。结论:活血化瘀中药能维持患者认知功能,并且具有良好的安全性和耐受性,其远期疗效及安全性尚需大样本临床研究证实。
BACKGROUND： Vascular dementia （VaD） is the second common subtype of dementia after Alzheimer＇s disease. However, there is still a lack of medication that demonstrates clinically relevant symptomatic improvement. Static blood obstructing the brain is the main Chinese medicine syndrome of VaD. （ OBJECTIVE= To evaluate the effects of Chinese medicine for promoting blood circulation and removing blood stasis in patients with mild to moderate VaD. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： In this 12-week randomized, double-blind, parallel-controlled trial, a total of 48 patients with mild to moderate VaD were enrolled between March 2009 and December 2010. All the patients entered a two-week placebo run-in period followed by a 12-week treatment with Chinese medicine for promoting blood circulation and removing blood stasis （n=24） or placebo （n=24）, respectively. The placebo tablets have the identical taste and appearance as the Chinese medicine tablets. MAIN OUTCOME MEASURES： The primary outcome measure was the Alzheimer＇s Disease Assessment Scale-cognitive subscale （ADAS-cog） ; the secondary outcome measures includedthe Activities of Daily Living （ADL） and the Mini-Mental State Examination （MMSE）. RESULTS： The Chinese medicine group showed a slight deterioration of 0.25 points and the placebo group showed a deterioration of 2.35 points from baseline by the ADAS-cog, and there was a significant difference between the two groups （P = 0. 027）. The ADL and the MMSE showed no significant difference from baseline in both groups. Adverse events were rare in both groups. CONCLUSION： The Chinese medicine for promoting blood circulation and removing blood stasis may improve cognition and it is safe and well tolerated.
出处
《中西医结合学报》
CAS
2012年第11期1240-1246,共7页
Journal of Chinese Integrative Medicine
基金
高等学校学科创新引智计划(No.B08006)
教育部阿尔茨海默病及其他神经变性病防治创新团队资助项目(No.IRT0810)
"十一五"国家科技支撑计划资助项目(No.2009BA177B09)
国家自然科学基金面上资助项目(No.30973738)
首都医学科技发展基金资助项目(No.SF-2009-Ⅲ-11)
新世纪优秀人才支持计划(No.NECT-07-0117)
中药新药临床评价研究技术平台资助项目(No.2011ZX09302-006-01)
北京中医药大学科研创新团队资助项目(No.2011-CXTD-21)
北京中医药大学自主选题资助项目 (No.2011JYBZZXS-003)
北京市科技计划资助项目(No.Z111107056811043)
关键词
痴呆
血管性
中草药
活血祛瘀剂
随机对照试验
dementia, vascular drugs, Chinese herbal blood-activating stasis-removingagents
randomized controlled trial
