目的:验证“通督调髓”电针法干预轻度认知功能障碍(MCI)患者的临床疗效,拟为针灸临床治疗该病提供循证医学A级证据。方法:采用多中心随机对照试验(RCT)的方法,将192例MCI患者随机分为电针组和尼莫地平组.每组96例。电针组采用电针神庭、百会、四神聪、风池隔日1次;尼莫地平组采用口服尼莫地平每日3次,4周为一疗程,共治疗8周。治疗前、治疗1个疗程和治疗2个疗程后分别进行简易精神状态检查表(minimummentalstateexamination,MMSE)和图形再认测验,结束治疗后的1个月、3个月和6个月分别采用MMSE量表进行随访评价。结果:电针组的总有效率为50.0%(47/94),优于尼莫地平组的34.4%(32/93,P〈0.05)。治疗第1疗程后两组MMSE总评分,认知、记忆和言语维度评分组间比较差异均无统计学意义(均P〉0.05);治疗第2疗程后MMSE量表总评分.认知、记忆和视空间技能维度评分两组均有显著提高(均P〈0.01),且电针组优于尼莫地平组(均P〈0.05),但言语维度评分两组间比较差异无统计学意义(P〉0.05)。电针组图形再认得分治疗2个疗程后较治疗前显著改善(P〈0.01),并优于尼莫地平组(P〈0.05)。治疗后1个月、3个月和6个月的MMSE量表总评分组间比较差异均有统计学意义(均P〈0.01).电针组远期疗效优于尼莫地平组。结论:“通督调髓”电针法和尼莫地平均能显著改善MCI患者的认知功能,电针较尼莫地平更能显著提高MCI患者的综合认知能力和短时记忆能力,且在改善MCI患者认知、记忆和视空间技能维度方面尤佳;在结束治疗后的半年时间内,电针的远期疗效优于尼莫地平。
Objective To verify the clinical efficacy on mild cognitive impairment (MCI) treated with electro acupuncture (EA) intervention based on the principle as "promoting the circulation of the Governor Vessel and regulating the marrow" and plan to provide the A-grade evidence of the evidence based medicine for the clinical treatment of this disease with acupuncture and moxibustion. Methods The multi-center randomized controlled trial (RCT) was adopted. One hundred aud ninety two cases of MCI were randomized into an EA group and a nimodi- pine group, 96 cases in each one. In the EA group, EA was applied to Shenting (GV 24), Baihui (C-V 20), Sishen cong (EX HN 1) and Fengchi (GB 20). once every other day. In the nimodipine group, Nimodipine was pre- serihed for oral administration. Four weeks constituted one course, the treatment of 8 weeks was required. The minimum mental state examination (MMSE) and the graphic recognition test (GRT) were applied before and in the 1st and 2nd session of treatment separately. The follow-up visit of MMSE scale was provided in tile 1st, 3rd and 6th months after treatment separately. Results The total effective rate was 50.0% (47/94) in the EA group, which was superior to 34.40% (32/93) in the nimodipine group (P〈2.0.05). At the end of the 1st session treatment,the differences in MMSE total score and the cognitive, memory and speech dimensional scores were not significant statistically between two groups (all P〉0.05). At the end of the 2nd session treatment, the MMSE total score and the cognitive, memory, visual-space skill dimensional scores were improved in comparison before treatment (all P〈0.05). The results in the EA group were superior to those in the nimodipine group (all P〈0.05). But the difference in the speech dimensional score was not significant statistically between the two groups (P〉0.05). In the EA group, the GRT score was improved significantly after 2 sessions of treatment as compared with that