三焦针法治疗轻中度阿尔茨海默病的随机对照临床研究

Clinical Observation of Sanjiao Acupuncture on Mild to Moderate Alzheimer's Disease: A Randomized Controlled Trial

目的:与安理申对照评价三焦针法治疗轻中度阿尔茨海默病(AD)的有效性和安全性。方法:将82例AD患者随机分为针刺组和西药组,针刺组给予三焦针法治疗3次/周加西药模拟剂5 mg/d,西药组给予西药安理申5 mg/d,同时进行假针刺3次/周,疗程12周,分别于治疗前后进行中西医疗效判定标准评定。西医判定标准主要疗效指标为ADAS-cog、CIBIC-Plus,次要疗效指标为MMSE、ADL和NPI。结果:71例患者完成试验,两组患者治疗前后ADAScog、ADL减分及MMSE加分差异具有统计学意义(均P<0.05),NPI得分针刺组减分差异具有统计学差异(P<0.05),而西药组加分差异不具有统计学意义(P>0.05);治疗12周后,两组患者的ADAS-cog、MMSE评分差异不存在统计学意义(P>0.05),而CIBIC-Plus、ADL和NPI评分差异具有统计学差异(P<0.05),中医证候疗效评定针刺组临床总有效率68.57%,西药组为52.78%,两组比较差异具有统计学意义(P<0.05)。治疗过程中针刺组无明显不良事件发生。结论:三焦针法治疗可显著改善轻中度AD患者的认知障碍、日常生活能力、神经精神症状和总体功能,尤其在日常生活能力、神经精神症状和总体功能方面优于西药安理申,安全性良好。

Objective： To assess the efficacy and safety of Sanjiao acupuncture in treatment of mild to moderate Alzheimer disease（ AD）. Methods： A total of 82 patients with AD were randomly divided into acupuncture treatment group（ TG） and control group（ CG）. The TG added Sanjiao acupuncture（ 3 times/weeks） and Western medicine placebo 5mg/d. The CG received donepezil 5mg/d and sham acupuncture（ 3 times/week）. The treatment lasted for 12 weeks. Main outcome measures were ADAS-Cog and CIBIC-Plus. The secondary efficacy indicators were MMSE,ADL and NPI. Results： Seventy-one patients completed the study. There were significant differences before and after treatment in the scores of ADAS-cog,ADL and MMSE（ P〈0. 05）.NPI score differences of TG had statistical difference（ P〈0. 05） and the NPI score differences difference of CG had no statistical significance（ P〉0. 05）. After treatment,there were no significant differences between groups in the scores of ADAS-cog and MMSE（ P〉0. 05） and there were significant differences between groups in the scores of CIBIC-Plus,ADL and NPI. The clinical total efficacy of TCM syndrome in the treatment group and control group was 68. 57% and 52. 78% respectively,with significant difference between groups（ P〈0. 05）. No significant adverse events occurred in the TG. Conclusion： Sanjiao acupuncture is effective in treating patients with mild to moderate AD. It could produce improvements in cognition,ability of daily life,neuropsychiatric symptoms and overall function,especially in ability of daily lifeneuralpsychiatric symptoms and the whole function is superior to donepezil. Sanjiao acupuncture was safe.