益智安神方治疗遗忘型轻度认知障碍肾虚痰瘀证临床疗效观察

Clinical efficacy of Yizhi Anshen Formula on amnestic mild cognitive impairment with syndrome of kidney deficiency and phlegm stasis

目的:观察益智安神方对遗忘型轻度认知障碍(aMCI)肾虚痰瘀证的临床疗效。方法:采用随机、对照研究方法,将符合aMCI肾虚痰瘀证诊断标准的62位患者按随机化数字表分为治疗组和对照组,每组各31例,两组均给予基础治疗,治疗组加用益智安神方智能免煎颗粒,疗程4个月,随访2年。采用ADAS-cog作为主要指标,中医证候积分、MMSE量表评分以及血清炎性因子水平作为次要指标,评价益智安神方治疗aMCI患者肾虚痰瘀的临床疗效。结果:治疗组总有效率(93.55%)显著优于对照组(45.16%)(P<0.05);随访2年后,治疗组向AD的转化率为16.13%,显著低于对照组(38.71%)(P<0.01);治疗组中医证候积分、MMSE量表评分、炎性因子IL-1β、IL-6水平与对照组同期比较,均有显著改善(P<0.05,P<0.01)。结论:益智安神方能够降低aMCI向AD的转化率,具有改善aMCI肾虚痰瘀证患者临床症状的作用,其作用机制可能与降低外周血清中炎性因子IL-1β、IL-6水平有关。

To observe the therapeutic effects of Yizhi Anshen Formula on amnestic mild cognitive impairment(aMCI) with syndrome of kidney deficiency and phlegm stasis. Methods: Included 62 aMCI patients who were in accordance with the diagnostic criteria into the randomized controlled trial. They were randomly divided into treatment group and control group respectively according to the random number table, thirty-one patients per group. Both groups were given conventional therapy treatment for 4 months, while the treatment group was additionally given the boil-free granule of Yizhi Anshen Formula, followed by a 2-year follow-up. Alzheimer's disease assessment scale cognitive subscale(ADAS-cog) was adopted as the primary indicator, and the TCM syndrome score, the MMSE measuring scale score and the serum inflammatory factors levels were adopted as the secondary indicators to evaluate the therapeutic effects of Yizhi Anshen Formula on aMCI patients. Results: The total effective rates of the treatment group and the control group were respectively 93.55% and 45.16%(P<0.05). The results of 2-year follow-up showed that the conversion rates to Alzheimer's disease(AD) of the treatment group and the control group were 16.13% and 38.71%, respectively(P<0.01). Significant differences in the TCM syndrome score, MMSE measuring scale scores and levels of inflammatory factors IL-1β and IL-6 were found between the two groups(P<0.05, P<0.01). Conclusion: Yizhi Anshen Formula decreases the conversion rate of aMCI to AD and improves the clinical symptoms of aMCI, the mechanism of which may be related to decrease the levels of inflammatory factors IL-1β and IL-6 in peripheral serum.