Guo Ren-zhen, Zhou Wen-quan, Luo Zeng-gang
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091.
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 Jan;30(1):33-6.
To observe the clinical efficacy of modified Huanglian Wendan Decoction (HWD) in treating senile mild cognitive impairment (MCI) of turbid-phlegm blocking orifice syndrome.
With a block randomized, double-blinded and controlled design adopted, the 64 patients of MCI selected from December 2007 to February 2009 were randomly and equally assigned to two groups. The treatment group was treated with HWD in dose of 200 mL, twice a day; the control group was given Aniracetam 0.2 g (for patients over 70-years-old, 0.1 g) three times a day. And the illusive medicine in dosage-form of capsule/decoction simulated to that used in the opposite group was applied. The medication and observation lasted for three months. Chinese medicine syndrome, cognition capacity (by MMSE), laboratory indexes [acetylcholine (Ach), superoxide dismutase (SOD), malondialdehyde (MDA)] and safety related indexes in patients were observed.
After treatment, MMSE score increased in both groups, but the increment in the treatment group was significantly higher than that in the control group (P<0.01); Chinese medicine syndrome estimated by scoring showed that after treatment, all scores of syndromes, excepting the expectoration, were improved in the treatment group with the post-treatment scores significantly lower than those in the control group respectively (P<0.05 or P<0.01); while in the control group, lowering of scores only showed in some symptoms such as poor memory, heavy head or dizziness, and heavy sensation in limbs and body. Serum levels of Ach and SOD decreased and MDA increased in both groups after treatment, but the change of Ach was more significant in the treatment group (P<0.01). No obvious adverse reactions were found during the treatment.
For treatment of MCI, HWD shows effects in improving patients' symptoms, cognition capacity and elevating serum Ach content better than that of Aniracetam; and with effects for raising SOD activity and reducing MDA level similar to those of Aniracetam.
观察加味黄连温胆汤治疗老年痰浊阻窍型轻度认知功能障碍（MCI）的临床疗效。
采用区组随机、双盲、对照设计，选取2007年12月至2009年2月的64例MCI患者，随机等分为两组。治疗组予加味黄连温胆汤200 mL，每日2次；对照组予阿尼西坦0.2 g（70岁以上患者为0.1 g），每日3次。并应用模拟对方组剂型的胶囊/汤剂安慰剂。用药及观察3个月。观察患者的中医证候、认知能力（采用简易精神状态检查表MMSE）、实验室指标[乙酰胆碱（Ach）、超氧化物歧化酶（SOD）、丙二醛（MDA）]及安全性相关指标。
治疗后两组MMSE评分均升高，但治疗组升高幅度明显高于对照组（P<0.01）；评分法评定中医证候显示，治疗后治疗组除咯痰外各证候评分均改善，治疗后评分分别显著低于对照组（P<0.05或P<0.01）；而对照组仅部分症状如记忆力差、头重头晕、肢体及身体沉重感评分降低。治疗后两组血清Ach、SOD水平均降低，MDA升高，但治疗组Ach变化更显著（P<0.01）。治疗期间未发现明显不良反应。
加味黄连温胆汤治疗MCI在改善患者症状、认知能力及提高血清Ach含量方面优于阿尼西坦；在提高SOD活性、降低MDA水平方面与阿尼西坦效果相似。
