清灵方联合盐酸多奈哌齐治疗卒中后认知功能障碍的临床研究

Clinical Research of Qingling granule combined with donepezil hydrochloride in the treatment of cognitive dysfunction after stroke

目的 观察清灵方联合盐酸多奈哌齐治疗卒中后认知功能障碍的临床疗效。方法 选取上海市静安区中医医院2019年7月至2021年7月收治卒中后认知功能障碍者82例,采用随机数字表法将病人分为对照组和治疗组,每组各41例。其中对照组除了基础治疗外给予盐酸多奈哌齐片(每片5 mg)口服,每日1次,每次1片;治疗组在对照组基础上联合清灵方治疗,将一日量的清灵方(颗粒剂)51 g,加开水至200 mL冲化温服,分早晚两次服用。两组均连续治疗3个月。比较两组治疗前后简易精神状态量表(MMSE)、蒙特利尔认知评估量表(MoCA)、美国国立卫生研究院卒中量表(NIHSS)、日常生活活动能力(ADL)、血清神经元特异性烯醇化酶(NSE)、同型半胱氨酸(HCY)变化,统计两组临床治疗总有效率,并记录两组治疗期间不良反应情况。结果 治疗后,两组MoCA积分[对照组(17.56±2.59)分、治疗组(21.57±3.28)分],两组MMSE积分[对照组(18.31±3.91)分、治疗组(23.27±4.34)分]较治疗前两组MoCA积分[对照组(15.48±3.01)分、治疗组(15.96±3.41分)]和MMSE积分[对照组(16.78±5.53)分、治疗组(16.78±5.53)]分均有增高(P<0.05),且治疗组优于对照组(P<0.05)。治疗后,两组ADL积分、NIHSS积分均较治疗前有所改善(P<0.05),治疗组优于对照组(P<0.05)。治疗后,对照组总有效率73.17%(30/41),治疗组总有效率90.24%(37/41),两组差异有统计有意义(P<0.05)。治疗后,两组NSE、HCY水平均低于治疗前,且治疗组优于对照组(P<0.05);两组不良反应发生率差异无统计学意义(P>0.05)。结论 清灵方联合盐酸多奈哌齐片治疗能有效减轻卒中后认知功能障碍病人临床症状,改善神经功能和认知功能,调节NSE、HCY水平,且安全性高。

Objective To investigate clinical effect of Qingling granule combined with donepezil hydrochloride in the treatment of cognitive dysfunction after stroke.Methods Eighty-two patients with cognitive dysfunction after stroke with sputum and blood stasis were randomized into the control group and the observation group,with forty-one cases in each group.The patients in the control group were treated with donepezil hydrochloride on the basis of conventional treatment for three months and the patients in the observation were also treated with Qingling granule that 51 g added into 200 ml water in the morning and evenig per day and donepezil hydrochloride on the basis of conventional treatment for three months.The changes of Mini-Mental State Examination(MMSE),Montreal Cognitive Assessment(MoCA),NIH Stroke Scale(NIHSS),activities of daily living(ADL),neuron-specific enolase(NSE),homocysteine(Hcy) were observed before and after treatment.We also had a comprehensive statistics of the total effective rates of the control group and the observation group and recorded the adverse reaction.Results After treatment,the MoCA scores of the two groups were 17.56±2.59 and 21.57±3.28 and the MMSE scores of the two groups were 18.31±3.91 and 23.27±4.34 respectively,which were increased than those before treatment that the MoCA scores of the two groups were 15.48±3.01 and 15.96±3.41 and the MMSE scores of the two groups were 16.53±3.94 and 16.78±5.53(P<0.05) and those in the observation group were better than those in the control group(P<0.05).ADL scores and NIHSS scores were also improved(P<0.05);The total effective rate of the observation group 90.24%(37/41) was significantly higher than that of the control group 73.17%(30/41)(P<0.05).The factor of NSE and HCY after treatment both decreased than before and the difference was statistically significant(P<0.05).The adverse reactions of the two groups were not statistically different(P>0.05).Conclusion Qingling granule combined with donepezil hydrochloride in the treatment of cognitive dysfunction could relieve the clinical symptoms of cognitive dysfunction after stroke,improve neurological and cognitive function,regulate the factor level of NSE and HCY and crowned with high security.