目的 观察复方苁蓉益智胶囊联合美金刚治疗阿尔茨海默病的疗效。方法 依据随机数字表法将2024年1月－2025年3月邯郸市邯钢医院收治102例阿尔茨海默病患者分为对照组和治疗组，各51例。对照组口服盐酸美金刚片，10 mg/次，2次/d。治疗组给予复方苁蓉益智胶囊联合盐酸美金刚片，口服复方苁蓉益智胶囊，1.2 g/次，3次/d，盐酸美金刚片用法用量同对照组。治疗12周后，观察两组临床疗效、中医证候积分、简易智能状态检查量表（MMSE）评分、阿尔茨海默病评定量表-认知分量表（ADAS-cog）评分、氧化应激、神经元损伤标志物水平。结果 治疗后，治疗组总有效率（90.20%）显著高于对照组（74.51%）（P＜0.05）。两组患者的中医证候积分、ADAS-cog评分均较治疗前显著降低，MMSE评分则显著升高（P＜0.05）；且治疗组在中医证候积分、ADAS-cog评分的降低幅度及MMSE评分的升高幅度均优于对照组（P＜0.05）。在氧化应激指标方面，两组8-OHdG、丙二醛水平均较治疗前下降，SOD水平上升（P＜0.05）；其中治疗组8-OHdG、丙二醛的下降程度及SOD的上升程度均显著超过对照组（P＜0.05）。治疗后，两组视锥蛋白样蛋白-1（VILIP-1）、β-淀粉样蛋白（Aβ）、磷酸化tau 181蛋白（p-tau181）、神经丝轻链蛋白（NFL）较治疗前降低（P＜0.05），且治疗组患者VILIP-1、Aβ、p-tau181、NFL较对照组低（P＜0.05）。结论 复方苁蓉益智胶囊联合美金刚治疗阿尔茨海默病疗效肯定，可降低中医证候积分，改善认知功能，调节氧化应激指标、神经元损伤标志物水平。

Objective To observe the therapeutic effect of Compound Congrong Yizhi Capsules combined with memantine in treatment of Alzheimer’s disease. Methods According to the random number table method, the January 2024 -In March 2025, 102 patients with Alzheimer’s disease admitted to Handan Hangang Hospital were divided into control group and treatment group, with 51 cases in each group. The control group was given oral administration of Memantine Hydrochloride Tablets at a dose of 10 mg each time, twice daily. The treatment group was given the combination of Compound Congrong Yizhi Capsules and Memantine Hydrochloride Tablets. The treatment group was given Compound Congrong Yizhi Capsules at a dose of 1.2 g each time, three times daily, and the dosage and administration method of Memantine Hydrochloride Tablets were the same as those of control group. Both groups were treated continuously for 12 weeks. The clinical efficacy of two groups was observed, and traditional Chinese medicine syndromes scores, MMSE scores, ADAS-cog scores, oxidative stress, and neuronal damage markers were compared. Results After treatment, the total effective rate of the treatment group (90.20%) was significantly higher than that of the control group (74.51%) (P < 0.05). The TCM syndrome scores and ADAS-cog scores of the two groups were significantly lower than those before treatment, and the MMSE score was significantly higher than that before treatment (P < 0.05). Compared with the control group, the treatment group had a significantly better reduction in TCM syndrome score and ADAS-cog score and a significantly better increase in MMSE score (P < 0.05). In terms of oxidative stress indicators, the levels of 8-OHdG and malondialdehyde in the two groups were lower than those before treatment, and the level of SOD was higher than that before treatment (P < 0.05). The decrease of 8-OHdG and malondialdehyde and the increase of SOD in the treatment group were significantly higher than those in the control group (P<0.05). After treatment, VILIP-1, Aβ, p-tau181, and NFL of both groups decreased compared with those before treatment, and treatment group was lower than control group (P < 0.05). Conclusion Compound Congrong Yizhi Capsules combined with memantine has a definite therapeutic effect in treatment of Alzheimer’s disease, and can reduce the TCM syndrome score, improve cognitive function, and regulate oxidative stress indicators and neuronal damage markers.

R971

河北省卫生健康委资助项目(20261254)