潜阳育阴颗粒早期介入延缓高血压认知障碍患者脑白质病变的临床研究

  目的  观察潜阳育阴颗粒治疗高血压认知障碍患者的临床疗效及对脑白质病变体积的影响。  方法  采用随机对照、多中心入组，将患者分成治疗组64例、对照组33例、多奈哌齐组34例。对照组予以西医常规基础治疗，治疗组在对照组治疗基础上加服潜阳育阴颗粒，多奈哌齐组在对照组治疗基础上加服多奈哌齐，疗程均为6个月，治疗前后比较3组患者血压、脑白质病变体积、简易精神状态检查表(MMSE)、血管性痴呆评估量表(VaDAS-cog)和中医证候积分变化情况。同时观察3组患者血常规、肝肾功能等安全性指标变化。  结果  治疗后, 3组患者血压均明显下降(P < 0.01)，组间无明显差异(P>0.05);3组中医证候积分均有下降(P < 0.01), 治疗组优于对照组与多奈哌齐组(P < 0.01);3组患者脑白质病变体积均显著增加(P < 0.01), 治疗组的脑白质病变体积增加少于对照组与多奈哌齐组(P < 0.05);治疗组MMSE评分明显增加(P < 0.01)，优于对照组和多奈哌齐组(P < 0.01);治疗组VaDAS-cog评分显著降低(P < 0.01), 优于对照组(P < 0.01)。治疗期间3组患者均未出现明显不良反应。  结论  潜阳育阴颗粒能显著改善高血压患者认知功能, 延缓脑白质病变进展, 并具有安全性。 

Clinical Study on Early Intervention of Qianyang Yuyin Granules to Slow Progression of Leukoencephalopathy in Hypertensive Patients with Cognitive Impairment

  OBJECTIVE  To observe the clinical efficacy of Qianyang Yuyin Granules in the treatment of hypertensive patients with cognitive impairment and the effect on their leukoencephalopathy volume.  METHODS  The patients were randomly divided into 64 cases in the treatment group, 33 cases in the control group, and 34 cases in the donepezil group by randomized controlled, multicenter enrollment. In the control group, the patients were treated with conventional western medicine, while in the treatment group and donepezil group, the patients were separately treated with Qianyang Yuyin Granules and donepezil based on the therapies in the control group. The course of the treatment was 6 months.The changes of blood pressure, leukoencephalopathy volume, Mini-Mental State Examination (MMSE), Vascular Dementia Assessment Scale (VaDAS-cog), as well as traditional Chinese medicine (TCM) syndrome score were compared before and after treatment in the three groups. Besides, the changes of safety indexes such as blood routine examination, liver and kidney function were also observed.  RESULTS  After treatment, blood pressure was lowered significantly in all three groups (P < 0.01), with no significant differences between each groups(P>0.05). The TCM syndrome score were reduced in all three groups (P < 0.01), while the treatment group showed better results than the control group and the donepezil group did (P < 0.01). The leukoencephalopathy volumes were increased significantly in all three groups (P < 0.01), but the increase of leukoencephalopathy volume in the treatment group was less than that in the control group and the donepezil group (P < 0.05). MMSE scores were increased significantly in the treatment group (P < 0.01), whose results were better than those in the control group and the donepezil group (P < 0.01). VaDAS-cog scores were decreased significantly in the treatment group (P < 0.01), whose results were also better than those in the control group (P < 0.01). In addition, no significant adverse reactions were observed in any of the three groups during the treatment period.  CONCLUSION  The Qianyang Yuyin Granules can notably improve the cognitive function of hypertensive patients, and can evidently slow their progression of leukoencephalopathy with safety.