“补肾生髓”理念下龟鹿二仙胶干预AD患者VRS及炎症的临床研究

Clinical study of Guilu Erxian glue on VRS and inflammation in the patients with Alzheimer’s disease under the concept of "tonifying kidney and generating marrow"

目的观察龟鹿二仙胶干预阿尔茨海默病(AD)Virchow-Robin腔(VRS)及炎症的效应机制。方法80例西医诊断为AD,中医诊断为肾虚髓空证的患者随机分成两组,每组40例。两组患者都睡前口服安理申,每次1片(5mg),在此基础上对照组给予安慰剂,治疗组采用龟鹿二仙胶治疗,疗程为60天。两组患者治疗前(第0天)、治疗后第31天及第61天分别进行头颅核磁共振成像(Nuclear Magnetic Resonance Imaging,MRI)检查,计数中脑、基底节区、岛叶深部白质、半卵圆中心VRS的数目,并测量其直径;此外,检测两组患者血清中肿瘤坏死因子-α(TNF-α)、白介素-6(IL-6)、白介素-1(IL-1)。结果两组患者各项指标在第31天时候皆无变化,差异无统计学意义(P>0.05);第61天,两组患者各部位VRS数目较各自第0天无变化(P>0.05),组间比较差异亦无统计学意义(P>0.05),而VRS直径、TNF-α、IL-6、IL-1,两组与治疗前比较皆有统计学差异(P<0.05,P<0.01),且组间差异亦有统计学意义(P<0.05,P<0.01)。结论龟鹿二仙胶具有改善患者VRS直径及调节炎症的作用,此可能为其补肾生髓的作用机制之一。

Objective To observe the effect mechanism of Guilu Erxian Gum on Virchow-Robin spaces(VRS)in Alzheimer's disease(AD).Methods 80 patients with AD diagnosed by Western medicine and vacuity of marrow diagnosed by traditional Chinese medicine were randomly divided into two groups,40 cases in each group.Patients in both groups were given an oral cholinesterase inhibitor,aricept,one tablet(5mg)each time,before going to bed at night.The control group was given a placebo.The treatment group was treated with Guilu Erxian glue for 60 days.the respective number of VRS in middle brain,Basal Ganglia,deep white matter of insular lobe and central half-ovale were counted and the diameter of the Magnetic Resonance imagin was measured before Treatment(0d),after treatment(31d)and after treatment(61d);In addition,tumor necrosis factor-α(TNF-α),interleukin-6(IL-6)and interleukin-1(IL-1)in the serum of the two groups were detected.Results The indexes of the two groups did not change on the 31th day,and the difference was not statistically significant(P>0.05);on the 61th day,the respective number of VRS in each part of the two groups did not change compared with the 0th day(P>0.05),and the difference between the two groups was not statistically significant(P>0.05).The diameter of VRS,TNF-α,IL-6,IL-1 in the two groups was statistically significant compared with that before treatment(P<0.05,P<0.01),and the difference between the two groups was statistically significant(P<0.05,P<0.01).Conclusion The Guilu Erxian gum has the effect of adjusting the diameter of VRS and inflammation in patients,which may be one of the mechanism of tonifying kidney and generating marrow.