益智清心方治疗瘀毒互结血管性痴呆多中心随机双盲安慰剂对照研究OA

Objective To evaluate the clinical efficacy and safety of Yizhi Qingxin Formula(YQF)for vascular dementia(VaD)with syndrome of blood stasis and toxin.Methods A multicenter,randomized,double-blind,placebo-controlled trial was performed.A total of 120 VaD patients were enrolled and randomly assigned to the YQF group or the placebo group at a 1∶1 ratio.The participants received 1 sachet of the intervention twice daily for a 3-month treatment course.The changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-cog),mini-mental state examination(MMSE),Activities of Daily Living(ADL),Chinese medicine(CM)syndrome score,neurofilament light chain(NFL),fibrinogen(FIB),interleukin(IL)-6,IL-1β and TNF-α were evaluated before and after treatment.Safety indicators including routine blood tests,electrocardiogram(ECG),liver and kidney function and routine urine and stool tests were monitored throughout the trial.Results During the study,18 patients dropped out,and 102 patients(51 cases in each group)were included in the final analysis.Compared with baseline,both groups showed significant improvements in ADAS-cog,MMSE,ADL,and CM syndrome scores(P＜0.01),as well as reductions in NFL,IL-6,IL-1β,and TNF-α levels(P＜0.05).Compared with the placebo group,YQF group showed greater improvements in ADAS-cog and CM syndrome score(P＜0.05),and greater reductions in NFL,IL-6,IL-1β(P＜0.05).The total response rates of ADAS-cog(62.7％vs.43.2％)and CM syndrome score(66.6％vs.43.1％)were higher in the YQF group(P＜0.05).No obvious adverse reactions were observed.Conclusion YQF significantly ameliorates cognitive dysfunction and CM syndrome patterns in VaD patients with intertwined toxin and blood stasis pattern,possibly by regulating neurofilament light chain and inhibiting inflammatory responses,and demonstrates a favorable safety profile.(Chinese Clinical Trial Registry No.ChiCTR2200056255)