Clinical Study On The Treatment Of Vertigo (blood Stasis Syndrome) Caused By Cerebral Arteriosclerosis With Ginkgo Ketone Ester Dropping Pills

Objective:To evaluate the efficacy and safety of GBE50 in the treatment of dizziness(blood stasis syndrome)caused by cerebral arteriosclerosis.Methods:A total of 404 patients were randomly divided into experimental group(GBE50 group)and control group(Naoxinqing group),202 cases in each group.GBE50 group was given GBE50 and Naoxinqing tablet of mimetic agent,and the control group was given Naoxinqing tablet and GBE50 of mimetic agent for 6 weeks.The primary efficacy indexes were the efficacy of TCM syndromes score of blood stasis for 6 weeks,and the secondary efficacy indexes were DHI score,vertigo visual analogue scale(VAS)score,the university of California vertigo questionnaire(UCLA-DQ)score and TCM single symptom score before and 2,4 and 6 weeks after treatment.Safety measures included adverse events and laboratory indicators such as liver and kidney function.Results:A total of 404 subjects were included in this study,including 11 who did not complete the experiment(5 in the experimental group,including 4 cases of lost follow-up and 1 case of violating the test protocol;The abscission rate was 2.72%(experimental group 2.48%,control group 2.97%).Statistical analysis of demographic information,vital signs and physical examination of patients in the two groups showed no significant difference(P>0.05),indicating comparability.1.Evaluation of the efficacy of TCM syndromes:the total effective rate of the experimental group was 92.67%after 6 weeks of treatment,and the total effective rate of the control group was 83.07%.2.The scores of the vertigo disorder scale in both groups were lower than those in the control group.The total score and baseline scores of the vertigo disorder scale in the experimental group were lower than those in the control group after 6 weeks of treatment(P=0.0188).3.VAS score in both groups decreased compared with that in the control group.The VAS score in the experimental group was significantly different from that in the control group after 6 weeks of treatment(P=0.0008),and the reduction value between the experimental group and the baseline after 6 weeks of treatment was higher than that in the control group(P=0.0001).4.The UCLA-DQ score decreased in both groups compared with those of the control group.The UCLA-DQ score of the 6-week treatment group was different from those of the control group(P=0.0056),and the reduction scores of the 6-week treatment and baseline were higher in the experimental group than in the control group(P=0.0001).5.Compared with the control group,there was statistically significant difference in the single symptom scores of TCM(dizziness,dizziness,headache and amnesia)in the experimental group at 6 weeks and the reduced scores at the time of inclusion(P<0.05).6.Safety assessment:There was 1 case(1 time,0.05%)of adverse events related to the study drug in the test group,presenting as mild "abnormal ALT","abnormal AST" and"abnormal GGT",and the patient's liver function was normal after discontinuation of statins.There was 1 serious adverse event in the control group,which was not related to drugs.Conclusion:The efficacy of GBE50 in treating patients with vertigo caused by cerebral arteriosclerosis is better than that of Naoxinqing tablets,improves the TCM syndrome and has better safety.