| Objective:The aim was to study the efficacy and safety in treating dementia of QSBS with Dengyin Naotong Capsule.Methods:A prospective,randomized,double-blind,double-simulation,single-center, positive-controlled, parallel group trial was adopted72cases were enrolled in this study,and all patients were randomly divided into two groups.Treatment group took orally "Dengyin Naotong Capsule",0.52g and two tablets of placebo/time,tid. Control group was given two tablets of Hydergine and two placebo capsule/time,tid.Two groups were given the basis medicine treatment to control hypertension,diabetes, hyperlipidaemia and so on.and were stopped taking all the medicine for treating vascular cognitive impairment.All patients in the two groups treated for12w±7days. Before and after treatment,we compared and analysised MMSE scale.MoCA scale,ADL-R scale scores of two groups,we summarized and observed the wave amplitude and latency of ERP P300,integral of syndrome of Traditional Chinese Medicine and laboratory indexes.Results:1.MMSE scale,ADL-R scale,MoCA scale scores comparison:The comparison of MMSE scale,ADL-R scale and MoCA scale scores of all patients in the two groups before treatment have no difference (P>0.05);Three scales scores in the two groups were found significantly statistical different before and after treatment (p<0.01);The results showed that the two medicines can improve patients’cognitive function;After treatment,the comparison of three scales scores in the two groups has no significant differences (P>0.05).So both drugs showed similar efficacy in the treatment of VCI. 2.ERP(Event-related Potentials) comparison:Before treatment,P30o markers showed no difference between the two groups (P>0.05).Compared with6th weeks and12th weeks, the variations of P300markers of patients were remarkable differences among Cz sites in treatment group,among the Fz and Pz sites in control group (p<0.05).It showed that Dengyin Naotong Capsule and Hydergine have similar effect in making P300latency shortened.3.Integral of syndrome of Traditional Chinese Medicine comparison:Before treatment, integral of syndrome of TCM in treatment group was not different from that in control group (P>0.05); Compared with pre-post treatment, integral of syndrome of TCM in the two groups descented obviously (p<0.01); Integral of syndrome of TCM in treatment group was not different from that in control group at the6th week (P>0.05), but was different significantly at the12th week(P<0.05).It showed that Dengyin Naotong Capsule was better than Hydergine in improving QSBS symptom.4. LDL-C/TC comparison:Compared with pre-post treatment, LDL-C and TC in treatment group were decreased obviously (p<0.05).but in control group were not different significantly (P>0.05).It showed that Dengyin Naotong Capsule was better than Hydergine in decreasing the levels of LDL-C and TC5. Assessment of the therapeutic efficacy:After treatment,8patients showed excellent in efficiency.19demonstrated effective and9with no response in the treatment group, total effective rate was75%. As for the control group,2cases were significantly effective,14cases were effectual and20cases were unfruitful with a total cure rate of44.4%. Total effective rate showed a significantly statistical difference between the two groups (p<0.01).So Dengyin Naotong Capsule was better than Hydergine in improving QSBS symptom.6.Safety judgement:During treatment,all patients in the two groups had not severe adverse reaction, so it is easy to take and be accepted by patients. Compared with pre-post treatment.blood routine,liver function and kidney function in the two groups were not different significantly (P>0.05)Conclusions:Dengyin Naotong Capsule for the treatment of Dementia of QSBS(Vascular Cognitive Impairment,VCI)was effective and safe.It can effectively improve cognitive function,latency of P3oo,serum lipid of dementia of QSBS(VCI)patients and has no effect on the routine blood test,liver function test and kidney function test.During the clinical observation,Dengyin Naotong Capsule had not adverse reactions and side effects.So Dengyin Naotong Capsule is effective and safe for the treatment of dementia of QSBS(VCI),and it is worthy of further study. |
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