ABSTRACT
ObjectiveTo systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia. MethodA randomized， double-blind， double-simulated， positive drug/placebo parallel controlled multi-center phase Ⅳ clinical trial and an open multi-center phase Ⅳ clinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted. Safety data of 1 492 patients were included and analyzed according to inclusion and exclusion criteria. The main evaluation measures were the incidence rate of adverse events/adverse reactions， laboratory indicators， vital signs， and electrocardiogram （ECG） results. ResultA total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial， and the symptoms were all mild and recovered. The incidence of adverse events was not statistically different among Tianzhi granules， donepezil， and placebo groups. Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial， and the symptoms were mild and recovered. Laboratory tests （blood routine， urine routine， liver function， kidney function， and coagulation） and vital signs were compared before treatment （baseline） and after treatment of 12 and 24 weeks， respectively. There was no statistical significance in the main indicators before and after treatment. In the double-blinded trial， there was no significant difference in safety indicators between different groups before and after treatment. The most frequent adverse reaction was gastrointestinal discomfort， with an incidence rate of 6.64‰. ConclusionAdverse reactions occasionally occur in patients using Tianzhi granules， and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.
ABSTRACT
OBJECTIVE:To investigate the clinical efficacy and safety of Memantine hydrochloride tablets combined with Tianzhi granules in the treatment of vascular dementia. METHODS:A total of 94 patients with vascular dementia selected from our hospital during Jun. 2014-Jun. 2016 were divided into observation group and control group according to random number table,with 47 cases each. Besides basic therapy,control group was given Tianzhi granules 5 g,po,tid. Observation group was additionally given Memantine hydrochloride tablets with initial dose of 5 mg,increasing by 5 mg every week,maintaining dose of 20 mg/d at 4th week,po,qd,on the basis of control group. Both groups received treatment for consecutive 4 weeks. Clinical efficacies as well as MMSE,MoCA,ADL scores,the levels of brain-derived neurotrophic factor(BDNF),malondialdehyde(MDA)and super-oxide dismutase(SOD)before and after treatment were observed in 2 groups.The occurrence of ADR was recorded.RESULTS:To-tal response rate of observation group(80.85%)was significantly higher than control group(61.70%),with statistical significance (P<0.05). Before treatment,there was no statistical significance in MMSE,MoCA,ADL scores,the levels of BDNF,MDA or SOD between 2 groups(P>0.05).After treatment,MMSE,MoCA,ADL scores,the levels of BDNF and SOD in 2 groups were increased significantly,while MDA level was decreased significantly;observation group was significantly better than control group,with statistical significance(P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:Memantine hydrochlo-ride tablets combined with Tianzhi granules in the treatment of vascular dementia show significant therapeutic efficacy,and can im-prove cognitive function,daily living activity and BDNF,MDA and SOD levels of patients with good safety.
ABSTRACT
OBJECTIVE:To investigate the clinical efficacy and safety of Memantine hydrochloride tablets combined with Tianzhi granules in the treatment of vascular dementia. METHODS:A total of 94 patients with vascular dementia selected from our hospital during Jun. 2014-Jun. 2016 were divided into observation group and control group according to random number table,with 47 cases each. Besides basic therapy,control group was given Tianzhi granules 5 g,po,tid. Observation group was additionally given Memantine hydrochloride tablets with initial dose of 5 mg,increasing by 5 mg every week,maintaining dose of 20 mg/d at 4th week,po,qd,on the basis of control group. Both groups received treatment for consecutive 4 weeks. Clinical efficacies as well as MMSE,MoCA,ADL scores,the levels of brain-derived neurotrophic factor(BDNF),malondialdehyde(MDA)and super-oxide dismutase(SOD)before and after treatment were observed in 2 groups.The occurrence of ADR was recorded.RESULTS:To-tal response rate of observation group(80.85%)was significantly higher than control group(61.70%),with statistical significance (P<0.05). Before treatment,there was no statistical significance in MMSE,MoCA,ADL scores,the levels of BDNF,MDA or SOD between 2 groups(P>0.05).After treatment,MMSE,MoCA,ADL scores,the levels of BDNF and SOD in 2 groups were increased significantly,while MDA level was decreased significantly;observation group was significantly better than control group,with statistical significance(P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:Memantine hydrochlo-ride tablets combined with Tianzhi granules in the treatment of vascular dementia show significant therapeutic efficacy,and can im-prove cognitive function,daily living activity and BDNF,MDA and SOD levels of patients with good safety.
ABSTRACT
Objective To observe the clinical effects of treating Vetigo due to Vertebrobasilar Insufficient blood supply and hyperactivity of liver-Yang with Tianzhi Granules. Methods 118 cases were randomly recruited into a treatment group with 62 cases and a control group with 56 cases. On base of routine treatment, the treatment group was treated with Tianzhi Granules orally; and the control group was treated with Duflomed Hydrochloride orally. One course of treatment was 14 days. Results The total effective rates were 96.77%and 78.57% in treatment group and control group respectively. There was a significant difference between the two groups(P<0.05). The blood flow rat(BFR)of brain was improved in both groups, but the improvement of the BFR in brain was significantly better in the treatment group than the control group (P< 0.05). No adverse reaction was found in the treatment group. Conclusion Tianzhi Granules is effective and safe in treating Vetigo due vertebrobasilar insufficient blood supply.