| Objective:Schizophrenia has high morbidity and many patients need lifelong treatment.Many guidelines recommends single medication rather than combined use of antipsychotic drugs.But multi drugs combination therapy is very common.For a long time,the reasonability of drug combination therapy is under debate.To verify the efficacy and safety of drugs combination therapy,this study compares risperidone combined with aripiprazole and a single risperidone,to investigate the clinical efficacy and safety of risperidone combined with aripiprazole for the treatment of schizophrenia.Methods:In this study,146 outpatients and inpatients with schizophrenia were enrolled from September 2016 to July 2017 in Tianjin Anding Hospital.Patients were treated with risperidone alone or risperidone combined with aripiprazole when they were enrolled in the group.And the time of using the above regimen was no longer than 1months,in addition to PANSS scores are more than 60 points.The patients were divided into experimental group and control group according to their medications when they were enrolled.The experimental group was treated with risperidone combined with aripiprazole,and the control group was treated with risperidone alone.The patients were observed for 12 weeks without changing the types of antipsychotic drugs.At the baseline and on the 12th week of treatment,routine blood tests,biochemical tests,and electrocardiogram were conducted.The clinical efficacy of the test group and the control group was evaluated according to the PANSS score reduction rate,the effective rate and theΔPANSS score.The TESS scale was used to assess the occurrence of side effects of drugs.Assessments were made at baseline and on the 12th week of treatment.SPSS17.0 statistical software package was used for data analysis,P<0.05 was considered statistically significant.Results:1、There were 135 patients who completed the study for the last 12 weeks,with a loss of 11 cases.In the control group,there were 6 cases were dropped off:4 cases were due to discharge and loss of follow-up;1 case had epilepsy;and 1 case refused to continue to participate in the study.In the test group,there were 5 cases were dropped off:4 cases were due to discharge from the hospital and lost to follow-up,and 1 case changed treatment drugs due to somatic complications.2、After 12 weeks of treatment,the effective rate of the experimental group was86.76%,and the effective rate of control group was 70.15%,χ2=6.609,P=0.037。3、In the experimental group the scores of PANSS,positive factor,negative factor scores and general psychopathology score before and after treatment paired sample rank sum test,the results of P<0.05.The control group before and after treatment,PANSS total score,positive factor score and general psychopathology score of paired samples t test,negative factor before and after treatment by paired sample rank sum test,the results of P<0.05.Two independent samples rank sum test was used to evaluate the total score of PANSS,positive factor,negative factor and general psychopathology in the treatment of the two groups.The difference of PANSS total score,negative factor difference and general psychopathology difference test group was greater than that of the control group,indicating that the reduction of PANSS score in the test group before and after treatment was greater than that of the control group.4、At the end of the 12th week,side effects of constipation,weight gain and cathisophobia were compared.The side effects of the control group were more than those in the test group,P<0.05.5、By the end of 12th week,the dosage of risperidone in experimental group were significantly lower than that of in control group.6、There was no difference in theΔPANSS scores between the first-episode patients and recurrent patients in the trial group(P>0.05).There was no difference in theΔPANSS scores between the first-episode patients and recurrent patients in the control group(P>0.05).There was no difference in the PANSS scores between the trial group and the control group in the first patient(P>0.05);in the recurrent patients,the PANSS scoreΔtotal score andΔnegative factor scores in the trial group and the control group were subjected to independent sample rank sum tests,and two independent scores were obtained for theΔpositive factor score andΔgeneral psychopathological score.For theΔtotal score,Δnegative factor score,Δgeneral psychopathology,the scores of the trial group aresignificantly greater than that of the control group(P<0.05).7、In the trial group,the first-episode patients had more weight gain than did the non-first-episode patients;in the control group,the first-episode patients experienced increased salivation,weight gain,abnormal liver function,and seizures compared with non-first-episode patients;in the first-episode patients,constipation,salivation,and weight gain in the control group were more than those in the trial group;in the non-first-episode patients,the control group had more dizziness,weight gain,and akathisia than the trial group.Conclusion:1、The treatment effect of the trial group was better than that of the control group.2、Risperidone combined with aripiprazole is better than risperidone in the treatment of patients with recurrent patients.But for the first episode patients,there is no difference between the two treatments.3、All kinds of side effects occurred in the two groups.However,for constipation,weight gain and akathisia,,the control group was obvious than the trial group The study showed that the combination therapy did not increase the incidence of side effects of drugs.4、No matter in the trial group or the control group,there were more side effects in the first-episode group than in the recurrent group.5、The combination of aripiprazole treatment can reduce the dosage of risperidone,which reduces the incidence of some dosage related side effects. |