| Objective:(1)Meta analysis was used to compare the therapeutic efficacy and side effects of paliperidone extended release and aripiprazole in patients with schizophrenia,and it can supply information for clinical application.At the same time,the clinical trials of the two drugs were carried out.(2)At the same time,a randomized double-blind controlled trial was conducted to observe whether the results of meta analysis were consistent with the clinical trial.Methods:(1)Randomized controlled trial(RCT)related to the paliperidone extended release and aripiprazole in patients with schizophrenia were searched in PubMed,Embase,Cochrane Library,CNKI,Wanfang,VIP,CBM databases.Search time was from January 2009 to December 2019.Meta analysis was carried out with RevMan5.3 software.Sensitivity analysis and publication bias analysis were performed on meta analysis results.(2)152 patients with schizophrenia were randomly assigned into experimental group(using paliperidone extended release)and control group(using aripiprazole),76 cases in each group.The positive and negative symptom scale(PANSS),personal and social functioning scale(PSP)were used to evaluate the clinical efficacy and social function,and the treatment emergent symptom scale(TESS)was used to assess the adverse reactions before the treatment or after 2,4,8,12 weeks treatment.Results:(1)Finally,a total of 16 RCT literatures were included.Meta analysis showed that,the total score of PANSS in the paliperidone extended release group were lower than aripiprazole group after the treatment of week 2,4 and 8,and the difference was statistically significant(after 2 weeks treatment: MD =-5.32,95%CI [-7.21,-3.42],P<0.01;after 4 weeks treatment: MD =-2.46,95%CI [-4.63,-0.28],P = 0.03;after 8 weeks treatment: MD =-2.63,95%CI [-4.68,-0.58],P = 0.01).At the end of the treatment,the positive symptoms scores(MD =-0.74,95% CI [-1.50,0.02],P = 0.06),negative symptoms scores(MD =-1.13,95% CI [-2.31,0.06],P = 0.06)and general psychotic symptoms scores(MD =-0.48,95% CI [-1.44,0.47],P = 0.32)were no significant differences between the two groups;compared with aripiprazole group,the total score of PANSS in paliperidone extended release group was lower,and the difference was statistically significant(MD =-4.18,95% CI [-6.62,-1.75],P = 0.0007);the PSP scores of paliperidone extended release group was higher than aripiprazole group,and the difference was statistically significant(MD = 11.32,95% CI [5.02,17.61],P = 0.0004).(2)At the end of the treatment,the TESS score was no significant differences between the two groups(MD =-0.04,95% CI [-0.58,0.50],P = 0.88);the prolactin level in paliperidone extended release group was higher than aripiprazole group,and the difference was statistically significant(MD =31.39,95% CI[13.62,49.15],P=0.0005).Adverse reactions were no significant differences from two groups(P>0.05).(3)Totally 144 patients were included in the analysis,71 for the experimental group and 73 for the control group.At the end of 12 weeks,the total PANSS scores,positive symptoms,negative symptoms,general psychopathology symptoms and PSP scores of the two groups were obviously better compared with those before the treatment(P<0.05).Compared between groups,the improvement of PANSS total scores and PSP scores of the experimental group in the same observation period were better than that of the control group,the difference was statistically significant(P <0.05).There were no significant differences in TESS scores and adverse reactions between the two groups(P> 0.05).Conclusion:Meta analysis results are consistent with clinical trial: paliperidone extended release is better than aripiprazole in the treatment of schizophrenia.And it has faster effect and has much better effect for the PSP scores.The adverse reactions between the two drugs is similar,but paliperidone extended release can elevate the serum prolactin.The results need to be confirmed by high-quality large samples of RCT. |
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