Abstract
Background In schizophrenia,a subset of patients may progress to treatment-resistant schizophrenia owing to inadequate response to standard antipsychotic therapies,resulting in profound impairments in cognitive and social functioning alongside a cumulative burden of adverse drug reactions during the prolonged treatment.Currently,evidence supporting the use of blonanserin for treatment-resistant schizophrenia remains limited.Objective To investigate the efficacy and safety of blonanserin in the treatment of treatment-resistant schizophrenia,so as to provide references for clinical management of this condition.Methods A total of 43 inpatients fulfilling the International Classification of Diseases,tenth edition(ICD-10)diagnostic criteria for treatment-resistant schizophrenia were consecutively recruited from Taiyuan Psychiatric Hospital from September 2024 to January 2025.Subjects were assigned to either the study group(n=21)or the control group(n=22)using the random number table method.The study group received blonanserin at a daily dosage ranging from 8 to 24 mg,while the control group was administered amisulpride at a daily dosage from 400 to 1 200 mg.At baseline and at the end of the 4th and 8th week of treatment,the Positive and Negative Symptom Scale(PANSS)and the Personal and Social Performance scale(PSP)were used to access patients'psychotic symptoms and social functioning,respectively.Cognitive function was evaluated using the Hopkins Verbal Learning Test(HVLT),the Stroop Color-Word Test(SCWT),the Trail Making Test(TMT),the Digit Span Test(DST),and the Digit Symbol Substitution Test(DSST).During the treatment process,treatment-related adverse reactions were recorded between two groups.Results Significant time effects were found in PANSS total scores,as well as its positive symptom,negative symptom,and general psychopathological subscale scores(F=186.505,149.318,135.671,416.744,P<0.01).The group-by-time interaction effect was significant in PANSS total scores and general psychopathological subscale scores(F=3.483,4.318,P<0.05).At the end of the 8th week,the study group exhibited lower general psychopathological subscale scores and the PANSS total scores compared to the control group,with statistically significant differences(t=-2.106,-2.429,P<0.05).Significant group effects were detected in HVLT scores,Stroop word scores and Stroop color scores(F=6.720,7.921,11.383,P<0.05 or 0.01).The group-by-time interaction effect for Stroop word scores,Stroop interference scores,TMT scores and DSST scores were statistically significant(F=3.571,4.095,3.463,37.000,P<0.05 or 0.01).At the end of the 8th week,the DSST score of the study group was higher than that of the control group(t=2.074,P<0.05).For PSP scores,significant time effect,group effect and group-by-time interaction effect were all observed(F=433.710,4.463,10.491,P<0.05 or 0.01).At the end of the 8th week,the study group reported higher PSP score compared to the control group,with a statistically significant difference(t=3.451,P<0.05).No significant difference in the incidence of adverse reactions was exhibited between the two groups(P>0.05).Conclusion Blonanserin demonstrates efficacy comparable to amisulpride in ameliorating positive and negative symptoms in patients with treatment-resistant schizophrenia.Notably,blonanserin exhibits a superior efficacy to amisulpride in improving general psychopathological symptoms,cognitive and social functioning,while both agents show comparable safety profiles.(www.chictr.org.cn number:ChiCTR2400094222).关键词
难治性精神分裂症/布南色林/疗效/安全性Key words
Treatment-resistant schizophrenia/Blonanserin/Efficacy/Safety分类
医药卫生
