布南色林治疗难治性精神分裂症的效果和安全性

Efficacy and safety of blonanserin in the treatment of treatment-resistant schizophrenia

中文关键词:  难治性精神分裂症  布南色林  疗效  安全性

英文关键词:Treatment-resistant schizophrenia  Blonanserin  Efficacy  Safety

中文摘要:

      背景 部分精神分裂症患者由于治疗抵抗最终发展为难治性精神分裂症，患者会出现更严重的认知和社会功能受损，且在长期服用抗精神病药物的过程中出现诸多不良反应。目前，关于布南色林治疗难治性精神分裂症的证据有限。目的 探讨布南色林对难治性精神分裂症的疗效和安全性，以期为难治性精神分裂症的治疗提供参考。方法 纳入2024年9月—2025年1月在太原市精神病医院住院治疗的、符合《国际疾病分类（第10版）》（ICD-10）难治性精神分裂症诊断标准的患者43例，采用随机数字表法分为研究组（n=21）和对照组（n=22）。研究组接受布南色林（8~24 mg/d）治疗，对照组接受氨磺必利（400~1 200 mg/d）治疗。于治疗前、治疗第4周末及治疗第8周末，使用阳性和阴性症状量表（PANSS）、个人和社会功能量表（PSP）分别评定患者的精神病性症状和社会功能，采用霍普金斯词汇学习测验（HVLT）、Stroop色词测验（SCWT）、连线测验（TMT）、数字广度测验（DST）、数字符号转换测验（DSST）评定患者的认知功能。治疗过程中，记录两组不良反应发生情况。结果 两组PANSS阳性症状分量表评分、阴性症状分量表评分、一般精神病理分量表评分及总评分的时间效应均有统计学意义（F=186.505、149.318、135.671、416.744，P均<0.01）；两组PANSS一般精神病理分量表评分和总评分的时间与组别的交互效应均有统计学意义（F=3.483、4.318，P均<0.05）。治疗第8周末，研究组PANSS一般精神病理分量表评分和总评分均低于对照组，差异均有统计学意义（t=-2.106、-2.429，P均<0.05）。两组HVLT、SCWT词语测试和颜色测试评分的组别效应均有统计学意义（F=6.720、7.921、11.383，P<0.05或0.01）；两组SCWT词语测试和色词干扰测试、TMT以及DSST评分的时间与组别的交互效应均有统计学意义（F=3.571、4.095、3.463、37.000，P<0.05或0.01）。治疗第8周末，研究组DSST评分高于对照组，差异有统计学意义（t=2.074，P<0.05）。两组PSP评分的时间效应、组别效应以及时间与组别的交互效应均有统计学意义（F=433.710、4.463、10.491，P<0.05或0.01），治疗第8周末，研究组PSP评分高于对照组，差异有统计学意义（t=3.451，P<0.05）。两组不良反应发生率比较，差异均无统计学意义（P均>0.05）。结论 布南色林对改善难治性精神分裂症患者阳性症状和阴性症状的效果与氨磺必利相当，布南色林对一般精神病理症状、认知功能和社会功能的改善效果优于氨磺必利，且二者安全性相当。

英文摘要:

      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 4^th and 8^th 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 8^th 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 8^th 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 8^th 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）