摘要
目的探讨两种起始剂量的鲁拉西酮治疗急性精神分裂症的安全性及疗效。方法根据随机、开放、前瞻性的研究设计,选取2021年10月至2023年6月在杭州市第七人民医院接受治疗的精神分裂症患者61例,采用随机化系统分为40 mg/d起始剂量组(28例)与80 mg/d起始剂量组(33例)。两组均给予鲁拉西酮治疗,持续治疗6周,起始固定剂量治疗7 d后调整或维持剂量。安全性评估包括不良事件导致的停药率、不良事件和不良反应发生率、体重和其他代谢指标。疗效评估包括第1周末和第2周末应答者的比例[阳性和阴性症状量表(PANSS)总分改善≥20%]、治疗结束时的PANSS总分、PANSS分量表(阳性、阴性和一般精神病理量表)、临床总体印象严重程度(CGI-S)量表和卡尔加里精神分裂症抑郁量表(CDSS)评分及较基线的变化。结果两组患者均未发生导致停药的不良事件,治疗期间的不良事件和不良反应发生率相似(均P>0.05)。治疗结束时两组体重较基线的变化差异均无统计学意义(均P>0.05)。两组代谢指标从正常转变为有临床意义的异常患者比例均较低,且两组比较差异均无统计学意义(均P>0.05);两组第1周末和第2周末的应答率比较差异均无统计学意义(56.0%比30.8%、68.0%比61.5%,均P>0.05),两组在所有访视点的PANSS总分和分量表评分、CGI-S量表评分和CDSS评分均较基线明显改善(均P<0.05),两组比较差异均无统计学意义(均P>0.05)。结论40 mg/d起始剂量与80 mg/d起始剂量的鲁拉西酮治疗精神分裂症均安全有效,患者耐受良好。
Objective To compare the safety and efficacy of two initial doses of lurasidone in treatment of patients with acute schizophrenia.Methods Sixty-one patients with acute schizophrenia admitted in Hangzhou Seventh People's Hospital from October 2021 to June 2023 were randomly assigned to two groups.Both groups were treated with lurasidone for 6 weeks,28 patients had initial dose of 40 mg/d(low initial dose group)and 33 cases had initial dose of 80 mg/d(high initial dose group),the dose was adjusted or maintained after 7 days.Safety assessments included the discontinuation rates due to adverse events,the incidence of adverse events and adverse reactions,body weight,and other metabolic parameters.Positive and Negative Ssyndrome Scale(PANSS),Clinical Global Impression-Severity(CGI-S)and Calgary Depression Scale for Schizophrenia(CDSS)were used to assess the efficacy.The proportion of responders at week 1 and 2(total PANSS score improvement≥20%),the changes in PANSS total score and PANSS subscales,the changes of CGI-S and CDSS scores from baseline to the end of treatment and at each visit point were compared between two groups.Results No discontinuations due to adverse events occurred in either group,and the incidence of adverse events and adverse reactions during treatment was similar in both groups(P>0.05).No significant difference was observed in the weight change from baseline to treatment endpoint in either group(P>0.05).The proportion of patients whose metabolic parameters shifted from normal to clinically significant abnormal at the endpoint was low in both groups,and there was no significant difference between the two groups(P>0.05).There was no significant difference in the proportion of responders at week 1 and 2(P>0.05),and both treatment groups demonstrated significant improvements in the PANSS total score,CGI-S scale score,and CDSS scale score at all visit points compared with those at the baseline(all P<0.05),and there was no significant difference between the two groups(all P>0.05).Conclusion Lurasidone
作者
高可润
谭忠林
董介正
陈松
朱春燕
吕文
胡楠楠
胡希文
朱丞
江长旺
王卓
张开元
李涛
GAO Kerun;TAN Zhonglin;DONG Jiezheng;CHEN Song;ZHU Chunyan;LYU Wen;HU Nannan;HU Xiwen;ZHU Cheng;JIANG Changwang;WANG Zhuo;ZHANG Kaiyuan;LI Tao(Department of Psychiatry,Affiliated Mental Health Center&Hangzhou Seventh People's Hospital,Zhejiang University School of Medicine,Hangzhou 310013,China)
出处
《浙江医学》
CAS
2024年第20期2143-2149,共7页
Zhejiang Medical Journal
基金
浙江省医药卫生科技计划项目(2021RC025)
杭州市卫生科技计划项目(A20200609)。
