鲁拉西酮与利培酮治疗急性期精神分裂症患者的临床研究  

Clinical trial of lurasidone hydrochloride and risperidone in patients with acute schizophrenia

作　　者：陈杰 宋立平 曾宽 王刚 CHEN Jie;SONG Li-ping;ZENG Kuan;WANG Gang(Psychosomatic Ward,Wuhan Mental Health Center,Wuhan 430022,Hubei Province,China;Department of Psychiatry,Wuhan Mental Health Center,Wuhan 430022,Hubei Province,China;Drug Addiction Ward,Wuhan Mental Health Center,Wuhan 430022,Hubei Province,China)

机构地区：[1]武汉市精神卫生中心心身医学病区,湖北武汉430022 [2]武汉市精神卫生中心精神科,湖北武汉430022 [3]武汉市精神卫生中心成瘾病区,湖北武汉430022

出　　处：《中国临床药理学杂志》2024年第16期2307-2310,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察鲁拉西酮治疗急性期精神分裂症患者的疗效、认知功能恢复及安全性。方法将急性期精神分裂症患者随机分为试验组、对照组。试验组给予鲁拉西酮初始剂量40 mg·d^(-1),1周内逐渐调整为40~80 mg·d^(-1)维持治疗,每日1次。对照组口服利培酮片4~6 mg·d^(-1),分2次服用;2组患者均治疗6周。于用药前和用药第1、2、4、6周后分别进行阳性与阴性症状量表(PANSS)和蒙特利尔认知评估量表(MoCA)评定。比较2组患者的临床疗效和药物不良反应发生率。结果试验组和对照组分别有42例和41例纳入分析。试验组和对照组的总有效率分别为80.95%和80.49%,在统计学上差异无统计学意义(P>0.05)。用药前,试验组和对照组PANSS总分分别为(88.12±8.99)和(88.68±9.29)分,MoCA评分分别为(20.48±2.65)和(20.24±2.85)分;用药6周后,PANSS总分分别为(55.90±11.14)和(54.68±13.34)分,MoCA评分分别为(26.74±1.99)和(25.22±2.46)分。用药后与用药前比较,2组PANSS总分和MoCA评分差异均有统计学意义(均P<0.01)。用药后试验组MoCA评分与对照组比较,在统计学上差异有统计学意义(P<0.01)。试验组和对照组的药物不良反应发生率分别为30.95%和56.10%,在统计学上差异有统计学意义(P<0.05)。结论鲁拉西酮治疗急性期精神分裂症的疗效与利培酮相当,能更好地改善认知功能,且鲁拉西酮药物不良反应发生率更低,耐受性更好。Objective To observe the efficacy,cognitive function and safety of lurasidone hydrochloride in the treatment of acute schizophrenics.Methods Patients with acute schizophrenia were randomly divided into treatment group and control group.The treatment group was given lurasidone hydrochloride at the dosage of 40 mg on day 1,and 40-80 mg according to the need within 1 week,once a day.The control group received 4-6 mg·d^(-1)risperidone twice a day.The total observation lasted for 6 weeks.The positive and negative symptoms scales(PANSS)were performed at baseline,the 1st,the 2nd,the 4th and the 6th weekend of the treatment.Both groups were evaluated by Montreal cognitive assessment(MoCA)at baseline,and the 6th weekend.Compare the clinical efficacy and incidence of adverse drug reactions between the 2 groups of patients.Results 42 patients in the treatment group and 41 patients in the control group.The total effective rates for the treatment and control groups were 80.95%and 80.49%,respectively,with no statistically significant difference(P>0.05).In treatment group and control group,at baseline,the total PANSS scores were 88.12±8.99 and88.68±9.29,the MoCA scores were 20.48±2.65 and 20.24±2.85,respectively.At the 6th weekend of the treatment,the total PANSS scores were 55.90±11.14 and 54.68±13.34,the MoCA scores were 26.74±1.99 and25.22±2.46,respectively,both were statistically different with those before treatment(all P<0.01).MoCA scores were higher in the treatment group than those in the control group at the 6th weekend(P<0.01).The incidences of adverse reaction in the treatment group and the control group were 30.95%and 56.10%,respectively,with significant difference(P<0.05).Conclusion The efficacy of lurasidone hydrochloride and risperidone in the treatment of acute schizophrenia is equivalent.It is a kind of cognitive function well improved drug,as well as fewer adverse drug reactions,and well tolerated.

关 键 词：鲁拉西酮 利培酮 急性期精神分裂症 认知功能 

分 类 号：R97[医药卫生—药品]