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1.山东省戴庄医院药学部,山东 济宁 272051
2.山东省戴庄医院精神科,山东 济宁 272051
副主任药师。研究方向:精神药理学。电话:0537-3165623。E-mail:550290515@qq.com
主任医师,硕士。研究方向:临床精神病学。电话:0537-3165633。E-mail:chenhong1569@126.com
纸质出版日期:2023-12-30,
收稿日期:2023-05-05,
修回日期:2023-11-27,
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李秀英,陈莹,陈宏.国产帕利哌酮缓释片治疗稳定期精神分裂症的疗效与安全性[J].中国药房,2023,34(24):3051-3054.
LI Xiuying,CHEN Ying,CHEN Hong.Efficacy and safety of domestic Paliperidone extended-release tablets in the treatment of stable schizophrenia[J].ZHONGGUO YAOFANG,2023,34(24):3051-3054.
李秀英,陈莹,陈宏.国产帕利哌酮缓释片治疗稳定期精神分裂症的疗效与安全性[J].中国药房,2023,34(24):3051-3054. DOI: 10.6039/j.issn.1001-0408.2023.24.17.
LI Xiuying,CHEN Ying,CHEN Hong.Efficacy and safety of domestic Paliperidone extended-release tablets in the treatment of stable schizophrenia[J].ZHONGGUO YAOFANG,2023,34(24):3051-3054. DOI: 10.6039/j.issn.1001-0408.2023.24.17.
目的
2
探讨国产帕利哌酮缓释片替代原研帕利哌酮缓释片治疗稳定期精神分裂症的疗效和安全性。
方法
2
收集2021年6月至2022年6月于山东省戴庄医院门诊就诊或住院且单一使用原研帕利哌酮缓释片治疗2个月及以上的精神分裂症患者65例,按随机数字表法分为国产组(33例)和原研组(32例);国产组患者换用相同剂量国产帕利哌酮缓释片治疗2个月,原研组患者继续使用原研药原剂量治疗2个月。分别于入组时和入组治疗1周末、1个月末和2个月末分别进行阳性和阴性症状量表(PANSS)、治疗伴发症状量表(TESS)评分,计算入组治疗2个月末的不良反应发生率;另外抽取静脉血检测空腹血糖、血脂指标(甘油三酯、总胆固醇、低密度脂蛋白、高密度脂蛋白、极低密度脂蛋白)、血清泌乳素水平和帕利哌酮血药浓度,计算帕利哌酮血药浓度与剂量的比值(
C
/
D
值),并行心电图检查。
结果
2
国产组和原研组分别有31、30例患者完成试验。两组患者在入组时及入组治疗1周末、1个月末和2个月末的PANSS评分、TESS评分、
C
/
D
值比较,以及在入组时和入组治疗2个月末的空腹血糖、血脂指标、血清泌乳素水平比较,差异均无统计学意义(
P
>0.05),而各组患者在入组治疗1个月末和2个月末的PANSS评分与同组入组时比较均显著降低(
P
<0.01)。国产组和原研组的不良反应发生率分别为25.81%、30.00%,组间比较差异无统计学意义(
P
>0.05),且两组患者的心电图均无明显异常。
结论
2
国产帕利哌酮缓释片可直接替代原研药治疗稳定期的精神分裂症,二者的临床疗效和安全性相当。
OBJECTIVE
2
To investigate the efficacy and safety of domestic Paliperidone extended-release tablets as a substitute for original Paliperidone extended-release tablets in the treatment of stable schizophrenia.
METHODS
2
A total of 65 patients with schizophrenia, who were treated with single original Paliperidone extended-release release tablets for 2 months or more in the outpatient or inpatient department of Shandong Daizhuang Hospital from June 2021 to June 2022, were collected and randomly divided into the domestic group (33 cases) and the original group (32 cases). The domestic group was treated with the same dose of domestic Paliperidone extended-release tablets instead for 2 months, and the original group continued to use the previous dose of the original drug for 2 months. Positive and negative syndrome scale (PANSS) and treatment emergent symptom scale (TESS) were used to evaluate the two groups at the time of enrollment and the end of 1 week, 1 month and 2 months after enrollment. The incidence of ADR was calculated at the end of 2 months after enrollment. The fasting blood glucose, blood lipid indicators (triglyceride, total cholesterol, low-density lipoprotein, high-density lipoprotein, very-low-density lipoprotein), serum prolactin levels, and paliperidone blood concentration were determined after the intravenous blood sample was collected. The ratio of paliperidone blood concentration to dose (
C/D
value) was calculated, and an electrocardiogram was performed.
RESULTS
2
There were 31 and 30 patients in the domestic group and the original group who completed the trial, respectively. There were no statistical significances in PANSS score, TESS score or
C
/
D
value at the time of enrollment and the end of 1 week, 1 month and 2 months after enrollment; there were no statistical significances in the levels of fasting blood glucose, blood lipid or serum prolactin at the time of enrollment and at the end of 2 months after enrollment (
P
>0.05). PANSS scores of both groups significantly decreased at the end of 1 month and 2 months after enrollment (
P
<0.01). The incidences of ADR were 25.81% in the domestic group and 30.00% in the original group, without significant difference (
P
>0.05), and there were no significant abnormalities in the electrocardiograms of the two groups.
CONCLUSIONS
2
Domestic Paliperidone extended-release tablets can directly replace the original tablets in the treatment of stable schizophrenia, and their clinical efficacy and safety are comparable.
帕利哌酮缓释片精神分裂症国产制剂原研制剂疗效安全性
schizo-phreniadomestic preparationoriginal preparationefficacysafety
VAN OS J,KAPUR S. Schizophrenia[J]. Lancet,2009,374(9690):635-645.
PHILLIPS M R,ZHANG J X,SHI Q C,et al. Prevalence,treatment,and associated disability of mental disorders in four provinces in China during 2001-05:an epidemiological survey[J]. Lancet,2009,373(9680):2041-2053.
SI T M,ZHUO J M,FENG Y,et al. Long-term efficacy and safety of paliperidone palmitate once-monthly in Chinese patients with recent-onset schizophrenia[J]. Neuropsychiatr Dis Treat,2019,15:1685-1694.
李凌江. 精神分裂症长期药物治疗的依从性[J]. 中华精神科杂志,2018,51(1):67-68.
LI L J. Compliance of long-term drug treatment for schizophrenia[J]. Chin J Psychiatry,2018,51(1):67-68.
俞悦,张利锋,潘裕生,等. 帕利哌酮缓释片的制备及体内外评价[J]. 中国医院药学杂志,2017,37(19):1947-1951,1968.
YU Y,ZHANG L F,PAN Y S,et al. Preparation and in vitro-in vivo evaluation of paliperidone extended-release tablets[J]. Chin J Hosp Pharm,2017,37(19):1947-1951,1968.
李春娟. 帕利哌酮缓释片的临床研究进展[J]. 齐齐哈尔医学院学报,2018,39(6):700-702.
LI C J. Clinical study of paliperidone sustained release tablets[J]. J Qiqihar Med Univ,2018,39(6):700-702.
SI T M,SUN L,ZHANG Y L,et al. Dose adjustment model of paliperidone in patients with acute schizophrenia:a post hoc analysis of an open-label,single-arm multicenter study[J]. Front Psychiatry,2021,12:723245.
GATTAZ W F,SARACCO-ALVAREZ R,DALTIO C S,et al. Treatment of patients with recently exacerbated schizophrenia with paliperidone palmitate:a pilot study of efficacy and tolerability[J]. Neuropsychiatr Dis Treat,2020,16:2063-2072.
TOST M,GONZÁLEZ-RODRÍGUEZ A,AGUAYO R,et al. Switching from risperidone to paliperidone palmitate in schizophrenia:changes in social functioning and cognitive performance[J]. Prog Neuropsychopharmacol Biol Psychiatry,2023,120:110619.
SI T M,CAI S L,ZHUO J M,et al. Switching to paliperidone extended release in patients with schizophrenia dissatisfied with previous olanzapine treatment:post hoc analysis of an open-label,prospective study[J]. Medicine,2019,98(3):e13688.
孙文文,程宇琪,陈娴瑜,等. 帕利哌酮治疗精神分裂症的血药浓度与临床疗效研究[J]. 中国现代医学杂志,2017,27(4):126-130.
SUN W W,CHENG Y Q,CHEN X Y,et al. Correlation between paliperidone plasma concentration and clinical efficacy in treatment of schizophrenia[J]. China J Mod Med,2017,27(4):126-130.
HIEMKE C,BERGEMANN N,CLEMENT H W,et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology:update 2017[J]. Pharmacopsychiatry,2018,51(1/2):9-62.
CAI S L,LU H F,BAI Z H,et al. Paliperidone extended-release tablets in Chinese patients with schizophrenia:meta-analysis of randomized controlled trials[J]. Neuropsychiatr Dis Treat,2015,11:1817-1834.
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