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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
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| 篇名： | 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 |
| TITLE： | Efficacy and safety of domestic Paliperidone extended-release tablets in the treatment of stable schizophrenia |
| 摘要： | 目的 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。 |
| ABSTRACT： | OBJECTIVE 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 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 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 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. |
| 期刊： | 2023年第34卷第24期 |
| 作者： | 李秀英；陈莹；陈宏 |
| AUTHORS： | LI Xiuying，CHEN Ying，CHEN Hong |
| 关键字： | 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 |
| KEYWORDS： | Paliperidone extended-release tablets； schizo- |
| 阅读数： | 65 次 |
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