棕榈酸帕利哌酮治疗大学生精神分裂症40例

目的探讨棕榈酸帕利哌酮长效针剂对大学生精神分裂症患者疗效、安全性、治疗依从性、痊愈率和复发率的影响。方法 80例大学生精神分裂症患者口服利培酮治疗6周待病情稳定后(PANSS≤70分),采用随机数字表法随机分为口服利培酮组(简称口服组,n=40)和棕榈酸帕利哌酮长效注射剂组(简称长效注射剂组,n=40)进行12个月的治疗随访。评估分组前和分组后1,3,6,9和12个月的阳性和阴性症状量表(PANSS)、不良反应量表(TESS)、个人和社会功能评分(PSP)量表、用药满意度问卷(MSQ)以评定疗效、安全性、社会功能和用药满意度,同时比较两组患者的痊愈率、停药率、复发率和再住院率。结果长效注射剂组40例患者中,有36例(90.0%)完成研究,口服组40例患者中,有29例(72.5%)完成研究。长效注射剂组TESS、PSP和MSQ评分均优于口服组(P<0.05)。长效注射剂组临床痊愈率为41.6%,高于口服组23.3%(P<0.05)。长效注射剂组4例停药(10.0%)、3例复发(7.5%)和1例再住院(2.5%),口服组11例停药(27.5%)、10例复发(25.0%)和8例再住院(20.0%)。结论棕榈酸帕利哌酮长效针剂能改善社会功能和用药满意度,提高治疗依从性和临床痊愈率,降低停药率、复发率和再住院率,能安全有效地用于大学生精神分裂症患者的院外长期维持治疗。     

棕榈酸帕利哌酮长效针剂治疗精神分裂症效果观察

目的 探讨棕榈酸帕利哌酮长效针剂治疗精神分裂症的效果.方法 选取宁波市社区管理的精神分裂症患者120例,随机分为试验组与对照组各60例.对照组常规口服抗精神病药物,试验组肌内注射棕榈酸帕利哌酮长效针剂,比较两组精神症状、危险性评估、副反应、社会功能、公安出警率及再入院率等指标.结果 治疗1、3个月末试验组阳性和阴性精神...     

棕榈酸帕利哌酮对精神分裂症患者代谢及脑部CT特征的影响

目的:探讨棕榈酸帕利哌酮对精神分裂症患者代谢及脑部CT特征的影响.方法:以某院2018年1月—2019年7月收治的76例精神分裂症患者为研究对象,以病程、年龄为区组因素,采用分层随机化分组法将患者分为观察组与对照组.对照组予以利培酮药物治疗,观察组予以棕榈酸帕利哌酮注射治疗,比较两组阳性和阴性症状量表(PANSS)评分...     

棕榈酸帕利哌酮长效剂治疗精神分裂症的随机对照观察

目的:观察棕榈酸帕利哌酮长效剂(PP)治疗精神分裂症的疗效.方法:采用随机数字表法,将110例精神分裂症患者分为PP组(55例,PP治疗12个月)和利培酮组(55例,利培酮治疗12个月),比较两组临床症状及安全性.结果:治疗前,两组患者PANSS各项及总分比较,差异无统计学意义(P>0.05);治疗1个月,两组患者TE...     

不同剂型棕榈酸帕利哌酮治疗精神分裂症有效性及安全性分析

目的 比较1个月注射1次的棕榈酸帕利哌酮注射液（PP1M）与3个月注射1次的棕榈酸帕利哌酮注射液（PP3M）在有效性和安全性方面的差异。方法 检索中国知网、万方数据知识服务平台、PubMed、Embase、the cochrane Library等数据库中关于PP1M与PP3M有效性及安全性比较研究的文献,检索时间为数据库建库至2023年11月。结果 共纳入10篇文献,研究对象均为成人精神分裂症患者,研究周期7～24个月。结果显示,PP1M和PP3M对于精神分裂症患者的症状改善程度相似,PP3M比PP1M更能降低因精神疾病住院率和疾病复发风险,使用PP3M发生锥体外系综合征和体质量增加的风险低于PP1M,其他安全性指标在二者之间没有明显区别。结论 PP1M和PP3M的疗效与安全性相当,PP3M用药依从性更好。     

棕榈酸帕利哌酮治疗首发精神分裂症对患者认知功能障碍的影响

目的 探讨棕榈酸帕利哌酮治疗首发精神分裂症对患者认知功能障碍的影响。方法 选取2021年3月～2023年2月收治的79例首发精神分裂症患者,按照抽签法分为对照组（n=39）和观察组（n=40）,其中对照组采用利培酮口崩片治疗,观察组采用棕榈酸帕利哌酮治疗。评估两组患者临床疗效、症状评分、认知功能、神经营养因子及不良反应。结果 观察组的总有效率、认知功能评分及神经营养因子水平均高于对照组（P <0.05）;治疗后观察组的神经症状评分及不良反应发生率均低于对照组（P <0.05）。结论 首发精神分裂症患者采用棕榈酸帕利哌酮治疗效果显著,可改善患者的认知功能和精神症状,降低不良反应,调节神经营养因子水平,安全性高。     

棕榈酸帕利哌酮PP1M治疗精神分裂症的药物经济学研究进展

目的 系统总结棕榈酸帕利哌酮(PP1M)治疗精神分裂症的药物经济学相关研究结果,为抗精神病药的临床应用提供依据.方法 系统检索Taylor&Francis、ScienceDirect、PubMed、Embase、CBM、中国知网和万方数据库等,检索时间从建库至2019年12月,纳入2015～2019年棕榈酸帕利哌酮(P...     

棕榈酸帕利哌酮注射液治疗精神分裂症的临床疗效及安全性

目的 研究棕榈酸帕利哌酮注射液治疗精神分裂症的临床疗效及安全性.方法 50例精神分裂症患者,随机分为对照组及观察组,各25例.对照组给予帕利哌酮缓释片治疗,观察组给予棕榈酸帕利哌酮注射液治疗.对比两组患者的临床疗效,治疗前后的阳性和阴性症状量表(PANSS)评分,不良反应发生情况.结果 观察组患者的总有效率96.0％高...     

棕榈酸帕利哌酮长效针剂对精神分裂症患者认知和社会功能改善及内分泌代谢的影响

目的 探讨棕榈酸帕利哌酮长效针剂对精神分裂症患者认知和社会功能改善及内分泌代谢效果。方法 选择120例惠州市第二人民医院收治的精神分裂症患者为对象,研究开始、结束时间分别为2021年7月、2022年7月。随机分为对照组、试验组,各60例。对照组口服利培酮治疗,试验组采用棕榈酸帕利哌酮长效针剂治疗。分别在入组时、6、12个月评价各项指标并检测内分泌指标。结果 入组时,两组患者PANSS各症状评分差异无统计学意义,P> 0.05。入组6、12个月时,试验组患者阳性、阴性症状评分、一般精神病理评分和总分均低于对照组,差异有统计学意义,P <0.05。入组6个月、12个月时,两组TSEE评分比较差异有统计学意义,P <0.05。入组时,两组患者PSP、MoCA评分差异无统计学意义,P> 0.05。入组6、12个月时,试验组患者PSP、MoCA评分均高于对照组,差异有统计学意义,P <0.05。入组时两组患者血糖、血脂（总胆固醇、三酰甘油）、血清泌乳素差异无统计学意义,P> 0.05。入组6、12个月时,试验组患者血糖、血脂（总胆固醇、三酰甘油）、血清泌乳素均...     

棕榈酸帕利哌酮注射液治疗老年精神分裂症的有效性及安全性分析

目的:探讨棕榈酸帕利哌酮注射液治疗老年精神分裂症患者的疗效、耐受性、安全性及社会功能的恢复.方法:将天津市安定医院2014年8月-2016年3月老年科收治的80例老年精神分裂症患者随机分为研究组和对照组,每组40例患者.研究组用棕榈酸帕利哌酮注射液治疗,第1日注射75 mg,第8日注射75 mg,此后每隔1个月左右注射50~75 mg;对照组用利培酮片剂治疗,第1日口服0.5 mg,在2周内逐步增量至最佳给药剂量,最大给药剂量不超过2 mg/d,疗程24周.治疗前及治疗后4、8、16和24周采用阳性和阴性症状量表(PANSS)、依从性评定量表(MARS)、副反应量表(TESS)来评估疗效及安全性,用个人和社会功能量表(PSP)来评估社会功能.结果:72例患者完成24周临床治疗,有8例患者脱落.①两组PANSS评分在治疗第4、8、16和24周时均低于基线水平,差异均有统计学意义(P均<0.01);两组间同一时点PANSS评分比较,差异均无统计学意义(P均>0.05).②研究组MARS评分在治疗第4、8、16和24周均高于基线水平,差异均有统计学意义(P均<0.01);对照组MARS评分在治疗第4、8周均有显著统计学意义(P均<0.05);两组间除基线外同一时点MARS评分比较,差异均有统计学意义(P均<0.01).③研究组同一治疗时点PSP评分均高于对照组,且差异均有统计学意义(P均<0.01);对照组PSP评分在治疗第4、8、16和24周均高于基线水平,差异有统计学意义(P均<0.05);两组间除基线外同一时点PSP评分均高于对照组,差异均有统计学意义(P均<0.05).④两组患者均无严重不良反应发生,组间不良反应发生率比较差异无统计学意义(P均>0.05).结论:老年精神分裂症患者采用棕榈酸帕利哌酮注射液治疗疗效与利培酮片剂相当,但服药依从性好,社会功能明显恢复,无明显不良反应.     

Once-monthly paliperidone palmitate in recently diagnosed and chronic non-acute patients with schizophrenia

Objective: To explore the treatment response, tolerability and safety of once-monthly paliperidone palmitate (PP1M) in non-acute patients switched from oral antipsychotics, stratified by time since diagnosis as recently diagnosed (≤3 years) or chronic patients (>3 years).

Research design and methods: Post hoc analysis of a prospective, interventional, single-arm, multicentre, open-label, 6-month study performed in 233 recently diagnosed and 360 chronic patients.

Main outcome measures: The proportion achieving treatment response (defined as ≥20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to endpoint) and maintained efficacy (defined as non-inferiority in the change in PANSS total score at endpoint [Schuirmann’s test]).

Results: 71.4% of recently diagnosed and 59.2% of chronic patients showed a ≥20% decrease in PANSS total score (p = 0.0028 between groups). Changes in PANSS Marder factors, PANSS subscales, and the proportion of patients with a Personal and Social Performance scale (PSP) total score of 71–100 were significantly greater in recently diagnosed compared with chronic patients. PP1M was well tolerated, presenting no unexpected safety findings.

Conclusion: These data show that recently diagnosed patients treated with PP1M had a significantly higher treatment response and improved functioning, as assessed by the PSP total score, than chronic patients.     

Practical guidelines on the use of paliperidone palmitate in schizophrenia

Abstract

Objective:

Paliperidone palmitate is an atypical long-acting injectable (LAI) antipsychotic that has been approved for use in the US, EU, Australia and numerous other countries for acute and maintenance therapy of schizophrenia.

LAI antipsychotics are often viewed as a ‘last-resort’ treatment for difficult-to-treat patients, however this article considers their role more broadly in the management of partial or non-adherence in schizophrenia.     

Real-world outcomes post-transition to once-every-3-months paliperidone palmitate in patients with schizophrenia within US commercial plans

Objectives: To compare comorbidity-related outcomes, adherence to antipsychotics (APs), healthcare resource utilization (HRU), and costs pre- and post-transition to once-every-3-months paliperidone palmitate (PP3M) in commercially-insured patients with schizophrenia.

Methods: Adults with ≥1 claim for PP3M, ≥2 schizophrenia diagnoses, and adequate treatment with once-monthly paliperidone palmitate (PP1M; i.e. no gap of >45?days in PP1M coverage for ≥4?months, same PP1M dosage for the last two PP1M claims, and appropriate PP1M to PP3M dosing conversion) were selected from the IQVIA PharMetrics Plus database (May 2014–February 2018). Generalized estimating equation models adjusted for repeated measurements were used to compare patient characteristics, adherence to APs, HRU, and costs during the 6-month period pre- vs post-transition to PP3M.

Results: Of 152 included patients, the mean age was 41.0?years and 36.2% were females. Post-PP3M transition, patients were less likely to have a claim with a diagnosis for substance-related and addictive disorders (odds ratio [OR]?=?0.57), psychoses (OR?=?0.57), diabetes without chronic complication (OR?=?0.72), and drug abuse (OR?=?0.64; all p?<?.05). Patients were more likely to be adherent to APs (OR?=?2.01, p?=?.007), compared to the period pre-PP3M transition. There was no significant difference in HRU pre- vs post-transition. All-cause total (mean monthly cost difference [MMCD]?=?$242), pre-rebate pharmacy (MMCD?=?$65), and medical costs (MMCD?=?$176) remained similar pre- vs post-transition (all p?>?.05).

Conclusions: Transitioning to PP3M was associated with an improvement in adherence and in comorbidity-related outcomes related to substance-related and addictive disorders, psychoses, diabetes without chronic complication, and drug abuse. These findings suggest PP3M may enhance comorbidity-related outcomes and adherence while remaining cost neutral.     

Extended-release intramuscular paliperidone palmitate: a review of its use in the treatment of schizophrenia

Extended-release intramuscular paliperidone palmitate (Xeplion?; Invega? Sustenna?) [henceforth referred to as intramuscular paliperidone palmitate] is a long-acting injectable (LAI) formulation of the well established atypical antipsychotic agent paliperidone (9-hydroxyrisperidone), which is the major active metabolite of risperidone. This article reviews, from an EU perspective, the therapeutic efficacy and tolerability of intramuscular paliperidone palmitate in the treatment of adults with schizophrenia, and the pharmacology of paliperidone that is relevant to the intramuscular formulation. Intramuscular paliperidone palmitate 25-150 mg equivalents (mg eq.) effectively reduced symptoms of schizophrenia in most short-term (9-13 weeks) placebo-controlled trials, as demonstrated by improvements in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to endpoint that were significantly greater in intramuscular paliperidone palmitate than placebo recipients. The onset of clinical response was 8 days in patients who received the recommended initial 150 mg eq. dose of intramuscular paliperidone palmitate into the deltoid muscle on day 1. In a longer-term (24-week maintenance phase and variable length double-blind phase) placebo-controlled trial, intramuscular paliperidone palmitate was associated with a significantly longer time to relapse than placebo in patients with schizophrenia at a preplanned interim analysis conducted after 68 relapse events. Because of these favourable results, the study was terminated early. In two 13-week trials, one of which was conducted in Chinese patients, intramuscular paliperidone palmitate administered using the recommended initiation dosage regimen was noninferior to LAI-risperidone in patients with schizophrenia in terms of the between-group treatment difference (intramuscular paliperidone palmitate vs LAI-risperidone) for the mean change from baseline to endpoint in PANSS total score. The tolerability of intramuscular paliperidone palmitate was generally acceptable in clinical trials of schizophrenia. No new safety concerns were revealed compared with oral paliperidone, except for injection site-related reactions. In conclusion, intramuscular paliperidone palmitate is a useful option for the treatment of patients with schizophrenia.     

Baseline characteristics and treatment patterns of patients with schizophrenia initiated on once-every-three-months paliperidone palmitate in a real-world setting

Objectives: Since May 2015, adult patients with schizophrenia adequately treated with once monthly paliperidone palmitate (PP1M) may be transitioned to once-every-three-months paliperidone palmitate (PP3M). This study aims to describe baseline characteristics and treatment patterns of patients with schizophrenia initiated on PP3M in a real-world setting.

Methods: Pharmacy and medical claims from May 2014 to September 2016 for adult patients with schizophrenia initiated on PP3M (index date) in the Symphony Health Solutions database were analyzed. The cohort consisting of all patients and the one restricted to those transitioning from PP1M as per prescribing guideline recommendations were considered. Baseline characteristics were assessed during the 12 month baseline period. PP1M treatment patterns, proportion of days covered (PDC) by mental-health-related medications, and healthcare resource utilization (HRU) patterns were evaluated for each baseline quarter. PP3M treatment patterns were assessed post-index.

Results: Among the 1545 adult patients initiated on PP3M who formed the first cohort, 68.8% transitioned from PP1M based on prescribing guidelines and on an adaptation of the strict clinical trial protocol for PP1M to PP3M transition, forming the second cohort. In both cohorts, the proportion of patients with a PDC ≥80% for antipsychotics, antidepressants, anxiolytics, and mood stabilizers increased while the proportion of patients with ≥1 emergency room, inpatient, or outpatient visit decreased in baseline quarters closer to PP3M initiation. Among patients with ≥4 months of follow-up after the first dose, 85–88% had a second dose. Similarly, among those with ≥4 months of follow-up after the second dose, 87–90% received a third dose.

Conclusions: Patients initiated on PP3M demonstrated decreased HRU and increased adherence in quarters closer to PP3M initiation, and were persistent on their PP3M treatment.     

帕利哌酮与阿立哌唑治疗男性精神分裂症患者疗效及对性功能的影响对照

目的:研究帕利哌酮治疗男性精神分裂症患者的疗效及对性功能的影响。方法:将78例已婚男性精神分裂症患者分别给予帕利哌酮(38例)与阿立哌唑(40例)治疗,在基线时及8周末采用阳性与阴性症状(PANSS)量表、个人和社会功能量表(PSP)及简明男性性功能量表评价临床疗效及性功能,检测血清泌乳素(PRL)水平。结果:治疗8周末,2组有效率无显著性差异(P>0.05);2组间PANSS评分无统计学意义(P>0.05),帕利哌酮组PSP评分明显高于阿立哌唑组(P<0.01);帕利哌酮组的性欲、性唤起、性高潮及性功能总分均显著低于基线值(P<0.01),阿立哌唑组性功能各因子无明显下降;治疗第8周末,帕利哌酮组的泌乳素(PRL)水平明显高于基线时水平,高于阿立哌唑组(P<0.01)。结论:帕利哌酮治疗男性精神分裂症疗效与阿立哌唑相当,社会功能恢复优于阿立哌唑,但可能导致性功能下降。