帕利哌酮缓释片治疗复发精神分裂症疗效与社会功能评定

目的 探讨帕利哌酮缓释片对复发精神分裂症疗效及社会功能的影响。方法 选取38例复发精神分裂症患者使用帕利哌酮缓释片持续治疗4周,于治疗前及治疗后第4周末采用阳性和阴性综合征量表（PANSS）、个人和社会功能量表（PSP）及治疗中需处理的不良反应症状量表（TESS）评定并比较患者的精神症状、社会功能和不良反应。结果患者治疗后第4周末PANSS各因子分、总分及PSP各因子分较治疗前均降低（P〈0.01）;PSP总分较治疗前升高（P〈0.01）。总不良反应发生率42%。结论 帕利哌酮缓释片可有效改善复发精神分裂症患者的精神症状、个人及社会功能,且不良反应轻。     

帕利哌酮缓释片与利培酮片治疗精神分裂症对照研究

目的：比较帕利哌酮缓释片与利培酮片治疗精神分裂症的疗效和不良反应。方法：64例精神分裂症患者随机分为研究组和对照组各32例,分别给予帕利哌酮缓释片与利培酮治疗。疗程8周。分别于治疗前和治疗1、2、4和8周采用阳性与阴性症状量表（PANSS）评定疗效;以治疗中出现的症状量表（TESS）评定不良反应。结果：研究组显效率和有效率分别为59.4%和81.2%,对照组分别为57.1%和75.0%,两组比较,差异无统计学意义（P〉0.05）。两组PANSS评分治疗后均较治疗前明显下降（P〈0.05或P〈0.01）,以研究组阴性症状因子分在治疗4周和8周时[分别为（15.8±3.1）分和（11.9±2.1）分]显著低于对照组[分别为（20.2±3.2）分和（17.6±5.4）分],两组比较,差异有统计学意义（P〈0.05或P〈0.01）。结论：帕利哌酮缓释片是一种安全有效的抗精神病药,对阴性症状的改善更为显著。     

重复经颅磁刺激联合帕利哌酮缓释片治疗精神分裂症的对照试验

目的比较重复经颅磁刺激联合帕利哌酮缓释片与单用帕利哌酮缓释片治疗精神分裂症患者的疗效、安全性和社会功能恢复,为临床选择治疗方案提供参考依据。方法选择符合条件的88例精神分裂症患者,随机分成研究组和对照组,治疗时间为4周。在治疗前和治疗后第1周、第2周、第4周末,用阳性与阴性症状量表(PANSS)及减分率评定疗效,治疗时出现的症状量表(TESS)评定不良反应,个体和社会功能量表(PSP)评定患者的社会功能。结果治疗后,与各组治疗前比较,两组PANSS总分及阴性症状分和阳性症状分、PSP均有明显改善,具有统计学意义(P0.05);组间比较,第2周和第4周末PANSS总分和阴性症状分、PSP评分比较差异有统计学意义(P0.05)。至治疗终点,观察组治疗有效率优于对照组(P0.05),两组间TESS评分差异无统计学意义(P0.05)。重复经颅磁刺激和帕利哌酮缓释片都是安全有效、可以耐受的。结论与单一使用帕利哌酮缓释片相比,重复经颅磁刺激联合帕利哌酮缓释片治疗能取得更好的疗效,改善阴性症状和提高社会功能,;同时副反应方面无明显差异。     

帕利哌酮缓释片与盐酸哌罗匹隆片治疗精神分裂症患者临床疗效观察

目的 比较帕利哌酮缓释片与盐酸哌罗匹隆片治疗精神分裂症患者的疗效和安全性。方法 将70例精神分裂症患者随机分为帕利哌酮组和哌罗匹隆组。两组患者入组治疗前均停用抗精神病药至少2周。哌罗匹隆组患者给予盐酸哌罗匹隆片口服,初始剂量8毫克,2周后逐渐增加至12-48毫克;帕利哌酮组给予帕利哌酮缓释片,初始剂量3毫克,2周后剂量逐渐增加至6-9毫克。两组患者疗程均为8周。观察两组患者治疗前、治疗后阳性和阴性症状量表（Positive And Negative Syndrome Scale PANSS）、副反应量表（Treatment Emergent Symptom Scale TESS）评分变化。结果 治疗前,两组患者的PANSS量评分对比差异无统计学意义。治疗后,帕利哌酮组PANSS量表分低于哌罗匹隆组,帕利哌酮组有效率高于哌罗匹隆组,差异具有统计学意义（P<0.05）。结论 帕利哌酮在改善精神分裂症患者阳性、阴性症状方面优于哌罗匹隆。帕利哌酮更容易出现体重增加及泌乳素升高,哌罗匹隆更容易出现静坐不能。     

精神分裂症患者MDR1C3435T基因多态性与帕利哌酮疗效的相关性

目的:研究精神分裂症患者MDR1C3435T基因多态性与帕利哌酮缓释片疗效的相关性。方法:收集服用非典型抗精神病药物帕利哌酮缓释片患者68例,采用阳性和阴性症状量表(PANSS)评定疗效,个人与社会功能量表(PSP)评定社会功能,根据PANSS减分率(≥50%为有效)分为有效组和无效组。采用聚合酶链反应-限制性片段长度多态性分析(PCR-RFLP)技术检测其MDR1C3435T位点的基因型。将有效组和无效组的基因型进行卡方检验。结果:治疗前后PANSS及PSP量表评分比较差异有统计学意义(P<0.001),有效组与无效组基因型差异无统计学差别(P>0.05)结论:帕利哌酮缓释片治疗精神分裂症疗效肯定,未发现MDR1C3435T基因多态性与帕利哌酮的疗效有关。     

帕利哌酮缓释片与利培酮治疗精神分裂症的对照研究

目的讨论帕利哌酮缓释片对精神分裂症的治疗效果及对患者社会功能的影响。方法采用随机数字表将84例精神分裂症患者分为帕利哌酮缓释剂组和利培酮组,各42例,分别使用帕利哌酮缓释剂和利培酮片治疗,疗程均为8周。两组均在治疗前及治疗第2、4、8周末采用阳性与阴性症状量表(PANSS)评定疗效,副反应量表(TESS)评定不良反应,在治疗前和8周末采用个人和社会功能量表(PSP)评定社会功能恢复状况。结果PANSS评定:两组在治疗前后差异均有统计学意义(P均0.05),同时两组在8周末差异有统计学意义(P0.05)。TESS评定:两组药物的副反应差异无统计学意义(P0.05)。PSP量表评定:两组治疗前后及两组之间相比差异有统计学意义(P0.05),并且帕利哌酮缓释片优于利培酮。结论帕利哌酮缓释片和利培酮治疗精神分裂症阳性及阴性症状均有效。但帕利哌酮缓释片起效相对迅速,不良反应少且轻微,对于精神分裂症患者的整体社会功能改善具有明显的效果。     

丙戊酸镁缓释片辅助治疗精神分裂症攻击行为的疗效观察

目的：探讨阿立哌唑联合丙戊酸镁缓释片治疗精神分裂症患者攻击行为的疗效及安全性。方法：70例有攻击行为的精神分裂症患者随机分为合用药组和单用药组,各35例,分别给予阿立哌唑联合丙戊酸镁缓释片与单一阿立哌唑治疗,疗程6周。用阳性与阴性症状量表（PANSS）、外显攻击行为量表（修订版）（MOAS）和治疗中出现的症状量表（TESS）评定疗效和不良反应。结果：治疗后两组PANSS评分及MOAS评分较治疗前均显著下降（P均〈0．01）;以合用药组PANSS总分及阳性症状分、MOAS总分较单用药组下降显著（P〈0．05或P〈0．01）;两组不良反应差异无统计学意义（P〉0．05）。结论：阿立哌唑联合丙戊酸镁缓释片治疗精神分裂症攻击行为疗效好,安全性高。     

帕利哌酮合用艾司西酞普兰对精神分裂症患者BDNF及阴性症状的影响

目的探讨帕利哌酮舍用艾司西酞普兰对精神分裂症患者血清脑源性神经营养因子（BDNF）浓度及阴性症状的影响。方法将84例以阴性症状为主的精神分裂症患者随机分为研究组（帕利哌酮合用艾司西酞普兰）与对照组（单用帕利哌酮）,治疗12周。于治疗第0、4、8、12周监测血清BDNF浓度,同时采用阳性与阴性症状量表（PANSS）和副反应量表（TESS）评定疗效和不良反应。结果①两组有效率分别为85．7％和64．3％,经比较差异有统计学意义（χ^2=4．29;P〈O．05）;②疗后8、12周,两组BDNF浓度较治疗前升高,但研究组BDNF浓度升高较对照组明显（t=2．0814,2．4719;P〈0．05）;③两组PANSS总分和各阴性因子均较治疗前减少（P均〈0．05）,但研究组PANSS总分及各阴性因子分差异较对照组差异有统计学意义（t=2．059,2．014,P〈0．05）;④两组药物不良反应比较无显著差异。结论帕利哌酮合用艾司西酞普兰可明显提高BDNF浓度,改善精神分裂症的阴性症状。     

帕利哌酮联合社会认知交互训练对青少年精神分裂症社会功能及依从性影响

目的探讨帕利哌酮联合社会认知交互训练对青少年精神分裂症患者社会功能及依从性影响。方法选择2018年1月~2021年1月我院住院的80例青少年精神分裂症患者,随机分为研究组和对照组,对照组服用帕利哌酮治疗,研究组服用帕利哌酮基础上联合社交训练治疗,均干预24周,比较两组疗效。结果两组治疗前阳性与阴性症状量表(Positive and Negative Symptom Scale,PANSS)、个体和社会功能量表(Personal and Social Performance scale,PSP)及自知力与治疗态度问卷(Insight and Treatment Attitude Questionnaire,ITAQ)评分无差异(P>0.05),治疗24周后,两组患者各评分均有改善;两组治疗后PANSS评分无统计学差异(P>0.05),研究组治疗后PSP及ITAQ评分显著优于对照组(P<0.05)。结论社会认知交互训练在帕利哌酮治疗基础上可以改善青少年精神分裂症的社会功能和依从性。     

棕榈酸帕利哌酮长效针剂对精神分裂症急性期及维持期的效果

目的 探讨精神分裂症患者使用棕榈酸帕利哌酮长效针剂的价值。方法 本研究纳入80例精神分裂症患者（2020年1月～2021年4月）,按随机数字表法分为对照组和观察组。对照组（n=40）采用利培酮治疗,观察组（n=40）采用棕榈酸帕利哌酮长效针剂治疗,统计比较两组临床疗效、不良反应、临床症状评分、心理社会功能。结果 （1）临床疗效：观察组（95.00%）高于对照组（80.00%）(P<0.05)。（2）不良反应：观察组不良反应评分（1.24±1.05）低于对照组（2.87±1.41）(P<0.05)。（3）临床症状评分：治疗后3月、6月、12月,观察组阳性和阴性症状量表（PANSS）评分低于对照组（P<0.05）。（4）心理社会功能：治疗前、急性期个人和社会功能量表（PSP）评分对比无差异,维持期观察组PSP评分高于对照组（P<0.05）。结论 棕榈酸帕利哌酮长效针剂在精神分裂症治疗中效果确切,可改善其临床症状及心理社会功能,亦可确保治疗安全性。     

帕利哌酮缓释剂治疗首发与复发精神分裂症的临床疗效比较

目的比较帕利哌酮缓释剂治疗首发、复发精神分裂症患者的临床疗效。方法以28例首发精神分裂症患者（首发组）和32例复发再次住院的精神分裂症患者（复发组）为研究对象,分别给予帕利哌酮缓释剂治疗,于入院时、治疗2、4及8周末,采用阳性与阴性症状量表（PANSS）评定疗效。结果治疗前首发组与复发组PANSS总分、阳性症状量表分、阴性症状量表分及一般病理量表分差异均无统计学意义（P〉0.05）。治疗后第2、4和第8周末,首发组PANSS总分、阳性症状分量表分、阴性症状分量表分及一般病理量表分逐渐降低,差异有统计学意义（P〈0.05）;复发组PANSS总分、阳性症状分量表分及一般病理量表分逐渐降低,差异有统计学意义（P〈0.05）;而复发组阴性症状分量表分虽也逐渐降低,但至第4周后差异方有统计学意义。治疗8周末首发组显效率为46.43%,复发组显效率为43.75%,两组比较差异无统计学意义（χ2=0.043,P=0.835）。两组患者不良反应差异无统计学意义（P〉0.05）。结论帕利哌酮缓释剂治疗首发、复发精神分裂症患者阴阳性症状均具有良好的疗效,且安全性、依从性好,可在临床进一步推广应用。     

帕利哌酮缓释片治疗急性精神分裂症疗效及安全性的对照研究

Objective The study was designed to evaluate the efficacy and safety of flexible doses of paliperidone extended-release tablets (paliperidone ER) (3 -12) mg/d comparing with olanzapine (5 -15)mg/d in acute hospitalized patients with schizophrenia. Methods All 288 hospitalized patients with DSM-Ⅳ schizophrenia were randomized into paliperidone ER ( n = 143 ) or olanzapine ( n=145 ) treatment in a 6-week, multicenter, double-blind, parallel-group study. The primary efficacy measure was the total score changes of the Positive and Negative Syndrome Scale (PANSS). Clinical Global Impression (CGI),response rate and Visual Analogue Scale (VAS) were adopted as secondary efficacy measures. Results Both paliperidone ER and olanzapine groups demonstrated a significant improvement in total PANSS score (P<0.001). The PANSS total score in paliperidone ER group was reduced (32.3 ± 17.1) at end point,and olanzapine group (34.1 ± 17.4). There was no statistically significant difference between the two groups (P =0.369) after 6-week treatment. There were no statistical differences between two groups in CGI,response rate and VAS sleep quality assessments by the end of the treatment. The common adverse events were extrapyramidal symptoms, insomnia, constipation and prolactin increasing in paliperidone ER group,and somnolenee, EPS, abnormal liver function and abnormal lipid metabolism in olanzapine group.Conclusion Paliperidone ER and olanzapine are similarly effective in significantly improving the symptoms of inpatient with acute schizophrenia. Paliperidone ER demonstrates a favorable safety profile with fewer somnolence, abnormal liver function and abnormal lipid metabolism comparing with olanzapine.     

齐拉西酮注射液与氟哌啶醇注射液治疗精神分裂症急性激越症状的对比研究

目的验证甲磺酸齐拉西酮注射液治疗精神分裂症急性激越症状的临床疗效和安全性。方法将64例具有急性激越症状的精神分裂症患者随机分为齐拉西酮组（研究组,32例）和氟哌啶醇组（对照组,32例）,进行开放式临床对照研究,患者入组后即给予臀大肌深部注射齐拉西酮注射液10mg或氟哌定醇注射液5~10mg,6~8小时后可重复使用;甲磺酸齐拉西酮和氟哌啶醇每日总量均不超过30mg,每日注射不超过3次,疗程3天。采用阳性和阴性症状量表（PANSS）、阳性与阴性症状量表兴奋因子（PANSS-EC）、临床总体印象量表（CGI）评分评价疗效;采用药物不良反应量表（TESS）、锥体外系副反应量表（SAS）评价副反应。结果治疗72小时后,齐拉西酮组和氟哌啶醇组的PANSS-EC总分均明显减低,齐拉西酮组PANSS-EC减分率为（47.79±12.94）%,氟哌啶醇组为（47.79±11.49）%,差异无统计学意义（t=0.063,P〉0.05）。齐拉西酮组临床总有效率为46.9%;氟哌啶醇组为40.6%,差异无统计学意义（χ2=0.063,P〉0.05）。齐拉西酮组不良反应发生率为28.1%,氟哌啶醇组65.6%,差异有统计学意义（χ2=9.035,P〉0.05）。结论甲磺酸齐拉西酮治疗精神分裂症的急性激越症状疗效明显,耐受性良好。     

Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension.

OBJECTIVE: The objective of this multicenter, international study was to evaluate safety and tolerability of paliperidone extended-release (ER) tablets in elderly (age > or =65 years) patients with schizophrenia. The authors conducted a 6-week, double-blind, randomized, placebo-controlled, optional 24-week open-label extension study. Interventions consisted of flexible, once-daily doses of paliperidone ER (3-12 mg/day; 6-mg starting dose, adjusted in 3-mg dose increments) or placebo (2:1) during double-blind treatment and paliperidone ER only during open-label treatment. Measurements included adverse events, laboratory tests, physical examinations, 12-lead electrocardiograms, movement disorder rating scales, Positive and Negative Syndrome Scale, and Clinical Global Impression scale. The study was not powered to show statistical differences. RESULTS: Patients (N = 114) were predominantly female (73%); mean age was 70 years (double-blind phase). Concomitant disease presence was consistent with that of an older population. During the double-blind phase, discontinuation rates resulting from adverse events were similar between groups (paliperidone ER: 7%, placebo: 8%) as were incidences of treatment-emergent adverse events (paliperidone ER: 67%, placebo: 71%). Serious adverse events occurred in 3% of the paliperidone ER- and 8% of the placebo-treated patients. Elevated prolactin levels occurred in approximately one half of patients. No prolactin- or glucose treatment-related adverse events or noteworthy mean changes in body weight (0 kg [standard deviation: 2.1] and 0 kg [standard deviation: 2.3] for paliperidone ER and placebo, respectively) were observed. Safety and tolerability results in the extension were consistent with the shorter-term results. Efficacy measures did not show consistent statistical improvement between treatment groups. CONCLUSION: Paliperidone ER (3-12 mg/day) treatment over a 30-week period was generally well-tolerated and may improve symptom severity in elderly patients with schizophrenia.     

3种非典型抗精神病药对精神分裂症患者心电图的影响

目的:探讨3种非典型抗精神病药对精神分裂症患者心电图的影响。:方法:将270例精神分裂症患者随机分成3组,分别给予利培酮、阿立哌唑和齐拉西酮治疗,于治疗前和治疗2、4、8周进行心电图检查。结果:利培酮组、阿立哌唑组和齐拉西酮组的心电图异常率分别为27.8%、26.7%和22.2%。其中利培酮组与阿立派唑组女性异常率显著高于男性(P<0.05)。心电图改变主要为T波改变、窦性心动过速、窦性心动过缓、室性期前收缩、不完全右束支传导阻滞。结论:3种非典型抗精神病药对精神分裂症患者心电图均有影响,但轻而可逆。     

齐拉西酮与利培酮治疗精神分裂症阴性症状疗效的对照研究

目的：观察齐拉西酮对精神分裂症患者阴性症状的疗效和安全性。方法：将68例以阴性症状为主的住院精神分裂症患者随机分为齐拉西酮组（34例）与利培酮组（34例）,疗程8周。采用阳性与阴性症状量表（PANSS）及治疗中出现的症状量表（TESS）评定疗效和不良反应。结果：齐拉西酮组疗效（67.7%）与利培酮组（62.5%）差异无显著性（P〉0.05）。两组不良反应发生率（38.7%,43.8%）差异无显著性（P〉0.05）。结论：齐拉西酮治疗精神分裂症阴性症状的疗效及安全性与利培酮相当。     

重复经颅磁刺激联合帕利哌酮对精神分裂症患者认知功能的影响

目的 探讨重复经颅磁刺激(rTMS)联合帕利哌酮缓释片对精神分裂症患者认知功能的疗效及安全性.方法 选择符合入组条件的首发精神分裂症患者61名,随机分成治疗组30例(帕利哌酮缓释片联合rTMS),对照组31例(单纯药物).分别于治疗前及治疗4周后应用阳性与阴性症状量表(PANSS)评定临床症状;应用数字划消测验(CT)...     

Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial

BACKGROUND: Paliperidone extended-release tablet (paliperidone ER) is an investigational oral psychotropic developed for schizophrenia treatment. It utilizes OROS technology to provide a unique pharmacokinetic profile, eliminating the need for titration and potentially leading to improved tolerability. Furthermore, paliperidone undergoes limited hepatic metabolism. METHODS: The efficacy and safety of once-daily paliperidone ER (6 mg, 9 mg and 12 mg) were assessed versus placebo in 628 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study. RESULTS: All doses of paliperidone ER demonstrated significant improvement in PANSS score, all PANSS Marder factor scores (p<0.001) and personal and social functioning versus placebo (p<0.001). The PANSS total score also improved significantly in the olanzapine treatment arm. Significantly higher percentages of paliperidone ER patients demonstrated a > or =30% reduction in PANSS total score versus placebo (p<0.001). The incidence of movement disorder-related AEs and rating scales measurements were similar to placebo for the paliperidone ER 6 mg group and higher in the 9 mg and 12 mg groups. In the paliperidone ER groups there were no reports of glucose-related AEs or clinically relevant changes in plasma lipid levels and changes in mean bodyweight<1 kg. CONCLUSION: In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. Paliperidone ER offers a distinctive treatment profile and may provide a valuable new treatment option for patients with schizophrenia.     

Influencing Factors and Predictors of Early Response in Schizophrenia Patients Receiving the Paliperidone Extended-Release Tablets (Paliperidone ER)

Objective

Paliperidone extended-release tablet (paliperidone ER) is a new oral psychotropic agent developed for schizophrenia treatment. There have been some studies about paliperidone''s good efficacy and tolerability. Clinicians appear to change the antipsychotic medication to paliperidone ER. However, it is not known what patients are favorable responsive to paliperidone ER. The aim of this study was to evaluate the characteristics of early responders and investigate predictors of acute response when the medications changed to paliperidone ER.

Methods

Data were analyzed from schizophrenic patients who participated in a multi-center, open-label, non-comparative clinical trial. Total 320 patients were examined in this study. Sociodemographic, psychopathology, social function and metabolic data were evaluated. Unpaired t-test for continuous and χ² for categorical data, respectively, were used to compare early responder and non-responders. Logistic regression analysis was used to establish a prediction model.

Results

38.7% of study subjects (124 of 320) responded to paliperidone ER treatment. Logistic regression analysis showed that a good paliperidone ER response was more likely when patients were social drinkers, when patients had started medication at inpatient, when negative symptoms were less severe, and when patients'' social relationship and self-care were better.

Conclusion

Early response to paliperidone ER treatment is associated with less negative symptoms and good social relationships and self-care. Strategies to reduce these symptoms may contribute to early response to paliperidone ER.