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1.
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.  相似文献
2.
目的 探讨中国汉族精神分裂症患者多药耐药基因(multidrug resistance gene 1,MDR1)多态性与帕利哌酮和注射用利培酮微球治疗精神分裂症的临床疗效的关联.方法 对入组的133例精神分裂症患者分别给予帕利哌酮或注射用利培酮微球治疗12周;以阳性与阴性症状量表(PANSS)作为主要疗效评价工具,以治疗结束时临床总体印象-严重程度量表(CGI-S)及人际和社交能力量表(PSP)作为次要疗效评价工具;每2周进行PANSS评定;应用聚合酶链反应-限制性片段长度多态性和DNA测序的方法检测受试者多药耐药基因5个多态性位点的基因型,应用卡方检验和方差分析法分析各基因型与临床疗效的关联性.结果 MDR1基因多态性与主要疗效指标PANSS减分率及有效率的关联分析中未发现差异有统计学意义(P>0.05);非参数检验分析显示:位点rs1045642 CC基因型携带者在阴性症状条目抽象思维障碍(Z=-2.62,P=0.009)及阳性症状条目夸大(Z=-2.84,P=0.005)有较好疗效;rs2032582位点GG基因型携带者在一般病理学症状条目紧张改善较差(Z=-2.50,P=0.012);rs1202169位点A等位基因携带者在一般病理学条目主动社会回避改善较好(Z=-2.09,P=0.036);rs13233308位点CC基因型携带者在一般病理学条目罪恶观念(Z=-2.09,P=0.036)和交流缺乏自发性和主动性疗效(Z=-2.73,P=0.006)改善不佳,该位点携带TT基因型的个体在紧张条目的 疗效改善较好(Z=-2.54,P=0.011).次要疗效指标分析显示,rs1045642位点C等位基因与PSP评分高度相关(Z=-2.18,P=0.029).结论 多药耐药基因多态性可能并不影响中国汉族精神分裂症患者帕利哌酮和注射用利培酮微球的临床疗效,但与妄想、社交回避的改善可能相关.  相似文献
3.
目的研究可变剂量的帕利哌酮缓释剂治疗急性期精神分裂症患者的有效性、耐受性与安全性。方法采用开放性、单组、多中心研究,使用可变剂量的帕利哌酮缓释剂(3~12mg/d)治疗急性期精神分裂症患者608例,观察期8周,通过阳性和阴性综合征量表(PANSS)评价有效性。通过体检、实验室检查、心电图检查及其他不良事件的报告评价安全性。结果治疗有效率(PANSS减分率≥30%)随治疗时间而增加,治疗8周末有效率为82.6%。研究终点PANSS总分与基线相比,差异具有统计学意义(P〈0.01)。终点平均剂量为(7.9±2.2)mg/d。治疗8周时40.11%患者的治疗剂量保持6mg/d的水平,4.44%患者的治疗剂量下调至3mg/d。常见的不良事件为锥体外系反应、便秘、肝功能异常、睡眠障碍、嗜睡、疲乏及恶心。结论可变剂量帕利哌酮缓释剂(3~12mg/d)治疗急性期精神分裂症有效,且耐受性、安全性良好。  相似文献
4.
帕利哌酮缓释片与利培酮片治疗精神分裂症对照研究   总被引:1,自引:0,他引:1  
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。  相似文献
5.
6.

Objectives

Paliperidone-associated motor tics.

Method

Case report.

Results

We report a 30-year-old man with schizophrenia who developed motor tics (eye blinking) after treatment of paliperidone up to 15 mg daily.

Conclusion

Tic-like symptoms, from simple eye blinking to complex Tourette-like syndrome, may occur during paliperidone treatment, especially with high dose.  相似文献
7.
The aim of this study was to investigate the serum levels or activities of oxidative stress markers in patients with schizophrenia in acute phase and evaluate the changes in superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx), glutathione (GSH) and thiobarbituric acid-reactive substances (TBARS) after treatment. We consecutively enrolled 41 patients with schizophrenia in acute phase, and 27 patients were followed up with a 4-week antipsychotic treatment. Serum oxidative stress markers were measured with assay kits. We found that Positive and Negative Syndrome Scale (PANSS) total scores were significantly negatively correlated with serum GPx activity and GSH levels and positively correlated with serum SOD activity in patients with schizophrenia in acute phase. In addition, serum GPx activity had a positive correlation with GSH levels and negative correlation with SOD activity. We also found that serum SOD activity was significantly negatively correlated with TBARS levels in patients in acute phase. Furthermore, we found significantly increased changes only in GPx activity in female patients receiving the 4-week treatment (P=0.006). In conclusion, our results suggest that SOD, GPX and GSH might be indicators of schizophrenia severity in acute phase. Furthermore, antipsychotic drugs might affect serum GPx activity in female patients receiving the 4-week treatment.  相似文献
8.
B cell lymphoma protein-2 (Bcl-2) may contribute to the pathophysiology of schizophrenia in the brain. The aim of this study was to investigate the serum levels of Bcl-2 in schizophrenic patients in an acute phase, and evaluate Bcl-2 level changes after antipsychotic treatment. We consecutively enrolled 41 schizophrenia patients in an acute phase; 28 were followed up with a 4-week antipsychotic treatment. Serum Bcl-2 levels were measured with assay kits. All patients were evaluated by examining the correlation between Bcl-2 levels and Positive and Negative Syndrome Scale (PANSS) scores, using Pearson correlation coefficients. In schizophrenic patients in an acute phase, positive PANSS subscores were significantly negatively correlated with Bcl-2 levels. In addition, we found Bcl-2 levels had a significantly negative correlation with PANSS total scores and positive subscores in male patients in an acute phase. Using the paired t-test, we found no significant changes in Bcl-2 levels in schizophrenia patients who had received the 4-week treatment with antipsychotic drugs (n=28). In conclusion, our results suggest that Bcl-2 might be an indicator of schizophrenia severity in the acute phase. In addition, Bcl-2 levels might be associated with positive symptoms in male patients with schizophrenia.  相似文献
9.
目的:探讨帕利哌酮与利培酮对精神分裂症首次发病患者血清催乳素水平( PRL)及体质量的影响。方法:130例首发精神分裂症患者随机分成帕利哌酮组66例(实际完成31例)和利培酮组64例(实际完成42例),分别给予帕利哌酮和利培酮治疗,观察12周。采用阳性与阴性症状量表( PAN-SS)在治疗前后进行测评;同时检测血清PRL及体质量,比较治疗前后的变化。结果:两组PANSS总分治疗后各周期均显著下降(P均<0.01),而血清PRL和体质量均较治疗前明显增加(P<0.05);两组间比较,差异无统计学意义。结论:帕利哌酮与利培酮治疗精神分裂症首次发病患者疗效相当,但两药均可致血清PRL及体质量增高。  相似文献
10.
目的 探索新型抗精神病药对肝功能的影响,以及帕利哌酮与其他新型抗精神病药相比是否具有优势.方法 采用病例回顾研究方法,收集2010年1月-2014年2月北京回龙观医院新入院精神分裂症患者91例,均符合《国际疾病分类(第10版)》(ICD-10)诊断标准.给予单一或联合新型抗精神病药系统治疗,于治疗前后检测血清丙氨酸转氨酶(ALT)、门冬氨酸转氨酶(AST)、谷氨酰转肽酶(GGT)、血清总胆汁酸(TBA)、总胆红素(T-BIL)、直接胆红素(D-BIL)、间接胆红素(I-BIL)、白蛋白/球蛋白(A/G)水平.结果 使用新型抗精神病药物治疗后肝功能异常率为14.28%.用药后ALT、GGT、TBA水平增加,ALT、TBA异常率增加,差异有统计学意义(P<0.05).T-BIL、D-BIL、I-BIL水平下降,I-BIL异常率下降,差异有统计学意义(P<0.05).方差分析显示,帕利哌酮组、利培酮组和其他组三组间血清ALT水平差异有统计学意义(F=3.664,P=0.03),多重比较显示,帕利哌酮组分别与其他两组血清ALT水平差异有统计学意义(P<0.05).结论 新型抗精神病药物对肝功能的影响主要体现在对肝细胞实质的影响.帕利哌酮与其他新型抗精神病药相比对肝脏的安全性更好.  相似文献
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