Parkinson＇s disease has a negative impact on health-related quality of life in Parkinson＇s disease patients. Depression, cognitive impairment, coping strategies, dyskinesia, gait disorders and complications of dopam...Parkinson＇s disease has a negative impact on health-related quality of life in Parkinson＇s disease patients. Depression, cognitive impairment, coping strategies, dyskinesia, gait disorders and complications of dopaminergic drugs are the variables that most affect health-related quality of life. The ecological model of human development focuses attention on both individual and social environmental factors as targets for health interventions. From this perspective, the aim of this cross-sectional survey was to evaluate the influence of gender, family size and perceived autonomy on health-related quality of life in Parkinson＇s disease patients in nOrtheastern Sicily, Italy. Ninety Parkinson＇s disease patients, attending the Movement Disorders Clinic at IRCCS Centro Neurolesi ＂Bonino-Pulejo＂ （Messina）, were consecutively enrolled. The Unified Parkinson Disease Rating Scale motor subscale （UPDRS-Ⅲ） scores, the Parkinson Disease Questionnaire-39 Item scores （as a disease-specific measure of health-related quality of life）, scores on the Short Form （36） Health Survey Questionnaire （as a generic measure）, and answers to a brief checklist were recorded. A total of 85 Parkinson＇s disease patients （49% males and 51% females; mean age 70.8 ± 8.6 years mean UPDRS-Ⅲ 24.15 ± 6.55; mean disease duration 5.52 ± 4.65 years） completed the booklet of questionnaires. In the multivariate regression analysis, we included clinical and social variables as independent predictors of health-related quality of life. Our results suggest a potential compounding effect of ecological intrapersonal and interpersonal levels on health-related quality of life outcomes. Gender, self-evaluated autonomy and family size significantly impacted health-related quality of life. If quality of life is used as an indicator of treatment outcomes, an ecological perspective of the case history will be important to disclose relevant prognostic information and trigger personalized health care interventions.展开更多
Background The clinical utility and safety of sargramostim has previously been reported in cancer,acute radiation syndrome,autoimmune disease,inflammatory conditions,and Alzheimer’s disease.The safety,tolerability,an...Background The clinical utility and safety of sargramostim has previously been reported in cancer,acute radiation syndrome,autoimmune disease,inflammatory conditions,and Alzheimer’s disease.The safety,tolerability,and mecha-nisms of action in Parkinson’s disease(PD)during extended use has not been evaluated.Methods As a primary goal,safety and tolerability was assessed in five PD patients treated with sargramostim(Leukine®,granulocyte-macrophage colony-stimulating factor)for 33 months.Secondary goals included numbers of CD4+T cells and monocytes and motor functions.Hematologic,metabolic,immune,and neurological evaluations were assessed during a 5-day on,2-day off therapeutic regimen given at 3μg/kg.After 2 years,drug use was discon-tinued for 3 months.This was then followed by an additional 6 months of treatment.Results Sargramostim-associated adverse events included injection-site reactions,elevated total white cell counts,and bone pain.On drug,blood analyses and metabolic panels revealed no untoward side effects linked to long-term treatment.Unified Parkinson’s Disease Rating Scale scores remained stable throughout the study while regulatory T cell number and function were increased.In the initial 6 months of treatment,transcriptomic and proteomic mono-cyte tests demonstrated autophagy and sirtuin signaling.This finding paralleled anti-inflammatory and antioxidant activities within both the adaptive and innate immune profile arms.Conclusions Taken together,the data affirmed long-term safety as well as immune and anti-inflammatory responses reflecting clinical stability in PD under the sargramostim treatment.Confirmation in larger patient populations is planned in a future phase II evaluation.展开更多
Objective:To evaluate the non-inferiority of pramipexole extended-release(ER)versus immediate-release(IR)in Chinese patients with Parkinson’s disease(PD)in a double-blind,randomized,parallel-group study.Methods:Subje...Objective:To evaluate the non-inferiority of pramipexole extended-release(ER)versus immediate-release(IR)in Chinese patients with Parkinson’s disease(PD)in a double-blind,randomized,parallel-group study.Methods:Subjects were Chinese patients with idiopathic PD with diagnosis≥2 years prior to trial,age≥30 years old at diagnosis,and Modified Hoehn and Yahr score 2-4 during‘on’-time.Subjects received treatment with pramipexole ER(n=234)or IR(n=239).Non-inferiority was based on the primary endpoint,the change from baseline to end of maintenance(week 18)in the UPDRS(Parts II+III)total score.Results:For the primary endpoint,the adjusted mean changes(standard error)of UPDRS Parts II+III at week 18 were−13.81(0.655)and−13.05(0.643)for ER and IR formulations,respectively,using ANCOVA adjusted for treatment and centre(fixed effect)and baseline(covariate).The adjusted mean between group difference was 0.8 for the 2-sided 95%CI(−1.047,2.566).Since the lower limit of the 2-sided 95%CI(−1.047)for treatment difference was higher than the non-inferiority margin of−4,non-inferiority between pramipexole ER and IR was demonstrated.The incidence of adverse events(AEs)was 68.8%in the ER arm and 73.6%in the IR arm with few severe AEs(ER:2.1%;IR:3.8%).Conclusion:Based on the UPDRS II+III score,pramipexole ER was non-inferior to pramipexole IR.The safety profiles of pramipexole ER and IR were similar.These results were based on comparable mean daily doses and durations of treatment for both formulations.展开更多
Objective:To study the relationship between sleep disturbances and symptoms in patients with Parkinson’s disease(PD).Methods:The Parkinson’s Disease Sleep Scale-Chinese Version(PDSS-CV)was used to evaluate the sleep...Objective:To study the relationship between sleep disturbances and symptoms in patients with Parkinson’s disease(PD).Methods:The Parkinson’s Disease Sleep Scale-Chinese Version(PDSS-CV)was used to evaluate the sleep disturbances of PD patients in a cross sectional study.The Unified Parkinson’s Disease Rating Scale(UPDRS)parts II-IV,and the Hoehn&Yahr(H&Y)stage were used to determine the level of motor function in PD and the severity of PD.The Spearman correlation and a multiple regression analysis were used to identify the relationship between sleep disturbances and symptoms of PD.The quantities derived from the UPDRS and the H&Y stage and disease duration were compared between groups of patients either with or without sleep disturbances identified by the PDSS.This study was conducted from December 2011 to March 2012 at the First Affiliated Hospital of Sun Yat-sen University,in Guangzhou.Results:A total of 136 PD patients were included in this study.The overall total PDSS score in PD patients was 107.58±23.35 points(range:30–146).There were significant differences in the disease duration,the H&Y stage,and the UPDRS section subscores between groups of patients either with or without sleep disturbances(Kruskal-Wallis Test,p<0.05).There were significant negative correlations between PDSS scores and the UPDRS subscores,the H&Y stage and the disease duration(Spearman correlation,p<0.05).The multiple regression analysis indicated that sleep disturbances identified by the PDSS were only associated with daily life activity,tremor intensity and clinical fluctuation(R2=0.22,F(3,132)=12.4,p<0.001).The correlations were also significant when the contribution of the other two factors was excluded using partial correlations.Conclusions:The level of daily life activity and the occurrences of tremor and clinical fluctuation are likely to be important factors that lead to PD patients’sleep disturbances.This study may elucidate an important clue for the relationship between sleep disturbances and PD symptoms.展开更多
目的运用网状meta分析探讨血管性帕金森综合征(vascular parkinsonism,VP)药物治疗的疗效及安全性。方法计算机检索中国知网、万方数据知识服务平台、维普中文期刊服务平台、PubMed、Web of Science、MEDLINE、Embase、Cochrane Librar...目的运用网状meta分析探讨血管性帕金森综合征(vascular parkinsonism,VP)药物治疗的疗效及安全性。方法计算机检索中国知网、万方数据知识服务平台、维普中文期刊服务平台、PubMed、Web of Science、MEDLINE、Embase、Cochrane Library收录的VP药物治疗的随机对照试验,检索时限为各数据库建库至2023年1月1日。由两名研究员独立进行文献筛选、数据提取并对纳入的研究进行质量评价,应用R软件对数据进行网状meta分析。结果最终纳入20项研究,包括丁苯酞联合多巴丝肼、依达拉奉联合多巴丝肼、盐酸普拉克索联合多巴丝肼、单用多巴丝肼4种药物疗法。总体文献质量水平中等。网状meta分析结果显示:(1)在治疗总有效率方面,优选概率排名曲线(surface under the cumulative ranking curve,SUCRA)排序结果显示,丁苯酞联合多巴丝肼>依达拉奉联合多巴丝肼>盐酸普拉克索联合多巴丝肼>单用多巴丝肼;(2)在帕金森病统一评分量表(unified Parkinson’s disease rating scale,UPDRS)评分改善方面,SUCRA排序结果显示,丁苯酞联合多巴丝肼>依达拉奉联合多巴丝肼>盐酸普拉克索联合多巴丝肼>单用多巴丝肼;(3)在不良反应方面,SUCRA排序结果显示,丁苯酞联合多巴丝肼>单用多巴丝肼>盐酸普拉克索联合多巴丝肼>依达拉奉联合多巴丝肼。结论丁苯酞联合多巴丝肼治疗VP的有效率最高,对UPDRS评分改善最明显,且安全性最好,未观察到有明显增加不良反应的风险。但纳入的研究方法学质量普遍偏低,故结论仍待更多大样本、高质量的研究进一步验证。展开更多
基金supported by a grant from the Ministry of Health (Research for the Strategic Program 2007)
文摘Parkinson＇s disease has a negative impact on health-related quality of life in Parkinson＇s disease patients. Depression, cognitive impairment, coping strategies, dyskinesia, gait disorders and complications of dopaminergic drugs are the variables that most affect health-related quality of life. The ecological model of human development focuses attention on both individual and social environmental factors as targets for health interventions. From this perspective, the aim of this cross-sectional survey was to evaluate the influence of gender, family size and perceived autonomy on health-related quality of life in Parkinson＇s disease patients in nOrtheastern Sicily, Italy. Ninety Parkinson＇s disease patients, attending the Movement Disorders Clinic at IRCCS Centro Neurolesi ＂Bonino-Pulejo＂ （Messina）, were consecutively enrolled. The Unified Parkinson Disease Rating Scale motor subscale （UPDRS-Ⅲ） scores, the Parkinson Disease Questionnaire-39 Item scores （as a disease-specific measure of health-related quality of life）, scores on the Short Form （36） Health Survey Questionnaire （as a generic measure）, and answers to a brief checklist were recorded. A total of 85 Parkinson＇s disease patients （49% males and 51% females; mean age 70.8 ± 8.6 years mean UPDRS-Ⅲ 24.15 ± 6.55; mean disease duration 5.52 ± 4.65 years） completed the booklet of questionnaires. In the multivariate regression analysis, we included clinical and social variables as independent predictors of health-related quality of life. Our results suggest a potential compounding effect of ecological intrapersonal and interpersonal levels on health-related quality of life outcomes. Gender, self-evaluated autonomy and family size significantly impacted health-related quality of life. If quality of life is used as an indicator of treatment outcomes, an ecological perspective of the case history will be important to disclose relevant prognostic information and trigger personalized health care interventions.
基金supported by National Institute of Neurological Disorders and Stroke Grant 5 R01NS034239-25 and private donations provided through the University of Nebraska Foundation.
文摘Background The clinical utility and safety of sargramostim has previously been reported in cancer,acute radiation syndrome,autoimmune disease,inflammatory conditions,and Alzheimer’s disease.The safety,tolerability,and mecha-nisms of action in Parkinson’s disease(PD)during extended use has not been evaluated.Methods As a primary goal,safety and tolerability was assessed in five PD patients treated with sargramostim(Leukine®,granulocyte-macrophage colony-stimulating factor)for 33 months.Secondary goals included numbers of CD4+T cells and monocytes and motor functions.Hematologic,metabolic,immune,and neurological evaluations were assessed during a 5-day on,2-day off therapeutic regimen given at 3μg/kg.After 2 years,drug use was discon-tinued for 3 months.This was then followed by an additional 6 months of treatment.Results Sargramostim-associated adverse events included injection-site reactions,elevated total white cell counts,and bone pain.On drug,blood analyses and metabolic panels revealed no untoward side effects linked to long-term treatment.Unified Parkinson’s Disease Rating Scale scores remained stable throughout the study while regulatory T cell number and function were increased.In the initial 6 months of treatment,transcriptomic and proteomic mono-cyte tests demonstrated autophagy and sirtuin signaling.This finding paralleled anti-inflammatory and antioxidant activities within both the adaptive and innate immune profile arms.Conclusions Taken together,the data affirmed long-term safety as well as immune and anti-inflammatory responses reflecting clinical stability in PD under the sargramostim treatment.Confirmation in larger patient populations is planned in a future phase II evaluation.
基金Boehringer lngelheim lnternational GmbH sponsored this study.
文摘Objective:To evaluate the non-inferiority of pramipexole extended-release(ER)versus immediate-release(IR)in Chinese patients with Parkinson’s disease(PD)in a double-blind,randomized,parallel-group study.Methods:Subjects were Chinese patients with idiopathic PD with diagnosis≥2 years prior to trial,age≥30 years old at diagnosis,and Modified Hoehn and Yahr score 2-4 during‘on’-time.Subjects received treatment with pramipexole ER(n=234)or IR(n=239).Non-inferiority was based on the primary endpoint,the change from baseline to end of maintenance(week 18)in the UPDRS(Parts II+III)total score.Results:For the primary endpoint,the adjusted mean changes(standard error)of UPDRS Parts II+III at week 18 were−13.81(0.655)and−13.05(0.643)for ER and IR formulations,respectively,using ANCOVA adjusted for treatment and centre(fixed effect)and baseline(covariate).The adjusted mean between group difference was 0.8 for the 2-sided 95%CI(−1.047,2.566).Since the lower limit of the 2-sided 95%CI(−1.047)for treatment difference was higher than the non-inferiority margin of−4,non-inferiority between pramipexole ER and IR was demonstrated.The incidence of adverse events(AEs)was 68.8%in the ER arm and 73.6%in the IR arm with few severe AEs(ER:2.1%;IR:3.8%).Conclusion:Based on the UPDRS II+III score,pramipexole ER was non-inferior to pramipexole IR.The safety profiles of pramipexole ER and IR were similar.These results were based on comparable mean daily doses and durations of treatment for both formulations.
基金This study was supported by grants from the Guangdong Natural Science Foundation(No.10151008901000187)the Guangdong Science and Technology Foundation(No.2010B080701107).
文摘Objective:To study the relationship between sleep disturbances and symptoms in patients with Parkinson’s disease(PD).Methods:The Parkinson’s Disease Sleep Scale-Chinese Version(PDSS-CV)was used to evaluate the sleep disturbances of PD patients in a cross sectional study.The Unified Parkinson’s Disease Rating Scale(UPDRS)parts II-IV,and the Hoehn&Yahr(H&Y)stage were used to determine the level of motor function in PD and the severity of PD.The Spearman correlation and a multiple regression analysis were used to identify the relationship between sleep disturbances and symptoms of PD.The quantities derived from the UPDRS and the H&Y stage and disease duration were compared between groups of patients either with or without sleep disturbances identified by the PDSS.This study was conducted from December 2011 to March 2012 at the First Affiliated Hospital of Sun Yat-sen University,in Guangzhou.Results:A total of 136 PD patients were included in this study.The overall total PDSS score in PD patients was 107.58±23.35 points(range:30–146).There were significant differences in the disease duration,the H&Y stage,and the UPDRS section subscores between groups of patients either with or without sleep disturbances(Kruskal-Wallis Test,p<0.05).There were significant negative correlations between PDSS scores and the UPDRS subscores,the H&Y stage and the disease duration(Spearman correlation,p<0.05).The multiple regression analysis indicated that sleep disturbances identified by the PDSS were only associated with daily life activity,tremor intensity and clinical fluctuation(R2=0.22,F(3,132)=12.4,p<0.001).The correlations were also significant when the contribution of the other two factors was excluded using partial correlations.Conclusions:The level of daily life activity and the occurrences of tremor and clinical fluctuation are likely to be important factors that lead to PD patients’sleep disturbances.This study may elucidate an important clue for the relationship between sleep disturbances and PD symptoms.
文摘目的运用网状meta分析探讨血管性帕金森综合征(vascular parkinsonism,VP)药物治疗的疗效及安全性。方法计算机检索中国知网、万方数据知识服务平台、维普中文期刊服务平台、PubMed、Web of Science、MEDLINE、Embase、Cochrane Library收录的VP药物治疗的随机对照试验,检索时限为各数据库建库至2023年1月1日。由两名研究员独立进行文献筛选、数据提取并对纳入的研究进行质量评价,应用R软件对数据进行网状meta分析。结果最终纳入20项研究,包括丁苯酞联合多巴丝肼、依达拉奉联合多巴丝肼、盐酸普拉克索联合多巴丝肼、单用多巴丝肼4种药物疗法。总体文献质量水平中等。网状meta分析结果显示:(1)在治疗总有效率方面,优选概率排名曲线(surface under the cumulative ranking curve,SUCRA)排序结果显示,丁苯酞联合多巴丝肼>依达拉奉联合多巴丝肼>盐酸普拉克索联合多巴丝肼>单用多巴丝肼;(2)在帕金森病统一评分量表(unified Parkinson’s disease rating scale,UPDRS)评分改善方面,SUCRA排序结果显示,丁苯酞联合多巴丝肼>依达拉奉联合多巴丝肼>盐酸普拉克索联合多巴丝肼>单用多巴丝肼;(3)在不良反应方面,SUCRA排序结果显示,丁苯酞联合多巴丝肼>单用多巴丝肼>盐酸普拉克索联合多巴丝肼>依达拉奉联合多巴丝肼。结论丁苯酞联合多巴丝肼治疗VP的有效率最高,对UPDRS评分改善最明显,且安全性最好,未观察到有明显增加不良反应的风险。但纳入的研究方法学质量普遍偏低,故结论仍待更多大样本、高质量的研究进一步验证。
