From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.
Neurology. 2019 Mar 5;92(10):e1109-e1120. doi: 10.1212/WNL.0000000000007037. Epub 2019 Feb 8.
To investigate predictors for improvement of disease-specific quality of life (QOL) after deep brain stimulation (DBS) of the subthalamic nucleus (STN) for Parkinson disease (PD) with early motor complications.
We performed a secondary analysis of data from the previously published EARLYSTIM study, a prospective randomized trial comparing STN-DBS (n = 124) to best medical treatment (n = 127) after 2 years follow-up with disease-specific QOL (39-item Parkinson's Disease Questionnaire summary index [PDQ-39-SI]) as the primary endpoint. Linear regression analyses of the baseline characteristics age, disease duration, duration of motor complications, and disease severity measured at baseline with the Unified Parkinson's Disease Rating Scale (UPDRS) (UPDRS-III "off" and "on" medications, UPDRS-IV) were conducted to determine predictors of change in PDQ-39-SI.
PDQ-39-SI at baseline was correlated to the change in PDQ-39-SI after 24 months in both treatment groups ( < 0.05). The higher the baseline score (worse QOL) the larger the improvement in QOL after 24 months. No correlation was found for any of the other baseline characteristics analyzed in either treatment group.
Impaired QOL as subjectively evaluated by the patient is the most important predictor of benefit in patients with PD and early motor complications, fulfilling objective gold standard inclusion criteria for STN-DBS. Our results prompt systematically including evaluation of disease-specific QOL when selecting patients with PD for STN-DBS.
NCT00354133.
探讨伴有早期运动并发症的帕金森病(PD)患者接受丘脑底核(STN)深部脑刺激(DBS)后,疾病特异性生活质量(QOL)改善的预测因素。
我们对先前发表的 EARLYSTIM 研究的数据进行了二次分析,这是一项前瞻性随机试验,比较了 STN-DBS(n=124)与最佳药物治疗(n=127)在 2 年随访时的疗效,以疾病特异性 QOL(39 项帕金森病问卷综合指数[PDQ-39-SI])为主要终点。采用线性回归分析,以基线时的年龄、病程、运动并发症持续时间和疾病严重程度(采用统一帕金森病评定量表[UPDRS]测量,包括 UPDRS-III“关”和“开”药物、UPDRS-IV),对基线特征进行分析,以确定 PDQ-39-SI 变化的预测因素。
在两组治疗中,PDQ-39-SI 基线值与 24 个月后 PDQ-39-SI 的变化相关(<0.05)。基线评分越高(QOL 越差),24 个月后 QOL 的改善越大。在任何一组治疗中,均未发现其他基线特征与变化有相关性。
患者主观评估的 QOL 受损是 PD 伴早期运动并发症患者获益的最重要预测因素,满足 STN-DBS 客观金标准的纳入标准。我们的结果提示,在选择 PD 患者进行 STN-DBS 时,应系统地评估疾病特异性 QOL。
临床试验.gov 标识符:NCT00354133。