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Rheumatoid arthritis: First face-off in RA biologic therapy declared a draw

机译:类风湿关节炎:RA生物疗法中的首次对峙宣告平息

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Background: Patients with advanced Parkinson's disease often have rapid swings between mobility and immobility, and many respond unsatisfactorily to adjustments in pharmacological treatment. We assessed whether globus pallidus pars interna (GPi) deep brain stimulation (DBS) gives greater functional improvement than does subthalamic nucleus (STN) DBS. Methods: We recruited patients from five centres in the Netherlands who were aged 18 years or older, had idiopathic Parkinson's disease, and had, despite optimum pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia. By use of a computer-generated randomisation sequence, we randomly assigned patients to receive either GPi DBS or STN DBS (1:1), applying a minimisation procedure according to drug use (levodopa equivalent dose <1000 mg vs ≥1000 mg) and treatment centre. Patients and study assessors (but not those who assessed adverse events) were masked to treatment allocation. We had two primary outcomes: functional health as measured by the weighted Academic Medical Center Linear Disability Scale (ALDS; weighted by time spent in the off phase and on phase) and a composite score for cognitive, mood, and behavioural effects up to 1 year after surgery. Secondary outcomes were symptom scales, activities of daily living scales, a quality-of-life questionnaire, the occurrence of adverse events, and drug use. We used the intention-to-treat principle for all analyses. This trial is registered with www.controlled-trials.com, number ISRCTN85542074. Findings: Between Feb 1, 2007, and March 29, 2011, we enrolled 128 patients, assigning 65 to GPi DBS and 63 to STN DBS. We found no statistically significant difference in either of our primary outcomes: mean change in weighted ALDS (3·0 [SD 14·5] in the GPi group vs 7·7 [23·2] in the STN group; p=0·28) and the number of patients with cognitive, mood, and behavioural side-effects (36 [58%] of 62 patients in the GPi group vs 35 [56%] of 63 patients in the STN group; p=0·94). Secondary outcomes showed larger improvements in off-drug phase in the STN group compared with the GPi group in the mean change in unified Parkinson's disease rating scale motor examination scores (20·3 [16·3] vs 11·4 [16·1]; p=0·03), the mean change in ALDS scores (20·3 [27·1] vs 11·8 [18·9]; p=0·04), and medication (mean levodopa equivalent drug reduction: 546 [SD 561] vs 208 [521]; p=0·01). We recorded no difference in the occurrence of adverse events between the two groups. Other secondary endpoints showed no difference between the groups. Interpretation: Although there was no difference in our primary outcomes, our findings suggest that STN could be the preferred target for DBS in patients with advanced Parkinson's disease. Funding: Stichting Internationaal Parkinson Fonds, Prinses Beatrix Fonds, and Parkinson Vereniging.
机译:背景:帕金森氏病晚期患者经常在活动和不活动之间快速摆动,许多人对药理学调整的反应不令人满意。我们评估了大脑内侧苍白球(GPi)深部脑刺激(DBS)是否比丘脑下核(STN)DBS有了更大的功能改善。方法:我们从荷兰的五个中心招募了年龄在18岁以上,患有特发性帕金森氏病并且尽管采取了最佳药物治疗后仍具有至少以下症状之一的患者:严重反应波动,运动障碍,疼痛性肌张力障碍或运动迟缓。通过使用计算机生成的随机序列,我们随机分配患者接受GPi DBS或STN DBS(1:1),并根据药物使用情况(应用左旋多巴等效剂量<1000 mg vs≥1000 mg)应用最小化程序并进行治疗中央。患者和研究评估者(但未评估不良事件的评估者)被掩盖为治疗分配。我们有两个主要结局:通过加权学术医学中心线性残疾量表(ALDS;通过在停产期和停产期所花费的时间进行加权)衡量的功能健康,以及长达1年的认知,情绪和行为影响的综合评分手术后。次要结果是症状量表,日常生活活动量表,生活质量问卷,不良事件的发生和吸毒。我们在所有分析中都使用了意向治疗原则。该试验已在www.control-trials.com上注册,编号为ISRCTN85542074。结果:在2007年2月1日至2011年3月29日之间,我们招募了128位患者,其中65位分配给GPi DBS,63位分配给STN DBS。我们发现我们的两个主要结局均无统计学差异:加权ALDS的平均变化(GPi组为3·0 [SD 14·5],而STN组为7·7 [23·2]; p = 0· 28)以及具有认知,情绪和行为副反应的患者数量(GPi组62例患者中的36 [58%],而STN组63例患者中35 [56%]; p = 0·94) 。继发结局显示,与帕金森病统一的帕金森氏病评分量表运动检查评分的平均变化相比,STN组与GPi组相比,药物阶段的改善更大(20·3 [16·3] vs 11·4 [16·1] ; p = 0·03),ALDS评分的平均变化(20·3 [27·1] vs 11·8 [18·9]; p = 0·04)和药物治疗(平均左旋多巴等效药物减少量:546) [SD 561]与208 [521]; p = 0·01)。我们没有记录两组之间不良事件发生的差异。其他次要终点显示两组之间无差异。解释:尽管我们的主要结局没有差异,但我们的发现表明,STN可能是晚期帕金森病患者DBS的首选靶标。资金来源:Stichting国际帕金森基金会,Prinses Beatrix Fonds和帕金森基金会。

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