對巴金森氏症病人刺激下視丘核比動手術來得有效


  Jan. 30, 2004-根據1月27日發表在神經學(Neurology)期刊的隨機比對臨床試驗結果顯示,控制巴金森氏症病人症無狀刺激兩側下視丘核(STN)會比單邊的蒼白球燒灼術(Pallidotomy)來得更為有效。
  
  荷蘭阿姆斯特丹學術醫學中心醫務部的合著醫師J.D.Speelman在新聞稿中指出,這些研究結果更進一步顯示在後階段巴金森氏症的疾病中減少症狀時,兩側腦刺激作用是更有效的療法,另外,與蒼白球燒灼術(Pallidotomy)相比,腦刺激作用的結果更能減少抗巴金森氏症藥用的使用。
  
  在這個觀察員遮盲跨國多中心試驗中,隨機挑選有後階段巴金森氏症的34個病人來作單方面蒼白球燒灼術(Pallidotomy)或者是雙邊的STN刺激療法(Activa療法,Medtronic,Inc.),後階段巴金森氏症的持續時間至少是 12 年,且儘管使用最理想藥物,他的症狀仍是嚴重的。
  
  主要結果是看在後期帕金森病統一評定量表(UPDRS),從基線到六個月的離線階段動量分數的變化。次要結果是在連線階段的動量UPDRS,運動困難的UPDRS,臨床診斷之運動困難評定量表,由日常生活中量測到的活動機能狀態的UPDRS,Schwab和英國的分數,意見徵詢的帕金森病生活品質,在藥物處理的改變以及反相影響的改變。
  
  在蒼白球燒灼術(Pallidotomy)小組裡離線階段的動量分數UPDRS可從46.5改進到37個點,而在STN刺激作用小組裡的改進可從51.5到26.5(P=0.002)。用STN刺激作用對待的病人也按照在連線階段的動量UPDRS,運動困難的UPDRS,中位數的持續時間的UPDRS,和抗巴金森氏症藥物的減少使用。
  
  用pallidotomy對待的一個病人堅決自殺了,而用STN刺激作用處理的一個病人卻產生了嚴重認知退化。
  
  在2002年美國食品和藥物管理局為後期帕金森病的治療批准了Activa療法,並且在2003年4月國家醫療保險給付範圍核准通過,結果發現是可改進療效和抑制反作用的,而其可逆性是因為它能夠調離改變或者移除。
  
  研究局限,包括在處理小組裡的病人時,從每一中心對待病人的數目不平衡、開放式標籤的設計、和鑒定者的不完全瞎的分發中所產生的某些統計權限的損失。
  
  研究者指出,單方面pallidotomy比雙側STN刺激作用來得更為有效的可能解釋是STN小組裡的雙邊干涉,並且在STN小組操作後個別地調改刺激作用參數的可能性,亦或是對減少帕金森病而言,STN比內部 pallidum更是一個有效目標的可能性。
  
  Speelman博士和他的同事表示,在對用於某些刺激作用參數調整的強制性常態不可能的遠程地區,或者是某些擁有豐富資訊的病人決定不使用刺激作用,他們仍然考慮單方面pallidotomy是一個對帕金森病病人處理方獲得選擇項,對STN刺激作用的長期研究仍未完善,但是與單方面的pallidotomy比較的優勢,由於帕金森病是一種雙側進行性的疾病,因此結果長期以來仍是愈趨明顯。

Subthalamic Nucleus Stimulatio

By Laurie Barclay, MD
Medscape Medical News

Jan. 30, 2004 — Bilateral subthalamic nucleus (STN) stimulation is more effective than unilateral pallidotomy for controlling symptoms of Parkinson's disease (PD), according to the results of a randomized trial published in the Jan. 27 issue of Neurology.

"These results further demonstrate that bilateral brain stimulation is a more effective therapy in reducing symptoms in advanced Parkinson's disease," coauthor J. D. Speelman, MD, from the Academic Medical Center in Amsterdam, the Netherlands, says in a news release. "In addition, brain stimulation resulted in greater reduction in dosages of antiparkinsonian drugs, compared to pallidotomy."

In this observer-blind, multicenter trial, 34 patients with advanced PD were randomized to treatment with unilateral pallidotomy or bilateral STN stimulation (Activa therapy; Medtronic, Inc.). Duration of PD was at least 12 years, and symptoms were severe despite optimal pharmaceutical treatment.

The primary outcome was the change from baseline to six months in the off-phase motor score of the Unified PD Rating Scale (UPDRS). Secondary outcomes were on-phase motor UPDRS; dyskinesias UPDRS; Clinical Dyskinesia Rating Scale score; functional status measured by the activities of daily living UPDRS, Schwab and England scales; PD Quality of Life questionnaire; changes in drug treatment, and adverse effects.

Improvements in the off-phase motor UPDRS score were from 46.5 to 37 points in the pallidotomy group and from 51.5 to 26.5 in the STN stimulation group (P = .002). Patients treated with STN stimulation also fared better in terms of on-phase motor UPDRS, dyskinesias UPDRS, median duration of dyskinesia, and reduction in antiparkinsonian drugs.

One patient treated with pallidotomy committed suicide, and one patient treated with STN stimulation developed severe cognitive deterioration.

The U.S. Food and Drug Administration approved Activa therapy for the treatment of advanced PD in 2002, and it was approved for national Medicare coverage in April 2003. It is said to be adjustable to improve efficacy and limit adverse effects, and reversible in that it can be switched off or removed.

Study limitations include loss of some statistical power from imbalance in distribution of the patients in the treatment groups, imbalance in the number of patients treated per center, open-label design, and incomplete blinding of the assessors.

"Possible explanations for the greater efficacy of bilateral STN stimulation compared to unilateral pallidotomy are the bilateral intervention in the STN group, the possibility of individually fine tuning the stimulation parameters after the operation in the STN group, and the possibility that STN is a more effective target than the internal pallidum for reducing PD symptoms," the authors write.

"We still consider unilateral pallidotomy as an option in the treatment of patients with PD in remote areas where the mandatory frequent follow-up for adjustment of stimulation parameters is impossible, or in well-informed patients who decide against stimulation....," write Dr. Speelman and colleagues. "Studies on the long-term effects of STN stimulation are not yet available, but the benefits of bilateral STN stimulation, compared to unilateral pallidotomy, might become more pronounced over time, because PD is a progressive bilateral disease."

The Prinses Beatrix fonds funded this study. Medtronic provided an unrestricted research grant to the Academic Medical Center, hired Dr. Speelman as an independent consultant, and gave travel grants to several of the study authors.

Neurology. 2004;62:201-207

Reviewed by Gary D. Vogin, MD

    
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