本帖最後由 yanjw2000 於 2009-7-28 20:09 編輯
作者:Laurie Barclay, MD
出處:WebMD醫學新聞
July 14, 2009 — 根據一項發表在7月8日美國醫學會期刊的隨機分派研究結果,對坐骨神經痛來說,傳統微椎間盤切開術可能比管狀椎間盤切開術好。
荷蘭海牙Haaglanden醫學中心的Mark P. Arts醫師與其來自Leiden-The Hague Spine Intervention Prognostic研究團隊的同事們表示,因為椎間盤突出造成坐骨神經痛,傳統微椎間盤切開術是最常進行的手術。經肌肉管狀椎間盤切開術已經被引進來增加復原率,即使有關其療效的證據並不多。
坐骨神經痛微內視鏡椎間盤切開術研究的目的在於比較接受管狀椎間盤切開術、與傳統微椎間盤切開術病患的預後與復原時間。從2005年1月到2006年10月,總共有328位年齡介於18至70歲因為椎間盤突出罹患持續性腿部疼痛的病患(超過8週),從荷蘭7家綜合醫院收納到這項研究中,他們被隨機分派接受管狀椎間盤切開術(共167位)與傳統微椎間盤切開術(共161位)。受試者們與研究者們在後續追蹤中都不知道分派結果,這項研究在最終收納後一年結束。
這項研究的主要終點是Roland-Morris失能問卷(RDQ)的功能性評估,在隨機分派後8個月與1年進行。這項檢測從0分到23分,分數越高代表功能表現越差。腿部與背部疼痛以疼痛指數(VAS)評分(從0到100 mm),而病患自行通報Likert分數代表復原程度(以7級分評分)作為次級試驗終點。以意項分析作為分析原則。
在術後第一年間,管狀椎間盤切開術的平均RDQ分數為6.2分(95%信賴區間[CI]為5.6-68),傳統微椎間盤切開術為5.4分(95% CI為4.6-6.2;組間平均差距為0.8;95% CI為-0.2-1.7)。術後8週的平均RDQ分數,管狀椎間盤切開術為5.8±0.4分,而傳統微椎間盤切開術為4.9±0.5分;組間平均差距為1.3;95% CI為0.03-2.6)。
在痛覺分數上,傳統微椎間盤組也比較好,一年間兩組之間平均差異,在腿部疼痛為改善4.2 mm(95% CI為0.9-7.5 mm),而背痛改善3.5 mm(95% CI為0.1-6.9 mm)。自我通報一年回復良好比例,在管狀椎間盤切開組為156位中有107位(69%),傳統微椎間盤切開術則是151位有107位(79%)(勝算比為0.59;95% CI為0.35-0.99;P=0.05)。
研究作者們寫到,使用管狀椎間盤切開術,相較於傳統微椎間盤切開術,並未顯著改善Roland-Morris失能問卷分數。管狀椎間盤切開在病患自我通報的腿部疼痛、背痛以及復原上,結果是較差的。
這項研究的限制包括,參與中心之間的異源性,僅收納較大椎間盤突出和遠端神經根壓迫病患,以及可能低估復原率等等。
研究作者們的結論是,雖然管狀椎間盤切開術的微創技術在治療坐骨神經痛上看起來是比較吸引人的術式,但當與傳統微椎間盤切開術比較時,我們的研究數據並未支持有更好的復原率。另一方面,接受管狀椎間盤切開術的病患們,在腿部與背部疼痛上表現得較差,且術後一年完全恢復的病患數目也比較少。
荷蘭健康照護機構委員會贊助這項研究。研究作者們表示沒有相關資金上的往來。
Conventional Microdiskectomy May Be Better Than Tubular Diskectomy for Sciatica
By Laurie Barclay, MD
Medscape Medical News
July 14, 2009 — Conventional microdiskectomy may be better than tubular diskectomy for sciatica, according to the results of a randomized controlled trial reported in the July 8 issue of the Journal of the American Medical Association.
"Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica due to lumbar disk herniation," write Mark P. Arts, MD, from Medical Center Haaglanden, in the Hague, Netherlands, and colleagues from the Leiden-The Hague Spine Intervention Prognostic Study Group. "Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking of its efficacy."
The goal of The Sciatica Micro-Endoscopic Diskectomy trial was to compare outcomes and time to recovery in patients treated with tubular diskectomy vs conventional microdiskectomy. From January 2005 to October 2006, a total of 328 patients aged 18 to 70 years with persistent leg pain (> 8 weeks) caused by lumbar disk herniations were enrolled from 7 general hospitals in the Netherlands and randomly assigned to receive tubular diskectomy (n = 167) vs conventional microdiskectomy (n = 161). Participants and investigators were blinded during the follow-up, which ended 1 year after final enrollment.
The main endpoint of the study was functional assessment on the Roland-Morris Disability Questionnaire (RDQ) for sciatica at 8 weeks and 1 year after randomization. This test is scored from 0 to 23, with higher scores reflecting worse functional performance. Leg pain and back pain measured on the visual analog scale (scored from 0 - 100 mm) and Likert score for patient self-report of recovery (measured on a 7-point scale) were secondary study endpoints. Analysis was by intent-to-treat.
During the first year after surgery, the mean RDQ score was 6.2 for tubular diskectomy (95% confidence interval [CI], 5.6 - 6.8) vs 5.4 for conventional microdiskectomy (95% CI, 4.6 - 6.2; between-group mean difference, 0.8; 95% CI, ?0.2 to 1.7). Mean RDQ score at 8 weeks after surgery was 5.8 ± 0.4 for tubular diskectomy and 4.9 ± 0.5 for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, ?0.4 to 2.1). Mean RDQ score at 1 year favored conventional microdiskectomy (4.7 ± 0.5 for tubular diskectomy vs 3.4 ± 0.5 for conventional microdiskectomy; between-group mean difference, 1.3; 95% CI, 0.03 - 2.6).
The conventional microdiskectomy group also fared better on the visual analog scale, with the 1-year between-group mean difference in improvement of 4.2 mm for leg pain (95% CI, 0.9 - 7.5 mm) and 3.5 mm for back pain (95% CI, 0.1 - 6.9 mm). Self-report of good recovery at 1 year occurred in 107 (69%) of 156 patients in the tubular diskectomy group vs 120 (79%) of 151 patients in the conventional microdiskectomy group (odds ratio, 0.59; 95% CI, 0.35 - 0.99; P = .05).
"Use of tubular diskectomy compared with conventional microdiskectomy did not result in a statistically significant improvement in the Roland-Morris Disability Questionnaire score," the study authors write. "Tubular diskectomy resulted in less favorable results for patient self-reported leg pain, back pain, and recovery."
Limitations of this study include some heterogeneity between the participating centers, inclusion only of patients with larger herniated disks and distinct nerve root compression, and possible underestimation of recovery rate.
"Although the minimally invasive technique of tubular diskectomy seemed to be an attractive surgical method for treating sciatica, our data do not support a higher rate of recovery when compared with conventional microdiskectomy," the study authors conclude. "On the contrary, patients who underwent tubular diskectomy fared worse with regard to leg and back pain and fewer patients reported complete recovery at 1 year."
The Dutch Health Care Insurance Board supported this study. The study authors have disclosed no relevant financial relationships.
JAMA. 2009;302:149-158. |
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