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腰椎论坛»腰椎论坛 突友大家谈 腰椎间盘突出症,哪些患者需要手术?(转贴)中英对照资料 ...   『 交流腰椎间盘突出治疗方法,分享腰突症康复经验 』
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标题: 腰椎间盘突出症,哪些患者需要手术?(转贴)中英对照资料

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 楼主|发表于 2010-1-4 09:38 | 个人空间 | 显示全部楼层 | 收藏本帖
从丁香园上转贴过来的,应该给突友们带来信心:时间可以治愈一切!

从丁香园上转贴过来的,应该给突友们带来信心:时间可以治愈一切!
1.腰椎间盘突出症,哪些患者需要手术?『0105』  Copy to clipboard
Posted by: hotstone
Posted on: 2009-12-27 14:17
腰椎间盘突出症的处理被很多脊柱外科医生认为是很基础,很简单的,然而,与之相关的问题,比如手术时机、手术适应证、手术方式等等,从来都是充满争议的,从来都没有统一的意见。在咱们论坛中,对这些问题也进行了很多讨论,争论不断,没有结果。
循证医学应该作为指导我们临床的明灯,它的权威应该比最牛的专家意见还要权威。在争论中谁也不服谁的时候,还是让我们来看看这盏明灯吧。
我先提供一篇循证医学综述:
[地址=http://www.semspinesurg.com/article/S1040-7383(09)00069-0/abstract]http://www.semspinesurg.com/article/S1040-7383(09)00069-0/abstract
Volume 21, Issue 4, Pages 223-229 (December 2009)
Treatment of Lumbar Disc Herniation: An Evidence-Based Review
Wayne Moschetti, MD, Adam M. Pearson, MD, MS, William A. Abdu, MD, MS
针对腰椎间盘突出症,广泛综合现有的循证医学证据,这两句话或许值得一提:
1、手术是安全的,并发症的发生率也较低,通过手术通常能更快更大程度地改善症状;
2、非手术也是安全的,即使具有手术适应证的患者,也可以选择非手术治疗,最终也能获得较好的结果。
也就是说大多数的椎间盘切除术都是可以避免的,并且没有任何长期损害。具备手术指征的患者,如果无法忍受其症状,如果希望尽早恢复,可以考虑手术治疗。
全文:
mbar Disc Herniation An Evidence-Based Review.pdf (183.04k)  

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 楼主| 发表于 2010-1-4 09:40 | 个人空间 | 显示全部楼层

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 楼主| 发表于 2010-1-4 09:42 | 个人空间 | 显示全部楼层
Weber’s Classic Randomized Control Trial
In 1983, from a single referral center in Norway, Weber7 published the first randomized control trial (RCT) comparing surgery and nonoperative treatment for patients with a her¬niated lumbar disc and radicular symptoms. Excluding pa¬tients with “intolerable” pain and those with “no indication” for operative intervention, this paper looked at 126 patients with “uncertain” indications for surgical treatment. These pa¬tients were randomized to surgical or nonoperative treatment. Follow-up examination was performed at 1, 4, and 10 years. Those undergoing surgery improved significantly more on a descriptive outcome scale (good, fair, poor, bad) compared with those treated nonoperative at the 1-year follow-up examination. Sixty-five percent of surgical patients had a “good” outcome compared with 36% in the nonoperative group. At the 4-year follow up, the surgical patients still showed better results (70% “good” outcome vs 51% for nonoperative patients), but the dif¬ference was no longer statistically significant. Only minor changes took place during the last 6 years of the study.
Weber经典随机对照试验
1983年,来自挪威一个转诊中心的Weber[7]发表了比较手术和非手术治疗伴有根性症状的腰椎间盘突出的研究,这是针对该问题发表的第一个随机对照试验(RCT)。研究排除了伴有“无法忍受”的疼痛的患者,以及没有手术干预指征的患者,文章共纳入了126例“指征不明确的”患者。这些患者随机进行手术和非手术治疗,1、4、10年是进行随访复查。在1年随访时,按照疗效评价标准(好、一般、较差、差),与非手术治疗的患者相比,进行手术的患者改善更明显。手术治疗的患者65%治疗结果为“好”,而非手术治疗者仅为36%。4年随访时,手术患者仍然显示出更好的治疗结果(70%为“好”,非手术治疗者为51%),但此后两组的差异不再具有统计学意义。在该研究的最后6年中只发生了很微小的改变。
Weber’s study represented the first effort to perform a prospective RCT comparing surgery with nonoperative treat¬ment for IDH. Similar to subsequent RCTs, this study was affected by a substantial number of patients crossing over from nonoperative treatment to surgery. In the first year after randomization, 17 of the 66 patients (26%) assigned to non-operative treatment underwent surgery while 1 patient as¬signed to surgery refused and was treated nonoperatively. Weber performed both an intention to treat (ITT) and an as-treated analysis, with similar results for the 2 analyses. By today’s standards, this study would seem limited by vague inclusion criteria, antiquated imaging techniques (magnetic resonance imaging (MRI) was not routinely obtained in the assessment of patients), and a lack of validated outcomes and power analysis. However, 10-year follow-up for a similar RCT has not been accomplished by any subsequent study, and its findings are similar to more modern studies.
Weber的研究第一次对IDH的手术和非手术治疗进行了前瞻性的RCT,与后来的RCT类似,该研究由于较多患者从非手术治疗改为手术治疗,而受到了一些影响。在随机化后的第一年内,66例安排进行非手术治疗的患者中,17例(26%)患者进行了手术治疗,同时也有1例分配到手术组的患者拒绝手术也进行了非手术治疗。Weber进行了意向治疗分析(ITT)和接受治疗分析,这两个分析的结果类似。按照现在的标准,这一研究还是存在一些局限性,主要由于其纳入标准较含糊、影像学方法较陈旧(接受评估的患者并没有常规进行MRI检查),且缺乏有效的效力分析。然而,后来的任何研究也没有对一个类似的RCT进行10年的随访,并且其研究结果与很多现代的研究都很相似。
译者注:意向治疗分析(intention to treat analysis, ITT)、接受治疗分析(as-treated analysis)和效力分析都是RCT相关的三种重要的分析方法。详见[地址=http://cc.bjmu.edu.cn/download/da4e58d0ac2b470d59dde5420946-3149709012011.pdf]http://cc.bjmu.edu.cn/download/da4e58d0ac2b470d59dde5420946-3149709012011.pdf
Weber 1983年发表在Spine上的经典文献:[地址=http://www.dxy.cn/bbs/user/download/15391877/ospective%20Study%20with%20Ten%20Years%20of%20Observation..pdf]http://www.dxy.cn/bbs/user/download/15391877/ospective%20Study%20with%20Ten%20Years%20of%20Observation..pdf


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 楼主| 发表于 2010-1-4 09:43 | 个人空间 | 显示全部楼层
Modern RCTs
In a smaller, more recent, RCT with shorter follow-up, Osterman et al8 attempted to assess the effectiveness of microdiskectomy for lumbar disc herniation. Fifty-six patients with a lumbar disc herniation, clinical findings of nerve root compression, and radicular pain lasting 6-12 weeks were randomized to microdiskectomy or an isometric physical therapy program. In this study, no clinically or statistically significant differences between the groups in leg or back pain, Oswestry disability index (ODI), or quality of life were noted at the 2-year follow-up. Compared with the nonoperative patients, the surgery group improved significantly more on the leg pain visual analog scale (VAS) at 6 weeks and was more likely to be satisfied with their treatment at all follow-up visits other than at 1 year. In a subgroup analysis, patients with an L4-L5 disc herniation (n = 28) improved more with surgery than with nonoperative treatment on all outcome measures. Those with an L5-S1 herniation (n = 28) improved to a similar degree with surgery and nonoperative treatment. Shortcomings of this study include the small sample size and the 36% crossover from nonoperative treatment to surgery. The authors reported that the study was powered to detect a 15 point change on the VAS, while the observed differences were 9 points on leg pain and 10 points on back pain at 2 years. These differences may have been clinically meaningful, but the study was not sufficiently powered to detect them. In addition, 10 out of 28 (36%) patients in the control group crossed over to surgery and were analyzed according to the ITT principle. As such, a beneficial treatment effect of surgery may have been obscured due to crossover. The authors did note that an as-treated analysis revealed no significant differences, however, the nonoperative group included only 17 patients after the crossover occurred, limiting power even further.

现代的RCT
在最近的一项短期随访的小规模RCT中,Osterman等[8]试图对腰椎间盘突出症微创椎间盘切除的有效性进行评价。56例腰椎间盘突出的患者,临床上有神经根受压的表现,根性疼痛持续6-12周,纳入研究后随机分配接受微创椎间盘切除术或等长理疗计划。在该研究中,从两年随访时记录的腰或腿痛、Oswestry功能障碍评分(ODI)及生活质量等数据来看,两组间没有任何明显的临床或统计学差异。与非手术治疗的患者相比,6周时手术组腿痛的视觉模拟评分(VAS)改善更为明显,与1年时不同,这一点可能使患者在整个随访过程中都对其治疗感到满意。在其亚组的分析中,L4-5椎间盘突出的患者(n=28),与非手术治疗相比,手术后治疗结果各项指标的改善都更为明显。而L5S1突出的患者(n=28)手术与非手术改善的程度类似。这一研究的不足主要包括样本含量较小,36%的患者从非手术治疗改为手术治疗。作者报告其研究中将VAS存在15点的变化视为是有意义的,两年时,观察到的差异腿痛为9点,背痛为10点。而这些差异也许是具有临床意义的,但该研究无法充分说明这一点。此外,对照组的28例患者中有10例(36%)改而行手术治疗,作者按照ITT的原则进行了分析。同样地,由于这种变换,手术治疗有利的治疗效果也被模糊化了。作者没有注意到接受治疗分析显示差异没有统计学意义,然而,这些患者变换治疗方式后非手术组仅剩下17例患者,则更进一步限制了其效力。
A recent RCT by Peul et al9 compared early microdiskectomy with prolonged nonoperative treatment followed by surgery if needed (Table 1). This study randomized 283 pa tients to early surgery or prolonged nonoperative treatment. Patients were 18-65 years old, had sciatica for 6-12 weeks before enrollment and had MRI-confirmed disc herniations that correlated with their symptoms. The primary outcome measures were the Roland Disability Questionnaire for Sciatica, VAS for leg pain and 7-point Likert scale of perceived recovery, with recovery defined as complete or nearly complete disappearance of symptoms. Eighty-nine percent of patients assigned to early surgery underwent surgery at a median of 1.9 weeks. The other 16 patients initially assigned to surgery had recovered before undergoing surgery. Of the patients assigned to prolonged nonoperative care, 39% un-derwent surgery at a median of 14.6 weeks. All the patients were followed for 52 weeks.
Peul等[9]近来的一项RCT对早期微创椎间盘切除术与延期非手术治疗后如果须要再行手术进行了比较(表1)。该研究随机对283例患者进行早期手术或延期非手术治疗。患者年龄18-65岁,纳入研究前坐骨神经痛持续6-12周,MRI证实存在与症状相对应的椎间盘突出。对治疗结果的主要评价指标包括Roland功能障碍调查问卷以评价坐骨神经痛,VAS评价腿痛,7点Likert标尺评价感觉功能恢复情况,恢复是指症状完全或几乎完全消失。被分配进行早期手术的患者中89%实施了手术,接受手术的时间其中位数为1.9周。另外16例患者最初分配进行手术,而实施手术前痊愈。在分配进行延期非手术治疗的患者中,39%进行了手术,手术时间的中位数为14.6周。所有患者均随访了52周。
There were no differences in the primary outcome measures at 1 year in the ITT analysis. Not surprisingly, the early surgery group improved more rapidly than the prolonged nonoperative care group. This was quanti&#64257;ed by comparing the areas under the curves for the Roland Disability Questionnaire and the leg pain VAS over the 52-week follow-up. This analysis revealed no signi&#64257;cant differences for the Roland Disability Questionnaire, whereas the results for leg pain favored early surgery. The Kaplan–Meier curve comparing time with recovery also showed signi&#64257;cantly faster recovery for the early surgery group (median recovery time 4.0 weeks for early surgery vs 12.1 weeks for prolonged nonoperative care, P < 0.001), though about 95% of patients in each group had recovered by 1 year. It should be noted that about 10% of the nonoperative treatment group reached recovery between 50 and 52 weeks, so the curves were substantially different until the &#64257;nal follow-up. In a subgroup analysis, a Cox proportional hazards model demonstrated that the only subgroup that did not bene&#64257;t from early surgery was patients whose sciatica was not provoked by sitting.
经ITT分析,1年时主要治疗结果的差异没有统计学意义。不出意料,与延期非手术治疗组相比,早期手术组改善更快。在52周的随访过程中,对Roland功能障碍调查问卷和腿痛VAS的曲线下面积进行量化比较。分析结果显示,Roland功能障碍调查问卷的差异没有统计学意义,而早期手术组腿痛的结果则更好一些。通过Kaplan-Meier曲线对恢复时间进行比较也显示,虽然各组95%的患者在1年时都恢复了,但早期手术组恢复得更快(早期手术组恢复时间的中位数4周,延期非手术组为12.1周,p<0.001)。值得注意的是,非手术组大约10%的患者直到50-52周才恢复,因此在最终随访之前,曲线一直存在显著的差异。在其亚组分析中,Cox比例风险模型显示,在早期手术的患者中,唯一没有获得较好疗效的亚组,便是坐着时没有激发坐骨神经痛的患者。


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 楼主| 发表于 2010-1-4 09:44 | 个人空间 | 显示全部楼层
This study was a high quality RCT that had well-de&#64257;ned inclusion and exclusion criteria, validated outcomes, and very low attrition. However, rather than comparing the results of surgery and nonoperative treatment, it compared the results of early surgery vs continued conservative care followed by later surgery if necessary. This study focused on evaluating the optimal timing of surgery, not the ef&#64257;cacy of surgery. The study does convincingly suggest that diskectomy can be avoided in many patients who satisfy the indications for surgery without any long-term harm. By contrast, it also indicates that patients who value a quicker recovery are best treated with early diskectomy. The limitations of the study included the inability to blind patients or researchers to the treatment received, the lack of standardization of conservative care, and the high cross-over rate.
该研究是一项高质量的RCT,对纳入和排除标准都进行了明确的定义,结果有效,丢失也很小。然而,该研究并不是比较手术与非手术治疗的差异,而是比较早期手术与延期保守治疗后如果须要再行手术的治疗结果。这一研究主要评价的是最佳的手术时机,并份额手术的有效性。这一研究很有说服力,提示对于有手术指征的很多患者,椎间盘切除术都是可以避免的,并且没有任何长期损害。相反,该研究也指出,对于期望快速恢复的患者,最好的办法便是早期椎间盘切除术。该研究的局限性主要包括对于接受的治疗,无法对患者或研究者实行盲法,保守治疗缺乏统一的标准,治疗方式组间变换率较高。




表1 坐骨神经痛手术与延期保守治疗的比较

——————————————————————————————————————————————————
研究设计■多中心RCT,ITT分析
患者 ■总共283例患者(早期手术组141例,保守治疗组142例)。手术的患者平均年龄41.7岁,非手术的患者平均43.4岁(范围在18-65岁之间)。
纳入标准■年龄18-65岁,“导致功能障碍的腰骶神经根综合征”6-12周,MRI显示与症状相符的椎间盘突出。
排除标准■马尾损伤表现,肌肉麻痹,肌力下降不足以抵抗重力,既往12个月内有类似的神经根症状,脊柱手术史,骨性狭窄,腰椎滑脱,妊娠,或伴有严重的合并病症。
治疗比较■2周内行微创椎间盘切除术与延期保守治疗(教育、如果须要给予止痛药、对于害怕运动的患者给予理疗)
失访 ■手术组141例中有4例失访,保守治疗组142例有3例失访
结果评价■主要的:Rowland功能障碍调查问卷评价坐骨神经痛,100mmVAS评估腿痛,7点Likert自我评定标尺对整体的感觉功能恢复程度进行评价。将恢复定义为完全或几乎完全恢复,2、4、8、12、26、38、52周进行评估。
次要的:SF-36,焦虑指数,100mmVAS健康感知,神经系统查体,8、26、52周进行评估。
研究结果■初始数据没有组间差异。早期手术组接受手术的时间中位数为1.9周,早期手术组11%的患者在接受手术前恢复,而没有进行手术。延期保守治疗组39%的患者进行了手术治疗,中位数时间14.6周。52周时两组患者主要指标评价的结果没有显著的差异。早期手术组恢复的时间中位数为4.0周,而延期保守治疗组为12.1周(p<0.001)。早期手术组腿痛的改善更早,早期手术组中除了坐着时不能激发坐骨神经痛的亚组以外,都显示出较好的有效性。
可信度 ■多中心,前瞻性,应用有效结果评价的RCT。
研究缺陷■对手术的最佳时机进行比较,而不是评价手术的有效性。非手术治疗没有特异性,无法应用盲法,随访时间限于1年。
基线 ■早期手术可使患者更快恢复,但1年时的结果没有差别。
——————————————————————————————————————————————————
ITT, intention to treat,意向治疗分析; VAS, visual-analogue scale,视觉模拟评分。


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 楼主| 发表于 2010-1-4 09:44 | 个人空间 | 显示全部楼层

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 楼主| 发表于 2010-1-4 09:46 | 个人空间 | 显示全部楼层

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 楼主| 发表于 2010-1-4 09:46 | 个人空间 | 显示全部楼层
SPORT represents the largest study to date comparing surgery with nonoperative treatment for lumbar disc herniations. Its strengths include the use of stringent inclusion criteria, validated back-speci&#64257;c and general health outcome measures, powerful statistical modeling to account for baseline differences between the groups, and the inclusion of patients from 13 different spine centers. The major limitation of the SPORT RCT was the high rate of protocol nonadherence that prevented a meaningful ITT analysis of the data. While the as-treated analysis was carefully adjusted to account for the baseline differences between the 2 groups, the bene&#64257;ts of randomization were lost. As a result, there is still no Level I evidence comparing surgery with nonoperative treatment for the treatment of lumbar disc herniations. Given that it is not possible to control for unmeasured confounders, the as-treated analysis may have overstated the treatment effect of surgery. Another limitation of SPORT and all other studies of disc herniation was the lack of blinding of patients to treatment received. Sham surgery is the only way to overcome this threat to validity, and although it has been suggested, it seems unlikely that patients would enroll in such a study or that institutional review boards would approve it.22 Given the lack of blinding, perhaps the placebo effect of surgery may have contributed to the better outcomes for the surgery patients.
SPORT是迄今为止比较腰椎间盘突出症患者手术与非手术治疗样本量最大的研究。该研究的优势主要包括采用了较为严格的纳入标准,应用了有效的脊柱特异性和一般健康结果评价方法,有效的统计模型对组间初始状况的差异进行了处理,纳入的患者来自13个不同的脊柱临床中心。SPORT RCT的局限主要是未能坚持预定方案的比率较高,从而无法对数据进行有效的ITT分析。虽然应用接受治疗分析进行谨慎的调节可解决2组间基础状况差异的问题,但却削弱了随机化的优势。最终仍然无法得到比较腰椎间盘突出症手术与非手术治疗的Ⅰ级证据。考虑到不可能控制那些无法预测的混杂,接受治疗分析则可能会夸大手术的治疗效果。SPORT和所有其他关于椎间盘突出的研究都具有的另一个不足之处,便是无法对患者接受的治疗实施盲法,为了克服对有效性的干扰,假手术是唯一的途径,虽然有这样的观点,但不太可能实施,因为患者可能不愿意加入这样的研究,抑或伦理委员会不会批准[22]。考虑到没有实施盲法,或许手术治疗的安慰剂效应也会使手术治疗的患者获得更好的治疗结果。

Proponents of various nonoperative therapies have criticized studies like SPORT for failing to specify a well-de&#64257;ned nonoperative regimen.23 The advantage of specifying “usual care” as the nonoperative treatment was the increased generalizability this provided as it more closely re&#64258;ected what was being offered to patients. However, patients may have improved more with a speci&#64257;c nonoperative treatment regimen, especially as they had failed to improve with “usual care” over time leading up to enrollment. Unfortunately, the best type of nonoperative care for disc herniations has not been rigorously de&#64257;ned, so it was not possible to select a more speci&#64257;c regimen based on the available scienti&#64257;c literature.
各种非手术治疗的研究者也批评类似SPORT这样的研究,没有对非手术治疗进行明确的限定[23]。限定非手术治疗为“常规处理”的好处在于,这些措施很多患者正在应用,这样更加容易推广应用。然而,患者可能应用某种特异性的非手术疗法可以获得更大的改善,尤其是某些纳入研究之前应用“常规处理”较长时间仍未能得到改善的患者。遗憾的是,腰椎间盘突出症最好的非手术治疗方式并没有严格的定义,因此参考现有的文献,选择一项更为明确的方法是不太可能的。


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 楼主| 发表于 2010-1-4 09:46 | 个人空间 | 显示全部楼层
Discussion
All the major studies comparing surgery with nonoperative treatment of lumbar disc herniation have reached the following conclusions: (1) surgery tends to improve symptoms faster and to a greater degree than nonoperative treatment, (2) surgery is safe and the complication rates are low, (3) patients who initially meet the indications for surgery but elect nonoperative treatment may eventually improve to an acceptable level of pain and function, (4) surgery does not improve the return to work rate compared with nonoperative treatment, and (5) nonoperative treatment is safe. The surgical outcomes of SPORT and MLSS patients were remarkably similar, though the nonoperative outcomes were not as favorable in the MLSS, which resulted in SPORT having a smaller treatment effect of surgery. While all enrolled patients met the indications for surgery, 55% of patients assigned to nonoperative treatment avoided surgery in the SPORT RCT as did 61% of the patients assigned to nonoperative treatment in the study by Peul et al.9 This suggests that many patients who can tolerate living with their symptoms for a period may be able to improve to an acceptable level of function without surgery if they choose. Despite consistent agreement across studies about the bene&#64257;t of surgery, the duration of bene&#64257;t is still unclear. While Weber’s study and the MLSS suggested that the treatment effect of surgery tends to decrease with time, the SPORT data gave no indication that the treatment effect was decreasing between 2 and 4 years. It is anticipated that SPORT will continue to follow patients out to 10 years, however, the MLSS and Weber’s study suggests that there is very little change in outcomes between 5 and 10 years.

讨论
综合所有比较腰椎间盘突出症手术与非手术治疗的主要研究,得出如下结论:

(1)相比非手术治疗,手术通常能更快更大程度地改善症状;
(2)手术是安全的,并发症的发生率也较低;
(3)起初具有手术适应证的患者,选择进行非手术治疗,最后其疼痛与功能也可获得改善,达到可接受的水平;
(4)与非手术治疗相比,手术不能改善患者恢复工作的比率;
(5)非手术治疗也是安全的。
SPORT和MLSS的患者手术结果非常相似,但非手术治疗的结果并不像MLSS那样好,SPORT的结果显示手术还是具有较小的治疗效果。对于纳入的所有具有手术指征的患者,SPORT RCT中55%的患者分配到非手术治疗组,没有进行手术治疗;而在Peul等[9]的研究中61%的患者分配进行了非手术治疗。这提示很多患者对于他们存在的症状,在其日常生活中是可以容忍一段时间的,如果他们选择非手术治疗的话,通过这段时间,他们的功能也可改善到可以接受的程度。虽然各项研究都一致认同手术治疗的优势,但这种优势能够持续的时间目前仍不清楚。Weber的研究和MLSS认为随着时间延长,手术治疗的效果有下降的趋势,而SPORT的数据则显示在2至4年间手术治疗的效果并没有下降。可以预料,SPORT将继续对这些患者进行随访至10年以上,然而,MLSS和Weber的研究都提示,5至10年间的治疗结果发生的变化非常小。


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 楼主| 发表于 2010-1-4 09:47 | 个人空间 | 显示全部楼层
Another striking similarity across all of these studies that span 4 decades is the relatively high rate of crossover to surgery for patients who initially chose or were randomized to nonoperative treatment. Weber reported a 26% crossover rate, Osterman et al. 36%, Peul et al. 39%, the MLSS 40%, and SPORT 45%.7-9 These results indicate that it is may not be possible to conduct an effective RCT comparing surgery to nonoperative treatment for lumbar disc herniation. At the same time, these results are not surprising given that patients who fail nonoperative treatment are unlikely to continue ineffective treatment. As would be expected, the SPORT patients who crossed over from nonoperative treatment to surgery had worse baseline symptoms and the perception that their symptoms were becoming worse, whereas those who crossed over from surgery to nonoperative treatment had less severe symptoms that were improving.
所有这些研究跨越40余年,具有另一个惊人的相似之处:患者最初选择或随机分配进行非手术治疗而后变换为手术治疗的比率相对较高。Weber报道有26%的变换率,Osterman等为36%,Peul等为39%,MlSS40%,SPORT高达45%[7-9]。这些结果提示,为了比较腰椎间盘突出症的手术与非手术治疗,要实施一个非常有效的RCT似乎是不太可能的。同时,考虑到这些患者非手术治疗失败后不可能再继续进行无效的治疗,而导致这样的结果也并不令人意外。如SPORT所预期的一样,从非手术治疗变换为手术的患者起初的症状更严重,并且他们认为其症状会变得更糟糕;而从手术治疗变换为非手术治疗的患者,症状严重者较少,并且认为可以得到改善。

Based on the evidence, most spine providers now agree that, on average, diskectomy results in a more rapid and greater degree of improvement, though nonoperative treatment can be successful in a large proportion of patients. Unfortunately, our ability to predict which patients will be successful with nonoperative treatment is quite limited. The next step for researchers is to use the available data to develop predictive models to improve our ability to determine which treatment is the most appropriate for individual patients. These studies should allow a shared decision model where patients can determine their preference for care based on their symptoms, values, and the available evidence.24 Such a tool would allow many patients to avoid unnecessary surgery and others to avoid prolonged periods of ineffective nonoperative treatment. While all the studies reviewed here provide answers for the “average” patient, we now have to work on applying evidence to the treatment of individual patients, none of whom are “average.”
基于以上证据,大多数脊柱外科医生目前都认同,平均来看,椎间盘切除术可以获得更快更大程度的改善,然而非手术治疗则可在一大部分患者中取得成功。遗憾的是,我们预测哪些患者通过非手术治疗可以获得成功的能力非常有限。研究人员接下来就要着手应用现有的数据,开发预测模型,以改善我们的决策能力,决定哪些治疗方法是最适合某些个体的。这些研究应该提供一个共享决策模型,患者可以根据他们的症状、价值取向以及现有的证据决定他们所喜欢的治疗方案[24]。这样一个工具可使很多患者避免不必要的手术,而使另一部分患者避免延长无效的非手术治疗的期限。通过对本文中所有研究的综述,为“一般”患者提供了答案,我们接下来将着手应用证据治疗个体患者,他们中没有谁是“一般”患者。


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 楼主| 发表于 2010-1-4 09:47 | 个人空间 | 显示全部楼层
References
1. Cherkin DC, Deyo RA, Loeser JD, et al: An international comparison of back surgery rates. Spine 19:1201-1206, 1994
2. Frymoyer JW: Back pain and sciatica. N Engl J Med 318:291-300, 1988
3. Taylor VM, Deyo RA, Cherkin DC, et al: Low back pain hospitalization. Recent United States trends and regional variations. Spine 19:12071212, 1994; discussion: 13
4. Andersson GB, Brown MD, Dvorak J, et al: Consensus summary of the diagnosis and treatment of lumbar disc herniation. Spine 21:75S-78S, 1996
5. Weinstein JN, Lurie JD, Olson PR, et al: United States’ trends and regional variations in lumbar spine surgery: 1992-2003. Spine 31: 2707-2714, 2006
6. van Tulder MW, Koes BW, Bouter LM: A cost-of-illness study of back pain in The Netherlands. Pain 62:233-240, 1995
7. Weber H: Lumbar disc herniation. A controlled, prospective study with ten years of observation. Spine 8:131-140, 1983
8. Osterman H, Seitsalo S, Karppinen J, et al: Effectiveness of microdiscectomy for lumbar disc herniation: a randomized controlled trial with 2 years of follow-up. Spine 31:2409-2414, 2006
9. Peul WC, van Houwelingen HC, van den Hout WB, et al: Surgery versus prolonged conservative treatment for sciatica. N Engl J Med 356:2245-2256, 2007
10. Atlas SJ, Deyo RA, Keller RB, et al: The Maine Lumbar Spine Study, Part
II. 1-year outcomes of surgical and nonsurgical management of sciatica. Spine 21:1777-1786, 1996
11. Atlas SJ, Keller RB, Chang Y, et al: Surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: &#64257;ve-year outcomes from the Maine Lumbar Spine Study. Spine 26:1179-1187, 2001
12. Atlas SJ, Keller RB, Wu YA, et al: Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Maine Lumbar Spine Study. Spine 30: 927-935, 2005
13. Keller RB, Atlas SJ, Singer DE, et al: The Maine Lumbar Spine Study, Part I. Background and concepts. Spine 21:1769-1776, 1996
14. Birkmeyer NJ, Weinstein JN, Tosteson AN, et al: Design of the Spine Patient Outcomes Research Trial (SPORT). Spine 27:1361-1372, 2002
15. Weinstein JN, Lurie JD, Tosteson TD, et al: Surgical vs nonoperative treatment for lumbar disk herniation. The Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA 296:2451-2459, 2006
16. Weinstein JN, Lurie JD, Tosteson TD, et al: Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine 33:2789-2800, 2008
17. Weinstein JN, Tosteson TD, Lurie JD, et al: Surgical vs nonoperative treatment for lumbar disc herniation. The Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 296:2441-2445, 2006
18. Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473-483, 1992
19. Daltroy LH, Cats-Baril WL, Katz JN, et al: The North American spine society lumbar spine outcome assessment instrument: reliability and validity tests. Spine 21:741-749, 1996
20. Tosteson AN, Skinner JS, Tosteson TD, et al: The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine 33:2108-2115, 2008
21. Pearson AM, Blood EA, Frymoyer JW, et al: SPORT lumbar intervertebral disk herniation and back pain: does treatment, location, or morphology matter? Spine 33:428-435, 2008
22. Flum DR: Interpreting surgical trials with subjective outcomes: Avoiding UnSPORTsmanlike conduct. JAMA 296:2483-2485, 2006
23. Brox JI, Sorensen R, Friis A, et al: Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine 28: 1913-1921, 2003
24. Weinstein JN: The missing piece: embracing shared decision making to reform health care. Spine 25:1-4, 2000


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发表于 2010-1-4 10:37 | 个人空间 | 显示全部楼层

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康复突友

发表于 2010-1-4 13:51 | 个人空间 | 显示全部楼层
好贴好贴,
本论坛需要更多这样的科普帖子。


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发表于 2010-1-4 15:11 | 个人空间 | 显示全部楼层
多谢楼主,搬个板凳慢慢看


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