腰椎间盘突出症治疗的循证医学综述（转自丁香园论坛）

jichao1979 · 楼主|发表于 2013-3-7 20:02

再次感谢丁香园骨科版主（hotstone)精彩翻译

Treatment of Lumbar Disc Herniation: An Evidence-Based Review
腰椎间盘突出症治疗的循证医学综述

Wayne Moschetti, MD, Adam M. Pearson, MD, MS, and William A. Abdu, MD, MS
Several randomized controlled trials (RCTs) and prospective observational cohort studies have compared surgical to conservative treatment for patients with sciatica caused by lumbar disc herniation. Whereas no RCT has been able to compare surgery with nonop¬erative treatment without substantial crossover between treatment groups, multiple RCTs and observational studies have suggested that surgery resulted in faster improvement and a greater degree of improvement compared with nonoperative treatment. However, many patients in these studies also experienced improvement with nonoperative care without adverse sequelae. This paper critically reviews the literature comparing surgery with nonoperative treatment for lumbar disc herniation. Semin Spine Surg 21:223-229 © 2009 Elsevier Inc. All rights reserved.
KEYWORDS Maine lumbar spine study, Spine Patient Outcomes Research Trial, sciatica, intervertebral disc herniation, low back pain, lumbar disc herniation
对于腰椎间盘突出导致的坐骨神经痛，有几项随机对照试验（RCTs）和前瞻性的观察队列研究对手术和保守治疗进行了比较。尽管目前还没有RCT能对手术和非手术治疗进行没有任何组间交叉的比较，多项RCT和观察研究都认为与非手术治疗相比，手术可以获得更快、更大程度的改善。然而，在这些研究中很多患者通过非手术治疗也获得了改善，并且没有导致不良的后果。本文对文献进行审慎的综述，以对腰椎间盘突出症的手术和非手术治疗进行比较。

关键词缅因州腰椎研究；脊柱患者治疗结果研究试验；坐骨神经痛；椎间盘突出；腰痛；腰椎间盘突出

ciatica is deﬁned as pain radiating in an area of the leg that is served by a single nerve root in the lumbar or sacral spine and may be associated with motor or sensory deﬁcits. A lumbar intervertebral disc herniation (IDH) is the most com¬mon cause of sciatica in working adults, with an estimated annual incidence of 5 per 1000 adults.1,2 Diskectomy is the most common lumbar spine surgery, and more than 250,000 elective lumbar spine surgeries occur each year in the USA.3 Many patients with sciatica will improve over time, yet sur¬gery is frequently considered for patients with severe symp¬toms or symptoms that persist. Most spine surgeons agree that surgery should be offered only after a course of nonop¬erative treatment for sciatica has failed. The most effective type and duration of conservative treatment has not been determined and varies substantially.4 In the USA, the rate of back surgery was found to be approximately 40% higher when compared with 11 other countries and was more than ﬁve times the rate in England and Scotland.1 There is also signiﬁcant regional variation in the rate of diskectomy in the USA and internationally, suggesting that the indications for surgery are also variable.3,5 Given this substantial variation in the rate of surgery, it is clear that the appropriate timing of and indications for surgery are inconsistent. The economic impact of back pain and sciatica is well known as demonstrated by a Dutch study concluding that low back pain was responsible for more time off work and disability than any other medical condition.6 In light of the uncertainty sur¬rounding the outcomes of surgical and nonoperative treat¬ment for lumbar IDH, this article aims to review the pertinent literature to assist spine care professionals in providing evi¬dence-based recommendations to their patients.
坐骨神经痛是指小腿的放射性疼痛，该区域由起源于腰骶部的单一神经支配，并可伴有运动或感觉障碍。腰椎间盘突出（IDH）是导致成年劳动者坐骨神经痛最常见的原因，据估计成人每年的发生率约为5‰[1,2]。椎间盘切除术是最常用的腰椎手术，在美国每年要实施超过250000例选择性的腰椎手术[3]。随着时间过去，很多患者的坐骨神经痛也可自行缓解，然而，对于症状持续或症状严重的患者，通常考虑手术治疗。大多数脊柱外科医生都认为，坐骨神经痛的患者只有经过系统的非手术治疗失败后，方可选择手术治疗。至于最有效的类型和合适的保守治疗期限，目前并没有统一的意见，且各种观点差异很大[4]。在美国，脊柱手术的比率高出其他11个国家约40%，是英格兰和苏格兰的5倍余[1]。美国和国际上椎间盘切除术的比率也都存在着明显的地区差异，这提示各地手术适应证上的差异也很大[3,5]。考虑到手术率上明显的差异，很显然，要确定适当的手术时机和手术适应证是不太现实的。众所周知，背痛与坐骨神经痛可对经济产生明显的影响，荷兰学者的研究也证实了这一点，其结论认为腰痛导致的工作时间缺失以及劳动能力的丧失比任何其他疾病都要多[6]。考虑到腰椎间盘突出症手术和非手术治疗相关结果的不确定性，本文旨在综述相关文献，帮助脊柱外科医生向他们的患者提供循证医学建议。

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http://cc.bjmu.edu.cn/download/da4e58d0ac2b470d59dde5420946-3149709012011.pdf

Weber 1983年发表在Spine上的经典文献：http://www.dxy.cn/bbs/user/download/15391877/ospective%20Study%20with%20Ten%20Years%20of%20Observation..pdf

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.

jichao1979 · 发表于 2013-3-7 20:03

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jichao1979 · 发表于 2013-3-7 20:04

This study was a high quality RCT that had well-deﬁned 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 efﬁcacy 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。

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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。

Maine Lumbar Spine Study
Despite the RCT being considered the most valid study design, the Maine lumbar spine study (MLSS), a prospective cohort study, provides some of the best long-term data comparing surgical and nonoperative treatment of sciatica caused by lumbar disc herniation (Table 2).10-13 The MLSS enrolled 507 (235 surgical and 272 nonoperative) patients from the practices of 25 surgeons and 5 occupational medicine specialists in Maine. Patients were enrolled if they suffered from sciatica, deﬁned as pain radiating to below the knee, though conﬁrmatory imaging studies were not required. Given that it was an observational study, treatment was determined by the treating physician and the patient. The primary outcome measure was self-reported improvement in the predominant symptom (leg pain or back pain). The exact deﬁnition of “improvement” varied among the 3 reports (1, 5, and 10-year follow-up), with patients reporting that their predominant symptom was “much better” or “completely gone” qualifying as improved in the 1-year report, whereas those answering “better” were also included in the “improved” group at 5 and 10 years. Many other outcome measures, including back and leg pain frequency and bothersomeness, sciatica frequency and bothersomeness indexes, Roland disability scale, SF-36 scores, and work status, were also recorded. Results were reported at 1, 5, and 10 years, and statistical modeling techniques were used to control for the signiﬁcant baseline differences between the 2 groups. Substantial crossover occurred, with 15% of patients who initially chose nonoperative treatment undergoing surgery within 3 months, and 25% of the remaining nonoperative patients undergoing surgery between 3 and 120 months. The authors addressed this by assigning patients who crossed over within the ﬁrst 3 months to the surgery group, while analyzing those who subsequently crossed over after 3 months with the nonoperative group.
缅因州腰椎研究
尽管RCT被认为是最为有效（可信度）的研究设计，缅因州腰椎研究（MLSS），一项前瞻性队列研究，针对腰椎间盘突出导致坐骨神经痛的患者，也为手术与非手术治疗的比较提供了一些长期随访的数据（表2）[10-13]。MLSS纳入了507例患者（235例手术，272例非手术），这些患者来自缅因州的25位外科医生和5为职业病学专家的门诊。如果患者存在坐骨神经痛，一般指膝部以下的放射痛，即使没有获得确切的影像学证据都纳入研究。由于这是一项观察研究，治疗方式取决于主治的医师和患者的意愿。评估结果的主要指标为主要症状（腿痛或腰痛）改善程度的自我评价。对于“改善”的确切定义在3个报告（1，5，10年随访）中存在差异，在1年随访的研究中，患者认为其主要症状“好得多”或“完全消失”则归为“改善”，而5年和10年随访的报告中，患者称其“较好”也归为“改善”。很多其他的治疗结果评价包括背痛和腿痛的频率和焦虑，坐骨神经痛的频率和焦虑指数，Roland功能障碍等级，SF-36评分，以及工作状况都记录在案。1、5、10年都报道了相关的结果，应用统计模型方法以控制两组间显著的基线差异。两组间治疗方式的变换较多，15%的患者起初选择非手术治疗3个月内进行了手术治疗，余下的非手术治疗患者25%在3-120个月之间进行了手术治疗。作者将3个月内变换治疗方式进行手术的患者直接分配到手术组，而对3个月以后非手术治疗组变换治疗方式进行手术治疗的患者进行分析。

jichao1979 · 发表于 2013-3-7 20:04

The MLSS demonstrated that surgical patients were significantly more likely to report improvement in their predominant symptom compared with the nonoperative patients at 1 and 5 years (71% vs 43%, P < 0.001 at 1 year; 70% vs 56%, P < 0.001 at 5 years). By 10 years, the difference on this outcome measure was no longer signiﬁcant (69% of the surgical patients reported improvement vs 61% for the nonoperative patients, P = 0.2). However, if only patients who answered that their predominant symptom was “much better” or “completely gone” were included in the improved category (as was the case for the 1-year results), the surgical group continued to have signiﬁcantly better results at 10 years compared with the nonoperative group (56% “deﬁnitely improved” with surgery vs 40% nonoperative, P = .006). The surgical group also had signiﬁcantly better results on most secondary outcome measures at all follow-up times, including low back pain improvement, leg pain improvement, sciatica frequency and bothersomeness indexes, and the Modiﬁed Roland Scale. The proportion of patients returning to work and receiving disability compensation was similar for the 2 treatment groups at all follow-up times. The timing of improvement varied between the 2 groups, with the surgery group reaching maximal improvement on the Modiﬁed Roland Scale within the ﬁrst year, whereas the nonoperative group continued to make small gains on this outcome between 2 and 10 years. By 10 years, 25% of surgical patients had undergone at least 1 additional spine operation, and a similar percentage of patients in the nonoperative group underwent surgery between 3 months and 10 years. In summary, the surgery patients had greater improvement of pain, function, and satisfaction, whereas there were no differences in work status between the 2 groups.
MLSS显示，1年和5年时，与非手术的患者相比，手术患者报告其主要症状的改善更为显著（1年时，71%vs43%，P<0.001；5年时，70%vs56%，p<0.001）。10年时，治疗结果的这一评价指标不再有明显的差异（69%的手术患者报告改善，而非手术患者为61%，p=0.2）。然而，如果针对主要症状的改善情况，只将回答“好很多”或“完全消失”的患者归入“改善”（与1年时结果评价类似），则手术组与非手术组相比，在10年仍然具有更好的结果（手术组56%的患者“明确地改善”，而非手术组则为40%，p=0.006）。在所有的随访时间点，手术组在很多次要的结果评价指标上也有明显更好的结果，包括腰痛的改善、腿痛的改善、坐骨神经痛的频率、焦虑指数、改良的Roland等级等。在所有时间点，两组患者恢复工作的比率和接受劳动能力丧失补偿的比率都相似。2组患者病情改善的时间差异较大，手术组改良Roland等级达到最大改善的时间出现在第一年内，而非手术组接近这一结果的时间要延迟至2-10之间。10年时，25%的患者经历了至少1次额外的脊柱手术，而非手术组3个月至10年间进行手术的患者也有类似的百分比。总的来说，手术的患者疼痛、功能和满意度等的改善更大，而两组间的工作状况则没有明显的差异。

The MLSS was the ﬁrst large-scale study to compare surgical and nonoperative outcomes for lumbar disc herniation. Its strengths include its size, prospective nature, multicenter involvement, long-term follow-up with relatively low attrition, and use of validated outcome measures. However, its limitations must be considered. Its observational design contributed to marked baseline differences between the surgical and nonoperative groups, with the surgical group generally having worse symptoms and fewer workers’ compensation patients than the non-operative group. Although statistical modeling could control for these measured baseline differences, the potential for confounding by unmeasured variables existed. Additionally, speciﬁc radiographic ﬁndings correlating with clinical ﬁndings were not required as inclusion criteria, so patients without actual disc herniations may have been included. There was a substantial crossover from initial nonoperative treatment to surgery after 3 months (25% of nonoperative patients), and these patients were included in the nonoperative group for analysis. A 10-year as-treated analysis was performed that showed no signiﬁcant differences between the two as-treated groups, with the exception of greater improvement on the Roland score for the surgical group. This suggests that the beneﬁt of surgery was not underestimated by including patients who underwent surgery beyond 3 months in the nonoperative group. In fact, patients who initially chose nonoperative treatment and subsequently underwent surgery had the worst results of all, with only 40% of these patients reporting improvement in their predominant symptom at 10 years. A ﬁnal concern was the use of mail-in questionnaires rather than actual clinical follow-up as this precluded repeat physical examinations. Despite these limitations, the MLSS currently offers the best long-term follow-up data comparing surgery with nonoperative treatment for lumbar disc herniation.
MLSS是第一个比较腰椎间盘突出症手术与非手术治疗结果的大样本研究。其优势主要体现在样本量、前瞻性、多中心、长期随访且缺失相对较小、应用了有效的结果评价指标。然而，也应该认识到它的局限性，其观察性的设计使得手术与非手术组的基线存在显著的差异，手术组通常症状更严重，且与非手术组相比接受职工补偿的患者更少。虽然应用统计模型能控制这些基线评估上的差异，但仍然存在一些无法测定的变量导致潜在的混杂。此外，与临床表现相符的特异性的影像学表现并没有将其作为纳入标准，因此，没有确切的椎间盘突出的患者也纳入了本研究。最初选择非手术治疗的患者有较大一部分（25%非手术治疗的患者）3个月后变换治疗方式，进行手术治疗，这些患者仍被归入非手术组进行分析。10年时进行的接受治疗分析显示，除了手术组Roland等级有较大的改善外，两个接受治疗组的差异没有统计学意义，这表明非手术组的患者3个月后进行手术治疗没有低估手术的效力。事实上，最初选择非手术治疗后来进行手术的患者在所有患者中治疗结果最差，10年时这些患者仅有40%报告其主要症状“改善”。最后一点顾虑则是该研究通过邮寄调查问卷而不是进行实际的临床随访，这样并没有进行反复的体格检查。尽管有如此多的局限，MLSS还是提供了目前最好的长期随访资料，对腰椎间盘突出症的手术与非手术治疗进行对比。

jichao1979 · 发表于 2013-3-7 20:04

Spine Patient Outcomes Research Trial
The largest study comparing surgical and nonoperative treatment for lumbar disc herniation is the Spine Patient Outcomes Research Trial (SPORT) (Table 3).14-17 This study was unique in that it included both randomized and observational arms, which allowed patients to be included even if they did not agree to randomization. Patients were enrolled at 13 multidisciplinary spine practices in 11 states. All patients had radicular pain, neurological ﬁndings, and an MRI-conﬁrmed disc herniation that coincided with their symptoms, which were at least 6 weeks in duration. The surgical intervention was a standard open diskectomy, and nonoperative treatment consisted of “usual care” that was suggested to include at least education and counseling, physical therapy, and nonsteroidal anti-inﬂammatory medications if tolerated. Many nonoperative patients also received narcotics and epidural injections. The study was powered to detect a 10 point change from baseline on its primary outcome measures; the Short Form-36 bodily pain and physical function scales18 and the ODI.19 Secondary outcome measures included patient self-reported improvement, satisfaction with symptoms and care, work status, and the Sciatica Bothersome Index. The initial reports detailed the ﬁrst 2 years of follow-up,15,17 while the 4-year follow-up data were recently reported.16 Addi-tional subgroup analyses evaluated the effect of herniation location, morphology, and intervertebral level on outcomes.20,21
脊柱患者治疗结果研究试验
对腰椎间盘突出症手术与非手术治疗进行比较的最大的研究便是脊柱患者治疗结果研究试验（SPORT）（表3）[14-17]。该研究的独特之处便是其包括随机性和观察性两种方式，这样即使患者不同意进行随机化研究也可以将其纳入进来。纳入的患者来自美国11各州的13个多学科脊柱外科临床中心，这些患者都具有根性疼痛，神经病学改变，MRI上有与症状相符的明确的椎间盘突出，并且症状持续至少6周。手术干预采用标准的开放椎间盘切除术，非手术治疗主要为“常规处理”，通常至少包括健康宣教与建议、理疗、如果能耐受的话给予非甾体类抗炎药。很多非手术患者还接受了麻醉药和硬膜外注射等治疗。该研究认定治疗结果的主要评价指标在其初始值基础上改变10个点视为有变化，这些指标包括SF-36躯体疼痛和运动功能等级评分[18]和ODI[19]。评价结果的次要指标包括患者自我报告的改善程度、对症状和治疗的满意度，工作状况和坐骨神经痛焦虑指数。其初步报告详细介绍了前两年的随访结果[15,17]，最近则发表了4年随访的数据[16]。另外的亚组分析则评价了椎间盘突出的部位、形态和椎间隙水平对治疗结果的影响[20, 21]。

The most surprising result of the SPORT RCT was the high rate of protocol nonadherence (ie, crossover from the assigned treatment group to the other group). In the ﬁrst 2 years, 40% of patients assigned to surgery never underwent surgery, whereas 45% of patients assigned to nonoperative treatment underwent surgical intervention. While the crossover from nonoperative treatment to surgery was expected, the high rate of crossover in the other direction (ie, surgery to nonoperative treatment) was not. This high rate of crossover precluded meaningful analysis of the data on an ITT basis because the 2 groups were very similar in treatment received at 2 years. Nonetheless, the ITT analysis was presented as the primary analysis. As would be expected, there were no signiﬁcant differences on any of the primary outcome measures. Despite the homogeneity of treatment across the 2 groups, the surgery group did improve signiﬁcantly more on the sciatica bothersome index over the ﬁrst 2 years (-10.1 vs -8.5 at 2 years, P = 0.003). A secondary as-treated analysis was performed with adjustment for potential confounders. This demonstrated large and statistically signiﬁcant treatment effects of surgery on the 3 primary outcome measures (ie, the surgery group improved 15 points more on the ODI than the nonoperative group at 1 year).
SPORT RCT最为意外的结果便是无法坚持既定方案（即从被分配的治疗组变换到另一治疗组）的比率很高。在最初2年，分配进行手术的患者40%没有进行手术，而分配进行非手术治疗的患者45%进行了手术治疗。虽然从非手术治疗变换为手术治疗是意料之中的，但另一个方向的变换（即手术变换为非手术治疗）则并非如此。如此高的变换率使得无法应用ITT分析方法对数据有效的分析，因为2年时，两组接受治疗的情况非常相似。尽管如此，ITT分析还是被当作主要的分析方法。同预期的结果相似，无论主要的还是次要的评价指标，两组间的差异没有统计学意义。虽然两组间治疗方式的变换存在均一性，在最初2年，手术治疗组坐骨神经痛焦虑指数的改善还是更为明显（两年时分别为-10.1和-8.5，P= 0.003）。同时还进行了次要的接受治疗分析，以调整可能的混杂。结果显示，在3项主要的评价指标上，手术治疗具有很大的有统计学意义的优势（手术组1年时ODI的改善比非手术组多15点）。

Similar to the as-treated analysis of the RCT, the observational trial demonstrated a large, signiﬁcant beneﬁt of surgery on all primary and secondary outcome measures over the ﬁrst 2 years after controlling for potential confounders. For example, the surgery patients improved 13 points more on the ODI at 2 years compared with the nonoperative patients. Work status was the 1 outcome measure on which the sur-gery patients did not improve signiﬁcantly more than the nonoperative patients at 2 years. Given the aforementioned problems with the ITT analysis, the 4-year data from the RCT and observational cohorts were combined, and an adjusted as-treated analysis was performed. The differences observed at the 2-year follow-up persisted at 4 years, with the surgery group improving signiﬁcantly more than the nonoperative group on all primary and secondary outcomes other than work status. Unlike the MLSS, the differences between the 2 groups did not appear to decrease over time.
与RCT的接受治疗分析结果类似，对潜在的混杂进行控制后，观察性试验中，2年时所有主要和次要的评价指标都显示手术治疗具有很大的明显的优势。例如，2年时手术治疗的患者比非手术者ODI的改善多13点。2年时工作状况是唯一一个手术组患者没有明显改善的评价指标。考虑到ITT分析存在上述的问题，将RCT研究中4年时的数据与观察性队列研究结合，校准后进行了接受治疗分析。2年随访时显示出的差异，至4年时仍然存在，除了工作状态以外的其他主要和次要评价指标，手术组的改善程度比非手术组更明显。与MLSS不同，两组间的差异并没有随着时间的延长而减小。

As-treated subgroup analyses were performed to evaluate the effect of herniation location, morphology, and intervertebral level on outcomes. These demonstrated that although patients with central disc herniations had worse back pain than patients with lateral herniations, and patients with protrusions had less severe symptoms at baseline than those with extrusions or sequestrations, the change from baseline in back pain scores was similar across location and morphology subgroups.21 Another subgroup analysis reported that patients with upper (L2-3 or L3-4) lumbar disc herniations had a greater treatment effect of surgery than patients with L5-S1 herniations.20 Patients with L4-5 herniations had intermediate treatment effects.
对亚组进行的接受治疗分析，评价了椎间盘突出的部位、形态和椎间隙水平对治疗结果的影响。结果显示，虽然中央型椎间盘突出的患者背痛程度比侧方突出的患者更显著，椎间盘突出的患者初始症状相比脱出或游离的患者要轻一些，而相对初始状况而言，背痛评分的改变与突出部位、和形态学等亚组无关[21]。另一项亚组分析显示高位腰椎间盘突出（L2-3或L3-4）的患者手术治疗的结果比L5S1突出的患者更好[20]，而L4-5突出的患者其疗效居中。

jichao1979 · 发表于 2013-3-7 20:05

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-speciﬁc 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 beneﬁts 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-deﬁned nonoperative regimen.23 The advantage of specifying “usual care” as the nonoperative treatment was the increased generalizability this provided as it more closely reﬂected what was being offered to patients. However, patients may have improved more with a speciﬁc 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 deﬁned, so it was not possible to select a more speciﬁc regimen based on the available scientiﬁc 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。

0

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 beneﬁt of surgery, the duration of beneﬁt 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.

jichao1979 · 发表于 2013-3-7 20:05

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打不死的小突 · 发表于 2013-3-8 11:08

一点想法：
1、手术种类相对单一。
2、非手术疗法国际和国内都有哪些？有限定范围吗？有一定的可归纳性吗？
3、以上统计应该不含中医手段吧？
4、对以上研究的工作人员致敬，感谢转帖的jichao1979同学
5、希望坛子里也组织起来坛子里广大突友的相应分类统筹工作，这个咱们有有优势啊。

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标题: 腰椎间盘突出症治疗的循证医学综述（转自丁香园论坛）

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