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经皮椎间孔内镜椎间盘切除术与显微镜下椎间盘切除术治疗腰椎间盘突出症的随机对照研究:两年结果。

Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy for Lumbar Disc Herniation: Two-Year Results of a Randomized Controlled Trial.

机构信息

Department of Spine Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.

出版信息

Spine (Phila Pa 1976). 2020 Apr 15;45(8):493-503. doi: 10.1097/BRS.0000000000003314.

DOI:10.1097/BRS.0000000000003314
PMID:31703056
Abstract

STUDY DESIGN

A prospective randomized controlled study.

OBJECTIVE

To clarify whether percutaneous transforaminal endoscopic discectomy (PTED) has better clinical outcomes and less surgical trauma compared with microendoscopic discectomy (MED).

SUMMARY OF BACKGROUND DATA

Two kinds of minimally invasive spine surgeries, PTED and MED, are now widely used for the treatment of lumbar disc herniation (LDH). It is still a controversial issue to choose the proper surgical approach.

METHODS

In this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imaging-confirmed LDH, and were randomly allocated to PTED or MED group. The primary outcome was the score of Oswestry Disability Index (ODI) and the secondary outcomes included the score of Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain and physical function scales, European Quality of Life-5 Dimensions, and Visual Analogue Scales for back pain and leg pain.

RESULTS

A total of 250 participants were randomly assigned to two treatment groups, 241 of that received the specific surgical procedure. Two hundred twenty-two patients (92.1%) have completed the 2-year follow-up. Both the primary and secondary outcomes did not differ significantly between the two treatment groups at each prespecified follow-up time (P > 0.05). For PTED, the postoperative improvement of ODI score in the median herniation subgroup was less compared with paramedian subgroup. For MED, less improvement of ODI score was found in far-lateral herniation subgroup compared with paramedian subgroup. Total complication rate over the course of 2 year was 13.44% in PTED group and 15.57% in MED group (P = 0.639). Ten cases (8.40%) in PTED group and five cases (4.10%) in MED group suffered from residue/recurrence of herniation, for which reoperation was required.

CONCLUSION

Over the 2-year follow-up period, PTED did not show superior clinical outcomes and did not appear to be safer procedure for patients with LDH compared with MED. PTED had inferior results for median disc herniation, whereas MED did not appear to be the best option for far-lateral disc herniation.

LEVEL OF EVIDENCE

摘要

研究设计

前瞻性随机对照研究。

目的

明确经皮椎间孔内窥镜椎间盘切除术(PTED)与微创内窥镜椎间盘切除术(MED)相比,是否具有更好的临床疗效和更小的手术创伤。

背景资料概要

PTED 和 MED 是两种广泛应用于腰椎间盘突出症(LDH)治疗的微创脊柱手术,选择合适的手术入路仍然存在争议。

方法

本研究为单中心、开放标签、随机对照试验,纳入符合以下条件的患者:持续存在神经根症状且影像学证实存在 LDH,并随机分配至 PTED 或 MED 组。主要结局为 Oswestry 功能障碍指数(ODI)评分,次要结局包括医疗结局研究 36 项简明健康调查问卷身体疼痛和身体功能评分、欧洲生活质量 5 维量表、腰背腿痛视觉模拟评分。

结果

共 250 例患者被随机分配至两组治疗组,241 例患者接受了特定的手术治疗。222 例患者(92.1%)完成了 2 年随访。在每个预设的随访时间点,两组的主要和次要结局均无显著差异(P>0.05)。对于 PTED,在椎间盘偏中央型突出亚组中,术后 ODI 评分的改善明显小于椎间盘旁正中型突出亚组。对于 MED,在远外侧型突出亚组中,ODI 评分的改善明显小于椎间盘旁正中型突出亚组。PTED 组 2 年总并发症发生率为 13.44%,MED 组为 15.57%(P=0.639)。PTED 组 10 例(8.40%)和 MED 组 5 例(4.10%)患者存在突出物残留/复发,需要再次手术。

结论

在 2 年随访期间,与 MED 相比,PTED 并未显示出更优的临床疗效,也未表现出对 LDH 患者更安全的手术方法。PTED 对于椎间盘偏中央型突出的效果较差,而 MED 似乎不是远外侧型椎间盘突出的最佳选择。

证据等级

2 级。

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