OrthoCarolina Spine Center, Charlotte, NC, USA.
Spine (Phila Pa 1976). 2012 Apr 15;37(8):631-41. doi: 10.1097/BRS.0b013e3182309af7.
Prospective, randomized, blinded clinical trial.
To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy.
Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy.
Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months after surgery using (1) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire [LSOQ]) and (2) clinical evaluations.
There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores, and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients (P = 0.05). The gel-treated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically significant reduction of leg pain and back pain (P < 0.01) in the treatment group compared with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs. 6).
These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation.
前瞻性、随机、双盲临床试验。
评估 Oxiplex 凝胶在减轻腰椎间盘切除术后疼痛和相关症状方面的效果。
Oxiplex 凝胶（羧甲基纤维素、聚氧化乙烯和钙）在椎间盘切除术中用于覆盖手术部位，以减轻腰椎间盘切除术后的疼痛和症状。
接受单节段腰椎间盘切除术（通过椎板切除术或椎板切开术进行）的患者随机分为接受手术加 Oxiplex 凝胶治疗（治疗组）或仅手术治疗（对照组），并在手术后 6 个月使用（1）生活质量问卷（腰椎结果问卷 [LSOQ]）和（2）临床评估进行评估。
治疗组（N=177）和对照组（N=175）在基线人口统计学、手术程序、LSOQ 评分和临床评估方面无统计学显著差异。与对照组相比，更多接受凝胶治疗的患者对手术治疗结果感到满意（P=0.05）。与仅手术对照组相比，凝胶治疗组在基线时疼痛和症状的减轻更为明显。在基线时存在明显背痛（LSOQ 疼痛评分大于或等于中位数 63）的患者人群中，凝胶的额外益处始终表现为 6 个月时腿部和背部疼痛的减轻。在该人群中，与对照组相比，治疗组腿部疼痛和背部疼痛有统计学显著减轻（P<0.01）。与对照组相比，治疗组在 6 个月时接受检查的患者中有较少的肌肉骨骼异常（P<0.01）。无脑脊液漏病例，实验室值或生命体征无差异。与对照组相比，治疗组在 6 个月的随访期间出现感觉迟钝、感觉异常、感觉丧失和再手术的患者更少（1 例对 6 例）。
这些数据表明，在腰椎间盘突出症的椎间盘切除术中使用 Oxiplex 凝胶可改善临床结果。
