腰骶段神经根压迫损伤患者椎管减压术后联合应用鼠神经生长因子的前瞻性研究

Effect of mouse nerve growth factor on patients with lumbosacral nerve root injury induced by compression after decompression surgery： a prospective study

目的 观察腰骶段神经根压迫损伤患者在椎管减压术后联合应用鼠神经生长因子（mNGF）的临床疗效. 方法 研究设计为前瞻性随机对照研究.选择广州中医药大学第一附属医院二骨科自2011年1月至5月收治的40例因腰椎间盘突出、腰椎管狭窄致腰骶段神经根压迫损伤患者,按随机数字表法分为治疗组20例及对照组20例,2组均成功完成椎管减压术,术中确认责任神经根无明显受压.治疗组术后联合应用鼠NGF（恩经复,肌注,18 μg/次,1次/d,连续使用28d）,对照组不使用恩经复治疗,其余治疗方案均相同.术前、术后3个月、末次随访时应用下腰痛JOA评分评定患者肢体功能状态,判断患者的功能恢复状况.记录使用mNGF期间的不良事件,观察其临床应用安全性. 结果 2组均获得随访,随访12～16月.2组术前JOA评分差异无统计学意义（P＞0.05）；所有患者术后JOA评分与术前比较均显著提高,差异有统计学意义（P＜0.05）；治疗组术后3个月JOA评分较对照组显著提高,差异有统计学意义（P＜0.05）；末次随访时JOA评分优于对照组,但差异无统计学意义（P＞0.05）.除6例患者出现注射区的疼痛外,未发现其他不良反应.结论 腰骶段神经根压迫损伤患者在实施椎管减压手术后联合应用mNGF可加速神经功能修复,其临床应用安全性较好.

Objective To explore the effect of mouse nerve growth factor （mNGF） on patients with lumbosacral nerve root injury （LNRI） induced by compression after decompression surgery.Methods A prospective randomized control clinical trail was designed,which included 40 patients diagnosed as having LNRI induced by compression caused by lumbar disc hemiation or lumbar canal stenosis,admitted to our hospital from January 2011 to May 2011; these patients were randomized into therapy group （n=20） and control group （n=20）.Patients were performed decompression procedure successfully,and then,accepted the same therapy procedure,excepted that patients in the therapy group accepted mNGF by muscle injection （18 μg per time,once daily for 28 d） additionally.Japanese Orthopaedic Association （JOA） scale was employed to evaluate the physical functional status of these patients before treatment,3 months after treatment and at final follow-up,and all adverse events were recorded.Results All patients were followed up for 12-16 months.No significant difference on the JOA scores was noted between the two groups before surgery （P〉0.05）; the postoperative JOA scores of both groups were improved significantly as compared with preoperative JOA scores （P〈0.05）; In postoperative 3 months,the JOA scores of therapy group were significantly better than the control group （P〈0.05）; at final follow-up,the JOA scores of therapy group were better than the control group without significant difference （P〉0.05）.All of patients were uneventful after injecting mNGF except that 6 patients felt painful in the injection region.Conclusion The mNGF can accelerate the function rehabilitation of patients with LNRI induced by compression,and it has moderate safety.