独活寄生汤联合盘黄间隙微创减压治疗肾气亏虚型退变性腰椎管狭窄症的中长期临床观察

Middle and Long-term Clinical Effiacacy of Duhuo Jishengtang Combined with Minimally Invasive Decompression of Lumber Spine in Treatment of Degenerative Lumbar Spinal Stenosis with Kidney Deficiency Syndrome

目的:随访观察独活寄生汤联合盘黄间隙微创减压治疗肾气亏虚型退变性腰椎管狭窄症的3年以上临床疗效。方法:通过单中心、平行随机对照临床试验设计,对2015年10月至2017年4月在江苏省中医院住院接受局麻盘黄间隙微创减压治疗的63例肾气亏虚型退变性腰椎管狭窄症患者行3年以上临床疗效观察。其中手术联合中药组(观察组)31例,手术联合塞来昔布、甲钴胺组(对照组)32例。两组术后均予一般治疗,观察组术后加用3周独活寄生汤口服,对照组术后加用塞来昔布、甲钴胺口服3周。结果:在疼痛改善方面,仅术后3月随访时观察组优于对照组(P<0.05),其他随访节点未见优势。术后3个月以及更长时间的随访,证实观察组在腰椎神经功能改善方面具有显著优势(P<0.01)。末次随访时,观察组疗效优良率为83.87%(26/31),对照组疗效优良率62.5%(20/32),差异无统计学意义。两组患者末次随访时均无不稳定表现,组内前后比较和组间比较,差异均无统计学意义。结论:术后3年有效随访证实局麻盘黄间隙微创减压治疗腰椎管狭窄症中长期随访效果满意,手术对腰椎节段稳定性无影响。口服独活寄生汤能够促进肾气亏虚型退变性腰椎管狭窄症患者术后神经功能恢复,提高临床治疗优良率,但在疼痛症状改善方面未见明显优势。

Objective:To observe the clinical efficacy of Duhuo Jishengtang combined with minimally invasive decompression of lumber spine in the treatment of degenerative lumbar spinal stenosis with kidney deficiency syndrome for more than 3 years.Method:Through a single-center parallel randomized controlled clinical trial,63 patients with degenerative lumbar spinal stenosis who were hospitalized in Jiangsu Hospital of Traditional Chinese Medicine from October 2015 to April 2017 were observed for more than three years.Among them,there were 31 cases in the operation combined with traditional Chinese medicine group(observation group)and 32 cases in the operation combined with Celebrex and Mecobalamin group(control group).Both groups were given routine treatment.The observation group was treated with Duhuo Jishengtang for 3 weeks,while the control group was treated with Celebrex and Mecobalamin for 3 weeks.Result:In the aspect of pain improvement,only 3 months after operation,the observation group was superior to the control group(P<0.05),with no significant advantage at other time nodes during follow-up.During the 3-month follow-up and a longer period,it was confirmed that observation group had a significant advantage in improving lumbar function(P<0.01).At the last follow-up,the good efficacy rate of observation group was 83.87%(26/31),while the good efficacy rate of the control group was 62.5%(20/32).There was no unstable performance in the last follow-up of the two groups.There was no statistically significant difference between two groups.Conclusion:The middle and long-term follow-up for minimally invasive decompression of lumber spine showed a satisfactory efficacy in the treatment of degenerative lumbar spinal stenosis,with no impact on the stability of the operative segments.For patients of lumbar spinal stenosis with kidney deficiency syndrome,Duhuo Jishengtang can promote the recovery of postoperative neurological function,and improve the good efficacy rate of clinical treatment,but with no obvious advantage in pain relieve after operation.