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董胜;黄文茁;吴时桢;袁俊;谢添.补阳还五汤联合OLIF-PIVOX系统治疗腰椎椎管狭窄症随机对照研究[J].中国中西医结合杂志,2023,43(12):1427-1432
补阳还五汤联合OLIF-PIVOX系统治疗腰椎椎管狭窄症随机对照研究
Effect of Buyang Huanwu Decoction Combined with OLIF-PIVOX System on Lumbar Spinal Stenosis:A Randomized Controlled Trial
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DOI:10.7661/j.cjim.20231108.310
中文关键词:  补阳还五汤  PIVOX系统  斜外侧腰椎椎间融合术  腰椎椎管狭窄  中药复方  中西医结合  随机对照试验
英文关键词:Buyang Huanwu Decoction  PIVOX system  oblique lumbar interbody fusion  lumbar spinal stenosis  Chinese herbal compound  integrative medicine  randomized controlled trial
基金项目:湖北省中医药管理局中医药科研项目(No.ZY2023Z011)
作者单位
董胜;黄文茁;吴时桢;袁俊;谢添 1.湖北中医药大学针灸骨伤学院(武汉 430065),2.武汉市中医医院骨伤科(武汉 430014) 
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中文摘要:
      目的 研究补阳还五汤联合斜外侧腰椎椎间融合术(OLIF)-PIVOX系统治疗腰椎椎管狭窄症的临床疗效。方法 选取2020年6月—2023年1月武汉市中医医院45例接受PIVOX系统联合OLIF治疗的患者进行随机对照研究。患者随机分为观察组和对照组,其中,观察组23例,对照组22例,对照组仅接受手术治疗,观察组在对照组基础上加补阳还五汤治疗,治疗4周,随访3个月。记录患者术前与术后第1天及末次随访时病变节段的椎间隙高度。记录患者术前,术后1周,术后1、3个月的疼痛视觉评分(VAS)及日本骨科协会评估治疗评分(JOA)。术后当天及术后第3天、1周检测患者全血细胞计数白细胞计数(WBC)及中性粒细胞计数(NEUT%)、C反应蛋白(CRP)及红细胞沉降率(ESR)。结果 最终完成研究42例,其中观察组20例,对照组22例。与本组术前比较,两组术后1天及末次随访椎间隙高度提高(P<0.01);与对照组末次随访比较,观察组的椎间隙高度较高(P<0.05)。与本组术前比较,两组术后1周、1、3个月VAS评分降低,JOA评分升高(P<0.01);与对照组同时段比较,观察组术后1、3个月VAS评分降低(P<0.01,P<0.05),术后1周、1、3个月JOA评分更高(P<0.01,P<0.05)。与本组术后当天比较,除了对照组术后3天CRP、WBC外,两组术后3天及1周WBC、ESR 、NEUT%及CRP水平降低(P<0.01,P<0.05)。与对照组比较,观察组术后3天的NEUT%及CRP水平均更低(P<0.05);术后1周的WBC较低(P<0.01)。结论 补阳还五汤联合PIVOX钢板联合OLIF可以有效增加椎间隙高度,恢复腰椎功能,减轻腰腿部疼痛,抑制炎症反应。
英文摘要:
      Objective To study the clinical effect of Buyang Huanwu Decoction combined with oblique lumbar interbody fusion(OLIF)-PIVOX system in the treatment of lumbar spinal stenosis. Methods A randomized controlled trial was carried out on 45 patients undergoing OLIF-PIVOX at Wuhan Hospital of Traditional Chinese Medicine from June 2020 to January 2023. The patients were randomly assigned to observation group and control group,with 23 cases in the observation group and 22 cases in the control group. The control group received surgery using OLIF-PIVOX system,while the observation group received Buyang Huanwu Decoction combined with OLIF-PIVOX. The treatment lasted for 4 weeks,and the follow-up was 3 months. The intervertebral height of the affected segment was measured before surgery, on the 1st day after surgery,and at the final follow-up after surgery. The Visual Analogue Scale (VAS) and Japanese Orthopedic Association (JOA) scores were recorded before surgery,as well as at 1 week,1 and 3 months after surgery. On the day of surgery,as well as 3 days and 1 week after surgery,the white blood cell count (WBC),neutrophil count (NEUT%),C-reactive protein (CRP),and erythrocyte sedimentation rate (ESR) were monitored. Results Finally,42 patients completed the study,including 20 cases in the observation group and 22 cases in the control group. Compared with baseline,the intervertebral height increased on the 1st day and at the last follow-up in both groups(P<0.01). Compared with the control group at the last follow-up,the intervertebral height was higher in the observation group(P<0.05). Compared with preoperative data,the VAS score decreased and JOA score increased at 1 week,1 and 3 months after surgery in both groups(P<0.01). Compared with the control group at the same time points,the VAS score was lower at 1 month and 3 months after surgery(P<0.01,P<0.05),and the JOA score was higher at 1 week,1 and 3 months after surgery in the observation group(P<0.01,P<0.05). Compared with the same group on day of surgery,WBC,ESR,NEUT%,and CRP levels decreased at 3 days and 1 week after surgery in both groups(P<0.01, P<0.05),except for CRP and WBC in the control group at 3 days after surgery. Compared with the control group,NEUT% and CRP levels were lower at 3 days after surgery(P<0.05), and WBC was lower at 1 week after surgery in the observation group(P<0.01). Conclusion The combination of Buyang Huanwu Decoction and OLIF-PIVOX significantly enhances intervertebral height,improve lumbar function,alleviates back and leg pain,and suppresses inflammatory reactions.
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