超声下5%葡萄糖注射治疗腰脊神经卡压综合征的非劣效研究

A non-inferiority study of Ultrasound-guided 5% dextrose in the treatment of lumbar spinal nerve entrapment syndrome

摘要:

目的： 观察比较超声下5%葡萄糖和消炎镇痛复合液注射治疗腰脊神经后支卡压综合征病人的疗效。方法：选择徐州医科大学附属医院疼痛科86例腰脊神经后支卡压综合征病人，按随机数字表法分为5%葡萄糖（5% dextrose water，D5W）治疗组（D5W组）和消炎镇痛复合液治疗组（对照组），每组43例。D5W组采用超声下双侧脊神经后支注射30ml D5W，对照组采用超声下双侧脊神经后支注射30mL消炎镇痛复合液。观察治疗前和治疗后1、2、4、12周的疼痛数字分级评分 (numerical rating scale, NRS)、Oswestry功能障碍指数(oswestry dability index, ODI)、镇痛药物使用人数以及不良反应发生情况；同时记录住院病人治疗前、治疗后2、3天空腹末梢血糖变化。以两组治疗后4周NRS评分差值的95％置信区间上限低于非劣效性界值（δ）0.4时，表示D5W组治疗效果非劣于对照组。结果：与治疗前相比，两组治疗后1、2、4、12周NRS评分及ODI评分均降低；与对照组相比，D5W组治疗后12周的NRS评分2.7±1.5显著低于对照组3.8±1.9（P＜0.05）及ODI评分明显改善（P＜0.05），治疗有效率增加（P＜0.05）。两组治疗后4周NRS评分差值为0.11（95%置信区间：-0.10~0.25）< δ（0.4），即D5W组治疗效果非劣于对照组。住院期间，与对照组相比，D5W组对住院病人治疗后2、3天空腹末梢血糖变化影响较小，但差异无统计学意义（P＞0.05）。随访治疗后2周，D5W组使用镇痛药物人数高于对照组（P < 0.05）；治疗后12周，D5W组仅有4例，对照组有5例病人继续口服镇痛药物，但差异无统计学意义。结论：超声下5％葡萄糖注射可缓解腰脊神经后支卡压综合征病人的疼痛，改善腰背功能，治疗效果非劣效于消炎镇痛复合液，是治疗此类病人的一种安全有效替代疗法，可在临床上推广使用。

Abstract:

Objective : To observe and compare the effectiveness of ultrasound-guided 5% dextrose and corticosteroid injections in the treatment of patients with lumbar spinal nerve entrapment syndrome. Methods: Eighty-six patients with lumbar spinal nerve entrapment syndrom were randomly divided into two groups: 5% dextrose water treatment group (D5W group) and corticosteroid injection treatment group (Control group) .The D5W group was ultrasound-guided with 30 ml of 5% dextrose in posterior branch of spinal nerves on both sides, and the Control group was ultrasound-guided with 30 ml of corticosteroid. Nnumerical rating scale (NRS), Oswestry Disability Index (ODI), number of cases of analgesic use, and the occurrence of adverse reactions were observed before and 1, 2, 4,12 weeks after treatment. The daily changes in fasting terminal blood glucose in hospitalized patients before treatment and on days 2 and 3 after treatment .When the upper limit of the 95% confidence interval for the difference in NRS scores between the two groups at 4 weeks after treatment was less than the noninferiority cutoff (δ) of 0.4, the D5W group was indicated to be noninferior to the control group. Results: NRS scores and ODI scores decreased significantly in both groups at 1, 2, 4, and 12 weeks after treatment compared with basal. At 12 weeks after treatment, The D5W group showed significantly lower NRS score 2.7±1.5 than the control group 3.8±1.9(P<0.05) and ODI scores significantly improved (P < 0.05), treatment efficacy increased (P < 0.05) compared to control group. The difference in NRS scores between the two groups at 4 weeks after treatment was 0.11 (95% confidence interval: -0.10 to 0.25) < δ (0.4), D5W group was noninferior to the control group. During hospitalization, although the D5W group had a smaller effect on the change in fasting terminal blood glucose on 2 and 3 days after treatment compared with control group, but the difference was not statistically significant (P > 0.05). At 2 weeks after treatment, more patients in the D5W group used analgesics than in the control group (P < 0.05); at 3 months, only 4 patients in the D5W group and 5 patients in the control group continued to take oral analgesics, but the difference was not statistically significant. Conclusion: Ultrasound-guided injection of D5W relieves pain and improves low back pain function in patients with lumbar spinal nerve entrapment syndrome. The effect of treatment is non-inferior to acorticosteroid. It is an effective and safe alternative therapy for the treatment of such patients and can be actively promoted..