舒筋健腰丸对腰椎间盘突出症患者腰痛及下肢窜痛的改善作用和安全性评价

Effects of Shujin Jianyao Pills on Low Back Pain and the Scurrying Pain of Lower Limb in Patients with Lumbar Disc Herniation and Its Safety Evaluation

目的:观察舒筋健腰丸对腰椎间盘突出症(lumbar disc herniation,LDH)患者腰痛及下肢窜痛的改善作用和安全性。方法:采用多中心、双盲双模拟、随机对照临床研究方案,将符合纳入标准的LDH患者240例随机分为试验组180例与对照组60例。试验组口服舒筋健腰丸和腰痹通胶囊模拟剂,对照组口服舒筋健腰丸模拟剂和腰痹通胶囊,两组疗程均为4周。观察治疗前及治疗第14天、第28天两组患者腰痛及下肢窜痛视觉模拟量表(visual analog scale,VAS)评分及不良反应情况。结果:两组患者腰痛及下肢窜痛VAS评分与治疗前比较及治疗第28天组间比较差异均有统计学意义(P<0.05);治疗前、治疗第14天两组间VAS比较差异均无统计学意义(P>0.05)。腰痛总有效率治疗第14天组间比较差异无统计学意义(P>0.05),治疗第28天组间比较差异具有统计学意义(P<0.05)。下肢窜痛总有效率治疗第14天、28天两组比较差异均无统计学意义(P>0.05)。两组不良反应发生率比较差异无统计学意义(P>0.05)。结论:舒筋健腰丸和腰痹通胶囊均具有较高的安全性;舒筋健腰丸和腰痹通胶囊均能有效改善LDH所致腰痛及下肢窜痛的临床症状,且疗效相当,而腰痛症状的远期疗效舒筋健腰丸优于腰痹通胶囊。

Objective:To observe the effects and its safety of Shujin Jianyao pill on low back pain and the scurrying pain of lower limb in patients with LDH.Methods:By adopting multicenter,double-blind,doublesimulation,randomized controlled clinical study,240 LDH patients who met the inclusion standard were randomized into 180 cases in the experimental group and 60 cases in the control group.The experimental group took Shujin Jianyao pills and the simulation agent of Yaobitong capsules orally,and the control group the simulation agent of Shujin Jianyao pills and Yaobitong capsules,the course was four weeks.To observe VAS scores of low back pain and the scurrying pain of lower limb,and the conditions of adverse reaction before the treatment,and at the 14th and 28th day of the treatment in the two groups.Results:The difference was statistically significant in VAS scores of low back pain and the scurrying pain of lower limb between both groups before the treatment and at the 28th day of the treatment(P<0.05);the difference had no statistical meaning between both groups before the treatment and at the 14th day of the treatment(P>0.05).There was no significant difference in total effective rate of low back pain at the 14th day of the treatment between both groups(P>0.05),the difference had statistical meaning at the 28th day of the treatment between both groups(P<0.05).The difference had no statistical meaning in total effective rate of the scurrying pain of lower limb at the 14th and 28th day of the treatment between both groups(P>0.05).The difference had no statistical meaning in the incidences of adverse reaxtion between both groups(P>0.05).Conclusion:Both Shujin Jianyao pill and Yaobitong capsules have higher safety;both medicine could effectively improve clinical symptoms of low back pain and the scurrying pain of lower limb induced by LDH,which show therapeutic equivalence,while long-term effects of Shujin Jianyao pills are superior to these of Yaobitong capsules in improving the symptoms of low back pain.