【摘要】 目的:观察舒筋健腰丸治疗腰椎间盘突出症(肝肾不足,风湿瘀阻证)的临床疗效及安全性。方法:采用多中心、随机、对照临床研究方案,将符合纳入标准的腰椎间盘突出症患者240例随机分为两组,试验组180例,对照组60例。两组患者基本资料差异无统计学意义(P>0.05),具有可比性。试验组口服舒筋健腰丸与腰痹通胶囊模拟剂,对照组口服舒筋健腰丸模拟剂与腰痹通胶囊,两组疗程均为4周。观察治疗前第14天和第28天的腰痛及下肢窜痛VAS评分、中医证候积分、简化McGill疼痛量表评分、JOA评分、Oswestry功能障碍指数(ODI),并记录不良反应。结果:两组在腰痛及下肢窜痛VAS评分、中医证候总积分、简化McGill疼痛量表评分、JOA评分、ODI评分方面基线、第14天和第28天的组内比较差异均有统计学意义(P<0.01),两组在第28天腰痛及下肢窜痛VAS评分和中医证候总积分的组间比较差异有统计学意义(P<0.05);两组在腰痛及下肢窜痛VAS评分和中医证候总积分的变化上(治疗前减第28天)组间比较差异有统计学意义(P<0.05);第28天两组中医证候总有效率的差异有统计学意义(P<0.05),而JOA评分总有效率差异无统计学意义(P>0.05)。两组不良事件以及严重不良事件的发生率差异均无统计学意义(P>0.05)。结论:舒筋健腰丸用于治疗肝肾不足,风湿瘀阻型腰椎间盘突出症的疗效确切,尤其在改善腰腿疼痛程度以及中医证候积分方面具有优势,且具有较高的安全性。更多还原

【Abstract】 Objective:To observe the clinical efficacy and safety of Shujinjianyao Pill in the treatment of LDH(lumbar disc herniation)(Ganshenbuzu and Fengshiyuzu syndrome).Methods:240 LDH patients who met the inclusion criteria were randomly divided into two groups,180 in the experimental group and 60 in the control group.There was no significant difference in the basic data between the two groups,which was comparable.The experimental group was given Shujinjianyao pill and Yaobitong capsule simulator orally,while the control group was given Shujinjianyao pill simulator and Yaobitong capsule orally.The treatment course of the two groups was 4 weeks.The VAS score,TCM(Traditonal Chinese Medcine)syndrome total score,simplified McGill pain scale score,JOA score,ODI(Oswestry dysfunction index)on day 0,14 and 28 of treatment were observed,and adverse reactions were recorded.Results:There were significant differences in VAS score,TCM syndrome total score,simplified McGill pain scale score,JOA score,ODI between two groups at baseline,14 d and 28 d(P<0.01).There were significant differences in VAS score and TCM total syndrome score between the two groups at 28 d(P<0.05).There were significant differences in VAS score and TCM syndrome total score between the two groups(day 0 minus day 28)(P<0.05).There was significant difference in total effective rate of TCM syndrome total score between the two groups on day 28(P<0.05),while there was no significant difference in total effective rate of JOA score(P>0.05). There was no significant difference in the incidence of adverse events and serious adverse events between the two groups(P>0.05).Conclusion:Shujinjianyao pill is effective in the treatment of Ganshenbuzu and Fengshiyuzu syndrome LDH,especially in improving the degree of lumbar-leg pain and TCM syndrome score,and has high safety.更多还原