舒筋健腰丸治疗腰椎管狭窄症(肝肾不足,风湿瘀阻证)的多中心随机对照试验

Multicenter Randomized Controlled Trial of Shujin Jianyao Pill in the Treatment of Lumbar Spinal Stenosis (Ganshenbuzu and Fengshiyuzu Syndrome)

目的:观察舒筋健腰丸治疗腰椎管狭窄症(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管狭窄症患者120例随机分为两组,试验组90例,对照组30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丹鹿通督片模拟剂,对照组口服舒筋健腰丸模拟剂与丹鹿通督片,两组疗程均为4周。观察治疗前、第14天及第28天的腰膝酸痛VAS评分、中医证候总积分、间歇性跛行距离、JOA评分、Oswestry功能障碍指数,并记录不良反应。结果:两组在腰膝酸痛VAS评分、中医证候总积分、间歇性跛行距离、JOA评分、Oswestry功能障碍指数方面于基线、第14天及第28天的组内比较差异均有统计学意义(P<0.01);两组在第28天腰膝酸痛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);两组在腰膝酸痛VAS评分和中医证候总积分的变化(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LSS的疗效确切,尤其在改善腰膝酸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。

Objective:To observe the clinical efficacy and safety of Shujin Jianyao pill in the treatment of LSS(Lumbar Spinal Stenosis)(Ganshenbuzu and Fengshiyuzu Syndrome).Methods:120 LSS patients who met the inclusion criteria were randomly divided into two groups,90 in the experimental group and 30 in the control group.There was no significant difference in the basic data between the two groups.The experimental group was given Shujin Jianyao pill and Danlutongdu tablet simulator orally,while the control group was given Shujin Jianyao pill simulator and Danlutongdu tablet orally for 4 weeks.The VAS score,TCM(traditonal Chinese medcine)syndrome total score,intermittent claudication distance,JOA score,ODI(Oswestry dysfunction index)on day 0,14 and 28 were observed,and adverse reactions were recorded.Results:There were significant differences in VAS score,TCM total syndrome score,intermittent claudication distance,JOA score,and ODI between the 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:Shujin Jianyao pill is effective in treating Ganshenbuzu and Fengshiyuzu syndrome LSS,especially in improving the degree of lumbar-knee pain and TCM syndrome,and has high safety.