舒筋健腰丸治疗肝肾不足、风湿瘀阻型腰椎间盘突出症的中医证候疗效观察

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)的中医证候临床疗效及安全性。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例随机分为观察组180例、对照组60例。观察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,2组疗程均为4周。观察治疗第0天、14天、28天的中医证候总积分、中医证候单项症状评分,并记录不良反应。结果2组中医证候总积分在第0天与第28天的组内比较差异均有统计学意义(P<0.01),2组第28天中医证候总积分的组间比较差异具有统计学意义(P<0.05);2组第28天总有效率、单项证候中腰痛症状总有效率的差异具有统计学意义(P<0.05)。2组患者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中医证候疗效确切,尤其在改善中医证候总积分及腰痛症状方面具有明显优势,且具有较高的安全性。

Observation of effect of Shujin Jianyao Pill in the treatment of lumbar disc herniation in TCM syndromes

Objective To observe TCM syndromes effect and safety of Shujin Jianyao Pill in the treatment of Lumbar Disc Herniation(LDH)(deficiency of liver and kidney syndrome and obstruction of wind damp and blood stasis syndrome).Methods According to the multi-centered,randomized and controlled clinical treatment regime,a total of 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 with comparability.The experimental group was given Shujin Jianyao Pill and Yaobitong Capsule Simulator orally,while the control group was given Shujin Jianyao Pill Simulator and Yaobitong Capsule orally.The treatment course of the two groups was 4 weeks.The total TCM syndrome score and single TCM symptom score on day 0,14 and 28 were observed,and the adverse reactions were recorded.Results There were significant differences in total TCM syndrome score between the two groups at baseline,on day 0 and day 28(P<0.01).There was significant difference in total TCM syndrome score between the two groups on day 28(P<0.05).There were significant differences between the two groups in total effective rate of total TCM syndromes and lumbago in single TCM syndromes score on day 28(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 on TCM syndromes in the treatment of LDH of deficiency of liver and kidney syndrome and obstruction of wind damp and blood stasis syndrome,especially in improving the score of total TCM syndrome score and lumbago with high safety.