腰痛宁胶囊治疗腰椎增生症(寒湿瘀阻证)临床观察

目的观察腰痛宁胶囊治疗腰椎增生症(寒湿瘀阻证)的临床有效性及安全性。方法以随机、盲法、安慰剂平行对照、多中心临床研究方法,选择符合研究标准的腰椎增生症患者144例,腰痛宁胶囊组(治疗组)72例,完成72例;安慰剂组(对照组)72例,完成70例。疗程2周,观察两组患者中医症侯、治疗后疼痛减轻的情况。结果腰痛宁胶囊治疗腰椎增生症(寒湿瘀阻证)疗效:治疗组控显率41.5%;对照组0.0%,组间差异有统计学意义(P0.001)。疼痛减轻情况:治疗组减轻率86.1%;对照组减轻率45.7%,组间差异有统计学意义(P0.001)。结论腰痛宁胶囊治疗腰椎增生症(寒湿瘀阻证)疗效显著,能够有效减轻腰椎增生引起的疼痛。

Clinical observation on Yaotongning Capsule in treatment of lumbar hyperplasia(cold-dampness stagnation syndrome)

Objective To observe the therapeutic effect and safety of Yaotongning Capsule in the treatment of lumbar hyperplasia.Methods A random, double-blind, placebo controlled, multicenter clinical research method was used.The lumbar hyperplasia patients(144 cases) were selected, divided into Yaotongning Capsule group(treatment group) with 72 cases, 72 cases completed;and placebo group(control group) with 72 cases, 70 cases completed.The treatment lasted for 2 weeks.After treatment, the symptom of traditional Chinese medicine and pain relief situation were observed in the two groups.Results The curative effects of Yaotongning Capsule in the treatment of lumbar hyperplasia disease(cold-dampness stagnation syndrome) were as follows:The control rate in treatment group was 41.5%, and that in the control group was 0.0%, superiority test(P<0.001) was established.Pain relief:the relieve rate in treatment group was 86.1%, and that in the control group was reduced to 45.7%, there was significant difference between the groups(P<0.001).Conclusion Yaotongning Capsule in the treatment of lumbar hyperplasia(cold-dampness stagnation syndrome) has obviously curative effect, and can effectively reduce the pain caused by lumbar hyperplasia.