腰痛消洗剂联合牵引治疗腰椎骨性关节炎寒湿瘀阻证127例随机、双盲、安慰剂对照临床研究

Clinical Observation on 127 Cases of Lumbar Vertebrate Osteoarthritis with Cold Dampness and Stasis Obstruction Syndrome Treated by Yaotongxiao Lotion (腰痛消洗剂) Combined with Traction: A Double-blind,Placebo,Randomize-Controlled Clinical Trial

目的观察腰痛消洗剂治疗腰椎骨性关节炎寒湿瘀阻证的临床疗效和安全性。方法采用随机、双盲、安慰剂平行对照的临床研究方法,纳入腰椎骨性关节炎患者260例,随机分为试验组和对照组,每组130例,试验组给予腰痛消洗剂熏蒸联合牵引治疗,对照组给予安慰剂熏蒸联合牵引治疗,均每日2次,共治疗14天。分别于治疗前、治疗7d、治疗14d、随访时(治疗结束后30d)观察两组患者疼痛视觉模拟评分(VAS)、Oswestry功能障碍指数(ODI)、中医症状积分的变化情况,并观察其临床疗效与不良反应。结果试验组脱落3例,对照组脱落2例。治疗后,两组VAS显著下降,同组治疗前后比较及同时间组间比较差异均具有统计学意义(P <0. 05);两组ODI评分均逐渐下降,但在治疗后7d、治疗后14d及随访时均以试验组在ODI评分改善更为显著(P <0. 05);两组患者中医症状积分均下降,且均以试验组改善更为明显(P <0. 05);试验组疗效优良率为68. 50%,对照组为59. 38%,试验组优于对照组(P <0. 05)。结论腰痛消洗剂联合牵引治疗腰椎骨性关节炎具有较好的临床疗效,可显著改善患者的腰椎活动功能,安全性较好。

Objective To observe the clinical efficacy and safety of Yaotongxiao Lotion( 腰痛消洗剂) in the treatment of lumbar osteoarthritis with cold and dampness syndrome. Methods A randomized,double-blind,placebo-controlled clinical study was performed in 260 patients with lumbar osteoarthritis. Patients were randomly divided into an test group and a control group,with 130 patients in each group. The test group was given Yaotongxiao Lotion fumigation combined with traction. The control group was given placebo fumigation combined with traction,twice a day,for a total of 14 days. The changes of pain visual analogue scale( VAS),Oswestry dysfunction index( ODI) and traditional Chinese medicine symptom scores were observed before treatment,7 days after treatment,14 days after treatment,and follow-up,and the clinical efficacy and adverse reactions were observed. Results There were 3 cases in the test group and 2 cases in the control group lost. After treatment,VAS of both groups decreased significantly. The difference before and after treatment as well as groups difference between groups at the same time were statistically significant( P < 0. 05). The ODI scores of both groups gradually decreased,but the improvement of ODI score was more significant in the test group after 7 days,14 days treatment and at the follow-up( P < 0. 05). The traditional Chinese medicine symptom scores of both groups were decreased,and the improvement was more obvious in the test group( P < 0. 05). The excellent and good rate of the test group and the control group was 68. 50% and59. 38% respectively. The test group was superior to the control group( P < 0. 05). Conclusion Yaotongxiao Lotion combined with traction therapy has a good clinical effect in the treatment of lumbar vertebrae osteoarthritis,which can significantly improve the lumbar motion of patients safely.