筋骨痛消颗粒治疗膝骨性关节炎(血瘀寒凝证)116例临床研究

Clinical Study on 116 Cases of Knee Joint Osteoarthritis (Blood Stasis and Cold Stagnation Syndrome) Treated by Jingu Tongxiao Granules

目的观察筋骨痛消颗粒治疗膝骨性关节炎有效性和安全性。方法采用随机化分组,试验组与对照组按1¨1分配,以筋骨痛消丸为对照药物,采用双盲双模拟临床试验方法。观察安全性检测指标和主要症状、体征、膝关节X线检查疗效性指标。结果两组总有效率、控显率,两组间的治疗前、中、后病情总积分,两组中医证候疗效总有效率、控显率,两组主要症状体征的总有效率,两组治疗前后的膝X线检查变化,差异均无显著性意义(P>0.05)。结论筋骨痛消颗粒治疗膝骨关节炎能有效缓解关节疼痛、晨僵、屈伸不利等临床症状,安全性好。同丸剂相比,在疗效与安全性方面差异均无显著性意义,保持了原剂型的效果。

Objective To observe the efficacy and safety of Jingu Tongxiao Granules for knee joint osteoarthritis. Methods The patients were equally randomized into experimental and control groups with Jingu Tongxiao Pills used as the medicine for control. The clinical trial of double-blind double-imitation was adopted to observe the safety and efficacy indices of symptoms, signs and X-ray examination of knee joint. Results The total effective rate, controlled-markedly effective rate, total score of pathological condition before and after treatment between two groups, total effective rate of therapeutic effect of TCM syndromes of two groups, controlled-markedly effective rate, total effective rate of rest pain of the main symptoms and signs, tenderness of knee joint, morning stiffness and motor impairment of two groups, and changes of X-ray examination of two groups before and after treatment were not significantly different （P〉0. 05）. Conclusion Jingu Tongxiao Granules could effectively relieve the pain, morning stiffness and motor impairment of knee joint osteoarthritis safely. Compared with the original form, the efficacy and safety of Jingu Tongxiao Granules were the same.