附桂骨痛颗粒治疗阳虚寒湿型颈椎病临床观察

Clinical Observation of Fugui Ostealgia Particles in the Treatment of Cervical Spondylosis(Yang-asthenia and Cold-damp Type)

目的临床评价附桂骨痛颗粒治疗阳虚寒湿型颈椎病的有效性和安全性。方法 2010年12月-2011年7月依照《中药新药临床研究指导原则》,设计为多中心、随机对照、双盲双模拟的临床观察研究。将240例患者按照试验组与对照组3︰1比例分为2组,试验组采用附桂骨痛颗粒,对照组采用抗骨增生片,疗程90 d。结果试验组与对照组分别有172、53例完成研究。试验组总有效率92.44%,对照组75.47%,差异有统计学意义(P<0.05);两组在中医证候总有效率比较差异有统计学意义(P<0.05)。主症颈项疼痛、畏寒肢冷的两组疗效比较差异有统计学意义(P<0.05)。两组治疗前后实验室检查结果均无异常,未发生与药物相关的不良反应。结论附桂骨痛颗粒是治疗阳虚寒湿型颈椎病有效、安全的中药复方制剂,对于改善颈项疼痛和畏寒肢冷的治疗效果尤为显著。

Objective To evaluate the efficacy and safety of Fugui ostealgia particles for cervical spondylosis （Yang-asthenia and cold-damp type）. Methods From December 2010 to July 2011, we carried out a multi-centered, randomized, double-blind and double-simulation clinical observation study based on the Guiding Principles for the Clinical Research on New Chinese Traditional Medicine （TCM）. A total of 240 patients were divided into experimental group and control group with the number of patients at a ratio of 3 ： 1. The treatment group （n=180） was treated by Fugui ostealgia particles, while patients in the control group （n=60） received Kangguzengsheng capsules. The treatment course lasted for 90 days. Results The total effective rate in the experimental group was 92.44%, and was 75.47% in the control group, with a significant difference between the two groups （P 〈 0.05）. The total effective rate for TCM syndromes was significantly different between the two groups （P 〈 0.05）. The effect on main symptoms such as nuchal pain, aversion to cold, and cold hands and feet, was significantly different between the two groups （P 〈 0.05）. Laboratory test results showed no abnormality before and after treatment, and no drug-related adverse reactions occurred. Conclusion Fugui ostealgia particles are safe and effective for the treatment of Yang-asthenia and cold-damp type cervical spondylosis, especially for the treatment of nuchal pain, aversion to cold, and cold hands and feet.