摘要
【目的】在Ⅱ期临床试验基础上,进一步评价芪葛颗粒治疗神经根型颈椎病(风寒阻络证)的临床疗效和安全性。【方法】采用多中心、随机、双盲、平行阳性药对照的方法,将468例神经根型颈椎病患者分成两组,治疗组352例采用芪葛颗粒治疗,对照组116例采用根痛平颗粒治疗,两组每次服用颗粒剂2袋(根痛平颗粒含1袋模拟剂),早、晚各1次,连服4周。按照症状、体征分级量化标准,对治疗前及用药后4周进行量化评分并评价疗效;并对患者进行用药前后的三大常规和心、肝、肾功能等安全性检查,观察以上安全性指标的变化。【结果】治疗后,试验组和对照组的中医证候均有显著改善,中医证候积分均显著降低,且试验组优于对照组,差异有显著性意义(P<0.05或P<0.01)。在安全性方面,两组均未见有明显的不良反应。【结论】芪葛颗粒治疗神经根型颈椎病(风寒阻络证)安全有效。
Objective To further evaluate the therapeutic effect and safety of Qige Granules （QG） on nerve-root cervical spondylosis （NRCS） with wind-cold obstructing collaterals syndrome based on the achievement of phase Ⅱ clinical trial. Methods A multi-center, double-blind, randomized and positive-control paralleled trial was carried out in 468 NRCS patients. The patients were divided into 2 groups： the treatment group （N = 352 ） received QG, 2 packs each time and two times per day, and the control group （N = 116） received one pack of Gentongping Granules and one pack of simulative preparation each time, two times per day. The treatment lasted 4 weeks. The therapeutic effect was evaluated according to the scores of clinical symptoms and signs before and after treatment, and the safety of QG was evaluated by blood, urine and stool routine examination, and by observing the function of the heart, liver and kidney. Results After treatment, the symptoms and signs were much improved, and the scores of TCM syndrome were decreased in the two groups; the above effect in the treatment group was superior to that in the control group （P 〈 0.05 or P 〈 0.01 ）. No obvious reverse reaction of QG was found. Conclusion Qige granules are safe and effective for the treatment of nerve-root cervical spondylosis with wind-cold obstructing collaterals syndrome.
出处
《广州中医药大学学报》
CAS
2009年第3期208-212,共5页
Journal of Guangzhou University of Traditional Chinese Medicine
基金
国家食品药品监督管理局新药临床研究项目(编号:2001ZL233)
