芪麝丸治疗神经根型颈椎病Ⅲ期临床试验

A phase Ⅲ clinical trial of the Qishe Wan in treatment of cervical radiculopathy

目的评价芪麝丸治疗神经根型颈椎病(气虚血瘀证)的临床疗效和安全性。方法采用随机双盲双模拟、阳性对照多中心临床研究,以颈复康颗粒为对照。共纳入440例神经根型颈椎病患者,随机分为试验组(芪麝丸组)和对照组(颈复康颗粒组)。芪麝丸组予芪麝丸+颈复康颗粒模拟剂,颈复康颗粒组予颈复康颗粒+芪麝丸模拟剂,均为每次各1袋,每日2次,口服,疗程4周。治疗前后进行颈椎病症状和体征综合疗效以及各单项疗效评价,并观察不良反应发生情况。结果 416例患者完成试验,芪麝丸组311例,颈复康颗粒组105例,治疗前两组各项指标均无显著差异。治疗后,两组颈项部疼痛或不适、上肢放射性疼痛、上肢麻木等各单项症状和体征评分均显著下降(P<0.01),芪麝丸组神疲症状评分下降幅度大于颈复康颗粒组(P<0.01),其他评分无显著差异(P>0.05)。治疗后,芪麝丸组症状和体征总分为(6.9±5.2)分,低于颈复康颗粒组[(8.2±5.9)分,P<0.05]。芪麝丸组、颈复康颗粒组总有效率分别为90.4%、83.8%,两组疗效比较无显著差异(P>0.05)。两组治疗后颈椎曲度无明显变化,组间比较亦无显著差异(P>0.05)。两组均无严重不良反应发生,芪麝丸组不良反应发生率为5.0%,颈复康颗粒组为3.6%(P>0.05)。结论芪麝丸治疗神经根型颈椎病(气虚血瘀证)疗效确切,改善主症明显,未见明显不良反应。

AIM To evaluate the efficacy and safety of Qishe Wan in treating patients with cervical radiculopathy （qideficiency and blood- stasis syndrome）. METHODS This study was a multicenter, randomized, doubleblind, positive controlled clinical trial. Four hundred and forty cervical radiculopathy patients were divided into two groups. The patients in the Qishe Wan group were treated with one pack of Qishe Wan and one pack of placebo, while the others in the Jingfukang granule group were treated with one pack of Jingfukang granule and one pack of placebo, twice a day for 4 weeks. The comprehensive effectiveness of symptoms and integral signs and the respective effectiveness were evaluated before and after the treatment. The adverse reactions were observed. RESULTS Four hundred and sixteen patients have completed the trial, including 311 patients in the Qishe Wan group and 105 patients in the Jingfukang granule group. After the treatment, the scores of neck pain or discomfort, upper limb pain of radioactivity or numbness and other symptoms were decreased significantly in both groups （P 〈 0.01 ）. The score of mental weariness symptom in the Qishe Wan group improved better than that in the Jingfukang granule group （P 〈 0.01） and the other scores showed no significant difference between two groups （P 〉 0.05）. The total score of symptoms and integral signs was significantly decline in the Qishe Wan group than in the Ji P 〈 0.05）. The total effective rate was 90.4% and 83.8% in th There was no statistical difference in clinical efficacy between ngfukang granule group （6.9 ± 5.2 vs. 8.2± 5.9, e Qishe Wan group and Jingfukang granule group. two groups （P 〉 0.05）. There was no significant change in cervical curvature in both groups and no statistical difference between two groups （P 〉 0.05）. No serious adverse reactions occurred in both groups and the incidence of adverse reactions in the Qishe Wan group and Jingfukang safety in the tre granule group were 5.0% and 3.6% （P 〉 0.05）. COUCLUSION Qishe Wan is effective and atment of cervical radiculopathy （qi-deficiency and blood-stasis syndrome）.