舒筋通络颗粒治疗神经根型和椎动脉型颈椎病2170例临床观察

Clinical Observation on 2170 Cases of Cervical Spondylosis of Nerve Root and Vertebral Artery Type Treated with Shujin Tongluo Granule(舒筋通络颗粒)

目的观察舒筋通络颗粒治疗肝肾亏虚、气虚血瘀证神经根型和椎动脉型颈椎病的临床疗效及安全性。方法将2170例患者根据疾病类型分为神经根型颈椎病1199例、椎动脉型颈椎病971例。所有患者均给予舒筋通络颗粒口服,每次12 g,每日3次,疗程为4周。治疗前、治疗2周及治疗4周对患者进行中医证候评分及临床症状和体征评分,并记录治疗期间发生的不良事件。结果神经根型颈椎病组共有1155例患者完成研究,椎动脉型颈椎病组共有956例患者完成研究。神经根型及椎动脉型颈椎病患者治疗2周、4周临床症状和体征评分及中医证候评分均较治疗前明显降低（P〈0.05）,治疗4周评分较治疗2周亦明显下降（P〈0.05）。治疗2周各临床症状和体征疗效有效率为40.64%~65.08%,中医证候各指标疗效有效率为34.08%~57.48%;治疗4周分别为71.03%~83.88%、63.98%~82.17%。用药期间有75例患者出现不良事件,其中与药物相关的63例出现不同程度胃肠道不适,停药后可自行缓解。结论舒筋通络颗粒能有效改善肝肾亏虚、气虚血瘀证神经根型及椎动脉型颈椎病患者的典型临床表现,且具有较高的安全性。

Objective To observe clinical efficacy and safety of Shujin Tongluo Granule（舒筋通络颗粒） in the treatment of cervical spondylosis of nerve root and vertebral artery type with liver and kidney deficiency and Qi deficiency and blood stasis syndrome. Methods There were 2170 patients divided into cervical spondylosis of nerve root type（ 1199 cases） and cervical spondylosis of vertebral artery type（ 971 cases） depending on disease type. All patients took Shujin Tongluo Granule orally,12 g each time,three times a day for 4 weeks. Before treatment,as well as 2weeks and 4 weeks after treatment,scores of Chinese medical syndrome,clinical signs and symptoms of patients were evaluated and adverse events occurred during treatment were recorded by researchers. Results A total of 1155 patients in the cervical spondylosis of nerve root type group and 956 patients in the cervical spondylosis of vertebral artery type group completed the study. Two weeks and 4 weeks after treatment,the scores of Chinese medical syndrome,clinical signs and symptoms of the patients with cervical spondylosis of nerve root and vertebral artery type were significantly lower than those before treatment（ P 〈 0. 05）,especially in 4 weeks after treatment（ P 〈 0. 05）.The effective rates of clinical symptoms and signs were 40. 64% ~ 65. 08%,and the effective rates of Chinese medical syndrome indexes were 34. 08% ~ 57. 48% two weeks after treatment,but 71. 03% ~ 83. 88% and 63. 98% ~82. 17% respectively 4 weeks after treatment. There were adverse events occurring in 75 patients during treatment,including 63 cases with different degree of gastrointestinal discomfort which were related to drug and can alleviate after drug withdrawal. Conclusion With good safety,Shujin Tongluo Granule may effectively improve typical clinical manifestations of cervical spondylosis of nerve root and vertebral artery type with liver and kidney deficiency and Qi deficiency and blood stasis.