痹证颗粒联合西医基础疗法治疗神经根型颈椎病肝肾不足、痰湿交阻证临床研究

Clinical Study on Bizheng Granules Combined with Basic Therapy in the Treatment of Liver and Kidney Insufficiency and Phlegm-Dampness Cross-Blocking Syndrome of Nerve Root Type Cervical Spondylosis Radiculopathy

目的观察痹证颗粒联合基础疗法治疗神经根型颈椎病肝肾不足、痰湿交阻证的临床疗效及安全性。方法选取神经根型颈椎病患者108例,采用随机数字表法分为痹证颗粒组、颈复康颗粒组、痹证颗粒安慰剂组各36例。3组均进行基础疗法治疗(口服甲钴胺片0.5mg,每日3次;颈椎间歇牵引,每次15min,每日1次),痹证颗粒组服用痹证颗粒,颈复康颗粒组服用颈复康颗粒,痹证颗粒安慰剂组服用痹证颗粒安慰剂,饭后冲服,每日2次。3组均连续治疗2周,于治疗后4、12周随访。于治疗前后及治疗后4、12周分别记录3组患者视觉模拟评分法(VAS)、颈椎功能障碍指数(NDI)、健康调查简表(SF-36)评分。记录3组治疗过程中及随访期间不良反应。结果痹证颗粒组脱落3例,颈复康颗粒组脱落3例,痹证颗粒安慰剂组脱落1例。与本组治疗前比较,3组患者治疗后及随访各时间点VAS评分、NDI评分、SF-36评分差异均有统计学意义(P<0.05)。治疗后12周,痹证颗粒组和颈复康颗粒组VAS评分、NDI评分均低于痹证颗粒安慰剂组,但痹证颗粒组与颈复康颗粒组VAS评分、NDI评分比较差异无统计学意义(P>0.05)。治疗后12周,痹证颗粒组SF-36评分高于痹证颗粒安慰剂组,但痹证颗粒组与颈复康颗粒组SF-36评分比较差异无统计学意义(P>0.05)。痹证颗粒组总有效率优于颈复康颗粒组和痹证颗粒安慰剂组(P<0.05)。3组患者不良反应发生率比较差异无统计学意义(P>0.05),3组均未出现严重不良事件。结论痹证颗粒联合基础疗法治疗在改善神经根型颈椎病肝肾不足、痰湿交阻证患者疼痛、恢复颈椎功能障碍、提高生活质量方面疗效显著,具有较好的安全性。

Objective To evaluate clinical efficacy and safety of Bizheng Granules combined with basic therapy in the treatment of liver and kidney insufficiency and phlegm-dampness cross-blocking syndrome of nerve root type cervical spondylosis radiculopathy.Methods Totally 108 patients with nerve root type cervical spondylosis radiculopathy were selected and divided into Bizheng Granules group,Jingfukang Granules group,and Bizheng Granules placebo group according to random number table method,with 36 cases in each group.The three groups were treated with the basic treatment(oral methylcobalamin tablets of 0.5 mg,three times a day,and cervical spine intermittent traction once a day,each time for 15 min),and Bizheng Granules were given in the Bizheng Granules group,and Jingfukang Granules in the Jingfukang Granules group,and Bizheng Granules placebo in the Bizheng Granules placebo group,twice a day after meals.All three groups were treated continuously for 2 weeks and followed up at 4 and 12 weeks after treatment.Visual analog scale(VAS),cervical dysfunction index(NDI),and 36-items short form survey(SF-36)score were recorded in the 3 groups before and after treatment and 4 and 12 weeks after treatment,respectively.Adverse reactions during treatment and follow-up were recorded in the 3 groups.Results 3 cases lost in the Bizheng Granules group,3 cases in the Jingfukang Granules group,and 1 case in the Bizheng Granules placebo group.Compared with the pre-treatment period,the differences in VAS score,NDI score,and SF-36 score among the three groups of patients at all time points of treatment and follow-up were statistically significant(P<0.05).At 12 weeks after treatment,the VAS score and NDI score of the Bizheng Granules group and the Jingfukang Granules group were lower than those of the Bizheng Granules placebo group,but the differences in VAS score and NDI score between Bizheng Granules group and Jingfukang Granules group were not statistically significant(P>0.05).12 weeks after treatment,the SF-36 score of Bizheng Granules group were higher than those of Bizheng Granules placebo group,but the difference in SF-36 score between Bizheng Granules group and Jingfukang Granules group was not statistically significant(P>0.05).The total effective rate of Bizheng Granules group was better than that of the Jingfukang Granules group and Bizheng Granules placebo group(P<0.05).The incidence of adverse reactions in the three groups was not statistically significant(P>0.05).There were no serious adverse events in the three groups.Conclusion Bizheng Granules combined with basic therapy has a definite therapeutic effect in improving pain,restoring cervical dysfunction,and improving quality of life in the treatment of liver and kidney insufficiency and phlegm-dampness cross-blocking syndrome of nerve root type cervical spondylosis radiculopathy,with good safety.