1. 上海中医药大学附属龙华医院骨伤科,上海,200032
2. 全国名老中医传承施杞工作室,上海,200032
3. 上海中医药大学脊柱病研究所,上海,200032
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许金海, 王国栋, 沈琪幸, 等. 筋痹颗粒治疗神经根型颈椎病的随机、双盲、双模拟、非劣效性平行对照临床研究[J]. 上海中医药杂志, 2020,54(2):54-60.
XU Jinhai, WANG Guodong, SHEN Qixing, et al. Clinical study on Jinbi granules in treating cervical spondylosis radiculopathy: a randomized, double-blind and double-dummy controlled trail[J]. Shanghai Journal of Traditional Chinese Medicine, 2020,54(2):54-60.
许金海, 王国栋, 沈琪幸, 等. 筋痹颗粒治疗神经根型颈椎病的随机、双盲、双模拟、非劣效性平行对照临床研究[J]. 上海中医药杂志, 2020,54(2):54-60. DOI: 10.16305/j.1007-1334.2020.02.014.
XU Jinhai, WANG Guodong, SHEN Qixing, et al. Clinical study on Jinbi granules in treating cervical spondylosis radiculopathy: a randomized, double-blind and double-dummy controlled trail[J]. Shanghai Journal of Traditional Chinese Medicine, 2020,54(2):54-60. DOI: 10.16305/j.1007-1334.2020.02.014.
目的:观察筋痹颗粒治疗神经根型颈椎病的临床疗效与安全性。 方法:将72例神经根型颈椎病患者随机分为试验组和对照组,每组36例,试验组服用筋痹颗粒和塞来昔布模拟胶囊,对照组服用塞来昔布胶囊和筋痹颗粒安慰剂。治疗前、治疗7 d、治疗14 d、治疗后2个月时,观察用药安全性,比较疼痛视觉模拟评分(VAS)、颈椎功能障碍评分(NDI)、生活质量SF-36评分的变化情况。 结果:①试验期间,试验组脱落1例,对照组脱落2例。②组内治疗后不同时间点与治疗前比较,两组疼痛VAS 评分差异均有统计学意义(P<0.05),且VAS评分逐渐降低,即存在时间效应;两组组间不同时间点疼痛VAS 评分差异无统计学意义(P>0.05),即不存在分组效应。时间因素和分组因素之间不存在交互效应(P>0.05)。治疗14 d与治疗前两组疼痛VAS评分差值的95%可信区间为2.45~2.81,按照预设20%的非劣标准,非劣效检验合格。③组内治疗后不同时间点与治疗前比较,两组NDI 评分差异均有统计学意义(P<0.05),且NDI 评分逐渐降低,即存在时间效应;两组组间不同时间点NDI 评分差异无统计学意义(P>0.05),即不存在分组效应。时间因素和分组因素之间不存在交互效应(P>0.05)。治疗14 d与治疗前两组NDI评分差值的95%可信区间为4.88~9.78,按照预设20%的非劣标准,非劣效检验合格。④组内治疗后不同时间点与治疗前比较,两组SF-36-PCS评分差异均有统计学意义(P<0.05),且SF-36-PCS评分逐渐升高,即存在时间效应;两组组间不同时间点SF-36-PCS评分差异无统计学意义(P>0.05),即不存在分组效应。时间因素和分组因素之间不存在交互效应(P>0.05)。⑤组内治疗后不同时间点与治疗前比较,两组SF-36-MCS评分差异均有统计学意义(P<0.05),且SF-36-MCS评分逐渐升高,即存在时间效应。组间治疗前和治疗7 d的SF-36-MCS评分差异无统计学意义(P>0.05);组间治疗14 d、随访2个月的SF-36-PCS评分差异有统计学意义(P<0.05),即存在分组效应。时间因素和分组因素之间存在交互效应(P<0.05)。⑥试验组和对照组均未出现严重不良事件。 结论:筋痹颗粒治疗神经根型颈椎病的临床疗效不劣于塞来昔布,能减轻患者的颈肩疼痛,改善颈椎功能障碍及患者的生活质量,尤其是改善心理健康问题,体现中医学“心身同治”的特点。
Objective:To observe the clinical efficacy and safety of Jinbi granules in the treatment of cervical spondylosis radiculopathy (CSR). MethodsA randomized, double-blind and double-dummy controlled clinical trial was conducted with 72 patients being randomly divided into 2 groups (36 patients per group). The experimental group was administered the Jinbi granules and Celebrex simulated capsules, while the control group was given the Celebrex capsules and the Jinbi granules placebo. VAS, NDI and SF-36 quality of life scores were recorded before treatment, and at 1 week, 2 weeks and 8 weeks after treatment respectively. Patients’ adverse reactions were recorded and their clinical efficacy and safety were evaluated. Results:①There was one drop-out case in the experimental group and two drop-out cases in the control group. ②The difference between VAS scores of pain in the two groups before and after treatment was statistically significant (P<0.05), and the VAS scores gradually decreased, indicating a time effect; There was no significant difference in VAS scores between the two groups at different time points (P>0.05), indicating there was no grouping effect. There was no interaction between time factor and grouping factor (P>0.05). The 95 % confidence interval of the VAS scores difference between the two groups after 14 days of treatment and before treatment was in the range from 2.45 to 2.81. According to the preset non-inferiority standard of 20 %, the non-inferiority test was passed. ③The difference of NDI scores between the two groups compared before and after treatment at different time points was statistically significant (P<0.05), and NDI scores gradually decreased, suggesting a time effect. There was no significant difference in NDI scores between the two groups at different time points (P>0.05), i.e., there was no grouping effect. There was no interaction between time and grouping factors (P>0.05). The 95 % confidence interval of NDI score difference between the two groups after 14 days of treatment and before treatment was in the range from 4.88 to 9.78. According to the preset non-inferiority standard of 20 %, the non-inferiority test was passed. ④There was significant difference in SF-36-PCS score between the two groups at different time points after treatment and before treatment (P<0.05), and SF-36-PCS score gradually increased, suggesting a time effect; there was no significant difference in SF-36-PCS score at different time points between the two groups (P>0.05), i.e., there was no grouping effect. There was no interaction between time and grouping factors (P>0.05). ⑤There was significant difference in SF-36-MCS score between the two groups at different time points after treatment and before treatment (P<0.05), and SF-36-MCS score gradually increased, indicating a time effect. There was no significant difference in SF-36-MCS scores between groups before and 7 days after treatment (P>0.05); there was significant difference in SF-36-PCS scores between groups after 14 days of treatment and 2 months of follow-up (P<0.05), suggesting a grouping effect. There was interaction between time and grouping factors (P<0.05). ⑥No serious adverse events occurred in the experimental group and the control group. Conclusion:The clinical efficacy of Jinbi granules in the treatment of CSR, which is not inferior to that of Celebrex. Jinbi granules can reduce the pain of neck and shoulder, improve the dysfunction of cervical vertebra and the quality of life of patients, and improve the mental health problems in particular, reflecting the characteristics of “treating both mind and body” in traditional Chinese medicine.
神经根型颈椎病筋痹颗粒塞来昔布安慰剂对照双盲临床试验心身同治
cervical spondylosis radiculopathy (CSR)Jinbi granulesCelebrexplacebo controldouble blindclinical trialpsychosomatic therapy
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