桂枝汤类方治疗神经根型颈椎病(太阳病)多中心随机对照临床研究OA

Objective:To investigate the clinical efficacy and safety of Guizhi Decoction-based formulations in treating cervi-cal spondylotic radiculopathy(CSR)through a multicenter,randomized controlled trial.Methods:This multicenter,strati-fied,randomized,controlled clinical trial enrolled 440 CSR patients from 12 medical institutions in Hunan Province.Pa-tients were classified into five syndrome types according to six-meridian syndrome differentiation.Within each syndrome type,patients were randomly assigned(1∶1)to either the Jingfang group(receiving Guizhi+Gegen decoction,Guizhi Xinjia decoction,Guizhi Fuzi decoction,Mahuang Fuzi Xixin decoction,or Chaihu Guizhi decoction)or the control group(receiving celecoxib and mecobalamin).The primary endpoint was the change in visual analogue scale(VAS)score at week 4.Secondary endpoints included VAS scores at weeks 1 and 2,neck disability index(NDI),TCM syndrome score,recurrence rate,and safety.Adverse events were graded according to CTCAE v5.0.Results:Baseline characteristics were comparable between groups(P＞0.05).At week 1,the reduction in VAS scores and NDI scores was significantly greater in the control group than in the Jingfang group(P＜0.05).The intergroup difference narrowed by week 2.At week 4 and at the 12-week follow-up,the improvement in VAS and NDI scores was significantly greater in the Jingfang group than in the control group(all P＜0.05).Improvement in TCM syndrome scores was superior in the Jingfang group,with the difference becoming significant from week 2 onwards(P＜0.05).Intention-to-treat(ITT)analysis showed that the total effective rate was 78.9％-86.2％in the Jingfang group,significantly higher than that in the control group(71.1％-79.3％)(x2 test,P＜0.05).At the 12-week follow-up,the recurrence rate was 5.3％-7.9％in the Jingfang group,sig-nificantly lower than the 10.5％-15.8％in the control group(P=0.022).The incidence of adverse events was low and not significantly different between the two groups.Conclusion:Guizhi decoction-based formulations,guided by six-meridian syndrome differentiation,demonstrate definite advantages in alleviating pain,improving function,and relieving TCM syndromes in patients with cervical spondylotic radiculopathy(Taiyang disease),with a favorable safety profile,providing evidence-based support for clinical treatment with traditional Chinese medicine.