中国骨伤2025，Vol.38Issue(11)：1112-1118,7.DOI:10.12200/j.issn.1003-0034.20240543
益气活血方治疗破裂型腰椎间盘突出症的多中心随机对照研究
Multicenter randomized controlled trial of Yiqi Huoxue formula(益气活血方)for the treatment of ruptured lumbar disc herniation
摘要
Abstract
Objective To observe the clinical symptoms and MRI outcomes of patients with ruptured lumbar disc hernia-tion(LDH)through a multicenter randomized controlled study,and to evaluate the clinical efficacy and safety of Yiqi Huoxue formula(益气活血方)in the treatment of this disease.Methods A total of 160 outpatients and inpatients with ruptured LDH admitted to 4 medical centers from January 2023 to June 2023 were selected and randomly divided into the Yiqi Huoxue for-mula group and the control group,with 80 patients in each group.In the Yiqi Huoxue formula group,there were 43 males and 37 females,with an age of(41.03±9.56)years and a disease duration of(10.45±25.37)days,and the patients were treated with Yiqi Huoxue formula.In the control group,there were 34 males and 46 females,with an age of(42.14±8.73)years and a disease duration of(11.31±21.14)days;during the acute phase,patients in this group could take celecoxib capsules orally,and methylcobalamin orally at the same time.The Japanese Orthopaedic Association(JOA)score,Oswestry disability index(ODI),changes in the volume of herniated disc tissue on MRI,herniation rate,and absorption rate were recorded at the time of enrollment and during follow-ups at the 3rd,6th,and 12th month after treatment.Results A total of 156 patients completed the clinical follow-up,and 4 patients withdrew midway.The clinical symptoms of all patients who completed the study were relieved to varying degrees,and reabsorption of herniated disc tissue was observed in all patients in the Yiqi Huoxue formula group after treatment.For the JOA score:in the Yiqi Huoxue formula group,it was(10.73±2.76)points before treatment and(24.65±2.19)points at the 12th month after treatment;in the control group,it was(11.01±1.20)points before treatment and(17.07±3.26)points at the 12th month after treatment.For the ODI score:in the Yiqi Huoxue formula group,it was(26.21±3.55)points before treatment and(5.65±2.19)points at the 12th month after treatment;in the control group,it was(27.92±2.51)points before treatment and(9.09±2.15)points at the 12th month after treatment.At the 12th month after treatment,the JOA and ODI scores of both groups were better than those before treatment,and the scores of the Yiqi Huoxue formula group were better than those of the control group,with statistically significant differences(P＜0.05).In terms of the herniated disc volume and herniation rate on MRI,the Yiqi Huoxue formula group was superior to the control group,with statistically significant dif-ferences(P＜0.05).Reabsorption occurred in 56.96％(45/79)of patients in the Yiqi Huoxue formula group,which was signifi-cantly higher than the 37.66％(29/77)in the control group.Conclusion After treatment with Yiqi Huoxue formula,patients with ruptured LDH show significant improvement in clinical symptoms and a marked reduction in the volume of herniated discs.During the follow-up period,no obvious adverse drug reactions are observed in patients,and no recurrence of symptoms is found at the last follow-up,indicating that the formula has safe and reliable efficacy.关键词
破裂型腰椎间盘突出/益气活血方/塞来昔布/甲钴胺/重吸收/中药疗法Key words
Ruptured lumbar disc herniation/Yiqi Huoxue formula(益气活血方)/Celecoxib/Mecobalamin/Resorption/Traditional Chinese medicine therapy分类
医药卫生引用本文复制引用
朱宇,陈梦菲,俞鹏飞,姜宏,刘锦涛,王志强,林顺,姚莹莹,沈学强,李晓春,俞峰,熊晓扬,宋奕..益气活血方治疗破裂型腰椎间盘突出症的多中心随机对照研究[J].中国骨伤,2025,38(11):1112-1118,7.基金项目
国家自然科学基金项目(编号:82474529) （编号:82474529）
江苏省自然科学基金项目(编号:BK20241802) （编号:BK20241802）
江苏省中医药科技发展计划项目(编号:MS2022080) （编号:MS2022080）
苏州市卫健委项目(编号:KJXW2023047)National Natural Science Foundation of China(No.82474529) （编号:KJXW2023047）
