摘要
目的:观察多中心随机对照研究破裂型腰椎间盘突出症(lumbar disc herniation,LDH)的临床症状及MRI转归,评价益气活血方治疗该病的临床有效性及安全性。方法:选择2023年1月至2023年6月于4家诊疗中心收治的160例破裂型LDH门诊及住院患者,随机分为益气活血方组和对照组,每组80例。益气活血方组,男43例,女37例,年龄(41.03±9.56)岁,病程(10.45±25.37)d,予益气活血方治疗;对照组,男34例,女46例,年龄(42.14±8.73)岁,病程(11.31±21.14)d,急性期可口服塞来昔布胶囊,同时口服甲钴胺。分别于纳入时及治疗3、6、12个月后随访时记录日本骨科协会(Japanese Orthopaedic Association,JOA)评分、Oswestry功能障碍指数(Oswestry disability index,ODI)与MRI突出椎间盘组织体积变化、突出率,计算吸收率。结果:156例患者完成临床随访,时间(12.4±1.2)个月,4例患者中途退出,完成研究的患者临床症状均实现不同程度缓解,益气活血方组患者经治疗后均出现重吸收现象。JOA评分:益气活血方组治疗前(10.73±2.76)分,治疗12个月后(24.65±2.19)分;对照组治疗前(11.01±1.20)分,治疗12个月后(17.07±3.26)分。ODI评分:益气活血方组治疗前(26.21±3.55)分,治疗12个月后(5.65±2.19)分;对照组治疗前(27.92±2.51)分,治疗12个月后(9.09±2.15)分。两组JOA、ODI治疗12个月后均优于治疗前,且治疗12个月后益气活血汤组均优于对照组,差异有统计学意义(P<0.05)。MRI影像上突出体积、突出率两组比较,益气活血方组均优于对照组,差异有统计学意义(P<0.05),益气活血方组有56.96%(45/79)的患者出现重吸收,明显高于对照组37.66%(29/77)。结论:破裂型LDH患者经过益气活血方治疗后,临床症状显著改善、突出椎间盘体积明显减小。随访期间,患者未出现明显的药物不良反应,且在末次随访时未见症状复发,表明疗效安全可靠。
Objective To observe the clinical symptoms and MRI outcomes of patients with ruptured lumbar disc herniation(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 formula 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 differences(P<0.05).Reabsorption occurred in 56.96%(45/79)of patients in the Yiqi Huoxue formula group,which was significantly 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.
作者
朱宇
王志强
林顺
姚莹莹
沈学强
李晓春
俞峰
熊晓扬
宋奕
陈梦菲
俞鹏飞
姜宏
刘锦涛
ZHU Yu;WANG Zhi-qiang;LIN Shun;YAO Ying-ying;SHEN Xue-qiang;LI Xiao-chun;YU Feng;XIONG Xiao-yang;SONG Yi;CHEN Meng-fei;YU Peng-fei;JIANG Hong;LIU Jin-tao(Suzhou Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine,Suzhou 215009,Jiangsu,China;Kunshan Hospital of Traditional Chinese Medicine,Suzhou 215313,Jiangsu,China;Suzhou Hospital of Integrated Traditional Chinese and Western Medicine,Suzhou 215101,Jiangsu,China;Suzhou Municipal Hospital,Suzhou 215006,Jiangsu,China)
出处
《中国骨伤》
2025年第11期1112-1118,共7页
China Journal of Orthopaedics and Traumatology
基金
国家自然科学基金项目(编号:82474529)
江苏省自然科学基金项目(编号:BK20241802)
江苏省中医药科技发展计划项目(编号:MS2022080)
苏州市卫健委项目(编号:KJXW2023047)。
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
Ruptured lumbar disc herniation
Yiqi Huoxue formula(益气活血方)
Celecoxib
Mecobalamin
Resorption
Traditional Chinese medicine therapy
