中药辨证论治结合骶管封闭术治疗腰椎间盘突出症的多中心随机对照临床研究

Multicenter randomized controlled clinical study on treatment of lumbar disc herniation with traditional Chinese herbal medicine syndrome differentiation combined with sacral canal block

目的观察中药辨证论治("益气化瘀补肾法"中药辨证内服外敷)结合骶管封闭术治疗腰椎间盘突出症的临床疗效。方法将5个分中心收集的430例病例随机分为治疗组和对照组,每组215例。治疗组采用"益气化瘀补肾法"中药辨证内服外敷结合骶管封闭术,对照组采用常规西药治疗。两组疗程均为2周,随访4周,观察用药安全性,比较局部疼痛视觉模拟评分(VAS)、日本骨科学会(JOA)腰椎治疗评分以及Oswestry功能障碍指数(ODI)问卷评分的变化情况。结果(1)试验期间,治疗组脱落5例,对照组脱落5例;最终完成试验者420例,其中治疗组210例,对照组210例。(2)治疗后各时间点与治疗前组内比较,两组局部疼痛VAS评分差异均有统计学意义(P<0.05),且其评分逐渐降低;组间局部疼痛VAS评分在治疗1周、治疗2周时比较,治疗组均低于对照组,差异有统计学意义(P<0.05);组间局部疼痛VAS评分在随访4周时比较,差异无统计学意义(P>0.05),且非劣效检验合格。(3)治疗后各时间点与治疗前组内比较,两组JOA腰椎治疗评分差异均有统计学意义(P<0.05),且其评分逐渐升高;组间JOA腰椎治疗评分在治疗1周、治疗2周时比较,治疗组均低于对照组,差异有统计学意义(P<0.05);组间JOA腰椎治疗评分在随访4周时比较,差异无统计学意义(P>0.05),且非劣效检验合格。(4)治疗后各时间点与治疗前组内比较,两组ODI问卷评分差异均有统计学意义(P<0.05),且其评分逐渐降低;组间ODI问卷评分在治疗2周时比较,治疗组低于对照组,差异有统计学意义(P<0.05);组间ODI问卷评分在随访4周时比较,差异无统计学意义(P>0.05)。(5)两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论相比常规西药治疗,"益气化瘀补肾法"中药辨证内服外敷结合骶管封闭术具有早期疗效优势,可更快地减轻患者疼痛症状及缓解腰椎功能障碍;而在随访期(中期)疗效方面,治疗组也不劣于对照组。

Objective To evaluate the clinical effect of traditional Chinese herbal medicine(TCHM)treatment based on syndrome differentiation(oral administration and external application of TCHM based on syndrome differentiation with"Yiqi Huayu Bushen method")combined with sacral canal block on lumbar disc herniation.Methods A total of 430 cases collected from 5 sub-centers were randomly divided into treatment group(n=215)and control group(n=215).The treatment group was given oral administration and external application of TCHM based on syndrome differentiation with"Yiqi Huayu Bushen method"combined with sacral canal block technique,while the control group was administered with conventional western medicine treatment.The course of treatment lasted 2 weeks,and each case was followed up for 4 weeks to observe the safety of medication,and compare the changes of local pain visual analogue scale(VAS)score,Japanese Orthopedic Society(JOA)lumbar score and Oswestry dysfunction index(ODI)score before and after treatment.Results(1)During the trial,there were 5 drop-out cases in the treatment group and 5 drop-out cases in the control group.Finally,420 cases completed the trial,including 210 cases in the treatment group and 210 cases in the control group.(2)According to the intra-group comparisons before treatment and at different time points after treatment,the differences in the VAS scores of local pain were statistically significant in both groups(P<0.05),and the VAS scores gradually decreased at different time points after treatment.The VAS score of local pain in the treatment group was lower than that in the control group after 1 week and 2 weeks of treatment respectively,and the differences were statistically significant(P<0.05).There was no significant difference in VAS score of local pain between groups at 4 weeks of follow-ups(P>0.05),and the non-inferiority test was qualified.(3)According to the intra-group comparisons before treatment and at different time points after treatment,the differences in the JOA lumbar scores were statistically significant in both groups(P<0.05),and the JOA lumbar scores gradually increased at different time points after treatment.The JOA lumbar score in the treatment group was lower than that in the control group after 1 week and 2 weeks of treatment,and the differences were statistically significant(P<0.05).There was no significant difference in JOA lumbar score between groups at 4 weeks of follow-ups(P>0.05),and the non-inferiority test was qualified.(4)According to the intra-group comparisons before treatment and at different time points after treatment,the differences in the ODI scores were statistically significant in both groups(P<0.05),and the ODI scores gradually decreased at different time points after treatment.The ODI scores in the treatment group were lower than those in the control group after 2 weeks of treatment,and the difference was statistically significant(P<0.05).There was no significant difference in ODI scores between groups at 4 weeks of follow-ups(P>0.05).(5)There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Compared with conventional western medicine treatment,oral administration and external application of TCHM based on syndrome differentiation with"Yiqi Huayu Bushen method"combined with sacral canal block technique has the advantage of early therapeutic effect,which can relieve pain symptoms and lumbar dysfunction of patients more quickly.In the follow-up period(mid-term),the therapeutic effect of treatment group is not inferior to that of the control group.