CAJ | 학술논문

目的：评价中药益气化瘀补肾法治疗腰椎间盘突出症的临床疗效及安全性。方法：采用随机对照试验研究方法，评价益气化瘀补肾法治疗腰椎间盘突出症的临床疗效。122例腰椎间盘突出症患者随机分为治疗组（61例）和对照组（61例），治疗组给予中药益气化瘀补肾法治疗，对照组口服西乐葆合甲钴胺。记录并统计分析患者治疗前、治疗后第4周、随访第12周的VAS评分、JOA评分、Os-westry功能障碍指数问卷评价临床疗效；同时观察并记录患者的不良反应，评价综合治疗的安全性。结果：①治疗前，治疗组和对照组基线资料无显著性差异，具有可比性。于与治疗前相比，治疗4周结束后，2组患者的VAS评分、ODI评分均明显降低，JOA评分明显升高（P<0.05），2组间ODI、JOA评分差异无统计学意义，治疗组VAS评分明显高于对照组（P<0.05）；③第12周随访时，2组患者的VAS评分、ODI评分、JOA评分呈上升趋势，2组间差异无统计学意义；2组患者的总体有效率差异无统计学意义。榆治疗组有4例手术、4例失访，4例轻度不良反应；对照组有6例手术、3例失访，2例出现轻度不良反应。结论：益气化瘀补肾法治疗腰椎间盘突出症随机对照试验表明，其临床疗效和西乐葆合甲钴胺临床疗效相当；能有效减轻腰椎间盘突出症患者的疼痛程度，改善患者的腰椎功能，提高患者的日常生活和社会活动能力，短期随访疗效确定，长期疗效有待进一步研究。
목적：평개중약익기화어보신법치료요추간반돌출증적림상료효급안전성。방법：채용수궤대조시험연구방법，평개익기화어보신법치료요추간반돌출증적림상료효。122례요추간반돌출증환자수궤분위치료조（61례）화대조조（61례），치료조급여중약익기화어보신법치료，대조조구복서악보합갑고알。기록병통계분석환자치료전、치료후제4주、수방제12주적VAS평분、JOA평분、Os-westry공능장애지수문권평개림상료효；동시관찰병기록환자적불량반응，평개종합치료적안전성。결과：①치료전，치료조화대조조기선자료무현저성차이，구유가비성。우여치료전상비，치료4주결속후，2조환자적VAS평분、ODI평분균명현강저，JOA평분명현승고（P<0.05），2조간ODI、JOA평분차이무통계학의의，치료조VAS평분명현고우대조조（P<0.05）；③제12주수방시，2조환자적VAS평분、ODI평분、JOA평분정상승추세，2조간차이무통계학의의；2조환자적총체유효솔차이무통계학의의。유치료조유4례수술、4례실방，4례경도불량반응；대조조유6례수술、3례실방，2례출현경도불량반응。결론：익기화어보신법치료요추간반돌출증수궤대조시험표명，기림상료효화서악보합갑고알림상료효상당；능유효감경요추간반돌출증환자적동통정도，개선환자적요추공능，제고환자적일상생활화사회활동능력，단기수방료효학정，장기료효유대진일보연구。
This study was aimed to evaluate the clinical effect and safety of Chinese medicine treatment of lumbar disc herniation with qi-tonifying, stasis-resolving and kidney-tonifying method. The randomized con-trolled trial (RCT) was applied in the study to evaluate the clinical effect of qi-tonifying, stasis-resolving and kidney-tonifying method in the treatment of lumbar disc herniation . A total of 122 lumbar disc herniation pa-tients were randomly divided into the treatment group ( n = 61 ) and the control group ( n = 61 ) . Chinese medicine treatment with the qi-tonifying, stasis-resolving and kidney-tonifying method was applied in the treatment group . And Celecoxib and Methycobal were orally administered in the control group . Then , the VAS scores, JOA scores, Oswestry disability index (ODI) were recorded and analyzed pre-treatment, four weeks af-ter treatment and the twelfth week of follow-up in order to evaluate the clinical effect . Adverse reactions were also observed and recorded at the same time to give a comprehensive evaluation on its safety . The results showed that there were no significant differences between the treatment group and control group in the baseline data before treatment . Hence , data from two groups were comparable . Compared with pre-treatment , the VAS scores and ODI scores were obviously reduced in both groups after four-week treatment . The JOA scores were increased obviously ( P < 0 . 05 ) . There were no statistical differences on ODI scores and JOA scores between two groups . The VAS scores of the treatment group were obviously higher than the control group ( P < 0 . 05 ) . In the twelfth week of follow-up , the VAS scores , ODI scores and JOA scores had increasing tendency in <br> both groups . There were no statistical differences between two groups . There were no statistical differences on the total effective rate between two groups . In the treatment group , four patients received surgery , four cases lost to follow-up , and four cases with mild adverse event . In the control group , six patients received surgery , three cases lost to follow-up , and two cases with mild adverse event . It was concluded that the RCT of Chi-nese medicine treatment of lumbar disc herniation with q i-tonifying , stasis-resolving and kidney-tonifying method received same clinical effect as the combination of Celecoxib and Methycobal . The Chinese medicine treatment can effectively relieve pain degree of lumbar disc herniation , improve function of the lumbar vertebrae and improve the daily life and social activity ability of patients. The short-term follow-up effects were con-firmed . However , the long-term efficacy still requires further study .