舒筋合剂联合西药治疗肝肾阴虚型类风湿关节炎66例
|
摘要
目的:观察舒筋合剂联合西药治疗肝肾阴虚型类风湿关节炎(RA)的临床疗效及安全性。方法:将符合观察标准的132例患者随机分为治疗组和对照组,每组各66例。两组均予甲氨喋呤与来氟米特,治疗组同时加舒筋合剂,疗程均为12周。观察患者症状体征、中医证候、血沉(ESR)、C反应蛋白(CRP)以及28个关节活动评分(DAS 28)反应情况,并评价其安全性。结果:(1)治疗组与对照组的总有效率分别为60.34%、45.00%,差异无统计学意义(P>0.05);中医证候疗效分别为86.21%和70.00%,差异有统计学意义(P<0.05)。(2)两组晨僵持续时间、肿胀关节数、压痛关节数、整体状况评估、ESR、CRP等指标的改善情况相当(P>0.05),但治疗组的DAS 28评分的改善情况却优于对照组(P<0.05);治疗组的中医证候积分在治疗8周后、12周后的改善情况均优于对照组(P<0.05),其中医次症(口渴、乏力、大便干)的改善情况亦优于对照组(P<0.05或P<0.01)。(3)两组不良反应发生率分别为9.1%和7.6%,差异无统计学意义(P>0.05)。结论:舒筋合剂联合西药治疗肝肾阴虚型RA的短期疗效虽不优于单用西药,但能有效改善部分肝肾阴虚证候、降低疾病活动度,且安全性较好。
Objective: To observe the clinical efficacy and safety of Shujin Mixture combined with western medicine in the treatment of rheumatoid arthritis( RA) with syndrome of yin deficiency of liver and kidney. Methods: 132 patients who met the observation criteria were randomly into the treatment group and control group,66 cases in each group. Both groups were treated with methotrexate and leflunomide,meanwhile the treatment group was additionally treated with Shujin Mixture,with a course of 12 weeks. The symptoms and signs,Chinese medical syndromes,erythrocyte sedimentation rate( ESR),C-reactive protein( CRP) and DAS 28 scores were observed,and the safety was evaluated.Results:(1)The total effective rates were 60.34% in the treatment group and 45.00% in the control group,with no statistically significant difference( P>0.05).The total effective rates of Chinese medical syndromes were 86.21% in the treatment group and 70.00% in the control group,with statistically significant difference( P< 0.05).(2)There were no significant differences on the duration of morning stiffness,swollen joints and tenderness joints counts,overall status score,ESR and CRP between the two groups after treatment( P>0.05),but the improvement on DAS 28 scores in the treatment group was better than that in the control group( P<0.05). After treatment for 8 and 12 weeks,the improvement on Chinese medical syndromes score in the treatment group was better than that in the control group( P<0.05),and the improvement on Chinese medical secondary symptoms( thirst,fatigue and dry stool) was also better than that in the control group( P<0.05 or P<0.01).(3)The incidence rates of adverse reaction were 9.1% in the treatment group and 7.6% in the control group,with no statistically significant difference( P>0.05). Conclusion: Although the short-term efficacy of"Shujin Mixture"combined with western medicine in the treatment of RA with syndrome of yin deficiency of liver and kidney was not better than that of western medicine alone,it can effectively improve part syndrome of yin deficiency of liver and kidney and reduce disease activity with good safety.
Objective: To observe the clinical efficacy and safety of Shujin Mixture combined with western medicine in the treatment of rheumatoid arthritis( RA) with syndrome of yin deficiency of liver and kidney. Methods: 132 patients who met the observation criteria were randomly into the treatment group and control group,66 cases in each group. Both groups were treated with methotrexate and leflunomide,meanwhile the treatment group was additionally treated with Shujin Mixture,with a course of 12 weeks. The symptoms and signs,Chinese medical syndromes,erythrocyte sedimentation rate( ESR),C-reactive protein( CRP) and DAS 28 scores were observed,and the safety was evaluated.Results:(1)The total effective rates were 60.34% in the treatment group and 45.00% in the control group,with no statistically significant difference( P>0.05).The total effective rates of Chinese medical syndromes were 86.21% in the treatment group and 70.00% in the control group,with statistically significant difference( P< 0.05).(2)There were no significant differences on the duration of morning stiffness,swollen joints and tenderness joints counts,overall status score,ESR and CRP between the two groups after treatment( P>0.05),but the improvement on DAS 28 scores in the treatment group was better than that in the control group( P<0.05). After treatment for 8 and 12 weeks,the improvement on Chinese medical syndromes score in the treatment group was better than that in the control group( P<0.05),and the improvement on Chinese medical secondary symptoms( thirst,fatigue and dry stool) was also better than that in the control group( P<0.05 or P<0.01).(3)The incidence rates of adverse reaction were 9.1% in the treatment group and 7.6% in the control group,with no statistically significant difference( P>0.05). Conclusion: Although the short-term efficacy of"Shujin Mixture"combined with western medicine in the treatment of RA with syndrome of yin deficiency of liver and kidney was not better than that of western medicine alone,it can effectively improve part syndrome of yin deficiency of liver and kidney and reduce disease activity with good safety.
引文
[1]栗占国.兼收并蓄博采众长——解读2016年EULAR类风湿关节炎治疗建议[J].中华医学信息导报,2016,31(19):13.
[2]SMOLEN J S,LANDEWE R,BREEDVELD F C.et al.EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease modifying antirheumatic drugs:2013update[J].Ann Rheum Dis,2014,73(3):492-509.
[3]李振彬.类风湿关节炎的现代治疗策略与方法[J].临床荟萃,2016,31(5):486-489.
[4]SMOLEN J S,ALETAHA D.Rheumatoid arthritis therapy reappraisal:strategies,opportunities and challenges[J].Nat Rev Rheum,2015,11(5):276-289.
[5]ARNETT F C,EDWORTHY S M,BLOCH D A,et al.The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis[J].Arthritis Rheum,1988,31(3):315-324.
[6]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:115-118.
[7]ALETAHA D,WARD M M,MACHOLD K P,et al.Remission and active disease in rheumatnid arthritis:defining criteria for diseaseactivity states[J].Arthritis Rheum,2005,52(9):2625-2636.
[8]姜泉,蒋红,曹炜,焦娟.475例类风湿关节炎患者中医临床证候分析[J].中医杂志,2007,48(3):253-255.
[9]候雷,马武开.类风湿关节炎中医证候分类临床文献研究[J].中国中西医结合杂志,2014,34(3):279-283.
[10]王英旭,周晓莉,崔丽,等.活动期类风湿关节炎中医证候分布研究[J].中医临床研究,2014,10(6):1-3.
[2]SMOLEN J S,LANDEWE R,BREEDVELD F C.et al.EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease modifying antirheumatic drugs:2013update[J].Ann Rheum Dis,2014,73(3):492-509.
[3]李振彬.类风湿关节炎的现代治疗策略与方法[J].临床荟萃,2016,31(5):486-489.
[4]SMOLEN J S,ALETAHA D.Rheumatoid arthritis therapy reappraisal:strategies,opportunities and challenges[J].Nat Rev Rheum,2015,11(5):276-289.
[5]ARNETT F C,EDWORTHY S M,BLOCH D A,et al.The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis[J].Arthritis Rheum,1988,31(3):315-324.
[6]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:115-118.
[7]ALETAHA D,WARD M M,MACHOLD K P,et al.Remission and active disease in rheumatnid arthritis:defining criteria for diseaseactivity states[J].Arthritis Rheum,2005,52(9):2625-2636.
[8]姜泉,蒋红,曹炜,焦娟.475例类风湿关节炎患者中医临床证候分析[J].中医杂志,2007,48(3):253-255.
[9]候雷,马武开.类风湿关节炎中医证候分类临床文献研究[J].中国中西医结合杂志,2014,34(3):279-283.
[10]王英旭,周晓莉,崔丽,等.活动期类风湿关节炎中医证候分布研究[J].中医临床研究,2014,10(6):1-3.