高频超声对断藤益母汤联合甲氨喋呤治疗类风湿性关节炎的疗效评估
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摘要
【目的】观察断藤益母汤联合甲氨喋呤治疗类风湿性关节炎(RA)的疗效,并探讨高频超声对其疗效的评估作用。【方法】将60例RA患者随机分为试验组和对照组,每组各30例。对照组给予甲氨喋呤片治疗,试验组给予断藤益母汤联合甲氨喋呤片治疗,疗程3个月。观察2组患者治疗前后症状和体征评分(包括压痛关节数、肿胀关节数、晨僵时间、患者总体评价和医生总体评价)、28处关节疾病活动度评分(DAS28)及相关实验室指标[包括C-反应蛋白(CRP)、红细胞沉降率(ESR)、类风湿因子(RF)等]的变化情况,同时应用高频超声对RA患者双手腕关节进行检查[包括滑膜厚度、关节腔积液、滑膜内血流信号、血管阻力指数(RI)],并评价2组疗效和安全性。【结果】(1)退出情况:试验组有1例退出,对照组有3例退出,最终有56例(试验组29例、对照组27例)患者完成了1个疗程的治疗。(2)治疗3个月后,试验组和对照组的总有效率分别为96.6%和77.8%,试验组疗效明显优于对照组(P <0.05)。(3)治疗后,2组患者的肿胀关节数、压痛关节数均较治疗前明显减少,晨僵时间均较治疗前明显缩短,患者总体评分和医生总体评分[视觉模拟评分(VAS)]均较治疗前明显下降(P <0.05),且试验组对各项症状和体征的改善作用均优于对照组(P <0.05)。(4)治疗后,2组患者病情活动度DAS28积分均较治疗前下降(P <0.05),且试验组对DAS28积分的降低作用明显优于对照组(P <0. 05)。(5)治疗后,2组患者CRP、ESR及RF水平均较治疗前明显下降(P<0.05),且试验组在降低CRP、ESR水平方面均明显优于对照组(P<0.05)。(6)治疗后,2组患者的滑膜厚度、关节腔积液均较治疗前减少(P <0.05),RI均较治疗前提高(P <0.05),且试验组对RI的提高作用明显优于对照组(P <0.05)。(7)治疗期间,2组患者的血尿常规、心电图及肝肾功能均未见明显异常。【结论】断藤益母汤联合甲氨喋呤治疗RA疗效显著,其疗效优于单用西药甲氨喋呤;高频超声具有无创性、无辐射、实时动态监测、操作简单易行等优点,可动态观察患者手关节的病变情况,同时从客观影像学角度证实了断藤益母汤的临床疗效。
Objective To observe the clinical efficacy of Duanteng Yimu Decoction combined with Methotrexate for the treatment of rheumatoid arthritis(RA),and to explore the efficiency of high frequency ultrasound imaging for the efficacy evaluation. Methods Sixty RA patients were randomized into trial group and control group,30 cases in each group. The control group was treated with Methotrexate orally,and the trial group was orally treated with Duanteng Yimu Decoction combined with Methotrexate, the course of treatment for the two groups lasting 3 months. Before and after treatment, we observed the clinical manifestations indexes(the number of joints with tenderness,the number of swelling joints,time for morning stiffness,the scores of overall patients' evaluation,and the scores of overall doctors' evaluation), Disease Activity Score of 28 joints(DAS28)and laboratory indicators such as C-reactive protein(CRP),erythrocyte sedimentation rate(ESR)and rheumatoid factor(RF).High frequency ultrasound imaging for the bilateral wrists was performed,and the observation indicators included synovial thickness,effusion in the articular cavity, synovial blood flow signal and vascular resistance index(RI)were detected. Results(1)One case from the trial group and 3 cases from the control group dropped out during the trial,and finally a total of 56 cases(29 in the trial group and 27 in the control group)completed the treatment for3 months.(2)After treatment for 3 months,the total effective rate of the trial group was 96.6% and was superior to that of the control group(77.8%),the difference being significant(P < 0.05).(3)After treatment,the number of joints with tenderness and the number of swelling joints in the two groups were reduced, the time for morning stiffness was shortened, and Visual Analogue Scale(VAS)scores of overall patients' evaluation and overall doctors' evaluation were decreased(P < 0.05 compared with those before treatment),and the improvement of the above indexes in the trial group was superior to that in the control group(P<0.05).(4)After treatment,DAS28 scores in the two groups were decreased(P < 0.05 compared with those before treatment),and the decrease in the trial group was superior to that in the control group(P < 0.05).(5)After treatment,CRP,ESR and RF levels in the two groups were decreased(P < 0.05 compared with those before treatment),and the decrease of CRP and ESR in the trial group was superior to that in the control group(P < 0.05).(6)After treatment,the synovial thickness and joint effusion in the two groups were alleviated and vascular RI was increased(P < 0.05 compared with those before treatment),and the effect on RI in the trial group were superior to that in the control group(P <0.05).(7) During the trial,blood and stool routine examination,electrocardiogram and hepato-renal function had no abnormal changes. Conclusion Duanteng Yimu Decoction combined with Methotrexate is more effective for the treatment of RA than Methotrexate alone. High frequency ultrasound imaging is non-invasive, nonradioactivity,and easy to check. It can be used to dynamically observe the lesions of hand joints,and can confirm the clinical efficacy of Duanteng Yimu Decoction by objective imaging.
Objective To observe the clinical efficacy of Duanteng Yimu Decoction combined with Methotrexate for the treatment of rheumatoid arthritis(RA),and to explore the efficiency of high frequency ultrasound imaging for the efficacy evaluation. Methods Sixty RA patients were randomized into trial group and control group,30 cases in each group. The control group was treated with Methotrexate orally,and the trial group was orally treated with Duanteng Yimu Decoction combined with Methotrexate, the course of treatment for the two groups lasting 3 months. Before and after treatment, we observed the clinical manifestations indexes(the number of joints with tenderness,the number of swelling joints,time for morning stiffness,the scores of overall patients' evaluation,and the scores of overall doctors' evaluation), Disease Activity Score of 28 joints(DAS28)and laboratory indicators such as C-reactive protein(CRP),erythrocyte sedimentation rate(ESR)and rheumatoid factor(RF).High frequency ultrasound imaging for the bilateral wrists was performed,and the observation indicators included synovial thickness,effusion in the articular cavity, synovial blood flow signal and vascular resistance index(RI)were detected. Results(1)One case from the trial group and 3 cases from the control group dropped out during the trial,and finally a total of 56 cases(29 in the trial group and 27 in the control group)completed the treatment for3 months.(2)After treatment for 3 months,the total effective rate of the trial group was 96.6% and was superior to that of the control group(77.8%),the difference being significant(P < 0.05).(3)After treatment,the number of joints with tenderness and the number of swelling joints in the two groups were reduced, the time for morning stiffness was shortened, and Visual Analogue Scale(VAS)scores of overall patients' evaluation and overall doctors' evaluation were decreased(P < 0.05 compared with those before treatment),and the improvement of the above indexes in the trial group was superior to that in the control group(P<0.05).(4)After treatment,DAS28 scores in the two groups were decreased(P < 0.05 compared with those before treatment),and the decrease in the trial group was superior to that in the control group(P < 0.05).(5)After treatment,CRP,ESR and RF levels in the two groups were decreased(P < 0.05 compared with those before treatment),and the decrease of CRP and ESR in the trial group was superior to that in the control group(P < 0.05).(6)After treatment,the synovial thickness and joint effusion in the two groups were alleviated and vascular RI was increased(P < 0.05 compared with those before treatment),and the effect on RI in the trial group were superior to that in the control group(P <0.05).(7) During the trial,blood and stool routine examination,electrocardiogram and hepato-renal function had no abnormal changes. Conclusion Duanteng Yimu Decoction combined with Methotrexate is more effective for the treatment of RA than Methotrexate alone. High frequency ultrasound imaging is non-invasive, nonradioactivity,and easy to check. It can be used to dynamically observe the lesions of hand joints,and can confirm the clinical efficacy of Duanteng Yimu Decoction by objective imaging.
引文
[1]葛均波,徐永健.内科学[M].8版.北京:人民卫生出版社,2013:808.
[2]林昌松,梁江,刘风震,等.断藤益母汤治疗类风湿关节炎的临床疗效观察[J].广州中医药大学学报,2012,29(6):632.
[3]Aletaha D,Neogi T,Silman A J,et al.2010 rheumatoid arthritis classification criteria:an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative[J].Arthritis Rheum,2010,62(9):2569.
[4]中国超声医学工程学会肌肉骨骼系统超声专业委员会.肌肉骨骼超声检查及报告规范[J].中华医学超声杂志(电子版),2015,12(1):11.
[5]Wahher M,Harms H,Krenn V,et al.Synovial tissue of the hip at power Doppler US:correlation between vascularity and power Doppler US signal[J].Radiology,2002,225(1):225.
[6]Lagnoeco A,Epis O,Delle-sedie A,et al.Ultrasound imaging for the rheumatologist XⅦ:role of color Doppler and power Doppler[J].Clin Exp Rheumatol,2008,26(5):759.
[7]中华人民共和国卫生部.中药新药临床研究指导原则[M].北京:人民卫生出版社,1993:349.
[8]Moreland L W.Potential biologic agents for treating rheumatoid arthritis[J].Rheum Dis Clin North Am,2001,27(2):445.
[9]潘东梅,王强,蔡叙东,等.断藤益母汤抑制PI3K/AKT通路诱导类风湿关节炎成纤维样滑膜细胞凋亡[J].中华中医药杂志,2018,33(5):2051.
[10]李振坚.断藤益母汤对比常规用药对类风湿关节炎患者血沉、C-反应蛋白及类风湿因子影响的研究[J].四川中医,2017,35(5):131.
[11]梁江,林昌松,林云斌.断藤益母汤含药血清对类风湿关节炎滑膜成纤维细胞增殖及TNF-α分泌的影响[J].风湿病与关节炎,2013,2(6):17.
[12]Van de Stadt L A,Bos W H,Meursinge-Reynders M,et al.The value of ultrasonography in predicting arthritis in autoantibody positive arthralgia patients:a prospective cohort study[J].Arthritis Res Ther,2010,12(3):98.
[13]Xu H,Zhang Y,Zhang H,et al.Comparison of the clinical effectiveness of US grading scoring system vs MRI in the diagnosis of early rheumatoid arthritis(RA)[J].Orthop Surg Res,2017,12(1):152.
[14]周凌,陈凌,宋婧,等.关节超声评分在类风湿性关节炎评价中的应用价值研究[J].中华航海医学与高气压医学杂志,2016,23(2):125.
[15]董霞,孙巍,刘鹏,等.高频超声与X线检查在类风湿关节炎早期诊断中的对照分析[J].中国实用医药,2013,8(3):25.
[16]于静,聂宏娟,王泽,等.超声对类风湿关节炎动物模型早期诊断价值的研究[J].中国药物与临床,2014,8(14):1056.
[17]杨银广,杨仁东,陈丽珍,等.高频彩超在类风湿性关节炎腕关节病变诊断和治疗中的应用[J].中国医药导报,2015,12(6):107.
[2]林昌松,梁江,刘风震,等.断藤益母汤治疗类风湿关节炎的临床疗效观察[J].广州中医药大学学报,2012,29(6):632.
[3]Aletaha D,Neogi T,Silman A J,et al.2010 rheumatoid arthritis classification criteria:an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative[J].Arthritis Rheum,2010,62(9):2569.
[4]中国超声医学工程学会肌肉骨骼系统超声专业委员会.肌肉骨骼超声检查及报告规范[J].中华医学超声杂志(电子版),2015,12(1):11.
[5]Wahher M,Harms H,Krenn V,et al.Synovial tissue of the hip at power Doppler US:correlation between vascularity and power Doppler US signal[J].Radiology,2002,225(1):225.
[6]Lagnoeco A,Epis O,Delle-sedie A,et al.Ultrasound imaging for the rheumatologist XⅦ:role of color Doppler and power Doppler[J].Clin Exp Rheumatol,2008,26(5):759.
[7]中华人民共和国卫生部.中药新药临床研究指导原则[M].北京:人民卫生出版社,1993:349.
[8]Moreland L W.Potential biologic agents for treating rheumatoid arthritis[J].Rheum Dis Clin North Am,2001,27(2):445.
[9]潘东梅,王强,蔡叙东,等.断藤益母汤抑制PI3K/AKT通路诱导类风湿关节炎成纤维样滑膜细胞凋亡[J].中华中医药杂志,2018,33(5):2051.
[10]李振坚.断藤益母汤对比常规用药对类风湿关节炎患者血沉、C-反应蛋白及类风湿因子影响的研究[J].四川中医,2017,35(5):131.
[11]梁江,林昌松,林云斌.断藤益母汤含药血清对类风湿关节炎滑膜成纤维细胞增殖及TNF-α分泌的影响[J].风湿病与关节炎,2013,2(6):17.
[12]Van de Stadt L A,Bos W H,Meursinge-Reynders M,et al.The value of ultrasonography in predicting arthritis in autoantibody positive arthralgia patients:a prospective cohort study[J].Arthritis Res Ther,2010,12(3):98.
[13]Xu H,Zhang Y,Zhang H,et al.Comparison of the clinical effectiveness of US grading scoring system vs MRI in the diagnosis of early rheumatoid arthritis(RA)[J].Orthop Surg Res,2017,12(1):152.
[14]周凌,陈凌,宋婧,等.关节超声评分在类风湿性关节炎评价中的应用价值研究[J].中华航海医学与高气压医学杂志,2016,23(2):125.
[15]董霞,孙巍,刘鹏,等.高频超声与X线检查在类风湿关节炎早期诊断中的对照分析[J].中国实用医药,2013,8(3):25.
[16]于静,聂宏娟,王泽,等.超声对类风湿关节炎动物模型早期诊断价值的研究[J].中国药物与临床,2014,8(14):1056.
[17]杨银广,杨仁东,陈丽珍,等.高频彩超在类风湿性关节炎腕关节病变诊断和治疗中的应用[J].中国医药导报,2015,12(6):107.