化瘀强肾通痹方联合甲氨蝶呤治疗类风湿关节炎的临床观察
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摘要
目的评价化瘀强肾通痹方联合甲氨蝶呤(MTX)治疗类风湿关节炎(RA)的疗效及安全性。方法 77例RA患者,根据治疗方案不同分为观察组[39例,采用MTX联合化瘀强肾通痹方治疗]和对照组[38例,采用MTX联合来氟米特(LEF)治疗]。比较两组治疗前、治疗后4、12周28个关节压痛数(TJC)、关节肿胀数(SJC)、晨僵持续时间、休息痛VAS评分、医生评估/总体情况VAS评分、患者评估/总体情况VAS评分、生活质量评价(HAQ评分)、超敏C-反应蛋白(hs-CRP)、血沉(ESR)、类风湿因子(RF)、疾病活动指数(DAS28-CRP)、ACR 20/50/70达标率等变化,评估疗效和安全性。结果 (1)治疗后4周,观察组ACR 20/50/70达标率分别为30.8%、17.9%、0,对照组ACR 20/50/70达标率分别为23.1%、10.5%、0;治疗后12周,观察组ACR 20/50/70达标率分别为59.0%、33.3%、12.8%,对照组ACR 20/50/70达标率分别为55.3%、34.2%、18.42%,两组比较,差异均无统计学意义(P>0.05);(2)与本组治疗前比较,两组治疗后TJC、SJC、晨僵时间、休息痛VAS评分、医生评估/总体情况VAS评分、患者评估/总体情况VAS评分、HAQ、hs-CRP、ESR、RF、DAS28-CRP均下降,差异有统计学意义(P<0.05,P<0.01);两组治疗后TJC、晨僵时间、休息痛VAS评分、医生自评/总体情况VAS评分、患者自评/总体情况VAS评分、HAQ、hs-CRP、ESR、RF、DAS28-CRP评分比较,差异均无统计学意义(P>0.05)。因两组治疗前SJC比较,差异有统计学意义(P<0.05),治疗后采用协方差分析进行组间SJC比较,结果提示差异无统计学意义(P>0.05)。治疗12周,不良反应发生观察组为3例,对照组为11例,观察组不良事件发生率明显低于对照组(P<0.05)。结论治疗后12周,化瘀强肾通痹方联合MTX(10～15 mg/w)的中西医结合方案与LEF(10～20 mg/d)联合MTX(10～15 mg/w)的常规西药方案疗效相当,并具有更好的安全性。
Objective To evaluate the clinical efficacy and safety of Huayu Qiangshen Tongbi Recipe(HQTR) combined with methotrexate(MTX) in treating rheumatoid arthritis(RA). MethodsAccording to different therapeutic programs, 77 RA patients were assigned to the experimental group(39 cases) and the control group(38 cases). Patients of the experimental group took MTX and HQTR, while those in the control group took MTX and leflunomide(LEF). Tender joint count(TJC), swollen joint count(SJC), morning stiffness, patient's assessment of pain, physician's assessment of disease activity, patient's assessment of disease activity, HAQ, hypersensitive C-reactive protein(hs-CRP), erythrocyte sedimentation rate(ESR), rheumatoid factors(RF), disease activity score in 28 joints(DAS28),hs-CRP, ACR 20/50/70 response rates were compared between the two groups before treatment, at week 4 and 12 after treatment. The efficacy and safety were assessed. Results(1)After 4-week treatment the ACR 20/50/70 response rates were respectively 30.8%, 17.9%, 0 in the experimental group, and they were respectively 23.1%, 10.5%, 0 in the control group; but there was no statistical difference between the two groups(P>0.05). After 12-week treatment the ACR 20/50/70 response rates were respectively 59.0%, 33.3%, 12.8% in the experimental group, and 55.3%, 34.2%, 18.42%, respectively in the control group, but with no statistical difference between the two groups(P>0.05).(2)TJC, SJC, morning stiffness, patient's assessment of pain, physician's assessment of disease activity, patient's assessment of disease activity, HAQ, hs-CRP, ESR, RF, and DAS28-CRP all decreased after treatment, with statistical difference as compared with before treatment in the same group(P<0.05, P<0.01). But there was no statistical difference in post-treatment TJC, morning stiffness, patient's assessment of pain, physician's assessment of disease activity, patient's assessment of disease activity, HAQ, hs-CRP, ESR, RF, or DAS28-CRP between the two groups(P>0.05). Pre-treatment SJC was significantly different between two groups(P<0.05), but there was no statistical difference in SJC analyzed by covariance analysis after treatment(P>0.05). After 12-week treatment adverse reactions occurred in 3 cases of the experimental group and 11 cases in the control group. The occurrence rate of adverse reactions was obviously lower in the experimental group than in the control group(P<0.05). Conclusion The efficacy of HQTR combined MTX(10-15 mg/week) at 12 weeks of treatment was equivalent to that of LEF(10-20 mg per day)combined MTX(10-15 mg/week) with better safety.
Objective To evaluate the clinical efficacy and safety of Huayu Qiangshen Tongbi Recipe(HQTR) combined with methotrexate(MTX) in treating rheumatoid arthritis(RA). MethodsAccording to different therapeutic programs, 77 RA patients were assigned to the experimental group(39 cases) and the control group(38 cases). Patients of the experimental group took MTX and HQTR, while those in the control group took MTX and leflunomide(LEF). Tender joint count(TJC), swollen joint count(SJC), morning stiffness, patient's assessment of pain, physician's assessment of disease activity, patient's assessment of disease activity, HAQ, hypersensitive C-reactive protein(hs-CRP), erythrocyte sedimentation rate(ESR), rheumatoid factors(RF), disease activity score in 28 joints(DAS28),hs-CRP, ACR 20/50/70 response rates were compared between the two groups before treatment, at week 4 and 12 after treatment. The efficacy and safety were assessed. Results(1)After 4-week treatment the ACR 20/50/70 response rates were respectively 30.8%, 17.9%, 0 in the experimental group, and they were respectively 23.1%, 10.5%, 0 in the control group; but there was no statistical difference between the two groups(P>0.05). After 12-week treatment the ACR 20/50/70 response rates were respectively 59.0%, 33.3%, 12.8% in the experimental group, and 55.3%, 34.2%, 18.42%, respectively in the control group, but with no statistical difference between the two groups(P>0.05).(2)TJC, SJC, morning stiffness, patient's assessment of pain, physician's assessment of disease activity, patient's assessment of disease activity, HAQ, hs-CRP, ESR, RF, and DAS28-CRP all decreased after treatment, with statistical difference as compared with before treatment in the same group(P<0.05, P<0.01). But there was no statistical difference in post-treatment TJC, morning stiffness, patient's assessment of pain, physician's assessment of disease activity, patient's assessment of disease activity, HAQ, hs-CRP, ESR, RF, or DAS28-CRP between the two groups(P>0.05). Pre-treatment SJC was significantly different between two groups(P<0.05), but there was no statistical difference in SJC analyzed by covariance analysis after treatment(P>0.05). After 12-week treatment adverse reactions occurred in 3 cases of the experimental group and 11 cases in the control group. The occurrence rate of adverse reactions was obviously lower in the experimental group than in the control group(P<0.05). Conclusion The efficacy of HQTR combined MTX(10-15 mg/week) at 12 weeks of treatment was equivalent to that of LEF(10-20 mg per day)combined MTX(10-15 mg/week) with better safety.
引文
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[3] 高秋莲,梅湘,陈俞池,等.中医药抑制类风湿关节炎血管翳形成的研究概况[J].中医药学报,2013,41(5):94-95.
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[6] 陈秀敏,黄闰月,晏菁遥,等.化瘀通痹方联合甲氨蝶呤治疗难治性类风湿关节炎临床观察[J].中国中西医结合杂志,2015,35(11):1326-1330.
[7] 张佳琪.基于焦树德教授治疗类风湿关节炎辨证分型学术经验的用药规律探讨[D].北京:北京中医药大学,2017.
[8] 孟庆良,张子扬,孟婉婷.朱良春教授益肾蠲痹法治疗风湿病经验[J].中医学报,2017,32(11):2103-2106.
[9] Aletaha D,Neogi T,Silman AJ,et al.2010 Rheumatoid Arthritis Classification Criteria:an American College of Rheumatology/European League Against Rheumatism collaborative initiative[J].Arthritis Rheumatol,2010,62(9):2569-2581.
[10] 韩曼.中国类风湿关节炎患者报告的临床结局量表优化及应用研究[D].北京:中国中医科学院,2017.
[11] 国家中医药管理局.中医病证诊断疗效标准[M].南京:南京大学出版社,1994:47.
[12] Landewé R,Smolen JS,Florentinus S,et al.Existing joint erosions increase the risk of joint space narrowing independently of clinical synovitis in patients with early rheumatoid arthritis[J].Arthritis Res Ther,2015,17(1):133.
[13] Kirwan JR,Boers M.Biological treatment in rheumatoid arthritis:when to stop?[J].Lancet,2014,383(9914):288-289.
[14] Malemud CJ,Blumenthal DE.Protein kinase small molecule inhibitors for rheumatoid arthritis:Medicinal chemistry/clinical perspectives[J].World J Orthop,2014,5(4):496-503.
[15] Geng Y,Han J,Deng X,et al.Deep clinical remission:an optimized target in the management of rheumatoid arthritis?Experience from an ultrasonography study[J].Clin Exp Rheumatol,2016,34(4):581-586.
[16] Wailoo A,Hock ES,Stevenson M,et al.The clinical effectiveness and cost-effectiveness of treat-to-target strategies in rheumatoid arthritis:a systematic review and cost-effectiveness analysis[J].Health Technol Assess,2017,21(71):251-258.
[17] Woodworth TG,den Broeder AA.Treating to target in established rheumatoid arthritis:Challenges and opportunities in an era of novel targeted therapies and biosimilars[J].Best Pract Res Clin Rheumatol,2015,29(4):543-549.
[18] 池里群,周彬,高文远,等.治疗类风湿性关节炎常用药物的研究进展[J].中国中药杂志,2014,39(15):2851-2858.
[19] He YT,Ou AH,Yang XB,et al.Traditional Chinese medicine versus Western medicine as used in China in the management of rheumatoid arthritis:a randomized,single-blind,24-week study[J].Rheumatol Int,2014,34(12):1647-1655.
[2] de Hair MJH,Jacobs JWG,Schoneveld JLM,et al.Difficult-to-treat rheumatoid arthritis:an area of unmet clinical need[J].Rheumatology,2017,57(7):1135-1144.
[3] 高秋莲,梅湘,陈俞池,等.中医药抑制类风湿关节炎血管翳形成的研究概况[J].中医药学报,2013,41(5):94-95.
[4] 李文杰.基于病因、证候分型及血栓素合酶探讨RA血瘀病机[D].广州:广州中医药大学,2014.
[5] 黄清春,黄闺月,李文杰,等.广东省RA患者证候分型特点及其与血瘀的相关性[A].全国第十二届中西医结合风湿病学术会议论文集[C].北京:中国中西医结合学会,2014.
[6] 陈秀敏,黄闰月,晏菁遥,等.化瘀通痹方联合甲氨蝶呤治疗难治性类风湿关节炎临床观察[J].中国中西医结合杂志,2015,35(11):1326-1330.
[7] 张佳琪.基于焦树德教授治疗类风湿关节炎辨证分型学术经验的用药规律探讨[D].北京:北京中医药大学,2017.
[8] 孟庆良,张子扬,孟婉婷.朱良春教授益肾蠲痹法治疗风湿病经验[J].中医学报,2017,32(11):2103-2106.
[9] Aletaha D,Neogi T,Silman AJ,et al.2010 Rheumatoid Arthritis Classification Criteria:an American College of Rheumatology/European League Against Rheumatism collaborative initiative[J].Arthritis Rheumatol,2010,62(9):2569-2581.
[10] 韩曼.中国类风湿关节炎患者报告的临床结局量表优化及应用研究[D].北京:中国中医科学院,2017.
[11] 国家中医药管理局.中医病证诊断疗效标准[M].南京:南京大学出版社,1994:47.
[12] Landewé R,Smolen JS,Florentinus S,et al.Existing joint erosions increase the risk of joint space narrowing independently of clinical synovitis in patients with early rheumatoid arthritis[J].Arthritis Res Ther,2015,17(1):133.
[13] Kirwan JR,Boers M.Biological treatment in rheumatoid arthritis:when to stop?[J].Lancet,2014,383(9914):288-289.
[14] Malemud CJ,Blumenthal DE.Protein kinase small molecule inhibitors for rheumatoid arthritis:Medicinal chemistry/clinical perspectives[J].World J Orthop,2014,5(4):496-503.
[15] Geng Y,Han J,Deng X,et al.Deep clinical remission:an optimized target in the management of rheumatoid arthritis?Experience from an ultrasonography study[J].Clin Exp Rheumatol,2016,34(4):581-586.
[16] Wailoo A,Hock ES,Stevenson M,et al.The clinical effectiveness and cost-effectiveness of treat-to-target strategies in rheumatoid arthritis:a systematic review and cost-effectiveness analysis[J].Health Technol Assess,2017,21(71):251-258.
[17] Woodworth TG,den Broeder AA.Treating to target in established rheumatoid arthritis:Challenges and opportunities in an era of novel targeted therapies and biosimilars[J].Best Pract Res Clin Rheumatol,2015,29(4):543-549.
[18] 池里群,周彬,高文远,等.治疗类风湿性关节炎常用药物的研究进展[J].中国中药杂志,2014,39(15):2851-2858.
[19] He YT,Ou AH,Yang XB,et al.Traditional Chinese medicine versus Western medicine as used in China in the management of rheumatoid arthritis:a randomized,single-blind,24-week study[J].Rheumatol Int,2014,34(12):1647-1655.