中西医结合治疗类风湿关节炎疗效与安全性的系统评价
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摘要
目的:系统评价益肾蠲痹丸联合西药治疗类风湿关节炎(Rheumatoid Arthritis,RA)的临床疗效与安全性。方法:计算机检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、万方数据库、维普中文期刊数据库(VIP)、Cochrane Library、PubMed、Embase,查找使用了益肾蠲痹丸治疗类风湿关节炎的随机对照试验(RCTs),检索时间均为建库至2018年1月。由2名研究员严格按照预先制定的纳入与排除标准,独立筛选文献并完成资料提取与录入,评价纳入研究的方法学质量后,采用RevMan 5.3软件进Meta分析。结果:共纳入9个研究,病例总数824例。Meta分析结果显示,益肾蠲痹丸联合西药在治疗RA的总有效率上高于单纯使用西药[RR=1.20,95%CI(1.13, 1.27),P<0.000 01],且在改善RA患者关节肿胀数[SMD=-1.03,95%CI(-1.51,-0.54),P<0.000 1]、压痛数[SMD=-1.36,95%CI(-1.92,-0.79),P<0.000 01]、晨僵时间[SWD=-1.07,95%CI(-1.44,-0.70),P<0.000 01]及ESR[SMD=-0.73,95%CI(-1.02,-0.44),P<0.000 01]、CRP[SMD=-0.72,95%CI(-0.98,-0.45),P<0.000 01]、RF[SMD=-0.99,95%CI(-1.70,-0.29),P<0.000 01]水平方面均具有优势,在不良反应发生率方面二者差异无统计学意义。结论:益肾蠲痹丸联合西药治疗类风湿关节炎在临床疗效上要优于单纯使用西药,同时并不会增加药物不良反应的发生,但受纳入研究数量及质量的限制,仍有待于更多大样本、多中心、高质量的临床随机对照试验进一步证实。
Objective: To systematically evaluate the clinical efficacy and safety of Yishen Juanbi Pills combined with western medicine in the treatment of rheumatoid arthritis(RA). Methods: We used computer to search the databases such as Chinese Biomedical Literature Database(CBM), Chinese Journal Full-text Database(CNKI), Wanfang Database, VIP Chinese Journal Database(VIP), Cochrane Library, PubMed and Embase,up to January 2018 and found randomized controlled trials(RCTs) for treating rheumatoid arthritis were with Yishen Juanbi Pills. Two investigators strictly followed the pre-defined inclusion and exclusion criteria, independently screened the literature, and completed the data extraction and entry. After evaluating the methodological quality of the included studies, RevMan 5.3 software was used for Meta-analysis. Results: A total of 9 studies were included and the total number of cases was 824. Meta-analysis showed that Yishen Juanbi PillsCombined with Western medicine was more efficient in treating RA than simply using Western medicine[RR=1.20,95% CI(1.13, 1.27),P<0.000 01], and hadadvantages in improving the number of joint swelling[SMD=-1.03,95% CI(-1.51,-0.54),P<0.000 1]. The number of tenderness[SMD=-1.36,95% CI(-1.92,-0.79),P<0.000 01], morning stiffness time [SWD=-1.07, 95% CI(-1.44,-0.70), P<0.000 01] and the level of ESR[SMD=-0.73,95% CI(-1.02,-0.44),P<0.000 01]、CRP[SMD=-0.72,95% CI(-0.98,-0.45),P<0.000 01],RF[SMD=-0.99,95% CI(-1.70,-0.29),P<0.000 01] in RA patients were significant. There was no statistical difference in the incidence of adverse reactions between them [OR=0.67, 95% CI(0.38, 1.17), P=0.16]. Conclusion:Yishen Juanbi Pills combined with Western medicine have better clinical efficacy than simply using Western medicine in the treatment of rheumatoid arthritis, andit will not increase the incidence of adverse drug reactions.But subject to the study of the number and quality restrictions, more largesample,multi-center,high-qualityclinicalrandomized controlled trialswere needed in order to draw firm conclusion.
Objective: To systematically evaluate the clinical efficacy and safety of Yishen Juanbi Pills combined with western medicine in the treatment of rheumatoid arthritis(RA). Methods: We used computer to search the databases such as Chinese Biomedical Literature Database(CBM), Chinese Journal Full-text Database(CNKI), Wanfang Database, VIP Chinese Journal Database(VIP), Cochrane Library, PubMed and Embase,up to January 2018 and found randomized controlled trials(RCTs) for treating rheumatoid arthritis were with Yishen Juanbi Pills. Two investigators strictly followed the pre-defined inclusion and exclusion criteria, independently screened the literature, and completed the data extraction and entry. After evaluating the methodological quality of the included studies, RevMan 5.3 software was used for Meta-analysis. Results: A total of 9 studies were included and the total number of cases was 824. Meta-analysis showed that Yishen Juanbi PillsCombined with Western medicine was more efficient in treating RA than simply using Western medicine[RR=1.20,95% CI(1.13, 1.27),P<0.000 01], and hadadvantages in improving the number of joint swelling[SMD=-1.03,95% CI(-1.51,-0.54),P<0.000 1]. The number of tenderness[SMD=-1.36,95% CI(-1.92,-0.79),P<0.000 01], morning stiffness time [SWD=-1.07, 95% CI(-1.44,-0.70), P<0.000 01] and the level of ESR[SMD=-0.73,95% CI(-1.02,-0.44),P<0.000 01]、CRP[SMD=-0.72,95% CI(-0.98,-0.45),P<0.000 01],RF[SMD=-0.99,95% CI(-1.70,-0.29),P<0.000 01] in RA patients were significant. There was no statistical difference in the incidence of adverse reactions between them [OR=0.67, 95% CI(0.38, 1.17), P=0.16]. Conclusion:Yishen Juanbi Pills combined with Western medicine have better clinical efficacy than simply using Western medicine in the treatment of rheumatoid arthritis, andit will not increase the incidence of adverse drug reactions.But subject to the study of the number and quality restrictions, more largesample,multi-center,high-qualityclinicalrandomized controlled trialswere needed in order to draw firm conclusion.
引文
[1] 葛均波,徐永健.内科学[M].8版.北京:人民卫生出版社,2013:808-814.
[2] 中华医学会风湿病学分会.类风湿关节炎诊断及治疗指南[J].中华风湿病学杂志,2010,14(4):265-270.
[3] 曾小峰, 朱松林, 谭爱春,等.我国类风湿关节炎疾病负担和生存质量研究的系统评价[J].中国循证医学杂志,2013,13(3):300-307.
[4] 余慧, 蒋艳珍, 尚文昌.中西医结合治疗老年性类风湿关节炎活动期临床研究[J].河北中医,2016,38(2):217-221.
[5] 周铁.甲氨蝶呤联合益肾蠲痹丸治疗老年类风湿关节炎的临床观察[J].临床合理用药杂志,2009,2(8):13-15.
[6] 岳双林.甲氨蝶吟联合益肾蠲痹丸对类风湿关节炎治疗效果的探讨[J].医药前沿,2016,6(4):51-52.
[7] 张波, 张继平, 周少雄,等.益肾蠲痹丸对类风湿性关节炎患者抗CCP抗体及AKA抗体的影响[J].广东医学,2009,30(1):137-140.
[8] 方海燕, 姚兴琼.来氟米特联合益肾蠲痹丸治疗类风湿关节炎的临床观察[J].甘肃医药,2014,33(2):117-119.
[9] 李雪芬, 钟诗婷, 邓矢明.益肾蠲痹丸联合来氟米特片治疗类风湿性关节炎临床研究[J].河南中医,2016,36(11):2007-2009.
[10] 白明华, 程蕾, 张自强.益肾蠲痹丸联合抗风湿药物治疗类风湿性关节炎疗效观察[J].陕西中医,2017,38(7):932-933.
[11] 郭进, 黄宝英.甲氨喋呤联合益肾蠲痹丸治疗类风湿性关节炎的临床观察[J].浙江临床医学,2005,7(11):1184.
[12] 罗敏.益肾蠲痹丸治疗类风湿关节炎临床观察[J].内蒙古中医药,2017,36(19):23-24.
[13] 王秀茹, 苏茵, 安媛,等.全国多中心类风湿关节炎患者门诊用药费用的调查[J].中华风湿病学杂志,2010,14(6):368-372.
[14] 李雪, 栗占国.2015年亚洲太平洋地区风湿病学学会联盟类风湿关节炎治疗建议[J].中华风湿病学杂志,2016,20(4):286-288.
[15] SINGH JA, SAAG KG, BRIDGES SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis[J]. Arthritis Care Res (Hoboken), 2016,68(1):1-25.
[16] 中华医学会风湿病学分会.2018中国类风湿关节炎诊疗指南[S].中华内科杂志,2018,57(4):242-251.
[17] 刘德鼎, 林博川, 邢福,等.非甾体抗炎药治疗类风湿关节炎及对心血管不良影响[J].药学实践杂志,2007,25(5):283-286,294.
[18] KIRWAN JR, BIJLSMA JW, BOERS M, et al. Effects of glucocorticoids on radiological progression in rheumatoid arthritis[J]. Cochrane Database Syst Rev, 2007(1):CD006356.
[19] Van Der GOES MC, JACOBS JW, BOERS M, et al. Monitoring adverse events of low-dose glucocorticoid therapy: EULAR recommendations for clinical trials and daily practice[J]. Ann Rheum Dis, 2010,69(11):1913-1919.
[20] DUREZ P, VANTHUYNE M, SOYFOO MS, et al. Efficacy of golimumab in Belgian patients with active rheumatoid arthritis despite treatment with non-biologic disease-modifying anti-rheumatic drugs: sub-analysis of the GO-MORE study[J]. Acta Clin Belg, 2017,72(6):424-428.
[21] DE PUNDER YM, FRANSEN J, KIEVIT W, et al. The prevalence of clinical remission in RA patients treated with anti-TNF: results from the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry[J]. Rheumatology (Oxford), 2012,51(9):1610-1617.
[22] LOPEZ-OLIVO MA, TAYAR JH, MARTINEZ-LOPEZ JA, et al. Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis[J]. JAMA, 2012,308(9):898-908.
[23] 李芯.雷公藤治疗类风湿关节炎的疗效及安全性评估[D].北京:北京协和医学院,2012.
[24] 闵伟琪, 魏琴, 李洪毓,等.白芍总苷治疗类风湿关节炎的多中心临床研究[J].中华风湿病学杂志,2005,9(8):487-491.
[25] 黄国栋, 李家邦, 黄媛华,等.青藤碱治疗类风湿关节炎100例临床研究[J].中国中医急症,2007,16(4):416-417,421.
[26] 王旻晋, 武永康, 林辉.甲氨蝶呤治疗类风湿性关节炎的不良反应及应对措施[J].华西医学,2013(6):940-943.
[27] 尪痹的诊断依据、证候分类、疗效评定——中华人民共和国中医药行业标准《中医内科病证诊断疗效标准》(ZY/T001.1-94)[S].辽宁中医药大学学报,2016,18(11):217.
[28] 焦树德, 王伟钢.尪痹病名及其证治规律的研究[J].浙江中医药大学学报,2009,33(5):681-685.
[29] 朱良春.益肾蠲痹丸[J].中国社区医师,1990(1):20.
[30] 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.
[31] 石磊, 李小峰, 王彩虹,等.大鼠胶原诱导性关节炎模型的制备及评价[J].临床医药实践,2011,20(4):245-247.
[32] 王晶晶, 刘静, 裴天仙,等.益肾蠲痹丸对Ⅱ型胶原致关节炎大鼠踝关节组织病理改变的影响及其机制研究[J].中草药,2016,47(17):3064-3069.
[33] 王贵.益肾蠲痹丸对胶原诱导性关节炎大鼠骨代谢及免疫调节的影响[D].北京:北京中医药大学,2017.
[34] PATHIRAGE-KAMAL P, 彭程, 吕雪,等.益肾蠲痹丸对类风湿性关节炎的药效学研究(英文)[J].中国天然药物,2010,8(1):57-61.
[35] 王莹, 马武开.益肾蠲痹丸对CIA模型大鼠关节滑膜细胞NF-KB的影响[J].医药前沿,2015,5(33):324-325.
[2] 中华医学会风湿病学分会.类风湿关节炎诊断及治疗指南[J].中华风湿病学杂志,2010,14(4):265-270.
[3] 曾小峰, 朱松林, 谭爱春,等.我国类风湿关节炎疾病负担和生存质量研究的系统评价[J].中国循证医学杂志,2013,13(3):300-307.
[4] 余慧, 蒋艳珍, 尚文昌.中西医结合治疗老年性类风湿关节炎活动期临床研究[J].河北中医,2016,38(2):217-221.
[5] 周铁.甲氨蝶呤联合益肾蠲痹丸治疗老年类风湿关节炎的临床观察[J].临床合理用药杂志,2009,2(8):13-15.
[6] 岳双林.甲氨蝶吟联合益肾蠲痹丸对类风湿关节炎治疗效果的探讨[J].医药前沿,2016,6(4):51-52.
[7] 张波, 张继平, 周少雄,等.益肾蠲痹丸对类风湿性关节炎患者抗CCP抗体及AKA抗体的影响[J].广东医学,2009,30(1):137-140.
[8] 方海燕, 姚兴琼.来氟米特联合益肾蠲痹丸治疗类风湿关节炎的临床观察[J].甘肃医药,2014,33(2):117-119.
[9] 李雪芬, 钟诗婷, 邓矢明.益肾蠲痹丸联合来氟米特片治疗类风湿性关节炎临床研究[J].河南中医,2016,36(11):2007-2009.
[10] 白明华, 程蕾, 张自强.益肾蠲痹丸联合抗风湿药物治疗类风湿性关节炎疗效观察[J].陕西中医,2017,38(7):932-933.
[11] 郭进, 黄宝英.甲氨喋呤联合益肾蠲痹丸治疗类风湿性关节炎的临床观察[J].浙江临床医学,2005,7(11):1184.
[12] 罗敏.益肾蠲痹丸治疗类风湿关节炎临床观察[J].内蒙古中医药,2017,36(19):23-24.
[13] 王秀茹, 苏茵, 安媛,等.全国多中心类风湿关节炎患者门诊用药费用的调查[J].中华风湿病学杂志,2010,14(6):368-372.
[14] 李雪, 栗占国.2015年亚洲太平洋地区风湿病学学会联盟类风湿关节炎治疗建议[J].中华风湿病学杂志,2016,20(4):286-288.
[15] SINGH JA, SAAG KG, BRIDGES SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis[J]. Arthritis Care Res (Hoboken), 2016,68(1):1-25.
[16] 中华医学会风湿病学分会.2018中国类风湿关节炎诊疗指南[S].中华内科杂志,2018,57(4):242-251.
[17] 刘德鼎, 林博川, 邢福,等.非甾体抗炎药治疗类风湿关节炎及对心血管不良影响[J].药学实践杂志,2007,25(5):283-286,294.
[18] KIRWAN JR, BIJLSMA JW, BOERS M, et al. Effects of glucocorticoids on radiological progression in rheumatoid arthritis[J]. Cochrane Database Syst Rev, 2007(1):CD006356.
[19] Van Der GOES MC, JACOBS JW, BOERS M, et al. Monitoring adverse events of low-dose glucocorticoid therapy: EULAR recommendations for clinical trials and daily practice[J]. Ann Rheum Dis, 2010,69(11):1913-1919.
[20] DUREZ P, VANTHUYNE M, SOYFOO MS, et al. Efficacy of golimumab in Belgian patients with active rheumatoid arthritis despite treatment with non-biologic disease-modifying anti-rheumatic drugs: sub-analysis of the GO-MORE study[J]. Acta Clin Belg, 2017,72(6):424-428.
[21] DE PUNDER YM, FRANSEN J, KIEVIT W, et al. The prevalence of clinical remission in RA patients treated with anti-TNF: results from the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry[J]. Rheumatology (Oxford), 2012,51(9):1610-1617.
[22] LOPEZ-OLIVO MA, TAYAR JH, MARTINEZ-LOPEZ JA, et al. Risk of malignancies in patients with rheumatoid arthritis treated with biologic therapy: a meta-analysis[J]. JAMA, 2012,308(9):898-908.
[23] 李芯.雷公藤治疗类风湿关节炎的疗效及安全性评估[D].北京:北京协和医学院,2012.
[24] 闵伟琪, 魏琴, 李洪毓,等.白芍总苷治疗类风湿关节炎的多中心临床研究[J].中华风湿病学杂志,2005,9(8):487-491.
[25] 黄国栋, 李家邦, 黄媛华,等.青藤碱治疗类风湿关节炎100例临床研究[J].中国中医急症,2007,16(4):416-417,421.
[26] 王旻晋, 武永康, 林辉.甲氨蝶呤治疗类风湿性关节炎的不良反应及应对措施[J].华西医学,2013(6):940-943.
[27] 尪痹的诊断依据、证候分类、疗效评定——中华人民共和国中医药行业标准《中医内科病证诊断疗效标准》(ZY/T001.1-94)[S].辽宁中医药大学学报,2016,18(11):217.
[28] 焦树德, 王伟钢.尪痹病名及其证治规律的研究[J].浙江中医药大学学报,2009,33(5):681-685.
[29] 朱良春.益肾蠲痹丸[J].中国社区医师,1990(1):20.
[30] 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.
[31] 石磊, 李小峰, 王彩虹,等.大鼠胶原诱导性关节炎模型的制备及评价[J].临床医药实践,2011,20(4):245-247.
[32] 王晶晶, 刘静, 裴天仙,等.益肾蠲痹丸对Ⅱ型胶原致关节炎大鼠踝关节组织病理改变的影响及其机制研究[J].中草药,2016,47(17):3064-3069.
[33] 王贵.益肾蠲痹丸对胶原诱导性关节炎大鼠骨代谢及免疫调节的影响[D].北京:北京中医药大学,2017.
[34] PATHIRAGE-KAMAL P, 彭程, 吕雪,等.益肾蠲痹丸对类风湿性关节炎的药效学研究(英文)[J].中国天然药物,2010,8(1):57-61.
[35] 王莹, 马武开.益肾蠲痹丸对CIA模型大鼠关节滑膜细胞NF-KB的影响[J].医药前沿,2015,5(33):324-325.