补肾强督方联合柳氮磺吡啶治疗强直性脊柱炎30例临床观察
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摘要
目的观察补肾强督方联合柳氮磺吡啶治疗强直性脊柱炎(AS)的临床疗效及安全性。方法 60例AS患者随机分为治疗组和对照组各30例。对照组给予柳氮磺吡啶口服,每次1 g,每日2次。治疗组在对照组基础上给予补肾强督方,每日1剂。两组均治疗3个月。观察两组治疗前后强直性脊柱炎评估指标(ASAS20)、Bath强直性脊柱炎病情活动指数(BASDAI)、Bath强直性脊柱炎功能指数(BASFI)、Bath强直性脊柱炎测量指数(BASMI)、患者总体评价VAS评分、脊柱痛、全身痛及夜间痛评分,并检测血沉(ESR)、C反应蛋白(CRP)水平。结果 57例患者完成了研究,其中治疗组29例,对照组28例。治疗组和对照组治疗后达到ASAS20的比例分别为82.75%(24例/29例)和71.43%(20例/28例)。治疗组治疗后BASDAI、BSAFI、BASMI、总体评价VAS评分、脊柱痛、全身痛及夜间痛评分均较治疗前明显降低(P<0.05或P<0.01)。治疗后治疗组BASDAI、总体评价VAS评分、脊柱痛、全身痛及夜间痛评分均明显低于对照组(P<0.05)。两组患者治疗后ESR和CRP水平均较治疗前明显下降(P<0.05或P<0.01)。治疗后治疗组ESR、CRP水平明显低于对照组(P<0.05)。治疗组不良反应发生率为10.0%,明显低于对照组的23.3%(P<0.05)。结论补肾强督方联合柳氮磺吡啶能显著改善AS临床症状、降低ESR和CRP水平,且比单用柳氮磺吡啶具有更好的疗效和安全性。
Objective To study the efficacy and safety of Bushen Qiangdu Recipe( BQR,补肾强督方) combined with sulfasalazine in the treatment of ankylosing spondylitis( AS). Methods Totally of 60 AS patients were randomly and equally assigned to the treatment group and control group. The treatment group received BQR twice a day and sulfasalazine 2 g daily for 3 months. The control group received only sulfasalazine 2 g daily for 3 months. The Assessment in Ankylosing Spondylitis 20( ASAS 20),Bath Ankylosing Spondylitis Disease Activity Index( BASDAI),Bath Ankylosing Spondylitis Functional Index( BASFI),Bath Ankylosing Spondylitis Metrology Index( BASMI),patient's general assessment,spinal pain,general pain and night pain were used for scoring( 1-10) patients with AS.A higher score indicated a more severe illness stage. Physical examination,blood and urine tests,erythrocyte sedimentation rate( ESR) and C-reactive protein( CRP) measurement were performed at each visit. Results A total of 57 patients completed the study. There were 29 patients in treatment group and 28 patients in control group. There was less side effect in the treatment group than that in the control group. After treated by combined medicine and sulfasalazine,the proportion of ASAS20 responders at 3 month was 82. 75%( 24/29) and 71. 43%( 20/28) respectively. Both combined medicine and sulfasalazine treatment induced significant decrease in the proportion of expressing ESR and CRP at 3-month of treatment compared with baseline values( P < 0. 05). The effective rate in the treatment group was significantly higher than that in the control group. Conclusion Combined treatment of BQR and sulfasalazine could improve the symptoms and inflammation level of AS and it showed better effect and safety than sulfasalazine alone.
Objective To study the efficacy and safety of Bushen Qiangdu Recipe( BQR,补肾强督方) combined with sulfasalazine in the treatment of ankylosing spondylitis( AS). Methods Totally of 60 AS patients were randomly and equally assigned to the treatment group and control group. The treatment group received BQR twice a day and sulfasalazine 2 g daily for 3 months. The control group received only sulfasalazine 2 g daily for 3 months. The Assessment in Ankylosing Spondylitis 20( ASAS 20),Bath Ankylosing Spondylitis Disease Activity Index( BASDAI),Bath Ankylosing Spondylitis Functional Index( BASFI),Bath Ankylosing Spondylitis Metrology Index( BASMI),patient's general assessment,spinal pain,general pain and night pain were used for scoring( 1-10) patients with AS.A higher score indicated a more severe illness stage. Physical examination,blood and urine tests,erythrocyte sedimentation rate( ESR) and C-reactive protein( CRP) measurement were performed at each visit. Results A total of 57 patients completed the study. There were 29 patients in treatment group and 28 patients in control group. There was less side effect in the treatment group than that in the control group. After treated by combined medicine and sulfasalazine,the proportion of ASAS20 responders at 3 month was 82. 75%( 24/29) and 71. 43%( 20/28) respectively. Both combined medicine and sulfasalazine treatment induced significant decrease in the proportion of expressing ESR and CRP at 3-month of treatment compared with baseline values( P < 0. 05). The effective rate in the treatment group was significantly higher than that in the control group. Conclusion Combined treatment of BQR and sulfasalazine could improve the symptoms and inflammation level of AS and it showed better effect and safety than sulfasalazine alone.
引文
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[12]DEAN LE,JONES GT,MACDONALD AG,et al.Global prevalence of ankylosing spondylitis[J].Rheumatology(Oxford),2014,53(4):650-657.
[13]LI Z,WONG SH,SHEN J,et al:The role of micro RNAS in ankylosing spondylitis[J].Medicine,2016,95(14):e3325.
[14]YANG CH,HUANG F.Immunogenetics and pathogenesis of ankylosing spondylitis[J].Curr Immnol,2007,27(3):265-268.
[15]KROON F,LANDEWE R,DOUGADOS M,et al.Continuous NSAID use reverts the effects of inflammation on radiographic progression in patients with ankylosing spondylitis[J].Ann Rheum Dis,2012,71(10):1623-1629.
[16]HOU ZD,XIAO ZY,GONG Y,et al.Arylamine Nacetyltransferase polymorphisms in Han Chinese patients with ankylosing spondylitis and their correlation to the adverse drug reactions to sulfasalazine[J].BMC Pharmacol Toxicol,2014,21(11):156-158.
[17]WANG LS,HUANG F.Biologic agent in inflammatory arthritis[J].Chin J New Drug(Chin),2007,16(2):1149-1153.
[18]彭建英,阎小萍.补肾强督方治疗强直性脊柱炎50例临床观察[J].北京中医药大学学报(中医临床版),2011,18(6):17-19.
[19]王昊,阎小萍,孔维萍,等.补肾强督方加减治疗强直性脊柱炎的临床研究[J].中国中医急症,2013,22(5):738-740.
[2]MARTINDALE J,SHUKLA R,GOODACRE J.The impact of ankylosing spondylitis/axial spondyloarthritis on work productivity[J].Best Pract Res Clin Rheumatol,2015,29(3):512-523.
[3]蒋明,DAVID YU,朱立平,等.中华风湿病学[M].北京:华夏出版社,2004:1019.
[4]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.
[5]ZOCHLING J,BRAUN J.Assessment of ankylosing spondylitis[J].Clin Exp Rheumatol,2005,23(5 Suppl 39):S133-136.
[6]GARRETT S,JENKINSON TR,KENNEDY LG,et al.A new approach to defining disease status in ankylosing spondylitis:the bath AS disease activity index[J].J Reumatol,1994,21(12):2286-2291.
[7]CALIN A,GARRETT S,WHITELOCK H,et al.A new approach to-defining functional ability in ankylosing spondylitis:the development of the Bath Ankylosing Spondylitis Functional Index[J].J Rheumatol,1994,21(12):2281-2285.
[8]JENKINSON T,MALLORIE PA,WHITELOCK HC,et al.Defining spinal mobility in ankylosing spondylitis(AS):The Bath AS Metrology Index[J].J Rheumatol,1994,21(9):1694-1698.
[9]DE GRANDMONT P,FEINE JS,TACHE R,et al.Within-subject comparisons of implant-supported mandibular prostheses:psychometric evaluation[J].J Dent Res,1994,73(5):1096-1104.
[10]张乃峥.临床风湿病学[M].上海:上海科学技术出版社,1999:161-164.
[11]ADERSON JJ,BARON G,VAN DER HEIJDE D,et al.Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis[J].Arthritis Rheum,2001,44(8):1876-1886.
[12]DEAN LE,JONES GT,MACDONALD AG,et al.Global prevalence of ankylosing spondylitis[J].Rheumatology(Oxford),2014,53(4):650-657.
[13]LI Z,WONG SH,SHEN J,et al:The role of micro RNAS in ankylosing spondylitis[J].Medicine,2016,95(14):e3325.
[14]YANG CH,HUANG F.Immunogenetics and pathogenesis of ankylosing spondylitis[J].Curr Immnol,2007,27(3):265-268.
[15]KROON F,LANDEWE R,DOUGADOS M,et al.Continuous NSAID use reverts the effects of inflammation on radiographic progression in patients with ankylosing spondylitis[J].Ann Rheum Dis,2012,71(10):1623-1629.
[16]HOU ZD,XIAO ZY,GONG Y,et al.Arylamine Nacetyltransferase polymorphisms in Han Chinese patients with ankylosing spondylitis and their correlation to the adverse drug reactions to sulfasalazine[J].BMC Pharmacol Toxicol,2014,21(11):156-158.
[17]WANG LS,HUANG F.Biologic agent in inflammatory arthritis[J].Chin J New Drug(Chin),2007,16(2):1149-1153.
[18]彭建英,阎小萍.补肾强督方治疗强直性脊柱炎50例临床观察[J].北京中医药大学学报(中医临床版),2011,18(6):17-19.
[19]王昊,阎小萍,孔维萍,等.补肾强督方加减治疗强直性脊柱炎的临床研究[J].中国中医急症,2013,22(5):738-740.