摘要
目的观察柳氮磺吡啶肠溶片联合羟氯喹片和甲氨蝶呤片治疗类风湿关节炎的临床疗效及安全性。方法将74例类风湿关节炎患者随机分为对照组和试验组,每组37例。对照组予以甲氨蝶呤每次15 mg,每周1次,口服;试验组在对照组治疗的基础上,予以羟氯喹片每次0. 2 g,bid,口服+柳氮磺吡啶肠溶片第1周每次0. 25 g,第2周每次0. 50 g,第3周每次0. 75 g,第4周开始每次1. 00 g,bid,口服。2组患者均治疗24周。比较2组患者的临床疗效,血清C反应蛋白(CRP)、类风湿因子(RF)和红细胞沉降率(ESR)的水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91. 89%(34例/37例)和72. 97%(27例/37例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的CRP分别为(6. 37±2. 51)和(9. 27±3. 25) mg·L-1,RF分别为(68. 54±21. 35)和(102. 37±24. 58) U·L-1,ESR分别为(35. 26±14. 52)和(53. 19±15. 56) mm·h-1,差异均有统计学意义(均P <0. 05)。试验组和对照组的药物不良反应主要有胃肠道不适(18. 92%vs13. 51%)、发热(5. 41%vs 10. 81%)和皮疹(13. 51%vs 10. 81%),差异均无统计学意义(均P> 0. 05)。结论柳氮磺吡啶肠溶片联合羟氯喹片和甲氨蝶呤片治疗类风湿关节炎的临床疗效确切,其能有效地降低血清CRP和RF含量及ESR,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of sulfasalazine enteric-coated tablets combined with hydroxychloroquine sulfate tablets and methotrexate tablets in the treatment of rheumatoid arthritis.Methods A total of 74 patients with rheumatoid arthritis were randomly divided into treatment and control groups with 37 cases per group.Control group received methotrexate 15 mg per time,once a week,orally.Treatment group received hydroxychloroquine sulfate 0.2 g per time,bid,orally + sulfasalazine enteric-coated tablets 0.25 g per time at the first week,0.50 g per time at the second week,0.75 g per time at the third week and 1.00 g per time at the fourth week,bid,orally,on the basis of the control group.Two groups were treated for 24 weeks.The clinical efficacy,serum C reactive protein( CRP),rheumatoid factor( RF),erythrocyte sedimentation rate( ESR),and adverse drug reactions were compared between two groups.Results After treatment, the total effective rates of treatment and control groups were 91.89%( 34 cases/37 cases) and 72.97%( 27 cases/37 cases)with significant difference( P < 0.05).After treatment,the main indexes of treatment and control groups were compared: CRP were( 6.37±2.51) and( 9.27±3.25) mg·L-1,RF were( 68.54±21.35) and( 102.37±24.58)U·L-1,ESR were( 35.26±14.52) and( 53.19±15.56) mm·h-1,the differences were statistically significant( all P < 0.05).The adverse drug reactions of treatment and control groups were gastrointestinal discomfort( 18.92%vs 13.51%),fever( 5.41% vs 10.81%) and rash( 13.51% vs 10.81%),the differences were not statistically significant( all P > 0.05).Conclusion Sulfasalazine enteric-coated tablets combined with hydroxychloroquine sulfate tablets and methotrexate tablets have a definitive clinical efficacy in the treatment of rheumatoid arthritis,which can effectively reduce serum CRP and RF levels and ESR,without increasing the incidence of adverse drug reactions.
作者
李国铨
叶凤
郭峰
王善志
韩锋
沈瑞明
王敏
郑颜萍
梁海琴
庄乙君
LI Guo-quan;YE Feng;GUO Feng;WANG Shan-zhi;HAN Feng;SHEN Rui-ming;WANG Min;ZHENG Yan-ping;LIANG Hai-qin;ZHUANG Yi-jun(Department of Nephrotic and Rheumatism Haikou 570102, China;Department of Laboratory, The First Affiliated Hospital of Hainan Medical University, Haikou 570102, China;Department of Nephrology, Hainan General Hospital Agriculture and Reclamalutn, Haikou 570311, China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2019年第6期507-509,共3页
The Chinese Journal of Clinical Pharmacology
基金
海南省自然科学基金资助项目(814342)
关键词
柳氮磺吡啶肠溶片
羟氯喹片
甲氨蝶呤片
类风湿关节炎
安全性评价
sulfasalazine enteric - coated tablet
hydroxychloroquine sulfate tablet
methotrexate tablet
rheumatoid arthritis
safety evaluation
