摘要
目的观察阿达木单抗(ADA)注射液联合甲氨蝶呤(MTX)片治疗类风湿关节炎(RA)患者的临床疗效和安全性,及其对骨代谢的影响。方法将RA患者按队列法分为试验组和对照组。对照组接受MTX片治疗,每次10 mg,每周1次,口服;试验组在对照组治疗的基础上,联用ADA注射液进行治疗,每次40 mg,每2周1次,皮下注射。2组患者均治疗24周。比较2组患者的临床疗效、症状改善情况、关节功能、血清骨代谢指标[骨碱性磷酸酶(B-ALD)、骨钙素(BGP)、Ⅰ型前胶原羧基端前肽(PICP)],并评价安全性。结果对照组入组37例、试验组入组43例。治疗后,试验组和对照组的总有效率分别为93.02%(40例/43例)和75.68%(28例/37例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的晨僵时间分别为(29.27±7.05)和(48.63±12.25)min,关节肿胀数分别为(2.64±0.66)和(4.04±1.09)个,关节压痛数分别为(4.51±1.12)和(6.23±2.07)个,血清B-ALP分别为(20.76±2.82)和(26.41±3.05)U·L^(-1),血清BGP分别为(27.45±3.41)和(23.86±3.17)ng·mL^(-1),血清PICP分别为(47.39±5.63)和(41.68±5.24)ng·mL^(-1),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头痛、注射部位瘙痒、腹泻、恶心,对照组的药物不良反应主要有腹泻、食欲缺乏、恶心。试验组和对照组的总药物不良反应发生率分别为11.63%和8.11%,在统计学上差异无统计学意义(P>0.05)。结论ADA注射液联合MTX片治疗RA的临床疗效确切,其能显著改善患者的临床症状,促进关节功能恢复,降低血清类风湿因子水平,缓解炎症反应,改善骨代谢。
Objective To observe clinical efficacy and safety of adalimumab(ADA)injection combined with methotrexate(MTX)tablets in the treatment of patients rheumatoid arthritis(RA)and its influences on bone metabolism.Methods According to cohort method,the RA patients were divided into treatment group and control group.The control group was treated with oral MTX tablets(10 mg/once,once/week),while treatment group was given subcutaneous injection of ADA ejection(40 mg/once,once/2 weeks)on basis of control group.Both groups were treated for 24 weeks.The clinical curative effect,symptoms improvement,joint function and serum bone metabolism indexes[bone alkaline phosphatase(B-ALP),bone glaprotein(BGP),carboxyterminal propeptide of type I procollagen(PICP)]in the two groups were compared,and safety was evaluated.Results There were 37 cases in control group and 43 cases in treatment group.After treatment,total response rates of treatment group and control group were 93.02%(40 cases/43 cases)and 75.68%(28 cases/37 cases),the difference was statistically significant(P<0.05).After treatment,morning stiffness time in treatment group and control group were(29.27±7.05)and(48.63±12.25)min,the number of joint swelling were 2.64±0.66 and 4.04±1,09,number of joint tenderness were 4.51±1.12 and 6.23±2.07,levels of serum B-ALP were(20.76±2.82)and(26.41±3.05)U·L^(-1);levels of serum BGP were(27.45±3.41)and(23.86±3.17)ng·mL^(-1);levels of serum PICP were(47.39±5.63)and(41.68±5.24)ng·mL^(-1),the differences were statistically significant(P<0.05).The adverse drug reactions in treatment group were mainly on headache,pruritus at the injection site,diarrhea and nausea,while which in control group were mainly on diarrhea,anorexia and nausea.The difference in incidence of adverse reactions between treatment group and control group was not statistically significant(11.63%vs 8.11%,P>0.05).Conclusion Clinical curative effect of ADA injection combined with MTX tablets is significant in RA patients,which can significantly relieve clinical
作者
贾会欣
吕昊哲
JIA Hui-xin;LU Hao-zhe(Department of Integrated Chinese and Western Medicine,Daqing 0ifield General Hospital,Daqing 163000,Heilongjiang Provicne,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2024年第19期2786-2790,共5页
The Chinese Journal of Clinical Pharmacology
关键词
阿达木单抗注射液
甲氨蝶呤片
类风湿关节炎
临床疗效
骨代谢
安全性评价
adalimumab injection
methotrexate tablet
rheumatoid arthritis
clinical curative effect
bone metabolism
safety evaluation
