锝[~(99)Tc]亚甲基二膦酸盐注射液联合甲氨蝶呤、来氟米特治疗类风湿关节炎的临床观察

目的:观察锝99Tc]亚甲基二膦酸盐注射液联合甲氨蝶呤、来氟米特治疗类风湿关节炎(RA)的临床疗效和安全性。方法:将76例RA患者按随机数字表法均分为对照组和观察组。对照组患者给予甲氨蝶呤10 mg,口服,1次/周+来氟米特20 mg,口服,1次/d;观察组患者在对照组治疗的基础上给予锝99Tc]亚甲基二膦酸盐,A剂(水剂)和B剂(粉剂)各3支混合,充分振摇,使冻干物溶解,室温静置5 min,制得锝99Tc]亚甲基二膦酸盐注射液,将其加入0.9%氯化钠注射液250 ml中静脉滴注,1次/d,连用10 d,每间隔20 d重复1个周期,共3个周期。两组患者疗程均为12周。观察两组患者临床疗效,治疗前后晨僵时间、C反应蛋白(CRP)、红细胞沉降率(ESR)、类风湿因子(RF)、抗环瓜氨酸肽抗体(CCP)、类风湿关节炎疾病活动性评分(DAS28),治疗后RA活动分期及不良反应发生情况。结果:观察组患者总有效率显著高于对照组,两组比较差异有统计学意义(P<0.05)。治疗前两组患者各指标比较,差异均无统计学意义(P>0.05);治疗后两组患者各指标均显著低于同组治疗前,且观察组低于对照组,差异均有统计学意义(P<0.05)。治疗后观察组患者缓解期、轻度活动期例数显著高于对照组,中度活动期、重度活动期例数显著低于对照组,两组比较差异有统计学意义(P<0.05)。观察组患者不良反应发生率低于对照组,两组比较差异有统计学意义(P<0.05)。结论:锝99Tc]亚甲基二膦酸盐注射液联合甲氨蝶呤、来氟米特治疗RA较甲氨蝶呤联合来氟米特疗效更显著,且安全性较好。

Clinical Observation of 99Tc-MDP Injection Combined with Methotrexate and Leflunomide in the Treatment of Rheumatoid Arthritis

OBJECTIVE：To observe the clinical efficacy and safety of technetium 99Tc] methylenediphosphonate（99Tc-MDP）injection combined with methotrexate（MTX）and leflunomide（LEF）in the treatment of rheumatoid arthritis. METHODS：76 rheumatoid arthritis（RA） patients were divided randomly into control group and observation group. Control group received MTX 10 mg orally,once a week ＋ leflunomide 20 mg orally,once a day. Observation group was additionally given99Tc-MDP injection,which was prepared by 3 bottles of A preparations（liquid）and 3 bottles of B preparations（powder）after shaking out completely,dissolving lyophilized product and setting for 5 min at room temperature,added into 0.9% sodium chloride injection 250 ml intravenously,once a day,for consecutive 10 days,every 20 days,for 3 times. Treatment course of 2 groups lasted for 12 weeks. Clinical efficacies of 2 groups were observed,and the duration of early morning stiffness,CRP,ESR,RF,CCP and DAS28 were observed before and after treatment. The stages of activity and ADR were observed after treatment. RESULTS：Total effective rate of observation group was significantly higher than that of control group;there was statistical significance（P〈0.05）. There was no statistical significance in clinical indicators between 2 groups before treatment（P〈0.05）;those indicators of 2 groups after treatment were significantly lower than before;the observation group was lower than the control group;there was statistical significance（P〈0.05）. The case number of observation group at remission stage and mild activity stage was significantly higher than in control group after treatment;but that of observation group was lower than that of control group at moderate and severe acivity stage;there was statistical significance（P〈0.05）. The incidence of ADR in observation group was significantly lower than in control group;there was statistical significance（P〈0.05）. CONCLUSIONS：99Tc-MDP injection combined with MTX and LEF is better tha