^(99)Tc 亚甲基二膦酸盐改善类风湿性关节炎患者晨僵时间及肿胀和压痛指数的效果(英文)

Effect of ^(99)Tc methylenediphosphonate injection on morning stiffness duration and tender swollen index of patients with rheumatoid arthritis

背景:目前治疗类风湿性关节炎药物众多,^(99)Tc亚甲基二膦酸盐利用微量元素锝的价态变化中电子得失而刺激镇痛消炎作用的产生,是治疗类风湿性关节炎的一种新药。目的:观察^(99)Tc亚甲基二膦酸盐治疗类风湿性关节炎。设计:随机对照实验。单位:解放军第三军医大学新桥医院的中医科。对象:2000-03/2001-12新桥医院被确诊的住院类风湿性关节炎患者85例,纳入者66例,晨僵至少1h、3个或3个以上关节受累、对称性关节炎、有类风湿结节、血清类风湿因子阳性、血沉增快、X射线表现,具备以上4项或以上,并至少持续6周。男23例,女43例,年龄18～62岁,平均42.23岁。病程2月～12年,最短者,将受试者随机分为试验组和对照组,每组各33例。方法:分为治疗组和对照组,治疗组用静脉滴注、^(99)Tc亚甲基二膦酸盐加口服安慰剂,对照组用静脉滴注,安慰剂加口服奈普生,12d为一疗程。观察两者的晨僵改善时间、关节压痛数、关节肿胀数及血沉、C-反应蛋白、类风湿因子及总有效率,以此进行疗效评价。主要观察指标:99Tc亚甲基二膦酸盐对风湿病患者晨僵时间、关节压痛数、关节肿胀数、血沉、类风湿因子、C-反应蛋白等指标变化的影响,药物的副反应,并与奈普生的效果相比较。结果:按意向处理分析,66例进入结果分析。①试验组在缩短晨僵时间(70.39±40.32)min、减少关节压痛数(3.27±2.21)个及肿胀数(3.20±2.38)个方面明显优于对照组犤(35.82±24.65)min,(3.12±2.08)个,(2.02±1.25)个犦,(P<0.01～0.05)。②试验组治疗前后血沉差值与对照组治疗前后差值比较基本相似、试验组治疗前后C-反应蛋白差值与对照组治疗前后比较基本相似,试验组治疗前后类风湿因子差值与对照组治疗前后差值比较基本相似。③试验组的有效率85%(28/33)明显高于对照组64%(21/33)(χ2=4.89,P<0.05)。结论:99Tc亚甲基二膦酸盐治疗类风湿性关节炎时,可改善患者的关节肿胀和压痛症状以及晨僵时间,其治疗作用优于奈普生对照组,而对血沉、C-反应蛋白及类风湿因子的影响同奈普生相似。

BACKGROUND:Among lots of drugs treating rheumatic arthritis,^(99)Tc methylenediphosphonate injection is a novel one whose anti-inflammation effect is enabled through electronic acquirement or deprivation of technetium.OBJECTIVE:To observe the effect of ^(99)Tc methylenediphosphonate injection on rheumatic arthritis.DESIGN:Randomized controlled trial.SETTING:A Traditional Chinese Medicine Department of Xinqiao Hospital Affiliated to the Third Military Medical University of Chinese PLA.PARTICIPANTS:There were 85 patients diagnosed with rheumatoid arthritis and admitted to Xinqiao Hospital from March 2000 to December 2001.Sixty-six patients were enrolled in this trial for the manifestation of four or more of the following signs for 6 weeks:morning stiffness for at least one hour,more than 3 joints affected,symmetrical arthritis,positive rheumatoid nodules and serum rheumatoid factor,accelerated erythrocyte sedimentation and typical X-ray signs of rheumatic arthritis.Among the 66 patients,23 were males and 43 were females with the age of 18- 62 years old(mean 42.23 years).The course varied from 2 months to 12 years.They were randomly assigned into treatment group and control group with 33 each.METHODS:The patients in the treatment group received 99Tc methylenediphosphonate injection injection and oral administration of placebo while those in the control group received placebo injection and oral administration of naproxen for 12 days.The morning stiffness duration,numbers of tender joints and swollen joints,erythrocyte sedimentation,C reactive protein,rheumatoid factor and total effective rate in the two groups were recorded and compared to assess the therapeutic effect.MAIN OUTCOME MEASURES:The morning stiffness duration,numbers of tender joints and swollen joints,erythrocyte sedimentation,C reactive protein and rheumatoid factor in the two groups and adverse effect of 99Tc methylenediphosphonate injection.RESULTS:According to intention to deal with the analysis,none of the 66 patients was lost during the trial.① The shortening of morning stiffness duration and the reduction in the number of tender and swollen joints in the treatment group were better than those in the control group[(70.39± 40.32) minute,(3.27± 2.21),(3.20± 2.38) vs(35.82± 24.65) minute,(3.12± 2.08),(2.02± 1.25)](P< 0.01- 0.05).② The changes in erythrocyte sedimentation,C reactive protein and rheumatoid factor in the two groups were similar.③ The total effective rate(85% ) in treatment group was significantly higher than that(64% ) in control group(χ 2 =4.89,P< 0.05).CONCLUSION:99Tc methylenediphosphonate injection is better than naproxen in ameliorating articular swelling and tenderness as well as morning stiffness of rheumatic arthritis while the effect of 99Tc methylenediphosphonate injection on erythrocyte sedimentation,C reactive protein and rheumatoid factor was similar to that of naproxen.