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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: At present, there are many drugs for the treatment of rheumatoid arthritis. The use of 99 Tc methylene diphosphonate to stimulate the analgesic and anti-inflammatory effects of valence electrons in the valence state of trace elements technetium is the treatment of rheumatoid arthritis A new drug for inflammation. Objective: To observe ~ (99) Tc methylene diphosphonate in the treatment of rheumatoid arthritis. Design: Randomized controlled experiment. Unit: Chinese PLA Third Military Medical University Xinqiao Hospital of Traditional Chinese Medicine. PARTICIPANTS: Eighty-five inpatients with rheumatoid arthritis admitted to Xinqiao Hospital from February 2000 to December 2001 were enrolled in this study. Sixty-six patients were enrolled, with at least 1 h of morning stiffness, three or more joints involved, and symmetrical arthritis with Rheumatoid nodules, serum rheumatoid factor-positive, ESR, X-ray performance, with more than 4 or more, and at least for 6 weeks. There were 23 males and 43 females, aged from 18 to 62 years, with an average of 42.23 years. Duration of 2 months to 12 years, the shortest, the subjects were randomly divided into experimental group and control group, 33 cases in each group. Methods: The treatment group was divided into the treatment group and the control group. The treatment group was treated with ~ (99) Tc methylene diphosphonate plus oral placebo, the control group with intravenous drip, placebo plus Naproxen, For a course of treatment. The duration of morning stiffness improvement, joint tenderness, joint swelling and ESR, C-reactive protein, rheumatoid factor and total effective rate were observed. MAIN OUTCOME MEATURES: Effect of 99Tc methylene diphosphonate on changes in morning stiffness, joint tenderness, joint swelling, erythrocyte sedimentation rate, rheumatoid factor, C-reactive protein and other side effects of rheumatic diseases, side effects of drugs Compare with the effects of Naproxen. Results: According to the intention-to-treat analysis, 66 cases entered the result analysis. ① The test group was significantly better than the control group (35.82 ± 24.65) min, (3.12 ± 2.65) min (3.12 ± 2.21) and swelling number (3.20 ± 2.38) in shortening morning stiffness (70.39 ± 40.32) min, ± 2.08), (2.02 ± 1.25) 犦, (P <0.01 ~ 0.05). The difference of serum erythrocyte sedimentation rate before and after treatment in the experimental group was basically similar to that in the control group before and after treatment. The difference of C-reactive protein in the experimental group before and after treatment was basically similar to that in the control group before and after treatment. The difference between before and after treatment is basically similar. ③ The effective rate of experimental group was 85% (28/33), which was significantly higher than that of control group (64%, 21/33) (χ2 = 4.89, P <0.05). CONCLUSIONS: 99Tc methylene diphosphonate treatment of rheumatoid arthritis can improve the patient’s symptoms of joint swelling and tenderness and morning stiffness, and its therapeutic effect is better than that of the Naproxen control group, The effect of protein and rheumatoid factor is similar to that of naproxen.