中国新药与临床杂志
中國新藥與臨床雜誌
중국신약여림상잡지
CHINESE JOURNAL OF NEW DRUGS AND CLINICAL REMEDIES
2003年
8期
451-455
,共5页
关节炎,类风湿%药物疗法,联合%药物协同作用%甲氨蝶呤%来氟米特
關節炎,類風濕%藥物療法,聯閤%藥物協同作用%甲氨蝶呤%來氟米特
관절염,류풍습%약물요법,연합%약물협동작용%갑안접령%래불미특
arthritis,rheumatoid%drug therapy,combination%drug synergism%methotrexate%leflunomide
目的:观察小剂量来氟米特和甲氨蝶呤联合应用治疗类风湿关节炎的疗效和安全性.方法:64例类风湿关节炎病人随机分入2组,各32例.2组病人于治疗前1 wk停用非甾体类抗炎镇痛药.试验开始时来氟米特+甲氨蝶呤组(Lef+MTX)给予来氟米特20 mg,po,qd+甲氨蝶呤(MTX)7.5 mg po, qw,服4 wk后来氟米特10 mg,po, qd+MTX 7.5 mg, po,qw;MTX组服甲氨蝶呤15 mg, po, qw,2组均以24 wk为一个疗程.治疗前、治疗后wk 12,24均做体检及实验室检查;治疗前后摄双手正位片.结果:Lef+MTX组显效88%(28/ 32例),MTX组38%(12/ 32例).Lef+MTX组不良反应4例占12%,主要为皮疹、恶心;MTX组14例占43%,主要为恶心、呕吐、口腔溃疡、脱发、ALT升高、心悸、月经不调等.结论:来氟米特与甲氨蝶呤联合治疗起效快、疗效佳、不良反应率低.
目的:觀察小劑量來氟米特和甲氨蝶呤聯閤應用治療類風濕關節炎的療效和安全性.方法:64例類風濕關節炎病人隨機分入2組,各32例.2組病人于治療前1 wk停用非甾體類抗炎鎮痛藥.試驗開始時來氟米特+甲氨蝶呤組(Lef+MTX)給予來氟米特20 mg,po,qd+甲氨蝶呤(MTX)7.5 mg po, qw,服4 wk後來氟米特10 mg,po, qd+MTX 7.5 mg, po,qw;MTX組服甲氨蝶呤15 mg, po, qw,2組均以24 wk為一箇療程.治療前、治療後wk 12,24均做體檢及實驗室檢查;治療前後攝雙手正位片.結果:Lef+MTX組顯效88%(28/ 32例),MTX組38%(12/ 32例).Lef+MTX組不良反應4例佔12%,主要為皮疹、噁心;MTX組14例佔43%,主要為噁心、嘔吐、口腔潰瘍、脫髮、ALT升高、心悸、月經不調等.結論:來氟米特與甲氨蝶呤聯閤治療起效快、療效佳、不良反應率低.
목적:관찰소제량래불미특화갑안접령연합응용치료류풍습관절염적료효화안전성.방법:64례류풍습관절염병인수궤분입2조,각32례.2조병인우치료전1 wk정용비치체류항염진통약.시험개시시래불미특+갑안접령조(Lef+MTX)급여래불미특20 mg,po,qd+갑안접령(MTX)7.5 mg po, qw,복4 wk후래불미특10 mg,po, qd+MTX 7.5 mg, po,qw;MTX조복갑안접령15 mg, po, qw,2조균이24 wk위일개료정.치료전、치료후wk 12,24균주체검급실험실검사;치료전후섭쌍수정위편.결과:Lef+MTX조현효88%(28/ 32례),MTX조38%(12/ 32례).Lef+MTX조불량반응4례점12%,주요위피진、악심;MTX조14례점43%,주요위악심、구토、구강궤양、탈발、ALT승고、심계、월경불조등.결론:래불미특여갑안접령연합치료기효쾌、료효가、불량반응솔저.
AIM: To investigate the efficacy and safety of low-dose leflunomide (Lef) combined with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA). METHODS: Sixty-four RA patients were randomly divided into two groups, with 32 patients in each group. All the patients were required to stop the treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for 1 wk before entering the trial. Patients in the Lef+MTX group received Lef 20 mg, po, qd in the first 4 wk, followed by 10 mg,po, qd for next 20 wk. Patients also received MTX 7.5 mg,po, qw during the trial. Patients in the MTX group received MTX 15 mg,po, qw for 24 wk. Physical and laboratory examinations were performed at the beginning of the trial, after 12 wk treatment and 24 wk treatment. Entopic X-ray examination of both hands was performed before and after the treatment. RESULTS: The rate of remarkable improvement was 88% (28/32) in Lef+MTX group and 38% in MTX group (12/32). Adverse reactions were reported in 12% (4/32) patients in Lef+MTX group and 43% (14/32) patients in MTX group. The reported adverse reactions were rash and nausea in Lef+MTX group and nausea, vomiting, oral ulcer, alopecia, ALT elevation, palpitation and menoxenia in MTX group. CONCLUSION: Combination of Lef with MTX is safe and effective in treatment of RA with less adverse reactions.
