CAJ | 학술논문

目的：探讨肿瘤坏死因子α（ TNF-α）拮抗药注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白、英夫利昔单抗治疗强直性脊柱炎（ AS）的疗效及安全性。方法将东莞康华医院2011年1月至2013年7月收治的122例AS患者采用随机数字表法分为 A 组（38例）、B 组（44例）、C 组（40例）组。 A组给予注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗，25 mg 加入1 mL 0.9％氯化钠注射液，三角肌下缘皮下注射，第0～6周每周2次，第7～24周每周1次；B组给予英夫利西单抗治疗，首次给予5 mg／kg静脉输注浓度，用药后的第2、6周及以后每隔6周均给予相同的剂量治疗；C组口服柳氮磺胺吡啶治疗，每次0.5 g，每日3次，如无不适，渐加量至每次1 g，每日3次。第6、12周对3组患者的疗效及安全性进行评估。结果治疗后6周， A、B、C 组总有效率分别为86.8％、86.4％和47.5％，而治疗后12周 A、B、C 组的总有效率分别为92.1％、93.2％和72.5％，3组治疗后12周的临床疗效优于治疗6周后，差异有统计学意义（ P＜0.05）。经治疗，3组 TNF-α水平均显著下降，差异有统计学意义（ P＜0.05）。其中，A、B两组TNF-α水平均显著低于C组，差异有统计学意义（P＜0.05）。 A、B、C组不良反应发生率分别为15.8％、22.7％、15.0％，差异无统计学意义（P＞0.05），且均未出现严重药物不良反应。结论 TNF-α拮抗药注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白、英夫利昔单抗治疗AS患者临床疗效显著、安全、可靠。
목적：탐토종류배사인자α（ TNF-α）길항약주사용중조인Ⅱ형종류배사인자수체-항체융합단백、영부리석단항치료강직성척주염（ AS）적료효급안전성。방법장동완강화의원2011년1월지2013년7월수치적122례AS환자채용수궤수자표법분위 A 조（38례）、B 조（44례）、C 조（40례）조。 A조급여주사용중조인Ⅱ형종류배사인자수체-항체융합단백치료，25 mg 가입1 mL 0.9％록화납주사액，삼각기하연피하주사，제0～6주매주2차，제7～24주매주1차；B조급여영부리서단항치료，수차급여5 mg／kg정맥수주농도，용약후적제2、6주급이후매격6주균급여상동적제량치료；C조구복류담광알필정치료，매차0.5 g，매일3차，여무불괄，점가량지매차1 g，매일3차。제6、12주대3조환자적료효급안전성진행평고。결과치료후6주， A、B、C 조총유효솔분별위86.8％、86.4％화47.5％，이치료후12주 A、B、C 조적총유효솔분별위92.1％、93.2％화72.5％，3조치료후12주적림상료효우우치료6주후，차이유통계학의의（ P＜0.05）。경치료，3조 TNF-α수평균현저하강，차이유통계학의의（ P＜0.05）。기중，A、B량조TNF-α수평균현저저우C조，차이유통계학의의（P＜0.05）。 A、B、C조불량반응발생솔분별위15.8％、22.7％、15.0％，차이무통계학의의（P＞0.05），차균미출현엄중약물불량반응。결론 TNF-α길항약주사용중조인Ⅱ형종류배사인자수체-항체융합단백、영부리석단항치료AS환자림상료효현저、안전、가고。
Objective To study the efficacy and safety of tumor necrosisfactor α( TNF-α) antagonist etanercept and infliximab on ankylosing spondylitis(AS).Methods A total of 122 patients with AS admit-ted to the Dongguan City Kanghua Hospital from Jan.2011 to Jul.2013 were divided into three groups ran-domly,38 cases in group A were treated with etanercept therapy 25 mg dissolved in 1 mL 0.9% NaCl,hypo-dermic injection at lower edge of deltoid,2 times/week during 1st-6th week, 1 time/week during 7th-24th week;44 cases in group B were given infliximab therapy,5 mg/kg IV.Infused at the first time,then given the same dosage at the 2nd and 6th week,then the same dosage every six weeks;40 cases in group C treated by sulfasalazine,orally 0.5g/time,3 times per day,then increased to 1 g/time if there was no adverse reactions, 3 times per day.The efficacy and safety of the three groups were assessed at 6th,12th week.Results After six weeks of treatment,the total effective rate of group A,B,C was 86.8%,86.4% and 47.5%respectively, after 12 weeks,the total effective rate of group A,B,C was 92.1%,93.2% and 72.5% respectively,which were significantly higher than the effect after 6 weeks(P<0.05);TNF-αlevel of the three groups were sig-nificantly decreased after treatment(P<0.05);the adverse reaction rate of the three groups were 15.8%, 22.7%15.0%,which were not statistically significantly different(P >0.05),while there were no serious adverse effect in any of the three groups.Conclusion TNF-αantagonist etanercept,infliximab have signifi-cant effect for AS patients with good clinical safety and reliability.