CAJ | 학술논문

目的评价重组人血小板生成素(rhTPO)联合糖皮质激素治疗重症新诊断原发免疫性血小板减少症(ITP)的疗效和安全性.方法 2009年6月至2012年12月,62例重症新诊断ITP患者纳入研究,男24例、女38例,中位年龄50(21～84)岁.随机分为试验组(31例)和对照组(31例).试验组给予rhTPO联合糖皮质激素治疗;对照组予以糖皮质激素治疗.结果试验组治疗第3、7和14天的平均血小板计数均高于对照组[(35.5±24.9)×109/L对(24.5±15.6)×109/L,P=0.022;(135.2±94.9)×l09/L对(78.2±121.9)× 109/L,P=0.009;(192.0±109.1)×109/L对(95.8±60.5)×109/L,P=0.001].治疗后第28、90天试验组和对照组平均血小板计数差异无统计学意义[(147.8±59.1)×109/L对(105.1±56.9)×109/L,P=0.243;(137.4±52.3)×109/L对(104.3±59.8)×109/L,P=0.568].试验组第7、14、28天的完全反应率(61.3％、87.1％、80.6％)均高于对照组(16.1％、29.0％、48.3％),差异有统计学意义(P＜0.05).试验组和对照组中位起效时间分别为3、5d,中位完全反应持续时间分别为76、54 d;试验组、对照组分别有4、11例患者进行了血小板输注.结论 rhTPO联合糖皮质激素治疗重症新诊断ITP患者,起效时间、血小板增幅、完全反应率及完全反应持续时间均优于单用糖皮质激素方案,不良反应较少且可耐受.
목적 평개중조인혈소판생성소(rhTPO)연합당피질격소치료중증신진단원발면역성혈소판감소증(ITP)적료효화안전성.방법 2009년6월지2012년12월,62례중증신진단ITP환자납입연구,남24례、녀38례,중위년령50(21～84)세.수궤분위시험조(31례)화대조조(31례).시험조급여rhTPO연합당피질격소치료;대조조여이당피질격소치료.결과 시험조치료제3、7화14천적평균혈소판계수균고우대조조[(35.5±24.9)×109/L대(24.5±15.6)×109/L,P=0.022;(135.2±94.9)×l09/L대(78.2±121.9)× 109/L,P=0.009;(192.0±109.1)×109/L대(95.8±60.5)×109/L,P=0.001].치료후제28、90천시험조화대조조평균혈소판계수차이무통계학의의[(147.8±59.1)×109/L대(105.1±56.9)×109/L,P=0.243;(137.4±52.3)×109/L대(104.3±59.8)×109/L,P=0.568].시험조제7、14、28천적완전반응솔(61.3％、87.1％、80.6％)균고우대조조(16.1％、29.0％、48.3％),차이유통계학의의(P＜0.05).시험조화대조조중위기효시간분별위3、5d,중위완전반응지속시간분별위76、54 d;시험조、대조조분별유4、11례환자진행료혈소판수주.결론 rhTPO연합당피질격소치료중증신진단ITP환자,기효시간、혈소판증폭、완전반응솔급완전반응지속시간균우우단용당피질격소방안,불량반응교소차가내수.
Objective To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) combined with glucocorticoid in treatment of severe newly diagnosed primary immune thrombocytopenia(ITP).Methods From June 2009 to December 2012,24 male patients and 38 female patients with the diagnosis of severe primary ITP in our hospital were randomized into trial group (31cases) or control group (31 cases),the median age was 50 years (range:21-84 years).Trial group was treated with rhTPO combined with glucocorticoid,and control group was treated with glucocorticoid only.Results At the day 3,7 and 14 from the beginning of treatment,the average platelet count (APC) in trial group [(35.5±24.9) × 109/L,(135.2±94.9) × 109/L and (192.0±109.1) × 109/L] were significantly higher than that in control group [(24.5± 15.6) × 109/L,(78.2± 121.9) × 109/L and (95.8±60.5) × 109/L,P=0.022,0.009and 0.001,respectively].There was no significant difference in APC between the two groups at day 28 and 90 after treatment [(147.8±59.1)× 109/L vs (105.1±56.9) × 109/L,P=0.243 ; (137.4±52.3) × 109/L vs (104.3±59.8) × 109/L,P=0.568,respectively].At the day 7,14 and 28,the complete response rates in trial group were 61.3％,87.1％ and 80.6％,which were also significantly higher than that in control group (16.1％,29.0％ and 48.3％,P=0.000,0.000 and 0.004,respectively).The median time to response in trial group was 3 days while in the control group was 5 days; the median duration of complete response in trial group was 76 days while in the control group was 54 days.In trial group,there were 4 cases treated with platelet transfusion,while in control group there were 11 cases,respectively.Conclusion For patients with severe primary ITP,rhTPO combined with glucocorticoid could rapidly increase the platelet count,significantly improve the complete response rate and prolonged the effect with a low incidence of tolerable adverse events compared to single use of glucocorticoid.rhTPO combined with glucocorticoid could be a new therapeutic choice to those patients.