CAJ | 학술논문

目的探讨沙利度胺(thalidomide,Thal)治疗多发性骨髓瘤(MM)患者的疗效及安全性.方法回顾性分析Thal单药及联合其他化疗方案治疗102例MM患者的疗效及不良反应.结果 ①102例患者共接受Thal治疗139例次,中位用药剂量200 mg/d.②52例次患者诱导治疗的有效[完全缓解(CR)+部分缓解(PR)]率为65.4%,66例次患者挽救治疗有效率为45.5%.其中Thal单药治疗13例次,联合化疗105例次;联合组的有效率优于单药组(分别为58.1%和23.1%,P=0.017),无反应和疾病进展(NR)率低于单药组(分别为15.2%和46.2%,P=0.015).联合组中,50例次初治患者NR率低于55例次复发和难治患者(分别为6.0%和23.6%,P=0.012);72例次Thal联合VAD(长春新碱、多柔比星和地塞米松)或M2[长春新碱、苯丙氨酸氮芥(马法兰)、卡氮芥、环磷酰胺和泼尼松]等静脉用药方案的患者与33例次联合MP(苯丙氨酸氮芥和泼尼松)等非静脉用药方案的患者有效率分别为62.5%和48.5%,差异无统计学意义.③采用Thal维持治疗的患者用药至疾病进展的中位时间为15.5(1～58)个月.④在可随访的97例患者中,患者使用Thal的中位用药时间为8(1～46)个月.中位随访20(1～67)个月,预计中位总体生存(OS)期为44个月.单因素分析显示累计用药时间长于6个月(P=0.0014),治疗前骨髓涂片巨核细胞多于20个/片(P=0.0101),血红蛋白浓度大于100 g/L(P=0.019)的患者OS期较长.⑤多因素分析显示累计用药时间长于6个月[P=0.006,相对危险度(RR)0.430],骨髓涂片巨核细胞多于20个/片(P=0.036,RR 0.502)是OS期的预后良好因素.⑥患者对Thal治疗的不良反应多可耐受,血栓性疾病发生率显著低于国外文献报道.结论 Thal单药或联合化疗对MM患者有疗效.累计用药时间达6个月者可以显著提高OS时间.
목적 탐토사리도알(thalidomide,Thal)치료다발성골수류(MM)환자적료효급안전성.방법 회고성분석Thal단약급연합기타화료방안치료102례MM환자적료효급불량반응.결과 ①102례환자공접수Thal치료139례차,중위용약제량200 mg/d.②52례차환자유도치료적유효[완전완해(CR)+부분완해(PR)]솔위65.4%,66례차환자만구치료유효솔위45.5%.기중Thal단약치료13례차,연합화료105례차;연합조적유효솔우우단약조(분별위58.1%화23.1%,P=0.017),무반응화질병진전(NR)솔저우단약조(분별위15.2%화46.2%,P=0.015).연합조중,50례차초치환자NR솔저우55례차복발화난치환자(분별위6.0%화23.6%,P=0.012);72례차Thal연합VAD(장춘신감、다유비성화지새미송)혹M2[장춘신감、분병안산담개(마법란)、잡담개、배린선알화발니송]등정맥용약방안적환자여33례차연합MP(분병안산담개화발니송)등비정맥용약방안적환자유효솔분별위62.5%화48.5%,차이무통계학의의.③채용Thal유지치료적환자용약지질병진전적중위시간위15.5(1～58)개월.④재가수방적97례환자중,환자사용Thal적중위용약시간위8(1～46)개월.중위수방20(1～67)개월,예계중위총체생존(OS)기위44개월.단인소분석현시루계용약시간장우6개월(P=0.0014),치료전골수도편거핵세포다우20개/편(P=0.0101),혈홍단백농도대우100 g/L(P=0.019)적환자OS기교장.⑤다인소분석현시루계용약시간장우6개월[P=0.006,상대위험도(RR)0.430],골수도편거핵세포다우20개/편(P=0.036,RR 0.502)시OS기적예후량호인소.⑥환자대Thal치료적불량반응다가내수,혈전성질병발생솔현저저우국외문헌보도.결론 Thal단약혹연합화료대MM환자유료효.루계용약시간체6개월자가이현저제고OS시간.
Objective To analyse the efficacy and safety of thalidomide(Thal)for patients with multiple myeloma(MM).Methods Effectiveness and adverse events of 102 MM patients treated with thalidomide at a median dosage of 200 mg/d.Thirteen cases were treated with Thal alone(group A),and 105 case with Thal in combination with other therapeutic agents(group B)were retrospectively analyzed.Result ① The response rate(RR)(CR+PR)was 65.4%for induction therapy in 52 cases and 45.5%for salvage therapy in 66 eases.RR in group B was higher than that in group A(58.1%versus 23.1/%,P=0.017),and the non-response/progress(NR)rate was lower(15.2%versus 46.2%,P=0.015).In group B,the NR rate was lower in 50 cases of newly diagnosed MM than in 55 cases of refractory or relapsed MM(6.0%versus 23.6%,P=0.012).In group B,RR between Thal+VAD or M2 regimen(72 cases)and Thal+MP regimen(33 cases)was not statistically significant(62.5%versus 48.5%,P＞0.05).(2)The median duration of response maintenance was 15.5(1.0～58.0)months in 21 cases. ③Among 97 patients with follow-up data,the estimated median duration of OS was 44 months in a median follow-up duration of 20 months and the accumulative time for use of Thal was 8 months.In univariate analysis.the accumulative duration for use of Thal≥6 months,hemoglobin≥100 g/L and bone marrow megakaryocytes＞20 per smear were associated with longet OS(P=0.0014,0.0101,0.019,respectively).④Multivariate analysis suggested that the accumulativetime for use of Thal and bone marrow megakaryocytes＞20 were independent good prognostic factors for OS(P=0.006,0.036,respectively).⑤The adverse events of Thal were mostly endurable,the rate of thrombus events was lower than that reposed in literature.Conclusion Thalidomide alone or combined with chemotherapy is an useful therapy for MM.The accumulative time for use longer than 6 months may improve survival.