国际输血及血液学杂志
國際輸血及血液學雜誌
국제수혈급혈액학잡지
INTERNATIONAL JOURNAL OF BLOOD TRANSFUSION AND HEMATOLOGY
2015年
1期
28-32
,共5页
骨髓增生异常综合征%粒细胞集落刺激因子%阿柔比星%阿糖胞苷%药物治疗,联合
骨髓增生異常綜閤徵%粒細胞集落刺激因子%阿柔比星%阿糖胞苷%藥物治療,聯閤
골수증생이상종합정%립세포집락자격인자%아유비성%아당포감%약물치료,연합
Myelodysplastic syndromes%Granulocyte colony-stimulating factor%Aclarubicin%Cytarabine%Drug therapy,combination
目的 探讨阿糖胞苷(Ara-C)、阿柔比星(Acla)联合粒细胞集落刺激因子(G-CSF)治疗骨髓增生异常综合征(MDS)的临床疗效及安全性.方法 选择2011年1月至2013年1月,深圳市第四人民医院收治的初治MDS患者56例为研究对象.按照随机数字表法将其分为研究组(n=28)与对照组(n=28).研究组予以Ara-C、Acla联合G-CSF治疗,对照组按照标准化方案治疗.对两组的临床疗效、外周血常规结果及骨髓细胞原始比例、不良反应发生情况、巩固及维持治疗及生存情况进行统计学分析.本研究征得受试对象的知情同意,并与之签署临床研究知情同意书.两组患者的年龄、性别构成比、病程、疾病类型构成比及危险分型构成比与治疗前白细胞计数、血小板计数、血红蛋白(Hb)水平、中性粒细胞(Neut)计数及骨髓原始细胞比例等一般临床资料比较,差异均无统计学意义(P＞0.05).结果 ①研究组完全缓解(CR)率、治疗总有效率分别为50.0％(14/28)与82.1％(23/28),均显著高于对照组的32.1％(9/28)与53.6％(15/28),差异均有统计学意义(P＜0.05).②治疗后,研究组患者白细胞计数、血小板计数、Hb水平及Neut计数均显著高于对照组,骨髓原始细胞比例显著低于对照组,差异均有统计学意义(P＜0.05).治疗后,研究组组内白细胞计数、血小板计数、Hb水平及Neut计数较治疗前,均显著提高,骨髓原始细胞比例则显著下降,差异均有统计学意义(P＜0.05).治疗后,对照组组内白细胞计数与治疗前比较,差异无统计学意义(P＞0.05),而血小板计数、Hb水平及Neut计数则均较治疗前显著提高,骨髓原始细胞比例显著下降,差异均有统计学意义(P＜0.05).③研究组Ⅲ～Ⅳ级骨髓抑制、肺部感染、口腔溃疡及胃肠道等不良反应发生率均显著低于对照组,差异均有统计学意义(x2=12.847,17.044,7.212,14.684;P＜0.05).④研究组急性髓细胞白血病(AML)转化率(14.3％,4/28)显著低于对照组(25.0％,7/28),且差异有统计学意义(P＜0.05);研究组患者中位总体生存时间(22.0个月)较对照组(18.2个月)显著延长,差异有统计学意义(P＜0.05).结论 应用Ara-C、Acla联合G-CSF治疗MDS,治疗疗效显著,不良反应较少.因本研究纳入样本量较小,该方案是否为安全、可靠的治疗方案而值得临床推广应用,尚需多中心、大样本的前瞻性随机对照试验进一步研究证实.
目的 探討阿糖胞苷(Ara-C)、阿柔比星(Acla)聯閤粒細胞集落刺激因子(G-CSF)治療骨髓增生異常綜閤徵(MDS)的臨床療效及安全性.方法 選擇2011年1月至2013年1月,深圳市第四人民醫院收治的初治MDS患者56例為研究對象.按照隨機數字錶法將其分為研究組(n=28)與對照組(n=28).研究組予以Ara-C、Acla聯閤G-CSF治療,對照組按照標準化方案治療.對兩組的臨床療效、外週血常規結果及骨髓細胞原始比例、不良反應髮生情況、鞏固及維持治療及生存情況進行統計學分析.本研究徵得受試對象的知情同意,併與之籤署臨床研究知情同意書.兩組患者的年齡、性彆構成比、病程、疾病類型構成比及危險分型構成比與治療前白細胞計數、血小闆計數、血紅蛋白(Hb)水平、中性粒細胞(Neut)計數及骨髓原始細胞比例等一般臨床資料比較,差異均無統計學意義(P＞0.05).結果 ①研究組完全緩解(CR)率、治療總有效率分彆為50.0％(14/28)與82.1％(23/28),均顯著高于對照組的32.1％(9/28)與53.6％(15/28),差異均有統計學意義(P＜0.05).②治療後,研究組患者白細胞計數、血小闆計數、Hb水平及Neut計數均顯著高于對照組,骨髓原始細胞比例顯著低于對照組,差異均有統計學意義(P＜0.05).治療後,研究組組內白細胞計數、血小闆計數、Hb水平及Neut計數較治療前,均顯著提高,骨髓原始細胞比例則顯著下降,差異均有統計學意義(P＜0.05).治療後,對照組組內白細胞計數與治療前比較,差異無統計學意義(P＞0.05),而血小闆計數、Hb水平及Neut計數則均較治療前顯著提高,骨髓原始細胞比例顯著下降,差異均有統計學意義(P＜0.05).③研究組Ⅲ～Ⅳ級骨髓抑製、肺部感染、口腔潰瘍及胃腸道等不良反應髮生率均顯著低于對照組,差異均有統計學意義(x2=12.847,17.044,7.212,14.684;P＜0.05).④研究組急性髓細胞白血病(AML)轉化率(14.3％,4/28)顯著低于對照組(25.0％,7/28),且差異有統計學意義(P＜0.05);研究組患者中位總體生存時間(22.0箇月)較對照組(18.2箇月)顯著延長,差異有統計學意義(P＜0.05).結論 應用Ara-C、Acla聯閤G-CSF治療MDS,治療療效顯著,不良反應較少.因本研究納入樣本量較小,該方案是否為安全、可靠的治療方案而值得臨床推廣應用,尚需多中心、大樣本的前瞻性隨機對照試驗進一步研究證實.
목적 탐토아당포감(Ara-C)、아유비성(Acla)연합립세포집락자격인자(G-CSF)치료골수증생이상종합정(MDS)적림상료효급안전성.방법 선택2011년1월지2013년1월,심수시제사인민의원수치적초치MDS환자56례위연구대상.안조수궤수자표법장기분위연구조(n=28)여대조조(n=28).연구조여이Ara-C、Acla연합G-CSF치료,대조조안조표준화방안치료.대량조적림상료효、외주혈상규결과급골수세포원시비례、불량반응발생정황、공고급유지치료급생존정황진행통계학분석.본연구정득수시대상적지정동의,병여지첨서림상연구지정동의서.량조환자적년령、성별구성비、병정、질병류형구성비급위험분형구성비여치료전백세포계수、혈소판계수、혈홍단백(Hb)수평、중성립세포(Neut)계수급골수원시세포비례등일반림상자료비교,차이균무통계학의의(P＞0.05).결과 ①연구조완전완해(CR)솔、치료총유효솔분별위50.0％(14/28)여82.1％(23/28),균현저고우대조조적32.1％(9/28)여53.6％(15/28),차이균유통계학의의(P＜0.05).②치료후,연구조환자백세포계수、혈소판계수、Hb수평급Neut계수균현저고우대조조,골수원시세포비례현저저우대조조,차이균유통계학의의(P＜0.05).치료후,연구조조내백세포계수、혈소판계수、Hb수평급Neut계수교치료전,균현저제고,골수원시세포비례칙현저하강,차이균유통계학의의(P＜0.05).치료후,대조조조내백세포계수여치료전비교,차이무통계학의의(P＞0.05),이혈소판계수、Hb수평급Neut계수칙균교치료전현저제고,골수원시세포비례현저하강,차이균유통계학의의(P＜0.05).③연구조Ⅲ～Ⅳ급골수억제、폐부감염、구강궤양급위장도등불량반응발생솔균현저저우대조조,차이균유통계학의의(x2=12.847,17.044,7.212,14.684;P＜0.05).④연구조급성수세포백혈병(AML)전화솔(14.3％,4/28)현저저우대조조(25.0％,7/28),차차이유통계학의의(P＜0.05);연구조환자중위총체생존시간(22.0개월)교대조조(18.2개월)현저연장,차이유통계학의의(P＜0.05).결론 응용Ara-C、Acla연합G-CSF치료MDS,치료료효현저,불량반응교소.인본연구납입양본량교소,해방안시부위안전、가고적치료방안이치득림상추엄응용,상수다중심、대양본적전첨성수궤대조시험진일보연구증실.
Objective To investigate the efficacy and safety of arabinoside cytosine (Ara-c) and aclarubicin (Acla) combined with granulocyte colony stimulating factor (G-CSF) in treatment of myelodysplastic syndrome (MDS).Methods From January 2011 to January 2013,a total of 56 cases of newly diagnosed MDS patients from the Fourth People's Hospital of Shenzhen were randomly divided into study group (n=28) and control group (n=28).Study group were given Ara-c,Acla and G-CSF treatment and control group were given standardized chemotherapy treatment.The clinical efficacy,peripheral blood and percentage of bone marrow blast cells,adverse reactions,maintenance therapy and survival of two groups were compared.Informed consent was obtained from all participants in the study.There were no significant differences between two groups among age,gender,course of disease,type of disease,International Prognostic Scoring System (IPSS) typing,platelet count,hemoglobin (Hb) level,neutrophil (Neut) count and percentage of bone marrow blast cells (P＞0.05).Results ① The complete remission (CR) rate of study group was 50.0％ (14/28),which was significantly higher than that of control group (32.1 ％,9/28),and the difference was statistically significant (P＜0.05).The total effective rate of study group was 82.1％ (23/28),which was significantly higher than that of control group (53.6 ％,15/28),and the difference was statistically significant (P＜ 0.05).② After treatment,the white blood cell count,platelet count,Hb level and Neut count of study group were significantly higher than those of control group,while percentage of bone marrow blast cells was significantly lower than that of control group,and all the differences were statistically significant (P＜0.05).After treatment,the white blood cell count,platelet count,Hb level and Neut count in study group improved,while the percentage of bone marrow blast cells decreased,and all the differences were statistically significant (P＜0.05).White blood cell count in control group did not changed,and the difference was not statistically significant (P＞0.05),while platelet count,Hb level and Neut count in control group all increased compared with before treatment,and the percentage of bone marrow blast cells decreased,all the differences were statistically significant (P＜0.05).③ The rate of Ⅲ ～ Ⅳ grade bone marrow suppression,lung infections,mouth ulcers and gastrointestinal side effects in study group were significantly lower than those in control group,and the differences were statistically significant (x2 =12.847,17.044,7.212,14.684; P＜0.05).④ Acute myelocytic leukemia (AML) transformation rate of study group was significantly lower than that of control group (14.3％ vs 25.0％,P＜0.05).The median overall survival time of study group was significantly longer than that of the control group (22.0 months vs 18.2 months,P＜0.05).Conclusions Ara-c and Acla combined with G-CSF therapeutic regimen for MDS has significant treatment efficiency and fewer adverse reactions.As the sample size of this study is small,whether it is a safe and reliable treatment options and worthy of clinical application,it still needs more multi-center,large randomized controlled trials to confirm.
