兒童急性淋巴細(xì)胞白血病生存率、緩解率、復(fù)發(fā)率和死亡率的多因素分析
發(fā)布時(shí)間：2018-07-28 16:52
【摘要】：目的：采用回顧性隊(duì)列研究方法，收集整理急性淋巴細(xì)胞白血�。ˋLL）患兒的臨床癥狀、體征、實(shí)驗(yàn)室檢查結(jié)果和生存情況。通過對(duì)其入選的22個(gè)研究指標(biāo)進(jìn)行統(tǒng)計(jì)學(xué)分析，計(jì)算ALL患兒的無事件生存率，探討研究指標(biāo)對(duì)無事件生存時(shí)間、緩解率、復(fù)發(fā)率和死亡率的影響。為更科學(xué)的判斷兒童ALL的預(yù)后，正確的評(píng)估ALL患兒的危險(xiǎn)度，選擇合理的個(gè)體化化療方案提供理論依據(jù)。 方法：回顧性的分析2006年01月01日至2012年01月01日于河北醫(yī)科大學(xué)第二醫(yī)院小兒內(nèi)科血液專業(yè)組住院治療的132例ALL患兒。 1、納入標(biāo)準(zhǔn)：①年齡≤14歲。②符合兒童ALL診斷標(biāo)準(zhǔn)。診斷標(biāo)準(zhǔn)依據(jù)《兒童急性淋巴細(xì)胞白血病診療建議（第三次修訂草稿）---2006年》或2010年《兒童急性淋巴細(xì)胞白血病臨床路徑（2010年版）》。排除標(biāo)準(zhǔn)：未經(jīng)我院首診、初治或治療未滿一個(gè)療程的ALL患兒。 2、設(shè)計(jì)病史摘錄表，系統(tǒng)摘錄ALL患兒的性別、發(fā)病年齡、初診時(shí)外周血白細(xì)胞的數(shù)目（WBC）、血紅蛋白的含量(HGB)、血小板的數(shù)目(PLT)、是否有幼稚細(xì)胞、是否有中樞神經(jīng)系統(tǒng)白血�。–NSL）或睪丸白血病、免疫學(xué)分型、融合基因(BCR/ABL)、肝腫大、脾腫大、淋巴結(jié)腫大、潑尼松誘導(dǎo)試驗(yàn)、第19天（D19）骨髓形態(tài)學(xué)檢查、第33天（D33）骨髓形態(tài)學(xué)檢查、肝損傷、肺損傷、治療過程中感染、輸注血液制品、治療過程中的依從性、乳酸脫氫酶（LDH）和治療方案共22個(gè)研究指標(biāo)。 3、設(shè)計(jì)隨訪表，收集統(tǒng)計(jì)ALL患兒的生存情況并計(jì)算生存時(shí)間。 4、分組整理數(shù)據(jù)：性別（男；女）、年齡（1歲或10歲；1歲-10歲）、初診時(shí)外周血WBC（＜50×10~9/L；(50-100)×10~9/L；≥100×10~9/L）、HGB（＜60g/L；≥60g/L）、PLT（＜20×10~9/L；≥20×10~9/L）、幼稚細(xì)胞（無；有）、免疫學(xué)分型（B系；T系）、融合基因（BCR/ABL）（陰性；陽性）、CNSL或睪丸白血�。ǚ�；是）、肝腫大（距離肋緣下的距離）（＜5cm；≥5cm）、脾腫大（距離肋緣下的距離）（＜5cm；≥5cm）、淋巴結(jié)腫大（未觸及；頸部、腋窩、腹股溝淋巴結(jié)可觸及腫大）、潑尼松誘導(dǎo)試驗(yàn)（良好；不良）、D19骨髓形態(tài)學(xué)檢查（原始淋巴細(xì)胞+幼稚淋巴細(xì)胞）（＜5%；≥5%）、D33骨髓形態(tài)學(xué)檢查（原始淋巴細(xì)胞+幼稚淋巴細(xì)胞）（＜5%；≥5%）、化療過程中感染（否；是）、肝損傷（否；是）、肺損傷（否；是）、輸注血液制品（否；是）、治療過程中的依從性（治療是否中斷3月以上）（否；是）、LDH（＜240u/L；≥240u/L）和治療方案（2006方案；臨床路徑；特殊方案）。 5、統(tǒng)計(jì)學(xué)分析：所有數(shù)據(jù)均采用SPSS17.0統(tǒng)計(jì)學(xué)軟件進(jìn)行統(tǒng)計(jì)學(xué)分析。其中采用Kaplan-Meier法計(jì)算三年、五年無事件生存率；采用Log-Rank檢驗(yàn)進(jìn)行生存曲線比較；采用COX風(fēng)險(xiǎn)比例回歸模型進(jìn)行單因素分析，篩選無事件生存時(shí)間的影響因素，進(jìn)一步建立COX風(fēng)險(xiǎn)比例回歸模型進(jìn)行多因素分析，進(jìn)一步篩選無事件生存時(shí)間的影響因素；采用Logistic回歸分析各個(gè)研究指標(biāo)對(duì)緩解率、復(fù)發(fā)率或死亡率的影響；計(jì)量資料均數(shù)計(jì)算采用t檢驗(yàn)；P0.05表示差異有統(tǒng)計(jì)學(xué)意義。 結(jié)果：收集病例共132例，其中包括無事件生存105例(誘導(dǎo)治療未緩解2例，再次誘導(dǎo)治療均達(dá)緩解)，，復(fù)發(fā)19例，死亡8例。緩解率為98.48%，復(fù)發(fā)率為14.39%，死亡率為6.07%。三年無事件生存率為（74.9±0.05）%，五年無事件生存率為（63.3±0.07）%。依據(jù)危險(xiǎn)度分級(jí)將132例ALL患兒劃分為低危組、中危組和高危組。其中低危組52例，中危組42例，高危組38例。低危組三年無事件生存率為（87.2±0.06）%，五年無事件生存率為（71.5±0.10）%。中危組三年無事件生存率為（67.6±0.10）%，五年無事件生存率為（67.6±0.10）%。高危組三年無事件生存率為（63.1±0.10）%，五年無事件生存率為（50.5±0.14）%。不同危險(xiǎn)度分組的ALL患兒進(jìn)行生存曲線比較，差異（P=0.023）存在統(tǒng)計(jì)學(xué)意義。并且隨著危險(xiǎn)度的提高，ALL患兒的無事件生存率下降。COX風(fēng)險(xiǎn)比例回歸模型單因素篩選結(jié)果顯示：免疫學(xué)分型（P=0.005）和依從性(P=0.046)對(duì)ALL患兒的無事件生存時(shí)間有影響。COX風(fēng)險(xiǎn)比例回歸模型多因素分析結(jié)果顯示：免疫學(xué)分型（P=0.005）和依從性(P=0.045)為獨(dú)立的預(yù)后影響因素。 Logistic回歸分析結(jié)果顯示：治療過程中輸入血液制品（P=0.040）可以提高緩解率；融合基因（BCR/ABL）陽性（P=0.004）增加復(fù)發(fā)率；22個(gè)研究指標(biāo)均對(duì)死亡率無影響。132例ALL患兒在化療過程中感染者45例，感染率為34.09%。在感染的ALL患兒中，以呼吸道為主（36例），占80.43%。4例重癥感染ALL患兒均死亡，占ALL死亡患兒的50%。 結(jié)論： 1、兒童ALL的危險(xiǎn)度級(jí)別越高，無事件生存率越低。 2、免疫學(xué)分型和依從性為獨(dú)立的預(yù)后影響因素。B-ALL患兒的無事件生存率明顯的高于T-ALL患兒，堅(jiān)持規(guī)范化治療是預(yù)后良好的重要保證。 3、融合基因（BCR/ABL）陽性增加復(fù)發(fā)率。 4、治療過程中輸入血液制品可以提高緩解率。 5、兒童急性淋巴細(xì)胞白血病化療過程中的感染以呼吸道為主，重癥感染易導(dǎo)致死亡。
[Abstract]:Objective: to collect and collate the clinical symptoms, signs, laboratory results and survival conditions of children with acute lymphoblastic leukemia (ALL) by retrospective cohort study. By statistical analysis of the 22 research indicators selected, the non event survival rate of children with ALL was calculated, and the time of life free survival and mitigation were discussed. The effect of rate, recurrence rate and death rate. To judge the prognosis of ALL in children more scientifically, to evaluate the risk of ALL in children correctly, and to provide the theoretical basis for selecting reasonable individualized chemotherapy scheme.
Methods: a retrospective analysis of 132 ALL children hospitalized in the pediatric department of pediatric department of Hebei Medical University, second hospital from 01 from 01 months to 2012, 2012, 2006.
1, the criteria were included: (1) age less than 14 years of age. (2) compliance with children's ALL diagnostic criteria. Diagnostic criteria were based on the recommendations of children's acute lymphoblastic leukemia (Third Revised Draft) ---2006 > or in 2010 < the clinical pathway of childhood acute lymphoblastic leukemia (2010 Edition) >. ALL children of the course.
2, an excerpt of medical history was designed to systematically extract the sex of ALL children, the age of onset, the number of white blood cells in peripheral blood (WBC), the content of hemoglobin (HGB), the number of platelets (PLT), whether there were naive cells, whether there were central nervous system leukemia (CNSL) or testicular leukemia, immunological typing, fusion gene (BCR/ABL), hepatomegaly, and splenomegaly Large, lymph node swelling, prednisone induction test, nineteenth days (D19) bone marrow morphological examination, thirty-third days (D33) bone marrow morphology examination, liver injury, lung injury, treatment process infection, transfusion of blood products, treatment compliance, lactate dehydrogenase (LDH) and treatment regimen were 22 research indicators.
3, design follow-up table, collect statistics of ALL children's survival and calculate the survival time.
4, group sorting data: sex (male; female), age (1 years or 10 years old; 1 year old -10), WBC (< 50 x 10~9/L; (50-100) * * 10~9/L; > 100 * 10~9/L) at first visit, HGB (< 60g/L; > 60g/L), PLT (< 20 x 10~9/L; > 20 x 10~9/L), infant fine cell (B; Immune), fusion gene (negative; positive) CNSL or testicular leukemia (no; yes), hepatomegaly (distance from the ribbed margin) (< 5cm; > 5cm), splenomegaly (distance from the ribbed margin) (< 5cm; > 5cm), lymph node enlargement (unpalpable; neck, axillary, inguinal lymph node palpable), prednisone induction test (good; bad), D19 bone marrow morphology examination (primitive lymph fines) Cell + infantile lymphocyte) (< 5%; > 5%), D33 bone marrow morphological examination (primary lymphocyte + naive lymphocyte) (< 5%; > 5%), infection (no; yes), liver injury (no; yes), lung injury (no; yes), transfusion of blood products (no; yes), compliance in the course of treatment (whether the treatment was interrupted by March) (no; yes), LDH (no), 240u/L; > 240u/L) and treatment plan (2006 scheme; clinical pathway; special scheme).
5, statistical analysis: all data were statistically analyzed using SPSS17.0 statistics software. Among them, Kaplan-Meier method was used to calculate three years and five years of no event survival rate; Log-Rank test was used to compare the survival curve; COX risk ratio regression model was used for single factor analysis to screen the influence factors of the event free survival time. The COX risk proportional regression model was further established for multi factor analysis, and the influence factors of the event free survival time were further screened. Logistic regression analysis was used to analyze the effect of each research index on the rate of remission, the recurrence rate or the mortality, and the average number of measurement data was calculated by t test, and P0.05 indicated that the difference was statistically significant.
Results: a total of 132 cases were collected, including 105 cases of non event survival (2 cases without remission, 2 remission), 19 cases of recurrence, 8 cases of death. The remission rate was 98.48%, the recurrence rate was 14.39%, the mortality rate was (74.9 + 0.05)% (74.9 + 0.05)%, and the mortality rate of five years was (63.3 + 0.07)%. According to the risk degree. 132 children with ALL were divided into low risk group, middle risk group and high risk group, including 52 cases in low risk group, 42 cases in middle risk group and 38 cases in high risk group. The three year survival rate of low risk group was (87.2 + 0.06)%, and the survival rate of five years was (71.5 + 0.10)%. The non event survival rate in the middle risk group three years was (67.6 + 0.10)%, and the non event survival rate was (87.2)%. The three year non event survival rate of the high-risk group was (63.1 + 0.10)%, and the five year event free survival rate was (50.5 + 0.14)%. The survival curve of ALL children with different risk groups was compared, the difference (P=0.023) was statistically significant. And with the increase of risk, the survival rate of ALL children decreased by the.COX risk proportion regression model single factor screening knot. The results showed that immunological typing (P=0.005) and compliance (P=0.046) had influence on the event free survival time of children with ALL. The multifactor analysis of the.COX risk proportional regression model showed that immunological typing (P=0.005) and compliance (P=0.045) were independent prognostic factors. The results of Logistic regression analysis showed that the input of blood in the treatment process was in the course of treatment. P=0.040 could increase the remission rate, and the fusion gene (BCR/ABL) positive (P=0.004) increased the recurrence rate; the 22 study indexes had no effect on the mortality of.132 cases in children with ALL in the chemotherapy process, the infection rate was 34.09%. in the infected ALL children, and the respiratory tract was the main (36 cases), and all of the children with severe infection of ALL in 80.43%.4 cases were all dead. 50%. in children with ALL death
Conclusion:
1, the higher the risk level of children's ALL, the lower the event free survival rate.
2, immunological classification and compliance are independent prognostic factors of.B-ALL children's non event survival rate is significantly higher than that of children with T-ALL, and adherence to standardized treatment is an important guarantee for good prognosis.
3, the fusion gene (BCR/ABL) positive increased the recurrence rate.
4, blood products can increase the remission rate during treatment.
5, the infection of children with acute lymphoblastic leukemia during chemotherapy is mainly respiratory tract, and severe infection can easily lead to death.
【學(xué)位授予單位】：河北醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2012
【分類號(hào)】：R733.7
本文編號(hào)：2150938
[Abstract]:Objective: to collect and collate the clinical symptoms, signs, laboratory results and survival conditions of children with acute lymphoblastic leukemia (ALL) by retrospective cohort study. By statistical analysis of the 22 research indicators selected, the non event survival rate of children with ALL was calculated, and the time of life free survival and mitigation were discussed. The effect of rate, recurrence rate and death rate. To judge the prognosis of ALL in children more scientifically, to evaluate the risk of ALL in children correctly, and to provide the theoretical basis for selecting reasonable individualized chemotherapy scheme.
Methods: a retrospective analysis of 132 ALL children hospitalized in the pediatric department of pediatric department of Hebei Medical University, second hospital from 01 from 01 months to 2012, 2012, 2006.
1, the criteria were included: (1) age less than 14 years of age. (2) compliance with children's ALL diagnostic criteria. Diagnostic criteria were based on the recommendations of children's acute lymphoblastic leukemia (Third Revised Draft) ---2006 > or in 2010 < the clinical pathway of childhood acute lymphoblastic leukemia (2010 Edition) >. ALL children of the course.
2, an excerpt of medical history was designed to systematically extract the sex of ALL children, the age of onset, the number of white blood cells in peripheral blood (WBC), the content of hemoglobin (HGB), the number of platelets (PLT), whether there were naive cells, whether there were central nervous system leukemia (CNSL) or testicular leukemia, immunological typing, fusion gene (BCR/ABL), hepatomegaly, and splenomegaly Large, lymph node swelling, prednisone induction test, nineteenth days (D19) bone marrow morphological examination, thirty-third days (D33) bone marrow morphology examination, liver injury, lung injury, treatment process infection, transfusion of blood products, treatment compliance, lactate dehydrogenase (LDH) and treatment regimen were 22 research indicators.
3, design follow-up table, collect statistics of ALL children's survival and calculate the survival time.
4, group sorting data: sex (male; female), age (1 years or 10 years old; 1 year old -10), WBC (< 50 x 10~9/L; (50-100) * * 10~9/L; > 100 * 10~9/L) at first visit, HGB (< 60g/L; > 60g/L), PLT (< 20 x 10~9/L; > 20 x 10~9/L), infant fine cell (B; Immune), fusion gene (negative; positive) CNSL or testicular leukemia (no; yes), hepatomegaly (distance from the ribbed margin) (< 5cm; > 5cm), splenomegaly (distance from the ribbed margin) (< 5cm; > 5cm), lymph node enlargement (unpalpable; neck, axillary, inguinal lymph node palpable), prednisone induction test (good; bad), D19 bone marrow morphology examination (primitive lymph fines) Cell + infantile lymphocyte) (< 5%; > 5%), D33 bone marrow morphological examination (primary lymphocyte + naive lymphocyte) (< 5%; > 5%), infection (no; yes), liver injury (no; yes), lung injury (no; yes), transfusion of blood products (no; yes), compliance in the course of treatment (whether the treatment was interrupted by March) (no; yes), LDH (no), 240u/L; > 240u/L) and treatment plan (2006 scheme; clinical pathway; special scheme).
5, statistical analysis: all data were statistically analyzed using SPSS17.0 statistics software. Among them, Kaplan-Meier method was used to calculate three years and five years of no event survival rate; Log-Rank test was used to compare the survival curve; COX risk ratio regression model was used for single factor analysis to screen the influence factors of the event free survival time. The COX risk proportional regression model was further established for multi factor analysis, and the influence factors of the event free survival time were further screened. Logistic regression analysis was used to analyze the effect of each research index on the rate of remission, the recurrence rate or the mortality, and the average number of measurement data was calculated by t test, and P0.05 indicated that the difference was statistically significant.
Results: a total of 132 cases were collected, including 105 cases of non event survival (2 cases without remission, 2 remission), 19 cases of recurrence, 8 cases of death. The remission rate was 98.48%, the recurrence rate was 14.39%, the mortality rate was (74.9 + 0.05)% (74.9 + 0.05)%, and the mortality rate of five years was (63.3 + 0.07)%. According to the risk degree. 132 children with ALL were divided into low risk group, middle risk group and high risk group, including 52 cases in low risk group, 42 cases in middle risk group and 38 cases in high risk group. The three year survival rate of low risk group was (87.2 + 0.06)%, and the survival rate of five years was (71.5 + 0.10)%. The non event survival rate in the middle risk group three years was (67.6 + 0.10)%, and the non event survival rate was (87.2)%. The three year non event survival rate of the high-risk group was (63.1 + 0.10)%, and the five year event free survival rate was (50.5 + 0.14)%. The survival curve of ALL children with different risk groups was compared, the difference (P=0.023) was statistically significant. And with the increase of risk, the survival rate of ALL children decreased by the.COX risk proportion regression model single factor screening knot. The results showed that immunological typing (P=0.005) and compliance (P=0.046) had influence on the event free survival time of children with ALL. The multifactor analysis of the.COX risk proportional regression model showed that immunological typing (P=0.005) and compliance (P=0.045) were independent prognostic factors. The results of Logistic regression analysis showed that the input of blood in the treatment process was in the course of treatment. P=0.040 could increase the remission rate, and the fusion gene (BCR/ABL) positive (P=0.004) increased the recurrence rate; the 22 study indexes had no effect on the mortality of.132 cases in children with ALL in the chemotherapy process, the infection rate was 34.09%. in the infected ALL children, and the respiratory tract was the main (36 cases), and all of the children with severe infection of ALL in 80.43%.4 cases were all dead. 50%. in children with ALL death
Conclusion:
1, the higher the risk level of children's ALL, the lower the event free survival rate.
2, immunological classification and compliance are independent prognostic factors of.B-ALL children's non event survival rate is significantly higher than that of children with T-ALL, and adherence to standardized treatment is an important guarantee for good prognosis.
3, the fusion gene (BCR/ABL) positive increased the recurrence rate.
4, blood products can increase the remission rate during treatment.
5, the infection of children with acute lymphoblastic leukemia during chemotherapy is mainly respiratory tract, and severe infection can easily lead to death.
【學(xué)位授予單位】：河北醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2012
【分類號(hào)】：R733.7
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