重组人促红细胞生成素预治早产儿贫血的临床研究

为探讨重组人促红细胞生成素 (r HuEPO)防治早产儿贫血的疗效 ,将 5 2例早产儿按入院顺序随机分成治疗组 2 7例 ,对照组 2 5例。治疗组于生后 1周内给予rHu EPO 2 0 0IU/(kg·w) ,一周两次 ,皮下注射 ,共 6周 ;对照组未予rHu EPO。两组早产儿均给予口服铁剂 ,元素铁 3mg/(kg·d) ,每周增加 2mg/(kg·d) ,维生素E 2 5mg/d。必要时输血 ,共观察 7周。结果显示 :两组早产儿生后其血红蛋白值 (Hb)均逐渐下降 ,但程度不同。治疗组程度较轻 ,于第 6周时降至最低点 (118 0 4± 9 5 6g/L) ,第 7周时开始上升 ;治疗结束时二者差异显著 (P <0 0 0 1)。治疗组与第 2周开始网织红细胞计数 (Ret)较对照组明显升高 (P <0 0 0 1) ,于第 3周达到峰值 ,治疗结束时两组Ret无明显差异 (P >0 0 5 )。治疗组血清铁 (SI)第 2周时较对照组明显降低(P <0 0 0 1) ,第 4周时降至最低 (8 76± 1 84umol L) ,治疗结束时两组SI无明显差异(P >0 0 5 )。治疗组输血率 (7 4% )较对照组 (3 6% )明显减少 (P <0 0 5 )。两组早产儿治疗结束时体重无明显差异 (P >0 0 5 )。观察期间未发现明显副作用。结论 ,早期应用 (生后 1周以内 )rHu EPO能有效地减轻早产儿的贫血程度 ,并减少输血次数。     

重组人促红细胞生成素对早产儿神经行为发育的影响

目的探讨重组人促红细胞生成素对早产儿神经行为发育的影响。方法将40例早产儿按入院先后次序分为促红细胞生成素治疗组和对照组各20例,治疗组于生后第5天给予重组人促红细胞生成素250IU/kg,每周3次,疗程4周,其它治疗措施同对照组。两组早产儿均于纠正胎龄40周时进行新生儿行为神经测定,在纠正年龄3个月、12个月时采用婴幼儿智能发育量表评估神经系统发育情况。结果治疗组早产儿在纠正胎龄40周时的行为神经测定得分(38.10±0.91)分,明显高于对照组的(36.1±1.59)分(P<0.01)。3个月和12个月时进行的智能发育评估显示智力发育指数和心理运动发育指数在促红细胞生成素治疗组明显高于对照组(P<0.05)。结论重组人促红细胞生成素对早产儿神经行为发育有促进作用。     

重组人促红细胞生成素对早产儿贫血和细胞免疫功能的影响

目的　观察重组人促红细胞生成素 (rHu Epo)对早产儿贫血的预防和细胞免疫功能的影响。 方法　将 6 0例早产儿随机分为治疗组和对照组各 30例 ,治疗组用rHu Epo 6 0 0IU/kg ,隔日一次× 6周 ,加常规治疗[速力菲 8mg/ (kg·d) ,VitC 0 .1Bid ;VitE 10mg ,qd],对照组仅用常规治疗。两组同时监测红细胞计数 (RBC)、血红蛋白 (Hb)、网织红细胞 (Ret) )、血清铁和细胞免疫功能的变化。结果　疗程结束后治疗组Ret 2 .0 7% ,对照组 0 .80 9% ,两组Ret相差 10个百分点左右。治疗组血清铁 13μmol/L ,对照组 2 2 .13μmol/L ,P<0 .0 1。治疗组贫血发生率 3.3% ,对照组 6 3.4% ,P <0 .0 1,两组贫血症状有明显差异。结论　rHu Epo能预防早产儿贫血     

重组人类促红细胞生成素防治早产儿贫血的临床研究

目的探讨重组人类促红细胞生成素(rHu-Epo)防治早产儿贫血的疗效.方法将33例早产儿按入院次序分成治疗组17例,对照组16例.治疗组出生第1周即予rHu-Epo500IU*kg-1*w-1,隔日1次,每周3次皮下注射,共5周;对照组未予rHu-Epo治疗.两组早产儿生后第3周开始口服铁剂[元素铁5mg*kg-1*d-1],必要时输血,共观察7周.结果治疗组第2周开始网织红细胞较对照组明显升高(P＜0.01),第3周后渐下降但与对照组比较仍有显著差异(P＜0.05);两组患儿出生后Hb均渐下降,但治疗组程度较轻,最低Hb值较对照组高(P＜0.01),达最低Hb值的时间较对照组早(P＜0.01).治疗组血清铁蛋白第2周开始较对照组低(P＜0.01).治疗组输血率与对照组比较明显减少(P＜0.05).观察期末治疗组早产儿体重增长的速率较对照组高(P＜0.05).结论早期大剂量rHu-Epo能减轻早产儿贫血的程度,减少或避免输血;体内充足的铁储备是确保rHu-Epo疗效的重要因素.     

早期应用重组人促红细胞生成素对早产儿脑白质发育的影响

目的 应用磁共振弥散张量成像（DTI）的部分各项异性参数（FA）评价早期应用重组人促红细胞生成素（rhEPO）对早产儿脑白质发育的影响。方法 以81例胎龄≤ 32周、出生体重 < 1 500 g、生后24 h内住院的早产儿为研究对象,随机分为两组：rhEPO组（42例）使用rhEPO治疗,对照组（39例）使用等体积的生理盐水注射。2组均于纠正胎龄35~37周行头部MRI、DWI、DTI检查,并测定相同感兴趣区的部分各项异性参数（FA）。结果 两组早产儿颅内出血、脑室周围白质软化、局灶性脑白质损伤、广泛性脑白质损伤等发生率的差异无统计学意义（P > 0.05）。rhEPO组早产儿内囊后肢、胼胝体压部、额叶白质、枕叶白质FA值高于对照组（P < 0.05）,2组早产儿顶叶白质、丘脑、豆状核、尾状核FA值的差异无统计学意义（P > 0.05）。结论 早期应用重组人红细胞生成素对早产儿脑白质发育有神经保护作用。     

促红细胞生成素对早产儿脑损伤的保护作用

随着产科和新生儿重症监护治疗技术的发展和早产儿存活率的不断提高，早产儿脑损伤问题也日益突出。在围产期发生的早产儿脑损伤可造成远期神经系统发育障碍，其中脑性瘫痪占了很大部分，而25％-50％则表现为轻度神经发育障碍，后者不仅涉及运动功能，也涉及到认知和行为，从而引起学习障碍。采取有效的方法阻止和改善神经系统的损伤，可能对早产儿脑损伤起到一定的保护作用。     

国产重组人类促红细胞生成素防治早产儿贫血的临床效果研究

为评价国产重组人类促红细胞生成素（rhEPO）防治早产儿贫血的效果和安全性，将40例胎龄≤34周的早产儿随机分为治疗组及对照组各20例。治疗组予国产rhEPO750IU／（kg.w），每周分3次皮下注射，用药6周；对照组未用rhEPO；两组早产儿均口服铁剂。结果显示治疗组用药后血清促工细胞生成素水平显著高于对照组（P＜0．01）；治疗组血红蛋白、红细胞压积比、网积红细胞显著高于对照组（P＜0．01）；血清铁蛋白水平在用药后治疗组明显低于对照组（P＜0．01）；治疗组输血率较对照组明显减少（P＜0．01）；治疗组体重增长指标高于对照组9P＜0．05）。研究提示，国产rhEPO能有效防治早产儿贫血，且用药安全，无明显副作用。     

红细胞生成素与早产儿贫血

早产儿贫血一直是新生儿领域十分受人关注的问题，其病因至今尚未完全清楚，近年来红细胞生成素（ｅｒｙｔｈｒｏｐｏｉｅｔｉｎ，ＥＰＯ）水平低下逐渐受到重视，并认为是导致早产儿贫血的首要因素。临床上也开始应用重组人类ＥＰＯ（ｒｈＥＰＯ）治疗早产儿贫血，并取得了令人鼓舞的效果。     

重组人类促红细胞生成素预防极低出生体重儿贫血的研究

目的　评价重组人类促红细胞生成素 (rhu EPO)在相同剂量下不同应用频度对预防极低出生体重儿(VLBWI)贫血的效果。方法　将东南大学附属徐州医院儿科 2 0 0 1年 9月至 2 0 0 3年 9月收治的 2 2例VLBWI随机分成两组 ,均在出生第 8天开始予rhu EPO ,每周 75 0IU/kg ,共 6周。Ⅰ组 (12例 )每周 3次给药 ;Ⅱ组 (10例 )每周 1次给药。另设未予rhu EPO的 12例VLBWI作为对照组 (Ⅲ组 )。动态观察血红蛋白、红细胞计数、红细胞压积比等。结果　 (1) 3组患儿在出生第 2 8天血红蛋白值的差异均有统计学意义 (P <0 0 1) ,出生第 6 4天的差异有统计学意义 (P <0 0 1) ,但Ⅰ、Ⅱ组间 P =0 0 5 2。 (2 ) 3组患儿在出生第 2 8天红细胞计数的差异均有统计学意义(P <0 0 1) ,出生第 6 4天的差异有统计学意义 (P <0 0 1) ,但Ⅰ、Ⅱ组间P =0 0 74。 (3) 3组患儿在出生第 2 8天红细胞压积比的差异有统计学意义 (P <0 0 1) ,但Ⅰ、Ⅱ组间P =0 14 0 ,出生第 6 4天的差异有统计学意义 (P <0 0 1) ,但Ⅰ、Ⅱ组间P =0 195。结论　在rhu EPO相同的每周总量下 ,每周 3次给药比每周 1次给药能明显提高VLBWI的血红蛋白及红细胞计数     

Effect of recombinant human erythropoietin on transfusion needs in preterm infants

OBJECTIVE: To study the efficacy, safety and cost effectiveness of recombinant human erythropoietin (r-HuEPO) in reducing erythrocyte transfusion needs in very low birthweight (VLBW) infants. METHODS: We conducted a non-blind randomized controlled trial and assigned 100 VLBW infants, less than 33 weeks gestation, to receive either r-HuEPO 750 U/kg per week subcutaneously from day 5 to day 40 or no erythropoietin (EPO). Infants received oral iron 3-6 mg/kg per day from day 10. Transfusion needs were analysed for all enrolled infants and in five weight subgroups: birthweight of less than 600 g, 600-799 g, 800-999 g, 1000-1199 g and infants more than 1200 g. RESULTS: VLBW infants on r-HuEPO attained higher reticulocyte counts and haematocrit than control infants but the mean number of transfusions and volume of erythrocyte transfused per infant were not statistically different. Of infants 800-999 g at birth, the mean number of transfusions per infant was 2.1 compared with 3.5 transfusions per control infant (P = 0.04). Volume of erythrocytes transfused was 34.9 +/- 32.1 mL/kg in r-HuEPO-treated infants and 56.6 +/- 25.8 mL/kg in control infants (P = 0.03). The cost per patient for transfusion and EPO was S$388 for r-HuEPO recipient and S$438 for control infant. Blood pressure, neutrophil count, platelet count and complications of prematurity were not significantly different in both groups of VLBW infants. CONCLUSION: r-HuEPO at 750 U/kg per week stimulates erythropoiesis in VLBW infants but significantly reduces the need for erythrocyte transfusion only in infants weighing 800-999 g at birth.     

重组人促红细胞生成素对极低出生体重儿神经智能发育的影响

目的 评估早期给予重组人促红细胞生成素（rhEPO）对极低出生体重儿（VLBWI）神经智能发育的临床疗效。方法 选取VLBWI 78例,根据患儿父母的选择分为rhEPO治疗组（n=35）与对照组（n=43）。治疗组生后4~5 h内给予rhEPO（250 IU/kg,每周3次,连用4周）。纠正胎龄40周时行新生儿神经行为检测（NBNA）,纠正胎龄3月、6月、12月时进行Gesell发育量表评估,并比较纠正胎龄6月时脑干诱发电位（ABR）及头颅B超的异常率。结果 治疗组纠正胎龄40周的NBNA评分高于对照组（P<0.05）。治疗组纠正胎龄3月时的适应能力优于对照组,纠正胎龄6月时的大运动、适应能力、社交能力优于对照组,纠正胎龄12月时的大运动、适应能力、精细动作、社交能力、语言明显优于对照组,差异均具有统计学意义（均P<0.05）。治疗组纠正胎龄6月时的ABR异常率、头颅B超异常率明显低于对照组（P<0.05）。结论 早期rhEPO治疗可以促进VLBWI神经系统症状早期恢复,改善患儿的认知、运动及语言能力,对神经系统具有一定的保护作用。     

Weekly intravenous administration of recombinant human erythropoietin in infants with the anaemia of prematurity

To study the safety and efficacy of administering human recombinant erythropoietin (rHuEPO) to infants with anaemia of prematurity, a combined phase I/II trial of weekly intravenous injections for 4 weeks was undertaken. We treated 16 infants with 10, 25, 50, 100 or 200 units/kg body weight in groups of two to four patients per dose level. They were all born prematurely (mean gestational age: 29 weeks; range 27–32), had a mean post-natal age of 42 days (range: 25–59) and haemoglobin concentration of 87 g/l (range: 72–94) when treatment was started. Four patients (25%) needed a transfusion during the trial, one at day 7 treated with 10 units/kg and 3 at days 15, 25, 29 with 100 units/kg. In the others, a progressive rise in mean haemoglobin values was seen in each group after 21 days of treatment, without a dosedependent effect. A positive change in absolute reticulocyte counts with a peak after 7–14 days of therapy was observed with low (25–50 units/kg) but not with higher doses, with a significant difference at day 14 between 25 and 100 units/kg (P<0.01). A dose-limiting severe neutropenia (absolute neutrophil count<0.5×10⁹/l) occurred transiently in five patients, with doses >25 units/kg. No infectious complication and no sign of iron deficiency were observed. Weekly low doses of rHuEPO appear safe, convenient to administer and able to induce a reticulocytic response in infants with anaemia of prematurity. A phase III placebo-controlled trial is needed to confirm these results. Neutropenia associated with rHuEPO administration in infants might be related to their stage of human ontogeny.     

Effects of early human recombinant erythropoietin therapy on the transfusion in healthy preterm infants

Objective  Early recombinant erythropoietin therapy and iron therapy would decrease the need for red blood cells transfusions and prevents anemia of prematurity. Methods  Fifty-eight preterm infants in newborn services at Ghaem Medical Center randomly were assigned, among them 18 patients were excluded. A total of 40 preterm infants with gestational age 28–34 weeks, birth weight 1000–1750 g followed the study: 20 infants in treatment group and 20 infants in control group were randomized to treatment (rhu EPO, 500u per kg, per week, 2 times weekly, subcutaneous) and control (no treatment). Therapy was initiated 4 days after birth and continued throughout the 4 weeks. All infants on enteral feeds received supplements: iron 3 mg/kg/d, vitamins and folat. Complete blood cells and reticulocyte counts were measured weekly. Transfusions and phlebotomy data were recorded. Statistical significance was determined by chi-square test, student t test and Mann-Whitney. A P value of < 0.05 was considered statistically significant. Results  The reticulocyte counts were higher in treated infants during the study (p: 0.009). Final hematocrits were higher in treated infants (p: 0.02).The volume of packed red blood cells transfusions mililiter per infant significantly reduced (p: 0.05), the average number of transfusion per infant was also lower for treated infant than control [2 (10 % )vs 8 (40%) respectively]. No adverse effects of EPO or supplemental iron occurred. Conclusion  The combination of early rhu EPO and iron as administered in the present study stimulated erythropoiesis and decreased red blood cells transfusion in premature infants who were 1000–1750 g at birth. The enrollments of the larger and healthier preterm infants, who are at lower risk for transfusion, are limitation of the present study.     

早期应用rhu-EPO对早产儿神经行为发育的影响

目的：评价重组人类基因促红细胞生成素(rhu-EPO)对早产儿神经行为发育的影响。方法：对44例早产儿（男30例,女14例）随机分为对照组、rhu-EPO治疗组,每组各22例,治疗组于生后第7天予rhu-EPO治疗4周,所有早产儿于纠正胎龄40周行新生儿行为神经检测(NBNA),生后6,12月用Gesell量表法进行神经发育评价。结果：①治疗组NBNA评分36.20±0.75分,高于对照组的34.40±1.05分(P<0.05);②治疗组Gesell发育量表在生后6月,治疗组精细动作的发育商高于对照组,在生后12月治疗组有3个能区（即大运动、精细动作和语言能区）的发育商高于对照组,差异有统计学意义（P<0.05）。结论：早期应用rhu-EPO可促进早产儿神经行为的发育。     

Recombinant human erythropoietin therapy in low-birthweight preterm infants: A prospective controlled study

BACKGROUND: This study aimed to detect the effectiveness of recombinant human erythropoietin therapy in preventing premature anemia in low-birthweight preterm infants. METHODS: A total of 292 premature infants who were born earlier than 33 gestational weeks and smaller than 1500 g birthweight were enrolled into the study. In addition to their conventional supportive therapy (medications), recombinant human erythropoietin 200 U/kg twice a week, subcutaneously, was given to randomly selected 142 premature infants for 6 weeks. The blood count variables and need for transfusions were compared with the remaining 150 premature infants during 6 months follow up. RESULTS: Serum erythropoietin levels were 11.3 +/- 6.1 mU/mL and 38.3 +/- 19.1 mU/mL in the erythropoietin group before and at the fourth week of the study, respectively (P < 0.001). Reticulocyte counts of the group treated with erythropoietin were 146 x 10(6) +/- 28 x 10(6)/mL and 122 x 10(6) +/- 27 x 10(6)/mL at the fourth and seventh week of the study, respectively, and these values were significantly higher when compared with the control group (P < 0.001 and P < 0.001). At the same period, hematocrit values were also found to be higher in the treatment group than the control group (P < 0.001). Serum ferritin levels were lower in the treatment group compared with the control group at the fourth week of the study. No side-effects related to erythropoietin usage were encountered. The need for packed cell transfusions were 47% in the group treated with erythropoietin and 62.6% in the control group. A statistically significant difference was found for transfusion needs between the control and treatment groups (P < 0.001). CONCLUSION: Recombinant erythropoietin is effective therapy for maintaining stable hematocrit levels in low-birthweight preterm infants and prevents the need for blood transfusions.