Publication: Erken ve Geç Eritropoetin Tedavisinin Prematürelik Anemisi Gelişimi ve Transfüzyon İhtiyacı Üzerindeki Etkinliğinin Karşılaştırılması
Abstract
ÖZET Yaşamın ikinci haftasından sonra verilen eritropoetin (rHuEPO) tedavisi prematürelerin transfuzyon ihtiyacını azaltır. Bununla birlikte tetkikler için alman kanın sebep olduğu aneminin engellenmesinde, eritropoetin tedavisine ilk iki haftada başlanıp başlanmaması tartışma konusudur. Bu çalışmada hayatın ilk iki haftasında başlanan rHuEPO tedavisinin prematürelerdeki transfuzyon sayısı ve miktarını azaltıcı etkisinin olup olmadığının ve erken ve geç eritropoetin tedavisinin prematürelik anemisini engellemede farklı etkinlikleri olup olmadığının araştırılması planlanmıştır. Ondokuz Mayıs Üniversitesi Tıp Fakültesi Neonatoloji Bilim Dalı'nda takip edilen, gebelik haftaları 32 haftanın ve doğum ağırlıkları 1500 gramın altında olan 63 hasta çalışmaya alındı. Hastalar randomize olarak erken rHuEPO grubu ( rHuEPO ilk iki haftada başlanan 17 bebek), geç rHuEPO grubu (rHuEPO ikinci haftadan sonra başlanan 16 bebek) ve kontrol grubu (rHuEPO almayan 35 bebek) şeklinde gruplandırıldı. Grup I ve IF deki hastalara rHuEPO 600 İÜ/kg/hafta dozunda, subkutan olarak, 6 hafta süresince verildi. Bütün hastalar oral yoldan demir (6 mg/kg/gün), folik asit (25u.g/gün) ve E vitamini (50 ünite/gün) aldılar. Ortalama doğum ağırlıkları grup Fde 1085.88 ± 178.15 (720-1430) gram, grup IF de 1030.63 ± 252.23 (690-1420) gram, kontrol grubunda 1132 ± 134 (650-1400) gram idi (p>0.05). Grup Fin ortalama gebelik haftası 28.41 ± 2.27 (24-32 ) hafta, grup ü'nin 27.63 ± 1.82 (25-31 ) hafta ve kontrol grubunun 28.83 ± 1.27 (26-31) hafta idi (p>0.05). Ortalama yatış süreleri grup Fde 41.35 ± 14.36 (15-72) gün, grup IF de 56.38 ± 20.08 (29-105) gün, kontrol grubunda ise 28.66 ± 16.1 1 (10-63) gündü ( p<0.05). Olguların klinik tablosunu etkileyecek durumlar açısından yapılan CRIB (Clinical Risk Index For Babies) skorlamasında grup Fin ortanca skoru 3 (0- 8), grup IFnin ise 3 (1- 7) idi (p>0.05). Grup III ise retrospektif değerlendirildiğinden CRIB skorlaması yapılmamıştır. Grup Fe transfüze edilen kan miktarı ortalama 14.12 ± 15.02 (0-40) ml/kg, grup Il'ye 30.00 ± 19.32 (0-60) ml/kg, kontrol grubuna 7.71±14.97 (0-70) ml/kg idi (p<0.05). Ortanca transfuzyon sayısı grup Fde 1 (0-4), grup IF de 4 (0-6) ve kontrol grubunda 0 (0-7) idi (p<0.05). Ortalama alman kan miktarı grup Fde 23.29 ± 9.38 (6-36), grup IF de 31.3U13.87 (12-50) ve kontrol grubunda 12.66 ± 9.43 (4-42) ml/kg idi (p<0.05). Grup I ve IFnin tedavi süresince ve yaşamlarının 2. aylarında bakılan ortalama hematokrit, retikülosit, trombosit ve nötrofil sayıları benzerdi (p>0.05). Eritropoetin tedavisi boyunca %25 hastada trombositoz görüldü. Grup Fde 6 haftalık eritropoetin tedavisinin maliyeti hasta başına ortalama 110±11 VI(86-133) YTL, grup IFde 106±14 (86-133) YTL idi. Grup Fdeki prematürelerin hasta başına ortalama transfüzyon maliyeti 220±219 (0- 600) YTL, grup ITde 450±289 (0-900) YTL, grup III' de 1 15±224 (0- 1050) YTL idi. Transfüzyon maliyeti bakımından grup I ile grup II ve III arasında istatistiksel olarak fark bulunmadı (p>0.0167), grup II ve III arasındaki fark ise istatistiksel olarak anlamlı bulundu (p<0.0167). Çalışma süresince klinik olarak eritropoetin, oral demir, folik asit ve E vitamini tedavisine bağlanabilecek bir yan etki görülmedi. Çalışmamızın sonuçlarına göre, erken eritropoetin tedavisi 1500 gramın ve 32 haftanın altındaki prematürelerde transfüzyon ihtiyacını azaltmada etkilidir. Erken eritropoetin tedavisi verilen bebeklerde transfüzyon miktarı ve sayısı geç eritropoetin grubundan daha azdır. Erken rHuEpo tedavisi verilen grupta transfüzyon sayı ve miktarı geç gruptan az; kontrol grubundan ise farklı değildir. Genel durumu iyi hastalardan alman kan miktarının en aza indirilmesi ve transfüzyon için sıkı kriterler uygulanması durumunda, transfüzyon sayışım azaltmak için eritropoetin tedavisine gereksinim duyulmayabilir. Anahtar kelimeler: Eritropoetin, anemi, prematürite, transfüzyon. vn
ABSTRACT The administration of recombinant human erythropoietin (rHuEpo) after the first 2 weeks of life reduces the transfusion requirement in premature infants. However, its use throughout first 2 weeks of life, when anemia results predominantly from phlebotomy losses, remains controversial. We investigated whether early use of rHuEpo would reduce the total transfusion requirement, and the number of transfusions throughout first 2 weeks of life and to compare the effectiveness of early and late use rHuEpo to prevent the anemia of prematurity. 63 patients with birth weight <1500 g and gestational age < 32 week followed in Ondokuz Mayıs University Neonatology Unit were allowed. Patients were randomly assigned either to a early rHuEPO group (rHEpo from the second week, n=17), a late rHuEpo group (rHEpo from the third week, n=16), or a control group (no rHuEpo, n=35). All patients received rHuEpo 600units/kg/week, subcutaneously, for 6 weeks. All infants were given oral iron (6 mg/kg/day), folic acid (25 p.g/day) and E vitamin (50 units/day). Mean birth weight was 1085.88 ± 178.15 (720-1430) versus 1030.63 ± 252.23 (690- 1420) versus 1132 ± 134 (650-1400) gram (p>0.05) and mean gestational age 28.41 ± 2.27 (24-32 ) versus 27.63 ± 1.82 (25-31 ) versus 28.83 ± 1.27 (26-31) weeks (p>0.05) in the early rHuEpo group, the late rHuEpo group, and control group, respectively. Mean lenght of stay was 41.35 ± 14.36 (15-72) day in the early rHuEPO group, 56.38 ± 20.08 (29-105) day in the late rHuEPO group and 28.66 ± 16.1 1 (10-63) day in control group ( p<0.05). Median CRIB (Clinical Risk Index For Babies) score was 3 (0-8) in the early rHuEpo group and 3 (1-7) in the late rHuEpo group (p>0.05). The control group was investigated retrospectively so the CRTB score of that group were not available. Mean transfusion volume was 14.12 ± 15.02 (0-40) versus 30.00 ± 19.32 (0-60) versus 7.71±14.97 (0-70) ml/kg ( p<0.05), median number of transfusion 1 (0-4) versus 4 (0-6) versus 0 (0-7) ( p<0.05), and mean volume of phlebotomy loss was 23.29 ± 9.38 (6-36) versus 31.31±13.87 (12-50) versus 12.66 ± 9.43 (4-42) ml/kg ( p<0.05) in the early rHuEpo group, the late rHuEpo group, and control group, respectively. Mean hematocrit level, reticulocyte counts, platelet count and neutrophil counts were similar during the course of treatment and in the second month of life in the early rHuEpo group and the late rHuEpo group (p>0.05). Thrombocytosis was detected during rHuEpo treatment in %25 of the infants. Mean charge per patient for rHuEpo charge for 6 weeks was 110±11 (86-133) YTL YTL in the early rHuEpo group and 106±14 (86-133) YTL in the late rHuEpo group. Mean VIIIcharge per patient for transfusion was 220±219 (0- 600) versus 450±289 (0-900) versus 115±224 (0- 1050) YTL in the early rHuEPO group, the late rHuEPO group, and control group, respectively (for group I and group II and IH p>0.05, for group II and III p<0.05). No clinical adverse effects attributable to rHuEpo, oral iron, folic acid, or E vitamin administration were observed. In conclusion, early rHuEPO treatment effectively reduces the need for transfusion in infants with birth weight <1500 g and gestational age < 32 week. The number of transfusions and transfusion volume were lower in the early group than in the late group, and similar with the control group. We conclude that in stable infants, where phlebotomy losses are minimized and stringent transfusion guidelines are adhered to, EPO does not significantly decrease the number of transfusions. Key words: Erythropoietin, anemia, prematurity, transfusion DC
ABSTRACT The administration of recombinant human erythropoietin (rHuEpo) after the first 2 weeks of life reduces the transfusion requirement in premature infants. However, its use throughout first 2 weeks of life, when anemia results predominantly from phlebotomy losses, remains controversial. We investigated whether early use of rHuEpo would reduce the total transfusion requirement, and the number of transfusions throughout first 2 weeks of life and to compare the effectiveness of early and late use rHuEpo to prevent the anemia of prematurity. 63 patients with birth weight <1500 g and gestational age < 32 week followed in Ondokuz Mayıs University Neonatology Unit were allowed. Patients were randomly assigned either to a early rHuEPO group (rHEpo from the second week, n=17), a late rHuEpo group (rHEpo from the third week, n=16), or a control group (no rHuEpo, n=35). All patients received rHuEpo 600units/kg/week, subcutaneously, for 6 weeks. All infants were given oral iron (6 mg/kg/day), folic acid (25 p.g/day) and E vitamin (50 units/day). Mean birth weight was 1085.88 ± 178.15 (720-1430) versus 1030.63 ± 252.23 (690- 1420) versus 1132 ± 134 (650-1400) gram (p>0.05) and mean gestational age 28.41 ± 2.27 (24-32 ) versus 27.63 ± 1.82 (25-31 ) versus 28.83 ± 1.27 (26-31) weeks (p>0.05) in the early rHuEpo group, the late rHuEpo group, and control group, respectively. Mean lenght of stay was 41.35 ± 14.36 (15-72) day in the early rHuEPO group, 56.38 ± 20.08 (29-105) day in the late rHuEPO group and 28.66 ± 16.1 1 (10-63) day in control group ( p<0.05). Median CRIB (Clinical Risk Index For Babies) score was 3 (0-8) in the early rHuEpo group and 3 (1-7) in the late rHuEpo group (p>0.05). The control group was investigated retrospectively so the CRTB score of that group were not available. Mean transfusion volume was 14.12 ± 15.02 (0-40) versus 30.00 ± 19.32 (0-60) versus 7.71±14.97 (0-70) ml/kg ( p<0.05), median number of transfusion 1 (0-4) versus 4 (0-6) versus 0 (0-7) ( p<0.05), and mean volume of phlebotomy loss was 23.29 ± 9.38 (6-36) versus 31.31±13.87 (12-50) versus 12.66 ± 9.43 (4-42) ml/kg ( p<0.05) in the early rHuEpo group, the late rHuEpo group, and control group, respectively. Mean hematocrit level, reticulocyte counts, platelet count and neutrophil counts were similar during the course of treatment and in the second month of life in the early rHuEpo group and the late rHuEpo group (p>0.05). Thrombocytosis was detected during rHuEpo treatment in %25 of the infants. Mean charge per patient for rHuEpo charge for 6 weeks was 110±11 (86-133) YTL YTL in the early rHuEpo group and 106±14 (86-133) YTL in the late rHuEpo group. Mean VIIIcharge per patient for transfusion was 220±219 (0- 600) versus 450±289 (0-900) versus 115±224 (0- 1050) YTL in the early rHuEPO group, the late rHuEPO group, and control group, respectively (for group I and group II and IH p>0.05, for group II and III p<0.05). No clinical adverse effects attributable to rHuEpo, oral iron, folic acid, or E vitamin administration were observed. In conclusion, early rHuEPO treatment effectively reduces the need for transfusion in infants with birth weight <1500 g and gestational age < 32 week. The number of transfusions and transfusion volume were lower in the early group than in the late group, and similar with the control group. We conclude that in stable infants, where phlebotomy losses are minimized and stringent transfusion guidelines are adhered to, EPO does not significantly decrease the number of transfusions. Key words: Erythropoietin, anemia, prematurity, transfusion DC
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