Method of treating low-body-weight premature newborns

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly to paediatrics and neonatology, and can be used for treating small premature infants at the hospital stage of developmental care. A therapeutic complex comprises administering a probiotic preparation into the newborns. The preparation is presented with a liquid probiotic containing E.faecium L3 109 CFU in 1 ml. If the enteral nutrition volume of the newborn is 5 ml or more, this preparation is orally administered in a dose of 0.5 ml 3 times a day for 14 days.

EFFECT: method is effective in children with a very low body weight, promotes normalising the intestinal microflora and reducing a rate of manifestations of infectious complications.

2 ex, 3 dwg, 3 tbl

 

The invention relates to medicine, in particular to the field of Pediatrics and neonatology, can be used to treat premature infants during the stationary phase of nursing.

There is a method of treatment of preterm infants with the use of probiotic preparations on the basis of lactobacilli and bifidobacteria (Tasheva NB Optimization in premature newborns with indirect hyperbilirubinemia and a violation of microbial colonization of the intestine: author. Diss. ... candles. the honey. Sciences. M; 2004. - 36 S.). However, despite the abundance of probiotic agents, treatment of premature children is not always successful, there are infectious complications such as intrauterine infection, vnutrietnicheskoe infection, necrotizing enterocolitis.

There is a method of treatment of functional disorders of the intestine and correction of the intestinal microflora in premature infants using a probiotic preparation Linex, which includes probiotic strains of B. infantis, L. acidophylus, E. faecium M74 (Gorobchenko Century, Kurashina I., Miller Y. Clinical and bacteriological efficacy of the probiotic "Linex" in premature infants. Doctor. 2008; No. 5. - P.70).

The disadvantage of this method is the use of freeze-dried and not liquid, forms of probiotic and to a much lesser dose (1,2×107SOME) put the m leaking capsules, that is not optimal, as well as the lack of data about the use of the drug Linex in the treatment of preterm infants during the stationary phase of nursing.

The purpose of the invention - expanding Arsenal of therapeutic tools for the treatment of preterm infants with very low birth weight conducive to the normalization of the intestinal microflora, and to improve treatment results in a reduction in the frequency of manifestation of infectious complications.

The purpose of the invention is achieved by including in the comprehensive treatment of the probiotic, and use liquid probiotic-based strain of E. faecium L3 containing 1 ml of 109KOE, and when the volume of enteral feeding newborn 5 ml and more the drug is administered orally in a dose of 0.5 ml 3 times a day for 14 days.

This probiotic form E. faecium L3 is a lactic acid ferment (no RU. 77.99.26.009.E.002272.02.11)used in the production of dairy products for therapeutic feeding in 1 ml contains 109SOME living microbial cells of Enterococcus.

The method is implemented as follows. Premature newborns with very low birth weight along with the standard treatment program include a comprehensive probiotic treatment, and use of liquid probiotic-based strain of E. faecium L3 containing 1 ml of 109SOME, and when the volume of enteral p is Tania newborn 5 ml and more the drug is administered orally in a dose of 0.5 ml 3 times a day for 14 days.

Dignity liquid probiotic forms of E. faecium L3 is the preservation of strains of probiotic bacteria active in a viable state.

Below is an example of practical realization of the proposed method of treatment.

Premature girl Efimova C. was treated at children's hospital No.1 in St. Petersburg in 2012 (history No. 777) with a clinical diagnosis of Prematurity, gestation 31 week. Outdoor aortic duct, medical closure. Early anemia of prematurity mild. Perinatal CNS hypoxic Genesis.

She was born at term pregnancy 31 week with weight 1340 was on the standard scheme for the nursing of premature infants receiving total parenteral nutrition with subsequent transition on partial parenteral nutrition and enteral nutrition (getting through the probe of breast milk and formula, Brenan) on day 6 of life. At the age of 7 days of life, given the good tolerance of the used mode of enteral nutrition in the child's diet was introduced liquid probiotic form on the basis of E. faecium L3 at a dose of 0.5 ml 3 times a day (using bolus in enteral probe during feedings). Therapy was carried out within 14 days. The total duration of mixed feeding through a tube (breast milk and supplementary feeding with a mixture of Brenan) amounted to 30 days. Next Devo the spacecraft was transferred to breast milk in the mode of physiological needs. Antibiotic therapy was given for 26 days with changing groups of drugs (at the time of standing Central venous catheter). In the observation period for a child there were increasing numbers of anemia of prematurity (hemoglobin with 172 g/l decreased to 106 g/l), and do not require replacement therapy; leukocytosis was not significantly increased (8,1*109/l to 11.2*109/l), neutrophil shift in leukocyte formula was not observed. Eosinophilia for discharge is not marked (the relative number of eosinophils in the blood was 4%). In repeated coprogrammed inflammatory changes were found. In the biochemical analysis blood was not recorded increase of ALT, AST, CRP.

According to the bacteriological examination of faeces for the admission of the child to inpatient treatment was marked by the growth of opportunistic flora: K. pneumoniae in high titer of 106CFU/g

The follow-up bacteriological examination of faeces (14 days after completion of therapy liquid probiotic form on the basis of E. faecium L3) K. pneumoniae was not detected. Evaluation of the indigenous intestinal microflora according to the study of faeces by PCR in real time after complex therapy with the use of the probiotic on the basis of E. faecium L3 in the number of lactobacilli and bifidobacteria corresponded to a sufficient level of 108To the E/g

The girl was discharged home with body weight 2010 at the age of 1 month 15 days. Side effects of combined therapy with the use of the probiotic on the basis of E. faecium L3 was not observed. The number of days of hospitalization was 45.

Clinical example 2 using the traditional method of treatment of extremely premature infants at the stage of nursing in the hospital shows less favorable results.

Premature girl Frolov D. was treated at children's hospital No.1 in St. Petersburg in 2011 (case history No. 11882) with clinical diagnosis of Prematurity, gestation 29 weeks. The syndrome of respiratory disorders. Early anemia of prematurity grade. Perinatal CNS hypoxic Genesis. Acute respiratory disease (rhinitis).

Born with gestational age 29 weeks with a weight of 1500 was on the standard scheme for the nursing of premature infants receiving total parenteral nutrition with subsequent transition on partial parenteral nutrition and enteral nutrition (getting through the probe nutrient mixture Prenan) on day 12. Received antibiotic therapy within 30 days from the change of groups of drugs (at the time of standing Central venous catheter). During the observation period, the child was noted to increase the overall leukocytosis (14.8*109/l to 19.9*109/l) without neutrophilic shift in leukocytospermia. There are also significant fall in hemoglobin level (with 158 g/l to 90 g/l); increased eosinophilia (from 4% to 20%), monocytosis (15%). In coprogrammed noted the presence of fungi of the genus Candida. According to biochemical analysis blood was not recorded increase of ALT, AST, CRP.

According to the bacteriological examination of faeces for the admission of the child to inpatient treatment there is a high titer of K. pneumoniae (106CFU/g). In future studies marked increase in titer of K. pneumoniae to 107CFU/g in Addition, selected in the re-examination of the faeces of a child opportunistic organism K. pneumoniae were characterized by a higher resistance to antimicrobial agents and bacteriophages. Evaluation of indigenous microflora of the intestine according to the study of faeces method of Poland in the real time dynamics monitoring showed a reduction in the level of bifidobacteria (108CFU/g to 107CFU/g).

The baby is discharged from hospital was delayed (despite the achievement level of body weight 2000) by reason of the accession of infectious process in the form of acute rhinitis.

The girl was discharged from hospital at the age of 1 month 26 days with body weight 2540, the Number of days of hospitalization was 57.

Experience in the use of probiotics in premature infants includes Bifidumbacterin, Bifidumbacterin Forte, Probit is, Acipol, Azilect, Lactobacterin, Linex, Sifilis (www.disbak.ru). As of probiotics in preterm infants used probiotic strains B. bifidus, B. infantis, B. brevis, B. lactis, Str. thermophilus, L. acidophilus, L. casei, Lactobacillus GG, S. boulardii (Deshpande g, Rao s, Patole S. Probiotics for prevention of necrotising enterocolitis in preterm neonates with very low birth weight: a systematic review of randomised controlled trials. Lancet 2007; 369:1614-1620).

In the previous analogues in premature infants has not been used probiotic strain E.faecium L3.

To prove the possibility of industrial applicability of the proposed method was investigated treatment outcomes of premature infants at the stage of nursing in the hospital.

In the specialized neonatal care unit, children's multidisciplinary pediatric hospital in the process of nursing watched 55 preterm with very low birth weight (ONMT): 24 boys and 31 girls, born on 29,0±0,3 (M±M) weeks of gestation. Patients were enrolled from maternity wards and the intensive care unit of the hospital; the child's age at the time of admission was 3.3±0,5 DN., body weight - 1204,0±26,6 g; body length is 37.0±0.4 cm In the study did not include patients with gross malformations, severe perinatal lesions of the Central nervous system. Standard program in premature newborns with ANMT included: adequate primary resuscitation, respiratory support (primaveraestate), thermal regime, antibiotic therapy, early provision of nutrients, including total parenteral nutrition, then partial parenteral nutrition supplemented enteral nutrition. The transfer of children on enteral nutrition provided consistent use of nutrient formulas Alfare, Prenen, NAN Hypoallergenic (and/or breast milk).

The observed patients were randomized into two groups. Group 1 (n=26, the comparison group) received standard therapy. Group 2 (n=29, the main group) in the absence of signs of intolerance to enteral nutrition advanced through enteral tube had received liquid probiotic form on the basis of E. faecium L3 containing 1 ml of 109KOE, 0.5 ml 3 times a day for 14 days.

Efficiency programs nursing children with EMT was assessed by frequency of occurrence in children situations "power supply", the frequency of diagnosis of infectious complications, the nature of changes in hematological indices, duration of parenteral nutrition, duration of antibiotic therapy, length of hospital stay, the dynamics of the composition of the intestinal microbiota. To infectious complications attributed diagnosed viral intrauterine infection (IUI) in 9 children, vnutrietnicheskoe infection (VAI) 10 infants, necrotizing enterocolitis (ne is) - 2. The implementation of the programme of study was approved by the Committee on ethics.

Qualitative and quantitative composition of the intestinal microbiota in preterm children studied three times with an interval of 14 days according to the study of faeces methods real-time PCR and advanced bacteriological analysis with determination of the number of anaerobic and aerobic microorganisms (periods of research 1-2-3). Fence faeces for study 1 was made the next day after receipt of children. In group 1 study 2 was conducted after completion of therapy probiotic form on the basis of E. faecium L3. By the time of first sampling no child received probiotic preparations.

Study of clinical and paraclinical parameters were adapted for mathematical treatment and analyzed using simple methods (parametric and non-parametric statistics and multivariate statistical analysis.

Table 1 shows the frequency characteristics of the unfavourable flow of premature infants with very low birth weight in the comparison group (group 1) and experimental group (group 2).

The study of the characteristics common to the adverse currents of nursing observed in preterm children with EMT, revealed significantly higher frequency shown is th infectious complications in patients of group 1.

It should be noted that the NEC was diagnosed only in group 1 2 (7,7%) children. In this same group also noted the high frequency of occurrence of situations of "power supply"; leukocytosis, monocytosis (p<0.05) and eosinophilia in the blood. The incidence of bronchopulmonary dysplasia, neonatal jaundice in groups 1 and 2 did not differ significantly.

Comparison of used programs for the treatment of premature infants of group 1 and group 2 for the duration of inpatient treatment (52,5±2,8 days.; 54,2±4,1 days.; p>0.05), and the duration of parenteral nutrition (18,0±1,9 days.; 19,8±2,2 days.; p>0.05), and the duration of the period before the transition to full enteral nutrition (18,8±1,9 days.; 20,3±2,2 days.; p>0,05) showed no significant differences.

Figure 1 presents the evaluation of the dynamics of the number of bacteria (CFU/g) during periods 1, 2, 3 by the method of variance analysis according to the study of faeces by PCR in real time in premature infants with ANMT the comparison group and the experimental group.

Figure 2 presents the assessment of the dynamics in the number of lactobacilli (CFU/g) during periods 1, 2, 3 by the method of variance analysis according to the study of faeces by PCR in real time in premature infants with ANMT the comparison group and the experimental group.

Figure 3 presents the assessment of the dynamics of the number of Klebsiella (CFU/g) during periods 1, 2, 3 method of analysis of variance bacteriological data and the sequence of faeces in premature infants with ANMT the comparison group and the experimental group.

By variance analysis was to study the dynamics of the composition of the indigenous and conditionally pathogenic microflora in premature infants with EMT and installed the following. Unlike premature babies group 2, the number of bifidobacteria (Fig.1) and lactobacilli (Fig.2) between periods 1 and 2 in children of group 1 were significantly more. The number of Klebsiella between periods of studies 1 and 2 in group 1 was increased (Fig.3).

Table 2 presents the assessment of the dynamics of the composition of the intestinal microflora in paired samples using Wilcoxon'a premature infants of group 1.

Table 3 presents the assessment of the dynamics of the composition of the intestinal microflora in paired samples using Wilcoxon'a premature infants group 2.

Comparison of the dynamics of the composition of the indigenous and UPM intestines of premature infants with ANMT under the influence of various regimens method Wilcoxon'a (not limited by the normal distribution of the data for paired samples revealed that children in group 1 significant decrease (p<0,05) in the amount of bifidobacteria (periods 1-3) and the increase in the number of Klebsiella (p<0.05) in periods 1-2. In children of group 2 showed a significant increase (p<0,05) number of Klebsiella in periods 1-3.

Thus, during the nursing of premature infants in the hospital in both groups of patients on the background of the oppression of the indigenous flora was noted n is increased Klebsiella, which is the brightest representatives of nosocomial flora.

The use of probiotic forms of E. faecium L3 in premature infants with OMT group 2 inhibited the growth of pathogenic microorganisms on the background of antibiotic treatment that was one of the defining factors contributing to the decrease in the frequency of infectious complications in this group.

Table 1
The studied parametersGroup 1Group 2Pearson
χ2
p-level
nono
Central venous access more than 10 days.3 (11,5%)23 (88.5 percent)2 (6,9%)27 (93,0%)0,02>0,05
Antibiotic therapy for more than 10 days.2 (8,7%)24 (92.3 per cent)3 (10,3%)26 (89,7%)0,09 >0,05
The situation of power supply"16 (61,5%)10 (38,5%)23 (79.3 percent)6 (20,7%)1,88>0,05
VUI20 (76,9%)6 (23.1 per cent)26 (89,7%)3 (10,3%)1,62>0,05
VAI19 (73.1 per cent)7 (26.9 per cent)26 (89,7%)3 (10,3%)2,53>0,05
Infectious complications12 (46,2%)14 (53.8 per cent)23 (79.3 percent)6 (20,7%)6,51<0,05
Positive seeding from the blood25 (96,2%)1 (3,8%)27 (93.1%)are2 (6,9%)0,24>0,05
Leukocytosis14 (53.8 per cent) 12 (46,2%)17 (58.6 per cent)12 (41.4 per cent)0,06>0,05
Anemia4 (15,4%)22 (84,6%)4 (13,8%)25 (86.2 per cent)0,26>0,05
Monocytosis026 (100%)5 (17,2%)24 (82,8%)4,01<0,05
(0%)
Eosinophilia12 (46,2%)14 (53.8 per cent)18 (62.1 per cent)11 (37.9 per cent)1,15>0,05

Table 2
Compare the characteristics and periods of studies of the intestinal microfloraValid NTZp-level
Bifidobacteria (periods 1-2) 22level 113.00,08>0,05
Bifidobacteria (periods 1-3)2051,51,99<0,05
Lactobacilli (periods 1-2)18of 60.50,39>0,05
Lactobacilli (periods 1-3)1875,50,05>0,05
Klebsiella (periods 1-2)70,02,37<0,05
Klebsiella (periods 1-3)96,51,27>0,05

Table 3
Compare the characteristics and periods of studies of the intestinal microfloraValid NTZp-level
Bifidobacteria (periods 1-2)2094,50,39>0,05
Bifidobacteria (periods 1-3)2071,00,63>0,05
Lactobacilli (periods 1-2)2094,50,39>0,05
Lactobacilli (periods 1-3)1872,00,21>0,05
Klebsiella (periods 1-2)119,01,60>0,05
Klebsiella (periods 1-3)101,01,99<0,05

A method of treating premature babies with low birth weight by including in the comprehensive treatment of the probiotic, characterized in that use liquid probiotic-based strain of E. faecium L3 containing 1 ml of 109SOME, and when the amount of enteral the th power of the newborn 5 ml and more the drug is administered orally in a dose of 0.5 ml 3 times a day for 14 days.



 

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