Method for pre-operative prediction of complicated course of early post-transplantation period manifested by transplant dysfunction following living-related liver transplantation in infants with congenital hepatobiliary diseases

FIELD: medicine.

SUBSTANCE: preoperative prediction of the complicated course of the early post-transplantation period is ensured by measuring the pre-transplantation blood plasma concentration of insulin-like growth factor-1 (IGF-1) and growth hormone (GH), ng/ml. That is followed by calculating a prediction index for the post-transplantation course (K) by formula: K=lg (IGF-1/GH). If K is less than minus 1.7, the complicated course of the early post-transplantation period is predicted.

EFFECT: using the method enables the objective prediction in the infants suffering congenital hepatobiliary diseases accompanying the early post-transplantation period manifested by transplant dysfunction.

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The invention relates to medicine, namely to organ transplantation and clinical laboratory diagnostics, can be used for pre-operative predicting the course of the early post-transplant period in young children after liver transplantation for congenital diseases of the hepatobiliary system.

The problem of predicting the course of the early postoperative period in children of early age after liver transplantation is essential due to the fact that this category of patients refers to patients with a high risk of complications and adverse outcome, as evidenced by the numerous publications of foreign and domestic authors.

The peculiarity of infants with congenital hepatobiliary disease, which is related liver transplantation is a combination of factors, multidirectional influence on the prognosis of treatment effectiveness, for example: due to the age of Hyper-reactivity of the immune system and at the same time, high ability to develop immunological tolerance to the graft. The combined effect of these factors is difficult to assess. Dysfunction of the graft in the early postoperative period may be due to several reasons: immunological, infectious, metabolic, SOS is done and other It is believed that young children after liver transplantation prevails the risk of infectious complications, against which there is a necessity of correction of the standard Protocol immunosuppressive therapy (deferred the appointment of immunosuppressants, their temporary cancellation, lower doses of immunosuppressants).

Safety minimization of immunosuppressive therapy in the early postoperative period, as the need for more careful preoperative preparation of patients (strengthening antibacterial, antiviral therapy, correction of metabolic status) can be estimated taking into account the risk of complications during the early postoperative period. That is why there is a need in the way of forecasting the preoperative stage of the complicated course of the early post-transplant period due to graft dysfunction in children of early age related liver transplantation.

A method for the prediction of 6-month survival of patient and graft after liver transplantation for children with congenital diseases of the hepatobiliary system (McDiarmid SV, Anand R, Martz K, et al. A multivariate analysis of pre-, peri-, and post-transplant factors affecting outcome after pediatric liver transplantation. Pediatric Transplant. 2011 Jun; 15 (4): 400-5) the Essence of the method lies in the fact that, with the development in the early post-transplantation per the ode complications such as vascular thrombosis, intestinal perforation, septicemia, predict a high risk of death or graft loss within the next 6 months. However, this method allows to predict the survival of recipient and graft on the basis of the analysis of postoperative events.

In the prior art there is also known a method of pre-operative prediction of the development of graft dysfunction in infants with congenital diseases of the hepatobiliary system (Shevchenko O. P., Hickon O. E., Kuntsevich N. In., and other Communication between sCD40L level and nature of the current post-transplant period in the recipient liver. Bulletin of Transplantology and artificial organs. App. The materials of the V all-Russian Congress of transplantologists / Moscow, 2010, S. 126-127), which is chosen as a prototype.

It consists in the following. In the blood plasma of children of candidates for liver transplantation, using the ELISA method to measure the concentration of a soluble form of CD40 ligand (sCD40L) and identifying the source of the high level of sCD40L (>3.3 ng/ml) predict the development of graft dysfunction.

However, this method allows to predict a narrow range of complications, such as graft dysfunction, manifested by immunological mechanisms, because of the co-stimulatory signal system CD40-CD40L plays important is Yu role in the mechanisms of immune regulation, in particular, activation of T-lymphocytes, antigen presenting cells and endothelial cells.

The present invention is a pre-operative prediction of complications during the early post-transplant period due to graft dysfunction in children of early age after liver transplantation for congenital diseases of the hepatobiliary system.

The technical result of the invention is the possibility of accurate preoperative prediction of complications during the early postoperative period, manifested by graft dysfunction of various etiologies in children of early age after liver transplantation for congenital diseases of the hepatobiliary system, which would take into account the integral indicator of metabolic and immune mechanisms in the development of dysfunction of the graft liver, while maintaining the simplicity, availability of study do not require a long time, unique reagents and instruments.

The essence of the proposed method for the preoperative prediction of complications during the early postoperative period, manifested by graft dysfunction after liver transplantation in young children with congenital diseases of the hepatobiliary system is as follows.

Before transplantation, pécs and in the blood plasma of candidates for transplantation to determine the concentration in ng/ml insulin-like growth factor-1 (IGF-1) and somatotropic hormone (STH). Next, calculate the index of forecasting according To the formula: K=lg (IGF-1/STH). When the value of K less minus 1.7, predict complications during the early post-transplant period, manifested by dysfunction of the graft.

We have empirically found that a certain ratio of the concentrations of IGF-1 and STG in plasma before the operation, expressed by the decimal logarithm, is an informative predictor of the course of the early post-transplant period after related liver transplantation in young children with congenital diseases of the hepatobiliary system.

Congenital liver diseases are accompanied by deficiency of IGF-1, increasing as the progression of the disease and reduce belkovosinteticescuu liver function. In response to the deficiency of IGF-1 on the mechanism of negative feedback there is an increase in the secretion of STH, one of whose functions is to stimulate the synthesis of IGF-1. Thus, as the progression of diseases of the hepatobiliary system increases the deficit IGF-1 and increases the concentration of STH. Both hormones have an effect on the metabolic status of the patient and the state of his immune system. It turned out that a pronounced imbalance between IGF-1 and STG before liver transplantation has an adverse influence on the course early in reoperations period and increases the risk of graft dysfunction, that may be associated with metabolic and immune mechanisms and is a reliable prognostic indicator. Thus, we found the index forecasting, assessing the imbalance in the system STH - IGF-1, allows us to predict a wider spectrum of complications in the early post-transplantation period.

The applicant is not aware of the application of the logarithm of IGF-1/STH with the aim of predicting the course of the early postoperative period after related liver transplantation.

The method is as follows.

Measurement of IGF-1 and STG conduct quantitative immunoassay method ELISA reagents IDS IGF-I ELISA, USA, and Diagnostic Biochem Canada Inc., respectively (see, for example, instructions to the kit reagents IDS IGF-I ELISA and assay kit Growth hormone, Diagnostic Biochem Canada Inc; B. C. Kamyshnikov. Handbook of clinical-biochemical laboratory and laboratory diagnosis / Moscow, Medpress-inform, 2009, 371 S.; Liss C. L., Nikolaev, L. C., Nagorno I. I. et al. Laboratory diagnostics and functional test in pediatric endocrinology. SPb.: Special literature, 1996. - 136 C.) on the photometer Zenyth 340 (Anthos Labtec Instruments GmbH, Austria).

If the index patient To less than minus 1.7 to operations, predict complications during the early postoperative period, manifested on what funkcia transplant.

The possibility of practical use of the method of achieving the specified purpose and the technical result is proved the following data.

Example 1. The patient W-VA, 7 months, (b 1892/2011) was admitted with a diagnosis of cirrhosis of the liver in the clinical outcome of bailer with syndromes of liver cell failure, portal hypertension (splenomegaly, ascites), cholestasis. When entering the weight 6.5 kg (5-15 percentile), height 67 cm (25-50 percentile). Score PELD 24,6. Before the surgery, the concentration of IGF-1 in plasma of 0.01 ng/ml, STH and 4.4 ng/ml, the index K=-2,7. The forecast adverse trends early postoperative period. The patient underwent an operation orthotopic transplantation of the left lateral sector of the liver from a living related donor, cousin, grandmother, 44 years. The postoperative period for 15 days was uneventful. Immunosuppressive therapy was assigned according to the standard scheme. On the 16th day post-operative period was complicated by formation of a partial external biliary fistula. In further noted the development of bacteremia, the formation of septic conditions that demanded the cancellation of immunosuppressive therapy. Laboratory indicated an increase in the activity of alanine aminotransferase and aspartate aminotransferase, increased concentrations of total and direct bilirubin and decrease the end of the ation of albumin and total protein in blood plasma. On the background of multiple changes, antibacterial Protocol normalized body temperature, decreased leukocytosis in the blood, blood cultures became sterile, however, continued to grow manifestations of dysfunction of the graft. Given the long-term abolition of immunosuppressive therapy on the background of the septic condition, the clinical picture was interpreted as a rejection of the graft liver. Conducted in vitro detoxification (low flow veno-venous ultradilute). Reported a temporary positive dynamics of biochemical parameters of blood. However, the patient's condition continued to deteriorate, there was a growing signs of respiratory, cardiovascular, hepatic, renal insufficiency. The patient died on the 35th day after the operation. According to the results of the postoperative period prediction was confirmed.

Example 2. The patient On s, 12 months (and/b 1659/2010), was admitted with a diagnosis of cirrhosis in the outcome of congenital malformation of the biliary tract with symptoms of cholestasis, hepatic cell failure, portal hypertension (splenomegaly, ascites, varices esophageal 1-2 degrees), protein-energy malnutrition (underweight 18%); after portoenterostomy by Kasai, recurrent cholangitis. The PELD score of 21.7. Before the surgery, the concentration of IGF-1 in plasma is 0.001 ngml, STH - 12,25 ng/ml, the index K=-4,1. Was made unfavorable prognosis of early post-operative period. The patient performed orthotopic transplantation of the left lateral sector of the liver from a living related donor, father, 24 years. Immunosuppressive therapy is assigned according to the standard scheme. During the early postoperative period was complicated by formation of a partial external biliary fistula. In connection with the occurrence of fever was canceled tacrolimus, and then, after 7 days, became a marked increase of transaminase activity. Immunosuppressive therapy was resumed in full, which led to normalization of biochemical parameters of liver function. Incomplete outer fistula independently closed at 53-and the day after surgery. The patient was discharged with satisfactory graft function on the 56th day after the operation. The prediction was confirmed in relation to the current early postoperative period.

Example 3. The patient In society, 27 months (and/b 1479/2011), was admitted with a diagnosis of cirrhosis in the outcome of biliary atresia with syndromes of liver cell failure, cholestasis. Portal hypertension (splenomegaly, varices esophageal 3-4 St); after portoenterostomy by Kasai; physical development below average, harmonic. Score PELD 7(forecast 3-month survival without transplantation favorable). However, before the surgery, the concentration of IGF-1 in plasma - 0,0068 ng/ml, STH - 31.5 ng/ml, the index K=was 3.7. The prediction was made adverse trends early post-transplant period. The patient performed orthotopic transplantation of the left lateral sector of the liver from a living related donor, grandmother, 53 years. During the early postoperative period was complicated by formation of a partial external biliary fistula, right upper lobe pneumonia, CMV infection, thrombosis of the portal vein. Against the background of these complications were temporary elimination of immunosuppressive therapy, which was accompanied by increased activity of transaminases, increased coagulopathy. Was renewed monotherapy immunosuppressants tacrolimus (therapy with methylprednisolone was not renewed due to long-lasting outer incomplete biliary fistula). On the background skorrigirovanna therapy showed improvement of the child's condition. The patient was discharged on the 70th day after the operation with satisfactory performance of the functions of the liver transplant. For during the early postoperative period, the prediction was confirmed.

Example 4. Patient G s, 7 months (and/b 1821/2010), was admitted with a diagnosis of biliary cirrhosis in the outcome of atresia extrahepatic bile ducts, hepatic syndromes-cell failure, then what happens hypertension (varicose veins of the esophagus 2-3 article, splenomegaly, ascites); after portoenterostomy on Kasai. Score PELD 21. Before the surgery, the concentration of IGF-1 in plasma or 0.035, STH with 4.65 ng/ml, the index K=of-2.1. The prediction was made adverse trends early post-transplant period. The patient performed orthotopic transplantation of the left lateral sector of the liver from a living related donor, mother, 34 years. Immunosuppressive therapy was carried out according to the standard scheme, tacrolimus assigned on day 7 after surgery. To the 15 th day after the operation - smooth postoperative period. With a 15-day was marked increase of transaminase activity, according to the survey, there were no vascular, biliary, or infectious complications. Was held pulse therapy with corticosteroids, with a positive effect, therefore, a conclusion was made about the immunological character of transient dysfunction of the graft. For during the early postoperative period, the prediction was confirmed.

Example 5. The patient-s, 7 months (and/b 613/2010), was admitted with a diagnosis of cirrhosis in the outcome of biliary atresia, with the syndrome of portal hypertension (ascites, hepatosplenomegaly), hepatic cell failure; status post cholecystectomy, portoenterostomy on Kasai. The patient noted a pronounced retardation times the development (weight 6,7 kg less than 3 percentile, growth of 55 cm, less than 3 percentile). Score PELD at entry 36. On the eve before surgery in plasma were measured concentration of IGF-1 is 13.4 ng/ml and STG - 1,67 ng/ml, index To 0.9. The patient was taken to the favorable prognosis of early postoperative period, despite the severity of liver failure. The patient was performed orthotopic transplantation of the left lateral sector of the liver from a living related donor, mother, 26 years. During the early postoperative period was without complications. The drains are removed within the first three weeks after surgery. Immunosuppressive therapy was carried out on a standard two-part Protocol. The child was discharged on the 23rd day after the operation. For during the early postoperative period, the prediction was confirmed.

Example 6. Patient T-VA, 4 months (and/b 376/2010), was admitted with a diagnosis of cirrhosis in the outcome of biliary atresia with syndromes of liver cell failure, portal hypertension (hepatosplenomegaly, ascites, varices esophageal 3-4 degrees). The PELD score of 15.7. Before the operation, the concentration of IGF-1 in plasma - 79 ng/ml, STH - to 33.9 ng/ml, the index K=0,37. Was made a favorable prognosis early postoperative course. The patient was performed orthotopic transplantation of the left lateraling the sector liver from a living related donor, mother, 37 years. During the early postoperative period smooth. The patient was discharged on the 32nd day after surgery with satisfactory function of the graft liver.

The proposed method is tested in clinical practice in 39 patients, and the prognosis of early post-transplant period, made by the claimed method was confirmed in 33 cases, which amounted to 84.6%.

Use in clinical practice patentable method allows a rational approach to the selection and more thorough preparation of patients for surgery, as well as the establishment of appropriate therapy protocols for selected risk groups, which suggests the possibility of increasing the effectiveness of treatment.

The way the preoperative prediction of the complicated course of the early post-transplant period, manifested by dysfunction of the graft, after a related liver transplantation in young children with congenital diseases of the hepatobiliary system, including the study of blood plasma of the recipient before the operation, characterized in that in the blood plasma was measured concentration in ng/ml insulin-like growth factor-1 (IGF-1) and somatotropic hormone (STH), and complications during the early post-transplant period, manifested by dysfunction of the graft, predict when meant and lg (IGF-1/STH) less minus 1.7.



 

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