| Intravenous immunoglobulin(IVIG)is a preparation containing pooled immunoglobulins derived from a large number of healthy people.Its clinical application is affected by many factors,such as disease,medical insurance policy,plasma source,unit price and so on.At present,there is no domestic clinical guideline for IVIG,IVIG is used widely in the clinic under circumstances that greatly exceeded its dispensatory scope: some uses are backed by strong evidence,others are empirical,and some are not recommended by guidelines issued in other countries.In recent years,health insurance policies for IVIG have undergone continual adjustment.In the replacement of children severe viral infection,added 6 categories of specific diseases,some disease which irreplaceable application of IVIG in clinical has been covered by Medicare.Therefore,how to best use IVIG that is a limited blood products has become an important topic of investigation.Objective: To examine IVIG administration status and undertake a large retrospective analysis of its clinical use in pediatrics with the aim of establishing reference criteria regarding the appropriate use of IVIG that can be used by both government and hospital management,as well making recommendations regarding the future formulation of medical insurance policies.Methods: The current situation with respect to IVIG production and use was investigated using a survey method,This included a questionnaire survey,a literature search,and a content analysis.Retrospective mathematical statistical analysis methods were then used to examine the use of IVIG at Children's Hospital Affiliated to Medical University of Chongqing over a period of 4 years.The data were entered into Microsoft EXCEL,to calculate dosage indices.Diseases were classified according to the main diagnosis at discharge.Statistical analyses were performed using SPSS24.0 statistical software,which validated whether or not the data were distributed normally,non-normally distributed data as the median and inter-quartile range(IQR).Finally,the application of IVIG was compared between groups by the Mann-Whitney U and Kruskal-Wallis H test on the basis of categories of diseases,medical insurance.Results: 1.Domestic IVIG administration status(1)By December 2016,there are 27 manufacturers produce seven different specifications of IVIG products.The advantages of six dominant blood product enterprises are obvious,in annual plasma collect volume and apheresis station.(2)The number of IVIG batches issued has grown rapidly,reaching 9,955,000 bottles(2.5 g/bottle)in 2016,an increase of 23.9% compared with 2015.(3)By December 2016,a 2.5 g bottle of IVIG cost between 540 and 721 yuan;the IVIG health insurance policy has been adjusted in part of province compared to national edition,after removing the starting line.The amount reimbursed by Medicare varies from 0–90%(according to geographic region).2.Data acquired from the children's Hospital Affiliated to Medical University of Chongqing over 4 years(1)A total of 14361 patients were hospitalized and received IVIG 25933 times(total amount: 213480.16g;total cost: 47,790,500 yuan);this represents an average annual increase of 14.5% in dosage and 11.3% in cost.The difference between annual case costs and annual case usage was statistically significant.In terms of age,most IVIG was prescribed for infants and young children(54.6% of all patients).(2)The IVIG median dosage was 10(5,20)g,Concerning the total amount of IVIG used,the majority of the top 20-ranked diseases in our hospital,11 types are rational use,accounting for 57.56% of the total amount(122879.2g).The total amount of IVIG used to treat six diseases that was covered by medical insurance was 99600.5 g,the total number of cases was 4081,which accounted for 46.7% of the total amount and 28.4% of the total amount of IVIG used over the past 4 years.(3)Concerning the disease,patients with Kawasaki disease consumed the most IVIG resources,accounting for 19.41% in terms of cases and 34.43% in terms of total amount,with an median dose of 25(20,30)g/cases.Patients with primary immunodeficiency disease(3.33% of the total number of patients)consumed less IVIG(3.10% of the total amount),with an median dose of 10(5,15)g/cases.Autoimmune encephalitis accounted for the top median case dosage(up to 40(30,60)g/cases).(4)The top two median case dose disease(Autoimmune encephalitis and multiple sclerosis),are not covered by medical insurance?When compared with the third one Green Barre syndrome,which were already covered by medical insurance,in the drug cost and total hospitalization expenses,the difference was statistically significant,the drug cost and total hospitalization expenses of former two were not lower than those of Guillian-Barre syndrome.(5)The Departments of Nephrology & Immunology,Hematology,and Respiratory medicine used the most IVIG.However,in terms of mean case dose,the Neurology Division was at the forefront,the difference was statistically significant.(6)The main specification of domestic IVIG product is 2.5G/bottle;however,a dosage of 5g and above is used more frequently in clinical practice.Newborns accounted for 12.4% of the total number of patients.When used for newborns,IVIG infusion per time dosage <1g accounted for 21.9% and <1.25 g accounted for 32.8% of cases.Conclusion : 1.The annual IVIG growth rate is fast,and the clinical demand also increased rapidly.2.IVIG prices and health insurance policies show large regional differences.3.The clinical application of IVIG in Children's Hospital of Medical University of Chongqing has been comparative standard in totally,but there is still room for improvement.A high proportion of clinical rational use of drugs accounted for most of IVIG resource consumption.4.The national catalog of Basic Medical Insurance and worker injury insurance(2017 edition)added 6 new diseases which provides extensive health care coverage,but there are still have needs of disease refinement and amplification.Most of the PID patients for which IVIG is the most recommended,should infusion IVIG every month to maintain life.However,the present study shows that both the total amounts and the number of cases of IVIG use are insufficient,meaning that patients have not accepted standard IVIG replacement therapy.This problem is a social concern.Autoimmune encephalitis and multiple sclerosis require high doses of IVIG and pose a heavy economic burden.It is recommended that such patients should have appropriate insurance policies.5.The domestic leading IVIG specification is 2.5g/ bottle,which does not fully meet the needs of clinical applications.The optimum specifications for IVIG is 5g/bottle.However,1.25g/bottle sizes have wide clinical application requirements in neonates.Manufacturers should increase the production of those two kinds of preparations. |
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