| ObjectiveAccording to our clinical reflects several commercially available epirubicin hydrochloride for injection bladder perfusion of excitant differences,by understanding the influence factors of bladder perfusion after local reactions,from the Angle of clinical pharmacy drug quality and kinds of drugs for respectively to study the influence of adverse reactions,and collect the bladder perfusion drug use in the real world data usage.At the same time,according to the professional requirements of the rotation of each workshop and participate in clinical pharmacy work,understand the nature and characteristics of each job,familiar with the actual work process of the operation system and management process.At the same time,in the process of hospital pharmacy practice,the study of pharmaceutical management,and taking blood products as an example,to analyze the inclusion of drugs in China(including the mainland and Taiwan),Australia,the United Kingdom and the World Health Organization essential medicines list,to provide reference for the selection and management of China's blood products medical insurance directory.MethodsReferred to relevant quality standards and combined with clinical application,a comparative study was conducted on the appearance,pH value,resolution time of powder,content,related substances and stability of the preparations to explore the quality differences between the three manufacturers of epirubicin hydrochloride preparations.A total of 96 patients with bladder cancer who underwent bladder perfusion with epirubicin,pirubicin and BCG after tranurethral resection of bladder tumor in our hospital from December 2020 to April 2021 were included.The patients were divided into three groups according to different infusion drugs,and the clinical data and pathological data of the three groups were retrospectively analyzed.The local adverse reactions of urinary system in bladder perfusion chemotherapy were collected by questionnaire and telephone follow-up.The clinical drug use data and procurement data of epirubicin,pirubicin and BCG vaccine were collected on multiple platforms,and the data were analyzed to explore the use of some drugs for bladder cancer.In the process of participating in the research on pharmaceutical administration,descriptive analysis was used to compare the similarities and differences of the drug varieties covered by the medical insurance catalog of mainland China,Taiwan region,the United Kingdom,Australia and WHO,and to form comparative data,which could provide reference for the dynamic adjustment of the medical insurance catalog in China.ResultsA total of 9 batches of epirubicin samples from 3 manufacturers were orange-red loose lumps.In the comparison of instructions,the storage conditions of manufacturer B and manufacturer C are stricter than that of manufacturer A,and the storage requirements of manufacturer B and manufacturer C are increased in shade.As for the dissolution time,the resolution time of products from both manufacturers A and C was less than 60s,while the average resolution time of products from manufacturer B was more than 2min.In terms of the percentage content and related substances of each batch of samples from the three manufacturers prepared into solutions in different solvents,the amount of doxorubicin in the products of manufacturer A was about two times that of manufacturer B,while only A few samples of manufacturer C were detected in the first batch.In the exploration of the influence of drug types on local adverse reactions of bladder perfusion,the results showed that there were significant differences in the incidence of adverse reactions among EPI,THP and BCG groups(P=0.006).The incidence of adverse reactions such as urgent urination(P=0.001),hematuria(P=0.003)and dysuria(P=0.017)in BCG group were significantly higher than those in EPI group and THP group.Real world data collection results show that epirubicin is produced by the most manufacturers and purchased by the most volume;In terms of dosage,epirubicin and pirubicin were comparable,and BCG were both the least.Comparison results of medical insurance catalogs showed that a total of 32 kinds of blood products were included in the 5 catalogs,and 3 kinds of blood products were unique in the national medical insurance catalogs,which were immunoglobulin-type anti-human T cell rabbit immunoglobulin,anti-human T cell porcine immunoglobulin and thrombin.There are two varieties that are included in other catalogs but not included in the national medical insurance catalog,namely anti-D(Rho)immunoglobulin and coagulation factor ?.Apart from the EML catalogue,which serves as a reference for the national catalogue,hepatitis B immunoglobulin is included in the other three catalogs,but not included in the national medical insurance catalogue.ConclusionThis study of different manufacturers epirubicin hydrochloride for injection related index contrast research results show that the product of different manufacturer,there exist certain differences of the material more soft than the stars and more gentle than star ketone,degree of dissolution time,easy to operate,and other differences,suggested that domestic epirubicin preparations manufacturers in the packaging material,production process carefully evaluated,to improve the solubility.At the same time to increase the dissolution time of powder inspection,to ensure the clinical use of safety and convenience.The incidence and severity of adverse reactions were similar between EPI and THP,and there was no significant difference.Compared with EPI and THP,BCG has a higher incidence of adverse reactions,but there is no significant difference in severity.Compared with the other four directories,it was found that the number of drugs for blood products included in the National Directory of Health Insurance in China was similar to that of the other four directories,and the strength of health insurance was relatively strong.However,no trace protein drugs were included in the Directory of Health Insurance in China.The comparative analysis could provide reference for the dynamic adjustment of the Directory of Health Insurance in China. |
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