FOREWORD
Clinical applications of human serum albumin : Perspectives from pharmacy and clinical practice
Rongsheng Tong PhD Chief Pharmacist , Pharmacy Department , Sichuan Provincial People ’ s Hospital , China
References 1 Chinese Medical Doctor Association – Society of Emergency Physicians . China sepsis / septic shock emergency treatment guideline ( 2018 ). Infection Inflammation Repair 2019 ; 20 ( 1 ): 3 – 22 . 2 Chinese Medical Association- Chinese Society of Hepatology . Treatment guideline of cirrhotic ascites and related complications . Chinese J Hepatol 2017 ; 25 ( 9 ): 664 – 77 . 3 Hui-bo Li et al . A protocol of rapid advice guideline for pharmacological management of human albumin cirrhosis treated with human serum albumin . Chinese J Pharmacoepidemiol 2017 ; 26 ( 11 ): 781 – 5 . 4 Chinese Society of Extracorporeal Circulation . White Book of Chinese cardiovascular surgery and extracorporeal circulation in 2017 and 2018 . Chinese J Extracorporeal Circ 2019 ; 17 ( 5 ): 257 – 60 .
Human serum albumin ( HSA ) has been used in clinical practice extensively since the 1940s ; however , guidelines on the use of HSA in various clinical scenarios are still lacking . In 2013 , Hospital Pharmacy Europe invited European experts to review the safety , efficacy and cost-effectiveness of HSA , and published their first educational handbook on HSA , which was received favourably by healthcare providers worldwide . An updated second edition was published in 2019 , also receiving high praise in Europe . Experts in China have been accumulating a wealth of experience in clinical practice in the use of HSA , which is worthy of dissemination to healthcare providers outside of China and internationally . Therefore , for a third update , Hospital Pharmacy Europe invited experts from the fields of pharmacy , cardiac surgery , hepatology , oncology and critical care in China to interpret latest evidence from a pharmacy and clinical perspective in an aim to provide more precise recommendations and guidance for the use of HSA for healthcare providers ( especially pharmacists ). This is also the first collaboration between pharmaceutical and clinical experts in an international educational handbook published under the Hospital Pharmacy International brand .
Furthermore , this special issue coincided with the COVID-19 global epidemic , and HSA has considerable clinical value in treating respiratory distress in COVID-19 patients . A European expert discusses the principles of fluid therapy in acute respiratory failure , clinical conditions of HSA use and corresponding benefits based on clinical evidence , thereby providing a professional viewpoint on handling the COVID-19 epidemic and development of fluid therapy .
Albumin used in clinical care is derived from fractionated human plasma , with indications for correction of hypovolaemia and hypoalbuminaemia . Manufacture of HSA requires stringent production processes and rigorous safety assurances . Thus , medication regulatory authorities worldwide pay great attention to standards in HSA manufacturing , including virus deactivation and elimination etc . Chapter 3 details manufacturing processes , which involve a combination of cutting-edge techniques and stringent quality control methodologies to ensure the highest standard HSA for clinical use .
Fluid therapy is pivotal for severe illness and in surgical patients . High-quality clinical studies and meta-analyses have shown that hydroxyethyl starch is associated with mortality and renal impairment in critically ill patients , leading to a black-box warning imposed by the European Medicines Agency and the US Food and Drug Administration . As an osmotic natural colloid , HSA has an irreplaceable role in fluid therapy . It is clearly demonstrated in the China Sepsis / Septic Shock Emergency Treatment Guideline ( 2018 ) 1 that use of HSA along with crystalloids is essential for improving efficacy of fluid resuscitation and volume therapy . Moreover , other uses of HSA in critical illness include plasma exchange , in brain oedema , pulmonary oedema , burns and acute pancreatitis ( as detailed in Chapters 6 and 7 ).
There is a high prevalence of liver disease in China . Cirrhosis , which is inevitable for progressive liver disease , can cause a number of severe complications . The first China Guideline of Cirrhotic Ascites and Related Complications , published in 2017 , details the rational use of HSA in the treatment and / or prevention of hepatic ascites , spontaneous bacterial peritonitis and hepato-renal syndrome . 2 Concurrently , the Chinese Pharmaceutical Association-Pharmaceutical Committee collaborated with the Chinese Medical Association-Chinese Society of Hepatology to produce the first evidence-based guideline . 3 Evidence and practical experiences supporting these guidelines are discussed in Chapters 4 and 5 .
Many cardiac surgeries are performed in China each year . According to statistics , 240,614 cardiovascular surgeries were completed by 693 hospitals in China during 2017 – 2018 . 4 Based on clinical evidence and practical experiences from Chinese experts , Chapter 9 discusses important issues such as characteristics and requirements of fluid management and evaluation of fluid therapy in cardiac surgical patients , and details the multiple advantages of HAS in this arena , including haemodynamic improvements and lower fluid overload .
Hypoalbuminaemia can occur in various clinical scenarios and is mostly associated with poor prognosis . The therapeutic value of HSA for hypoalbuminaemia has always been controversial , but it should be noted that the aim of HSA administration is not only correcting serum albumin levels , but alleviating the effects related to significant decreases in the level of serum albumin , such as raised mortality , oedema of vital organs , abnormal drug metabolism , and so forth . Chapter 10 discusses the association between hypoalbuminaemia and poor prognosis in cancer patients , and potential reasons for this are outlined .
In summary , the clinical benefits of HSA are supported by a growing body of evidence . Furthermore , multiple biological effects ( antiinflammatory , anti-oxidation , etc ) contributing to potential mechanisms for disease treatment have been elucidated . As a successful example of international collaboration , this handbook has established a multidisciplinary communication platform to enhance interaction and knowledge for pharmaceutical and clinical experts . The contributing authors are not only pharmaceutical and clinical experts but have also participated in the development of related guidelines and consensus . The opinions and recommendations contained in this educational handbook are therefore highly evidence-based , systematic and practical , and will help readers ensure optimal outcomes and benefits for patients in their care .
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