Читать книгу Clinical Pancreatology for Practising Gastroenterologists and Surgeons - Группа авторов - Страница 157

Previous systematic reviews of clinical trials in AP have provided disappointing results [64]. Initial poor risk stratification and inappropriate outcome measures have been inhibitory to progress. Common primary outcome measures previously used have been mortality, organ failure, pancreatic infections, and SIRS [1]. Looking to the future, study end points in AP should be determined based on the context of the proposed intervention. Traditional approaches for the development of novel therapeutics in AP have focused on prevention or reduction of severe forms of illness, with expectations that may have been too high. These studies incorporated initial risk stratification to identify higher‐risk subgroups of patients, which takes time for amelioration in outcomes such as persistent organ failure or mortality. These strategies have been accompanied by recruitment within 72–96 hours of admission, despite the emergency nature of the condition. An alternative approach would be to include all AP patients as early as possible after disease onset. In parallel with this, improvement in patient‐reported outcomes (as sought by regulatory agencies) related to pain, nutritional deficit, and quality of life alongside inclusion of surrogate outcomes of severity, such as C‐reactive protein, albumin and neutrophil count, offer the potential for enhanced and more rapid recruitment with greater generalizability of results. However, it remains important that all surrogates closely parallel severe outcomes, which would themselves preferably be included in trials at least as secondary outcome measures. However, this approach has yet to be validated [1,2]. Realistically, as acute pancreatitis has proven a tough disease to solve with any drug treatment, it is desirable to establish a pipeline of interventional trials to achieve regulatory approval for any treatment that improves outcomes from AP. This will require increased input from major funding agencies as well as investment through, and commitment from, Pharma. Nor will the quest stop once this is achieved, since there will continue to be a drive to improve AP outcomes further with effective, personalized treatments.