A Study Of Comparing The Applicability Of Historical (Criteria_Hist) And Iwg (Criteria_Iwg) Itp Criteria

Background:Immune thrombocytopenia originally called Idiopathic Thrombocytopenic Purpura, still called ITP for short. It is the most common hemorrhagic disease, about one third of that. It is a group of diseases which caused by the increase of platelet destruction or the reduce of platelet production by the immune system dysfunction caused resulting in the risk of bleeding increased, the pathogenesis is immune-mediated anti-platelet autoantibodies generated, leading to the destruction of platelets increased; and immune-mediated megakaryocyte’s quantity and quality maked abnormal, causing the production of platelets reduced. ITP affects all age groups with peak incidences in young childhood and in adulthood.Unfortunately, definitions and clinical criteria for ITP have varied among studies. Nevertheless, many studies and the majority of clinicians previously used the historical terminology and definitions shown in Tables I and II. These definitions and criteria allow easy classification in clinical situations and across a wide age range. However, they are often vague and based on clinically less-relevant criteria, particularly, platelet count without regard to bleeding rather than bleeding itself. Discrepant criteria used to evaluate patients and clinical outcomes have made it difficult to compare clinical trials and cohort studies. Recognizing this issue,in2009,an International Working Group(I WG) of experts developed consensus terminology, definitions, and outcome criteria in ITP in adults and children to apply to future investigational clinical trials and cohort studies in patients with primary ITP.In2010,an international group of ITP experts published updated consensus guidelines on the investigation and management of primary ITP,which accepted and integrated the IWG criteria into the document without specific validation of the criteria for this role.A retrospective analysis to investigate the standardization of diagnosis and treatment of ITP in our hospital, in accordance with the old and the new standard in our hospital143cases of adult ITP patients. The objective of this study was to apply both the historical ITP criteria(criteriaHist) and the IWG criteria(criteriaIWG) to the clinical data of a large population previously diagnosed.Collecting past cases as the statistics of the demographics, laboratory data, various treatment methods, the indicators of the efficacy, as well as prognosis.The insufficient data might be available for individual patients to classify them according to the criteriaIWG and that patients might be reclassified, especially interms of severity and chronicity based on the criteriaIWG in comparison to the criteriaHist.Methods:Study data were collected a retrospective medical record review of all ITP patients seen at Qilu Hospital of Shandong University with a first visit between2009.12and2010.6. This study all patients with ECOG (the eastern cooperative oncology group) performance status should be<3. Demographic, laboratory, treatment data and drug efficacy were collected through a retrospective chart review. Both historical (criteriaHist) and IWG (criteriaIWG) ITP criteria were applied to available clinical data.Results:Among the143patients seen for ITP about2years, Only50%met criteriaIWG for severe ITP, whereas70.8%met criteriaHist for severe ITP.A striking difference was that overall response to therapies was lower if the criteriaIWG were used rather than the criteriaHist, particularly for rituximab(35.3%vs73.7%,P=0.05),which were depending on whether the criteriaHist or the criteriaIWG response rates were used.Conclusions:We applied the2009international consensus terminology and criteria for ITP to our clinical population. In comparison to the criteriaHist, fewer patients met criteriaIWG for severe ITP in the143patients seen at our hospital for ITP during a 2-year period. The most striking finding was that the overall response to therapies was significantly lower if the criteriaIWG were used rather than the criteriaHist, which will impact the comparability of future studies with older studies. In addition, very few patients met criteria for refractory ITP. Overall, contrasting with our initial hypothesis, the criteria could be applied to our retrospective, dataset reasonably well.We believe that the criteriaIWG are more consistent with the actual clinical course of ITP, in which many patients achieve remission between3and12months from diagnosis.Using the criteriaIWG, only half as many patients are classified as " severe ".This change might prevent ITP patients from being labeled " severe " and then treated with a pharmacologic intervention based upon platelet count alone, rather than bleeding symptoms.In general, the response rates to the most common treatments were lower using the criteriaIWG than the criteriaHist, most notably for IVIG and rituximab. This difference is due to the more-strict criteriaIWG, which specify both a platelet response, including doubling of the baseline platelet count, and a bleeding response. In ourview, this difference is of mixed utility. We hasten to point out that the actual response in individual patients is unchanged, only their categorization. Clinically, it is clear that patients who continue to bleed after treatment for ITP failed to respond to the treatment, generally regardless of the platelet count. Thus, the criteriaIWG for treatment response are consistent with clinical decision making.Outside of a research setting, platelet counts are infrequently checked in ITP patients without symptoms. Therefore, the duration of a particular patient’s response to a drug in the clinical setting is often not known. This limitation of the criteriaIWG only applies to clinical retrospective data, as adequate follow up data on duration could easily be available in a prospective ITP trial.Overall, the most limited data was about duration of response, which was expected in our non-research ITP population. Nevertheless, unlike the criteriaHist, the criteriaIWG are clinically relevant and provide a rational framework for classifying ITP related to bleeding. The criteriaIWG will need to be integrated into prospective trials to determine whether they provide a high quality tool for classifying ITP. These results add confidence to the ability to use the criteriaIWG in future trials.