Category: Professional Posters
Purpose: To investigate the actual use of Ulinastatin in the clinical department in hospital through an open-label prospective clinical observational study, to initially calculate the incidence of ADR/E and to study the suspicious influencing factors of ADR/E, to provide a reference for next larger trial and some information for clinical rational use.
Methods: The study was collected two types of inpatients, which were normal inpatients and ICU inpatients. After medical ethics review, 10,000 cases were collected and a two-stage sampling method was used to conduct a large-scale, multi-center, prospective drug safety combined with nested case-control study. Inpatients who had been used at least once Ulinastatin during the hospitalization period were included in the study, and patients who did not use Ulinastatin for injection at the same time were not included as controls. All safety events found in the study were reported by the attending physician, and then reviewed and finally determined the relevance of safety to Ulinastatin by experts. All data were processed by SPSS 18, in which the measurement data was to be tested by two independent samples t test, and the count data was calculated by chi-square test; logistic regression was used to calculate the OR value and 95% confidence interval of risk factors.
Results: A total of 11252 valid cases were collected in this study, including ICU 7009, and 11 ADR/E cases, including 9 ICU inpatients and 2 normal inpatients. The incidence of ADR/E of Ulinastatin for injection during the study period was 0.98‰, and after the rejection of irrational use, the incidence of adverse reactions was calculated to be 3.06‰, which was “occasional”. It’s involved in the system classification of skin and its attachment damage, digestive system and blood. The relevance evaluation is “very likely relevant” in 1 case and “possibly relevant” in 10 cases. The severity of adverse reactions was graded up to 8 in grade 1, 2 in grade 2, and only 1 in grade 4. The time of ADR/E occurred within 6 days after administration; most of the ADR/E cases were discontinued the Ulinastatin, and most of them were not treated. Only one case of rash was coated with calamine lotion. All ADR/E inpatients were cured or improved within 11 days after ADR/E happened.
Conclusion: This study found that the incidence of adverse drug reactions of Ulinastatin is less than 5‰, and the rate of adverse reactions is low, and ADR involves limited sites, mainly in the skin and its attachment damage, digestive system, blood. Afterwards, in most ADR cases, the symptoms of ADR will gradually improve or cure after stopping the drug. The clinical application of the drug is still unreasonable, and these may bring the risk of drug use.