Automatic surveillance for cinepazide maleate related liver injury and kidney injury in 11665 patients

HU Peng-zhou; WANG Xiao-yu; GUO Dai-hong; MA Liang; FAN Qi; LIU Jia; XIA Yu-kun; TIAN Xiao-yan

doi:10.3969/j.issn.1672-8157.2017.02.009

Abstract：Objective: To obtain the incidence of cinepazide maleate related liver injury and kidney injury by means of a large sample study. Methods: A self-developed specific system was used to automatic surveillance for the hospitalized patients in our hospital of PLA who received cinepazide maleate (two specifications, 320 mg/10 mL & 80 mg/2 mL ) between August 1, 2014 and July 31, 2016 , and suspected cases submitted by system were evaluated by professionals. Results: A total of 11665 patients included and the incidence of cinepazide maleate-related liver injury and kidney injury were 0.87% and 1.45% respectively, the average age were (63.0 ± 14.3) years old and (72.0 ± 14.7) years old respectively, the level of ALT was rising on (190.0 ± 102.5) U·L-1 by an average in liver injury patients, the number of male liver injure patients was more than that of female significantly. The level of SCr rose by an average of (41.0 ± 14.1) μmol·L-1 in kidney injury patients, and their average age was greater than that of general drug used population obviously. All the positive cases had returned to normal after drug withdrawal or self-healing. Dose difference had no significant effect on the occurrence of ADR. Conclusion: By docking with the HIS system, our specific system could obtain rich data to complete automatic surveillance efficiently and provide reliable results. The cinepazide maleate related liver injury happened occasionally and kidney injury happened commonly. In the course of clinic application, the liver injury and kidney injury caused by cinepazide can be prevented effectively by reducing the dose in the patients of old age and poor conditions.