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To explore the effect of Kudiezi injection on renal function in the real world, in order to provide the basis for the clinical medication safety. Patient aged between 18-80 were selected from 18 large hospitals information system (HIS) databases established by clinical research institute for basic traditional Chinese medicine of China academy of Chinese medical sciences. The patients who were treated with Kudiezi injection (24 225 cases) were defined as the exposed group, whereas those who were not treated with Kudiezi injection (14,191 cases) were defined as the non-exposed group. The propensity score method was used to balance the confounding factors. Classic logistic regression, GBM weighted propensity score logistic regression, GBM propensity score weighted logistic regression with covariate and sensitivity analysis were adopted to study the effect of Kudiezi injection on renal function. The results showed no significant difference in the possibility in abnormality in serum creatinine (Scr) (P = 0.940, 0.679, 0.834) and urea nitrogen (BUN) (P = 0, 0.045, 0.164) between both groups. Therefore, the existing data indicated no damage of Kudiezi injection on renal function. Because this study is a retrospective study based on the real world, there may be unknown confounding factors and potential bias. Therefore, further studies shall be conducted to monitor whether Kudiezi injection causes damage on renal function, in order to ensure the clinical medication safety. |
