Abstract:
OBJECTIVE To systematically analyse the incidence rates and influencing factors of adverse drug reactions (ADRs) associated with salvianolate injection, and to provide reference for its rational application.
METHODS Databases such as PubMed, EMbase, the Cochrane Library, CNKI, the VIP database, and Wanfang database were investigated using computer-based. The retrieval time was from the database establishment date to February 28, 2018. Meta-analysis and subgroup analysis were performed using R3.4.3 software.
RESULTS Seventy-eight studies were included, with 4 118 patients involving salvianolate injection, and 256 presenting ADRs. The meta-analysis showed that the total incidence rate of ADRs was 5.68%95%
CI(0.049 3, 0.064 6), the incidence of ADRs of nervous system was 3.05%95%
CI (0.023 0, 0.038 8), and the incidence of ADRs of digestive system was 3.5%95%
CI (0.025 9, 0.045 2). In the subgroup analysis of ADRs of nervous system, the incidence of 5% glucose injection, 7 d ≤ course of treatment ≤ 14 d, combination drug, dose ≤ 100 mg·d
-1 and off-label use was higher. In the digestive system ADRs subgroup, the incidence of ADRs was relatively high in 0.9% sodium chloride injection, course of treatment >14 d, combination drug, and off-label use. The results of
χ2 test showed that the type of solvent and the mode of administration could affect the incidence of ADRs of salvianolate injection.
CONCLUSION The influencing factors of ADRs of salvianolate injection are significantly correlated with the type of solvent and mode of administration. Therefore, these factors must be fully considered in clinical practice. In addition, further investigation is required to confirm whether other factors such as age, dosage, and the course of treatment.