Influencing Factors for Adverse Drug Reactions of Chinese Herbal Formula Aidi Injection

Objective: To analyze the adverse drug reactions (ADRs) of Aidi injection and the corresponding influencing factors. Methods: All clinical studies and ADR reports on Aidi injection were searched from EMBASE, VIP, CBM and CNKI, etc., from inception to January 2016, as well as tracing relevant references, etc. Data was reviewed and extracted independently by 2 reviewers. Results: 602 studies involving 377 patients were included, and 588 literatures were clinical researches (97.7%). Among these 588 literatures, 494 studies (84.2%) did not mention whether ADRs had happened, 94 studies (15.9%) reported relative information of ADRs, 76 studies (12.9%) described ADRs more detailedly (363 patients). 14 case reports included 14 patients with ADRs. The inherent fact that lacking of data on the total amount of product output and clinical usage, resulted in calculation difficultly with respect to the incidence rate of ADRs. Conclusion: The occurrence rate of ADRs was low in clinical practice, and the mild ADRs could be tolerant after regular treatments. But several problems on ADRs should be neglected, including lack of integrated key information, fewer articles and small samples of ADRs, etc. Hence, we could not calculate ADRs rate, and the reporting quality also remained to be improved.