Journal of evidence-based medicine
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Clearly report adverse effect or adverse event occurred in the clinical practice is very important for understanding the potential risk of using a drug for treatment of diseases, and with other advantages. This document aims to help healthcare providers to organize, report, and publish information on ADR/AE occurrences and to identify the nature of the ADR/AE in TCM and integrative medicine practice. ⋯ In each part, there are some samples could be references for the development of a report and ADR/AE. We welcome any comments for improving this recommendation.
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Review
Adverse drug reactions of Shuanghuanglian injection: a systematic review of public literatures.
To systematically evaluate the clinical characteristics of ADRs caused by Shuanghuanglian Injection (SHLI) and to provide reference for post-market evaluation and clinical application of SHLI. ⋯ The clinical manifestations of ADRs caused by SHLI mainly include skin allergic reactions and gastrointestinal reactions. There is an increased risk of ADR induced by combined uses of SHLI and other drugs, especially antibiotics. Compared to the solution, the powder has lower ADR occurrence and higher safety with statistical significance. We propose strengthening management and surveillance on SHLI from manufacturing to application, and improving the level of the risk management for post-market drugs.