• Yi Que, Yan-Ming Xie, Xing Liao, and Yi-Li Zhang.
• Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
• Zhongguo Zhong Yao Za Zhi. 2016 Oct 1; 41 (20): 3866-3874.

AbstractThis systematic review aims to evaluate the drug safety of sofren injection in clinical studies. Seven databases were retrieved, and the articles were extracted by 2 researchers according to inclusion and exclusion criteria. Then the quality of all studies and extracted information was evaluated. Sixty three articles were finally included in our study, including 58 randomized controlled trials, 3 non randomized controlled trials, and 2 case reports. All studies included 5 872 patients. Intervention group had a total of 23 cases of adverse drug reaction(ADR), accounting for 0.39% of the total number of patients. ADRs mainly included headache(6 cases), palpitations(4 cases) and dizziness(4 cases). ADRs mainly occurred in the nervous system, cardiovascular system, digestive system and so on. Serious adverse events about sofren injection have not been found in the study, but it is still needed to be cautious in clinical applications. As the current systematic review is based on the previous studies, it is necessary to strengthen the safety monitoring in a long period, and regulate its clinical use as well.Copyright© by the Chinese Pharmaceutical Association.

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