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[Post-marketing study on clinical safety of ginkgo diterpene lactone meglumine injection in 6 300 patients with ischemic stroke]. | LitMetric

AI Article Synopsis

  • A clinical safety study evaluated the use of ginkgo diterpene lactone meglumine injection in 6,300 ischemic stroke patients across 82 units from June 2013 to December 2014.
  • The study revealed a low adverse reaction rate of 0.46%, with most (86.21%) being mild and transient, such as headaches and dizziness, while only 4 cases had moderate reactions.
  • No serious adverse reactions were reported, indicating that the overall incidence of side effects was low and manageable.

Article Abstract

To further evaluate the safety of ginkgo diterpene lactone meglumine injection in the clinical use in ischemic stroke patients. Clinical safety study was conducted in 82 clinical units and 6 300 cases were completed and included from June 2013 to December 2014 by using multicenter, prospective, open and uncontrolled design methods for clinical research. A total of 29 cases of adverse reactions were observed in the experiment. Adverse reaction ratio (ADR) was 0.46%, and about 86.21% (25 cases) of them was mild with transient response which could be alleviated or disappeared without intervention; about 13.79% (4 cases) was moderate, including 2 cases of headache, 1 case of dizziness and 1 case of rash; no serious adverse reactions were found. The adverse reactions occurred in this study were pre-known adverse reactions or common adverse reactions of Chinese medicine injection. The overall incidence of adverse reactions was low, and the risk was controllable.

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Source
http://dx.doi.org/10.19540/j.cnki.cjcmm.2017.0211DOI Listing

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