ABSTRACT
Objective: To evaluate the safety of Tanreqing injection among children in the real world. Methods: A multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection. Univariate analysis was used to explain the risk factors of ADR. Results: The overall incidence of ADE was 4.20 (26 cases), including 4 serious ones. The incidence of ADR was 3.07 (19 cases), including 17 cases of general ADR and 2 cases of new ADR. All the ADR cases were mild or moderate, mostly showing damages in skin and appendages. The onset of disease happened in 24 hours after the Tanreqing injection but all the ADR cases got improved or cured. Having histories of allergies to drugs or foods would increase the incidence of ADR. Conclusion:Tanreqing injection caused low incidence of ADR in children. Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of Tanreqing injection.
Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Drugs, Chinese Herbal/adverse effects , Injections/adverse effects , Product Surveillance, Postmarketing , Adolescent , Child , Child, Preschool , China , Cohort Studies , Drugs, Chinese Herbal/administration & dosage , Female , Humans , Male , Safety , Skin/drug effectsABSTRACT
Oxidant stress, in vivo or in vitro, is known to induce oxidative changes in human red blood cells (RBCs). Our objective was to examine the effect of augmenting RBC glutathione (GSH) synthesis on 1) degenerative protein loss and 2) RBC chemokine- and free radical-scavenging functions in the oxidatively stressed human RBCs by using banked RBCs as a model. Packed RBCs were stored up to 84 days at 1-6 degrees C in Adsol or in the experimental additive solution (Adsol fortified with glutamine, glycine, and N-acetyl-L-cysteine). Supplementing the conventional additive with GSH precursor amino acids improved RBC GSH synthesis and maintenance. The rise in RBC gamma-glutamylcysteine ligase activity was directly proportional to the GSH content and inversely proportional to extracellular homocysteine concentration, methemoglobin formation, and losses of the RBC proteins band 3, band 4.1, band 4.2, glyceraldehyde-3-phosphate dehydrogenase, and Duffy antigen (P < 0.01). Reduced loss of Duffy antigen correlated well with a decrease in chemokine RANTES (regulated upon activation, normal T-cell expressed, and secreted) concentration. We conclude that the concomitant loss of GSH and proteins in oxidatively stressed RBCs can compromise RBC scavenging function. Upregulating GSH synthesis can protect RBC scavenging (free radical and chemokine) function. These results have implications not only in a transfusion setting but also in conditions like diabetes and sickle cell anemia, in which RBCs are subjected to chronic/acute oxidant stresses.