RESUMEN
Objective:To investigate whether the adverse reactions of Xuebijing injection (XBJJ) are mainly pseudoallergic reactions and explore the influencing factors of its pseudoallergic reactions. Method:Mouse model of pseudoallergic reaction was used to study the anaphylactoid reaction of XBJJ which at 0.5, 1 and 2 times of the highest clinical concentration. Next, we compared the differences in pseudoallergic reactions caused by XBJJ for different storage times after preparation. Specifically, XBJJ was prepared into different concentrations, stored for 10 minutes, 2.5 hours, 6 hours and 24 hours, and then injected into the tail vein of mice. Finally, three different injection speeds of 3 seconds, 45 seconds and 90 seconds were selected for XBJJ injection, and then the differences in the paeudoallergic reactions induced by XBJJ in mice under different injection speeds were compared. Result:XBJJ induces pseudoallergic reactions in mice when the drug concentration is higher than the clinically recommended concentration. Compared with storage for 10 minutes after preparation, the degree of pseudoallergic reaction in mice induced by the same concentration of XBJJ increased with the extension of storage time. In addition, when XBJJ was injected in 3 s (the injection rate was 0.083 mL·s<sup>-1</sup>), it produced the strongest pseudoallergic reaction. Conclusion:The adverse reactions induced by XBJJ are mainly pseudoallergic reactions. Excessive storage time after preparation and fast injection speed of XBJJ will lead to aggravation of pseudoallergic reactions in mice. When XBJJ is used clinically, it should strictly follow the usage, dosage, concentration, and drip rate recommended in the drug instruction manual. Rational drug use is of positive significance for improving the safety of XBJJ.
RESUMEN
Allergic hypersensitivity reactions (AHRs) are the most commonly reported adverse reactions of traditional Chinese medicine injections, mainly including skin and mucosa redness, itching, abdominal pain, chest tightness, dyspnea and nausea, blood pressure decline, with clinical symptoms, and even shock or death. In this paper, we analyzed the characteristics of clinical adverse reactions and preclinical study results of traditional Chinese medicine injections, and proposed a view of point that the main adverse reactions of traditional Chinese medicine injections are nonallergic hypersensitivity reactions (NHRs) or pseudoallergic reactions (PARs) instead of real AHRs. Because there are absolute differences in the characteristics and the pathogenesis mechanisms between PARs and AHRs, they should not be confused, otherwise, the clinical processing measures and the direction of basic research on the adverse reactions of traditional Chinese medicine injections would be misleading. This paper also discussed the approaches for risk prevention and control of PARs of traditional Chinese medicine injections.
RESUMEN
BACKGROUND: Chronic idiopathic urticaria (CIU) is considered a complex and multifactorial disease. Excessive histamine intake may induce an attack of urticaria. The main enzyme for histamine metabolism is diamine oxidase (DAO). OBJECTIVE: Plasma histamine concentrations and DAO activities were evaluated to determine whether there are abnormalities in the histamine metabolism of CIU patients. METHODS: Seventy-five CIU patients and twenty-five healthy control subjects were included in the study. Blood was taken from all subjects to measure plasma levels of the histamine and DAO. RESULTS: Mean plasma histamine levels were significantly higher in CIU patients (11.59+/-10.98 nM) than in the control subjects (8.75+/-2.55 nM) (p=0.04). Mean DAO activities were lower in patients of CIU (80.86+/-26.81 histamine degrading unit [HDU]/ml) than in the controls (81.60+/-9.67 HDU/ml), but without significant difference. In 15 CIU patients with gastrointestinal symptoms, the mean histamine concentration was higher (12.43+/-7.97 nM) and DAO activity was lower (77.93+/-27.53 HDU/ml) than in the remaining 60 CIU patients without gastrointestinal symptoms (11.38+/-11.67 nM and 81.58+/-26.82 HDU/ml), without significant difference. The relationship between DAO activity and plasma histamine concentrations showed a significant negative linear value (p=0.001). There were no significant relationships between plasma histamine concentrations and symptom severity score. CONCLUSION: In CIU patients, a high plasma histamine concentration may not be explained by DAO activity. CIU patients with gastrointestinal (GI) symptoms showed no significantly lower DAO activity. Larger group studies are required to elucidate the relationship between plasma histamine concentrations and DAO activity, especially of CIU patients with GI symptomsto understand the difference in CIU patients with and without GI symptoms.