Prediction of allergic reaction risk of Shenmai injection based on real‐world evidence coupled with UPLC–Q‐TOF‐MS

Abstract

The allergic reaction (AR) of Chinese herbal injection (CHI) has become one of the most noticeable focuses of public health in China. However, it still remains a considerable controversy as to whether low‐molecular‐weight components in CHI have potential sensitization. In this study, the relationship between AR and low‐molecular‐weight component profile of Shenmai injection was explored by an interdisciplinary technology integrating real‐world evidence and ultra‐performance liquid chromatography–quadrupole time‐of‐flight mass spectroscopy (UPLC–Q‐TOF‐MS). The AR information of hospitalized patients was obtained by comprehensively analyzing real‐world evidence from January 2015 to June 2019 at two Chinese hospitals. The UPLC–Q‐TOF‐MS was exploited to systematically investigate the low‐molecular‐weight component profile with 50–1500 m/z mass range, and 3725 MS1 peaks were detected. The optimized partial least squares discriminant analysis model was established to map the influence of low‐molecular‐weight components on AR. The results of this study showed that high levels of organic acids administered intravenously might be a potential risk factor for inducing AR. By using this method, Shenmai injection with high AR risk could be recognized precisely with 100% accuracy before clinical use.

The immediate adverse drug reactions induced by ShenMai Injection are mediated by thymus-derived T cells and associated with RhoA/ROCK signaling pathway

“…Natural medicine injections are an important method in the application of natural medicine. It was an innovation that has been proven to have high bioavailability and rapid curative effects in extensive clinical applications ( 1 ). ShenMai injection (SMI) is a natural medicine injection product for treating coronary atherosclerotic cardiopathy and viral myocarditis.…”

Quantitative profiling of comprehensive composition in compound herbal injections: An NMR approach applied on Shenmai injection

“…However, primary metabolites such as amino acids, carbohydrates, and nucleosides can play a role as key regulators of nutritional metabolism, while some polysaccharides also have special pharmacological effects, which altogether provide comprehensive efficacy of herbal injections 6 . In addition, more than 90% of CHIs‐induced allergic reaction cases were related to CHIs containing organic acids 7 . Therefore, organic acids also need to be paid special attention considering drug safety.…”

“…In this study, 1 H qNMR was applied for the quantitative profiling of comprehensive composition in Shenmai injection (SMI), which is widely utilised to treat cardiovascular diseases 19 . As one of the most commonly used CHIs in China, 7 SMI is made from Ginseng Radix et Rhizome Rubra (red ginseng) and Ophiopogonis Radix , and has biological activities including reducing myocardial injury, restoring mitochondrial function, antioxidant properties, etc 20 . In recent years, ginsenosides have been the focus of quality analysis to SMI 21,22 .…”

“…6 In addition, more than 90% of CHIs-induced allergic reaction cases were related to CHIs containing organic acids. 7 Therefore, organic acids also need to be paid special attention considering drug safety. Therefore, comprehensive profiling of chemical constituents is essential to ensure the consistency, safety, and efficacy of CHIs.…”