Effect of Sucralfate Suspensoid Gel on Blood Aluminum Concentration: A Single Arm Single-center Clinical Study / 胃肠病学

ABSTRACT

Background; Sucralfate is a commonly used gastric mucosal protector in clinical practice. It can be dissociated into aluminum hydroxide and sucrose sulfate under the action of gastric acid. As a topical agent, sucralfate is mainly excreted with feces, and the tiny amount of sucralfate absorbed in gastrointestinal tract is excreted with urine in the form of disaccharide sulfate. Aims; To study the effect and safety of a domestic made oral sucralfate suspensoid gel on blood aluminum concentration. Methods; Twenty-three healthy volunteers participated in this study from June 2021 to September 2021 at the Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. All subjects received sucralfate suspensoid gel daily (1 h before breakfast in the morning, and before bedtime in the evening, 1 g each time) for 2 weeks. Blood samples were collected on day 1 (before sucralfate administration) and day 15 (after medication completion) for determination of blood aluminum concentration. Any adverse events (including abnormal laboratory indicators) were recorded. Results: No significant difference was existed in mean blood aluminum concentration of the healthy subjects between time points before and after sucralfate administration [(47. 66 ± 15. 64) μg/L vs. (39. 12 ± 2 0. 42) μg/L, P > 0. 0 5]. All the blood aluminum values after medication were within the reference range (70 μ g/L), so did the blood routine, urine routine and blood biochemical indicators before and after medication. No severe adverse events were reported. Conclusions; The domestic made sucralfate suspensoid gel used in this study for 2 weeks has no adverse effect on blood aluminum concentration in healthy subjects. It is considered to be safe and reliable, and is worthy for clinical application.