Abstract: 【Abstract】 Objective To observe the effects of saccharum iron on restless legs syndrome (RLS) in maintenance hemodialysis (MHD) patients. Methods We recruited 40 patients who underwent hemodialysis for at least three months before the study and with restless legs syndrome (RLS). RLS was diagnosed according to the criteria from the International Restless Legs Syndrome Study Group (IRLSSG). These patients were randomly divided into two groups, treatment group (20 cases) and control group (20 cases). In the treatment group, 100mg of saccharum iron were infused to the patient during the dialysis treatment once a week with a total dose of 1000 mg, while in the control group no iron preparations were used. Hemoglobin (Hb), serum Fe (Fe), serum ferritin (SF), transferrin saturation (TSAT) and RLS rating scale were determined every four weeks during the treatment. Side-effects of the drug were also recorded.  Results At the initiation of the investigation, there were no significant differences in Hb, Fe, SF, TSAT and RLS rating scale between the two groups. After the treatment for 10 weeks, Fe, SF and TSAT increased significantly compared with those before treatment (P＜0.05 or P＜0.01) in the treatment group, but changed insignificantly in the control group (P＞0.05). RLS rating scale was 16.29±10.08 and 15.79±10.42 before the treatment (P＞0.05), 14.02±9.18 and 16.03±10.4 after the treatment for 4 weeks (P<0.05), 10.94±9.03 and 15.12±9.34 after the treatment for 8 weeks (P＜0.01), and 10.02±8.14 and 14.97±10.13 after the treatment for 10 weeks (P＜0.01) in the treatment group and control group, respectively. No significant side-effects were found in the treatment group. Conclusion   Intravenous supplement of saccharum iron appears to be associated with the improvement of RLS in MHD patients.

Key words: Hemodialysis, Saccharum iron, Restless legs syndrome