Effects of modified hydration method on acute-phase reaction of zoledronic acid injection

Abstract

Objective To explore the effects of self-established method of modified hydration on the acute-phase reaction (APR)of zoledronic acid injection. Methods This study was designed as randomized controlled trial. The subjects were inpatients with rheumatism and osteoporosis who were intended to receive zoledronic acid injection for the first or second time in Department of Rheumatology & Immunology, Xuanwu Hospital, Capital Medical University from August 2016 to December 2017. The patients who meet the inclusion criteria were randomly divided into the modified hydration group and the routine hydration group. The patients in the modified hydration group received IV infusions of 0.9% sodium chloride injection 500 ml before and after IV infusion of zoledronic acid injection, respectively and water 750 ml measured with mould under the care of nurses within 2 hours before and after medication, respectively. The total amount of liquid was more than 2 500 ml. The patients in the routine hydration group were only told to drink a large amount of water before and after IV infusion of zoledronic acid injection. The total amount of liquid was required to be more than 2 000 ml, but the water measuring mould was not provided. After IV infusion, the intravenous infusion tube was washed by 0.9% sodium chloride injection 100 ml. The total amount of liquid was more than 2 000 ml. The incidence of APR within 3 days of medication and levels of serum creatine on day 3 of medication in patients in the 2 groups were compared. Results A total of 190 patients were enrolled in the study, including100 and 90 patients in the modified hydration group and the routine hydration group, respectively. The differences of sex distribution, age, proportion of patients with zoledronic acid injection for the first or second time, minimum bone mineral density T value before medication, and the levels of serum creatine before medication between the 2 groups were not statistically significant (P>0.05 for all). The incidences of APR and fever in the modified hydration group were significantly lower than those in the routine hydration group [40.0% (40/100) vs.68.9% (62/90), P<0.01; 23.0% (23/100) vs. 44.4% (40/90), P<0.01] within 3 days of IV infusion of zoledronic acid injection. The incidences of APR and fever in patients treatment with zoledronic acid injection for the first or second time in the modified hydration group were significantly lower than those in the routine hydration group [first medication: 53.3% (32/60) vs. 73.6% (39/53), 30% (18/60) vs. 50.9% (27/53); second medication: 20.0% (8/40) vs.62.2% (23/37), 12.5% (5/40) vs. 35.1% (13/37)]; the incidences of APR and weakness in patients treatment with zoledronic acid injection for the second time were significantly lower than those for the first time[20.0% (8/40) vs. 53.3% (32/60), 17.5%(7/40) vs. 41.7% (25/60)]; the incidence of headache in patients treatment with zoledronic acid injection for the second time in the routine hydration group were significantly lower than those for the first time[0 (0/37) vs. 13.2% (7/53)]; all above-mentioned differences were statistically significant (P<0.05 or P<0.01). No patients developed acute kidney injury in the 2 groups. The levels of serum creatine in the 2 groups were (52±20) and (52±13) μmol/L, respectively. Conclusion The modified hydration method can decrease the incidence of APR effectively in patients with zoledronic acid injection treatment for the first or second time. Key words: Diphosphonates; Hydration; Osteoporosis; Acute-phase reaction