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Macdougall IC, Roche A
Am J Kidney Dis 2005 Aug;46(2):283-9.
ITO review
Reviewed by: Donald Silverberg
Design
A prospective, single-center, cohort study. Period: unknown. Setting: Department of Renal Medicine, King’s College Hospital, London, UK.
Intravenous (IV) therapy is used in conjunction with erythropoietin (EPO) therapy in order to optimize erythropoiesis, especially in anemic patients undergoing hemodialysis (HD). IV iron used alone has been shown to increase hemoglobin (Hb) levels, whereas when used in conjunction with EPO it enables a reduction in EPO dose requirements and therefore an increase in cost savings.
The Revised European Best Practice Guidelines (ITO Link) advocate the use of IV iron in all HD patients. Optimum IV iron therapy protocols for patients receiving peritoneal dialysis, or with failing renal transplants or with chronic kidney disease (CKD) not on dialysis, remain to be established. Due to the fact that these patients do not have a ready vascular access for the administration of IV iron, many clinics in the UK administer large doses of IV iron as an infusion often lasting more than one hour; this is impractical in an outpatient setting. The administration of IV iron as a bolus injection is more practical.
In this way the authors of the present study sought to examine both the safety and the practicability of the administration of a 200 mg bolus injection of IV iron sucrose to non-hemodialysis CKD patients.
Methods
All patients referred to the Anemia Nurse Specialist (AR) for the administration of IV iron were included in this study (47.6% males, mean age 59.9 years). Exclusion criteria were patients undergoing HD as they were already undergoing IV iron treatment, and patients with previous reaction to IV iron. The mean (± SD) Hb concentration for the total population was 11.2 ± 1.5 g/dL, and serum ferritin (SF) 89 ± 67 µg/L. Of the patients, 59 % received EPO therapy (mean dose, 6,487 ± 3,957 U/wk).
A butterfly cannula was used to administer 200 mg of IV iron sucrose as an undiluted bolus injection over 2 minutes. Patients were observed for between 30 and 60 minutes following IV iron administration. Hb, SF, EPO doses were recorded at the time of injection. Adverse events were recorded by the AR up to 30 minutes following injection. The presence of phlebitis within 2 days of IV iron injection was also assessed.
Results
During the study period, 2,297 injections were administered to
657 patients: 217 with a calculated creatinine clearance > 30 mL/min, 215
with a calculated creatinine clearance < 30 mL/min, 124 patients were
undergoing peritoneal dialysis, 87 patients had failing renal transplants and
there were 14 nonrenal patients.
In 412 injections (17.9%), patients noted a
metallic taste. Upon their second injection, 97.5% of patients reported that
they had had an otherwise uneventful first injection without reactions or side
effects; no case of phlebitis was recorded. Only 57 patients (2.5%) had an
adverse event other than metallic taste; 7 of these reactions were anaphylactoid
reaction to the IV iron, of these 5 were classed as “serious” because the
patients were administered hydrocortisone (100 mg), chlorpheniramine (10 mg),
and metoclopramide (10 mg); however, no patient required hospitalization. The
anaphylactoid reactions were characterized by symptomatic hypotension, patients
had nausea, 2 patients experienced vomiting, 1 patient experienced headache and
1 patient had a transient loss of vision. In the 2 patients with “nonserious”
anaphylactoid reactions the symptoms resolved naturally after 10-20 minutes. All
7 patients were rechallenged with 200 mg IV iron given as a 2 hour infusion and
no adverse events were reported. The remaining 50 adverse events were: pain
during injections (n = 31), pain after injection with or without bruising (n =
9), nausea, with or without gastrointestinal symptoms (n = 3), lethargy (n = 4),
lightheadedness (n = 3).
Conclusion
The authors conclude that not only is this protocol safe but there are enormous benefits including cost and timesavings. With regard to cost savings of the two?minute push compared with a two?hour infusion dissolved in 100 mL of saline, the two?minute push requires no expenditure on saline or administration tubing. The total cost saving during the study period was over US$5,007. Time savings were also reported: the infusion requires two hours to deliver and 15 minutes to prepare the iron, dissolve it in saline and dispose of equipment. The two?minute push can be prepared in three minutes. A total of five minutes is required compared with 135 minutes for IV iron infusion. This corresponds to a time saving of 6.9 months over the period of study (period of study not known).
Key Points
· A butterfly cannula can be used to administer 200 mg of IV iron sucrose as an undiluted bolus injection over 2 minutes to nonhemodialysis CKD patients.
· 2,297 injections of IV iron sucrose were administered to 657 patients.
· In 412 injections (17.9%), patients noted a metallic taste.
· Upon the second injection, 97.5% of patients reported that they had had an otherwise uneventful first injection without reactions or side effects.
· No case of phlebitis was recorded.
· A total of 57 patients (2.5%) had an adverse event other than metallic taste.
· A total of 7 patients experienced anaphylactoid reactions to IV iron sucrose, 5 of which were classed as serious but not requiring hospitalization. After being rechallenged with 200 mg IV iron given as a 2-hour infusion, no adverse events were reported in these patients.
· Other adverse events (n = 50) were pain during or after injection, nausea, lethargy, and lightheadedness.
· The cost saving of using a 2-minute IV iron push compared to infusion was calculated as being US$ 5,007.
· The time saving of administering IV iron as a bolus injection over 2 minutes rather than a 135-minute infusion corresponded to a saving of 6.9 months.
Limitations
· Study period is not mentioned; it would be interesting to know over what time period the cost savings correspond.
· The efficacy of IV iron was not assessed.