A robust voltammetric method has been developed and validated for the determination of Fe（Ⅱ） and Fe（Ⅲ） in pharmaceutical iron polysaccharidic complexes. Undesirable low molecular weight iron complexes, at concen...A robust voltammetric method has been developed and validated for the determination of Fe（Ⅱ） and Fe（Ⅲ） in pharmaceutical iron polysaccharidic complexes. Undesirable low molecular weight iron complexes, at concentration about 3% in the pharmaceutical formulation, can be easily determined with good accuracy and precision. This methodology can be proposed as a viable, environmentally sustainable substitute for the conventional Normal Pulse Polarographic method in US Pharmacopeia, with better analytical figures of merit, and reduced Hg consumption. A deeper insight in Fe（Ⅱ） and Fe（Ⅲ） composition can be gained by the combined use of a new potentiometric technique after chemical decomposition of the complex.展开更多
Iron deficiency(ID)and ID anemia(IDA)pose significant public health concerns in China.Although iron sucrose(IS)treatment is well-established in the country,ferric carboxymaltose(FCM)offers the advantage of higher dose...Iron deficiency(ID)and ID anemia(IDA)pose significant public health concerns in China.Although iron sucrose(IS)treatment is well-established in the country,ferric carboxymaltose(FCM)offers the advantage of higher doses and fewer infusions.This open label,randomized,controlled,non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM(maximum of 2 doses,500 or 1000 mg iron)and IS(up to 11 infusions,200 mg iron)treatments in subjects with IDA.The primary endpoint was the achievement of hemoglobin(Hb)response(an increase of⩾2 g/dL from baseline)within 8 weeks,whereas secondary endpoints included changes in Hb,transferrin saturation,and serum ferritin levels.Among the 371 randomized subjects,a similar percentage of subjects treated with FCM and IS achieved Hb-response(FCM 99.4%,IS 98.3%),thereby confirming the non-inferiority of FCM compared with IS(difference 1.12(−2.15,4.71;95%confidence interval(CI))).Furthermore,a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2(FCM 85.2%,IS 73.2%;difference 12.1(3.31,20.65;95%CI)).Additionally,the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects.The safety profiles of FCM and IS were comparable,with the exception of transient hypophosphatemia and pyrexia,which are consistent with FCM’s known safety profile.In conclusion,FCM proves to be an efficacious treatment for IDA,providing faster Hb-response and correction of ID with fewer administrations than IS.展开更多
Background:Intravenous iron sucrose is not recommended by its manufacturers for use in children despite extensive safety and effi cacy data in adults.Methods:We reviewed the experience of our department between Januar...Background:Intravenous iron sucrose is not recommended by its manufacturers for use in children despite extensive safety and effi cacy data in adults.Methods:We reviewed the experience of our department between January,2011 and February,2014 with the use of intravenous iron sucrose in children≤14 years of age who failed in oral iron therapy for iron defi ciency anemia(IDA).Results:Twelve children(6 females)aged 1.2-14 years(median age 8.9 years)received at least one dose of intravenous iron sucrose.Ten patients had IDA inadequately treated or non-responsive to oral iron therapy.One patient received therapy for blood transfusion avoidance and one for presumed iron refractory iron deficiency anemia(IRIDA).Iron sucrose infusions were given on alternate days up to three times per week.The number of infusions per patient ranged from 2 to 6(median,3),the individual doses from 100 mg to 200 mg(median,200 mg),and the total doses from 200 mg to 1200 mg(median,400 mg).Iron sucrose was effective in raising the hemoglobin concentration to normal in all patients with IDA,i.e.,from 7.6±2.38 g/dL to 12.4±0.64 g/dL,within 31-42 days after the fi rst infusion.The single patient with IRIDA demonstrated a 1.8 g/dL rise.Injection site disorders in three cases and transient taste perversion in one case were the only side effects.Conclusion:Intravenous iron sucrose appears to be safe and very effective in children with IDA who do not respond or cannot tolerate oral iron therapy.展开更多
基金supported by FAR, Fondo Ateneoper la Ricerca Universitá di Pavia,Italy
文摘A robust voltammetric method has been developed and validated for the determination of Fe（Ⅱ） and Fe（Ⅲ） in pharmaceutical iron polysaccharidic complexes. Undesirable low molecular weight iron complexes, at concentration about 3% in the pharmaceutical formulation, can be easily determined with good accuracy and precision. This methodology can be proposed as a viable, environmentally sustainable substitute for the conventional Normal Pulse Polarographic method in US Pharmacopeia, with better analytical figures of merit, and reduced Hg consumption. A deeper insight in Fe（Ⅱ） and Fe（Ⅲ） composition can be gained by the combined use of a new potentiometric technique after chemical decomposition of the complex.
基金support was provided by Vifor Pharma,Glattbrugg,Switzerland.
文摘Iron deficiency(ID)and ID anemia(IDA)pose significant public health concerns in China.Although iron sucrose(IS)treatment is well-established in the country,ferric carboxymaltose(FCM)offers the advantage of higher doses and fewer infusions.This open label,randomized,controlled,non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM(maximum of 2 doses,500 or 1000 mg iron)and IS(up to 11 infusions,200 mg iron)treatments in subjects with IDA.The primary endpoint was the achievement of hemoglobin(Hb)response(an increase of⩾2 g/dL from baseline)within 8 weeks,whereas secondary endpoints included changes in Hb,transferrin saturation,and serum ferritin levels.Among the 371 randomized subjects,a similar percentage of subjects treated with FCM and IS achieved Hb-response(FCM 99.4%,IS 98.3%),thereby confirming the non-inferiority of FCM compared with IS(difference 1.12(−2.15,4.71;95%confidence interval(CI))).Furthermore,a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2(FCM 85.2%,IS 73.2%;difference 12.1(3.31,20.65;95%CI)).Additionally,the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects.The safety profiles of FCM and IS were comparable,with the exception of transient hypophosphatemia and pyrexia,which are consistent with FCM’s known safety profile.In conclusion,FCM proves to be an efficacious treatment for IDA,providing faster Hb-response and correction of ID with fewer administrations than IS.
文摘Background:Intravenous iron sucrose is not recommended by its manufacturers for use in children despite extensive safety and effi cacy data in adults.Methods:We reviewed the experience of our department between January,2011 and February,2014 with the use of intravenous iron sucrose in children≤14 years of age who failed in oral iron therapy for iron defi ciency anemia(IDA).Results:Twelve children(6 females)aged 1.2-14 years(median age 8.9 years)received at least one dose of intravenous iron sucrose.Ten patients had IDA inadequately treated or non-responsive to oral iron therapy.One patient received therapy for blood transfusion avoidance and one for presumed iron refractory iron deficiency anemia(IRIDA).Iron sucrose infusions were given on alternate days up to three times per week.The number of infusions per patient ranged from 2 to 6(median,3),the individual doses from 100 mg to 200 mg(median,200 mg),and the total doses from 200 mg to 1200 mg(median,400 mg).Iron sucrose was effective in raising the hemoglobin concentration to normal in all patients with IDA,i.e.,from 7.6±2.38 g/dL to 12.4±0.64 g/dL,within 31-42 days after the fi rst infusion.The single patient with IRIDA demonstrated a 1.8 g/dL rise.Injection site disorders in three cases and transient taste perversion in one case were the only side effects.Conclusion:Intravenous iron sucrose appears to be safe and very effective in children with IDA who do not respond or cannot tolerate oral iron therapy.
