羟苯磺酸钙不良反应外文资料.docVIP

一．不良反应 1．羟苯磺酸钙诱发粒性白血球缺乏症 1) TI: Risk of drug-induced agranulocytosis: the case of calcium dobesilate. AU: Zapater, P; Horga, JF; Garcia, A AF: Unidad de Farmacologia Clinica, Hospital General Universitario de Alicante, c/o Maestro Alonso 109, 03010, Alicante, Spain. zapater_ped@gva.es SO: European journal of clinical pharmacology, 2003 Mar, 58(11):767-72 IS: 0031-6970 AB: BACKGROUND: In the last 20 years, some cases of agranulocytosis associated with calcium dobesilate consumption in Spain have been reported. A high risk of dobesilate-associated agranulocytosis (121 cases per million per year) calculated using both a case-control and a case-population strategy has been published. However few spontaneous reports have been noted in the same period of time. No explanation exists for this disagreement. METHODS: Estimated incidence rates of agranulocytosis in the IAAAS study and the calculated risk of dobesilate-associated agranulocytosis were used as background risks in a Poisson-based methodology, to calculate the number of coincidental reports of agranulocytosis among patients treated with dobesilate. The influence of treatment duration, notification rate and population characteristics were calculated. RESULTS: During the period 1978-2000, a total of 23 cases would have taken place if the background risk of agranulocytosis were 4.7 per million per year (IAAASs risk); however, only 9 spontaneous cases of agranulocytosis associated to dobesilate were noted. A simulation showed that with notification rates equal to or higher than 17%, it was not possible to exclude that the 9 cases were false-positives. With notification rates equal or inferior to 16%, it would be unlikely that cases of agranulocytosis were noted in this population with a risk of 4.7 per million per year; therefore, it is necessary to assume a higher agranulocytosis risk. More than 1 case per year could be a false-positive if the background risk of agranulocytosis is 9.5 per million per year, this b