de Souza Ernane C, Matos Dalyara M, Viana Milainy R, Alvim Marcela C O, Bonfante Herval L, Pinto Alexandre F, Nascimento Jorge W L
University of Iowa College of Pharmacy, Division of Medicinal and Natural Products Chemistry, Iowa City, IA, USA.
Department of Pharmaceutical Sciences, College of Pharmacy, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.
J Basic Clin Physiol Pharmacol. 2018 Jul 26;29(4):385-390. doi: 10.1515/jbcpp-2017-0037.
Background Dipyrone is a non-narcotic analgesic/antipyretic widely used in some countries but prohibited in others due to suspected risk of agranulocytosis. The primary goal of this study was to evaluate hematological alterations in healthy adult volunteers after treatment with dipyrone. Methods The study enrolled 30 healthy volunteers of both genders, aged 19-37 years. They received tablets containing 500 mg of dipyrone sodium to be used four times daily for 7 consecutive days. Before the first administration, arterial pressure was measured and blood was collected in order to evaluate hematological baseline parameters. On the 8th day after the beginning of treatment, the volunteers had their blood pressure assessed once more and underwent a second blood draw. Total and specific leukocyte counts, creatinine, urea, aspartate aminotransferase (AST), alanine aminotransferase (ALT), erythrocytes, and platelets were quantitatively determined. Results No statistically significant difference was observed among total or specific leukocyte counts. Number of platelets, erythrocytes, hemoglobin, and hematocrit decreased after treatment. Diastolic pressure, mean arterial pressure (MAP), and urea concentration declined, while creatinine, AST, and ALT showed no significant alterations. It is noteworthy that, even for parameters that showed statistically significant changes, the highest and lowest values remained within the normal ranges. Conclusions Although dipyrone has historically been associated with agranulocytosis, leukocyte counts remained practically unchanged after oral administration of dipyrone. On the other hand, the present study adds evidence that dipyrone is able to produce statistically relevant decrease in number of platelets, erythrocytes, hemoglobin, and hematocrit in healthy adults, even after short-term treatment.
安乃近是一种非麻醉性止痛/退烧药,在一些国家被广泛使用,但在其他国家因怀疑有粒细胞缺乏症风险而被禁用。本研究的主要目的是评估健康成年志愿者在接受安乃近治疗后的血液学变化。方法:该研究招募了30名年龄在19至37岁之间的健康志愿者,男女均有。他们服用含500毫克安乃近钠的片剂,每天服用4次,连续服用7天。在首次给药前,测量动脉血压并采集血液,以评估血液学基线参数。在治疗开始后的第8天,再次评估志愿者的血压并进行第二次采血。定量测定白细胞总数和分类计数、肌酐、尿素、天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、红细胞和血小板。结果:白细胞总数或分类计数之间未观察到统计学上的显著差异。治疗后血小板、红细胞、血红蛋白和血细胞比容的数量减少。舒张压、平均动脉压(MAP)和尿素浓度下降,而肌酐、AST和ALT无显著变化。值得注意的是,即使对于显示有统计学显著变化的参数,最高值和最低值仍在正常范围内。结论:尽管安乃近在历史上一直与粒细胞缺乏症有关,但口服安乃近后白细胞计数实际上保持不变。另一方面,本研究补充了证据,表明即使在短期治疗后,安乃近也能使健康成年人的血小板、红细胞、血红蛋白和血细胞比容数量产生统计学上的显著下降。