Kawamata Saori, Yamada Hitoshi, Sato Yoshikazu, Sasagawa Yuji, Iwama Yasuhiro, Matumoto Masato
Pharmacovigilance Dept. Reliability & Quality Assurance Center, Meiji Seika Kaisha, Ltd.
Jpn J Antibiot. 2010 Aug;63(4):299-311.
Rheumatic fever and acute glomerulonephritis are known to occur secondary to infection with Streptococcus pyogenes, and early elimination of the Streptococcus pyogenes by treatment with an appropriate antibiotic is required. Treatment with penicillins for 10 days has been recommended for Streptococcus pyogenes infections, but cephems are also now being used, and cefditoren pivoxil (CDTR-PI) is listed as one of the recommended drugs in the Guidelines for the Management of Respiratory Infectious Disease in Children in Japan 2007. We therefore conducted this study in order to collect appropriate use information in the clinical setting of CDTR-PI to treat Streptococcus pyogenes infections. In this study, 790 patients were enrolled in 147 institutions. Of them, 734 and 718 patients were chosen for safety and efficacy analysis, respectively. There were 11 adverse drug reactions in 11 patients, and the incidence of adverse drug reactions was 1.50% (11/734 patients). The most common adverse drug reactions were diarrhea and hematuria, and there were 3 events of each, but a positive urinalysis after administration were only obserbed without the clinical symptoms. With the exception of the 3 patients in which the patient did not return to the hospital and the outcome is unknown, the patients either recovered from all of the adverse drug reactions or they were relieved. No serious adverse drug reactions were reported in this study. The response rate was 98.5% for laryngopharyngitis (457/464 patients) and 98.4% (250/254 patients) for tonsillitis. Examination of the response rates according to patient background showed that they were high, 95% or more, in every group. The Streptococcus pyogenes eradication rate was 94.6% for laryngopharyngitis (194/205 patients) and 92.4% (110/119 patients) for tonsillitis. In summary, CDTR-PI exhibited excellent safety and efficacy in laryngopharyngitis and tonsillitis caused by Streptococcus pyogenes, and CDTR-PI was reconfirmed as a useful drug.
已知风湿热和急性肾小球肾炎继发于化脓性链球菌感染，因此需要通过使用适当的抗生素治疗来尽早清除化脓性链球菌。对于化脓性链球菌感染，推荐使用青霉素治疗10天，但目前也在使用头孢菌素，在《2007年日本儿童呼吸道传染病管理指南》中，头孢托仑匹酯（CDTR-PI）被列为推荐药物之一。因此，我们开展了这项研究，以收集CDTR-PI在临床环境中治疗化脓性链球菌感染的合理使用信息。在本研究中，147家机构共纳入790例患者。其中，分别选取734例和718例患者进行安全性和疗效分析。11例患者出现11例药物不良反应，药物不良反应发生率为1.50%（11/734例患者）。最常见的药物不良反应是腹泻和血尿，各有3例，但给药后仅观察到尿检呈阳性而无临床症状。除3例患者未回院且结局不明外，其余患者的药物不良反应均已恢复或缓解。本研究未报告严重药物不良反应。喉咽炎的有效率为98.5%（457/464例患者），扁桃体炎的有效率为98.4%（250/254例患者）。根据患者背景对有效率进行的检查显示，每组的有效率都很高，达到95%或更高。喉咽炎的化脓性链球菌清除率为94.6%（194/205例患者），扁桃体炎的清除率为92.4%（110/119例患者）。总之，CDTR-PI在化脓性链球菌引起的喉咽炎和扁桃体炎中表现出优异的安全性和疗效，再次证实CDTR-PI是一种有用的药物。
