Adverse drug reactions of intravesical bacillus Calmette-Guerin instillation and risk factors of the development of adverse drug reactions in superficial cancer and carcinoma in situ of the bladder
Adverse drug reactions of intravesical bacillus Calmette-Guerin instillation and risk factors of the development of adverse drug reactions in superficial cancer and carcinoma in situ of the bladder
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DOI：
10.1111/j.1442-2042.2005.01000.x
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发表时间：
2005-02-01
影响因子：
2.6
通讯作者：
Naito, S
中科院分区：
文献类型：
--
作者：
Koga, H;Kuroda, M;Naito, S
背景：我们检查了膀胱内灌注卡介苗（BCG）治疗浅表性膀胱癌（包括原位癌）后药物不良反应的发生率和严重程度。我们调查了药物不良反应与患者背景之间的关系，以明确药物不良反应发生的危险因素。方法：本研究纳入1997年4月至2000年6月期间接受卡介苗膀胱灌注治疗和预防的123例患者。药物不良反应分为局部和全身两类，反应的严重程度根据是否推迟或停止滴注、是否对反应本身进行治疗进行分类。结果：123名患者中，95.9%出现药物不良反应，50.4%需要某种治疗。观察到 9 名患者因药物不良反应而停止滴注。对于药物不良反应治疗的必要性，滴注目的和卡介苗剂量是多因素分析的独立显着因素。结论：卡介苗膀胱滴注后虽然药物不良反应发生率较高，但停滴率不高，严重不良反应很少见。本研究的规模虽小，但这些结果表明卡介苗滴注的耐受性良好。当出于治疗目的进行滴注且卡介苗剂量为 80 毫克时，可能需要更加注意监测药物不良反应的发生。
Background: We examined the incidence and severity of adverse drug reactions following intravesical bacillus Calmette-Guerin (BCG) instillation for superficial bladder cancer including carcinoma in situ. We investigated the relationship between adverse drug reactions and patient background to clarify risk factors for the development of adverse drug reactions.Methods: A total of 123 patients who underwent intravesical BCG instillation for treatment and prophylaxis between April 1997 and June 2000 were included in this study. Adverse drug reactions were divided into local and systemic categories and the severity of reactions was classified according to the presence or absence of postponement or discontinuation of instillation, with or without treatment for the reaction itself.Results: Of 123 patients, 95.9% showed adverse drug effects and 50.4% needed some sort of treatment. Discontinuation of instillation due to adverse drug reactions was observed in nine patients. Regarding the necessity of treatment for adverse drug effects, the purpose of instillation and BCG dose were independent significant factors on multivariate analysis.Conclusion: Although there was a high rate of adverse drug reactions after intravesical BCG instillation, the rate of discontinuation of instillation was not high and serious adverse reactions were rare. The scale of the present study was small, but these results suggest that BCG instillation was well tolerated. When instillation is being performed for the purpose of treatment, and the BCG dose is 80 mg, greater attention might be needed to monitor for the development of adverse drug effects.