Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
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DOI：
10.7150/ijms.43789
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发表时间：
2020-01-01
影响因子：
3.6
通讯作者：
Nakamura, Mitsuhiro
中科院分区：
文献类型：
--
作者：
Nakao, Satoshi;Hasegawa, Shiori;Nakamura, Mitsuhiro
艰难梭菌相关结肠炎（CDAC）可能导致胃肠道疾病，严重程度从轻度腹泻到暴发性结肠炎，甚至死亡。本研究的目的是使用日本药物不良事件报告 (JADER) 数据库评估抗感染相关的 CDAC 概况。方法：我们选择了《监管活动医学词典》中指定的 CDAC 不良事件病例报告。使用报告比值比 (ROR) 评估抗感染药物服用次数与衰老之间的关联，并使用多元逻辑回归调整协变量。我们还使用 Weibull 形状参数评估了抗感染相关的 CDAC 发病概况。结果：JADER 数据库包含 2004 年 4 月至 2018 年 6 月的 534 688 份报告。其中有 1222 起抗感染相关的 CDAC 事件。排名前五位的抗感染药物依次为：第三代头孢菌素类（ATC代码：J01DD，313例）、氟喹诺酮类药物（ATC代码：J01MA，201例）、大环内酯类药物（ATC代码：J01FA，146例）、碳青霉烯类药物（ATC代码：J01DH，143例）、 广谱青霉素（ATC 代码：J01CA，103 例）。使用 1、2 种和 >= 3 种抗感染药物的个体的调整后 ROR（95% 置信区间）分别为 8.88 (7.05-11.18)、9.77 (6.89-13.86) 和 18.39 (11.85-28.54)。此外，47.2% 的 CDAC 发生在抗感染治疗开始后 7 天内。 >= 70 年 x 1 种药物的相互作用项的调整 ROR 为 21.81 (14.56-32.68)。结论：我们的结果表明，服用抗感染药物的数量和患者年龄与 CDAC 相关。这些数据可能对处方者特别有益，并将有助于改善 CDAC 的管理。
Clostridium difficile-associated colitis (CDAC) may cause gastrointestinal illness, ranging in severity from mild diarrhea to fulminant colitis and even mortality. The purpose of this study was to evaluate anti-infective-related CDAC profiles using the Japanese Adverse Drug Event Report (JADER) database.Methods: We selected case reports of adverse events of CDAC as specified in the Medical Dictionary for Regulatory Activities. The association between the number of administered anti-infectives and aging was evaluated using reporting odds ratio (ROR) and adjusted for covariates using multiple-logistic regression. We also evaluated anti-infective-related CDAC-onset profiles using Weibull shape parameter.Results: The JADER database contained 534 688 reports from April 2004 to June 2018. There were 1222 anti-infective related CDAC events. The top five anti-infectives were as follows: third-generation cephalosporins (Anatomical Therapeutic Chemical (ATC) code: J01DD, 313 cases), fluoroquinolones (ATC code: J01MA, 201 cases), macrolides (ATC code: J01FA, 146 cases), carbapenems (ATC code: J01DH, 143 cases), and penicillins with extended spectrum (ATC code: J01CA, 103 cases). The adjusted RORs (95% confidence interval) in individuals using 1, 2, and >= 3 anti-infectives were 8.88 (7.05-11.18), 9.77 (6.89-13.86), and 18.39 (11.85-28.54), respectively. Moreover, 47.2% of CDACs occurred within 7 days of anti-infective therapy initiation. The adjusted ROR of interaction terms of >= 70 years x 1 drug was 21.81 (14.56-32.68).Conclusion: Our results suggest that the number of administered anti-infectives and patient age are associated with CDAC. These data may be particularly beneficial to prescribers and would contribute to improving the management of CDAC.