ツムラ補中益気湯エキス顆粒（医療用）の副作用発現頻度調査

Adverse Drug Reaction Frequency Investigation of TSUMURA Hochuekkito Extract Granules for Ethical Use

要　　旨

　ツムラ補中益気湯エキス顆粒（医療用）の使用実態下における副作用発現頻度調査を2021年10月～2024年9月の3年間にわたり実施した．安全性解析対象集団3,247例において本剤投与開始後に発現した副作用は83例に認められ，副作用発現頻度は2.6%であった．主な副作用は低カリウム血症，下痢がともに0.3%，次いで肝機能異常，上腹部痛，悪心およびそう痒症がそれぞれ0.2%であった．

　患者背景別の副作用発現頻度における解析では，年齢，入院外来別，アレルギー歴，肝機能障害および合併症の背景項目において有意な関連性を認めた．入院患者と発現頻度に有意な関連性がみられた要因の1つとして臨床検査状況の違いが推察された．その他の背景項目と発現頻度における有意な関連性についての要因を見出すには至らなかった．

　本剤の使用においては患者の観察とそれに応じた適切な検査を十分に行い，適正に使用することが副作用発現リスクの軽減と重篤化の予防につながると考えられた．

　We conducted an adverse drug reaction（ADRs）frequency investigation on TSUMURA Hochuekkito Extract Granules for Ethical Use（TJ-41）for three years between October 2021 and September 2024. The number of cases evaluated for the safety analysis was 3,247. Among these cases, there were 83 reported the occurrence of ADRs including abnormal laboratory values after the administration of TJ-41. The ADRs frequency rate was 2.6%. The most common ADRs were as follows：hypokalemia（0.3%）, diarrhea（0.3%）, abnormal liver function, upper abdominal pain, nausea, and pruritus（0.2% each）. In the results of the patient subgroup analysis, statistically significant differences were observed with regard to “age,” “inpatient/outpatient status,” “history of allergy,” “hepatic disorder,” and “complications”. As one of the factors with higher incidence of the inpatient ADRs, the difference in the laboratory test situation was guessed. As for the cause of the incidence of ADRs in other background factors, not all factors were found. Careful observation of patients and proper use of the drug should be considered to reduce the risk of ADRs, when using this drug.