Ishii Masami, Nagaoka Soshi, Tatsumi Masumi, Kitagawa Natsuko, Taketsuna Masanori, Okubo Sumiko, Maeda Kaijiro, Takeuchi Kohji
Medical Science, LRL DCOE-J, Eli Lilly Japan K. K.
Gan To Kagaku Ryoho. 2011 Dec;38(13):2607-16.
To elucidate the detailed profiles of major adverse events associated with gemcitabine hydrochloride, such as myelosuppression and interstitial pneumonitis (IP), we reanalyzed the results from Japanese clinical studies conducted by Eli Lilly Japan K. K. in patients with various types of cancer. Myelosuppression was clearly apparent after starting therapy at 2-3 weeks in the 28- day course monotherapy group, and at 2 weeks in the 21-day course combination therapy group with paclitaxel, cisplatin, or docetaxel. Increases in the number of courses did not necessarily lead to worsening of myelosuppression. IP possibly related to gemcitabine was seen in 6 out of 5 23 monotherapy patients and 5 out of 233 combination therapy patients. Five of these 11 patients were diagnosed in the first course; however, another patient was diagnosed with IP in Course 6. Two of these patients died of IP, one of whom had a past history of interstitial lung disease. These results indicate that ample attention should be paid to myelosuppression 2-3 weeks after the start of therapy, and to IP during the entire course of therapy.
为了阐明与盐酸吉西他滨相关的主要不良事件的详细情况，如骨髓抑制和间质性肺炎（IP），我们重新分析了日本礼来公司在各类癌症患者中开展的临床研究结果。在28天疗程单药治疗组中，治疗开始后2 - 3周骨髓抑制明显，在与紫杉醇、顺铂或多西他赛联合的21天疗程治疗组中，治疗开始后2周骨髓抑制明显。疗程数增加不一定会导致骨髓抑制加重。在523名单药治疗患者中有6例、233名联合治疗患者中有5例出现可能与吉西他滨相关的IP。这11例患者中有5例在第一个疗程被诊断出；然而，另有1例患者在第6个疗程被诊断为IP。其中2例患者死于IP，其中1例有间质性肺疾病病史。这些结果表明，治疗开始后2 - 3周应充分关注骨髓抑制，在整个治疗过程中应关注IP。
