Arase Yasuji, Ikeda Kenji, Suzuki Fumitaka, Suzuki Yoshiyuki, Saitoh Satoshi, Kobayashi Masahiro, Akuta Norio, Someya Takashi, Hosaka Tetsuya, Sezaki Hitomi, Kobayashi Mariko, Kumada Hiromitsu
Department of Gastroenterology, and Hepatic Research Unit, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, 105-8470, Tokyo, Japan.
J Gastroenterol. 2004 Nov;39(11):1090-4. doi: 10.1007/s00535-004-1483-x.
Hemolytic anemia is one of the major adverse events of the combination therapy of interferon and ribavirin. Because of ribavirin-related hemolytic anemia, dose reduction is a common event in this therapy. In this clinical retrospective cohort study we have examined the suitable timing of ribavirin reduction in patients with hemolysis during combination therapy.
Thirty-seven of 160 patients who had HCV-genotype 1b, had high virus load, and received 24-week combination therapy developed anemia with hemoglobin level <10 g/dl or anemia-related signs during therapy. After that, these 37 patients were reduced one tablet of ribavirin (200 mg) per day. After reduction of ribavirin, 27 of 37 patients could continue combination therapy for a total of 24 weeks (group A). However, 10 of 37 patients with reduction of ribavirin could not continue combination therapy because their <8.5 g/dl hemoglobin values decreased to or anemia-related severe side effects occurred (group B). We assessed the final efficacy and safety after reduction of ribavirin in groups A and B.
A sustained virological response (SVR) was 29.6% (8/27) in group A and 10% (1/10) in group B, respectively. A 34.4% (12/27) of SVR + biological response in group A was higher than 10% (1/10) in group B ( P = 0.051), with slight significance. With respect to hemoglobin level at the time of ribavirin reduction, a rate of continuation of therapy in patients with > or =10 g/dl hemoglobin was higher than that in patients with <10 g/dl ( P = 0.036).
Reduction of ribavirin at hemoglobin level > or =10 g/dl is suitable in terms of efficacy and side effects.
溶血性贫血是干扰素与利巴韦林联合治疗的主要不良事件之一。由于利巴韦林相关的溶血性贫血，在该治疗中减少剂量是常见情况。在这项临床回顾性队列研究中，我们研究了联合治疗期间溶血患者中利巴韦林减量的合适时机。
160例丙型肝炎病毒1b型、病毒载量高且接受24周联合治疗的患者中，有37例在治疗期间出现血红蛋白水平<10 g/dl的贫血或贫血相关体征。此后，这37例患者每天减少一片利巴韦林（200 mg）。利巴韦林减量后，37例患者中有27例能够继续联合治疗共24周（A组）。然而，37例利巴韦林减量的患者中有10例因血红蛋白值降至<8.5 g/dl或出现贫血相关严重副作用而无法继续联合治疗（B组）。我们评估了A组和B组利巴韦林减量后的最终疗效和安全性。
A组持续病毒学应答（SVR）率为29.6%（8/27），B组为10%（1/10）。A组SVR+生物学应答率为34.4%（12/27），高于B组的10%（1/10）（P = 0.051），有轻微显著性差异。关于利巴韦林减量时的血红蛋白水平，血红蛋白≥10 g/dl的患者继续治疗的比例高于<10 g/dl的患者（P = 0.036）。
从疗效和副作用方面来看，血红蛋白水平≥10 g/dl时减少利巴韦林剂量是合适的。
