三、安全性评估 1.不良事件:在 2,200例患者 12个月的治疗过程中,出现一种或一种以上不良事件的患者共364例(17％,共报告561例次不良事件)。不良事件大多为轻度(51％),少数为中度(11％),个别为重度(1％)。63％的不良事件经研究者判断与研究药物无关或可能无关,32％的不良事件经研究者判断与研究药物可能有关,4％的不良事件研究者认为无法判断其与研究药物的关系。仅有6例(1％)患者7项不良事件经研究者判断肯定与研究药物有关:1例口干(患者缓解并脱落),1例全身猩红热样皮疹(患者缓解,未脱落),1例磷酸肌酸激酶(Creatine Phosphokinase,CPK)升高和血小板下降(患者缓解并脱落),2例总胆红素升高(1例未缓解,1例缓解,都未脱落),1例血小板下降(患者缓解,未脱落)。 III. Safety Assessment 1. Adverse Events: A total of 364 patients (17%, 561 adverse events were reported) of one or more adverse events during the 12 months treatment of 2,200 patients. Adverse events were mostly mild (51%), a few moderate (11%), and individual severe (1%). Sixty-three percent (6%) of the adverse events were judged by investigators as unrelated to or possibly unrelated to the investigational drug, 32% of the adverse events were likely to be related to the study drug at the investigator’s discretion, and 4% of the adverse event investigators did not consider it relevant to study the drug. Only 6 (1%) of the 7 adverse events were judged by the investigators to be definitely related to the investigational drug: 1 case of dry mouth (patient relief and shedding), 1 case of systemic scarlet fever-like rash (patient remission without shedding) and 1 case Elevated creatine phosphokinase (CPK) and thrombocytopenia (patients were relieved and shed), two cases of elevated total bilirubin (one without remission, one with remission, none without shedding) and one with decreased platelet count Patients remission, did not fall off).