论文部分内容阅读
目的评价佩乐能50mcg/次,每周一次皮下注射联合利巴韦林治疗慢性丙型病毒性肝炎患者(包括初治和复发患者)的安全性,并与对照药物甘乐能3MIV/次,一周三次皮下注射联合利巴林治疗进行比较。方法本试验为开放的、2:1随机化的阳性对照临床试验。符合所有入选/排除标准后,所有符合入选/排除标准的患者将随机分配进入试验。随机分组后,进入治疗组的受试者每周一次皮下注射佩乐能50mcg,同时口服利巴韦林800～120mg/天。进入对照组的受试将接受甘乐能3MIU/次,每周三次皮下注射,利巴韦林的剂量和服法与治疗组相同;总疗程均为48周,治疗结束后停药观察24周。评估安全性及副作用。结果治疗组和对照组均未发生死亡或其他严重不良事件。(1)在48周治疗期间,治疗组发生药物相关性不良事件26例,发生率为100.00%;对照组发生药物相关性不良事件14例,发生率为100.00%,两组间无差异。(2)在停药随访期间,治疗组与对照组均未发生不良事件。结论治疗组发生药物相关性不良事件与对照组比较,差异无统计学意义。结果表明,佩乐能联合利巴韦林治疗慢性丙型病毒性肝炎的安全性与甘乐能联合利巴韦林治疗的安全性相当。
Objective To evaluate the safety of PegIntron 50 mcg / time, subcutaneous injection of ribavirin once a week in the treatment of patients with chronic hepatitis C (including initial treatment and relapse patients) and with the control drug Ganluo 3MIV / Subcutaneous injections were administered three times a week combined with ribavirin for comparison. Methods This test is an open, 2: 1, randomized, positive controlled clinical trial. After all inclusion / exclusion criteria have been met, all patients eligible for inclusion / exclusion will be randomized into the trial. After randomization, subjects entering the treatment group received subcutaneous injection of PegIntron 50 mcg once weekly while oral ribavirin 800 to 120 mg daily. Participants in the control group will receive Gannuenergy 3MIU / time, subcutaneous injection three times a week, ribavirin dose and service method and the treatment group the same; the total course of treatment were 48 weeks after treatment was discontinued for 24 weeks. Assess safety and side effects. Results No death or other serious adverse events occurred in the treatment group and the control group. (1) During the 48 weeks of treatment, there were 26 cases of drug-related adverse events in the treatment group, the incidence was 100.00%; 14 cases of drug-related adverse events occurred in the control group, the incidence was 100.00%, there was no difference between the two groups. (2) No adverse events occurred in the treatment group and the control group during the withdrawal period. Conclusion There was no significant difference in the drug-related adverse events between the treatment group and the control group. The results showed that the safety of PegIntron combined with ribavirin in the treatment of chronic hepatitis C was comparable to that of combination of ribavirin and ribavirin.