CAJ | 학술논문

目的：：观察聚乙二醇干扰素α-2a(PEG-IFNα-2a)治疗慢性丙型肝炎的临床疗效和安全性。方法：85例慢性丙型肝炎患者随机分为两组,观察组(43例)予PEG-IFNα-2a 180μg,皮下注射,每周1次,同时口服利巴韦林900~1200 mg·d-1；对照组(42例)接受普通干扰素α-2b 500MU,皮下注射,1周3次,利巴韦林用法同观察组。48周治疗结束后随访24周,检测基线及治疗4,12,48周及治疗结束后24周时的血清HCV RNA和ALT水平,比较两组快速病毒学应答(RNA)率、早期病毒学应答(EVR)率、治疗终点病毒学应答( ETVR)率、持续病毒学应答( SVR)率以及ALT复常率与不良反应。结果： EVR、ETVR、SVR观察组分别为76.7%、86.0%和79.1%,明显高于对照组的54.8%、66.7%和57.1%,差异有统计学意义(P<0.05)。观察组治疗12周及48周时ALT复常率分别为81.4%和90.7%,明显高于对照组(P<0.05)。观察组白细胞计数下降和血小板减少的发生率高于对照组(P<0.05),中性粒细胞计数减少的发生率明显高于对照组(P<0.01),其他不良反应两组相近,未出现与聚乙二醇干扰素α-2a相关的新的不良反应。结论：PEG-IFNα-2a对慢性丙型肝炎患者的疗效优于普通干扰素,并具有较好的安全性和耐受性。
목적：：관찰취을이순간우소α-2a(PEG-IFNα-2a)치료만성병형간염적림상료효화안전성。방법：85례만성병형간염환자수궤분위량조,관찰조(43례)여PEG-IFNα-2a 180μg,피하주사,매주1차,동시구복리파위림900~1200 mg·d-1；대조조(42례)접수보통간우소α-2b 500MU,피하주사,1주3차,리파위림용법동관찰조。48주치료결속후수방24주,검측기선급치료4,12,48주급치료결속후24주시적혈청HCV RNA화ALT수평,비교량조쾌속병독학응답(RNA)솔、조기병독학응답(EVR)솔、치료종점병독학응답( ETVR)솔、지속병독학응답( SVR)솔이급ALT복상솔여불량반응。결과： EVR、ETVR、SVR관찰조분별위76.7%、86.0%화79.1%,명현고우대조조적54.8%、66.7%화57.1%,차이유통계학의의(P<0.05)。관찰조치료12주급48주시ALT복상솔분별위81.4%화90.7%,명현고우대조조(P<0.05)。관찰조백세포계수하강화혈소판감소적발생솔고우대조조(P<0.05),중성립세포계수감소적발생솔명현고우대조조(P<0.01),기타불량반응량조상근,미출현여취을이순간우소α-2a상관적신적불량반응。결론：PEG-IFNα-2a대만성병형간염환자적료효우우보통간우소,병구유교호적안전성화내수성。
Objective:To investigate the efficacy and safety of peginterferon alpha-2a plus ribavirin in the treatment of chronic hepatitis C. Methods:Totally 85 patients with chronic hepatitis C were randomly divided into the observation group and the control group. Each patient in the observation group was injected subcutaneously peginterferon alpha-2a with the dose of 180μg once a week plus ribavirin 900-1 200 mg/d, po, and each patient in the control was treated subcutaneously with 5 MU standard interferon alpha-2b three times a week plus the same used ribavirin. After the 48-week treatment, 24-week fellow-up was carried out. HCV RNA and ALT were detected at the baseline, 4th week, 12th week and 48th week during the treatment, and 24th week after the treatment, respective-ly. The rate of rapid virological response ( RVR) , early virological response ( EVR) , end of treatment virological response ( ETVR) , sustained virological response (SVR), ALT normalization and adverse reactions were respectively assessed. Results: The rates of EVR,ETVR and SVR in the observation group were 76. 7%(33/43), 86. 0%(37/43) and 79. 1%(34/43), respectively, which were significantly higher than those in the control group [54. 8%(23/43), 66. 7%(28/43) and 57. 1%(24/43),respectively] (P<0. 05). The ALT normalization rate at 12th and 48th week after the treatment in the observation group was 81. 4% and 90. 7%, re-spectively, which were higher than those in the control group [64. 3% and 71. 4%, respectively](P<0. 05). The rate of white cell counts and platelet underlying (58. 1% and 39. 5%) in the observation group were also higher than those in the control group (35. 7%and 19.0%)(P<0.05). The decreased rate of neutrophil (58.1%) in the observation group was higher than that in the control group(19. 0%)(P<0. 01). The other adverse reactions in the two groups were similar, and there was no new or unique adverse event related to peginterferon. Conclusion:Peginterferon alpha-2a has better effect than the standard interferon alpha-2b in the treatment of patients with chronic hepatitis C with promising tolerance.