CAJ | 학술논문

目的探讨通过短程联合拉米夫定以提高聚乙二醇干扰素α-2a 疗效的新治疗方法.方法所有患者以聚乙二醇干扰素α-2a 135μg开始治疗,在治疗12周时,若HBV DNA或HBeAg转阴,继续单独使用干扰素治疗至52周(A组),未达到上述条件者(B组)分为B1组及B2组,B1组短程联合拉米夫定治疗12周后继续干扰素治疗并完成52周疗程,B2组继续单独用干扰素治疗并完成52周疗程.符合正态分布的计量资料采用t检验;符合偏态分布的计量资料用中位数(全距)表示,采用秩和检验.结果共有58例患者入组,8例患者在治疗12周时出现HBV DNA或HBeAg转阴,单用干扰素完成52周疗程,治疗结束时HBV DNA转阴率、HBeAg血清学转换率,HBsAg转阴率及ALT复常率分别为8/8、6/8、0/8及8/8.B1组患者24例,治疗52周时HBV DNA转阴率、HBeAg血清学转换率,HBsAg转阴率及ALT复常率分别为50%(12/24)、38%(9/24)、4%(1/24)及63%(15/24);B2组患者26例,治疗52周时HBV DNA转阴率、HBeAg血清学转换率,HBsAg转阴率及ALT复常率分别为31%(8/26)、27%(7/26)、O(0/26)及35%(9/26).结论聚乙二醇干扰素α-2a治疗取得早期应答的患者治疗52周的应答率高;通过对早期疗效不佳的患者短程联合拉米夫定治疗,可提高干扰素的疗效,但有待更大样本量的随机临床试验证实.
목적 탐토통과단정연합랍미부정이제고취을이순간우소α-2a 료효적신치료방법.방법 소유환자이취을이순간우소α-2a 135μg개시치료,재치료12주시,약HBV DNA혹HBeAg전음,계속단독사용간우소치료지52주(A조),미체도상술조건자(B조)분위B1조급B2조,B1조단정연합랍미부정치료12주후계속간우소치료병완성52주료정,B2조계속단독용간우소치료병완성52주료정.부합정태분포적계량자료채용t검험;부합편태분포적계량자료용중위수(전거)표시,채용질화검험.결과공유58례환자입조,8례환자재치료12주시출현HBV DNA혹HBeAg전음,단용간우소완성52주료정,치료결속시HBV DNA전음솔、HBeAg혈청학전환솔,HBsAg전음솔급ALT복상솔분별위8/8、6/8、0/8급8/8.B1조환자24례,치료52주시HBV DNA전음솔、HBeAg혈청학전환솔,HBsAg전음솔급ALT복상솔분별위50%(12/24)、38%(9/24)、4%(1/24)급63%(15/24);B2조환자26례,치료52주시HBV DNA전음솔、HBeAg혈청학전환솔,HBsAg전음솔급ALT복상솔분별위31%(8/26)、27%(7/26)、O(0/26)급35%(9/26).결론 취을이순간우소α-2a치료취득조기응답적환자치료52주적응답솔고;통과대조기료효불가적환자단정연합랍미부정치료,가제고간우소적료효,단유대경대양본량적수궤림상시험증실.
Objective To investigate the efficacy of by combining a 12-week course of lamivudine in those HBeAg-positive hepatitis B patients receiving peginterferon alfa-2a (peg-IFN α-2a) therapy. Methods A total of 58 patients initiated a 52-week course of peginterferon alfa-2a were enrolled and divided into 3 groups. The patients with HBV DNA undetectable or HBeAg negative at week 12 were divided into group A, in this group treatment continued to week 52 with peg-IFN α -2a alone; The rest paitents were divided into group Bl and B2, in group Bl, lamivudine was combined at a course of 12 weeks, while in group B2 treatment continued to week 52 with peg-IFN α -2a alone. Clinical responses were assessed at week 52. Results 8 out of 58 patients achieved undetectable HBV DNA or HBeAg loss at week 12 and divide into group A. In this group the HBV DNA loss rate, HBeAg seroconversion rate, HBsAg loss rate and ALT normalization rate were 100% (8/8), 75% (6/8), 0% (0/8) and 100% (8/8) respectively at the end of treatment. In this group the HBV DNA loss rate, HBeAg seroconversion rate, HBsAg loss rate and ALT normalization rate were 100% (8/8), 75% (6/8), 0% (0/8) and 100%(8/8) respectively at the end of treatment. The rest 50 patients without early response to peg-IFN α -2a at week 12 were divided into group Bl (24 patients enrolled) and B2 (26 patients). At the end of treatment, the HBV DNA loss rate, HBeAg seroconversion rate, HBsAg loss rate and ALT normalization rate in Group B1 were 50% (12/24), 38% (9/24), 4% (1/24) and 63% (15/24) respectively, and 31% (8/26), 27% (7/26), 0% (0/26) and 35% (9/26) respectively in group B2. Conclusions Those patients with early responses to peg-IFN α -2a therapy can achieve high clinical responses at the end of 52-week treatment. The combining therpay of lamivudine for a course of 12-weeks can improve the clinical responses for the patients without early responses to peg-IFN α-2a.