中华传染病杂志
中華傳染病雜誌
중화전염병잡지
CHINESE JOURNAL OF INFECTIOUS DISEASES
2014年
5期
280-284
,共5页
梁雪松%李成忠%尹伟%范文瀚%刘亚允%薛建亚%万谟彬
樑雪鬆%李成忠%尹偉%範文瀚%劉亞允%薛建亞%萬謨彬
량설송%리성충%윤위%범문한%류아윤%설건아%만모빈
肝炎e抗原,乙型%聚乙烯二醇类%干扰素-α-2a%肝炎,乙型,慢性%优化治疗
肝炎e抗原,乙型%聚乙烯二醇類%榦擾素-α-2a%肝炎,乙型,慢性%優化治療
간염e항원,을형%취을희이순류%간우소-α-2a%간염,을형,만성%우화치료
Hepatitis B e antigens%Polyethylene glycols%Interferon alfa-2α%Hepatitis B,chronic%Optimal therapy
目的 评价聚乙二醇干扰素-α-2a(peg-IFN-α-2a)治疗24周应答不佳的HBeAg阳性CHB患者优化治疗策略的疗效和安全性.方法 本研究为开放、单中心、前瞻性临床观察研究.2009年1月至2011年12月上海长海医院感染科收治经peg-IFN-α-2a治疗24周应答不佳的HBeAg阳性CHB患者,根据病毒学指标结合患者意愿将24周干扰素应答不佳CHB患者分别纳入转换替比夫定(LdT)组和peg-IFN-α-2a联合阿德福韦酯(ADV)组.所有患者于优化治疗后12、24和48周接受HBV病毒学、血清学标志物和不良反应监测.治疗前、后和不同治疗组间比较采用x2检验,连续资料分析应用Kruskall-Wallis检验和Mann-Whitney检验.结果 经干扰素治疗的HBeAg阳性CHB患者193例,其中有67例应答不佳患者纳入本研究:peg-IFN-α-2a联合ADV组45例,转换LdT治疗组22例.67例患者优化治疗48周后HBeAg血清学转换率为25.3％,HBeAg阴转率为26.8％,HBV DNA＜1×103拷贝/mL检测下限率为73.1％,ALT复常率为83.5％.优化治疗12、24和48周时,转换LdT组较联合ADV组获得较好的HBV DNA抑制效率(P值分别为0.00、0.00和0.01),但两组48周时HBVDNA阴转率比较差异无统计学意义(x2=0.01,P=0.89).两种优化策略均未见明显不可耐受不良反应发生.结论 24周干扰素应答不佳HBeAg阳性CHB实施优化治疗48周可获得较高HBeAg血清学转换率;转换LdT策略较联合ADV策略具有更佳的HBV DNA抑制效率;两种优化策略耐受性均较好.
目的 評價聚乙二醇榦擾素-α-2a(peg-IFN-α-2a)治療24週應答不佳的HBeAg暘性CHB患者優化治療策略的療效和安全性.方法 本研究為開放、單中心、前瞻性臨床觀察研究.2009年1月至2011年12月上海長海醫院感染科收治經peg-IFN-α-2a治療24週應答不佳的HBeAg暘性CHB患者,根據病毒學指標結閤患者意願將24週榦擾素應答不佳CHB患者分彆納入轉換替比伕定(LdT)組和peg-IFN-α-2a聯閤阿德福韋酯(ADV)組.所有患者于優化治療後12、24和48週接受HBV病毒學、血清學標誌物和不良反應鑑測.治療前、後和不同治療組間比較採用x2檢驗,連續資料分析應用Kruskall-Wallis檢驗和Mann-Whitney檢驗.結果 經榦擾素治療的HBeAg暘性CHB患者193例,其中有67例應答不佳患者納入本研究:peg-IFN-α-2a聯閤ADV組45例,轉換LdT治療組22例.67例患者優化治療48週後HBeAg血清學轉換率為25.3％,HBeAg陰轉率為26.8％,HBV DNA＜1×103拷貝/mL檢測下限率為73.1％,ALT複常率為83.5％.優化治療12、24和48週時,轉換LdT組較聯閤ADV組穫得較好的HBV DNA抑製效率(P值分彆為0.00、0.00和0.01),但兩組48週時HBVDNA陰轉率比較差異無統計學意義(x2=0.01,P=0.89).兩種優化策略均未見明顯不可耐受不良反應髮生.結論 24週榦擾素應答不佳HBeAg暘性CHB實施優化治療48週可穫得較高HBeAg血清學轉換率;轉換LdT策略較聯閤ADV策略具有更佳的HBV DNA抑製效率;兩種優化策略耐受性均較好.
목적 평개취을이순간우소-α-2a(peg-IFN-α-2a)치료24주응답불가적HBeAg양성CHB환자우화치료책략적료효화안전성.방법 본연구위개방、단중심、전첨성림상관찰연구.2009년1월지2011년12월상해장해의원감염과수치경peg-IFN-α-2a치료24주응답불가적HBeAg양성CHB환자,근거병독학지표결합환자의원장24주간우소응답불가CHB환자분별납입전환체비부정(LdT)조화peg-IFN-α-2a연합아덕복위지(ADV)조.소유환자우우화치료후12、24화48주접수HBV병독학、혈청학표지물화불량반응감측.치료전、후화불동치료조간비교채용x2검험,련속자료분석응용Kruskall-Wallis검험화Mann-Whitney검험.결과 경간우소치료적HBeAg양성CHB환자193례,기중유67례응답불가환자납입본연구:peg-IFN-α-2a연합ADV조45례,전환LdT치료조22례.67례환자우화치료48주후HBeAg혈청학전환솔위25.3％,HBeAg음전솔위26.8％,HBV DNA＜1×103고패/mL검측하한솔위73.1％,ALT복상솔위83.5％.우화치료12、24화48주시,전환LdT조교연합ADV조획득교호적HBV DNA억제효솔(P치분별위0.00、0.00화0.01),단량조48주시HBVDNA음전솔비교차이무통계학의의(x2=0.01,P=0.89).량충우화책략균미견명현불가내수불량반응발생.결론 24주간우소응답불가HBeAg양성CHB실시우화치료48주가획득교고HBeAg혈청학전환솔;전환LdT책략교연합ADV책략구유경가적HBV DNA억제효솔;량충우화책략내수성균교호.
Objective To investigate the efficacy and safety of different optimal therapy strategies for hepatits B e antigen (HBeAg) positive chronic hepatitis B (CHB) patients with suboptimal response to peginterferon-α-2a (peg-IFN-α-2a) at 24 weeks.Methods This open-label,single-center and prospective clinical observational study was conducted in Department of Infectious Diseases at Shanghai Changhai Hospital between January 2009 and December 2011.The cases of HBeAg-positive CHB with suboptimal response to peg-IFN-α-2a at week 24 were enrolled.Based on virological markers and patient preference,patients were treated with either peg-IFN-α-2a add-on adefovir dipivoxil (ADV) or switch-to telbivudine (LdT).Hepatitis B virus (HBV) virological and serological data were collected at week 12,24 and 48 after the initiation of optimal therapy.Adverse reactions were also monitored.Therapeutic efficacy was compared between two groups of patients before and after treatment by x2 test.Kruskall Wallis test and Mann-Whitney test were used for analysis of continuous variables.Results Among 193 HBeAg positive CHB patients treated with interferon,67 had suboptimal response and were enrolled.Forty five cases received peg IFN-α-2a add-on ADV treatment and 22 cases received switch-to LdT treatment.After 48 weeks of optimized therapy,the total tBeAg seroconversion rate was 25.3 ％.The rates of HBeAg loss,HBV DNA negative and alanine aminotransferase normalization were 26.8％,73.1％ and 83.5％,respectively.The peg-IFN-α-2a switch-to LdT strategy had better HBV DNA inhibition efficiency compared with the peg-IFN-α-2a add-on ADV strategy at week 12,24 and 48 (P=0.00,0.00 and 0.01,respectively).However,there was no significant difference of HBV DNA negative rate between two groups at week 48 (x2 =0.01,P=0.89).The obviously intolerable adverse reaction was not reported in two optimized strategy groups.Conclusions The 48-week optimized treatment for HBeAg positive CHB with suboptimal response to peg-IFN-α-2a at week 24 could achieve a higher HBeAg seroconversion rate.The switch-to LdT strategy may have better HBV DNA inhibition efficiency.Both strategies show satisfactory safety and tolerance.
