中国肝脏病杂志(电子版)
中國肝髒病雜誌(電子版)
중국간장병잡지(전자판)
CHINESE JOURNAL OF LIVER DISEASES(ELECTRONIC VERSION)
2013年
1期
24-30
,共7页
凌琪华%陈建杰%郭静%陈逸云%叶青艳%陈晓蓉%张玮%聂红明%张盛杰%卓蕴慧%商斌仪
凌琪華%陳建傑%郭靜%陳逸雲%葉青豔%陳曉蓉%張瑋%聶紅明%張盛傑%卓蘊慧%商斌儀
릉기화%진건걸%곽정%진일운%협청염%진효용%장위%섭홍명%장성걸%탁온혜%상빈의
肝炎,乙型,慢性%恩替卡韦
肝炎,乙型,慢性%恩替卡韋
간염,을형,만성%은체잡위
Hepatitis B, chronic%Entecavir
目的观察中医辨证分型论治联合恩替卡韦(ETV)治疗慢性乙型肝炎的临床疗效.方法采取前瞻性、随机、多中心临床研究方法,按3︰1︰1随机分组(A组为辨证论治联合ETV组;B组为固定处方联合ETV组;C组为单用ETV组),共236例完成48周的疗程.分别检测治疗前、治疗12周、治疗24周、治疗36周、治疗48周的HBV-M、HBV DNA,观察患者的中医证候、健康调查简表(SF-36).结果A组治疗48周HBV DNA低于检测下限的比率为94.29%(132/140),显著高于C组78%(39/50)(P<0.05).A组治疗48周HBV DNA较基线下降≥2 log10拷贝/ml的应答率为99.29%(139/140),均显著高于B组93.48%(43/46)及C组90.00%(45/50),差异均有统计学意义(P<0.05).治疗48周,A组HBeAg低于检测下限的比率为37.50%(24/64),均高于B组26.67%(8/30)及C组15.00%(3/20)(P <0.05),差异有显著统计学意义.治疗48周,A组HBeAg血清学转换率为31.25%(20/64),与B组26.67%(8/30)及C组15.00%(3/20)比较,差异显著无统计学意义(P>0.05).治疗48周,A组中医证候积分(5.46±3.52)均低于B组(7.33±3.80)及C组(8.46±2.92),差异均有显著统计学意义(P均<0.05).治疗48周,A组总体生理健康均优于B组及C组,差异均有显著统计学意义(P均<0.05).3组患者病毒学应答率、中医证候疗效、总体生理健康比较,均呈A组>B组>C组的趋势.结论辨证论治联合ETV治疗能显著提高HBV DNA低于检测下限的比率、HBeAg血清学转换率、改善中医证候、提高生活质量.辨证论治联合ETV治疗有理想的近期疗效,远期疗效需延长随访时间以进一步研究.
目的觀察中醫辨證分型論治聯閤恩替卡韋(ETV)治療慢性乙型肝炎的臨床療效.方法採取前瞻性、隨機、多中心臨床研究方法,按3︰1︰1隨機分組(A組為辨證論治聯閤ETV組;B組為固定處方聯閤ETV組;C組為單用ETV組),共236例完成48週的療程.分彆檢測治療前、治療12週、治療24週、治療36週、治療48週的HBV-M、HBV DNA,觀察患者的中醫證候、健康調查簡錶(SF-36).結果A組治療48週HBV DNA低于檢測下限的比率為94.29%(132/140),顯著高于C組78%(39/50)(P<0.05).A組治療48週HBV DNA較基線下降≥2 log10拷貝/ml的應答率為99.29%(139/140),均顯著高于B組93.48%(43/46)及C組90.00%(45/50),差異均有統計學意義(P<0.05).治療48週,A組HBeAg低于檢測下限的比率為37.50%(24/64),均高于B組26.67%(8/30)及C組15.00%(3/20)(P <0.05),差異有顯著統計學意義.治療48週,A組HBeAg血清學轉換率為31.25%(20/64),與B組26.67%(8/30)及C組15.00%(3/20)比較,差異顯著無統計學意義(P>0.05).治療48週,A組中醫證候積分(5.46±3.52)均低于B組(7.33±3.80)及C組(8.46±2.92),差異均有顯著統計學意義(P均<0.05).治療48週,A組總體生理健康均優于B組及C組,差異均有顯著統計學意義(P均<0.05).3組患者病毒學應答率、中醫證候療效、總體生理健康比較,均呈A組>B組>C組的趨勢.結論辨證論治聯閤ETV治療能顯著提高HBV DNA低于檢測下限的比率、HBeAg血清學轉換率、改善中醫證候、提高生活質量.辨證論治聯閤ETV治療有理想的近期療效,遠期療效需延長隨訪時間以進一步研究.
목적관찰중의변증분형론치연합은체잡위(ETV)치료만성을형간염적림상료효.방법채취전첨성、수궤、다중심림상연구방법,안3︰1︰1수궤분조(A조위변증론치연합ETV조;B조위고정처방연합ETV조;C조위단용ETV조),공236례완성48주적료정.분별검측치료전、치료12주、치료24주、치료36주、치료48주적HBV-M、HBV DNA,관찰환자적중의증후、건강조사간표(SF-36).결과A조치료48주HBV DNA저우검측하한적비솔위94.29%(132/140),현저고우C조78%(39/50)(P<0.05).A조치료48주HBV DNA교기선하강≥2 log10고패/ml적응답솔위99.29%(139/140),균현저고우B조93.48%(43/46)급C조90.00%(45/50),차이균유통계학의의(P<0.05).치료48주,A조HBeAg저우검측하한적비솔위37.50%(24/64),균고우B조26.67%(8/30)급C조15.00%(3/20)(P <0.05),차이유현저통계학의의.치료48주,A조HBeAg혈청학전환솔위31.25%(20/64),여B조26.67%(8/30)급C조15.00%(3/20)비교,차이현저무통계학의의(P>0.05).치료48주,A조중의증후적분(5.46±3.52)균저우B조(7.33±3.80)급C조(8.46±2.92),차이균유현저통계학의의(P균<0.05).치료48주,A조총체생리건강균우우B조급C조,차이균유현저통계학의의(P균<0.05).3조환자병독학응답솔、중의증후료효、총체생리건강비교,균정A조>B조>C조적추세.결론변증론치연합ETV치료능현저제고HBV DNA저우검측하한적비솔、HBeAg혈청학전환솔、개선중의증후、제고생활질량.변증론치연합ETV치료유이상적근기료효,원기료효수연장수방시간이진일보연구.
@@@@Objective To observe the clinical efficacy of traditional Chinese medicine (TCM) combined with entecavir in patients with chronic hepatitis B. Methods According to randomized, multicenter clinical study and statistical methods, patients were divided into 3 groups (TCM differentiation treatment and entecavir of group A;TCM fixed treatment and entecavir of group B;entecavir monotherapy of group C) randomly. And HBV-M, HBV DNA, SF-36 were detected respectively. Results The negative rate of HBV DNA in group A (94.29%, 132/140) was higher than that of group C (78.00%, 39/50) (P<0.05) at 48th week. The response rate of HBV DNA level declined≥2 log10 copies/ml from baseline of group A (99.29%, 139/140) were higher than that of group B (93.48%, 43/46) and group C (90.00%, 45/50) (both P<0.05) at 48th week. The HBeAg negative rate of group A (37.50%, 24/64) were higher than group B (26.67%, 8/30) and group C (15.00%, 3/20) (both P<0.05) at 48th week. The HBeAg serological conversion rate of group A (31.25%, 20/64) were higher than that of group B (26.67%, 8/30) and group C (15.00%, 3/20) (both P<0.05) at 48th week. TCM symptoms curative effect of group A (5.46 ± 3.52) were lower than that of group B (7.33 ± 3.80) and group C (8.46 ± 2.92) (both P<0.05) at 48th week. The quality of life score (SF-36) of group A were better than that of group B and group C (both P<0.05) at 48th week. The trend of virological response rate, TCM symptoms curative effect and quality of life score of three groups were group A>group B>group C. Conclusions TCM syndrome differentiation treatment and entecavir can significantly improve the negative rate of HBV DNA, HBeAg seroconversion rate, TCM symptoms and quality of life. TCM syndrome differentiation treatment and entecavir have a ideal short-term efficacy, while its long-term effects need further study to explore.
