目的 观察扶正化瘀胶囊序贯联合核苷(酸)类似物(NAs)对NA单药治疗后获得完全病毒学应答,但肝纤维化指标仍然改善不佳的慢性乙型肝炎(CHB)的疗效. 方法 收集2008年1月至2010年12月的CHB合并肝纤维化的患者资料.患者均接受NAs初始治疗至少2年,病毒学指标均达到完全应答6个月以上,但肝纤维化指标仍然改善不佳.以1:1比例将患者随机分为两组,试验组继续口服NAs(拉米夫定、阿德福韦酯、替比夫定或恩替卡韦),同时加用扶正化瘀胶囊1.5g/次,3次/d,共48周,对照组继续单用NAs 1片/次,1次/d,共48周,观察治疗前后血清肝纤维化指标、肝纤维化分期、肝脾B超和肝功能指标改变.试验前两组数据的可比性分析,计量资料应用t检验,计数资料使用四格表x2检验、Fisher精确概率法和薛氏x 2检验.各组治疗前后的自身比较采用配对t检验.治疗后两组疗效的比较计量资料采用两组均数差别的t检验,计数资料采用薛氏x2检验,肝纤维化分期比较采用Ridit分析、U检验及其校正法.结果 共收集到110例患者资料,试验组肝纤维化血清学指标改善的显效率、有效率及无效率分别为69.8％、18.9％和11.3％,对照组分别为17.8％、20.0％和62.2％,两组相比,x2=32.899,P＜0.01,差异有统计学意义.治疗前相比,两组肝纤维化分期均在1～4期,均值分别为2.39和2.13,差异无统计学意义(P＞ 0.05).治疗后相比,两组肝纤维化分期均在0～4期,试验组和对照组均值分别为1.79和2.12,P＜0.01,差异有统计学意义.试验组显效、有效和无效率分别为11.3％、43.4％和45.3％,对照组分别为1.0％、22.2％和75.6％,两组比较,x2=9.408,P＜0.01,差异有统计学意义.试验组ALT活性改善显效、有效和无效率分别为24.4％、57.8％和17.8％,对照组分别为12.5％、25.0％和62.5％,两组比较,x2=18.09,P＜0.01,差异有统计学意义；试验组血清胆红素定量改善显效、有效和无效率分别为30.0％、55.0％和15.0％,对照组分别为12.5％、37.5％和50.0％,两组比较,x 2=5.348,P＞0.05,差异无统计学意义.治疗前相比,两组门静脉直径、脾脏厚度和脾静脉直径指标差异均无统计学意义(P值均＞0.05).治疗后相比,试验组门静脉直径、脾脏厚度均小于对照组,t值分别3.938和2.763,P值均＜ 0.01,差异均有统计学意义,但脾静脉直径比较,t=1.582,P＞0.05,差异无统计学意义.两组治疗前后血尿常规、肾功能、心电图均无明显变化.试验过程中两组均未出现明显不良反应.结论 NAs抗病毒治疗后,HBV即使获得完全病毒学应答,仍然有部分患者肝纤维化持续存在,在此基础上,序贯联合扶正化瘀胶囊,可以使肝纤维化指标得到明显的改善.
目的 觀察扶正化瘀膠囊序貫聯閤覈苷(痠)類似物(NAs)對NA單藥治療後穫得完全病毒學應答,但肝纖維化指標仍然改善不佳的慢性乙型肝炎(CHB)的療效. 方法 收集2008年1月至2010年12月的CHB閤併肝纖維化的患者資料.患者均接受NAs初始治療至少2年,病毒學指標均達到完全應答6箇月以上,但肝纖維化指標仍然改善不佳.以1:1比例將患者隨機分為兩組,試驗組繼續口服NAs(拉米伕定、阿德福韋酯、替比伕定或恩替卡韋),同時加用扶正化瘀膠囊1.5g/次,3次/d,共48週,對照組繼續單用NAs 1片/次,1次/d,共48週,觀察治療前後血清肝纖維化指標、肝纖維化分期、肝脾B超和肝功能指標改變.試驗前兩組數據的可比性分析,計量資料應用t檢驗,計數資料使用四格錶x2檢驗、Fisher精確概率法和薛氏x 2檢驗.各組治療前後的自身比較採用配對t檢驗.治療後兩組療效的比較計量資料採用兩組均數差彆的t檢驗,計數資料採用薛氏x2檢驗,肝纖維化分期比較採用Ridit分析、U檢驗及其校正法.結果 共收集到110例患者資料,試驗組肝纖維化血清學指標改善的顯效率、有效率及無效率分彆為69.8％、18.9％和11.3％,對照組分彆為17.8％、20.0％和62.2％,兩組相比,x2=32.899,P＜0.01,差異有統計學意義.治療前相比,兩組肝纖維化分期均在1～4期,均值分彆為2.39和2.13,差異無統計學意義(P＞ 0.05).治療後相比,兩組肝纖維化分期均在0～4期,試驗組和對照組均值分彆為1.79和2.12,P＜0.01,差異有統計學意義.試驗組顯效、有效和無效率分彆為11.3％、43.4％和45.3％,對照組分彆為1.0％、22.2％和75.6％,兩組比較,x2=9.408,P＜0.01,差異有統計學意義.試驗組ALT活性改善顯效、有效和無效率分彆為24.4％、57.8％和17.8％,對照組分彆為12.5％、25.0％和62.5％,兩組比較,x2=18.09,P＜0.01,差異有統計學意義；試驗組血清膽紅素定量改善顯效、有效和無效率分彆為30.0％、55.0％和15.0％,對照組分彆為12.5％、37.5％和50.0％,兩組比較,x 2=5.348,P＞0.05,差異無統計學意義.治療前相比,兩組門靜脈直徑、脾髒厚度和脾靜脈直徑指標差異均無統計學意義(P值均＞0.05).治療後相比,試驗組門靜脈直徑、脾髒厚度均小于對照組,t值分彆3.938和2.763,P值均＜ 0.01,差異均有統計學意義,但脾靜脈直徑比較,t=1.582,P＞0.05,差異無統計學意義.兩組治療前後血尿常規、腎功能、心電圖均無明顯變化.試驗過程中兩組均未齣現明顯不良反應.結論 NAs抗病毒治療後,HBV即使穫得完全病毒學應答,仍然有部分患者肝纖維化持續存在,在此基礎上,序貫聯閤扶正化瘀膠囊,可以使肝纖維化指標得到明顯的改善.
목적 관찰부정화어효낭서관연합핵감(산)유사물(NAs)대NA단약치료후획득완전병독학응답,단간섬유화지표잉연개선불가적만성을형간염(CHB)적료효. 방법 수집2008년1월지2010년12월적CHB합병간섬유화적환자자료.환자균접수NAs초시치료지소2년,병독학지표균체도완전응답6개월이상,단간섬유화지표잉연개선불가.이1:1비례장환자수궤분위량조,시험조계속구복NAs(랍미부정、아덕복위지、체비부정혹은체잡위),동시가용부정화어효낭1.5g/차,3차/d,공48주,대조조계속단용NAs 1편/차,1차/d,공48주,관찰치료전후혈청간섬유화지표、간섬유화분기、간비B초화간공능지표개변.시험전량조수거적가비성분석,계량자료응용t검험,계수자료사용사격표x2검험、Fisher정학개솔법화설씨x 2검험.각조치료전후적자신비교채용배대t검험.치료후량조료효적비교계량자료채용량조균수차별적t검험,계수자료채용설씨x2검험,간섬유화분기비교채용Ridit분석、U검험급기교정법.결과 공수집도110례환자자료,시험조간섬유화혈청학지표개선적현효솔、유효솔급무효솔분별위69.8％、18.9％화11.3％,대조조분별위17.8％、20.0％화62.2％,량조상비,x2=32.899,P＜0.01,차이유통계학의의.치료전상비,량조간섬유화분기균재1～4기,균치분별위2.39화2.13,차이무통계학의의(P＞ 0.05).치료후상비,량조간섬유화분기균재0～4기,시험조화대조조균치분별위1.79화2.12,P＜0.01,차이유통계학의의.시험조현효、유효화무효솔분별위11.3％、43.4％화45.3％,대조조분별위1.0％、22.2％화75.6％,량조비교,x2=9.408,P＜0.01,차이유통계학의의.시험조ALT활성개선현효、유효화무효솔분별위24.4％、57.8％화17.8％,대조조분별위12.5％、25.0％화62.5％,량조비교,x2=18.09,P＜0.01,차이유통계학의의；시험조혈청담홍소정량개선현효、유효화무효솔분별위30.0％、55.0％화15.0％,대조조분별위12.5％、37.5％화50.0％,량조비교,x 2=5.348,P＞0.05,차이무통계학의의.치료전상비,량조문정맥직경、비장후도화비정맥직경지표차이균무통계학의의(P치균＞0.05).치료후상비,시험조문정맥직경、비장후도균소우대조조,t치분별3.938화2.763,P치균＜ 0.01,차이균유통계학의의,단비정맥직경비교,t=1.582,P＞0.05,차이무통계학의의.량조치료전후혈뇨상규、신공능、심전도균무명현변화.시험과정중량조균미출현명현불량반응.결론 NAs항병독치료후,HBV즉사획득완전병독학응답,잉연유부분환자간섬유화지속존재,재차기출상,서관연합부정화어효낭,가이사간섬유화지표득도명현적개선.
Objective To investigate the ability of Fuzhenghuayu capsule to improve markers of liver fibrosis when provided as supplemental therapy in patients with chronic hepatitis B (CHB) who achieved complete virological response but unsatisfactory resolution of fibrosis markers with nucleos(t)ide analog (NAs) monotherapy.Methods One-hundred-and-ten patients with CHB-related liver fibrosis who had received NA for ≥ 2 years and achieved sustained virological response (SVR) but no improvement in liver fibrosis index were randomly divided into two equal groups:experimental group,continued oral NAs (one tablet,1 time/day) with simultaneous Fuzhenghuayu capsule (1.5 g,3 times/day) for 48 weeks; control group,continued oral NAs only for 48 weeks.Serum fibrosis markers (hyaluronic acid (HA),laminin (LN),amino terminal propeptide of type Ⅲ procollagen (PⅢP) and Ⅳ collagen (Ⅳ-C)),liver fibrosis stages,B ultrasonic wave,and liver function were observed before (baseline) and after treatment and compared by statistical analysis.Results The baseline levels of fibrosis markers were not significantly different between the experimental and control groups.After treatment,the levels of all of the fibrosis markers were lower in the experimental group (P ＜ 0.05 vs.control group; HA t =19.548,LN t =2.264,PⅢP t =2.230,and Ⅳ-C t =6.649)and lower than the baseline levels (P ＜ 0.01; HA t =12.458,LN t =7.402,PⅢP t =4.620,Ⅳ-C t =8.937).The control group also showed a significant reduction in HA and LN levels after treatment (P ＜ 0.01 vs.baseline; t =5.202 and 3.444),but PⅢP and Ⅳ-C were unaffected.The baseline liver fibrosis stages were not significantly different between the experimental and control groups.After treatment,only the experimental group showed significant improvement in liver fibrosis stages (P ＜ 0.01).The rates of excellent therapeutic outcome,effectiveness,and non-effectiveness were significantly different between the experimental group (11.3％,43.4％,and 45.3％) and the control group (1.0％,22.2％,and 75.6％) (x2 =9.408,P ＜ 0.01).Similar trends were observed for improvements in B ultrasonic wave for liver and spleen and in markers of liver function.Finally,neither treatment group experienced adverse effects.Conclusion For CHB patients who achieve SVR by antiviral treatment with NAs,but unsatifactory improvement in liver fibrosis indices,administration of supplemental Fuzhenghuayu capsule with continued NAs therapy may represent a safe and effective treatment.
