拉米夫定治疗HBeAg阴性慢性乙型肝炎的前瞻性研究

40例HBeAg阴性慢性乙型肝炎患者随机分为两组，治疗组拉米夫定100mg口服，1次／d，疗程12个月，并给以常规的护肝治疗和支持治疗。对照组给以常规护肝治疗和对症治疗。结果治疗组在治疗结束停药后12个月时、停药24个月时HBV-DNA阴转率及ALT复常率与对照组比较均有统计学意义（P〈0.01，P〈0。05）。治疗各时期HBsAg阴转率两组比较无统计学意义（P〉0．05）。认为拉米夫定治疗HBeAg阴性慢性乙型肝炎有较好的近期及远期效果。     

IFN α—lb与拉米夫定序贯治疗慢乙肝41例

目的观察IFN α-lb与拉米夫定序贯疗法治疗慢性乙型肝炎（慢乙肝）的效果及安全性。方法将同期收治的82例HBeAg阳性慢乙肝患者随机分为观察和对照组各41例。观察组序贯应用拉米夫定（口服）及IFN α-lb（肌注）；对照组仅予IFN α-lb肌注，均连续治疗32周。治疗结束时及停药后6个月检测肝功能、血常规、HBV标志物及HBV DNA等指标变化；观察有无不良反应。结果治疗结束及停药后6个月观察组HBeAg阴转率、抗-HBeAg转换率和HBV DNA阴转率均显著高于对照组，治疗结束时观察组ALT复常率显著高于对照组，P均〈0．05；治疗结束时观察组总有效率显著高于对照组（P〈0．05）；治疗过程中两组不良反应发生率无明显差异。结论IFN α-lb和拉米夫定序贯疗法抗HBV及促进肝功能恢复的效果优于IFN α-lb单一用药，且不良反应轻微。     

珠子肝泰胶囊联合阿德福韦酯治疗慢性乙型肝炎疗效和安全性评估

目的评价珠子肝泰胶囊联合阿德福韦酯治疗慢性乙型肝炎的安全性和疗效。方法选择200例慢性乙型肝炎患者,随机分成试验组（A组）和对照组（B组）,评价珠子肝泰胶囊联合阿德福韦酯（A组）与单用阿德福韦酯（B组）治疗慢性乙型肝炎的安全性和疗效。结果A组患者在治疗12周时发生肝功能改善、ALT复常;增强抗HBV作用,快速抑制HBV DNA;在这两方面A组明显优于B组（P均〈0．05）。但12周时两组在血清HBV DNA转阴率、HBeAg阴转率等方面比较无统计学差异。结论珠子肝泰胶囊联合阿德福韦酯治疗慢性乙型肝炎患者,在ALT复常、快速抑制HBV DNA方面都显示了较好的临床疗效。     

拉米夫定和α-干扰素序贯联合治疗慢性乙型肝炎疗效观察

目的探讨拉米夫定与干扰素序贯联合治疗慢性乙型肝炎的疗效。方法30例慢性乙型肝炎患者接受拉米夫定100mg／13口服，直到血清HBVDNA转阴后，联合应用重组人IFN-α2b3MU肌肉注射24周，停拉米夫定，再单用IFN-α24周；对照组30例单用拉米夫定100mg口服，疗程1年。结果治疗结束时ALT复常率治疗组和对照组分别为90．0％和86．7％，两组差异无统计学意义（p〉0．05）。但随访6个月时ALT复常率治疗组和对照组分别为83．3％和56．7％，两组相比有显著性差异（P〈0．05）；治疗组治疗结束时及随访6个月时HBeAg阴转率分别为60．0％和56．7％，对照组阴转率分别为23．3％和20．0％（P〈0．01）；HBeAg转换率治疗组治疗结束时及随访6个月时分别为53．3％和53．3％，对照组分别为20．0％和20．0％（P〈0．01）；治疗结束时HBVDNA阴转率治疗组和对照组分别为86．7％和83．3％，两组差异无统计学意义（P〉0．05），但随访6个月时治疗组和对照组分别为70．0％和43．3％（P〈0．05）。结论拉米夫定与干扰素序贯联合治疗慢性乙型肝炎能明显提高抗病毒疗效，持续应答优于单用拉米夫定治疗者。     

健脾补肾解毒降酶方治疗慢性乙型肝炎合并脂肪肝59例

目的：探讨健脾补肾解毒降酶方对慢性乙型肝炎合并脂肪肝的临床疗效。方法：选择慢性乙型肝炎合并脂肪肝患者105例。随机分为治疗组59例,对照组46例。治疗组患者1：7服健脾补肾解毒降酶方,对照组患者服用血脂康,疗程均为12周。观察两组治疗后的总有效率、肝功能及血脂的变化。结果：经治疗后治疗组总有效率优于对照组（P〈0．05）;患者丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）和γ-谷氨酰转肽酶（GGT）均明显降低,且优于对照组（P〈0．05或0．01）;同时总胆固醇（TC）、甘油三酯（TG）及低密度脂蛋白（LDL）较治疗前显著降低（P〈0．05或0．01）,其中TG在两组比较差异有显著性意义（P〈0．05）。结论：健脾补肾解毒降酶方治疗慢性乙型肝炎合并脂肪肝疗效显著,能明显改善肝功能,降低血脂。     

拉米夫定联合博尔泰力治疗慢性乙型肝炎临床研究

为探讨拉米夫定与博尔泰力联用对慢性乙型肝炎的临床治疗价值，将60例慢性乙肝患者随机分为两组，一组接受拉米夫定和博尔泰力联合治疗（LM组）。另一组单纯接受拉米夫定治疗（L组），结果两组HBVDNA阴转率分别为93．75％和89．29％，差异无显著性意义。但LM组HBeAg阴转率和ALT复常率均显著高于L组（50％对17．85％，P＜0．01和81．25％对50％，P＜0．05），两组不良反应发生率相近。拉米夫定联合博尔泰力治疗慢性乙型肝炎可有效地提高HBeAg阴转率和ALT复常率，且有希望缩短拉米夫定在慢性乙型肝炎治疗中的疗程。     

拉米夫定治疗慢性乙型肝炎停药后的临床观察

探讨拉米夫定药后慢性乙型肝炎患者临床变化的意义。对34例停用拉米夫定的慢性乙型肝炎患者，在停药1月、3月、6月时检测血清ALT、HBeAg、抗－HBe、HBVDNA，观察其转变情况。拉米夫定治疗前、后出现HBeAg至抗－HBe转变者为另一组（A组），未出现ABeAg至抗－HBe转变者为一组（B组），对比两组患者停药1月、3月、6月时ALT、HBV标志的变化。结果显示停药1月、3月、6月时ALT异常经累加后A、B两组分别0％和18．52％（P＞0．05）、0％和33．33％（P＞0．05）、14．29％和59．26％（P＜0．05）；HBVDNA阳转率分别为0％和25．93％（P＞0．05）、0％和44．44％（P＜0．05）、28．57％和77．78％（P＜0．05）。表明随着停药时间的延长。病情复发者增加。血清HBeAg至抗－HBe转变可作为拉米夫定停药的一个标志。     

拉夫米定联合苷必妥治疗慢性乙型肝炎病人的近期疗效

研究拉米夫定联合苷必妥治疗慢性乙型肝炎病人的近期疗效和安全性。选择16例慢性乙型肝炎患者用拉米夫定（100mg/d)和苷必妥(1mg/d）治疗为观察组，选择15例患者单独服用拉米夫定（100mg/d)作对照，共治疗12周。疗效评估包括肝功能和HBV复制指标。治疗12周疗程结束时，血清HBVDNA阴转率在两组间差异无显著性（100％对80．0％，P＞0．05），观察组HBeAg阴转率显著高于对照组（87．5％对26．7％，P＜0．01），HBeAg血清转换率在两组间差异有显著性（78．6％对25．09％，P＜0．05），观察组ALT的复常率显著高于对照组（100．0％对66．7％，P＜0．05）。未发生不良反应。拉米夫定联合苷必妥治疗慢性乙型肝炎的近期疗效肯定， 安全性好。     

乙肝解毒胶囊治疗慢性乙型肝炎随机双盲阳性对照临床研究

目的：观察乙肝解毒胶囊治疗慢性乙型肝炎（CHB）的疗效及安全性。方法：60例CHB患者随机分为治疗组（乙肝解毒胶囊）及对照组（当飞利肝宁），每组30例，剂量为4粒／次，3次／d。共6个月，治疗期间检查患者肝功能、乙肝病毒标志物（HBV—M）及HBV DNA的变化。结果：6个月后，治疗组HBeAg、HBV DNA阴转率及HBeAg／HBeAb转换率比对照组明显改善（P〈0．05或0．01），治疗组HBV DNA下降幅度明显大于治疗组（P〈0．05）。治疗3个月和6个月后，HBV DNA水平下降幅率〉2log10 copies／ml的比例治疗组明显高于对照组（P〈0．05或0．01），两组患者的肝功能均有明显改善，但无明显差别（P〉0．05）。结论：乙肝解毒胶囊为有效、安全的抗HBV药物，值得进一步研究及临床应用。     

拉米夫定联合苦参素治疗拉米夫定撤药性慢性乙型肝炎疗效观察

目的 比较苦参素联合拉米夫定与单用拉米夫定治疗拉米夫定撤药性慢性乙型肝炎治疗效果。方法 52例HBeAg阳性拉米夫定撤药性慢性乙型肝炎患者，随机分为治疗组30例和对照组22例，治疗组应用苦参素联合拉米夫定，对照组单用拉米夫定，疗程6个月。结果 治疗结束时，治疗组ALT复常率(100％)，明显高于对照组(86．7％)；停药半年后ALT复常率(86．7％)，明显高于对照组(63．6％)。治疗组血清HBeAg阴转率(63．3％)明显高于对照组(22．7％)；治疗组停药半年后HBeAg阴转率(53．3％)明显高于对照组(9．0％)。治疗组血清HBeAg血清转换率(46．7％)明显高于对照组(9．0％)；停药半年后血清HBeAg血清转换率治疗组(36．7％)明显高于对照组(4．5％)。治疗组血清HBVDNA阴转率(96．7％)明显高于对照组(77．3％)；治疗组停药半年后血清HBVDNA持续阴转率(76．7％)明显高于对照组(40．9％)。结论 苦参素联合拉米夫定治疗慢性乙型肝炎优于单用拉米夫定治疗，对拉米夫定撤药性肝炎有一定的疗效。     

拉米夫定治疗重度黄疸型慢性乙型肝炎临床疗效观察

目的评估拉米夫定治疗重度黄疸型慢性乙型肝炎(CHB)的短期疗效,观察血清HBV DNA水平与血清总胆红素(TBIL)水平之间的关系.方法179例重度黄疸型慢性乙型肝炎患者分为观察组101例和对照组78例.观察组给予拉米夫定100mg,每天1次口服,同时给予常规护肝治疗,治疗12周.对照组给予常规护肝治疗,治疗12周.结果观察组血清HBV DNA的下降水平明显好于对照组(P＜0.01),血清HBV DNA阴转率(＜5×102拷贝/ml)为91.1%,而对照组仅为14.1%.观察组丙氨酸转氨酶、TBIL下降水平均明显好于对照组(P值均＜0.01).线性回归分析y=85.534x-153.4,R2=0.9661(P＜0.01).结论短期应用拉米夫定治疗重度黄疸型CHB疗效明显好于常规护肝治疗,观察组血清HBV DNA水平与TBIL水平间存在相关性.     

愈肝龙胶囊联合恩替卡韦治疗乙型肝炎肝纤维化临床观察

目的:研究愈肝龙胶囊联合恩替卡韦治疗慢性乙型肝炎肝纤维化的临床疗效。方法:将符合纳入标准的116例慢性乙型肝炎肝纤维化患者随机分为观察组64例和对照组52例,两组患者均给予恩替卡韦抗病毒治疗,观察组加用愈肝龙胶囊。观察两组患者治疗前与治疗36个月后肝硬度值(LSM)、超声影像学指标(门静脉内径、脾脏厚度)、血清肝纤维化指标4项(HA、LN、C-Ⅳ、PC-Ⅲ)、肝功能(ALT、AST、PLT、Alb、TBil)、APRI指数的变化。结果:两组患者治疗36个月后,观察组的LSM值、肝纤维化指标(C-Ⅳ)、肝功能(ALT、AST、PLT、Alb、TBil)以及APRI指数优于治疗前(P<0.05),且与对照组比较差异有显著性意义(P<0.05)。结论:复方中成药愈肝龙胶囊联合恩替卡韦改善慢性乙型肝炎肝患者肝纤维化与肝功能的效果优于单用恩替卡韦。     

拉米夫定联合苦参素治疗慢性乙型肝炎68例临床观察

目的　探讨拉米夫定(LAM)联合苦参素治疗慢性乙型肝炎(CHB)患者的临床疗效。方法　将慢性乙型肝炎患者13 4例随机分为治疗组(68例)与对照组(66例)。治疗组给予LAM联合苦参素治疗;对照组单用LAM。疗程6个月,随访6个月。观察治疗前后的血生化,HBeAg ,HBVDNA等指标的变化情况。结果　疗程结束后和停药6个月后,治疗组患者血清HBeAg、HBVDNA等指标显著下降,与对照组比较差异有显著性(P <0 .0 5或P <0 .0 1)。结论　LAM联合苦参素治疗CHB疗效优于LAM单一用药。     

失代偿期肝硬化抗病毒治疗的临床价值

研究拉米夫定治疗失代偿期肝硬化的疗效及安全性。将活动期肝硬化和静止期肝硬化患者分成对照组和治疗组。对照组给予常规综合治疗12月;治疗组除上述治疗外,给予拉米夫定100mg/日,疗程12个月。观察治疗前后肝功能、HBV DNA、HBeAg阴转和病毒变异等。拉米夫定治疗12个月后,患者肝功能明显改善,Ch ild-pugh评分缩短(P<0.05),HBV DNA下降(P<0.05),HBeAg阴转率升高(P<0.05),血清转换率及病毒变异率无统计学意义。失代偿期肝硬化应用拉米夫定治疗可改善肝功能、阻止病情进一步发展;病毒变异率低,未见严重后果发生。     

Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B

AIM: To study the efficacy and safety of Fuzhenghuayu capsule (FZHY capsule, a capsule for strengthening body resistance to remove blood stasis) against liver fibrosis due to chronic hepatitis B. METHODS: Multicenter, randomized, double blinded and parallel control experiment was conducted in patients (aged from 18 to 65 years) with liver fibrosis due to chronic hepatitis B. Hepatic histologic changes and HBV markers were examined at wk 0 and 24 during treatment. Serologic parameters (HA, LM, P-Ⅲ-P, Ⅳ-C) were determined and B ultrasound examination of the spleen and liver was performed at wk 0,12 and 24. Liver function (liver function and serologic parameters for liver fibrosis) was observed at wk 0, 6, 12, 18 and 24. Blood and urine routine test, renal function and ECG were examined before and after treatment. RESULTS: There was no significant difference between experimental group (110 cases) and control group (106 cases) in demographic features, vital signs, course of illness, history for drug anaphylaxis and previous therapy, liver function, serologic parameters for liver fibrosis, liver histologic examination (99 cases in experimental group, 96 cases in control group), HBV markers, and renal function. According to the criteria for liver fibrosis staging, mean score of fibrotic stage(s) in experimental group after treatment (1.80) decreased significantly compared to the previous treatment (2.33, P<0.05), but there was no significant difference in mean score of fibrotic stage(s) (2.11 and 2.14 respectively). There was a significant difference in reverse rate between experimental group (52%) and control group (23.3%) in liver biopsy. With marked effect on decreasing the mean value of inflammatory activity and score of inflammation (P<0.05), Fuzhenghuayu capsule had rather good effects on inhibiting inflammatory activity and was superior to that of Heluoshugan capsule. Compared to that of pretreatment, there was a significant decrease in HA, LM, P-Ⅲ-P and Ⅳ-C content in experimental group after 12 and 24 wk of treatment. The difference in HA, LM, P-Ⅲ-P and Ⅳ-C content between 12 and 24 wk of treatment and pretreatment in experimental group was significantly greater than that in control group (P<0.01-0.05). The effect, defined as two of four parameters lowering more than 30% of the baseline, was 72.7% in experimental group and 27.4% in control group (P<0.01). Obvious improvement in serum Alb, ALT, AST and GGT was seen in two groups. Compared to that of control group, marked improvement in GGT and Alb was seen in experimental group (P<0.05). The effective rate of improvement in serum ALT was 72.7% in experimental group and 59.4% in control group. No significant difference was seen in blood and urine routine and ECG before and after treatment. There was also no significant difference in stable rate in ALT and serologic parameters for liver fibrosis between experimental group and control group after 12 wk of withdrawal. CONCLUSION: Fuzhenghuayu capsule has good therapeutic effects on alleviating liver fibrosis due to chronic hepatitis B without any adverse effect and is superior to that of Heluoshugan capsule.     

虎驹乙肝胶囊治疗慢性乙型肝炎及抗病毒临床疗效观察

观察虎驹乙肝胶囊治疗慢性乙型肝炎及抗病毒的临床疗效。将250例慢性乙型肝炎患者随机分为两组:治疗组128例口服虎驹乙肝胶囊。对照组122例口服护肝宁片。3个月为1疗程,连用2个疗程。治疗组的患者在改善症状和体征,恢复肝功能总疗效方面,其显效率和总有效率分别为26．56％和90．63％,对照组分别为 11．48％和63．9％,疗效明显高于对照组,(P均<0．01)。在HBeAg阴转方面,治疗组治疗3个月、6个月与随访6个月阴转率分别为32．29%、37．50％和35．42％。HBVDNA阴转率分别为36．72％、40．63%和42．97％,均明显优于对照组(P均<0．01)。停药后随访6个月复发率极低。虎驹乙肝胶囊治疗慢性乙型肝炎具有较好的恢复肝功能和抗病毒的疗效,并减少病情复发。     

Efficacy of lamivudine on hepatitis B viral status and liver function in patients with hepatitis B virus‐related hepatocellular carcinoma

Background/Aims: Treatment of patients with hepatocellular carcinoma (HCC) depends on the tumour extent and underlying liver function. Antiviral therapy with nucleoside/nucleotide analogues has been shown to be effective in improving the liver function of chronic hepatitis B (CHB) patients. We assessed whether lamivudine could induce biochemical and virological improvements in patients with hepatitis B virus‐related HCC. Patients/Methods: Of 148 CHB patients treated with 100 mg/day lamivudine for at least 6 months, 80 had HCC (CHB/HCC group) and 68 did not (CHB group). Biochemical and virological parameters were serially monitored. Results: Compared with the CHB group, the CHB/HCC group was older, had higher male predominance, bilirubin levels and liver cirrhosis rate, and lower albumin and hepatitis B virus (HBV) DNA levels and hepatitis B e antigen (HBeAg) positivity (P<0.05 each). The two groups showed similar cumulative rates of alanine aminotransferase normalization, HBV DNA seroconversion, HBeAg loss and viral breakthrough during 12 months of lamivudine treatment. After 12 months, the CHB/HCC group showed, relative to baseline, increased albumin levels (3.51±0.5 vs. 3.72±0.5 mg/ml) and decreased ascites scores (1.63±0.7 vs. 1.45±0.6) and Child–Pugh scores (6.92±1.9 vs. 6.02±1.38) (P<0.05 each). Conclusion: Lamivudine had comparable antiviral effects both in patients with CHB and CHB/HCC, and improved underlying liver function in the latter group. Treatment of HBV may increase the chance of curative treatments in patients with HBV‐related HCC.     

拉米夫定联合胸腺肽加乙肝疫苗治疗慢性乙型肝炎的临床观察

目的观察拉米夫定联合胸腺肽加乙肝疫苗治疗慢性乙型肝炎的临床效果。方法100例未曾接受过抗病毒治疗的慢性乙型肝炎患者随机分为治疗组和对照组,治疗组50例,给予拉米夫定100mg,每日一次口服,同时乙肝疫苗10μg皮下注射,每两周一次,胸腺肽20mg肌肉注射,隔日一次,共计26周,随后继续使用拉米夫定和乙肝疫苗26周,总疗程52周;对照组给予拉米夫定100mg·d-1,疗程52周。结果治疗结束时治疗组ALT下降、HBeAg/抗-HBe血清转换率明显高于对照组,差异有显著性(P<0·01),但HBVDNA下降差异无显著性(P<0·01),停药后随访6月、12月,治疗组ALT及HBVDNA下降、HBeAg/抗-HBe血清转换率明显高于对照组比,差异有显著性(P<0·01)。治疗组的完全应答率与对照组比,差异有高度显著性(P<0·01)。结论拉米夫定联合胸腺肽加乙肝疫苗能明显提高临床疗效及HBeAg/抗-HBe血清转换率及HBVDNA阴转率,且无明显毒性反应。     

Sustained response after a 2-year course of lamivudine treatment of hepatitis B e antigen-negative chronic hepatitis B

Lamivudine has demonstrated efficacy for the treatment of hepatitis B e antigen-negative chronic hepatitis B (e-CHB). However, treatment withdrawal after 1 year has been associated with a high rate of relapse while long-term treatment is associated with increasing risks of drug resistance. We report our treatment experience of 50 Chinese-Canadian patients with e-CHB. All patients received lamivudine for 2 years. Treatment was withdrawn at month 24 in patients who had undetectable hepatitis B virus (HBV) DNA by PCR and normal aminotransferases during the second year of therapy. All patients had HBV genotype B or C. Biochemical response at months 6, 12 and 24 was 74%, 71% and 66%, respectively. HBV DNA was undetectable at months 6, 12 and 24 by hybrid capture and PCR assays in 100%, 92% and 86%; and 94%, 88% and 74% patients, respectively. The cumulative rates of genotypic resistance (GR) after 1 and 2 years were 15% and 25%, respectively. Four (44%) patients with GR experienced a hepatitis flare. The probability of clinical and virological relapse 6, 12, and 18 months after treatment withdrawal were 12% and 30%, 18% and 50%, and 30% and 50%, respectively. Reinstitution of lamivudine resulted in prompt virological and biochemical responses. Our study demonstrates that a sustained response can be achieved after a 2-year course of lamivudine in a subset of patients with e-CHB.