单磷酸阿糖腺苷联合胸腺肽治疗慢性乙型肝炎疗效观察

研究单磷酸阿糖腺鞋联合胸腺肽治疗慢性乙型肝炎的临床疗效。选择62例慢性乙型肝炎患者，分为两组，A组用单磷酸阿糖腺苷联合胸腺肽，B组用干扰素α-2a，评估两组肝功能及乙肝病毒复制近、远期疗效。两组ALT复常率、HBeAg及HBV DNA阴转率均无明显差异(P＞0．05)。初步肯定了单磷酸阿糖腺苷联合胸腺肽治疗慢性乙型肝炎抗乙肝病毒的效果。     

苦参素与贺普丁、迈普新联合序贯治疗慢性乙型肝炎59例临床观察

目的 了解苦参素与贺普丁、迈普新（胸腺肽a1）联合治疗慢性乙型肝炎的临床疗效.方法 将118例HBeAg阳性的慢性乙型肝炎患者随机分为治疗组和对照组.治疗组59例,同时使用苦参素、贺普丁、迈普新13周,随后使用贺普丁及迈普新13周,最后单用贺普丁26周;对照组59例单用同样剂量贺普丁52周.疗程中定期检测血常规、谷丙转氨酶（ALT）、HBeAg、抗-HBe、HBV DNA、透明质酸酶（HA）.结果 全部患者完成1年治疗.治疗组ALT、HA复常率,HBeAg/抗-HBe血清转换率、HBV DNA阴转率明显高于对照组（分别为81.6%和53.1%,P＜0.005;44.9%和22.4%,P＜0.025;42.9%和20.4%,P＜0.025;79.6%和51.0%,P＜0.005）.结论 苦参素与贺普丁、迈普新联合治疗慢性乙型肝炎疗效优于单用贺普丁.     

单磷酸阿糖腺苷联合白细胞介素-2、乙肝免疫球蛋白和乙肝疫苗治疗慢性乙型肝炎疗效观察

目的 研究单磷酸阿糖腺苷联合白细胞介素-2、乙肝免疫球蛋白和乙肝疫苗治疗慢性乙型肝炎的临床疗效。方法 选择68例慢性乙型肝炎患者分为两组,治疗组用单磷酸阿糖腺苷联合应用白细胞介素-2、乙肝免疫球蛋白、乙肝疫苗,对照组用干扰素α2a,评估两组肝功能及乙型肝炎病毒复制的近、远期疗效。结果 两组ALT复常率、HBeAg及HBV DNA阴转率均无明显差异(P>0.05)。结论 初步结果显示单磷酸阿糖腺苷联合白细胞介素-2、乙肝免疫球蛋白和乙肝疫苗治疗慢性乙型肝炎有一定的效果。     

单磷酸阿糖腺苷联合母牛分枝杆菌菌苗治疗慢性乙型肝炎临床观察

目的观察单磷酸阿糖腺苷联合母牛分枝杆菌菌苗(微卡)治疗慢性乙型肝炎的临床疗效。方法将80例确诊的慢性乙型肝炎患者随机分为单磷酸阿糖腺苷联合母牛分枝杆菌菌苗组和单用单磷酸阿糖腺苷组,治疗结束后比较两组ALT、HBeAg、HBVDNA的变化。结果联合治疗组ALT恢复程度、HBeAg、HBVDNA阴转率均明显优于单用单磷酸阿糖腺苷组(P<0.01)。结论单磷酸阿糖腺苷联合母牛分枝杆菌菌苗治疗慢性乙型肝炎值得临床试用。     

免疫疗法联合干扰素治疗慢性乙型肝炎的初步研究

探讨免疫疗法联合干扰素治疗不同免疫应答期慢性HBV感染患者的疗效.145例慢性乙型肝炎患者(免疫耐受期66例,免疫清除期64例,残余整合期15例)随机分为联合治疗组(乙肝疫苗 胸腺肽 绿脓杆菌菌毛 干扰素,其中免疫耐受期42例,免疫清除期46例.共88例)和对照组(单用干扰素治疗,其中免疫耐受期24例,免疫清除期18例.共42例),观察ALT及病毒标志物变化.治疗后,免疫清除期联合治疗组的ALT复常率、HBeAg、HBV DNA阴转率和HBeAg/抗-HBe血清转换率均显著高于对照组(P＜0.05).免疫耐受期,治疗组HBeAg、HBV DNA阴转率和HBeAg/抗-HBe转换率均明显高于对照组(P＜0.05).免疫疗法联合干扰素治疗慢性乙型肝炎,疗效明显优于单用干扰素治疗.     

复方甘草酸苷联合单磷酸阿糖腺苷治疗慢性乙型肝炎45例

目的:探讨复方甘草酸苷(美能)联合单磷酸阿糖腺苷(可苷)治疗慢性乙型肝炎的临床疗效.方法:88例慢性乙型肝炎患者随机分为两组,对照组43例,单用单磷酸阿糖腺苷治疗;治疗组45例,在单磷酸阿糖腺苷治疗的基础上,加用复方甘草酸苷.观察并比较两组患者治疗结束时及6个月后随访的肝功能和病毒学指标.结果:治疗结束时,两组患者肝功能均有改善,但治疗组恢复程度优于对照组(P＜0.05);治疗结束时,两组患者HBV DNA阴转率为44.4%和41.8%,但随访结果发现治疗组明显优于对照组(P＜0.05);6个月后随访,两组患者HBeAg的阴转率比较,差异有显著性意义(P＜0.05).结论:复方甘草酸苷联合单磷酸阿糖腺苷对保护肝细胞和抑制乙型肝炎病毒复制有显著疗效.     

肝泰丸治疗慢性乙型肝炎的临床研究

目的：观察肝泰丸治疗慢性乙型肝炎的临床疗效。方法：将189例慢性乙型肝炎患者随机分为两组进行前瞻性研究。治疗组102例口服肝泰丸10s／次，4次／d；对照组87例选用α1b干扰素(IFN-α1b)3MU，皮下注射，1次／d，15天后改为隔日1次。两组病例疗程均为6个月。观察治疗后患者症状体征的改县情况、ALT、AST的复常情况和HBsAg、HBeAg、HBV DNA的阴转率及抗—HBe的阳转率。结果：治疗结束后治疗组和对照组有效率分别为87．25％和86．2％。HBsAg、HBeAg、HBV DNA阴转率及抗-HBe阳转率：治疗组分别为7.8％、40.2％、43．1％、37.2％；对照组分别为8．0％、41.3％、43.7％、36．8％。经统计学处理：两组的有效率、HBV-M、HBV DNA阴转率及抗-HBe阳转率差异无显著性意义(P＞0．05)。结论：肝泰丸对慢性乙型肝炎患者病毒复制有肯定的抑制作用。     

苦参素制剂治疗慢性乙型肝炎的临床试验

目的验证不同的苦参素制剂治疗慢性乙型肝炎的疗效.方法采用开放、随机对照法,分别用苦参素葡萄糖注射液静脉滴注、苦参素注射液肌肉注射及苦参素胶囊口服与硫普罗宁口服作为对照,治疗慢性乙型肝炎病人共303例,治疗结束及停药后6个月追踪随访观察病人.结果疗程结束时,苦参素各组与硫普罗宁组ALT复常率相似,停药后随访6个月,苦参素各组ALT复常率仍保持在53.3%～58.3%,较硫普罗宁组38.8%为优.HBeAg阴转率, 停药后随访6个月,苦参素各组达30.0%～40.9%, 均优于硫普罗宁组的16.7%,P＜0.01.对HBV DNA的阴转率,苦参素静脉滴注组和苦参素肌肉注射组在治疗2个月时,分别为42.0%和32.7%,均优于苦参素口服组(P＜0.01)和硫普罗宁组(P＜0.05), 治疗3个月时,苦参素口服组上升为37.6% ,优于硫普罗宁组(P＜0.01).停药6个月后,苦参素各治疗组HBV DNA阴转率继续上升,达39.2%～49.5%,均明显优于硫普罗宁组的18.4%(P＜0.01).结论苦参素各治疗组可以改善慢性乙型肝炎病人的肝功能,提高HBeAg和HBV DNA的阴转率,停药后仍有持久的疗效.     

阿德福韦酯联合苦参素治疗HBeAg阳性慢性乙型肝炎患者的临床研究

[目的]比较阿德福韦酯联合苦参素与阿德福韦酯单药治疗HBeAg阳性慢性乙型肝炎(CHB)患者的临床疗效和安全性.[方法]将124例患者随机分为2组,各62例,治疗组给予阿德福韦酯胶囊10mg/d和苦参素胶囊0.2 g/次,3次/d,口服52周;对照组给予阿德福韦酯胶囊10mg/d,52周.观察2组治疗前后患者HBV DNA阴转率、HBeAg阴转率和HBeAg血清学转换率及丙氨酸氨基转移酶(ALT)复常率.[结果]治疗组和对照组HBV DNA阴转率分别为48.14％和40.38％(P＞0.05),ALT复常率为72.46％和76.82％ (P＞0.05),HBeAg阴转率为40.74％和26.92％(P＜0.05),HBeAg血清学转换率为35.18％和19.23％ (P＜0.05).[结论]阿德福韦酯联合苦参素治疗能提高CHB HBeAg阴转和血清学转换率,可能与苦参素增强机体HBV特异性免疫功能,从而促进HBeAg血清学应答有关.     

乙型肝炎病毒特异性T细胞治疗慢性乙型肝炎的临床研究

据62例慢性乙型肝炎分组治疗观察,治疗组HBV DNA阴转率33.3％,对照组为11.1％,HBeAg阴转率和抗-HBe阳转率分别为44.4％和33.3％,对照组分别为13.3％和10.0％。治疗结束后半年随访HBV DNA、HBeAg阴转率和抗-HBe阳转率分别为50.0％、55.6％和44.4％。故认为HBV特异性细胞毒T淋巴细胞治疗,对慢性乙型肝炎可获满意临床效果。     

苦参素治疗低病毒载量慢性乙型肝炎患者的疗效观察

目的 观察序贯应用苦参素胶囊和苦参素注射液治疗低病毒载量慢性乙型肝炎的疗效.方法 选择60例低病毒载量慢性乙型肝炎患者,随机分为对照组和治疗组各30例,对照组给予常规保肝治疗,治疗组同时序贯应用苦参素胶囊和苦参素注射液治疗,总疗程24周,观察两组治疗4、12、24周时的ALT、HBV DNA转阴率及HBeAg/抗-HBe血清转换率.结果 治疗组在改善肝功能、HBV DNA转阴率及HBeAg/抗-HBe血清转换率方面优于对照组.结论 序贯应用苦参素胶囊和苦参素注射液治疗低病毒载量慢性乙型肝炎患者可以获得较高的应答率.     

氧化苦参碱治疗慢性乙型肝炎的随机双盲对照多中心研究

目的 观察氧化苦参碱胶囊治疗慢性乙型肝炎的疗效及安全性。方法 进行多中心、随机、双盲、安慰剂对照设计的临床试验，选择慢性乙型肝炎患者144例，随机分为氧化苦参碱胶囊组72例和空白对照组72例完成52周治疗并随访12周。治疗前后及停药12周后观察患者临床症状、肝功能、血清乙型肝炎病毒(HBV)标志物和不良反应等。结果 所有入组患者中脱落和不符合入选标准剔除共14例，故共有130例患者纳入疗效统计，其中氧化苦参碱胶囊组65例，空白对照组65例。氧化苦参碱胶囊组治疗慢性乙型肝炎52周其HBVDNA和乙型肝炎e抗原(HBeAg)阴转率分别为43．08％(28／65)和33．33％(20／60)，丙氨酸氨基转移酶(ALT)复常率为70．77％(46／65)；空白对照组HBV DNA和HBeAg阴转率分别为12．31％(8／65)和3．33％(2／60)，ALT复常率为39．68％(25／63)。治疗后完全反应率．部分反应率和无反应率胶囊组分别为23．08％(15／65)，58．46％(38／65)和18．46％(12／65);而对照组分别为3．08％(2／65)、44．62％(29／65)和52．31％(34／65)。两组间比较胶囊组均明显高于对照组(QCMH=21．02，P=0．001)。氧化苦参碱胶囊组治疗慢性乙型肝炎停药12周后其HBV DNA和HBeAg阴转率分别为41．54％(27／65)和23．33％(14／60)，ALT复常率为60．00％(39／65);空白对照组HBV DNA和HBeAg阴转率分别为3．08％(2／65)和1．67％(1／60)，ALT复常率为31．75％(20／63)。完全反应率、部分反应率和无反应率胶囊组分别为21．54％(14／65)、47．69％(31／65)和30．77％(20／65)，而对照组分别为0，41．54％(27／65)和58．46％(38／65)，两组间比较胶囊组均明显高于对照组(QCMH=15．22，P=0．001)。氧化苦参碱胶囊组有5例(7．69％)发生不良反应，空白对照组有4例(6．15％)发生不良反应，主要表现为恶心、乏力、皮疹、上腹不适和口苦，均为轻，中度，无严重不良反应发生，不良反应发生率两组间比较差异无显著性。结论 氧化苦参碱胶囊是治疗慢性乙型肝炎有效，安全的药物。     

Comparison of lamivudine and alpha-interferon combination with alpha-interferon alone in the treatment of HBeAg-positive chronic hepatitis B.

AIM: To compare the efficacy of a combination of a-interferon (IFN-a) and lamivudine with IFN-a alone in the treatment of patients with HBeAg-positive chronic hepatitis B (CHB). METHODS: Sixty-eight treatment-naove patients with HBeAg-positive CHB were randomized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily (Group 1), or IFN-a2a alone in the same dosage (Group 2), for 12 months. Serum ALT, HBeAg, anti-HBe and HBV DNA were tested at the end of treatment and 6 months later. Complete response was defined as normal ALT, negative HBeAg and negative HBV DNA, six months after stopping treatment. RESULTS: Of the 68 patients, 64 completed the study. In Group 1 (n=31), mean (SD) ALT levels decreased from 124 (59) IU/L to 39 (18) IU/L at 12 months; corresponding values in Group 2 (n=33) were 128 (57) and 56 (11) IU/L (p< 0.05). Absence of HBV DNA at the end of treatment was more common in Group 1 (28/31) than in Group 2 (22/33; p< 0.022). The number of patients with seroconversion to anti-HBe (4/31 [13%] vs. 4/33 [12%], respectively; p>0.05), as also those with complete response (4/31 [13%] and 4/33 [12%], respectively; p>0.05) six months after completion of treatment was similar in Group 1 and Group 2. CONCLUSION: Combination treatment with IFN-a and lamivudine was better than IFN-a monotherapy in normalization of ALT and clearance of HBV DNA; however, it did not have a better sustained response rate than IFN-a alone.     

Clinical characteristics and distribution of hepatitis B virus genotypes in Guangxi Zhuang population

AIM: To investigate the distribution of HBV genotypes and their YMDD mutations in Guangxi Zhuang population, China, and to study the relationship between HBV genotypes and clinical types of HB, ALT, HBV DNA, HBe system as well as the curative effect of Lamivudine (LAM) on hepatitis B. METHODS: A total of 156 cases were randomly chosen as study subjects from 317 patients with chronic hepatitis B (CHB). HBV genotypes were determined by PCR-microcosmic nucleic acid cross-ELISA. YMDD mutations were detected by microcosmic nucleic acid cross-nucleic acid quantitative determination. HBV DNA was detected by fluorescence ratio PCR analysis. LAM was given to 81 cases and its curative effect was observed by measuring ALT, HBV DNA load, HBeAg, and HBeAg/HBeAb conversion rate. RESULTS: HBV genotypes B, C, D, and non-classified genotypes were found in Guangxi Zhuang population, accounting for 25.6%, 47.4%, 58.3%, and 16.0%, respectively. Seventy-four cases were CD-, CB-, BD-mixed genotypes (47.7%). Forty-six (29.5%) cases had YMDD mutations. Genotype B was mostly found in mild and moderate CHB patients. Genotypes C, D and mixed genotype mostly occurred in severe CHB cases. Genotypes D and CD HBV-infected patients had higher ALT and HBV DNA than patients with other types of HBV infection. There was no significant difference among the genotypes in YMDD mutations, clinical types, ALT and HBV DNA level. Non-classified types geno had a significantly lower positive rate of HBeAg than other genotypes (X2=12.841,P<0.05). There was no significant difference in ALT recovery rate, HBV DNA load, HBeAg, and HBeAg/HBeAb conversion rate, 48 wk after LAM treatment between groups of genotypes D, CD, and non-classified type. CONCLUSION: Genotypes B, C, and D, non-classified and mixed genotype of HBV are identified in the Guangxi Zhuang population. Variations in genotypes are associated with clinical severity and serum ALT levels, but not with YMDD mutation or HBV DNA load. Therapeutic effects of LAM on clinical parameters are not influenced by differences in genotypes. Further studies are needed to gain an in-depth understanding of the relationship between HBV genotypes and serum HBeAb and HBeAg.     

Assessment of chronic hepatitis B: the importance of hepatitis B virus DNA testing

Background: Chronic hepatitis B (CHB) has an estimated prevalence of 90 000 to 160 000 in Australia. Cirrhosis and hepatocellular carcinoma are important complications of CHB and appropriate evaluation of hepatitis B surface antigen (HBsAg)‐positive individuals is vital to identify treatment candidates. Methods: A review of the database of a tertiary hospital was performed and 348 HBsAg‐positive individuals with baseline demographic, virological, serological and biochemical variables were identified and evaluated cross‐sectionally. A small subgroup of hepatitis B e antigen (HBeAg)‐negative patients with normal alanine aminotransferase (ALT) at baseline were identified and followed longitudinally. Results: 175/348 (50%) of patients were in the HBeAg‐negative, chronic hepatitis phase of disease, 22% in the HBeAg‐positive immune clearance and 6% in the immune tolerant phases. HBeAg‐negative patients were older and more likely to be male than HBeAg‐positive patients. The correlation between hepatitis B virus (HBV) DNA and ALT levels was examined. ALT and HBV DNA levels showed no correlation in HBeAg‐positive CHB and only a weak correlation in HBeAg‐negative patients. Furthermore, 35% of HBeAg‐negative patients with detectable HBV DNA had a normal ALT. Conversely 38% of HBeAg‐negative patients with no detectable HBV DNA had an elevated ALT. A persistently normal ALT over 24 months was seen in five of nine HBeAg‐negative patients with normal initial ALT and detectable HBV DNA. Conclusion: Appropriate evaluation of HBeAg‐negative CHB must include HBV DNA because the ALT is not a reliable guide to underlying viral replication.     

Oxymatrine therapy for chronic hepatitis B： A randomized double-blind and placebo-controlled multi-center trial

AIM: To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B. METHODS: A randomised double-blind and placebo-controlled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 weeks, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo. After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed. RESULTS: Among the 216 patients, six were dropped off, and 11 inconsistent with the standard were excluded. Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47% became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33% became normal in ALT level, 43.33% and 39.29% became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00% became normal in ALT level, 7.46% and 6.45% became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84% in the capsule treated patients, and 33.33% and 50.00% in the injection treated patients, and 2.99% and 41.79% in the placebo treated patients, respectively. There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule, injection and placebo were 7.77%, 6.67% and 8.82%, respectively. There was no statistically significant difference among them. CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.     

乙型肝炎患者血清中HBcAg与HBV复制指标的关系

目的探讨乙型肝炎患者血清ＨＢｃＡｇ与ＨＢＶ复制指标的关系及临床意义．方法对３１１例乙型肝炎患者进行了ＨＢｃＡｇ检测，并同时进行酶联法乙肝五项、地高辛法ＨＢＶＤＮＡ检测，其中２３７例进行乙肝ＤＮＡ聚合酶（ＤＮＡＰ）检测．结果ＨＢｃＡｇ阳性组的ＨＢＶＤＮＡ检出率（７７６％），明显高于ＨＢｃＡｇ阴性组（３５５％，Ｐ＜００１）；在ＨＢｃＡｇ阴性组中，抗ＨＢｅ阳性者仍能检出２９９％（４４／１４７）ＨＢＶＤＮＡ者阳性；ＨＢｅＡｇ，ＨＢｃＡｇ均阳性者其ＨＢＶＤＮＡ和ＤＮＡＰ的检出率高达８５９％；其他依次为ＨＢｅＡｇ、抗ＨＢｅ和ＨＢｃＡｇ均阳性者７１４％，抗ＨＢｅ，ＨＢｃＡｇ阳性者６９２％，ＨＢｅＡｇ阳性，ＨＢｃＡｇ阴性者６８４％，抗ＨＢｅ阳性，ＨＢｃＡｇ阴性者２７６％．结论血清ＨＢＶＤＮＡ，ＤＮＡＰ，ＨＢｅＡｇ和ＨＢｃＡｇ均是反映乙肝病毒复制的敏感指标，抗ＨＢｅ的出现并不表示病毒复制停止，应参考其他病毒复制指标情况．各种指标的不同组合可以清楚地反映出患者体内病毒复制状况．     

影响干扰素治疗慢性乙型肝炎疗效的因素探讨

目的探讨肝组织病理学变化、乙型肝炎病毒DNA（HBVDNA）水平、谷丙转氨酶（ALT）水平对慢性乙型肝炎患者干扰素抗病毒治疗疗效的影响。方法对97例适合抗HBV治疗的慢性乙型肝炎患者应用α-1b干扰素治疗24周，治疗前后对ALT、HBVDNA、HBeAg／HBeAb水平进行检测、分析，其中32例患者在治疗前行肝活检明确肝组织炎症活动情况。结果肝组织炎症活动度较高者抗HBV治疗后HBVDNA转阴率和HBeAg血清转换率较高，而治疗前ALT水平对治疗后HBVDNA转阴率和HBeAg血清转换率影响较小；基线HBVDNA水平在10^5～10^6 copies／ml的患者治疗后HBVDNA转阴率和HBeAg血清转换率较高。结论抗病毒前肝组织炎症活动程度明显者、HBVDNA水平在10^5-10^6copies／ml者干扰素抗HBV疗效较好。     

不同疗程干扰素治疗慢性乙型肝炎随访3年的临床研究

目的比较长疗程和短疗程干扰素治疗慢性乙型肝炎的治疗效果。方法在HBsAg和HBeAg、HBV DNA均为阳性的慢性乙型肝炎病人235例中,应用干扰素-α2b5MU肌肉注射,隔日1次,一组（153例）患者以12个月为一个疗程,另一组（82例）患者以6个月为一个疗程,两组病人于治疗结束后均随访36个月。结果两组患者HBsAg阴转率和近期应答率无明显差别（P〉0.05）;长疗程组的ALT复常率、HBeAg阴转率、HBeAb阳转率和HBV DNA阴转率均高于短疗程组（P〈0.05）;短疗程组的复发率高于长疗程组（P〈0.05）,其持续应答率低于长疗程组（P〈0.01）。结论长疗程干扰素治疗慢性乙型肝炎的疗效优于短疗程治疗。