氧化苦参碱胶囊治疗慢性乙型病毒性肝炎的随机、双盲、安慰剂对照多中心临床研究（I）

目的 观察氧化苦参碱(苦参素)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、安慰剂及阳性药物平行对照设计的临床试验，选择慢性乙型病毒性肝炎患者216例，随机分配到苦参素胶囊组(108例)、苦参素针剂组(36例)和空白对照组(72例)，完成24周治疗。治疗前后观察临床症状、肝功能、血清乙型肝炎病毒标志物和不良反应等。结果 所有人组患者中脱落6例，不符合人选标准剔除11例，共199例患者纳入疗效统计，其中胶囊组102例，针剂组30例，空白对照组67例。苦参素胶囊组治疗慢性乙型肝炎，其HBV DNA和HBeAg阴转率分别为38．61％和31．91％，ALT复常率为76．47％；苦参素针剂组HBV DNA和HBeAg阴转率分别为43.33％和39.29％，ALT复常率为83．33％，而空白对照组HBV DNA和HBeAg阴转率分别为7．46％和6.45％，ALT复常率为40．00％。治疗后完全反应率和部分反应率胶囊组分别为24．51％和57．84％，针剂组为33．33％和50．00％，而对照组为2．99％和41．79％，苦参素胶妻组与苦参素针剂组相比无显著差异，但显著高于对照组；苦参素胶囊组、针剂组和空白对照组不良反应发生率分别为7．77％、6．67％和8．82％，无严重不良反应发生。不良反应发生率3组间比较无显著差异。结论 氧化苦参碱(苦参素)胶囊是治疗慢性乙型病毒性肝炎有效和安全的药物。     

氧化苦参碱胶囊治疗慢性乙型病毒性肝炎的随机、双盲、安慰剂对照多中心临床研究(Ⅰ)

目的观察氧化苦参碱(苦参素)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、安慰剂及阳性药物平行对照设计的临床试验,选择慢性乙型病毒性肝炎患者216例,随机分配到苦参素胶囊组(108例)、苦参素针剂组(36例)和空白对照组(72例),完成24周治疗.治疗前后观察临床症状、肝功能、血清乙型肝炎病毒标志物和不良反应等.结果所有入组患者中脱落6例,不符合入选标准剔除11例,共199例患者纳入疗效统计,其中胶囊组102例,针剂组30例,空白对照组67例.苦参素胶囊组治疗慢性乙型肝炎,其HBV DNA和HBeAg阴转率分别为38 61%和31.91%,ALT复常率为76.47%;苦参素针剂组HBV DNA和HBeAg阴转率分别为43.33%和39 29%,ALT复常率为83.33%,而空白对照组HBV DNA和HBeAg阴转率分别为7.46%和6.45%,ALT复常率为40.00%.治疗后完全反应率和部分反应率胶囊组分别为24.51%和57.84%,针剂组为33.33%和50.00%,而对照组为2.99%和41.79%,苦参素胶囊组与苦参素针剂组相比无显著差异,但显著高于对照组;苦参素胶囊组、针剂组和空白对照组不良反应发生率分别为7.77%、6.67%和8.82%,无严重不良反应发生.不良反应发生率3组间比较无显著差异.结论 氧化苦参碱(苦参素)胶囊是治疗慢性乙型病毒性肝炎有效和安全的药物.     

氧化苦参碱联合肝炎灵注射液治疗慢性乙型肝炎60例分析

目的 探讨氧化苦参碱注射液联合肝炎灵注射液治疗慢性乙型肝炎的疗效。方法 60例患者应用氧化苦参碱150mg加入10％葡萄糖液中静脉滴注，同时给予肝炎灵70rag肌肉注射，每日一次，疗程12周。另30例患者接受拉米夫定和甘利欣治疗。结果 治疗结束时第一组HBeAg和HBVDNA阴转率分别为40．7％（21／60）和43．3％（26／60）、ALT、AST的复常率均为100％，优于第二组。结论 氧化苦参碱联合肝炎灵注射液能有效抑制HBV复制，治疗慢性乙型肝炎安全有效。     

氧化苦参碱注射液治疗慢性乙型肝炎43例分析

慢性乙型肝炎(HBsAg~+、HBeAg~+、HBV DNA+)86例,随机分成2组,治疗组43例,使用博尔泰力(氧化苦参碱)注射液40mg/d,肌注,3个月。对照组43例使用肝炎灵4ml/d,肌注,3个月。治疗结果(3个月后):2组ALT复常率分别为95.3％和97.1％,HBeAg转阴率分别为41.2％与3.9％,HBV DNA转阴率分别为39.5％与9.3％,2组间肝功能复常率相比无显著差异P>0.05,而HBeAg及HBV-DNA转阴率相比均有显著差异P<0.05,提示氧化苦参碱注射液治疗慢性乙型肝炎疗效较好。     

拉米夫定治疗慢性乙型肝炎停药后肝炎复发的临床观察

目的探讨拉米夫定治疗慢性乙型肝炎，停药前加用干扰素、氧化苦参素等药物对于长期疗效的影响。方法慢性乙型肝炎患者48例，随机分为A组(单用拉米夫定组)26例，B组(拉米夫定联合、序贯组)22例，观察停药后肝功能，HBeAg及HBV DNA的变化情况。结果A组在停用拉米夫定后出现肝炎的复发率为80．77％(21／26)，ALT反跳率为95．45％(21／22)，AST反跳率为90．91％(20／22)，HBeAg复阳率75%(6／8)，HBV DNA复阳率72．22％；(13／18)；B组停拉米夫定后肝炎复发率为54：54％(12／22)，ALT反跳率为60％(12／20)，AST反跳率为50％(10／20)，HBeAg复阳率50％(4／8)，HBV DNA复阳率56．25％(9／16)。A、B两组比较，复发率，ALT反跳率及AST反跳率，有非常显著差异(P值分别为0．050，0．037，0．004)。HBeAg复阳率和HBV DNA复阳率，无显著差异(P值分别为0．298，0．27)。结论拉米夫定治疗慢性乙型肝炎获得应答的患者，在开始时或停药前加用其他抗HBv药或免疫调节剂，在停用拉米夫定后，对减少肝炎复发率，ALT及AST反跳率等方面，可能有所帮助。     

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.     

阿德福韦酯初始治疗慢性乙型肝炎疗效观察

目的观察阿德福韦酯治疗慢性乙型肝炎患者的临床疗效及不良反应。方法选择慢性乙型肝炎患者433例,分为HBeAg（＋）组270例,HBeAg（-）组163例,口服阿德福韦酯10mg,1／d,连续服用。检测肝功能指标ALT、AST、TBIL及HBV血清学标志物HBV DNA、HBVM。结果随治疗时间的延长,2组患者血清ALT复常率、HBV DNA阴转率或HBeAg血清转换率均逐渐升高,HBV DNA下降幅度逐渐增大。在12个月时2组ALT复常率分别为77．4％和74．7％,HBV DNA阴转率为56．5％和54．2％,HBV DNA下降幅度3．79log10和2．96log10,HBeAg（＋）组HBeAg血清转换率为25．6％;在24个月时2组ALT复常率分别为92．9％和85．7％,HBV DNA阴转率分别为72．6％和66．7％,HBV DNA下降幅度分别为3．90log10和3．14log10,HBeAg（＋）组HBeAg血清转换率为33．3％。2组临床疗效相似,各指标未见统计学差异。所有病例均未见严重不良反应。结论阿德福韦酯是一种有效的抗HBV药物,对HBeAg（＋）和HBeAg（-）慢性乙型肝炎均能有效控制病毒复制,改善肝功能,促使HBeAg血清学转换。长期用药安全性及耐受性良好。     

叶下珠胶囊治疗慢性乙型肝炎的临床研究

目的：观察叶下珠胶囊治疗慢性乙型肝炎的临床疗效。方法：治疗组（135例）口服叶下珠胶囊，4粒／次，3次／d；对照组（54例）口服灭溴灵胶囊，4粒／次，3次／d。两组患者均服药3个月，观察其治疗前后（部分患者随访1年）HBV－M，HBV DNA，肝功能及症状变化情况。结果：治疗组HBeAg,HBV DNA的阴转率分别为59．0％，65．4％，对照组为14．0％，17．4％，P＜0．05，差异有显著性意义治疗组和对照组总有效率分别为71．0％，18．5％，P＜0．01，差异有非常显著性意义。随访1年，其中治疗组68例，对照组25例，治疗组HBsAg，HBeAg，HBV DNA阴转率分别为22．0％，73．5％，72．0％，对照组分别为4．0％，24．0％，23．5％，P＜0．05，差异有显著性意义。两组总有效率分别为92．6％，84．0％，P＜0．05，差异有显著性意义。结论：叶下珠胶囊治疗慢性乙型肝炎具有良好疗效，远期疗效满意。     

阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎的临床研究

目的研究阿德福韦酯片对拉米夫定耐药慢性乙型肝炎患者的疗效和安全性。方法采用多中心、随机，双盲双模拟、拉米夫定对照的临床试验，选择拉米夫定耐药的HBeAg阳性慢性乙型肝炎患者209例，按1：1的比例随机分为阿德福韦酯组105例，拉米夫定组104例。完成24周和48周治疗时，检测血清HBV DNA水平、乙型肝炎病毒血清学标志物及肝功能变化。结果治疗24周时阿德福韦酯组血清HBV DNA水平，平均下降2．40log10，病毒应答率为59．0％，丙氨酸氨基转移酶（ALT）复常率为54．3％，均显著高于拉米夫定组；治疗48周时阿德福韦酯组血清HBV DNA水平，平均下降2．71log10病毒应答率为61．9％，ALT复常率为54．3％，显著优于拉米夫定组；阿德福韦酯组治疗后血清HBeAg阴转率、HBeAg血清转换率及不良事件发生率与拉米夫定组相比，差异无统计学意义。未发生与研究药物相关的严重不良反应。结论阿德福韦酯片治疗拉米夫定耐药慢性乙型肝炎，可在病毒学及生物化学方面取得较好疗效，且安全性良好。     

免疫疗法联合拉米夫定治疗慢性乙型肝炎应用研究

目的 探讨免疫疗法联合拉米夫定对慢性乙型肝炎(CHB)的抗病毒治疗效果。方法 治疗组(免疫疗法 拉米夫定)76例，对照组(单用拉米夫定)38例。2组病例根据血清ALT、HBV标志物水平分为免疫耐受期、免疫清除期。免疫疗法包括应用乙型肝炎疫苗、绿脓杆菌菌毛注射液、胸腺肽注射液。结果 免疫清除期病例的HBeAg阴转率治疗组为15／34(44．1％)，对照组为2／17(11．8％)，P＜0．05。HBV DNA阴转率2组分别为82．5％和70．6％。免疫耐受期病例的HBeAg阴转率治疗组为11／42(26．2％)，对照组1／21(4．8％)，P＜0．05。HBV DNA阴转率治疗组为23／42(54．8％)，对照组6／21(28．6％)，P＜0．05。结论 免疫疗法联合拉米夫定可以提高CHB患者HBeAg及HBV DNA阴转率。     

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.     

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.     

苦参素治疗慢性乙型肝炎的临床研究

目的探讨苦参素治疗慢性乙型肝炎的疗效,寻找治疗慢性乙型肝炎的有效方法. 方法采用多中心的开放、对照研究,治疗分4组,分别为苦参素、苦参素联合单磷酸阿糖腺苷、干扰素α1b及葡萄糖组,共治疗慢性乙型肝炎患者196例,观察ALT、AST 及病毒标志物的变化. 结果治疗结束时,苦参素组、苦参素与单磷酸阿糖腺苷联合治疗组及干扰素组的HBV DNA、HBeAg阴转率、抗-HBe的阳转率及ALT的复常率均较葡萄糖组高,4组HBV DNA的阴转率分别为42.3%、55.8%、40.7%和2.1%(P＜0.01),HBeAg阴转率分别为36.5%、39.5%、38.9%和10.6%(P＜0.05);抗-HBe的阳转率分别为25%、30.2%、25.9%和6.4%(P＜0.05).ALT的复常率分别为36.5%、41.9%、27.8%和8.5%(P＜0.05).随访12个月,HBV DNA和HBeAg的阴转率及抗-HBe的阳转率在苦参素组、联合治疗组和干扰素组差异无显著性(P＞0.05).总有效率分别为40.8%、60.8%和43.1%. 结论苦参素或苦参素联合单磷酸阿糖腺苷治疗慢性乙型肝炎有较好的HBV DNA及HBeAg阴转率和抗-HBe的阳转率,其远期抗病毒疗效与干扰素相似.     

慢性乙型肝炎治疗中影响HBeAg转阴和定量的有关因素分析

背景：慢性乙型肝炎抗病毒治疗的完全应答包括血清HBVDNA低于检测水平和HBeAg血清学转换,HBeAg是评估乙型肝炎治疗效果和停药的监测指标。目的：探讨替比夫定治疗HBeAg阳性慢性乙型肝炎患者时影响HBeAg转阴的因素。方法：采用替比夫定治疗156例HBeAg阳性慢性乙型肝炎患者48周,观察ALT、HBVDNA、HBeAg治疗前后变化,分析治疗前基线HBVDNA载量、ALT水平、HBVDNA降至检测下限的时间对HBeAg转阴和定量的影响。结果：替比夫定治疗48周后,HBVDNA转阴128例（82．1％）,ALT恢复正常153例（98．1％）,HBeAg转阴52例（33．3％）;HBVDNA载量、HBeAg定量、ALT水平均显著降低（P〈0．01）。治疗前HBVDNA〈10^7 copies／mL、ALT≥200U／L组的HBeAg转阴率分别显著高于HBVDNA≥10^7 copies／mL、ALT〈200U／L组（46．4％对23．0％,P〈0．01;55．2％对16．9％,P〈0．叭）,且HBeAg定量显著降低（P〈0．01）。HBVDNA降至检测下限的不同时间组HBeAg转阴率和定量相比差异均有统计学意义（P〈0．05）。结论：基线HBVDNA〈10^7 copies／mL、ALT水平较高、治疗后HBVDNA降至检测下限的时间对替比夫定治疗48周时HBeAg转阴和定量具有明显的影响。     

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.     

A randomised double-blind placebo-controlled trial of prednisolone therapy in HBeAg and HBV DNA positive Chinese patients with chronic active hepatitis B

Forty-one hepatitis B e antigen (HBeAg) and hepatitis B virus (HBV) DNA positive Chinese patients with chronic active hepatitis B were randomized to receive either prednisolone or placebo oral for 8 weeks. The prednisolone group received 60 mg daily for 2 weeks, 40 mg for 2 weeks, 20 mg for 2 weeks, 10 mg for 1 week and 5 mg for 1 week. In 18 patients receiving prednisolone, serum HBV DNA levels rose during the course of therapy, but dropped abruptly within 1 month of cessation of treatment. Conversely, their serum alanine aminotransferase (ALT) levels decreased during high doses of prednisolone therapy, and then became transiently elevated during the period of withdrawal of prednisolone. At 1 year from initial treatment, the serum HBV DNA and ALT levels were similar between the groups of patients treated with prednisolone or placebo. In the prednisolone treated group, 66.7% of patients became HBV DNA negative, 50% became HBeAg negative, and 33.3% seroconverted to antibody to HBeAg (anti-HBe). In the placebo treated group, 60.9% of patients became HBV DNA negative, 60.9% became HBeAg negative, and 56.5% seroconverted to anti-HBe. Hepatic decompensation was not noted in any of the prednisolone-treated patients. Thus, the effects of the withdrawal prednisolone therapy on serum ALT and HBV DNA levels was temporary, and no differences in serum viral markers or biochemical parameters of liver inflammation between these two groups were noted at the 1 year follow-up period.     

氧化苦参碱治疗拉米夫定撤药性肝炎的临床研究

目的探讨氧化苦参碱治疗拉米夫定撤药性肝炎的疗效及安全性。方法将52例诊断为拉米夫定撤药性肝炎的患者随机分为A、B两组,在保肝治疗的基础上,分别给与氧化苦参碱和拉米夫定治疗6个月,观察HBV DNA、HBeAg阴转情况及ALT复常情况,并记录不良事件的发生情况。结果治疗过程中,两组各有1例发展为重型肝炎,其他不良反应轻微;治疗结束时,两组HBVDNA阴转率分别为53.6%和95.8%,差异有非常显著性意义(P<0.001);HBeAg阴转率分别为54.2%和21.0%,差异有显著性意义(P<0.05);ALT复常率分别为71.4%和64.7%,差异无显著性(P>0.05);完全应答、部分应答和无应答率在两组之间差异无统计学意义(32.1%对25.0%、53.6%对62.5%和14.3%对12.5%,P>0.05)。结论氧化苦参碱治疗拉米夫定撤药性肝炎安全有效,可以代替拉米夫定用于拉米夫定撤药性肝炎的治疗。     

Serum ALT levels as a surrogate marker for serum HBV DNA levels in HBeAg-negative pregnant women

In Stockholm, Sweden, the majority of pregnant women positive for hepatitis B surface antigen (HBsAg) are hepatitis Be antigen (HBeAg) negative. Newborns to HBeAg positive mothers receive vaccination and hepatitis B immunoglobulin (HBIg). Newborns to HBeAg negative mothers receive vaccine and HBIg only if the mothers have elevated ALT levels. The aim of this study was to retrospectively evaluate ALT levels as a surrogate marker for HBV DNA levels in HBeAg negative carrier mothers. Altogether 8947 pregnant women were screened for HBV markers from 1999 to 2001 at the Virology Department, Karolinska Hospital. Among mothers screened 192 tested positive for HBsAg (2.2%). 13 of these samples could not be retrieved. Of the remaining 179 sera, 8 (4%) tested positive for HBeAg and 171 (95.5%) were HBeAg negative. Among the HBeAg negative mothers, 9 had HBV DNA levels > 10(5) copies/ml, and of these 7 had normal ALT levels indicating low sensitivity of an elevated ALT level as a surrogate marker for high HBV DNA level. Furthermore, no correlation was found between ALT and HBV DNA levels. Hence, it is concluded that the use of ALT as a surrogate marker for high viral replication in HBeAg negative mothers could be questioned.     

苦参素缓释片治疗HBeAg阳性慢性乙型肝炎随机双盲对照研究

目的:探讨应用苦参素缓释片治疗HBeAg阳性慢性乙型肝炎(CHB)患者的临床疗效及安全性。方法:40例HBeAg阳性CHB患者被随机分为对照组20例和治疗组20例。对照组给予苦参素胶囊治疗,治疗组予以苦参素缓释片治疗24周。两组患者同时口服拉米夫定治疗48周。观察治疗4周、8周、24周时两组患者ALT、HBV DNA水平。结果:36例患者完成24周的治疗观察。苦参素缓释片治疗组和苦参素胶囊治疗对照组的HBV DNA转阴率分别为38.89%和33.33%,ALT复常率分别为66.67%和72.22%。两组患者在HBV DNA转阴率和ALT复常率等方面比较差异无统计学意义(P>0.05)。两组患者治疗期间无严重不良事件发生。结论:苦参素缓释片治疗HBeAg阳性CHB安全有效,其疗效与临床常用药苦参素胶囊相似。