叶峥嵘+杜卫星+吴琳

[摘要]为观察在“大辨证理论”指导下结合“攻下排毒”和“中药现代药理研究”认识组合而成的加味柴平汤治疗HBeAg阴性慢性乙型肝炎的临床效果，选择119例HBeAg阴性慢性乙型肝炎患者，随机分为治疗组69例，对照组50例。治疗组采用加味柴平汤治疗（每日1剂分2次口服，每周服用6剂），对照组采用拉米夫定治疗（每次100 mg，每日1次），共用药48周。2组患者分别在治疗12，24，36，48周进行肝功能、血清HBV-DNA和临床症状的观察，并对停药后24和48周的患者进行ALT和血清HBV-DNA的随访。治疗组在24周总有效率与对照组比较无统计学差异，但在12，36，48周总有效率高于对照组（P<0.05）；在12，36，48周改善肝功能方面优于对照组（P<0.01或P<0.05），但在24周改善ALT方面与对照组比较无统计学差异；在12周改善血清HBV-DNA方面明显低于对照组（P<0.01），但在24，36，48周改善血清HBV-DNA方面与对照组比较无统计学差异；在12，24，36周HBV-DNA阴转率低于对照组（P<0.01或P<0.05），但在48周HBV-DNA阴转率与对照组比较无统计学差异；在12周和24周改善疲乏、纳差、腹胀和胁痛优于对照组（P<0.01或P<0.05），但在36周和48周改善疲乏和胁痛方面与对照组比较无统计学差异；患者的ALT在停药后24和48周异常率明显低于对照组（P<0.01），血清HBV-DNA定量异常率在停药后24周与对照组比较无统计学差异，但在48周则低于对照组（P<0.05）。加味柴平汤长期用药与间歇用药相结合对HBeAg阴性慢性乙型肝炎具有较好的临床疗效，应进一步在辨病施治与辨证论治相结合指导下优化和完善其处方组成，并开展其对肝纤维化和生存质量影响的临床研究。

[关键词]大辨证理论； 加味柴平汤； HBeAg阴性慢性乙型肝炎； 临床疗效

[Abstract]To observe the clinical efficacy of modified Chaiping decoction for HBeAg-negative chronic hepatitis B under DaBianZheng theory（syndrome differentiation theory） guidance with understanding of purgative detoxing and modern pharmacology research of traditional Chinese medicine. The patients with HBeAg-negative chronic hepatitis B（n=119） were randomly divided into treatment group（n=69） and control group（n=50）. The patients in treatment group were treated with the modified Chaiping decoction（6 doses per week， one dose every day in two times by oral administration）， and the patients in control group were treated with lamivudine（LAM） （100 mg/time， once a day）. All of patients were treated for 48 weeks. The liver functions， levels of DNA of hepatitis B virus （HBV-DNA） and clinical symptoms were observed at weeks 12， 24， 36 and 48 in both groups. The levels of ALT and HBV-DNA in serum were also observed 24 weeks and 48 weeks after treatment in two groups. There was no significant difference in total effective rate between treatment group and control group at week 24， but the total effective rate in treatment group was higher than that in the control group at weeks 12， 36 and 48（P<0.05）； the improvement of liver functions in the treatment group was superior than that in the control group at weeks 12， 36 weeks and 48（P<0.01 or P<0.05）， but there was no significant difference at week 24； the improvement of serum HBV-DNA in the treatment group was significantly lower than that in the control group at week 12（P<0.01）， but there was no significant difference at weeks 24， 36 and 48； the negative converse rate of serum HBV-DNA in the treatment group was lower than that in the control group at weeks 12， 24 and 36（P<0.01 or P<0.05）， but there was no significant difference at week 48； the improvement of fatigue， lassitude， abdominal distension and hypochondriac pain in treatment group was significantly better than that in the control group at weeks 12 and 24（P<0.01 or P<0.05）， but there was no significant difference in the improvement of fatigue and hypochondriac pain at weeks 36 and 48； the abnormal rate of ALT in treatment group was significantly lower than that in the control group 24 weeks and 48 weeks after drug withdrawal（P<0.01）； there was no significant difference in abnormal rate of serum HBV-DNA 24 weeks after drug withdrawal， but it was significantly lower than that in the control group 48 weeks after drug withdrawal（P<0.05）. Modified Chaiping decoction with combination of long term medication and intermittent administration showed better clinical efficacy on HBeAg-negative chronic hepatitis B. Its prescription compositions shall be further optimized and consummated under guidance of disease differentiation and syndrome differentiation， and its clinical research on hepatic fibrosis and living quality shall be carried out.

[Key words]DaBianZheng theory； modified Chaiping decoction； HBeAg-negative chronic hepatitis B； clinical efficacy

doi：10.4268/cjcmm20162026

慢性乙型病毒性肝炎（chronic hepatitis B，CHB）患者根据血清HBeAg的状况可以分为HBeAg阳性和阴性2种。相关临床与基础研究资料表明^[1-3]，HBeAg阴性CHB不仅在CHB患者中所占的比例逐年增高，而且相对于HBeAg阳性的CHB患者来说肝组织损害严重，更易发展为肝硬化、肝细胞癌。因此，国内外将HBeAg阴性的CHB的治疗和研究都提到了一个很重要位置。笔者根据恩师刘国强教授所提出的“大辨证理论”指导疑难病中西医结合治疗思路^[4]，通过“慢性乙肝中医证型与病毒复制关系的回顾性研究”所发现的“湿浊之邪与乙肝病毒密切相关”^[5]，以祛除湿邪为核心并结合“攻下排毒”和“中药现代药理研究”治疗CHB的临床经验^[6]，组合成中药复方加味柴平汤（柴平汤加僵蚕、姜黄、丹参、槟榔、田基黄、垂盆草、叶下珠）应用于CHB的临床治疗，对HBeAg阳性CHB具有较好的临床疗效^[7]。……