银杏叶片治疗HBeAg阴性慢性乙型肝炎的随机对照临床研究

A Randomized Controlled Clinical Study on Ginkgo Biloba tablet for treatment of HBeAg-negative chronic hepatitis B

目的探讨银杏叶片对HBeAg阴性慢性乙型肝炎的治疗价值。方法按照入选标准，92例HBeAg阴性慢性乙型肝炎随机分为两组。治疗组46例，男21例，女25例；年龄（40±21）a，病程（31±21）mo；治疗前血清ALT（6．9±4．6）U／L，血清总胆红素（TBil）（3．7±2．2）μmol／L，清蛋白（Alb）（37±6）g／L，凝血酶原活动度（PTA）（81．7±19．1）％，HBVDNA7 log copy／mL；轻度16例，中度28例，重度2例；子干扰素（IFNα）3Mu，im，1次／d，连续1mo后改为3Mu，im，3次／wk联合银杏叶片2片，3次／d，po。总疗程48wk。对照组46例，男20例，女26例，年龄（41±23）a，病程（29±19）mo；治疗前血清ALT（5．7±3．7）u／L，TBi1（3．5±2．4）±mol／L，Alb（38±5）g／L，PTA（85．1±13．6）％，HBVDNA 6 log copy／mL；轻度18例，中度27例，重度1例；仅给予IFNα治疗，用法同上。结果治疗组于治疗12wk，48wk及停药后48wk ALT复常率为42．1％，88．7％，88．7％；病毒学应答率为32．1％，78．7％，79．4％。对照组各为43．2％，81．8％，81．8％；33．2％，53．1％，53，1％。与治疗前相比P〈0．05，0．01；两组相比P〈0．05，0．01。不良反应轻微。结论银杏叶片若与常规干扰素合用，如疗程超过12wk，确可提高后者治疗HBeAg阴性CHB的生物化学应答及病毒学应答，且不良反应轻微。

Objective To explore the value of Ginkgo Biloba tablet in treating HBeAg-negative chronic hepatitis B. Methods According to included criteria, 92 patients suffered from HBeAg-negative chronic hepatitis B were randomly divided into two groups. The therapy group of 46 patients involved 21 male cases and 25 females, the age was （40±21）a, the course of disease was （31±21）mo, the value of ALT was （6.9±4.6）U/L, serum total bilirubin was （3.7±2.2）μmol/L, plasma albumin was （37±6）g/L, prothrombin activity was （81.7±19.1）%, HBV DNA was 7 log copy/mL. The mild was 16 cases, the moderate was 28 cases, the severe was 2 cases. Patients were treated with interferon α 3Mu, im, qd ×1mo; then 3Mu, im, 3 time/wk and 2 Ginkgo Biloba tablets, po, rid. The control group of 46 patients involved 20 males and 26 females; the age was （41±23）a, the course of disease was （29±19）mo, the value of ALT was （5.7±3.7）U/L; serum total bilirubin was （3.5±2.4）μmol/L, plasma albumin was （38±5）g/L, prothrombin activity was （85.1±13.6）%, HBV DNA was 6 log copy/mL. The mild was 18 cases, the moderate was 27 cases, the severe 1 case; Patients were treated with interferon α only （as above）. The total course for treatment were 48wk. Results The normalization rates of ALT in group A were 42.1% at wk 12, 88.7% at wk48 and 48wk after Stopping treatment, while the virology responsive rates were 32.1% at week 12, 78.7% at week 48, 79.4% at 48wk after stopping treatment. There were 43.2%, 81.8%, 81.8%; 33.2%, 53.1%, 53.1% in group B （P〈0.05, 0.01）. The adverse reactions were mild. Conclusion Ginkgo Biloba tablet was beneficial in the treatment of HBeAg-negative chronic hepatitis B.