国产与进口低分子肝素治疗乙型肝炎肝硬化的前瞻性随机对照研究

Indigenous and imported low molecular weight heparin in the treatment of chronic hepatitis B and cirrhosis with hepatitis B virus ： a prospective randomized controlled clinical study

目的 评价国产低分子肝素（LMWH）治疗肝炎肝硬化的有效性和安全性。方法 采用前瞻性随机对照研究,将75例慢性乙型肝炎肝硬化患者分为常规治疗组（15例）、常规治疗＋进口低分子肝素钠治疗组（栓复欣组,30例）,常规治疗＋国产低分子肝素钙治疗组（博璞青组,30例）,对比3组的有关临床指标和治疗效果。结果 与常规治疗组比较,两种LMWH治疗组治疗后3周Child-Pugh评分均明显降低（P均〈0.05）,肝功能、纤维化指标型胶原（C）、型前胶原N端肽（PP）及门静脉流速均明显改善（P均〈0.05）,前白蛋白显著升高（P均〈0.05）;栓复欣组与博璞青组比较差异无显著性;但博璞青较栓复欣能显著降低皮下出血、血肿的发生率（10.0%比33.3%,P〈0.05）及缩小瘀斑的面积〔（0.0042±0.0127）cm2比（0.0164±0.0278）cm2,P〈0.05〕,而且减少了患者的疼痛感（8.3%比81.0%,P〈0.05）。结论 在常规治疗基础上加用LMWH能有效提高慢性乙型肝炎肝硬化的治疗效果。国产低分子肝素钙在该疾病应用中具有有效、安全、价低、患者痛苦少的特点。

Objective To evaluate the effect of indigenous and imported low molecular weight heparin （LMWH） in the treatment of chronic hepatitis and hepatic cirrhosis aiming at seeking a safe and effective antifibrosis therapy. Methods A prospective randomized controlled clinical study of the treatment of patients with chronic hepatitis B using indigenous and imported LMWH was performed. Seventy - five patients were randomly divided into three groups： conventional treatment group （n = 15）, conventional treatment plus imported LMWH treatment group （n = 30） and conventional treatment plus indigenous LMWH treatment group （n = 30）. The clinical parameters and treatment results in three groups were compared. Results Three weeks after treatment, Child -Pugh scores in LMWH treatment groups were significantly lower than that in conventional treatment group （all P〈0. 05）, hepatic function , serum P Ⅱ P and type Ⅳ collagen levels and portalevein blood flow velocity were much better （all P〈0.05）, levels of serum prealbumin were significantly elevated （all P〈0.05）. There were no significant differences between two groups with LMWH treatment. Subcutaneous hemorrhage, incidence of hematoma was lower （10.0% vs. 33.3%, P〈0.05）, area of ecchynosis was smaller [（0.004 2±0.012 7） cm^2 vs. （0.016 4± 0. 027 8） cm^2, P〈0.05], and pain was released （8. 3% vs. 81.0%, P〈0.05） in conventional treatment plus indigenous LMWH treatment group than in conventional treatment plus imported LMWH treatment group. Conclusion LMWH in combination with conventional treatment for patients with cirrhosis of liver, significantly improves the outcome, indigenous LMWH calcium is a safe and effective antifibrosis drug as imported LMWH, also the price is lower and pain is less intense during injection than the latter.