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目的:探讨前列腺素E1(PGE1)对早期乙型肝炎慢加急性肝衰竭患者的临床疗效及安全性。方法:采用随机对照方法进行前瞻性试验。将100例早期乙型肝炎慢加急性肝衰竭患者随机分为前列腺素E1治疗组和综合治疗组(对照组),前列腺素E1治疗组在常规内科综合治疗的基础上加用PGE1 10μg治疗,每天1次,疗程4周,综合治疗组为常规内科综合治疗。观察和比较治疗前后两组的肝功能指标水平、消化道和全身症状以及不良反应的发生情况,评价两组的临床疗效。结果:治疗过程中,前列腺素E1治疗组的总有效率为80%,显著优于综合治疗组的62%(P<0.05)。治疗过程中,两组患者血清胆红素水平均明显下降,但前列腺素E1治疗组下降幅度较对照组更加明显。治疗第2周时,治疗组和对照组患者血清胆红素水平分别为252±103μmol/L和269±113.2μmol/L(P<0.05),4周时,则分别为89.8±53.2μmol/L和114.8±62.5μmol/L(P<0.01),显著低于第2周时水平。临床症状好转率和其他化验指标(如ALT、GGT)均较治疗前显著降低,但无统计学差异(P>0.05)。前列腺素E1治疗组不良反应的发生率为14%,而综合治疗组未见不良反应发生。结论:PGE1治疗早期乙型肝炎慢加急性肝衰竭患者的疗效明显优于综合内科治疗组,能显著改善肝功能,促进黄疸消退,不良反应少。
Objective: To investigate the clinical efficacy and safety of prostaglandin E1 (PGE1) in patients with early-stage hepatitis B complicated with acute liver failure. Methods: A prospective trial was conducted using a randomized controlled trial. 100 patients with early-stage hepatitis B plus acute liver failure were randomly divided into prostaglandin E1 treatment group and comprehensive treatment group (control group). The prostaglandin E1 treatment group was treated with 10 μg PGE1 on the basis of general internal medicine treatment. 1 time, treatment for 4 weeks, comprehensive treatment group for conventional internal medicine treatment. The levels of liver function indicators, gastrointestinal and systemic symptoms and the incidence of adverse reactions in both groups were observed and compared before and after treatment, and the clinical efficacy was evaluated. Results: During the course of treatment, the total effective rate of the prostaglandin E1 treatment group was 80%, which was significantly better than that of the comprehensive treatment group (62%, P <0.05). During the course of treatment, serum bilirubin level decreased significantly in both groups, but the decrease in prostaglandin E1 group was more obvious than that in control group. At the second week of treatment, serum bilirubin levels were 252 ± 103μmol / L and 269 ± 113.2μmol / L in the treatment group and the control group (P <0.05), respectively, and were 89.8 ± 53.2μmol / L And 114.8 ± 62.5μmol / L (P <0.01), which were significantly lower than those at the second week. Clinical symptoms rate and other laboratory indicators (such as ALT, GGT) were significantly lower than before treatment, but no significant difference (P> 0.05). The incidence of adverse reactions in prostaglandin E1 treatment group was 14%, while no adverse reactions were found in the combination therapy group. Conclusion: PGE1 treatment of patients with early-onset hepatitis B and acute liver failure is significantly better than the comprehensive medical treatment group, can significantly improve liver function, promote jaundice subsides, fewer adverse reactions.