石军颗粒治疗轻微型肝性脑病的临床研究

Clinical study on treatment of minimal hepatic encephalopathy with Shijun Granule

目的观察石军颗粒治疗轻微型肝性脑病的临床疗效。方法将76例轻微型肝性脑病患者按随机数字表法分成治疗组与对照组,每组38例。治疗组予石军颗粒口服,对照组予乳果糖糖浆(杜密克)口服。两组疗程均为1个月,观察比较肝功能相关指标(ALT、AST)、血氨、血清氨基酸(芳香族、支链氨基酸)、数字连接试验及数字符号试验的情况。结果 (1)试验期间共出现脱落病例5例,最终完成试验者71例,治疗组36例、对照组35例。(2)组间治疗后比较,ALT、AST水平差异有统计学意义,治疗组指标降低更显著于对照组(P<0.05)。(3)治疗前后组内比较,两组血氨水平差异均有统计学意义(P<0.05);组间治疗前后血氨水平差值比较,差异有统计学意义,治疗组降低幅度较对照组更加明显(P<0.05)。(4)组间苯丙氨酸、酪氨酸水平比较,差异无统计学意义(P>0.05);组间治疗后比较,亮氨酸、异亮氨酸、缬氨酸水平差异有统计学意义(P<0.05),提示治疗组调节支链氨基酸代谢方面的作用较对照组明显。(5)组间治疗后比较,治疗组NCT-A所用时间明显较对照组更短(P<0.05);组间治疗后比较,治疗组DST评分明显较对照组更高(P<0.05)。结论石军颗粒治疗轻微型肝性脑病的疗效满意,值得在肝性脑病的早期干预阶段推广应用。

Objective To observe the clinical efficacy of Shijun Granule on minimal hepatic encephalopathy. Methods 76 patients with minimal hepatic encephalopathy were randomly divided into the treatment group and the control group ,38 cases in each group. The treatment group was treated orally with Shijun Granule, the control group was treated orally with lactulose syrup （ Duphalac）, with a course of one month. The related parameters of liver function （ ALT, AST）, blood ammonia, serum amino acids （aromatic, branched chain amino acid）, number-connection test type A （NCT-A） and digital symbol test （DST）were observed and compared. Results （1） During the trial, totally 5 cases fell off and 71 cases completed the whole test, among which 36 cases in the treatment group and 35 cases in the control group. （2）Comparison between the treatment group and control group after treatment, the differences on the level of ALT and AST were statistically significant,the indicators decrease in the treatment group were more significant than those in the control group （P 〈 0.05 ）. （3）Comparison of the treatment before and after within group, the difference on the blood ammonia level in both groups was statistically significant （ P 〈 0.05 ） ; comparison of the difference of blood ammonia before and after treatment, the difference between groups was statistically significant,the reduction in treatment group was more obvious than that in the control group（ P 〈0.05 ）. （4）There were no significant differences on the levels of phenylalanine and tyrosine between the treatment group and control group after treatment （P 〉 0.05 ）. Comparison between groups after treatment, the differences on the levels of leucine, isoleucine, valine were statistically significant （P 〈0.05 ）, which suggested that the effect of the treatment group on metabolism regulation of branched chain amino acid was more obvious than that of the control group. （5）Comparison between the two groups after treatment, the time of the treatment group in the NCT-A was obviously shorter than that of the control group （ P 〈 0.05 ）. The DST score in the treatment group was significantly higher than that in the control group （ P 〈0.05 ）. Conclusion Shijun Granule shows good effect in the treatment of minimal hepatic encephalopathy,which is worthy of promotion and application in the early intervention of hepatic encephalopathy.