中国药物警戒 ›› 2016, Vol. 13 ›› Issue (9): 525-528.

• 基础与临床研究 • 上一篇    下一篇

前列地尔注射液治疗失代偿期乙肝肝硬化的临床观察

盖兴文1, 2, 马勇1, 张文学1   

  1. 1 解放军第123医院肝病中心,安徽 蚌埠 233015;
    2 安徽省军区蚌埠军分区干休所,安徽 蚌埠 233000
  • 收稿日期:2016-10-31 修回日期:2016-10-31 出版日期:2016-09-20 发布日期:2016-10-31

Clinical Observation of Alprostadil Injection in Treatment of Patients with Decompensated Hepatitis B Cirrhosis

GAI Xing-wen1, 2, MA Yong1, ZHANG Wen-xue1   

  1. 1 Liver Center, People’s Liberation Army 123rd Hospital, Anhui Bengbu 233015, China;
    2 Bengbu Military Retired Cadre,s Sanatorium of Anhui military area command, Anhui Bengbu 233000, China
  • Received:2016-10-31 Revised:2016-10-31 Online:2016-09-20 Published:2016-10-31

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摘要： 目的 评价前列地尔注射液治疗失代偿期乙肝肝硬化的临床疗效与安全性,为该方案的临床应用提供参考。方法 选取我院2013年8月~ 2015年8月收治的176例失代偿期乙肝肝硬化患者,进行前瞻性对照分析。使用随机数字表法将176例患者分为观察组、对照组,各88例,均给予常规保肝及对症支持治疗,观察组加用前列地尔注射液静脉滴注,疗程均为4周。比较两组患者治疗前后肝功能、肾功能、凝血酶原活动度（PTA）、总胆红素（TBIL）、腹水深度、腹围及24 h尿量变化,观察治疗期间不良反应发生情况。结果 两组患者治疗4周后ALT、TBIL、BUN、SCr均较治疗前下降,ALB、PTA均较治疗前上升,观察组变化更为明显,差异有统计学意义（P<0.05）。两组患者治疗后肝功能分级及合并肝性脑病、腹水比例均较治疗前降低,观察组降低更为明显,差异有统计学意义（P<0.05）。两组患者治疗4周后腹水深度、腹围、 24 h尿量均较治疗前下降,观察组降低更为明显,差异有统计学意义（P<0.05）。观察组临床总有效率为81.82%,高于对照组的55.68%,差异有统计学意义（P<0.05）。观察组3例患者治疗时诉注射部位发红、疼痛,经减慢滴速后均好转,未影响治疗,对照组患者治疗期间未见明显不良反应发生。结论 前列地尔对失代偿期乙肝肝硬化患者肝肾功能的改善具有积极意义,可进一步促进其腹水症状的消退、提高临床疗效,且用药后未观察到严重不良反应。

关键词: 前列地尔, 静脉注射, 失代偿期乙肝肝硬化, 临床疗效, 安全性

Abstract: Objective To evaluate the clinical efficacy and safety of alprostadil injection in treatment of patients with decompensated hepatitis B cirrhosis, and provide some reference for the clinical application of the scheme. Methods From August 2013 to August 2015, 176 patients with decompensated hepatitis B cirrhosis in our hospital were studied prospectively. The patients were randomly divided into two groups, including 88 cases who received conventional liver protective and symptomatic supportive treatment as the control group, while 88 patients who received conventional treatment supplementary alprostadil injection as the observation group, four weeks for a course of treatment in both of the two groups. The changes of liver function, renal function, prothrombin activity (PTA), total bilirubin (TBIL), ascites depth, abdominal circumference and 24 h urine before and after treatment were observed and compared, the adverse reactions of the patients were observed during the treatment. Results Compared with the levels before treatment, the ALT, TBIL, BUN, SCr in both of the two groups decreased significantly, and the ALB, PTA increased significantly after four weeks treatment, the changes of the observation group were more obvious, the differences were statistically significant (P < 0.05). After treatment, the classification of liver function, the combination of hepatic encephalopathy, ascites ratio in both of the two groups decreased significantly, the changes of the observation groups were more obvious, the differences were statistically significant (P < 0.05). After four weeks treatment, ascites depth, abdominal circumference and 24 h urine in both of the two groups decreased significantly, the changes of the observation groups were more obvious, the differences were statistically significant (P < 0.05). The total effective rate of observation group was 81.82%, which was higher than that in the control group of 55.68%, the difference was statistically significant (P < 0.05). 3 cases of the observation group complained site redness, pain during the treatment, and the symptoms disappeared after the slow drop. There were no obvious adverse reactions in the control group during the treatment. Conclusion Alprostadil can improve liver function of the patients with decompensated hepatitis B cirrhosis, further promote the ascites symptoms relief, enhance the clinical efficacy, and no serious adverse reactions were observed after administration.

Key words: alprostadil, intravenous injection, decompensated hepatitis B cirrhosis, clinical efficacy, safety

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