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石文静,彭杰,张涛,伍玉南,陈斌.鳖龙软肝片联合抗病毒药治疗乙型肝炎肝硬化的回顾性临床研究[J].湖南中医药大学学报英文版,2024,44(3):473-478.[Click to copy
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| 鳖龙软肝片联合抗病毒药治疗乙型肝炎肝硬化的回顾性临床研究 |
| 石文静,彭杰,张涛,伍玉南,陈斌 |
| (湘西土家族苗族自治州民族中医院, 湖南 湘西 416000;湖南中医药大学第一附属医院, 湖南 长沙 410007) |
| 摘要: |
| 目的 探讨鳖龙软肝片联合抗病毒药治疗乙型肝炎肝硬化的临床疗效及安全性。方法 采用回顾性临床研究，收集湖南中医药大学第一附属医院肝病科2014年1月1日至2016年12月31日诊断为乙型肝炎肝硬化患者的临床资料，共纳入匹配前治疗组216例、匹配前对照组78例。依据基线资料将两组患者进行倾向性评分匹配（propensity score matching，PSM），得到治疗组和对照组各69例。观察PSM后两组患者1年、3年、5年生存率及生存时间，5年内肝硬化临床终点事件发生率和发生所需时间，以评价其疗效；分别观察PSM后两组患者上消化道出血发生率、不同血小板（platelet，PLT）计数层次的两组患者上消化道出血发生率以及其他不良反应，以评价其安全性。结果 （1）1年、3年、5年总体生存率比较，治疗组分别为97%、77%、68%，对照组分别为91%、57%、52%，平均生存时间治疗组长于对照组（P<0.05）。（2）肝硬化临床终点事件发生所需平均时间比较，治疗组长于对照组（P<0.05）；腹水发生率治疗组低于对照组（P<0.05）。（3）PSM后，两组上消化道出血发生率比较，差异无统计学意义（P>0.05）；两组患者按PLT计数不同各分为PLT<30×109/L、30×109/L≤PLT<50×109/L、50×109/L≤PLT<100×109/L、PLT≥100×109/L，各层次上消化道出血发生率差异无统计学意义（P>0.05）。（4）部分患者服用鳖龙软肝片后出现胃脘不适、腹泻、腹胀等不良反应，程度轻微，可自行缓解。结论 鳖龙软肝片能提高乙型肝炎肝硬化患者生存率，减少肝硬化腹水事件发生，延缓肝硬化终点事件的发生，有较好的远期疗效，临床安全性较好，不增加上消化道出血的风险。 |
| 关键词: 鳖龙软肝片 乙型肝炎肝硬化 肝硬化临床终点事件 生存率 倾向性评分匹配 |
| DOI：10.3969/j.issn.1674-070X.2024.03.019 |
| Received:September 19, 2023 |
| 基金项目:湖南省高层次卫生人才“225”工程学科带头人培养项目（湘卫函〔2019〕196号）。 |
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| Retrospective clinical study on Bielong Ruangan Tablets combined with antiviral drugs in treating hepatitis B cirrhosis |
| SHI Wenjing,PENG Jie,ZHANG Tao,WU Yunan,CHEN Bin |
| (Ethnic Hospital of Chinese Medicine in Xiangxi Tujia and Miao Autonomous Prefecture, Xiangxi, Hunan 416000, China;The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan 410007, China) |
| Abstract: |
| Objective To explore the clinical efficacy and safety of Bielong Ruangan Tablets (BLRGT) combined with antiviral drugs in treating hepatitis B cirrhosis. Methods A retrospective clinical study was conducted to collect the clinical data of patients diagnosed with hepatitis B cirrhosis in the Department of Hepatology of the First Hospital of Hunan University of Chinese Medicine from January 1, 2014 to December 31, 2016. A total of 216 cases in the pre-matching treatment group and 78 cases in the pre-matching control group were included. Based on the baseline data, propensity score matching (PSM) was carried out between the two groups, resulting in 69 cases in both of the treatment and control groups. After PSM, the one-, three-, and five-year survival rates and survival time, and the incidence and required time of clinical endpoint events of cirrhosis within five years in the two groups of patients were observed to evaluate the efficacy; the total incidence of upper gastrointestinal bleeding and the incidence of it in different levels of platelet (PLT) count, as well as other adverse reactions in the two groups of patients were observed to evaluate the safety. Results (1) The one-, three-, and five-year overall survival rates were 97%, 77%, and 68% in the treatment group, and 91%, 57%, and 52% in the control group, respectively. The average survival time of the treatment group was longer than that of the control group (P<0.05). (2) The average time required for the occurrence of clinical endpoint events of cirrhosis in the treatment group was longer than that in the control group (P<0.05); the incidence of ascites was lower in the treatment group than that in the control group (P<0.05); (3) After PSM, there was no statistically significant difference in the total incidence of upper gastrointestinal bleeding between the two groups (P>0.05). Besides, the patients in each group were divided into levels of PLT<30×109/L, 30×109/L ≤ PLT<50×109/L, 50×109/L ≤ PLT<100×109/L, and PLT ≥ 100×109/L according to the PLT count. The incidence of upper gastrointestinal bleeding at all levels was no statistically significant difference (P>0.05). (4) Some patients who have taken BLRGT may experience discomfort in the epigastrium, diarrhea, abdominal distension, and other adverse reactions. The severity is mild, and it can be relieved on its own. Conclusion BLRGT can improve the survival rate of patients with hepatitis B cirrhosis, reduce the incidence of ascites in cirrhosis, delay the occurrence of endpoint events in cirrhosis, and have a solid long-term efficacy, and sound clinical safety, without increasing the risk of upper gastrointestinal bleeding. |
| Key words: Bielong Ruangan Tablets hepatitis B cirrhosis clinical endpoint event in cirrhosis survival rate propensity score matching |
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