1、107临床研究 2023 年 03 月第 31 卷第 03 期作者简介：王万丰，男，副主任医师，本科。研究方向：各类肝病的治疗。中西医结合治疗复方鳖甲软肝片联合富马酸丙酚替诺福韦片治疗慢性乙肝肝硬化失代偿期患者的疗效观察王万丰(灵宝市城南医院 内科，河南 三门峡 472500)摘要：目的 探讨慢性乙肝(CHB)肝硬化失代偿期患者给予复方鳖甲软肝片联合富马酸丙酚替诺福韦片治疗疗效。方法 选取 2020 年 8 月至 2021 年 7 月灵宝市城南医院收治的 78 例 CHB 肝硬化失代偿期患者，按照随机摸球法分成治疗组(39 例)与对照组(39 例)，对照组给予富马酸丙酚替诺福韦片治疗，治疗组采
2、用复方鳖甲软肝片联合富马酸丙酚替诺福韦片，比较两组临床疗效、肝功能指标、肝纤维化指标及肝硬度数值。结果 治疗组治疗有效率(94.87%)高于对照组(76.92%)，差异有统计学意义(P 0.05)。两组治疗后白蛋白(ALB)水平明显提高，差异有统计学意义(P 0.05)，丙氨酸氨基转移酶(ALT)、总胆红素(TBIL)水平明显降低，差异有统计学意义(P 0.05)，且治疗组与对照组相比 ALB 水平明显更高，差异有统计学意义(P 0.05)，ALT、TBIL 水平明显更低，差异有统计学意义(P 0.05)。两组治疗后透明质酸(HA)、层粘连蛋白(LN)、型前胶原(PC )水平明显降低，差异有统
3、计学意义(P 0.05)，且治疗组与对照组相比明显更低，差异有统计学意义(P 0.05)。两组治疗后肝硬度数值明显降低，差异有统计学意义(P 0.05)，且治疗组与对照组相比明显更低，差异有统计学意义(P 0.05)。结论 CHB 肝硬化失代偿期患者给予复方鳖甲软肝片联合富马酸丙酚替诺福韦片治疗，能够提高临床疗效，改善患者肝功能及肝纤维化指标，降低肝硬度数值。关键词：慢性乙肝肝硬化失代偿期；复方鳖甲软肝片；富马酸丙酚替诺福韦片；肝功能中图分类号：R657.3文献标志码：B DOI：10.12385/j.issn.2096-1278(2023)03-0107-04Observation on t
4、he Effect of compound Biejia Ruangan Tablet combined with Propofol Tenofovir Fumarate Tablet in treating patients with chronic Hepatitis B Cirrhosis in Decompensation StageWANG Wanfeng(Department of Internal Medicine,Chengnan Hospital of Lingbao City,Sanmenxia Henan 472500,China)Abstract:Objective T
5、o investigate the therapeutic effect of compound Biejia Ruangan tablets combined with propofol tenofovir fumarate tablets on patients with chronic hepatitis B(CHB)cirrhosis in the decompensation stage.Methods From August 2020 to July 2021,78 patients with CHB cirrhosis in decompensated stage in Chen
6、gnan Hospital of Lingbao city were selected and divided into treatment group(39 cases)and control group(39 cases)according to the method of random ball touch.The control group was treated with propofol tenofovir fumarate tablets.The treatment group was treated with compound Biejia Ruangan tablets co
7、mbined with propofol tenofovir fumarate tablets.The clinical efficacy,liver function indicators,liver fibrosis indicators and liver hardness values of the two groups were compared.Results The effective rate of the treatment group(94.87%)was higher than that of the control group(76.92%),the differenc
8、e was statistically significant(P 0.05).After treatment,the level of albumin(ALB)was significantly increased in the two groups,and the difference was statistically significant(P 0.05).The levels of alanine aminotransferase(ALT)and total bilirubin(TBIL)was significantly decreased in the two groups,an
9、d the difference was statistically significant(P 0.05),and the levels of ALB in the treatment group were significantly higher than those in the control group,the difference was statistically significant(P 0.05),the levels of ALT and TBIL in the treatment group were lower than those in the control gr
10、oup,the difference was statistically significant(P 0.05).After treatment,the levels of hyaluronic acid(HA),laminin(LN)and procollagen type (PC )in the two groups were significantly lower,the difference was statistically significant(P 0.05),the treatment group were lower than the control group,the di
11、fference was statistically significant(P 0.05).After treatment,the liver hardness value of the two groups was significantly lower(P0.05),the treatment group were lower than the control group,the difference was statistically significant(P 0.05).Conclusion The treatment of patients with CHB cirrhosis
12、in decompensated period with compound Biejia Ruangan tablets combined with propofol tenofovir fumarate tablets can improve the clinical efficacy,improve the liver function and liver fibrosis index of patients,and reduce the liver hardness value.Key Words:decompensation period of chronic hepatitis B
13、cirrhosis;compound Biejia Ruangan tablets;propofol tenofovir fumarate tablets;liver function慢性乙肝(CHB)是临床常见的传染性疾病，由乙型肝炎病毒(HBV)感染导致，以患者肝脏病变为主要表现，随着病情进展，患者体内的 HBV 持续高水平复制，使得肝组织严重硬化、纤维化，肝功能进入无法代偿阶段，引起一系列临床症状1-2。富马酸丙酚替诺福韦片是治疗CHB 肝硬化失代偿期的抗病毒药物，能够阻止 HBV 逆108Clinical Research,Mar.2023,Vol.31 No.03转录过程，但长期单独
14、用药后易产生耐药性，且对患者肝硬化症状的缓解作用有限3。复方鳖甲软肝片作为一种中成药，具有化瘀养血、解毒益气、软坚散结的功效，可治疗气血亏虚兼毒热未尽、瘀血阻络之证，能够调理机体气血平衡4。本研究通过对 78 例 CHB 肝硬化失代偿期患者进行分析，旨在探讨复方鳖甲软肝片联合富马酸丙酚替诺福韦片治疗的疗效，详情如下。1资料与方法1.1一般资料选取 2020 年 8 月至 2021 年 7 月灵宝市城南医院收治的 78 例 CHB 肝硬化失代偿期患者，按照随机摸球法分成治疗组(N=39)与对照组(N=39)，治疗组男 18 例，女 21 例；年龄 29 75 岁，平均(52.164.37)岁；病
15、程 1 8 年，平均(3.861.02)年。对照组男 19 例，女 20 例；年龄 27 78 岁，平均(52.254.31)岁；病程 1 9 年，平均(3.971.15)年。两组患者基线资料比较，差异无统计学意义(P 0.05)，具有可比性。本研究已经本院伦理委员会审核通过。1.2纳入与排除标准纳入标准：均符合肝硬化诊治指南5中关于CHB 肝硬化失代偿期的诊断标准；均神志清醒、依从性良好；患者均知情同意。排除标准：合并脂肪肝、丙型肝炎、酒精性肝病等其他肝脏疾病者；合并恶性肿瘤、心脑血管疾病、自身免疫性疾病者；其他病毒重叠感染者；合并精神疾病者；研究开展前 6 个月内接受过干扰素、抗肝纤维化药
16、物治疗者；对本研究所用药物过敏者。1.3方法对照组给予富马酸丙酚替诺福韦片治疗，口服富马酸丙酚替诺福韦片(成都倍特药业股份有限公司；国药准字 H20203517；规格：25mg)，25mg/次，1 次/d，连续用药 6 个月。治疗组在对照组基础上联合复方鳖甲软肝片治疗，口服复方鳖甲软肝片(内蒙古福瑞医疗科技股份有限公司；国药准字 Z19991011；规格：0.5g)，2g/次，3 次/d，连续用药 6 个月。1.4观察指标(1)临床疗效：患者临床症状消失，肝功能明显改善，判定为显效；临床症状缓解，肝功能有所改善，判定为有效；临床症状及肝功能无改善甚至加重，判定为无效。治疗有效率=(显效例数+有效例数)/总例数 100%。(2)肝功能指标：治疗前、治疗 6 个月后分别抽取患者静脉血 3mL(晨起空腹)，使用全自动生化分析仪检测血清白蛋白(ALB)、丙氨酸氨基转移酶(ALT)、总胆红素(TBIL)水平。(3)肝纤维化指标：分别抽取患者治疗前、治疗 6 个月后的静脉血 3mL(晨起空腹)，使用化学发光法检测透明质酸(HA)、层粘连蛋白(LN)、型前胶原(PC )水平。(4)肝硬度数值：治疗前
