膈下逐瘀汤联用恩替卡韦治疗慢性乙型肝炎肝硬化临床疗效的Meta分析

Meta-Analysis of Clinical Efficacy of Gexia Zhuyu Decoction Combined with Entecavir in the Treatment of Chronic Hepatitis B Cirrhosis

摘要: 目的：采用系统评价方法评价膈下逐瘀汤联合恩替卡韦治疗慢性乙型肝炎肝纤维化的疗效。方法：检索中国知网(CNKI)、万方数据知识服务平台(WanFangData)、重庆维普全文数据库(VIP)、PubMed等资料库从建库至2022年11月的所有文献，选用膈下逐瘀汤联用ETV治疗慢性乙型肝炎肝纤维化的随机对照观察(RCT)，进行偏倚风险评价和使用RevMan 5.4版软件进行meta分析。结果：最终纳入10篇RCT，包含2081例患者，其中观察组1043例，对照组1038例。Meta分析结果提示：血清透明质酸HA [MD = −94.95, 95%CI = −116.2~−73.68, Z = 8.75 (P < 0.00001)]、层粘连蛋白LN [MD = −19.18, 95%CI = −25.94~−12.41, Z = 5.55 (P < 0.00001)]、III型前胶原PCIII [MD = −19.18, 95%CI = −25.94~−12.41, Z = 5.55 (P < 0.00001)]、IV型胶原IV-C [MD = −22.41, 95%CI = −28.85~−15.96, Z = 6.81 (P < 0.00001)]、天门冬氨酸氨基转移酶AST [MD = −15.67, 95%CI = −23.24~−8.09, Z = 4.05 (P < 0.00001)]、丙氨酸氨基转移酶ALT [MD = −14.66, 95%CI = −23.14~−6.18, Z = 3.39 (P < 0.00001)]、腹痛积分[MD = −0.51, 95%CI = −0.58~−0.43, Z = 12.97 (P < 0.00001)]、胁痛积分[MD = −0.46, 95%CI = −0.54~−0.38, Z = 11.23 (P < 0.00001)]、乏力积分[MD = −0.28, 95%CI = −0.51~−0.05, Z = 0.02 (P = 0.02)]。两组患者在改善TBIL、ALB方面，差异无统计学意义(P > 0.05)。结论：膈下逐瘀汤联用ETV在改善HA、LN、PC-III、IV-C、AST、ALT、中医症候积分(胁痛、腹胀、乏力)方面明显优于单用恩替卡韦。安全性分析结果提示两组均未出现明显严重不良反应。结论：高疗效性和高安全性是膈下逐瘀汤联用ETV治疗慢性乙型肝炎肝纤维化的独特之处；随着现代医学进步，尚需要更多严谨的大数据样本、高质量的双盲试验来充分评估其有效性。

Abstract: Objective: To evaluate the efficacy of Gexia Zhuyu Decoction combined with entecavir in the treatment of chronic hepatitis B fibrosis by systematic evaluation. Methods: Retrieved all literatures from CNKI, WanFangData, Chongqing VIP Full-text Database, PubMed and other databases from establishment to November 2022. A randomized controlled observation (RCT) on the treatment of chronic hepatitis B fibrosis with Gexia Zhuyu Decoction combined with ETV was used to evaluate the risk of bias and meta-analysis was performed using RevMan 5.4 software. Results Ten RCTS were included, including 2081 patients, with 1043 patients in the observation group and 1038 patients in the control group. The results of meta-analysis suggest that: Serum hyaluronic acid HA [MD = −94.95, 95%CI= −116.2~73.68, Z = 8.75 (P < 0.00001)], laminin LN [MD = 19.18, 95% CI = 25.94~12.41, Z = 5.55 (P < 0.00001), collagen type III before PC III [MD = 19.18, 95% CI = 25.94~12.41, Z = 5.55 (P < 0.00001), collagen type IV IV-C [MD = 22.41, 95%CI = 28.85~15.96, Z = 6.81 (P < 0.00001), aspartate amino transferase AST [MD = −15.67, 95%CI = −23.24~−8.09, Z = 4.05 (P < 0.00001)], alanine aminotransferase ALT [MD = 14.66, 95%CI = 23.14~6.18, Z = 3.39 (P < 0.00001)], abdominal pain points [MD = 0.51, 95%CI = 0.58~0.43, Z = 12.97 (P < 0.00001)], pain points about [MD = 0.46, 95%CI = −0.54~0.38, Z = 11.23 (P < 0.00001)], weak points [MD = 0.28, 95%CI = 0.51~0.05, Z = 0.02 (P = 0.02)]. There was no significant difference in TBIL and ALB between the two groups (P > 0.05). Conclusion: The effect of ETV combined with Qiyu Decoction on HA, LN, PC-III, IV-C, AST, ALT and TCM symptom score (hypocholic pain, abdominal distension and fatigue) was significantly better than entecavir alone. Safety analysis results indicated that there were no obvious serious adverse reactions in the two groups. Conclusion: High efficacy and safety are the unique features of Gexia Zhuyu Decoction combined with ETV in the treatment of chronic hepatitis B fibrosis. With modern medical advances, more rigorous large data samples and high- quality double-blind trials are needed to fully evaluate its effectiveness.