Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled trial
Entecavir combining Chinese herbal medicine for HBeAg-positive chronic hepatitis B patients: a randomized, controlled trial
复制标题
DOI：
10.1007/s12072-020-10097-z
复制
发表时间：
2020-10-30
影响因子：
6.6
通讯作者：
Ye, Yong'an
中科院分区：
文献类型：
--
作者：
Li, Xiaoke;Zhou, Daqiao;Ye, Yong'an
背景与目的中药与核苷类似物（NAs）在中国被广泛接受和使用。在这项双盲、安慰剂对照、随机、多中心的试验中，我们评估了恩替卡韦（ETV）联合中药调肝益脾颗粒（TGYP）和调肝健脾解毒颗粒（TGJPJD）是否会增加中国患者乙型肝炎e抗原（HBeAg）的丢失率。方法将596名符合条件的受试者按1:1的比例随机分为两组，试验组采用中药方剂加ETV治疗。对照组给予ETV +中药安慰剂。我们比较了两组在第108周结束时的HBeAg损失率作为主要终点。次要结局包括第108周时乙型肝炎表面抗原（HBsAg）水平、未检测到的HBV-DNA比例和肝酶（ALT、AST、GGT）。结果联合治疗在108周时取得了较好的HBeAg损失，无其他不良事件。第108周，试验组HBeAg损失率为37.54% (95% CI 31.9 ~ 43.2%)，对照组为27.21% （95% CI 22.0 ~ 32.4%）。两组间差异有统计学意义，为10.33% （95% CI 8.4-12.3%, p = 0.008）。到第108周结束时，两组之间的DNA损失率、血清HBsAg水平和肝酶相似。结论中药方剂联合ETV治疗对HBeAg的清除率优于ETV单药治疗。这一发现表明，这种联合治疗可以产生更好的治疗效果和安全性。
Background and aim Traditional Chinese medicine (TCM) is widely accepted and prescribed in China alongside Nucleoside analogs (NAs). In this double-blind, placebo-controlled, randomized, multi-center trial, we evaluated whether entecavir (ETV) plus TCM formulas Tiao-Gan-Yi-Pi granule (TGYP) and Tiao-Gan-Jian-Pi-Jie-Du granule (TGJPJD) increase the rate of hepatitis B e antigen (HBeAg) loss in Chinese patients. Methods 596 eligible participants were randomly assigned, in a 1:1 ratio, to two study groups in this 108-week trial: The experiment group was assigned ETV plus the TCM formula. The control group was assigned ETV plus a TCM placebo. We compared the rate of HBeAg loss by the end of week 108 between the two arms as the primary outcome. Secondary outcomes included hepatitis B surface antigen (HBsAg) level, proportion of undetectable HBV-DNA, and liver enzymes (ALT, AST, GGT) at week 108. Results The combination therapy achieved superior HBeAg loss at 108 weeks, without additional adverse events. The rate of HBeAg loss at week 108 was 37.54% (95% CI 31.9-43.2%) in the experiment group and 27.21% (95% CI 22.0-32.4%) in the control group. There was a statistically significant difference between the two arms of 10.33% (95% CI 8.4-12.3%, p = 0.008). The DNA loss rate, serum HBsAg level, and liver enzymes were similar between the groups by the end of 108th week. Conclusion Combining the Chinese herbal formula with ETV therapy demonstrated superior HBeAg clearance compared with ETV monotherapy. This finding indicates that this combined therapy could produce an improved therapeutic effect and safety profile.