Zhang Chenhao, Huang Chaolian, Kong Xiaolin, Liu Guannan, Li Ning, Liu Jie, Zhang Zongyao, Yang Dawei, Liang Chunling, Wang Jie
Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
Evid Based Complement Alternat Med. 2018 Oct 21;2018:3852196. doi: 10.1155/2018/3852196. eCollection 2018.
To evaluate the clinical efficacy of traditional Chinese medicine (TCM) supplementing Qi and hemostasis formula on gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) and thus find out the optimal therapeutic regimen to reduce incidence of GI bleeding without increase of major adverse cardiovascular events (MACEs).
In the randomized, double-blinded, controlled trial, 117 participants who underwent PCI were enrolled and evenly distributed into treatment arm (59) and control arm (58). Numerous end points were assessed including the primary endpoint of GI bleeding and MACEs and secondary endpoint of thromboelastogram (TEG) (mainly MAadp, inhibition of ADP, and inhibition of AA) and TCM syndrome score during the follow-up phase of 90 days.
Incidence of bleeding including GI bleeding and MACE did not differ significantly between two arms (28.82% in treatment arm versus 24.44% in control). However, on both days 30 and 90, TCM treatment remarkably reduced the TCM syndrome total score with notable alteration (P<0.05) except for some parameters such as pulse manifestation. When it came to TEG, however, MA increased significantly on day 30 in control arm, accompanied by a notable descending in inhibition rate of ADP pathway (both P<0.01).
(1) Supplementing Qi and hemostasis formula is equal to Pantoprazole Sodium Enteric-Coated Capsule in hemostasis and gastric mucosal protection; (2) supplementing Qi and hemostasis formula is superior to Pantoprazole Sodium Enteric-Coated Capsule in improving TCM syndrome manifestation possibly through the multitarget mechanism; (3) interference on clopidogrel of supplementing Qi and hemostasis formula might be much less than Pantoprazole Sodium Enteric-Coated Capsule due to the potential CYP450-independent mechanism. This trial is registered with ChiCTR1800014485.
评估中药益气止血方对经皮冠状动脉介入治疗（PCI）后胃肠道（GI）出血的临床疗效，从而找出在不增加主要不良心血管事件（MACEs）的情况下降低GI出血发生率的最佳治疗方案。
在这项随机、双盲、对照试验中，117名接受PCI的参与者被纳入并平均分为治疗组（59例）和对照组（58例）。在90天的随访期内评估了多个终点，包括GI出血和MACEs的主要终点，以及血栓弹力图（TEG）（主要是MAadp、ADP抑制率和AA抑制率）和中医证候评分的次要终点。
治疗组和对照组之间包括GI出血和MACEs在内的出血发生率无显著差异（治疗组为28.82%，对照组为24.44%）。然而，在第30天和第90天，除了一些参数如脉象外，中医治疗显著降低了中医证候总分，有显著变化（P<0.05）。然而，对于TEG，对照组在第30天MA显著增加，同时ADP途径抑制率显著下降（均P<0.01）。
（1）益气止血方在止血和胃黏膜保护方面与泮托拉唑钠肠溶胶囊相当；（2）益气止血方在改善中医证候表现方面可能通过多靶点机制优于泮托拉唑钠肠溶胶囊；（3）由于潜在的非CYP450依赖机制，益气止血方对氯吡格雷的干扰可能远小于泮托拉唑钠肠溶胶囊。本试验已在ChiCTR1800014485注册。
