Rational Dose of Dachengqi Decoction (大承气汤) in the Treatment of Primary and Non-primary Acute Intestinal Obstruction:A Randomize-controlled,Double-Blinded,Multicentered Clinical Trial
10.13288/j.11-2166/r.2024.21.009
- VernacularTitle:大承气汤治疗原发性和非原发性急性肠梗阻合理剂量的随机对照、双盲、多中心临床研究
- Author:
Xuedong AN
1
;
Nan ZHANG
2
;
Liyun DUAN
3
;
Xiangyang YU
2
;
Zhenli ZHOU
2
;
Fengmei LIAN
1
;
Naiqiang CUI
2
;
Xiaolin TONG
1
Author Information
1. Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053
2. Nankai Hospital,Tianjin
3. Shandong University of Traditional Chinese Medicine
- Publication Type:Journal Article
- Keywords:
acute intestinal obstruction;
Dachengqi Decoction (大承气汤, DCQD);
dose-effect relationship;
clinical studye
- From:
Journal of Traditional Chinese Medicine
2024;65(21):2217-2224
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo determine the optimal dose of Dachengqi Decoction (大承气汤, DCQD) for the treatment of acute intestinal obstruction (AIO) through a randomized, double-blind, dosage parallel controlled, multi-center clinical trial, and to providee evidence support for the reasonable dosage of DCQD in clinical practice. MethodsBased on the commonly used clinical dose of DCQD, three different groups were set up, including low-dose group which used Dahuang (Radix et Rhizoma Rhei) 12 g, Houpo (Cortex Magnoliae Officinalis) 9 g, Zhishi (Fructus Aurantii Immaturus) 9 g, and Mangxiao (Natrii Sulfas) 4.5 g, medium-dose group using Dahuang 36 g, Houpo 27 g, Zhishi 27 g, Mangxiao 13.5 g, and high-dose group using Dahuang 60 g, Houp0 45 g, Zhishi 45 g and Mangxiao 22.5 g. Initially, 149 AIO patients with Yangming (阳明) bowel excess syndrome were randomly assigned to three groups using a stratified randomization method, and both the patients and the doctors were blinded. In addition to conventional western medicine treatment, each group was given 12 bags of granules made from the raw herbs of DCQD at different doses, taken orally or injected through a gastric catheter once every 6 hours, 3 bags each time, for 3 consecutive days. After treatment, the indicators of the three groups of patients with primary AIO and non-primary AIO were evaluated respectively, and the full analysis set (FAS) and per-protocol set (PPS) were used for analysis. The primary outcomes were the time to recover voluntary bowel movements and voluntary flatulence. The secondary outcomes were the ideal rate of spontaneous defecation and the ideal rate of spontaneous flatus. The occurrence of adverse events during the study was recorded and analyzed using the safety analysis set (SS). ResultsA total of 91 patients with primary AIO and 58 patients with non-primary AIO were included in the FAS and SS analysis, while 80 primary AIO patients and 56 non-primary AIO patients were included in the PPS analysis. Both FAS and PPS analysis showed significant differences in the time to recover voluntary bowel movements and voluntary flatulence among primary AIO patients in different dose groups of DCQD (P<0.01), and the high- and medium-dose groups assumed less time than the low-dose group (P<0.05). There was no statistically significant difference in the ideal rate of spontaneous defecation and spontaneous flatus among the three groups (P>0.05). And consistent results were seen in the non-primary AIO patients among the three groups. Five adverse events occurred in primary AIO patients (3 in the low-dose group, 1 in the medium-dose group, and 1 in the high-dose group), mainly manifested as abdominal distension and abdominal pain, and there was no statistically significant difference in the incidence of adverse events (P>0.05). No adverse events occurred in patients with non-primary AIO. ConclusionDCQD, as an effective treatment for patients with AIO, is commonly used at a medium dose for patients with primary AIO and at a high dose for patients with non-primary AIO. The therapeutic advantage is mainly reflected in the shorter time to recover spontaneous defecation and spontaneous flatulence and the improvement of intestinal function.