Rational Dose of <italic style="font-style: italic">Dachengqi Decoction </italic>（大承气汤） in the Treatment of Primary and Non-primary Acute Intestinal Obstruction：A Randomize-controlled，Double-Blinded，Multicentered Clinical Trial

AN Xuedong; ZHANG Nan; DUAN Liyun; YU Xiangyang; ZHOU Zhenli; LIAN Fengmei; CUI Naiqiang; TONG Xiaolin

doi:10.13288/j.11-2166/r.2024.21.009

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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

更新时间：2024-10-30

- 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
- Journal of Traditional Chinese Medicine Vol. 65, Issue 21, Pages: 2217-2224(2024)
- 作者机构：
  
  1.中国中医科学院广安门医院，北京市西城区北线阁5号，100053
  2.天津市南开医院
  3.山东中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2024.21.009
  CLC：
- Received：30 January 2024，
  
  Revised：2024-07-30，
  
  Published：02 November 2024
- 稿件说明：
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安学冬,张楠,段丽云等.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[J].中医杂志,2024,65(21):2217-2224.

AN Xuedong,ZHANG Nan,DUAN Liyun,et al.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[J].Journal of Traditional Chinese Medicine,2024,65(21):2217-2224.
安学冬,张楠,段丽云等.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[J].中医杂志,2024,65(21):2217-2224. DOI： 10.13288/j.11-2166/r.2024.21.009.

AN Xuedong,ZHANG Nan,DUAN Liyun,et al.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[J].Journal of Traditional Chinese Medicine,2024,65(21):2217-2224. DOI： 10.13288/j.11-2166/r.2024.21.009.

摘要

目的

通过开展随机、双盲、剂量平行对照、多中心临床研究，明确大承气汤治疗急性肠梗阻的合理剂量，为临床合理选择大承气汤剂量提供证据支持。

方法

基于大承气汤的临床基础常用剂量，设置低剂量（大黄12 g、厚朴9 g、枳实9 g、芒硝4.5 g）、中剂量（大黄36 g、厚朴27 g、枳实27 g、芒硝13.5 g）、高剂量（大黄60 g、厚朴45 g、枳实45 g、芒硝22.5 g）3个组。将149例急性肠梗阻阳明腑实证患者按照分层区组随机方法以1∶1∶1的比例分配到3个组中，对患者和医生均设盲。各组均在西医常规治疗基础上，将每剂大承气汤生药提取制作成12袋颗粒剂，每6 h口服或通过胃导管注射1次，每次3袋，连续3天。治疗后分别统计原发性急性肠梗阻和非原发性急性肠梗阻患者各自3组的观察指标，并采用全分析集（FAS）和符合方案集（PPS）进行分析。主要疗效指标为治疗后恢复自主排便及自主排气时间；次要疗效指标为自主排便理想率、自主排气理想率；记录研究过程中不良事件的发生情况，采用安全分析集（SS）分析。

结果

共有91例原发性急性肠梗阻患者和58例非原发性急性肠梗阻患者进入FAS和SS分析，80例原发性肠梗阻患者和56例非原发性肠梗阻进入PPS分析。FAS和PPS分析均显示，原发性急性肠梗阻患者不同剂量组别恢复自主排便及自主排气时间比较，差异均具有统计学意义（

＜0.01），其中高剂量组、中剂量组均低于低剂量组（

＜0.05）；3组自主排便理想率、自主排气理想率比较差异无统计学意义（

＞0.05）。非原发性急性肠梗阻患者的FAS和PPS分析结果与原发性急性肠梗阻结果一致。原发性急性肠梗阻患者发生5例不良事件（低剂量组3例，中剂量组1例，高剂量组1例，主要表现为腹胀、腹痛），不良事件发生率比较差异无统计学意义（

＞0.05）。非原发性急性肠梗阻患者未发生不良事件。

结论

临床可用大承气汤中剂量作为原发性急性肠梗阻患者的较优剂量，高剂量作为非原发性急性肠梗阻患者的较优剂量，疗效优势主要体现在以更短的时间恢复自主排便和自主排气，改善肠道功能。

Abstract

Objective

To 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.

Methods

Based 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）.

Results

A 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 （

＜0.01）， and the high- and medium-dose groups assumed less time than the low-dose group （

＜0.05）. There was no statistically significant difference in the ideal rate of spontaneous defecation and spontaneous flatus among the three groups （

＞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 （

＞0

.05）. No adverse events occurred in patients with non-primary AIO.

Conclusion

DCQD， 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.

关键词

Keywords

references

HUCL T . Acute GI obstruction ［J］. Best Pract Res Clin Gastroenterol ， 2013 ， 27 （ 5 ）： 691 - 707 .

SARANI B ， PASPULATI RM ， HAMBLEY J ， et al . A multidisciplinary approach to diagnosis and management of bowel obstruction ［J］. Curr Probl Surg ， 2018 ， 55 （ 10 ）： 394 - 438 .

MALIK AM ， SHAH M ， PATHAN R ， et al . Pattern of acute intestinal obstruction： is there a change in the underlying etiology？［J］. Saudi J Gastroenterol ， 2010 ， 16 （ 4 ）： 272 - 274 .

吴孟超，吴在德 . 黄家驷外科学［M］. 7版 . 北京：人民卫生出版社， 2008 ： 1485 - 1495 .

全国中医标准化技术委员会 . 中医临床诊疗术语证候部分［S］. 北京：中国标准出版社， 1997 ： 53 .

国家药典委员会 . 中华人民共和国药典［M］. 北京：化学工业出版社， 2005 .

魏惠珍，胡景婷，饶毅，等 . 大承气汤高效液相色谱指纹图谱研究［J］. 环球中医药， 2012 ， 5 （ 6 ）： 425 - 428 .

周宗灿 . 毒理学教程［M］. 3版 . 北京：北京大学医学出版社， 2006 ： 137 - 144 .

刘起华，文谨，陈弘东，等 . 从《伤寒论》煎煮法探讨经方剂量的合理使用［J］. 中医杂志， 2016 ， 57 （ 13 ）： 1081 - 1085 .

吕云福，邹声泉，詹文华，等 . 肠梗阻诊断治疗学［M］. 北京：人民卫生出版社， 2007 ： 92 - 98 .

JACKSON P ， VIGIOLA CRUZ M . Intestinal obstruction： evaluation and management ［J］. Am Fam Physician ， 2018 ， 98 （ 6 ）： 362 - 367 .

CATENA F ， DE SIMONE B ， COCCOLINI F ， et al . Bowel obstruction： a narrative review for all physicians ［J］. World J Emerg Surg ， 2019 ， 14 ： 20 . doi： 10.1186/s13017-019-0240-7 http://dx.doi.org/10.1186/s13017-019-0240-7 .

YANG B ， XU FY ， SUN HJ ， et al . Da-cheng-qi decoction， a traditional Chinese herbal formula， for intestinal obstruction： systematic review and meta-analysis ［J］. Afr J Tradit Complement Altern Med ， 2014 ， 11 （ 4 ）： 101 - 119 .

TIAN AP ， YIN YK ， YU L ， et al . Topical delivery of modified Da-Cheng-Qi decoction using low-frequency ultrasound sonophoresis for refractory metastatic malignant bowel obstruction： an open-label single-arm clinical trial ［J］. Chin J Integr Med ， 2020 ， 26 （ 5 ）： 382 - 387 .

TANAKA S ， YAMAMOTO T ， KUBOTA D ， et al . Predictive factors for surgical indication in adhesive small bowel obstruction ［J］. Am J Surg ， 2008 ， 196 （ 1 ）： 23 - 27 .

JIANG M ， LU C ， ZHANG C ， et al . Syndrome differentiation in modern research of traditional Chinese medicine ［J］. J Ethnopharmacol ， 2012 ， 140 （ 3 ）： 634 - 642 .

何莉莎，宋攀，赵林华，等 . 方药量效关系临床研究概况［J］. 中医杂志， 2019 ， 60 （ 1 ）： 80 - 84 .

LI D ， LV B ， WANG D ， et al . Network pharmacology and bioactive equivalence assessment integrated strategy driven Q-markers discovery for Da-Cheng-Qi decoction to attenuate intestinal obstruction ［J］. Phytomedicine ， 2020 ， 72 ： 153236 . doi： 10.1016/j.phymed.2020.153236 http://dx.doi.org/10.1016/j.phymed.2020.153236 .

QI QH ， WANG J ， LIANG GG ， et al . Da-Cheng-Qi-Tang promotes the recovery of gastrointestinal motility after abdominal surgery in humans ［J］. Dig Dis Sci ， 2007 ， 52 （ 6 ）： 1562 - 1570 .

JIAN W ， HENG L ， HUI QQ . Effect of Da-Cheng-Qi-Tang on gastrointestinal motility in patients undergoing laparotomy ［J］. Hepatogastroenterol ， 2011 ， 58 （ 112 ）： 1887 - 1892 .

杨文修，金正根，许文胜，等 . 大承气汤和大黄对豚鼠结肠带平滑肌细胞电活动的影响［J］. 中国中西医结合杂志， 1993 ， 13 （ 1 ）： 33 - 35，6 .

HU X ， LIU S ， ZHU J ， et al . Dachengqi decoction alleviates acute lung injury and inhibits inflammatory cytokines production through TLR4/NF-κB signaling pathway in vivo and in vitro ［J］. J Cell Biochem ， 2019 ， 120 （ 6 ）： 8956 - 8964 .

WANG J ， CHEN G ， GONG H ， et al . Amelioration of experimental acute pancreatitis with Dachengqi decoction via regulation of necrosis-apoptosis switch in the pancreatic acinar cell ［J］. PLoS One ， 2012 ， 7 （ 7 ）： e40160 .

ZHANG X ， WANG L ， CHEN DC . Effect of Rhubarb on Gastrointestinal Dysfunction in Critically Ill Patients： a retrospective study based on propensity score matching ［J］. Chin Med J （Engl）， 2018 ， 131 （ 10 ）： 1142 - 1150 .

ZHANG HQ ， ZHOU CH ， WU YQ . Effect of emodin on small intestinal peristalsis of mice and relevant mechanism ［J］. World J Gastroenterol ， 2005 ， 11 （ 20 ）： 3147 - 3150 .

MIHARA T ， MIKAWA S ， KAJI N ， et al . Therapeutic action of honokiol on postoperative ileus via downregulation of iNOS gene expression ［J］. Inflammation ， 2017 ， 40 （ 4 ）： 1331 - 1341 .

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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

DOI：10.13288/j.11-2166/r.2024.21.009

摘要

Abstract

关键词

Keywords

references