连夏消痞颗粒治疗功能性消化不良：一项多中心、随机、双盲、安慰剂对照试验

YANG Yang; LIU Rui; ZHOU Qiang; XIA Qing; GONG Yang; LI Yu-feng; XU Lu-zhou; LENG Yan; ZHANG Bei-ping; ZHOU Zheng-hua; ZHOU Su-fang; ZHANG Tao; LIU Shao-neng; LIU Yu-fei; FENG Pei-min

doi:10.1007/s11655-026-3850-4

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连夏消痞颗粒治疗功能性消化不良：一项多中心、随机、双盲、安慰剂对照试验

Original Article | Updated：2026-08-04

- 连夏消痞颗粒治疗功能性消化不良：一项多中心、随机、双盲、安慰剂对照试验
- Lianxia Xiaopi Granules for Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-Blind and Placebo-Controlled Trial
- 中国结合医学杂志（英文版） 2026年32卷第8期页码：675-684
- Affiliations：
  
  1.Department of Gastroenterology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu ( 610075), China
  2.Tasly Pharmaceutical Group Co., Ltd., Tianjin ( 300410), China
  3.Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu ( 610041), China
  4.Department of Traditional Chinese Medicine, General Hospital of the PLA Northern Theater Command, Shenyang ( 110016), China
  5.Department of Gastroenterology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang ( 110032), China
  6.Department of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine, Nanjing ( 210029), China
  7.Department of Liver, Spleen and Gastroenterology, First Affiliated Hospital of Changchun University of Chinese Medicine, Jilin ( 130021), China
  8.Department of Spleen and Stomach Diseases, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou ( 510120), China
  9.Department of Gastroenterology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin ( 300193), China
  10.Department of Gastroenterology, the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang ( 550001), China
  11.Department of Gastroenterology, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning ( 530011), China
  12.Department of Digestive Diseases, Guang' anmen Hospital, China Academy of Chinese Medical Sciences, Beijing ( 100053), China
  13.School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu ( 611137), China
- Author bio：
  
  Prof. FENG Pei-min, E-mail: fpmmed@cdutcm.edu.cn
- Funds：
  
  National Good Clinical Practice Project(LCYJHT-JGB-YW-2021006);National Science and Technology Major Project—Major New Drug Innovation(2017ZX09301005)
- DOI：10.1007/s11655-026-3850-4
  中图分类号：
- 录用：2025-08-29，
  
  网络首发：2026-05-13，
  
  纸质出版：2026-08
- Accepted：
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YANG Yang, LIU Rui, ZHOU Qiang, 等. 连夏消痞颗粒治疗功能性消化不良：一项多中心、随机、双盲、安慰剂对照试验[J]. 中国结合医学杂志（英文版）, 2026,32(8):675-684.

YANG Yang, LIU Rui, ZHOU Qiang, et al. Lianxia Xiaopi Granules for Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-Blind and Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2026, 32(8): 675-684.
YANG Yang, LIU Rui, ZHOU Qiang, 等. 连夏消痞颗粒治疗功能性消化不良：一项多中心、随机、双盲、安慰剂对照试验[J]. 中国结合医学杂志（英文版）, 2026,32(8):675-684. DOI： 10.1007/s11655-026-3850-4.

YANG Yang, LIU Rui, ZHOU Qiang, et al. Lianxia Xiaopi Granules for Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-Blind and Placebo-Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2026, 32(8): 675-684. DOI： 10.1007/s11655-026-3850-4.

摘要

目的：

评估连夏消痞颗粒治疗功能性消化不良（FD）寒热错杂证的有效性与安全性。

方法：

于2021年4月1日至2022年10月24日期间，在中国11个研究中心开展了一项多中心、随机、双盲、安慰剂对照试验。采用分层区组随机法，按2:1比例将确诊为FD的患者随机分配至连夏消痞颗粒组或安慰剂组，分别接受连夏消痞颗粒（每袋3.5 g，相当于生药8.337 g）或安慰剂（每袋3.5 g）治疗，每日3次，共治疗8周。主要结局指标为消化不良症状应答率。次要结局指标包括单项消化不良症状应答率、中医证候疗效评价量表（包括中医证候总积分减分率、临床痊愈率及显效率），并进行安全性分析。同时根据餐后不适综合征（PDS）或上腹痛综合征（EPS）亚型及幽门螺杆菌（Hp）感染状况进行亚组分析。

结果：

共240例受试者完成试验，其中连夏消痞颗粒组160例，安慰剂组80例。第8周时，连夏消痞颗粒组患者消化不良症状应答率明显高于安慰剂组[54.38% (87/160) vs. 32.50% (26/80)，

=0.0013

]

。与安慰剂组比较，连夏消痞颗粒可明显改善餐后饱胀不适、早饱及腹胀症状（

0.05）。亚组分析显示，连夏消痞颗粒对PDS亚型及Hp阴性患者疗效更佳（

0.05）。安全性分析显示，两组不良事件发生率未见明显差异。

结论：

连夏消痞颗粒可以有效改善FD症状，尤其对PDS及Hp阴性患者效果更佳，为其在中医治疗中的应用提供了支持。（试验注册号：ChiCTR2100041993）

Abstract

Objective:

To evaluate the efficacy and safety of Lianxia Xiaopi Granules (LXXP) in treating functional dyspepsia (FD) with combined cold and heat pattern in Chinese medicine (CM).

Methods:

A multicenter

randomized

double-blind

and placebo-controlled trial was conducted at 11 centers between April 1

2021

and October 24

2022 in China. Using stratified block randomization at a 2:1 ratio

patients diagnosed with FD were randomly assigned to receive either LXXP (3.5 g/bag

equivalent to 8.337 g of raw herbs) or a placebo (3.5 g/bag) 3 times daily for 8 weeks. The primary outcome was dyspepsia symptom response rate. Secondary outcomes included individual dyspepsia symptom response rate

Chinese medicine syndrome efficacy evaluation scale including reduction rate of CM symptom total score

cure and effective rates

and safety analysis. Subgroup analyses were performed according to postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS) subtypes and

Helicobacter pylori

(Hp) infection status.

Results:

A total of 240 participants completed the trial

160 in the LXXP group and 80 in the placebo group. At week 8

the dyspepsia symptom response rate was significantly higher in the LXXP group than in the placebo group [54.38% (87/160)

. 32.50% (26/80)

=0.0013

]

. LXXP significantly improved postprandial fullness

early satiety

and bloating compared with the placebo group (

0.05). Subgroup analysis showed greater efficacy in PDS and Hp-negative patients (

0.05). Safety analysis revealed no significant differences in adverse events between the 2 groups.

Conclusion:

LXXP effectively improves FD symptoms

particularly in PDS and Hp-negative patients

supporting its application in CM-based treatment. (Trial registration No. ChiCTR2100041993)

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