[Efficacy and safety of compound azintamide on dyspepsia symptoms in a multicentre self-controlled trial].
OBJECTIVE
To investigate the efficacy and safety of compound azintamide on dyspepsia symptoms.


METHODS
One hundred and eighty dyspepsia patients were divided into two groups according to dyspepsia symptom related with gastrointestinal disease (group A) or biliary system disease (group B), whose dyspepsia symptom were not improved by the Domperidone 10 mg tid for 2 weeks. Two tablets of compound azintamide were administered orally following a meal, tid for 2 weeks. The changes of symptoms score of upper abdominal distention, upper abdominal pain or discomfort anorexia and effective rate as well as adverse events were recorded.


RESULTS
Compound azintamide greatly improved the symptoms of upper abdominal distention, upper abdominal pain or discomfort and anorexia. All symptoms scores were significantly decreased after 2 weeks of compound azintamide (P < 0.01). The effective rate of each symptom and total symptoms score were more than 84.9% and 92.5%. One patient reported mild rash at the fourteenth days, which disappeared 3 days later.


CONCLUSIONS
Compound azintamide showed effective and safety in treatment of patient with dyspepsia symptoms when Domperidone therapy is not satisfactory.
Zhu
Li-ming
LM
Department of Gastroenterology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.
Qian
Jia-ming
JM
Xu
Le
L
Zhao
Hong-chuan
HC
Yang
Yun-sheng
YS
Zhang
Mei
M
Liu
Yu-lan
YL
Xie
Peng-yan
PY
Hao
Jian-yu
JY
Han
Shao-mei
SM
D000328:Adult; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011724:Pyridazines / Q000627:therapeutic use*
D005765:Gastrointestinal Agents; D011724:Pyridazines; C011673:azintamid