Original Article
The efficacy and safety of morinidazole combined with appendectomy in treating purulent or gangrenous appendicitis: a randomized, controlled, double-blind, multi-center clinical trial
Yun Tang, Mingqing Tong, Hao Yu, Yanping Luo, Mingzhang Li, Yongkuan Cao, Mingfang Qin, Lie Wang, Xiaoqiang Wang, Bo Peng, Yong Yang, Shuguang Han, Chungen Xing, Bing Cai, Jianming Huang, Jiazeng Xia, Bainan Lyu, Liang Xu, Jilin Yi, Dechun Li, Guoqing Liao, Xiaofeng Zhen, Daogui Yang, Zhongcheng Huang, Haibo Wang
Published 2017-08-25
Cite as Chin J Gen Surg, 2017, 32(8): 678-682. DOI: 10.3760/cma.j.issn.1007-631X.2017.08.013
Abstract
ObjectiveTo assess the efficacy and safety of morinidazole combined with appendectomy in treating purulent or gangrenous appendicitis.
MethodsDouble-blind randomized controlled multicenter clinical trial was designed and conducted. Totally 437 patients were included, 219 in the control group and 218 in the experimental group. Cases of purulent or gangrenous appendicitis were enrolled and assigned to each of the two groups. The control group received ornidazole injection for 5 to 7 days while the experimental group received morinidazole injection. Both groups underwent appendectomy. Clinical response, micrombiological outcomes, overall response were evaluated. Adverse events and side effects were recorded.
ResultsNo significant difference was observed between the two groups regarding the clinical healing rate at 5-10 days after medicine withdrawal, anaerobia clearance and overall healing rates. Adverse events occurred in 140 patients (32.1%). Incidence of adverse events in the control group and the experimental group was 34.7% and 29.4%, respectively (P>0.05). The overall incidence of side effects was 15.1% (66 cases). Side effects were less seen in the experimental group compared with that in the control group (11.5% vs. 18.7%, P<0.05). The most frequent side effects were aminotransferase rising, thrombocytosis, nausea, vomiting and electrocardiographic abnormality.
ConclusionsThe effect of morinidazole plus operation was comparable with ornidazole in treating purulent or gangrenous appendicitis. The safety of morinidazole is better than ornidazole.
Key words:
Appendicitis; Ornidazole; Morinidazole
Contributor Information
Yun Tang
Department of General Surgery, General Hospital of the People′s Liberation Army, Beijing 100853, China
Mingqing Tong
Hao Yu
Yanping Luo
Mingzhang Li
Yongkuan Cao
Mingfang Qin
Lie Wang
Xiaoqiang Wang
Bo Peng
Yong Yang
Shuguang Han
Chungen Xing
Bing Cai
Jianming Huang
Jiazeng Xia
Bainan Lyu
Liang Xu
Jilin Yi
Dechun Li
Guoqing Liao
Xiaofeng Zhen
Daogui Yang
Zhongcheng Huang
Haibo Wang