Study on Marzulene combined with Omeprazole for treating peptic ulcer disease and the safety of Marzulene in children / 中华实用儿科临床杂志

ABSTRACT

Objective To assess the effect of Marzulene as an adjuvant therapy for peptic ulcer disease in children and the safety of Marzulene.Methods From Dec.2011 to Feb.2013,138 cases of peptic ulcer disease in children from Chongqing,Guiyang,Guangzhou,Chengdu and Xinjiang were randomly divided into trial group (n =75) and control group (n =63).The treatment protocls of the trial group was Marzulene combined with Omeprazole,and the control group gave Omeprazole only,all the cases with Helicobacter pylori (Hp) infection were treated by antibiotics,then clinical manifestations,gastroscopy and laboratory examinations were followed up after 8 weeks.Results The remission rates of clinical manifestations in the trial group were abdominal pain 91.8％ (56/61 cases),vomiting 90.2％(37/41 cases),melena 92.9％ (26/28 cases),nausea 93.1％ (27/29 cases),hematemesis 89.5％ (17/19 cases),abdominal discomfort 100.0％ (19/19 cases),abdominal distension 100.0％ (11/11 cases),sour regurgitation 100.0％ (9/9 cases),ozostomia 90.0％ (9/10 cases),eructaion 88.9 ％ (8/9 cases),bloody stools 100.0％ (4/4 cases),poor appetite 50.0％ (1/2 case),and abdominal tenderness 89.3 ％ (50/56 cases) ;the remission rates of clinical manifestations in the control group were abdominal pain 90.4％ (47/52 cases),vomiting 89.7％ (26/29 cases),melena 96.4％(27/28 cases),nausea 87.5 ％ (21/24 cases),hematemesis 92.9 ％ (13/14 cases),abdominal discomfort 58.3 ％ (7/12 cases),abdominal distension 85.7％ (12/14 cases),sour regurgitation 100.0％ (13/13 cases),ozostomia 80.0％(8/10 cases),eructaion 100.0％ (8/8 cases),bloody stools 100.0％ (4/4 cases),poor appetite 33.3％ (1/3 case),and abdominal tenderness 90.0％ (45/50 cases).Abdominal discomfort,abdominal distension,ozostomia,eructaion and poor appetite had significant statistical disparity between control group and trial group (P ＜ 0.05).One hundred and thirty-one cases reviewed gastroscopy,in the control group their ulcer clearance rate was 65.1％ (41/63 cases) ;the remission rates of gastroscopic manifestations were edema 54.8％ (34/62 cases),hyperemia 51.7％ (31/60 cases),areola 76.0％ (19/25 cases),atrophy 0％ (0/1 case),and hemorrhage 85.7％ (12/14 cases),the Hp clearance rate in the control group was 67.9％ (19/28 cases).In the trial group the ulcer clearance rate was 66.2％ (45/68 cases),and the remission rates of gastroscopic manifestation were edema 63.0％ (46/73 cases),hyperemia 64.7 ％ (44/68 cases),areola 86.1％ (31/36 cases),atrophy 50.0％ (1/2 case),and hemorrhage 100.0％ (19/19 cases) ;the Hp clearance rate in the trial group was 72.7％ (24/33 cases),and the remission rates of atrophy and hemorrhage had significant disparity between the control group and the trial group.The clinical effective rates of the trial and the control groups were 98.7％ (74/75 cases) and 98.4％ (62/63 cases),and the gastoscopic detection rates were 98.5％ (67/68 cases) and 96.8％ (61/63 cases).There was no adverse reaction in the trial group due to using marzulene for 8 weeks and 4 weeks' follow-up after its withdrawal.Conclusions Marzulene is helpful for improving the clinical and gastroscopic manifestations of peptic ulcer disease in children,and is effective and safe as an adjuvant therapy in children.