摘要
【摘要】目的了解L-谷氨酰胺呱仑酸钠颗粒(商品名:麦滋林)辅助治疗儿童消化性溃疡病的疗效以及麦滋林在儿童使用中的安全性。方法选择2011年9月至2013年2月重庆、贵阳、广州、成都和新疆5所三级甲等医院住院和门诊就诊的消化性溃疡患儿138例,按随机化、单盲法将试验对象分为试验组与对照组,试验组75例,对照组63例。试验组采用麦滋林联合奥美拉唑治疗方案,对照组采用奥美拉唑治疗方案,若伴幽门螺杆菌(Hp)感染则进行相应抗感染治疗,8周后随访临床表现、胃镜检查及实验室结果。结果试验组临床表现缓解率分别为腹痛91.8%(56/61例)、呕吐90.2%(37/41例)、黑便92.9%(26/28例)、恶心93.1%(27/29例)、呕血89.5%(17/19例)、腹部不适100.0%(19/19例)、腹胀100.0%(11/11例)、反酸100.0%(9/9例)、口臭90.0%(9/10例)、嗳气88.9%(8/9例)、血便100.O%(4/4例)、纳差50.0%(1/2例)、腹部压痛89.3%(50/56例);对照组临床表现缓解率分别为腹痛90.4%(47/52例)、呕吐89.7%(26/29例)、黑便96.4%(27/28例)、恶心87.5%(21/24例)、呕血92.9%(13/14例)、腹部不适58.3%(7/12例)、腹胀85.7%(12/14例)、反酸100.0%(13/13例)、口臭80.0%(8/10例)、嗳气100.0%(8/8例)、血便100.0%(4/4例)、纳差33.3%(1/3例)、腹部压痛90.0%(45/50例)。试验组与对照组相比,腹部不适、腹胀、口臭、嗳气、纳差差异有统计学意义(P〈0.05)。共131例患儿随访胃镜,对照组溃疡清除率为65.1%(41/63例),胃镜下黏膜表现缓解率分别为水肿54.8%(34/62例)、充血51.7%(31/60例)、红晕76.0%(19/25例)、萎缩0%(0/1例)、出血85.7%(12/14例),Hp清除率为67.9%(19/28例);试验组溃疡清除率为66.2%(45/68例),胃镜下黏膜表现缓解率分别为水肿63.0%(46/73例)、充血64.7%(44/68例)、红晕86.1%(31/36例)、萎缩50.0%(1/2例)、出血100.0%(19/19例),Hp清除率为72.7%(24/33例)。试验组与对照组相比,萎缩、出血缓解率差异有统计学意义(X2=66.67、15.05,P均〈0.05)。试验组和对照组临床有效率分别为98.7%(74/75例)、98.4%(62/63例),试验组和对照组胃镜有效率分别为98.5%(67/68例)、96.8%(61/63例)。试验组患儿服用麦滋林8周内及停药后4周随访无不良反应。结论麦滋林对于减轻儿童消化性溃疡病的临床表现及改善胃镜表现有一定疗效,对辅助治疗儿童消化性溃疡病有重要作用,且在儿童中使用具有较好的安全性。
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 re- mission 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 ), ab- dominal 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 manifesta- tions 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 andthirty-one cases reviewed gastroscopy, in the control group their ulcer clearance rate was 65.1% (41/63 cases) ;the re- mission rates of gastroscopic manifestations were edema 54. 8 % (34/62 cases), hyperemia 51.7 % (31/60 cases), areo- la 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), are- ola 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 dispari- ty between the control group and the trial group. The clinical effective rates ef 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.
出处
《中华实用儿科临床杂志》
CAS
CSCD
北大核心
2014年第7期493-497,共5页
Chinese Journal of Applied Clinical Pediatrics