| Background and ObjectiveFunctional constipation ( FC) refers to non-systemic disease or primaryintestinal diseases caused persistent constipation, also known as simpleconstipation, or habitual constipation.According to the RomeⅢcriteria for theclassification of functional constipation and functional fecal retention difficult todistinguish, so they collectively referred to as functional constipation.Constipation is a common pediatric gastrointestinal symptoms, domestic andinternational clinical studies have shown that about 95% children withconstipation are functional constipation (FC). In the latest children withfunctional gastrointestinal disorders Rome III criteria in 2006, it showed theincidence of FC in children was 0.3% - 8%, accounting for about 25% ofpediatric outpatient digestion. It about have 1.3 billion population by statistics inchina, about 3 million are children, of which around 20 million children sufferfrom functional constipation. In recent years, with the accelerated pace of lifehighly competitive approach to learning and learning pressure , the incidence of FC children is much higher than adults .Functional constipation has huge harm tochildren growth and development of the individual.It will sustained for a longtime without the system in the treatment, and about 25% - 30% or more willcontinue to adult.Not only directly affects the quality of life of children withphysical , mental health and psychosocial development, but also caused greatsuffering to the children. At last it will give a huge burden in psychological onchildren and their parents. Therefore, it is important to explore the safe andeffective treatment.Polyethylene glycol 4000 ( forlax)is safe and reliable.It has a rare adversereactions,and it hae be widely used in adults. It only has a small number offoreign report about security on Forlax for children ,and it only has over 8 yearsold children,s security reports in domestic .we carried out a preliminary studyto investigate the therapeutic effectiveness and safety of forlax in the treatment ofconstipation in children 4-14years old by positive drug-control study.We Used ofX-ray opaque marker measure colonic transit index (TI),and we used TI todecided the type of functional constipation . we also observed the changes ofthe function of colonic transit before and after treatment. In this experiment, ouraim is to to give experimental basis to pediatric clinicians in the selection and useof drugs in treating functional constipation .Methodswe using Rome III diagnostic criteria collect out patient and hospitalizationin children with functional constipation. A total of 81 children with functionalconstipation were enrolled in this study. The 81 patients were randomized toreceive either oral forlax (n = 40) or lactulose (n = 41) for 2 weeks. Forlax grouphave 40 patients (male 18 cases, female 22 cases),and lactulose group of 41patients (male 20 cases, female 21).Forlax Group:Those 8-14 years old children taking Forlax powder 20g, and 4-7 years old chidren taking Forlax 10g. Theywould take a dose of Forlax 14 days in the morning .They can dissolve Forlax ina glass of water or drink; lactulose Group: Those 8-14 years old children takingstarting dose lactulose, every time 15 mL, 1 times / d.Three days later they wouldchanged to a maintenance dose, each 10 mL ,1 times / d ,and even served 14 d.Those 4-7 years old children,s starting dose are every 10 mL, 1 times / d . Threedays later they also changed to take a maintenance dose after breakfast, each 7.5mL, 1 times / d , and even served 14 d. We observed two groups of childrenbefore and after treatment by colon transit test checks for decided the type offunctional constipation, and compare differences before and after treatment.Observation of the main outcome measures (the median and the quartile numberof bowel movements per week, the main weekly stool B ristol type of median andquartile and stool normal rate ),Secondary outcome measures (clinical completeremission rate, abdominal pain situation) and the safety of forlax and lactulosewere evaluated at 1 and 2 weeks of treatment .Results①Colonic transit test: After two weeks of treatment, 16 cases of Forlax groupinclude Slow transit constipation (STC) sub-group(n=7)andoutletobstruction constipation (OOC )sub-group(n=9) review colonic transitexperiment,they all returned to normal; In lactulose group, 18 patients (STCn=10, OOC n=8) review colonic transit experiment, they also returned tonormal. Those children who review colonic transit experiment not returned tonormal continue the original treatment of two weeks, of which 7 cases (Forlaxgroup 3 cases, 4 cases of lactulose group) in children reviewed colonic transittest, return to normal. ②Forlax lactulose group medication group and 1,2 weeks after the firstdefecation frequency per week increased by 4 times, 5 times (median), and 3times, 4 times (median), the difference was statistically significant.③The stool consistency of the two groups returned to normal were 87.5% and63.4%, there is significant difference between the two groups;④The clinical complete remission rate of constipation in the forlax and lactulosegroups was 72.5% and 43.9%respectively ( P < 0. 05) by 2 week of treatment.Abdominal pain disappeared in 60.9% of patients in the forlax group but inonly 54.5% in the lactulose group by week 2 of treatment, the difference wasnot statistically significant.⑤No serious adverse events happened and no abnormalities were found inlaboratory tests and physical examinations in the two groups after medication.ConclusionForlax is safe and effective in the treatment of constipation in children 4-14years old, and forlax better than lactulose;A small number of children withpoor efficacy after 2 weeks of treatment can increase the treatment to 4weeks;Forlax can effectively improve the colon transfer functions of childrenwith functional constipation . |
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