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Resumen El uso de los antiespasmódicos forma parte de la piedra angular del tratamiento en el síndrome de intestino irritable (SII), independientemente del subtipo. Consideramos relevante hacer una revisión de los medicamentos antiespasmódicos disponibles actualmente en Colombia, los cuales son usados crónicamente, de manera frecuente, en esta enfermedad.
Abstract Although antispasmodics are the cornerstone of treating irritable bowel syndrome, there are a number of antispasmodic medications currently available in Colombia. Since they are frequently used to treat this disease, we consider an evaluation of them to be important.
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Humans , Role , Therapeutics , Pharmaceutical Preparations , Irritable Bowel Syndrome , ParasympatholyticsABSTRACT
BACKGROUND/AIMS: Functional dyspepsia (FD) and irritable bowel syndrome (IBS) are common gastrointestinal (GI) disorders and these patients frequently overlap. Trimebutine has been known to be effective in controlling FD co-existing diarrhea-dominant IBS, however its effect on overlap syndrome (OS) patients has not been reported. Therefore, we investigated the effect of trimebutine on the model of OS in guinea pigs. METHODS: Male guinea pigs were used to evaluate the effects of trimebutine in corticotropin-releasing factor (CRF) induced OS model. Different doses (3, 10, and 30 mg/kg) of trimebutine were administered orally and incubated for 1 hour. The next treatment of 10 μg/kg of CRF was intraperitoneally injected and stabilized for 30 minutes. Subsequently, intragastric 3 mL charcoal mix was administered, incubated for 10 minutes and the upper GI transit analyzed. Colonic transits were assessed after the same order and concentrations of trimebutine and CRF treatment by fecal pellet output assay. RESULTS: Different concentrations (1, 3, and 10 μg/kg) of rat/human CRF peptides was tested to establish the OS model in guinea pigs. CRF 10 μg/kg was the most effective dose in the experimental OS model of guinea pigs. Trimebutine (3, 10, and 30 mg/kg) treatment significantly reversed the upper and lower GI transit of CRF induced OS model. Trimebutine significantly increased upper GI transit while it reduced fecal pellet output in the CRF induced OS model. CONCLUSIONS: Trimebutine has been demonstrated to be effective on both upper and lower GI motor function in peripheral CRF induced OS model. Therefore, trimebutine might be an effective drug for the treatment of OS between FD and IBS patients.
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Animals , Humans , Male , Charcoal , Colon , Corticotropin-Releasing Hormone , Dyspepsia , Guinea Pigs , Guinea , Irritable Bowel Syndrome , Peptides , TrimebutineABSTRACT
Objective To investigate the curative effect of mesalamine combined with trimebutine maleate in the treatment of diarrhea predominant irritable bowel syndrome .Methods According to the digital table ,112 patients with diarrhea predominant irritable bowel syndrome were randomly divided into control group and observation group , 56 cases in each group .The two groups were given conventional symptomatic treatment ,on this basis ,the control group recieved mesalamine treatment ,the observation group recieved mesalamine combined with trimebutine maleate treat -ment.The two groups were treated for 4 consecutive weeks.The main indicators,clinical efficacy and adverse reaction of the two groups were compared .Results The total effective rate of the observation group was 94.6％,which was significatnly higher than 78.6％of the control group (χ2 =3.925,P<0.05).The antidiarrheal time,stool recovery time between the two groups had statistically significant differences (t=19.337,18.068,all P<0.05).The mental status,emotional status,diet and sleep status in the two groups were all improved ,the differences were statistically significant(all P<0.05),which in the observation group improved more significantly than that in the control group , the differences were statistically significant(all P<0.05).The two groups had no other serious adverse reactions . Conclusion On the basis of conventional treatment ,mesalamine combined with trimebutine maleate in the treatment of diarrhea predominant irritable bowel syndrome can significantly improve clinical symptoms ,improve clinical curative effect,and it has good safety and great clinical significance .
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Introducción: la pseudobstrucción aguda de colon se caracteriza por dilatación marcada en ausencia de obstrucción mecánica, siendo poco frecuente en niños. Se señala un desequilibrio del sistema nervioso autonómico desencadenado por fármacos, isquemia intestinal, inflamación sistémica o local del peritoneo entre otras. Caso clínico : escolar masculino de 8 años, con dolor abdominal de fuerte intensidad, tipo cólico, asociado fiebre, y quinto día sin evacuar. Anteceden te de Rabdomiosarcoma Embrionario Testicular, quimioterapia reciente con Vincristina, Ifosfamida, Dacinomicina y Adriamicina. Examen físico: facies dolorosa, aftas en mucosa oral y queilitis. Taquicardia 120xmin. Abdomen: timpanico, defensa voluntaria en fosa iliaca derecha e hipogastrio, masa no móvil en la zona, ruidos hidroaéreos escasos. Eritema y exudado. Bolsa escrotal derecha vacía. Neurológico sin focalización. Laboratorio: anemia, leucocitosis con neutrofilia, cultivos negativos (sangre - orina - heces ). Radiografía de abdomen: aumento del contenido neúmico desde cámara gástrica a colon, patrón fecal aumentado en colon derecho y distensión. Tomografía de abdomen con contraste oral: No progresión del contraste desde íleon terminal hacia ciego después de 9 horas, distensión de colon con aire a predominio derecho con aumento del contenido fecal, líquido en recto. Diagnóstico clínico: Pseudobstrucción colónica aguda. Se indica desimpactación oral con Colayte ® y Trimebutina. Terapia del dolor: dipirona, tramadol y gabapentina. Buena evolución a las 72 horas. Discusión: la dilatación del colon en niños con estreñimiento después de la quimioterapia es altamente sugestiva de la pseudobstrucción y los estudios por imágenes son importantes para el diagnóstico en pacientes pediátricos.
Introduction: pseudo - obstruction of the colon is characterized by marked dilatation in the absence of mechanical obstruction, being uncommon in children. It indicates an imbalance of the autonomic nervous system triggered by drugs, intestinal ischemia, systemic or local inflammation of th e peritoneum among others. Clinical case : male schoolboy of 8 years old, with abdominal pain of strong intensity, colic type, associated with fever, and fifth day without evacuation. Background of Testicular Embryonal Rhabdomyosarcoma, recent chemotherapy with Vincristine, Ifosfamide, Dacinomycin and Adriamycin. Physical examination: painful facies, oral mucosa ulcers and cheilitis. Tachycardia 120xmin. Abdomen: tympanic, voluntary defense in the right iliac fossa and hypogastrium, non - mobile mass in the ar ea, scarce hydroaéreo noises. Erythema and exudate. Right scrotal pouch empty. Neurological without targeting. Laboratory: anemia, leukocytosis with neutrophilia, negative cultures (blood - urine - feces). Abdominal x - ray: increased neural content from gastric chamber to colon, fecal pattern increased in right colon and distention. Tumor tomography with oral contrast: No progression of contrast from terminal ileum to cecum after 9 hours, distension of the colon with air to right predominance with increased feca l content, fluid in the rectum. Clinical diagnosis: Acute colonic pseudobstruction. Oral detoxification is indicated with Colayte ® and Trimebutina. Pain therapy: dipyrone, tramadol and gabapentin. Good evolution at 72 hours. Discussion: Colon dilatation i n children with constipation after chemotherapy is highly suggestive of pseudobstruction and imaging studies are important for the diagnosis in pediatric patients.
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Background: Mast cell activation is a characteristic of irritable bowel syndrome (IBS).Study on mast cell and the related inflammatory mediators in colonic mucosa is helpful for the evaluation and treatment of IBS.Aims: To assess the effect of mesalazine combined with trimebutine on colonic mucosal mast cell and related inflammatory mediators in patients with IBS.Methods: Forty patients with diarrhea-predominant IBS (IBS-D) and 40 patients with constipation-predominant IBS (IBS-C) from Oct.2014 to June 2016 at Shanghai Jiading District Central Hospital were enrolled, 20 healthy volunteers were served as controls.Forty patients with IBS-D and 40 patients with IBS-C were randomly divided into mesalazine+trimebutine group and trimebutine group, the treatment courses were all 4 weeks.Number of mast cell was counted by modified toluidine blue staining.Score of related inflammatory mediators were evaluated by immunohistochemistry.Clinical efficacy was assessed.Results: Compared with healthy controls, number of mast cell at baseline was significantly increased both in IBS-D and IBS-C patients (P<0.05).After treatment with mesalazine+trimebutine, number of mast cell was significantly decreased (P<0.05).At baseline, immunohistochemical staining score of 5-HT, IL-1, TNF-α, histamine, tryptase were significantly increased in IBS patients than in healthy controls (P<0.000 1).After treatment with mesalazine+trimebutine, above-mentioned inflammatory mediators were significantly decreased (P<0.05).In IBS-D patients, the total efficacy rate in mesalazine+trimebutine group was significantly increased than that in trimebutine group (85.0% vs.45.0%, P=0.008).In IBS-C patients, no significant difference in total efficacy rate was found between mesalazine+trimebutine group and trimebutine group (55.0% vs.25.0%, P=0.053).Conclusions: Mesalazine combined with trimebutine is an effective and safe approach to reduce mast cell infiltration and release of related inflammatory mediators, and is more efficient for patients with IBS-D.
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Objective To study the effect of Trimebutine maleate tablets on serum tumor necrosis factor(TNF)-α,interleukin(IL)-23,erythrocyte sedimentation rate(ESR),D-dimer(D-D)ulcerative colitis in patients with ulcerative colitis.Methods 92 patients of ulcerative colitis who received therapy from October 2014 to October 2016 in our hospital were selected.According to random number table,those patients were divided into the observation group(n=46)and the control group(n=46).The control group was treated with mesalazine slow release tablets,while the observation group was treated with trimebutine maleate tablets on this basis.After 8 weeks of treatment,the changes of the disease activity index(Sutherland DAI score),TNF-α,IL-23,ESR,D-D and clinical effect were compared.Results After treatment,the Sutherland DAI score in the observation group was significantly lower than that of the control group DAI(P<0.05); the TNF-αand IL-23 in the observation group were significantly lower than that of the control group(all P<0.05); the ESR and D-D in the observation group were significantly lower than that of the control group(all P<0.05); the total effective rate in the observation group was significantly higher than that of the control group[93.48％(43/46)vs.69.57％(32/46)](P<0.05).Conclusion Trimebutine maleate tablets is well for ulcerative colitis,which can effectively reduce inflammation,improve hypercoagulable state,promote the recovery of the disease,it is worthy of application and promotion.
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Objective To study the clinical efficacy of live combined bacillus subtilis and enterococcus faecium enteric-coated capsules combined with trimebutine maleate and psychological intervention in the treatment of functional diarrhea. Methods 100 patients with functional diarrhea treated in our hospital from May 2015 to August 2016 were selected and randomly divided into the control group and the experimental group, with 50 patients in each group. The control group were treated with trimebutine maleate treatment, the experimental group were treated with live combined bacillus subtilis and enterococcus faecium enteric-coated capsules trimebutine therapy and psychological intervention, pay attention to the psychological status of patients and patients, strengthen communication and exchanges, increase confidence in the treatment and the treatment compliance of patients. The therapeutic effects of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, the effective rate was 92.0％ in the experimental group and 84.0％ in the control group. The difference was statistically significant (P<0.05). There was no obvious adverse reaction in the experimental group and the control group. After treatment, the number of diarrhea in the experimental group was (3.0±0.3), significantly less than that of the control group (4.3±0.3), the difference was statistically significant (P<0.05). Conclusion The clinical effect of live combined bacillus subtilis and enterococcus faecium enteric-coated capsules combined with trimebutine maleate and psychological intervention in the treatment of functional diarrhea is good, can improve clinical symptoms in a large extent, has the meaning of promotion.
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Objective To explore the clinical effect of flupentixol and melitracen(deanxit)combined with trimebutine maleate(TMB)in the treatment of patients with functional gastrointestinal disorders(FGID).Methods 135 patients with FGID were selected,and were divided into two groups accorded to the random number method,with 68 cases in the observation group and 67 cases in the control group.The control group was treated with oryzanol and vitamin B6 ,while the observation group was treated with deanxit combine with TMB on the basis of the control group. Main symptoms of postprandial discomfort,early satiety,abdominal pain and burning sensation on the abdomen in the two groups before and after treatment were monitored,adverse reactions of two groups were recorded,and the total efficacy was evaluated after the end of treatment.Results The difference of postprandial discomfort,early satiety, abdominal pain and upper abdominal burning sensation integration between the two groups had no statistically significant before treatment(all P >0.05).After treatment,the postprandial discomfort,early satiety,the abdominal pain and epigastric burning sensation were (4.1 ±1.6)points,(3.4 ±1.1)points,(4.2 ±1.2)points and(4.4 ± 0.7)points in the observation group,which were better than (5.9 ±2.4)points,(5.3 ±1.6 )points,(6.0 ± 1.2)points and(6.1 ±0.5)points in the control group(t =3.057,4.791,5.196,9.681,all P 0.05).Conclusion Deanxit combine with TMB can significantly improve symptoms in patients with FGID,and has a significant effect,thus it is a safe and effective therapy.
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Objective To investigate the effect of Trimebutine maleate on reflux esophagitis in elderly patients.Methods A total of 160 elderly patients with typical esophageal reflux symptoms diagnosed as reflux esophagitis by gastroscope,with concomitant gastroesophageal disease confirmed by esophageal motility manometry and 24 h esophageal pH impedance monitoring acid reflux,were selected and retrospectively analyzed.All patients were treated with proton pump inhibitor(PPI) esomeprazole 20 mg tid,antecibum(AC)for 8 weeks,and randomly divided into four groups:group A (itopride hydrochloride 50 mg tid,AC),group B(citrate mosapride 5 mg tid,AC),group C (trimebutine maleate 200 mg tid,AC),group D(treated without prokinetic drugs).After 4 and 8 weeks of therapy,the symptom improvements were observed in the four groups.Endoscopy,esophageal motility manometry,24h esophageal pH impedance monitoring were performed in the 160 cases after 8 weeks of treatment.Results The total effective rate was 97.5％(39 cases),95.0％ (38 cases),92.5％(37 cases)and 77.5％(31 cases)in group A,B,C and D respectively after 8 weeks of treatment.Endoscopic examination showed that the cure rate was 70.0％ (28 cases),62.5％ (25cases),72.5％(29 cases),67.5％(27 cases),and the effective rate was 87.5％,(35 cases),92.5％(37 cases),87.5％(35 cases)and 87.5％(35 cases)in group A,B,C and D respectively after 8 weeks of treatment,without statistically significant differences in the cure rate and effective rate between the four groups.The results of esophageal motility manometry showed that the lower esophageal sphincter pressure(LESP),lower esophageal sphincter relaxation (LESR),lower esophageal peristaltic wave pressure(LEPP) and percentage of abnormal esophageal body contraction had significant difference before versus after treatment in group A and B,but not in control group.The improvements in the percentage of total time of pH＜4.0,the percentage of time of pH＜4 at standing position,the percentage of time of pH＜4 at supine position,supine reflux times,the times of supine reflux＞5 min,the longest reflux time(min)at supine position were more significant in group A,B and C than in group D.Compared with pre-treatment,the times of non-acid reflux were reduced significantly in group A,B and D(all P＜0.01),and there was a significant difference(P＜0.05)between the three (A,B,C)groups and group D(P＜0.05).There were significant differences in the times of reflux liquid and gas reflux between the group A,B and D(P＜0.05).The proximal reflux times were improved more significantly in group A,B and C after treatment than in control group(P＜0.05).Conclusions Prokinetic drugs combined with PPI therapy has better effect than single PPI application in improving the clinical symptoms and upper gastrointestinal motility in elderly patients with RE.Trimebutine maleate is safe and effective in the elderly,and has a similar effect on esophageal motility with mosapride citrate and itopride hydrochloride,which may be involved in selectively improving esophageal motility,lower esophageal sphincter pressure and gastric emptying function.
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Objective To discuss the efficacy and pharmacological mechanism of Simo decoction to assist the treatment of postoperative gastrointestinal dysfunction. Methods 200 mice (100 male and 100 female) were randomly divided into four groups (n=50). The mice of blank group were feed as normal,and the mice in the other three groups were prepared for colon postoperative gastrointestinal dysfunction model. Then,trimebutine maleate group were given trimebutine maleate while the combined group were given trimebutine maleate and simo decoction through gavage,and model group and blank group were given the same doses of distilled water. One week later,the abdominal ve-nous blood of mice was extracted and serum levels of acetylcholine ( ACH) and norepinephrine ( NE) were detected using ELISA kit. At the samd time,the gastric emptying and intestinal propulsion experiment was carried on. Results After modeling,compared with blank group, MUPA of the rest three groups were significantly decreased (P0. 05). After drug intervention,MUPA of trimebutine maleate group was significantly higher than that of model group,and MUPA of combined group was significantly higher than that of trimebutine maleate group (P<0. 05). In addition,compared with blank group,the gas-tric emptying rate,intestinal propulsion rate,serum ACH concentration and NE concentration of the rest three groups were significantly lower (P<0. 05). Compared with model group,each index of both trimebutine maleate group and combined group was increased,and combined group increased higher (P<0. 05). Conclusion Simo decoction combined trimebutine maleate has high effect to improve the level of ACH and NE of postoperative gastrointestinal dysfunction mice,which benefit to promote gastrointestinal peristalsis and may be one of its pharmaco-logical mechanisms.
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Objective To observe the clinical efficacy of sishen pills plus trimebutine maleic acid tablets and bifid triple viable bacteria on treating ulcerative colitis.Methods 100 cases were randomly divided into two groups,with 50 cases for each group,the treatment group was given sishen pills plus trimebutine maleic tablets and bifid triple viable bacteria,the control group was treated with sishen pills.The clinical effect of the two groups were observed.Results The efficiency of the treatment group was 80%,which of the control group was 36%,there was statistically significant difference between the two groups (χ2 =8.16,P <0.05).Conclusion The efficacy of sishen pills plus trimebutine maleic tablets and bifid triple viable bacteria was better than that of sishen pills only.
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OBJECTIVE: According to the feature that trimebutine maleate has poor aqueous solubility, low bioavailability when taken orally, short biological half-life (2.7 h), sustained-release dropping pills were prepared to achieve release slowly, reduce the blood drug concentration fluctuations and decrease frequency of use.
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Objective To evaluate the efficacy and safety of trimebutine combined with mosapride on functional dyspepsia. Methods Patients with functional dyspepsia were randomly divided into three clinical groups. Group A (n=116) received 0.2 g trimebutine after meal,group the drug combination B (n=116) received 5 mg mosapride before meal,and the drug combination group (n=115) received 0. 2 g trimebutine after meal plus 5 mg mosapride before meal. All medications were taken orally three times daily for 4 weeks. Improvement in clinical symptoms and adverse reactions in each group were evaluated at the end of study. Results A total of 339 patients among 347 enrollees completed the treatment and follow-up. The clinical efficacy on postprandial fullness, early satiation, epigastric pain, epigastric burning, upper abdominal bloating and nausea were 88. 4%,76. 9%,72. 9%,61. 8%,86. 7% and 81. 7%,respectively in the drug combination group after 4-week treatment,which were superior to those in group A or B (P<0. 05) except for epigastric burning. The total effective rate of the drug combination group was 78. 8%,significantly higher than the other two groups (P<0. 05). The total incidence of side effects in the drug combination group was 1. 8%,similar to that of group A and B (1. 8% and 0. 9%,respectively, P =0. 776). Conclusion Trimebutine combined with mosapride is safe and effective for improving symptoms in functional dyspepsia.
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Objective To investigate the effect and recurrence of the esomeprazole combined with trimebutine on treatment for non-erosive reflux disease(NERD).Methods One hundred and twenty-five cases of patients with NERD were randomly divided into the treatment group (n =62) and the control group (n =63).Patients in treatment group were received the esomeprazole 20 mg,twice a day and trimebutine 0.2 g,3 times a day,in control group were received the esomeprazole 20 mg,twice a day and mosapride 5 mg,3 times a day.After 8 weeks treatment,6 months follow-up was conducted and the effects and recurrence were evaluated.Results The clinical curative rates at 4th and 8th weeks treatment in treatment group were 75.8％ (47/62) and 95.2％ (59/62),higher than that of control group (57.1％ (36/63),x2 =4.879,P =0.027 ; 84.1％ (53/63),x2 =4.083,P =0.043).The GERDQ curative rates at 4th and 8th weeks treatment in treatment group were 72.6％ (45/62),93.5％ (58/62) respectively,significantly higher than that of the control group (52.4％ (33/ 63),x2 =5.434,P =0.020 ; 79.4％ (50/63),x2 =5.350,P =0.021).The recurrence rates of 6 months followup were 77.4％ (48/62) in the treatment group and 81.0％ (51/63) in the control group,there was no significant difference between the two groups (P =0.627).Conclusion Esomeprazole combined with trimebutine is safe and effective treatment on non-erosive reflux disease,and the recurrence rates was lower than that in the control group.
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Objective To observe the clinical efficacy of esomeprazole combined with trimebutine maleate in the treatment of reflux esophagitis patients without helicobacter pylori infection.Methods 78 patients with reflux esophagitis were randomly divided into two groups,46 patients in study group and 32 patients in control group.30 minutes before the breakfast,all the patients took Nexium 20mg,twice a day.The study group was given trimebutine maleate 200mg,thrice a day additionally.The treatment course was 4 weeks.The effect and the result of gastroendoscopy were observed.Results The average time of clinical symptoms disappeared in study group was (10.51 ± 2.43) days,which was significantly shorter than (12.31 ± 3.17) days of the control group (t-2.84,P ＜ 0.01).The total effective rate of the study group was 97.83％,which was significantly higher than 81.25％ of the control group (x2 =4.48,P ＜ 0.05).Conclusion Esomeprazole combined with trimebutine maleate in the treatment of reflux esophagitis without helicobacter pylori infection can promote gastric emptying,prevent reflux,control esophageal inflammation and promote ulcer healing effectively.
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BACKGROUND/AIMS: Antispasmodic agents have been used in the management of irritable bowel syndrome. However, systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome. Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium. We compared fenoverine with trimebutine for the treatment of patients with IBS. METHODS: A multicenter, randomized, double-blind, non-inferiority clinical study was conducted to compared fenoverine with trimebutine. Subjects were randomized to receive either fenoverine (100 mg three times a day) or trimebutine (150 mg three times a day) for 8 weeks. A total of 197 patients were analyzed by the intention-to-treat approach. The primary endpoint was the proportion of patients who had 30% reduction in abdominal pain or discomfort measured by bowel symptom scale (BSS) score at week 8 compared to the baseline. The secondary endpoints were changes of abdominal bloating, diarrhea, constipation, overall and total scores of BSS, and overall satisfaction. RESULTS: At week 8, fenoverine was shown to be non-inferior to trimebutine (treatment difference, 1.76%; 90% CI, -10.30-13.82; p=0.81); 69.23% (54 of 78 patients) of patients taking fenoverine and 67.47% (56 of 83 patients) of patients taking trimebutine showed 30% reduction in abdominal pain or discomfort compared to the baseline. There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group. CONCLUSIONS: Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability.
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Adult , Female , Humans , Male , Middle Aged , Abdominal Pain/etiology , Constipation/etiology , Diarrhea/etiology , Double-Blind Method , Drug Administration Schedule , Irritable Bowel Syndrome/complications , Parasympatholytics/therapeutic use , Phenothiazines/therapeutic use , Severity of Illness Index , Treatment Outcome , Trimebutine/therapeutic useABSTRACT
BACKGROUND/AIMS: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders and when compared to the vast knowledge pertaining to adults with IBS, very little is known about IBS in children and adolescents. We aimed to explore the prevalence of IBS, identify symptoms and contributing factors and also to examine the efficacy of trimebutine maleate in children and adolescents. METHODS: The study involved 345 children and adolescents (4-18 years) and parents were requested to fill in a questionnaire, Rome III criteria was used to diagnose IBS. To exclude organic disease, all patients underwent medical investigations. Half of the randomly selected IBS patients were treated with trimebutine maleate while the rest of IBS patients were not. The IBS patients were reevaluated at the end of 3 weeks. RESULTS: The prevalence of IBS according to Rome III criteria in children and adolescents was 22.6% and IBS with constipation was the predominant subtype. Back pain (OR, 6.68), headache (OR, 4.72) and chronic fatigue (OR, 3.74) were significantly higher in IBS group. The prevalence of IBS in both parents and depression in mothers was greater for the patient group than the healthy controls (P < 0.0001). The prevalence of functional dyspepsia in IBS group was 80.8% and was significantly higher than control group. Clinical recovery was seen in 94.9% of the trimebutine maleate group versus spontaneous recovery in 20.5% of the non-medicated group. The difference was significant (P < 0.0001). CONCLUSIONS: IBS is a common disorder in children and adolescents. IBS is closely associated with somatic and familial factors. Trimebutine maleate is effective for pediatric IBS patients.
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Adolescent , Adult , Child , Humans , Back Pain , Constipation , Depression , Dyspepsia , Fatigue , Gastrointestinal Diseases , Headache , Incidence , Irritable Bowel Syndrome , Maleates , Mothers , Parents , Prevalence , Surveys and Questionnaires , Rome , TrimebutineABSTRACT
Objective To investigate the effects of trimebutine maleate (TM) on the expression of large conductance calcium-activated potassium channel (BKCa) and ryanodine receptors (RyR)channels at mRNA and protein level in colonic smooth muscle cell of cold restraint stress(CRS)induced rats.Methods A total of 24 Wistar rats were divided into CRS group,CRS with TM group and control group equally.The rats of CRS group were gavaged with 0.9％NaCl (6 ml/kg) daily; the rats of CRS with TM group were gavaged with 15 g/L TM (6 ml/kg) daily and activity was restricted in wire cage at 4 ℃ for two hours,continuously for five days.The rats of control group were gavaged with 0.9 ％ NaCl (6 ml/kg) once without CRS.The amount and characteristics of stool of rats in each group were observed.The colonic smooth muscle was isolated to detect the expression of BKCa and RyR at mRNA and protein level by reverse transcription-polymerase chain reaction (RT-PCR) and Western Blot.Results The median of rats defecation particles of CRS group was six,control group was one and CRS with TM group was five.Compared with control group,the defecation appearance of CRS group and CRS with TM group was looser and wetter observed by naked eyes.Compared with control group,there was no obvious pathological changes in CRS and CRS with TM group.There was no significant difference in the mRNA expression of BKCa and RyR channels between control group and CRS group.Compared with control group,the BKCa expression at mRNA level of CRS with TM group increased 1.45 fold.Compared with control group,the RyR2 expression at mRNA level of CRS with TM group increased 1.32 fold.Compared with control group,the BKCa expression at protein level of CRS with TM group increased 1.39 fold,and there was no RyR2 expression band at protein level.Conclusion TM might affect colonic smooth muscle contraction through the upregulation of BKCa expression at mRNA and protein level and RyR expression at mRNA level.
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Objective To evaluate the efficacy difference between flupentixol and melitracen combined with conventional medicine and conventional drug alone in the treatment of irritable bowel syndrome (IBS).Methods Studies on flupentixol and melitracen combined with conventional medicine (pinaverium bromide and trimebutine maleate) and conventional medicine alone in the treatment of IBS were collected and reviewed through searching the Chinese Academic Journals Full-text Database,Chinese VIP Full-text Database and PubMed database.After that,the test for homogeneity and the combined effect test were estimated. Results A total of 12 clinical studies on flupentixol and melitracen combined with conventional medicine for four to twelve weeks in the treatment of IBS were collected six studies indicated the homogeneity test of flupentixol and melitracen combined with pinaverium bromide (x2 =1.90,df=5,P=0.86,I2 =0).For the fixed-effect model,the odds ratio was 7.92 and 95％ CI was between 4.85 and 12.95,which suggested the combined therapy was better.The other six studies indicated the homogeneity test of flupentixol and melitracen combined with trimebutine maleate (x2 =5.60,df=5,P =0.35,I2 =10.6 ％).For the fixed-effect model,the odds ratio was 5.91 and 95％ CI was between 4.06 and 8.61,which suggested the combined therapy was better.After merging the 12 studies it indicated the homogeneity test of flupentixol and melitracen combined with conventional medicine (x2 =8.40,df =11,P =0.68,I2 =0).For the fixed effect model,the odds ratio was 6.63 and 95％ CI was between 4.92 and 8.93.Conclusion The efficacy of flupentixol and melitracen combined with conventional medicine in the treatment of IBS was better than that of conventional medicine alone,however,still more high quality trials are needed for further confirmation.
ABSTRACT
El objetivo del estudio fue evaluar la bioequivalencia entre dos formulaciones de liberación prolongada de trimebutina 300 mg, luego de una administración única en voluntarios sanos, a través de la determinación de su metabolito activo la desmetil-trimebutina. Se trata de un estudio abierto, randomizado, balanceado, con control activo, de dosis simple, cruzado, con dos períodos separados por un período de descanso y secuencial, realizado en 12 voluntarios sanos de ambos sexos. Los voluntarios recibieron de acuerdo al esquema asignado por la aleatorización y en dos períodos, una dosis única por vía oral después de un ayuno de 10 horas, de un comprimido de una formulación conteniendo 300 mg de Trimebutina AP de Laboratorios LETI S.A.V., o del producto de referencia DEBRIDAT AP®, de Laboratorios Pfizer. Después de la última muestra de sangre del primer período hubo un tiempo de lavado de siete días, luego del cual los voluntarios que recibieron el producto test en el primer período recibieron el producto de referencia y viceversa. Las tomas de muestras se realizaron antes de la dosis (tiempo cero), 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 24 h y 36 h. El análisis estadístico se realizó utilizando un paquete estadístico del programa Equiv test, empleándose el análisis de la varianza (ANOVA) de los parámetros cinéticos AUC 0-inf, AUC 0-36 h y Cmax y la aplicación de los intervalos de confianza para el 90%. En el análisis comparativo se tomaron los intervalos de confianza con el rango de referencia de 0.8-1.25%. Para la Trimebutina test los valores fueron: Cmax 1343.49 +/- 585.58, AUC 0-36 de 8197.19 +/- 3995.23 y AUC 0-inf de 8198.36 +/- 3995.3. Para la formulación de referencia los valores fueron de: Cmax 1023.99 +/- 587.57, AUC 0-36 7221.15 +/- 3211.97 y AUC 0-inf de 7225.97 +/- 3211.62 sin diferencias significativas entre los grupos...
The objective of this study is to assess the bioequivalence of two sustained release formulations of trimebutine 300 mg, after a single administration in healthy volunteers, through determination of the active metabolite desmethyl-trimebutine. This is an open, randomized, balanced, active controlled, single dose, crossover study with two periods separated by a rest period and sequentially, conducted in 12 healthy volunteers of both sexes. Volunteers were assigned according to the randomization scheme and two periods, a single oral dose after fasting for 10 hours, a tablet formulation containing 300 mg of trimebutine AP LETI SAV Laboratories, or product Reference DEBRIDAT AP®, Pfizer Laboratories. After the last blood sample of the first period there will be a wash time of seven days, after which the volunteers received the test product in the first period will received the reference product and viceversa. The sampling is performed: before dosing (time zero), 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 24 h and 36 h. Statistical analysis was performed using a statistical package Equiv test program, using analysis of variance (ANOVA) of the kinetic parameters AUC 0-inf, AUC 0-36h and Cmax and application of confidence intervals for 90%. In the comparative analysis we used the confidence intervals with the reference range of 0.8-1.25%. For the Trimebutine test values were Cmax 1343.49 +/- 585.58, AUC 0-36 of 8197.19 +/- 3995.23 and AUC 0-inf 8198.36 +/- 3995.3. For the formulation of reference values were: Cmax 1023.99 +/- 587.57, AUC 0-36 7221.15 +/- 3211.97 y AUC 0-inf of 7225.97 +/- 3211.62 no significant differences between groups. This study found that the Cmax and AUC, its log-transformed means and confidence intervals 90% away from each other not less than 80% or over 125%, so that both products are considered bioequivalent and therefore interchangeable