Efficacy of mosapride versus domperidone in the treatment of functional dyspepsia and its effects on gastric motility indexes and gastrointestinal hormone levels / 中国基层医药

Objective:To investigate the efficacy of mosapride versus domperidone in the treatment of functional dyspepsia and its effects on gastric motility indexes and gastrointestinal hormone levels. Methods:Ninety-four patients with functional dyspepsia who received treatment in Huzhou Linghu People's Hospital between May 2019 and May 2021 were included in this study. They were randomly assigned to undergo treatment with either domperidone (control group, n = 47) or mosapride (study group, n = 47). Efficacy was compared between the two groups. Results:Total response rate in the study group was significantly higher than that in the control group ( χ2 = 5.04, P = 0.025). After medication, motilin, plasma leptin and corticotropin-releasing hormone in the study group were (184.22 ± 25.36) μg/mL, (18.57 ± 2.44) μg/L, (7.21 ± 1.14) pg/mL, respectively, which were superior to those in the control group [(111.25 ± 21.00) μg/mL, (15.41 ± 2.28) μg/L, (9.02 ± 1.32) μg/mL, t = 15.19, 6.48, 16.23, P < 0.001, < 0.001, < 0.001]. After medication, cholecystokinin, somatostatin, vasoactive intestinal peptide and gastrin levels in the study group were (45.36 ± 5.12) ng/L, (5.48 ± 1.25) ng/L, (86.35 ± 12.11) pg/mL, and (105.24 ± 12.05) ng/L, respectively, which were significantly superior to those in the control group [(50.21 ± 6.18) ng/L, (7.01 ± 0.98) ng/L, (98.75 ± 14.18) pg/mL and (97.35 ± 11.48) ng/L, t = 4.14, 6.60, 4.55, 3.25, P < 0.001, < 0.001, < 0.001, < 0.002]. The recurrence rate in the study group was significantly lower than that in the control group (2.13% vs. 27.66%, χ2 = 4.66, P = 0.031). The incidence of adverse reactions in the study group was significantly lower than that in the control group (14.89% vs. 34.04%, χ2 = 10.80; P = 0.001). Conclusion:Mosapride has a better therapeutic effect on functional dyspepsia, exhibits a greater effect on improving gastric motility indexes and gastrointestinal hormone levels, and leads to a lower incidence of recurred functional dyspepsia than domperidone. Therefore, mosapride for treatment of functional dyspepsia deserves clinical promotion.

Prescription pattern & adverse drug reactions of prokinetics

Background & objectives: Prokinetics are extensively prescribed leading to several adverse events (AEs). The aim of this study was to assess the prescription pattern in patients receiving prokinetics, and characteristics of adverse drug reactions (ADRs) in an outpatient department set up in a tertiary care hospital in western India. Methods: Patients attending outpatient departments of a tertiary care hospital and who had received prokinetic agent for at least seven days over the last one month were enrolled. Causality assessment of AEs was done and assessed for severity, preventability, seriousness and predictability. Results: A total of 304 patients [161 males (52.96%); 143 females (47.04%)] were enrolled. Most prescriptions (299/304, 98%) included domperidone, most commonly prescribed as fixed-dose combination (FDC) with pantoprazole (274/304, 90%). Prokinetic dose was not mentioned in 251/304 (83%) prescriptions, and 18/304 (6%) did not mention frequency. Of the 378 AEs reported from 179 patients (47.35%), 306 (81%) were mild, all non-serious; 272 (72%) not preventable and 291 (77%) predictable in nature. Decreased appetite (n=31, 8.2%) and fatigue (n=27,7.14%) were most commonly reported. Causality assessment by the World Health Organization-Uppsala Monitoring Centre scale showed that 180 AEs were related to suspected drug (17 probable and 163 possible ADRs). Significant correlation was observed for AEs with increasing number of drugs per prescription (Spearman's R=+0.8, P =0.05) and with increasing therapy duration (Spearman's R=+1.00, P <0.001). Interpretation & conclusions: Our findings showed that prokinetics were often prescribed as FDCs, with incomplete prescriptions. Domperidone was found to be associated with multiple AEs. It is suggested that regular prescription monitoring should be done in hospitals to encourage rational use of drugs.

Use of domperidone in canine visceral leishmaniasis: gaps in veterinary knowledge and epidemiological implications

A pivotal strategy to decrease the risk of visceral leishmaniasis in humans is to control the infection and disease progression in dogs, the domestic reservoir of Leishmania infantum (L. chagasi). Immunotherapy is a viable approach to treat sick dogs because cell-mediated immunity is the principal defense mechanism against L. infantum. Domperidone is an immune-stimulatory drug increasingly used in veterinary medicine as a prophylactic or immunotherapeutic agent. Domperidone treatment has shown to prevent overt disease or improve the clinical condition of infected dogs. However, veterinarians should be aware of the potential cardiotoxicity of domperidone when given together with drugs that inhibit CYP450s liver enzymes or those that prolong the QT interval. On the other hand, learning whether domperidone treatment significantly decreases dog infectivity to sand fly vectors is of capital importance since this result should have a palpable impact on the infection risk of humans living in regions endemic for visceral leishmaniasis.

Clinical efficacy of amitriptyline combined with domperidone in the treatment of functional dyspepsia / 中国基层医药

Objective To observe and analyze the clinical efficacy of amitriptyline combined with domperidone in the treatment of functional dyspepsia ( FD) .Methods 156 patients with FD were selected as the study subjects , and they were randomly divided into the observation group and the control group ,78 cases in each group .The patients in the control group were treated with domperidone ,and the patients in the observation group were given amitriptyline combined with domperidone .The changes of clinical symptoms scores and the occurrence of adverse reactions were observed before and after treatment in both two groups ,and the clinical curative effect was compared .Results After treatment,the total effective rate of the observation group was 93.59％,which was significantly higher than 76.92％of the control group,and there was significant difference between the two groups (χ2 =10.59,P<0.01).The early satiety,postprandial bloating,nausea and vomiting,epigastric distending pain,belching and other clinical symptoms scores in two groups were significantly reduced ( tobservation group =21.95,33.78,42.12,37.58,42.64, tcontrol group =17.54,8.88,16.43,10.98,15.06,all P<0.01),and the clinical symptoms of the observation group improved more significantly (t=9.89,9.79,8.47,9.99,18.52,all P<0.01).The incidence rate of adverse reactions in the obser-vation group was 16.67％,which in the control group was 23.08％,the difference between the two groups was not statistically significant (χ2 =1.09,P>0.05).After the treatment,the adverse reactions disappeared spontaneously . Conclusion Compared with the use of domperidone alone , the clinical efficacy of amitriptyline combined with domperidone in the treatment of FD patients is significant with good safety ,and is conducive to improve the clinical symptoms of patients ,increase the efficacy and worthy of clinical application .

Efecto del protocolo de inducción hormonal en la espermiación y las características seminales de yaque ( Leiarius marmoratus ) / Effect of hormone induction protocol in the spermiation and seminal characteristics of yaque (Leiarius marmoratus) / Efeito do protocolo de indução hormonal sobre a spermiação e as características do sêmen do yaque (Leiarius marmoratus)

Resumen El yaque Leiarius marmoratus, es una especie de siluriforme nativo con gran potencial para la diversificación de la acuicultura colombiana; sin embargo, la espermiación en cautiverio aún presenta dificultades debido al bajo volumen seminal liberado con los protocolos de inducción tradicionales. En consecuencia, el objetivo fue evaluar los efectos de cinco protocolos de inducción hormonal, basados en Extracto de Hipófisis de Carpa (EHC), sGnRHa + domperidona (OVAPRIM®) y Gonadotropina Coriónica Humana (GHC) (FERTIVET®), sobre la calidad y volumen seminal de la especie. Fueron seleccionados 18 machos sexualmente maduros de 54,4 ± 2,2 cm de longitud total y 1,6 ± 0,1 kg peso corporal. Se evaluaron 5 tratamientos, así: T1: 0,25 ml/kg (0 h) y 1 ml/kg de OVAPRIM® (12 h); T2: 1 mg/kg de EHC (0 h) y 3 mg/kg de EHC (12 h); T3: dosis única de 200 UI/kg de GCH; T4: 3 mg/kg de EHC (0 h) y 200 UI/Kg de GHC (8h); T5: 1 ml/kg de OVAPRIM® (0h) y 200 UI/kg de GHC (8h); Control: 1 ml de suero fisiológico. El semen se colecto 6 h después de aplicada la última dosis hormonal. El T1 y T5 mostraron un volumen mayor (p<0,05) (5,4 ± 1,1; 4,8 ± 1,2 ml) cuando comparados con T2 (3,1 ± 1ml), T3 (2,3 ml) T4 (2,4 ± 1,1 ml) y el control (0,2 ml). En cuanto a la movilidad y tiempo de activación, T1 y T5 presentaron los mejores resultados (90 ± 0% y 54,2 ± 7 s; 90 ± 0% y 52,9 ± 3,8 s, respectivamente). La concentración espermática fue mayor (p<0,05) en T2 y T5 (1,275 ± 322; y 1,261 ± 225 sptz x 103/µl) comparadas con los otros tratamientos. Se concluye que la inducción hormonal con OVAPRIM® combinada con HCG, son efectivas para la producción seminal en la especie.

Abstract The yaque Leiarius marmoratus is specie of native silurid, with great potential for the diversification of the colombian aquaculture; however, the spermiation in captive yet presents difficulties due to the low seminal volume released with traditional induction protocols. In consequence, the aim of this study was to evaluate the effects of five protocols of hormonal induction based on carp pituitary extract (EHC), sGnRHa + domperidone (OVAPRIM®) and human chorionic gonadotropin (GHC) (FERTIVET®) on seminal quality and volume of the specie. Were selected 18 sexually mature males of 54,4 ± 2,2 cm in total length and 1,6 ± 0,1 kg body weight. 5 treatments were evaluated so: T1 : 0,25 ml/kg (0 h) and 1 ml/kg of OVAPRIM® (12 h ); T2: 1 mg/kg of EHC (0 h) and 3 mg/kg of EHC (12 h) ; T3 : single dose of 200 UI/kg HCG; T4: 3 mg/kg of EHC (0 h) and 200 UI /kg GHC (8h) ; T5: 1 ml/kg of OVAPRIM® (0h) and 200 U.I / kg of GHC (8h) ; Control: 1 ml of saline solution. Semen was obtained 6 hours after the last dose hormone. T1 and T5 showed a larger volume (p<0.05) (5,4 ± 1,1, 4,8 ± 1,2 ml) compared to T2 (3,1 ± 1ml), T3 (2,3 ml) T4 (2,4 ± 1.1 ml) and control (0.2 ml). Regarding motility and activation time, T1 and T5 had the best results (90 ± 0 % and 54,2 ± 7 s; 90 ± 0 % and 52,9 ± 3,8 s, respectively). The sperm concentration was higher in (p<0,05) T2 and T5 (1,275 ± 322, ± 225 and 1,261 sptz x 103/ul) compared with the other treatments. In conclusion, hormonal induction with OVAPRIM® combined with HCG, are effective for the seminal production in the specie.

Resumo O yaque Leiarius marmoratus, é uma espécie siluriforme nativa com grande potencial para a diversificação da aquicultura colombiana; No entanto, a spermiação em cativeiro ainda apresenta dificuldades devido ao baixo volume seminal liberado com protocolos de indução tradicionais. Por conseguinte, o objetivo foi avaliar os efeitos de protocolos de indução de cinco hormonais base de extrato de hipófise de carpa (EHC), sGnRHa + domperidona (Ovaprim®) e Gonadotropina coriónica humana (GHC) (FERTIVET®) sobre a qualidade e volume seminal das espécies. Foram Selecionados 18 machos sexualmente maduros de 54,4 ± 2,2 cm de comprimento total e 1,6 ± 0,1 kg de peso corporal. Foram avaliados cinco tratamentos: T1: 0,25 ml / kg (0 h) e 1 ml / kg de OVAPRIM® (12 h); T2: 1 mg / kg de EHC (0 h) e 3 mg / kg de EHC (12 h); T3: dose única de 200 UI / kg de HCG; T4: 3 mg / kg de EHC (0 h) e 200 UI / kg de GHC (8h); T5: 1 ml / kg de OVAPRIM® (0h) e 200 UI / kg de GHC (8h); Controle: 1 ml de solução salina fisiológica. O sêmen foi coletado 6 h após a última dose hormonal foi aplicada. T1 e T5 mostraram um volume maior (p <0,05) (5,4 ± 1,1, 4,8 ± 1,2 ml) quando comparado com T2 (3,1 ± 1 ml), T3 (2,3 ml) T4 (2,4 ± 1,1 ml) e controle (0,2 ml). Em relação à mobilidade e ao tempo de ativação, T1 e T5 apresentaram os melhores resultados (90 ± 0% e 54,2 ± 7 s, 90 ± 0% e 52,9 ± 3,8 s, respectivamente). A concentração de esperma foi maior (p <0,05) em T2 e T5 (1275 ± 322 e 1261 ± 225 sptz x 103 / µl) em comparação com os outros tratamentos. Conclui-se que a indução hormonal com OVAPRIM® combinada com HCG, é efetiva para a produção seminal nas espécies.

Clinical Observation of Predominant Clinical Efficacy of Xiang Sha Liujunzi Decoction for Treatment of Chronic Gastritis / 广州中医药大学学报

Objective To investigate the predominant clinical efficacy of syndrome differentiation treatment with Xiang Sha Liujunzi Decoction in treating chronic gastritis by observing its curative effect on traditional Chinese medicine(TCM) symptoms and gastroscopy of chronic gastritis pationts . Methods Ninety cases of chronic gastritis patients were randomly divided into control group and treatment group,each group having 45 cases. The control group received Omeprazole Tablets combined with Domperidone Tablets orally,4 weeks constituting a course of treatment. For the patients in the control group with Helicobacter pylori(HP)positive,Amoxicillin Capsules and Metronidazole Tablets were added, and the antibiotics were suspended after one week. The treatment group was given syndrome differentiation treatment with Xiang Sha Liujunzi Decoction on the basis of treatment for the control group. After one course of treatment,the scores of TCM symptoms were evaluated and the gastroscopy was re-examined. Results (1)After one course of treatment, the total effective rate for TCM symptoms in the treatment group was 93.3%, and that in the control group was 66.7%, the difference being statistically significant(P < 0.05).(2)The total effective rate for gastroscopy in the treatment group was 86.7%, and that in the control group was 68.9%,the difference being statistically significant(P < 0.05).(3)The results of Mann-Whitney U rank-sum test showed that the effects on TCM symptoms were superior to the effects on gastroscopy in the treatment group, the difference being statistically significant(Z=-1.974, P < 0.05). However, the differences of the two kinds of clinical efficacy in the control group were not statistically significant(Z =-0.662, P > 0.05), indicating that the application of Chinese medicine in the treatment group had obvious effect on relieving TCM symptoms. Conclusion Compared to western medicine alone, syndrome differentiation treatment with Xiang Sha Liujunzi Decoction plus western medicine can enhance the therapeutic effect in treating chronic gastritis. The application of Chinese medicine alone or combined with western medicine exerts predominant efficacy on relieving TCM symptoms of chronic gastritis patients,in particular for the patients mainly with the manifestations of self-perceived discomforts.

Efficacy of Drugs with Different Mechanisms of Action on Functional Dyspepsia:A Comparative Study / 胃肠病学

Background:Oryz-Aspergillus Enzyme and Pancreatin Tablet is a double-deck digestive enzyme pellet containing Oryz-Aspergillus enzyme and pancreatin that has been widely used for treatment of functional dyspepsia (FD)in clinical practice. However,there is no randomized controlled trial focusing on the efficacy of this agent versus other drugs used for treatment of FD such as prokinetics and proton pump inhibitors (PPI). Aims:To compare the efficacy and safety among Oryz-Aspergillus Enzyme and Pancreatin Tablet,Domperidone Tablet and Esomeprazole Magnesium Enteric-coated Tablet, three drugs with different mechanisms of action on FD,in Chinese population. Methods:A total of 82 Helicobacter pylori-negative outpatients fulfilling the diagnostic criteria of FD in Rome Ⅲ were recruited from Nov. 2015 to Jun. 2016 at the First Affiliated Hospital of Zhejiang Chinese Medical University. These patients were randomly allocated into 3 groups,and received Oryz-Aspergillus Enzyme and Pancreatin Tablet (group A),Domperidone Tablet (group B)and Esomeprazole Magnesium Enteric-coated Tablet (group C)orally for 4 weeks,respectively. The improvement of dyspeptic symptoms and adverse events were observed and recorded. Results:After 4 weeks treatment,the overall efficacies for global symptoms in group A,group B and group C were 93. 1%,88. 9% and 69. 2%,respectively,statistically significant difference was existed among the three groups (P < 0. 05). Domperidone Tablet was effective for postprandial fullness and early satiety;Esomeprazole Magnesium Enteric-coated Tablet was sensitive for epigastric pain,epigastric burning,and belching and regurgitation;the efficacies of Oryz-Aspergillus Enzyme and Pancreatin Tablet for all five dyspeptic symptoms were in between. No adverse events were observed during treatment course. Conclusions:Digestive enzymes,prokinetics and PPI have different sensitive symptoms and optimal indications for treatment of FD. The overall efficacy of Oryz-Aspergillus Enzyme and Pancreatin Tablet is superior to that of prokinetics and PPI.

Effect of Dachengqi decoction, omeprazole and cisapride in the treatment of gastric cancer radical operation in serum gastrin and motilin / 中国生化药物杂志

Objective To evaluate the effect of Dachengqi decoction,omeprazole and cisapride in the treatment of gastric cancer radical operation in serum gastrin and motilin.Methods 88 cases of gastric cancer after radical gastrectomy from May 2013 to July 2015 in our hospital were selected and divided into control group and treatment group with each 44 cases.Patients in both groups were given routine treatment and symptomatic treatment.Control group received omeprazole Enteric-coated capsules 20mg,qd,cisapride tablets 10mg,tid,treatment group received more Dachengqi decoction 200mL,bid,respectively by intragastric injection and retention enema,two times a day,a total of 21 days of treatment.The clinical efficacy,serumgastrin,plasma gastric motility,gastric juice volume and adverse reactions were compared between the two groups.Results The total effective rate in the treatment group was significantly higher than that in control group(P<0.05); After treatment,gastric juice volume of two groups was significantly lower than before treatment,the gastric juice volume in the treatment group were significantly lower than control group(P<0.05);Compare with pre-treatment,after treatment,the serum gastrin,plasma gastric motility levels of two groups were significantly higher,and the treatment group were significantly higher than the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups.Conclusion Omeprazole,cisapride combined with Dachengqi decoction in the treatment of gastric cancer radical operation was obvious and high safety.

Observation of the clinical effect of pantoprazole combined with domperidone in the treatment of chronic superficial gastritis / 中国基层医药

Objective To investigate the clinical efficacy of pantoprazole combined with domperidone in the treatment of chronic superficial gastritis.Methods 50 patients with chronic superficial gastritis were selected,and they were randomly divided into single drug treatment group and two drugs treatment group by the random number table method,25 cases in each group.The single drug treatment group was treated with domperidone,the two drugs treatment group was given pantoprazole combined with domperidone treatment.After 3 weeks of treatment,the total effective rate,disappearing time of abdominal pain,postprandial fullness belching disappeared time,the disappearance time of patients before meals;and after treatment,fullness,belching,abdominal pain score difference;psychological function of patients before and after treatment,differences in physical function indicators of the quality of life were compared between the two groups.Results The total effective rate of the two drugs treatment group was higher than that of the single drug treatment group (96.00％ vs.76.00％,x2 =4.153,P ＜ 0.05).The disappearance time of abdominal pain,postprandial fullness disappeared time,belching disappeared time of the two drugs treatment group were shorter than those of the single drug treatment group(t =8.201,9.155,10.762,all P ＜ 0.05).Before.treatment,the postprandial fullness,belching,abdominal pain points between the two groups had no statistically significant differences(all P ＞ 0.05).After treatment,the postprandial fullness,belching,abdominal pain of the two drugs treatment group decreased more significant (t =5.255,4.923,6.245,all P ＜ 0.05).Before treatment,the psychological function,physical function and quality of life index between the two groups showed no statistically significant differences (all P ＞ 0.05).After treatment,the psychological function,physical function and quality of life index of the two drugs treatment group increased more greatly (t =5.242,4.153,4.733,4.255,4.562,4.715,all P ＜ 0.05).Conclusion The clinical efficacy of pantoprazole combined with domperidone in the treatment of chronic superficial gastritis is effective,it can effectively improve the patients’ clinical symptoms and quality of life,shorten the treatment time,it is worthy of promoting.

Improvement of Domperidone Solubility and Dissolution Rate by Dispersion in Various Hydrophilic Carriers.

The aim of this work was to improve the solubility and dissolution rate of poorly-soluble, weakly-basic, anti-emetic drug; domperidone (DMP) using solid dispersion technique. Solubility studies of DMP with various hydrophilic carriers including sorbitol, mannitol, PEG 4000, PEG 6000, pluronic F-68 and pluronic F-127 were performed. Pluronic F-68 and pluronic F-127 showed the highest solubilizing effect on DMP and therefore; they were selected for the preparation of solid dispersions in different weight ratios by the fusion method. The solid dispersions were characterized using Fourier-transform infrared spectroscopy (FT-IR), Differential Scanning Calorimetry (DSC), Powder X-ray Diffractometry (P-XRD), solubility determination and in-vitro dissolution rate studies. FT-IR and DSC studies confirmed the absence of incompatibilities between DMP and the used carriers. DSC and P-XRD studies proved the transformation of drug from crystalline to amorphous state in the prepared solid dispersions. The results showed marked improvement of DMP solubility and dissolution rate from the solid dispersions compared with the pure drug and indicated the superiority of solid dispersions prepared with pluronic F-68 over those prepared with pluronic F-127. It can be concluded that solid dispersion technique was an effective tool in the enhancement of DMP dissolution.

Scopolamine tablet and transdermal agent in combination with domperidone for prevention and treatment of seasickness / 第二军医大学学报

Objective To observe the preventive and therapeutic effects of scopolamine tablet and transdermal agent in combination with domperidone for seasickness in different voyage distances and sea state conditions. Methods A total of 236 participants were selected and batched for three trials (Trial 1: 80 sea miles voyage. 1-2 degree of sea state; Trial 2; 80 sea miles voyage. 3-4 degree of sea state; and Trial 3: 200 sea miles voyage. 3-4 degree of sea state). The motion sickness susceptibility questionnaire (MSSQ) was used to assess the seasickness susceptibility. The participants in each trial were divided into comprehensive medication group (CMG) receiving low dose oral and transdermal scopolamine in combination with oral domperidone. prophylactic medication group (PMG) receiving low dose oral and transdermal scopolamine, and placebo control group (PCG) receiving oral vitamine C Motion sickness symptoms were evaluated by using Wiker rating scales. Results In trial 1. the Wiker scores and moderate seasickness incidence in the CMG and FMG were significantly lower than those in the PCG (P0. 05). In trial the Wiker scores were significantly lower in the CMC than in the PCG (P0. 05). In trial 3 the Wiker scores were significantly lower in the CMG than in the PCG (P0. 05). Conclusion low dose oral and transdermal scopolamine in combination with oral domperidone can alleviate seasickness symptoms and decrease incidence of severe seasickness during long-term voyage at sea.

The clinical effect of Shugan-Jieyu capsule combined with domperidone on functional dyspepsia / 国际中医中药杂志

Objective To observe the clinical effect ofShuganJieyu capsule combined with domperidone on functional dyspepsia (FD).Methods84 FD patients were recruited in this study. The patients were divided into the control group (n=42) and the observation group (n=42). Control group was treated with domperidone, and observation group was treated with combination ofShuganJieyu capsule and domperidone. Both groups were treated for 4 weeks. The gastric volume, gastric gas scores, and gastric emptying rates were detected by the ultrasound and X-ray. The clinical effect and adverse reactions was compared.ResultsThe clinic effective rate of observation group was 90.5% (38/42), and the control group was 76.2% (32/42). After treatment, the gastric volume of 60 min was significantly lower in observation group than that in control group (15.52 ± 3.21 mlvs. 23.54 ± 5.11 ml;t=2.412,P<0.05); the decreasing of gastric gas scores (0.42 ± 0.13vs. 0.64 ± 0.16;t=2.384,P<0.05) and increasing of gastric emptying rate (74.15% ± 11.62%vs. 54.82% ± 10.31%;t=2.324,P<0.05) were significantly higher in observation group than those in control group.ConclusionShugan-Jieyu capsule can improve gastric emptying and gastrointestinal motility, and showed better effect than domperidone alone.

Efectos adversos cardíacos de la domperidona en pacientes adultos: revisión sistemática / Cardiac adverse effects of domperidone in adult patients: a systematic review

Background: Domperidone is widely prescribed in patients with gastrointestinal disorders but some cardiac adverse effects have been recently reported. Aim: To evaluate the risk of QT prolongation, ventricular arrhythmias and sudden cardiac death associated with the use of oral domperidone in adults without cancer. Material and Methods: Systematic searches in MEDLINE, LILACS, SciELO, the Cochrane Library and regulatory agencies websites were performed, followed by a manual search of cited references. The search strategy consisted of combining free and indexed text words without any date or language restriction. Results: Three case-control studies met the inclusion criteria; none of them evaluated QT interval prolongation. With low risk of bias, each study quantified the risk of ventricular arrhythmia or sudden cardiac death (VA/SCD). The odds ratios for these events in these studies were 4.7 (95% confidence interval (CI): 1.4-16), 1.59 (95% CI: 1.28-1.98) and 11.02 (95% CI: 2.02-62.3) respectively. A significantly increased risk was observed in patients older than 60 years of age or receiving doses > 30 mg/day. Conclusions: Heterogeneity between selected studies did not allow the computation of a summary measure. However, evidence was found that an increased risk of VA/SCD is associated with the use of oral domperidone in adults.

The clinical observation and analysis of domperidone oral liquid combined with multienzyme tablets for the treatment of pediatric functional dyspepsia / 中国基层医药

Objective To explore the effect of domperidone oral liquid combined with multienzyme tablets for the treatment of functional dyspepsia.Methods 150 children with functional dyspepsia were selected,they were randomly divided into the observation group and control group by using the random number table method,with 75 ca-ses each group.The control group received domperidone oral liquid treatment and the observation group were given domperidone oral liquid combined with multienzyme tablets treatment.The main clinical symptom score and improve-ment time of two groups,and assess the adverse reactions were observed.Results The satiety,loss of appetite, abdominal discomfort,nausea and vomiting and fecal condition score of the observation group after treatment were (0.48 ±0.13),(0.53 ±0.22),(0.21 ±0.18),(0.79 ±0.38),(0.28 ±0.19),which were lower than the control group after treatment (t =8.46,9.27,7.94,10.11,8.04,all P 0.05).Conclusion There was better effect on domperidone oral liquid combined with multienzyme tablets on func-tional dyspepsia in children,which could improve the patient's clinical symptoms or signs significantly.And could in-duce the improvement time.

Comparative evaluation of itopride and domperidone in gastroesophageal reflux disease.

Background: Gastroesophageal reflux disease (GERD) presents in various ways in terms of symptoms and severity. This study was conducted to assess the severity of GERD patients and to evaluate the effect of itopride and domperidone on symptoms and severity of GERD. Methods: A single-blind study was carried out in 70 patients. Group A (n=35) patients were kept on itopride therapy, 50 mg thrice a day before meal. Group B (n=35) patients were kept on domperidone therapy, 10 mg thrice a day before meal. Patients of both groups were given rabeprazole, 20 mg once a day for hyperacidity. Patients served their own control. Each patient was followed-up at 2 weeks interval up to 8 weeks. Results: The most common symptom was heartburn, present in 95.71% patients. Regurgitation was the next most common symptom (65.71%). The most common lesion seen endoscopically (according to Savary Miller classification) was grade I (38.57%). In 24.29% patient, only symptoms of GERD were present without any endoscopically visible mucosal injury. At the end of 2, 4, 6, and 8 weeks, relief of symptoms was more with a combination of itopride and rabeprazole in comparison to the combination of domperidane and rabeprazole, but the difference was statistically insignificant. Healing rate at the end of 4th and 8th week was slight better with a combination of itopride and rabeprazole, but the difference again was statistically insignificant. Conclusion: Combination of itopride and rabeprazole showed insignificantly better results, both symptomatically and endoscopically in comparison to the combination of domperidone and rabeprazole.

Development and optimization of self microemulsifying drug delivery of domperidone

The present investigation is aimed to develop self-microemulsifying drug delivery system (SMEDDS) to improve the in vitro dissolution of a BCS (Biopharmaceutical Classification System) class II anti emetic agent, domperidone. Solubility study was performed to identify the ingredients showing highest solubility of domperidone. The ternary phase diagrams were plotted for selected components to identify the area of microemulsion existence. D-optimal mixture experimental design was applied to optimize a liquid SMEDDS using formulation variables; the oil phase X1 (Oleic acid), the surfactant X2 (Labrasol) and the co-surfactant X3 (Transcutol HP). The liquid SMEDDS were evaluated for droplet size, emulsification time, % transmittance and drug release. Stability study was performed at 40 °C/75% RH. Liquid formulation was solidified by adsorption on carrier Aerosil 300. Solid SMEDDS was evaluated and compared with liquid SMEDDS and marketed formulation. Oleic acid was selected as oil, Labrasol as surfactant and Transcutol HP as co-surfactant for formulation of SMEDDS. The optimized batch showed best results in terms of smaller droplet size (<170 nm), emulsification time (<40 s) and drug release (>85% in 15 min) and was stable for 3 months. Solid SMEDDS containing Aerosil 300 showed good flow properties and uniform drug content. XRPD study revealed that the crystalline drug was converted to amorphous form in solid SMEDDS. The rate and extent of drug dissolution from solid SMEDDS was significantly higher than pure drug and commercial tablet formulation. The results demonstrate the potential of SMEDDS as a means of improving solubility, dissolution and hence the bioavailability.

O presente estudo teve como objetivo desenvolver sistemas de liberação auto-microemulsificantes (Self-Microemulsifying Drug Delivery System - SMEDDS) de domperidona, agente antiemético, classe II, segundo o sistema de classificação Biofarmacêutica, para melhorar sua dissolução in vitro. Estudo foi realizado para identificar os componentes que revelaram maior solubilidade da domperidona. Determinaram-se os diagramas de fase ternários para esses componentes selecionados tendo em vista a identificação da região de formação da microemulsão. O planejamento experimental foi empregado para otimizar os SMEDDS líquidos, utilizando as seguintes variáveis de formulação: a fase oleosa X1 (ácido oleico), o agente tensoativo X2 (Labrasol) e co-tensoativo X3 (Transcutol HP). Os SMEDDS líquidos foram avaliados quanto às seguintes características: tamanho da gota, tempo de emulsificação,% de transmitância e liberação do fármaco. O estudo de estabilidade foi realizado a 40 °C/75% de umidade relativa. A formulação foi convertida em forma sólida por sua adsorção em Aerosil 300. Os SMEDDS sólidos foram avaliados e comparados com SMEDDS líquidos e a formulação comercializada. O ácido oléico foi selecionado para a fase oleosa, Labrasol como agente tensoativo e Transcutol como co-tensoativo para a formulação de SMEDDS. O lote otimizado mostrou os melhores resultados: menor tamanho de gota (<170 nm), menor tempo de emulsificação (<40 segundos), e de liberação do fármaco (> 85% em 15 min). Além disso, a formulação otimizada manteve-se estável no período de 3 meses. Os SMEDDS sólidos contendo Aerosil 300 apresentaram boas propriedades de fluxo e uniformidade de conteúdo do fármaco. O estudo de difração de raios-X revelou que o fármaco cristalino foi convertido para a forma amorfa, nos SMEDDS sólidos. A velocidade de dissolução do fármaco a partir dos SMEDDS sólidos foi significativamente maior, quando comparado ao fármaco livre e à formulação de comprimidos comercial. Os resultados demonstram o potencial dos SMEDDS como meio para melhorar a solubilidade, a dissolução e, consequentemente, a biodisponibilidade da domperidona.

Efficacy of Domperidone Combined with Pantoprazole and Hydrotalcite Tablets in the Treatment of Bile Reflux Gastritis / 中国药师

Objective:To observe the curative effects of the combined application of domperidone, pantoprazole and hydrotalcite tablets in the treatment of bile reflux gastritis ( BRG) and explore the underlying mechanism. Methods:Totally 80 patients with BRG were randomly divided into the treatment group and the control group with 40 cases in each. The treatment group was received panto-prazole, hydrotalcite tablets and domperidone, and the control group was treated by hydrotalcite tablets and domperidone. The efficacy was observed in both groups after 4 weeks. Results:The effective rate of symptom relief in the treatment group and the control group was respectively 92. 5% and 62. 5% (P<0. 05). After the 4 week treatment, the gastritis healing rate in the treatment group was higher than that in the control group (P<0. 05). The improvement of gastric mucosal hyperemia, edema and erosion in the treatment group was better than that in the control group with significant difference (P<0. 05). Cholic acid in gastric juice and gastric acid se-cretion were significantly reduced in both groups after the treatment, while the reduction of gastric acid secretion in the treatment group was more notable than that in the control (P<0. 05). Conclusion:Pantoprazole can be used to control BRG, and the combination of the three drugs shows better efficacy in the treatment of BRG.

The efficacy of domperidone in the treatment of childhood Gatroesophageal reflux disease: report of 220 cases.

The aim of this study was to investigate the efficacy and side effects of domperidone in childhood gastroesophageal reflux disease. This outcome study was done on 220 children (1month -15years) referred with reflux-related gastrointestinal and extra gastrointestinal symptoms during 3 years. Upper endoscopy with biopsy was performed in all subjects except in infants with apnea. Trial therapy was begun with domperidone (0.6mg/kg/BID) 30 minutes before meal. The efficacy and side effects were evaluated in 4-week follow up. Those free of symptom were considered as positive therapeutic response. In children with esophagitis, omeprazol was prescribed for 3 months too. Follow up continued monthly for three months and then every 3-6 months up to 2 years. Mean age of subjects was 4.99 ±3.5 years. There was no significant different between two sex(female=55%, male=45%).There was poor correlation between clinical symptoms with endoscopic and histologic findings (100%, 66.4%, 82.7%). Majority of the patients (85.5%) responded to the treatment in 4 weeks. There was no significant relationship between age, sex and clinical symptoms with response to domperidone. Although side effects were observed in 22.4%, but the most frequent side effect (15%) was loose stool .Moreover this complication (constipation) was beneficial in relieving simultaneous reflux related constipation. Serious complications such as extrapyramidal signs were observed only in 0.5%. According to this study, domperidone with few side effects can be efficient for the treatment of reflux in children with any gastrointestinal or extra- gastrointestinal symptom regardless of the sex or age group, moreover further study for finding out rare complications is suggested too.

Stability Indicating Simultaneous Equation Method for Determination of Domperidone and (S)-Esomeprazole Magnesium in Capsule Dosage Form Using UV-Spectrophotometer.

Aims: Stability indicating simultaneous equation method for determination of Domperidone and Esomeprazole Magnesium in capsule dosage form using UVSpectrophotometry. Study Design: A new simultaneous equation method was developed and validated for the determination of esomeprazole magnesium and domperidone in capsule dosage form. Place and Duration of Study: Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy, Invertis University, Bareilly, Uttar Pradesh during July 2012 to June 2013. Methodology: Simultaneous equation method was performed for estimation of dosage form and degradants. Results: The maximum wavelength (λmax) was found to be 299 nm for esomeprazole magnesium and 287 nm for domperidone. The linearity range was found to be 1-6 μg ml-1 (r2= 0.998) and 5-30 μg ml-1 (r2= 0.999) for esomeprazole magnesium and domperidone, respectively. The value of limit of detection and limit of quantification was 0.116 and 0.386 μgml-1 for esomeprazole magnesium and 0.657 and 2.18 μgml-1 for domperidone, respectively. Forced degradations were carried out under acid, base, thermal, photolytic and oxidative stress conditions. The method was satisfactorily validated as per the ICH guideline. Conclusion: This study shows that the proposed spectrophotometric method is useful for the routine determination of esomeprazole magnesium and domperidone in its combined pharmaceutical dosage form.

The role of prolactin in prostatic inflammation / O papel da prolactina na inflamação prostática

Several reports have shown that prolactin (PRL) plays a role in prostatic growth, but few studies considered the role of PRL in the process of prostatic inflammation. Young (45 ± 5 days old) and adult (75 ± 5 days old) male Wistar rats were subcutaneously injected daily with domperidone (4.0 mg.kg-1) to maintain high serum PRL levels. The animals were treated for 15, 30, 45 or 60 days. Blood and prostate samples were collected at the end of each treatment for PRL dosage and histological analysis, respectively. Only young animals treated with DOMP for 15 and 30 days displayed inflammatory infiltrate in the prostate. These results confirm literature data in regards to PRL involvement in inducing prostate inflammation. Moreover, it was concluded that young animals are more susceptible then adults to the PRL action concerning prostate inflammation...

A prolactina (PRL) influencia o crescimento prostático, entretanto poucos estudos investigaram o papel da PRL na inflamação prostática. Ratos Wistar jovens (45 ± 5 dias de idade) e adultos (75 ± 5 dias de idade) receberam injeções subcutâneas diárias de domperidona (4,0 mg.kg-1) para manter níveis séricos altos de PRL. Os animais foram tratados por 15, 30, 45 ou 60 dias. Amostras de sangue e próstata foram coletadas ao final dos tratamentos para dosagem de PRL e análise histológica, respectivamente. Apenas os animais jovens tratados com domperidona por 15 e 30 dias apresentaram infiltrado inflamatório na próstata. Esses resultados confirmaram a participação da PRL na indução da inflamação prostática. A conclusão obtida foi que animais jovens são mais susceptíveis à ação da PRL na inflamação da próstata que os adultos...