Evaluación comparativa de efectividad y tolerabilidad con polietilenglicol y picosulfato de sodio-citrato de magnesio como agentes de preparación intestinal para colonoscopia / Comparative evaluation of effectiveness and tolerability with polyethylene glycol and sodium picosulfate-magnesium citrate as intestinal preparation agents for colonoscopy

Resumen Introducción La efectividad de la colonoscopia depende de múltiples factores, destacando la calidad de preparación intestinal y la tolerabilidad que tenga el paciente a la preparación administrada. Objetivo Comparar dos agentes de preparación intestinal, el polietilenglicol (PEG) y el picosulfato de sodiocitrato de magnesio (PSCM) en términos de efectividad y tolerabilidad de la preparación. Pacientes y Método Ensayo clínico aleatorizado en pacientes ambulatorios sometidos a colonoscopia en Clínica INDISA. Evaluando efectividad y tolerabilidad con el Boston Bowel Preparation Score (BBPS) y cuestionario de Lawrence [compuesto por escala Likert, dos preguntas cualitativas y escala visual análoga (EVA)], respectivamente. Resultados 189 pacientes, de los cuales 123 se aleatorizaron a PEG y 66 a PSCM. El BBPS en los pacientes que utilizaron PEG, la media fue 7,51 (DS 1,66) y con PSCM fue 7,12 (DS 1,71) (p = 0,111). Al analizar la tolerabilidad con escala Likert, la media con PEG fue 0,94 (DS 0,68) y con PSCM fue 0,63 (DS 0,61) (p = 0,0004). La EVA con PEG tuvo una media de 7,68 (DS 2,4) y con PSCM de 9,04 (DS 1,59) (p < 0,0001). Al preguntar ausentismo laboral, no hubo diferencias significativas en ambos grupos y al preguntar si ocuparía la misma preparación en una futura colonoscopia, hubo significancia estadística a favor del PSCM (p = 0,026). Conclusión No encontramos diferencias en la efectividad de preparación intestinal al comparar PEG y PSCM, sin embargo, el PSCM es mejor tolerado.

Introduction The effectiveness of colonoscopy depends on multiple factors, being two of the most important ones an adequate bowel preparation and the patient's tolerability to the preparation. Objectives Compare effectiveness and tolerability of two bowel preparation agents, polyethylene glycol (PEG) and sodium picosulfate/magnesium citrate (SPMC). Patients and Methods Randomized clinical trial on outpatients that went into colonoscopy in INDISA Clinic. We evaluated effectiveness and tolerability with Boston Bowel Preparation Score (BBPS) and Lawrence questionnaire [composed by Likert scale, two qualitative questions and Visual Analogue Scale (VAS) for pain], respectively. Results 189 patients, 123 were randomized to PEG and 66 to SPMC. BBPS average in patients in the PEG branch was 7.51 (SD 1.66) and for SPMC 7.12 (SD 1.71) (p = 0.111). Likert scale for evaluating tolerability average for PEG was 0.94 (SD 0.68) and for SPMC 0.63 (SD 0.61) (p = 0.0004). VAS scale for PEG had an average of 7.68 (SD 2.4) and for PSCM 9.04 (SD 1.59) (p < 0.0001). When we asked for workplace absenteeism, there were no significant differences between both groups and when we asked about using the same intestinal preparation in a future colonoscopy there was statistical significance in favor to SPMC (p = 0.026). Conclusions No differences were noted on effectiveness between the PEG and SPMC bowel preparations. Nevertheless, SPMC appeared to be better tolerated by patients.

Estudio comparativo entre el uso de manitol y el picosulfato sódico como preparación para colonoscopía / Comparison of colon-cleansing methods in preparation for colonoscopy- comparative of solutions of mannitol and sodium picosulfate

Objetivos: El objetivo del presente estudio es comparar la preparación adecuada del colon con manitol y picosulfato sódico. Evaluar la aceptación de los pacientes, los efectos secundarios y la capacidad de limpieza. Materiales y métodos: Este es un estudio no aleatorio, prospectivo, ciego, en que el evaluador no tenía información sobre la preparación aplicada. La muestra obtenida se dividió en dos grupos de acuerdo con la preparación adecuada del colon, con 153 pacientes preparados con manitol al 10% y 84 pacientes con picosulfato sódico. La evaluación de la preparación se realizó usando la Escala de Boston (Boston Bowel Preparation Scale - BBP) a través de un sistema de puntuación para cada región del colon puntuada con 3 puntos: derecha, izquierda y colon transverso. Resultados: De los 237 pacientes que fueron evaluados, 146 (61,60%) eran mujeres y 91 (38,4%) eran hombres. En el grupo que utilizó manitol, 98 (64,05%) eran mujeres y 55 (35,95%) eran varones. Entre los pacientes que utilizaron picosulfato sódico, 48 (57,14%)eran mujeres y 36 (42,86%) eran hombres, sin diferencias estadísticas de ambos grupos (p>0,32). Teniendo en cuenta que con la adecuada preparación del colon y con puntuación de 6 puntos en la Escala de Boston, la preparación intestinal fue satisfactoria en ambos grupos. El 93% de los pacientes que utilizaron manitol y el 81% de los pacientes que utilizaron picosulfato sódico tenían preparación adecuada (puntuación de 6). La puntuación media en la preparación con manitol fue de 9 y en la preparación con picosulfato sódico fue de 7. No hubo diferencias significativas entre ambos grupos. Conclusión: Ambas preparaciones, demostraron ser seguras y eficaces para la limpieza del intestino, de acuerdo con la Escala de Boston, así como, la aceptabilidad de los pacientes y libre de complicaciones

Objectives: The purpose of the present study is to compare intestinal preparation with mannitol and sodium picosulphate, assessing patient’s acceptance, side effects and cleaning capacity. Material and methods: This is a prospective, nom randomized, blind study, in which the evaluator had no information about the preparation applied. The sample obtained was divided into two groups according to the bowel preparation applied, with 153 patients prepared with 10% mannitol and 84 patients with sodium picosulfate. The evaluation of colon preparation was done using the Boston Scale (Boston Bowel Preparation Scale - BBP) through a three-point scoring system for each of the three regions of the colon: right, left and transverse colon. Results: Of the 237 patients that were evaluated, 146 (61.60%) were female and 91 (38.4%) were male. Regarding the group that used mannitol, 98 were female (64.05%) and 55 were male (35.95%). Among the patients who used sodium picosulfate, 48 were female (57.14%) and 36 were male (42.86%), with no statistical differences between both groups (p> 0.32). Considering that an adequate preparation scores ≥ 6 in the Boston Scale, the bowel cleansing preparation was satisfactory in both groups. 93% of the patients who used mannitol and 81% of the patients who used sodium picosulfate had adequate preparation (score of ≥ 6). Moreover, we consider that the average score in the preparation with Mannitol was 9, while the sodium picosulfate score was 7. There were no significant differences between the two groups. Conclusion: There is consensus among authors who state that colonoscopy’s safety and success are highly related to the cleansing outcome, regardless of the method used. The same can be observed in the present study, on which both preparations were proved safe and effective for bowel cleansing, according to the Boston scale, as well as accepted by patients and free of complications

Sodium Picosulfate with Magnesium Citrate (SPMC) Plus Laxative Is a Good Alternative to Conventional Large Volume Polyethylene Glycol in Bowel Preparation: A Multicenter Randomized Single-Blinded Trial

BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.

Early Caffeine Use in Very Low Birth Weight Infants and Neonatal Outcomes: A Systematic Review and Meta-Analysis

The use of caffeine citrate for treatment of apnea in very low birth weight infants showed short-term and long-term benefits. A systematic review and meta-analysis of the literature was undertaken to document the effect providing caffeine early (0-2 days of life) compared to providing caffeine late (> or =3 days of life) in very low birth weight infants on several neonatal outcomes, including bronchopulmonary dysplasia (BPD). We searched MEDLINE, the EMBASE database, the Cochrane Library, and KoreaMed for this meta-analysis. The quality of the included studies was assessed using the Newcastle-Ottawa Scale and Jadad's scale. Studies were included if they examined the effect of the early use of caffeine compared with the late use of caffeine. Two reviewers screened the candidate articles and extracted the data from the full-text of all of the included studies. We included a total of 59,136 participants (range 58,997-59,136; variable in one study) from a total of 5 studies. The risk of death (odds ratio [OR], 0.902; 95% confidence interval [CI], 0.828 to 0.983; P=0.019), bronchopulmonary dysplasia (BPD) (OR, 0.507; 95% CI, 0.396 to 0.648; P<0.001), and BPD or death (OR, 0.526; 95% CI, 0.384 to 0.719; P<0.001) were lower in the early caffeine group. Early caffeine use was not associated with a risk of necrotizing enterocolitis (NEC) and NEC requiring surgery. This meta-analysis suggests that early caffeine use has beneficial effects on neonatal outcomes, including mortality and BPD, without increasing the risk of NEC.

Effects of Sodium Citrate on Salt Sensitivity and Kidney Injury in Chronic Renal Failure

Metabolic acidosis, which is observed in salt-sensitive hypertension, is also associated with kidney injury. Alkali therapy in chronic renal failure (CRF) may ameliorate the progression of kidney disease; however, few studies have examined the effects of alkali therapy on salt sensitivity and kidney injury in CRF. We randomly administered standard diet (SD), sodium chloride with 20% casein diet (NACL), or sodium citrate with 20% casein diet (NACT) to Sprague-Dawley rats after a CRF or a sham operation. Four weeks after 5/6 nephrectomy, serum bicarbonate levels were higher in the NACT-treated group. On the pressure-natriuresis curve, NACT-treated CRF rats were more salt-resistant than NACL-treated CRF rats. Additionally, the NACT-treated CRF group showed less tubulointerstitial damage than the NACL-treated CRF group. The expression and immunoreactivity of NHE3 in the kidney in the NACT-treated CRF group were lower than those in the NACL-treated CRF group. We observed that dietary NACT as alkali therapy in CRF might improve the altered salt-sensitivity and ameliorate the progression of kidney injury compared to the NACL diet, which may be related to reduced renal NHE3 expression.

The Evolution of Bowel Preparation and New Developments / 대한소화기학회지

Bowel preparation is essential for successful colonoscopy examination, and the most important factor is the bowel preparation agent used. However, selection of a bowel preparation agent invariably involves compromise. Originally, bowel preparation was performed for radiologic and surgical purposes, when the process involved dietary limitations, cathartics, and enemas, which had many side effects. Development of polyethylene glycol (PEG) solution led to substantive advancement of bowel preparation; however, despite its effectiveness and safety, the large volume involved, and its salty taste and unpleasant odor reduce compliance. Accordingly, modified PEG solutions requiring consumption of lower volumes and sulfate-free solutions were developed. Aqueous sodium phosphate is more effective and better tolerated than PEG solutions; however, fatal complications have occurred due to water and electrolyte shifts. Therefore, aqueous sodium phosphate was withdrawn by the US Food and Drug Administration, and currently, only sodium phosphate tablets remain available. In addition, oral sulfate solution and sodium picosulfate/magnesium citrate are also available, and various studies have reported on adjunctive preparations, such as hyperosmolar or stimulant laxatives, antiemetics, and prokinetics, which are now in various stages of development.

Influence of concentration, time and method of application of citric acid and sodium citrate in root conditioning

OBJECTIVES: The aim of this study was to establish the parameters of concentration, time and mode of application of citric acid and sodium citrate in relation to root conditioning. MATERIAL AND METHODS: A total of 495 samples were obtained and equally distributed among 11 groups (5 for testing different concentrations of citric acid, 5 for testing different concentrations of sodium citrate and 1 control group). After laboratorial processing, the samples were analyzed under scanning electron microscopy. A previously calibrated and blind examiner evaluated micrographs of the samples. Non-parametric statistical analysis was performed to analyze the data obtained. RESULTS: Brushing 25% citric acid for 3 min, promoted greater exposure of collagen fibers in comparison with the brushing of 1% citric acid for 1 minute and its topical application at 1% for 3 min. Sodium citrate exposed collagen fibers in a few number of samples. CONCLUSION: Despite the lack of statistical significance, better results for collagen exposure were obtained with brushing application of 25% citric acid for 3 min than with other application parameter. Sodium citrate produced a few number of samples with collagen exposure, so it is not indicated for root conditioning.

Disponibilidad potencial in vitro de hierro y zinc en una dieta infantil con pan fortificado con distintas fuentes de hierro o con agregado de promotores de la absorción / Iron and zinc in vitro potential availability in an infant diet with fortified bread with different iron sources or with the adition of different iron absorption promoters

Los alimentos complementarios más utilizados son las dietas caseras. En el presente trabajo se evaluó la disponibilidad de hierro y zinc en una dieta infantil de consumo habitual conteniendo pan fortificado con diferentes fuentes de hierro: sulfato ferroso, bisglicinato ferroso, NaFeEDTA. También se utilizó pan sin fortificar con agregado de ácido ascórbico, citrato de sodio o Na2EDTA como promotores de la absorción, combinada con diversas bebidas. La dieta (papa, zapallo, sémola, pan y manzana) se combinó con agua, leche, té, bebida cola y bebida artificial a base de naranja. La dializabilidad (D) mineral, como indicador de la disponibilidad potencial fue determinada utilizando un método in vitro. El análisis estadístico se realizó utilizando ANOVA, con test de Tukey a posteriori. No hubo diferencias significativas en la DFe entre las dietas del pan fortificado con sulfato o bisglicinato; con el NaFeEDTA aumentó significativamente (p<0,05). El aumento de la DFe fue mayor en las dietas que tenían panes con promotores que en las que tenían panes fortificados. La bebida a base de naranja aumentó la DFe, mientras que el té y la leche la disminuyeron significativamente (p<0,05). La DZn aumentó en forma significativa cuando el pan estaba fortificado con sulfato o NaFeEDTA, pero no cuando se fortificó con bisglicinato. El agregado de té o leche disminuyó la DZn mientras que la bebida a base de naranja la aumentó significativamente (p<0,05). En relación a los promotores, las mayores DFe y DZn se observaron en las dietas con el pan sin fortificar, con agregado de Na2EDTA.

Home-made diets are the most frequently used complementary foods. In the present work we evaluated iron and zinc availability in a usually consumed infant diet containing either iron-fortified bread with different iron sources: ferrous sulfate, ferrous bisglycinate, NaFeEDTA. We also used non-fortified bread with absorption promoters: ascorbic acid, sodium citrate, Na2EDTA, combined with different beverages. The diet (potato, pumpkin, grits, bread, and apple) was combined with water, milk, tea, a soft drink and an orange-based artificial drink. Mineral dialyzability (D) as an indicator of potential availability was determined using an in vitro method. Statistical analysis was performed by ANOVA, and a posteriori Tukey test. There were no significant differences in FeD between diets with ferrous sulfate or ferrous bisglycinate fortified bread; in NaFeEDTA fortified bread it increased significantly (p<0.05). Iron D increase was greater in diets with bread containing absorption promoters than in those with fortified bread. The orange-based artificial drink increased FeD, while tea and milk decreased it significantly (p<0.05). Zinc D increased significantly when the bread was fortified either with ferrous sulfate or NaFeEDTA, but remained unchanged in diets with ferrous bisglycinate fortified bread. The addition of tea or milk decreased ZnD while the orange-based artificial drink increased it significantly (p<0.05). Regarding absorption promoters, the greater values both in FeD and ZnD were observed in diets with iron nonfortified bread containing Na2EDTA.

Citrate attenuates tubulointerstitial fibrosis in 5/6 nephrectomized rats by decreasing transforming growth factor-beta1.

OBJECTIVE: Tubulointerstitial fibrosis plays an essential role in progression to end stage renal disease (ESRD) in various chronic renal failure (CRF) models including the 5/6 nephrectomy (5/6). The present study examines the renoprotective effect of citrate in the renal ablative model that is quite similar to CRF in human. MATERIAL AND METHOD: Male Wistar rats underwent 5/6 and were fed with tap water (5/6tap) or tap water containing 67 mEq/L citrate solution (5/6cit). Sham-operated rats (S) were divided into Stap and Scit groups. Renal function, renal histopathology, renal alpha-Smooth muscle actin (SMA), and renal transforming growth factor (TGF)-beta1 were determined immediately and at the 8th week after operation. RESULTS: Following the surgery, the values of glomerular filtration rate (GFR) in the 5/6tap and the 5/6cit groups were 2.39 +/- 0.25 and 2.35 +/- 0.25 (mL/kg/min), respectively, both were significantly lower than sham groups (p < 0.05). At the eighth week, the 5/6tap group had progressively decreased GFR and had higher fibrosis score, increased alpha-SMA positive cells, and renal tissue TGF- beta1 when compared with the sham groups. The 5/ 6cit group, when compared with the 5/6tap group, had higher GFR (2.51 +/- 0.22 vs 1.17 +/- 0.33 mL/kg/min; p < 0.05), lower fibrosis score (1.83 +/- 0.88 vs 3.0 +/- 0.4, p < 0.001), lower alpha-SMA activity (159 +/- 2.9 vs 187 +/- 12.3 cells per 1000 interstitial cells, p < 0.05), and lower renal TGF-beta1 levels (1771.3 +/- 239.5 vs 4716.9 +/- 871.2 pg/mg protein, p < 0.005). CONCLUSION: As such, in 5/6 nephrectomized rats, citrate therapy for eight weeks could decrease tubulointerstitial fibrosis mainly by reducing the heightened renal TGF-beta1 levels and additionally by attenuating the increased myofibroblast activity.

Efficacy and safety of Ascoril expectorant and other cough formula in the treatment of cough management in paediatric and adult patients--a randomised double-blind comparative trial.

The present study was undertaken to study the comparative safety and efficacy of two cough formulas viz, Ascoril expectorant and other cough formula in the management of cough associated with respiratory disorders. Fifty patients having cough associated with various respiratory disorders like bronchitis and upper or lower respiratory tract infections were randomly divided into 2 equal groups and were treated with one of the two cough formulas viz, Ascoril cough formula and other cough formula in double-blind manner over a period of 15 days. The evaluation of improvement was carried out by a rating scale using three clinical parameters--cough, sputum and breathlessness. The physicians were asked to rate the effectiveness of the therapy and patients were asked to rate the acceptability of therapy using pre-defined operational criteria. It was observed that the improvement and symptom relief was almost immediate, quicker and better in the group receiving Ascoril as compared to other group. On effectiveness parameter, 96% of the physicians rated Ascoril as having either 'very high effectiveness or high effectiveness' as opposed to only 34% of the physicians who rated other cough formula as having 'high' or 'very high effectiveness'. While on parameter of acceptability, 96% of the patients rated acceptability of Ascoril as 'high' or 'good' as opposed to only 24% of the patients who rated other cough formula 'high' or 'good'. The findings of this study suggests that Ascoril cough formula has better efficacy as well as better patient acceptability. Thus, Ascoril cough formula is superior to other cough formula in management of cough associated with respiratory disorders.

O emprego do citrato de clomifeno e gonadotrofina de mulher menopausada como alternativa de hiperestimulaçäo ovariana em pacientes com resposta idiopática inadequada na fertilizaçäo in vitro / Clomiphene citrate and gonadotropins of woman in menopause as an alternative approach to ovarian hyperstimulation in idiopatic poor response for in vitro fertilization

OBJETIVO: Avaliar os efeitos do esquema de estimulaçäo ovariana com citrato de clomifeno (CC)/gonadotrofina de mulher menopausada (hMG) nos resultados da fertilizaçäo in vitro e transferência de embriöes (FIVETE) em um grupo de pacientes que apresentaram resposta ovariana inadequada em ciclos prévios de FIVETE estimulados com um análogo do GnRH e gonadotrofinas (protocolo longo). MÉTODO: Os resultados de FIVETE em ciclos estimulados com CC/hMG e com o protocolo longo de uma mesma paciente foram comparados. Oito pacientes (grupo I) que apresentaram uma resposta ovariana idiopática inadequada (idade: < 38 anos, FSH<15 mU/mL, E2<60pg/mL, ciclos menstruais regulares e ausência de cirurgia ovariana) ao protocolo longo em 11 ciclos de FIVETE (grupo Ia), foram estimuladas com CC/hMG em 20 ciclos (grupo Ib). Administrou-se CC 100 mg/dia por 5 dias a partir do 3§ dia do ciclo e o hMG 150 UI/dia foi iniciado no 5§ dia, sendo a dose modificada de acordo com a resposta da paciente. Dezenove ciclos de 15 pacientes com resposta ovariana adequada ao protocolo longo, durante o mesmo intervalo de tempo, foram incluídas neste estudo como grupo controle (grupo II). Casais com fator masculino de infertilidade foram excluídos. RESULTADOS: As pacientes avaliadas näo apresentaram diferença em termos de idade, duraçäo da infertilidade e do índice de massa corpórea. Embora a duraçäo do estímulo ovariano tenha sido similar nos 3 grupos: 10,1 + 0,76, 10,9 + 0,34 e 10,3 + 0,21 dias para os grupos Ia, Ib e II, respectivamente, o número médio de ampolas de hMG utilizado no grupo Ib (13,6 + 1,36) foi significativamente menor (p<0.001) quando comparado aos grupos Ia e II (49,9 + 3,20, 43,7 + 2,73; respectivamente). A taxa de cancelamento foi de 36,4 por cento, 25,0 por cento e 0 por cento (grupos Ia, Ib e II; respectivamente), näo revelando diferença entre os grupos Ia e Ib. Os números médios de oócitos MII inseminados e fertilizados foram de 4,9 + 0,8 e 1,3 + 0,4 no grupo Ia e de 4,4 + 0,3 e 2,1 + 0,2 no grupo Ib, näo mostrando diferença entre os grupos. Contudo, os números médios de oócitos MII inseminados e fertilizados no grupo II, 11,4 + 2,0 (p<0.01) e 7,9 + 2,0 (p=0.01), respectivamente, foram significativamente maiores quando comparados aqueles do grupos Ia e Ib...

Dosagem de citrato urinario em individuos adultos normais e em pacientes com calculose urinaria recidivante / Urinary citrate dosage in normal adult persons and in patients with recurrent urinary calculi

A presenca de acido citrico na urina e sua habilidade em ligar ions calcio formando complexos soluveis esta bem reconhecida. Tem sido sugerido que, por este mecanismo, o citrato possa desempenhar papel importante na prevencao de calculos urinarios. No presente trabalho os autores discutem a utilidade da dosagem de citrato urinario em pacientes portadores de nefrolitiase, no sentido de identificar sua deficiencia. Apresentam ainda, revisao das atuais recomendacoes para a suplementacao de citrato para os pacientes hipocitraturicos, com o objetivo de prevenir a formacao de novos calculos. Foram analisadas urinas de 48 individuos adultos normais e de 46 pacientes calculosos. O citrato foi dosado em urina de 24 horas, utilizando-se um metodo enzimatico especifico. Os resultados sao expressos em concentracao (mg) e em relacao a excrecao de creatinina (mg/g). Dos pacientes analisados, 18 (39,1 por cento) se mostraram hipocitraturicos quando cotejados com os resultados obtidos no grupo controle de individuos do mesmo sexo. Em seis pacientes (13 por cento) a hipocitraturia foi a unica anormalidade metabolica detectada.