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Results of ambulatory dual-probe esophageal pH monitoring for patients with pulmonary symptoms and possible GERD
Esophageal, Gastric, and Duodenal Disorders A311
April 1998 G1271 RESULTS O F A M B U L A T O R Y DUAL-PROBE ESOPHAGEAL pH MONITORING FOR PATIENTS WITH PULMONARY SYMPTOMS AND POSSIBLE GELID. Tetsuya Tomonaga, Charles J. Filipi, Yutaka Shiino, Tomas E. Martinez, Robert E. Marsh, Ziad T. Awad, Department of Surgery, Creighton University, Omaha, Nebraska.
Table 2 Meds. PPI ] abstinent days 2-3 4-6 7-9 ~ 10 Total Frequency of pH test 88% 90% 72% 75% 79% positive pH patient 7 26 67 27 127 negative pH patient 1 3 25 9 33 There is no significantdifferencein frequencyof pH test positivitybetweengroups.
Introduction: Gastroesophageal reflux disease (GERD) ofteri is associated with pulmonary problems such as asthma and recurrent cough. Dual probe 24 hour pH monitoring may assist in establishing a cause and effect relationship. A retrospective study to better define the role of dual probe monitoring was undertaken. Methodology: Ambulatory dual-probe esophageal pH monitoring was performed on 114 patients with laryngeal or pulmonary symptoms thought to be secondary to GERD. A distal pH monitoring sensor was placed 5cm above the lower esophageal sphincter (LES), the proximal sensor at 1 cm below the upper esophageal sphincter. A proximal probe test result was considered positive if time % pH < 4.0 was > 0.6 and/or number of reflux episodes exceeded 10 in 24 hours. These two groups were compared for age, sex, LES pressure, body pressure, intraabdominal length of LES, total length of LES, intraabdominal vector volume and total vector volume. Distal probe DeMeester score results were also compared to proximal probe scores. In patients with a positive distal score (Group I), manometric comparisons were made to those patients with a positive and negative proximal probe score (Group II). In addition, the characteristics of 24 hour distal probe positive results were related to proximal probe results. The Mann-Whitney test was used for statistical comparisons. Results: The ages ranged from 18 to 83 years (mean age: 50.4 -+ 16.4 years). (Table).
Conclusion: Abstinence from PPI for only 4 days is appropriate and may improve patient compliance with the test. A prospective randomized trial to verify these results is recommended.
Distal probe data Group l(n=18) Group II(n=28) 61.5±35.2 98.4 ± 7.19 Upright # of reflux 2.4 ± 2.0 4.2±4.1 # of reflux longerthan 5 min. 9.1 ±6.3* Longestreflux episodes(min.) 17.3 ± 12.8" Total time pH below4 (rain.) 109.5 ± 82.0** 56.9±29.1"* Fraction time pH below4 (%) 13.4 ± 10.2"** 9.8 ± 15.5"** 20.2±33.3 40.8 ± 78.6 Supine # of reflux 1.8±2.9 2.2±3.2 # of reflux longer than 5 min. 9.6 ± 12.0 18.4 ± 33.4 Longestreflux episodes(min.) 26.4±31.7 64.5 ± 106.7 Total time pH below 4 (rain.) 5.7 ± 6.2 13.8 ± 23.2 Fraction time pH below4 (%) *,**,***: p < 0.05
Prox probe Group I 22.4±17.4 0.8 ± 1.3 6.2±7.7 18.7±17.4 2.3 ± 2.2 12.6±26.8 0.6±0.8 7.9 ± 17.1 14.6±21.7 3.2 ± 4.7
There was no difference between LES vector volume manometric values when comparing Group I and Group II. Reflux patterns in the distal and proximal probe corresponded as shown in the Table. Conclusion: In those patients with GERD, manometry and vector volumes do not assist in predicting proximal reflux. Proximal and distal probe data reveal a simple pattern of acid reflux. G1272 WHAT IS THE APPROPRIATE PERIOD OF ABSTINENCE FROM PROTON PUMP INHIBITORS PRIOR TO 24 H O U R pH MONITORING? A RETROSPECTIVE SYUDY. Tetsuya Tomonaga, Charles J. Filipi, Yutaka Shiino, Robert E. Marsh, Ziad T. Awad, Tomas Martinez, Department of Surgery, Creighton University, Omaha, Nebraska Introduction: Patients on proton pump inhibitors (PPI) may require 24 hour pH monitoring to determine appropriateness of surgical intervention. However, patients often become intolerant of long period PPI abstinence. Pharmaceutical data suggests that gastric secretory function returns within 2-5 days. To determine the correct period of PPI abstinence prior to 24 hour pH monitoring a retrospective analysis of 160 patients was completed. Methodology: One thousand four hundred and forty five patients have undergone 24 hour pH monitoring in our laboratory. Of these only patients on PPI and having manometric criteria strongly suggestive of gastroesophageal reflux disease (lower esophageal sphincter pressure (LESP) < 6.1 mmHg) were studied (n=160). Patients were categorized by length of PPI abstinence. LESP, esophageal body pressure (middle and distal levels), intraabdominal length of LES, total length of LES, intraabdominal vector volume(IVV) and total vector volume(TVV) scores were compared between groups of abstinence using the Kruskal-Wallis test. Frequency of positive results between groups was statisticallycompared using Fisher's test. Results:
period of abstinence LESP (mmHg) Body pressure middle (mmHg) distal Abd. lengthof LES Total length LES ( c m ) IVV (mmHg2.mm) TVV (mmH~2.mm)
Table 1
2-3 days 4-6 days 7-9 days > 10 days 3.4±1.8 2.6±1.4 2.9±1.5 3.1±1.9 34.8.±21.8 57.3±29.4 59.8+_27.8 57.7+33.3 51.0±47.4 63.4±32.7 67.8±45.3 68.1±38.7 1.4±0.7 1.6±0.9 2.0±1.1 1.9±0.9 3.3±0.5 4.2±1.8 4.7±1.8 4.6±1.7 none 731.7±649.6 932.3±967.7 900.9±1204.6 none 883.3±1019.4 1478.1±1349.6 1673.9±2062.6 There are no significant differences betweenvaluesin all 4 groups.
G1273 EFFECTS OF LOW DOSE RANITIDINE ON THE PHARMACOKINETICS OF ALCOHOL 0.15G/KG. S. Toon 1, C.C.L. Snell2, J. G. Mills2, J.R. Wood 2. 1Medeval Ltd, Manchester, UK; 2Glaxo Wellcome Research & Development, Middlesex, UK Low dose ranitidine (75mg) is now available for over-the-counter use. This study evaluated the effects of low doses of ranitidine on the pharmacokinetics of alcohol. Methods: This was a placebo-controlled, randomised, double-blind, 3-way crossover study in 24 healthy male subjects. Subjects were randomised using orthogonal latin squares and were dosed on three separate occasions. Fed subjects received ranitidine 25mg, ranitidine 75mg or placebo twice dally for seven days with a final dose of ranitidine or placebo in the morning one hour prior to dosing with a single oral dose of ethanol 0.15g/kg on day 8. An IV canula was inserted in the subject's forearm vein and blood samples were collected before and up to 3 hours after alcohol ingestion. Blood alcohol concentrations (BAC) were determined in whole blood using Head Space Gas Chromatography. Maximum BAC (C x), the area under the concentrationtime curve measured from time zero up to the last quantifiable alcohol concentration time point (AUC~L~), and the time to reach C ~ (Tin,x) were determined. Statistical comparisons were made between groups using ANOVA (Cm.~and AUC,L,) and Wilcoxon rank sign test ( T ) . Results: The BAC values were low in all dosing groups. There were no statistically significant differences in alcohol pharmacokinetics between placebo and ranitidine 25mg or ranitidine 75mg. Both ranitidine doses were well tolerated. Study Drag Placebo Ranitidine 25mg Ranitidine 75mg
AUClast Geometric Mean (95% CI) 3.4 (2.8, 4.3) 3.8 (3.1, 4.7) 4.3 (3.4, 5.4)
Cmax Geometric Mean (95% CI) 5.4 (4.4, 6.7) 6.1 (5.0, 7.4) 7.2 (5.8, 8.9)
Tmax Median (Range) 20 (10 to 30) 20 (10 to 40) 20 (10 to 30)
Conclusions: The use of ranitidine 75rag to treat or prevent episodic heartburn is unlikely to have any clinically or socially relevant effects on blood alcohol concentrations. This study was funded by Glaxo Wellcome Research and Development. G1274 MULTIDRUG RESISTANCE AMONG H. PYLOR/STRAINS INFECTING MEXICAN CHILDREN. Torres J, Gonz~ilez G, Gonzfilez B, Yafiez P, Monz6n E, Madrazo-de la Garza A. Hospital de Pediatria, CMN Siglo XXI, IMSS, MEXICO. The resistance of H. pylori to antimicrobials is increasing worldwide, mainly in developing countries. The aim of this study was to measure the in vitro susceptibility of H. pylori strains isolated from children to the most commonly used antimicrobials. Methods: Thirty five strains isolated from children with upper GI symptoms were included. Infected children were 2-16 years old. Gastric biopsies were cultured in selective blood agar plates and suspected colonies identified with the urease, catalase and oxidase tests. Susceptibility to amoxicillin, metronidazole and clarithromycin was tested with the epsilometer test (e-test). Results: Antibiotic Amoxicillin Clarithromycin Metronidazole Clarithro+Metro
cutoff value 4 lag/ml 8 ~tg/ml 29 lag/ml
No. resistant (%) 7 (20) 8 (23) 29 (83) 8 (23)
Resistance to amoxicillin was lost after subcultures in all 7 strains. Conclusions: H. pylori strains infecting Mexican children are highly resistant to metronidazole and frequently resistant to both metronidazole and clarithromycin. Some strains showed a very unstable resistance to amoxicillin.
April 1998 G1271 RESULTS O F A M B U L A T O R Y DUAL-PROBE ESOPHAGEAL pH MONITORING FOR PATIENTS WITH PULMONARY SYMPTOMS AND POSSIBLE GELID. Tetsuya Tomonaga, Charles J. Filipi, Yutaka Shiino, Tomas E. Martinez, Robert E. Marsh, Ziad T. Awad, Department of Surgery, Creighton University, Omaha, Nebraska.
Table 2 Meds. PPI ] abstinent days 2-3 4-6 7-9 ~ 10 Total Frequency of pH test 88% 90% 72% 75% 79% positive pH patient 7 26 67 27 127 negative pH patient 1 3 25 9 33 There is no significantdifferencein frequencyof pH test positivitybetweengroups.
Introduction: Gastroesophageal reflux disease (GERD) ofteri is associated with pulmonary problems such as asthma and recurrent cough. Dual probe 24 hour pH monitoring may assist in establishing a cause and effect relationship. A retrospective study to better define the role of dual probe monitoring was undertaken. Methodology: Ambulatory dual-probe esophageal pH monitoring was performed on 114 patients with laryngeal or pulmonary symptoms thought to be secondary to GERD. A distal pH monitoring sensor was placed 5cm above the lower esophageal sphincter (LES), the proximal sensor at 1 cm below the upper esophageal sphincter. A proximal probe test result was considered positive if time % pH < 4.0 was > 0.6 and/or number of reflux episodes exceeded 10 in 24 hours. These two groups were compared for age, sex, LES pressure, body pressure, intraabdominal length of LES, total length of LES, intraabdominal vector volume and total vector volume. Distal probe DeMeester score results were also compared to proximal probe scores. In patients with a positive distal score (Group I), manometric comparisons were made to those patients with a positive and negative proximal probe score (Group II). In addition, the characteristics of 24 hour distal probe positive results were related to proximal probe results. The Mann-Whitney test was used for statistical comparisons. Results: The ages ranged from 18 to 83 years (mean age: 50.4 -+ 16.4 years). (Table).
Conclusion: Abstinence from PPI for only 4 days is appropriate and may improve patient compliance with the test. A prospective randomized trial to verify these results is recommended.
Distal probe data Group l(n=18) Group II(n=28) 61.5±35.2 98.4 ± 7.19 Upright # of reflux 2.4 ± 2.0 4.2±4.1 # of reflux longerthan 5 min. 9.1 ±6.3* Longestreflux episodes(min.) 17.3 ± 12.8" Total time pH below4 (rain.) 109.5 ± 82.0** 56.9±29.1"* Fraction time pH below4 (%) 13.4 ± 10.2"** 9.8 ± 15.5"** 20.2±33.3 40.8 ± 78.6 Supine # of reflux 1.8±2.9 2.2±3.2 # of reflux longer than 5 min. 9.6 ± 12.0 18.4 ± 33.4 Longestreflux episodes(min.) 26.4±31.7 64.5 ± 106.7 Total time pH below 4 (rain.) 5.7 ± 6.2 13.8 ± 23.2 Fraction time pH below4 (%) *,**,***: p < 0.05
Prox probe Group I 22.4±17.4 0.8 ± 1.3 6.2±7.7 18.7±17.4 2.3 ± 2.2 12.6±26.8 0.6±0.8 7.9 ± 17.1 14.6±21.7 3.2 ± 4.7
There was no difference between LES vector volume manometric values when comparing Group I and Group II. Reflux patterns in the distal and proximal probe corresponded as shown in the Table. Conclusion: In those patients with GERD, manometry and vector volumes do not assist in predicting proximal reflux. Proximal and distal probe data reveal a simple pattern of acid reflux. G1272 WHAT IS THE APPROPRIATE PERIOD OF ABSTINENCE FROM PROTON PUMP INHIBITORS PRIOR TO 24 H O U R pH MONITORING? A RETROSPECTIVE SYUDY. Tetsuya Tomonaga, Charles J. Filipi, Yutaka Shiino, Robert E. Marsh, Ziad T. Awad, Tomas Martinez, Department of Surgery, Creighton University, Omaha, Nebraska Introduction: Patients on proton pump inhibitors (PPI) may require 24 hour pH monitoring to determine appropriateness of surgical intervention. However, patients often become intolerant of long period PPI abstinence. Pharmaceutical data suggests that gastric secretory function returns within 2-5 days. To determine the correct period of PPI abstinence prior to 24 hour pH monitoring a retrospective analysis of 160 patients was completed. Methodology: One thousand four hundred and forty five patients have undergone 24 hour pH monitoring in our laboratory. Of these only patients on PPI and having manometric criteria strongly suggestive of gastroesophageal reflux disease (lower esophageal sphincter pressure (LESP) < 6.1 mmHg) were studied (n=160). Patients were categorized by length of PPI abstinence. LESP, esophageal body pressure (middle and distal levels), intraabdominal length of LES, total length of LES, intraabdominal vector volume(IVV) and total vector volume(TVV) scores were compared between groups of abstinence using the Kruskal-Wallis test. Frequency of positive results between groups was statisticallycompared using Fisher's test. Results:
period of abstinence LESP (mmHg) Body pressure middle (mmHg) distal Abd. lengthof LES Total length LES ( c m ) IVV (mmHg2.mm) TVV (mmH~2.mm)
Table 1
2-3 days 4-6 days 7-9 days > 10 days 3.4±1.8 2.6±1.4 2.9±1.5 3.1±1.9 34.8.±21.8 57.3±29.4 59.8+_27.8 57.7+33.3 51.0±47.4 63.4±32.7 67.8±45.3 68.1±38.7 1.4±0.7 1.6±0.9 2.0±1.1 1.9±0.9 3.3±0.5 4.2±1.8 4.7±1.8 4.6±1.7 none 731.7±649.6 932.3±967.7 900.9±1204.6 none 883.3±1019.4 1478.1±1349.6 1673.9±2062.6 There are no significant differences betweenvaluesin all 4 groups.
G1273 EFFECTS OF LOW DOSE RANITIDINE ON THE PHARMACOKINETICS OF ALCOHOL 0.15G/KG. S. Toon 1, C.C.L. Snell2, J. G. Mills2, J.R. Wood 2. 1Medeval Ltd, Manchester, UK; 2Glaxo Wellcome Research & Development, Middlesex, UK Low dose ranitidine (75mg) is now available for over-the-counter use. This study evaluated the effects of low doses of ranitidine on the pharmacokinetics of alcohol. Methods: This was a placebo-controlled, randomised, double-blind, 3-way crossover study in 24 healthy male subjects. Subjects were randomised using orthogonal latin squares and were dosed on three separate occasions. Fed subjects received ranitidine 25mg, ranitidine 75mg or placebo twice dally for seven days with a final dose of ranitidine or placebo in the morning one hour prior to dosing with a single oral dose of ethanol 0.15g/kg on day 8. An IV canula was inserted in the subject's forearm vein and blood samples were collected before and up to 3 hours after alcohol ingestion. Blood alcohol concentrations (BAC) were determined in whole blood using Head Space Gas Chromatography. Maximum BAC (C x), the area under the concentrationtime curve measured from time zero up to the last quantifiable alcohol concentration time point (AUC~L~), and the time to reach C ~ (Tin,x) were determined. Statistical comparisons were made between groups using ANOVA (Cm.~and AUC,L,) and Wilcoxon rank sign test ( T ) . Results: The BAC values were low in all dosing groups. There were no statistically significant differences in alcohol pharmacokinetics between placebo and ranitidine 25mg or ranitidine 75mg. Both ranitidine doses were well tolerated. Study Drag Placebo Ranitidine 25mg Ranitidine 75mg
AUClast Geometric Mean (95% CI) 3.4 (2.8, 4.3) 3.8 (3.1, 4.7) 4.3 (3.4, 5.4)
Cmax Geometric Mean (95% CI) 5.4 (4.4, 6.7) 6.1 (5.0, 7.4) 7.2 (5.8, 8.9)
Tmax Median (Range) 20 (10 to 30) 20 (10 to 40) 20 (10 to 30)
Conclusions: The use of ranitidine 75rag to treat or prevent episodic heartburn is unlikely to have any clinically or socially relevant effects on blood alcohol concentrations. This study was funded by Glaxo Wellcome Research and Development. G1274 MULTIDRUG RESISTANCE AMONG H. PYLOR/STRAINS INFECTING MEXICAN CHILDREN. Torres J, Gonz~ilez G, Gonzfilez B, Yafiez P, Monz6n E, Madrazo-de la Garza A. Hospital de Pediatria, CMN Siglo XXI, IMSS, MEXICO. The resistance of H. pylori to antimicrobials is increasing worldwide, mainly in developing countries. The aim of this study was to measure the in vitro susceptibility of H. pylori strains isolated from children to the most commonly used antimicrobials. Methods: Thirty five strains isolated from children with upper GI symptoms were included. Infected children were 2-16 years old. Gastric biopsies were cultured in selective blood agar plates and suspected colonies identified with the urease, catalase and oxidase tests. Susceptibility to amoxicillin, metronidazole and clarithromycin was tested with the epsilometer test (e-test). Results: Antibiotic Amoxicillin Clarithromycin Metronidazole Clarithro+Metro
cutoff value 4 lag/ml 8 ~tg/ml 29 lag/ml
No. resistant (%) 7 (20) 8 (23) 29 (83) 8 (23)
Resistance to amoxicillin was lost after subcultures in all 7 strains. Conclusions: H. pylori strains infecting Mexican children are highly resistant to metronidazole and frequently resistant to both metronidazole and clarithromycin. Some strains showed a very unstable resistance to amoxicillin.