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Pralidoxime in organophosphate poisoning—A randomized controlled trial
J Clin Epidemiol, Vol. 49, Suppl. 1, pp. 3S-29S, Copyright 0 1996 Elsevier Science Inc.
0895-4356/96/$15.00 SSDI 0895-4356(95)00655-9
1996
ELSEVIER
CARE OF ADULTS “RETARDATION OF PATIENTS WITH TO NON-INSULIN (NIDDM)-A RCT OF
“VALIDITY ASSESSMENT
RENAL FUNCTION IMPAIRMENT IN ADVANCED NEPHROPATHY DUE DEPENDENT DIABETES MELLITUS ENALAPRIL (E) & METOPROLOL (M)!’
Mario H. Cardiel, Alejandro Arce-Salinas, Jaime Guzmin, and Jorge Alcocer-Varela, CEU, Instituto National de la Nutricibn, Mexico City, Mexico. Objective: To evaluate the validity of retrospective disease activity assessments derived from clinical charts. Design: Validation study. Setting: Hospital based, tertiary care center. Participants: Thirty five SLE patients were evaluated prospectively in 90 visits using Mex-SLEDAI, SLEDAI, and LACC to assess disease activity. Routine clinical notes were written by rheumatologists blind to indices scores. Notes were reviewed two years later to obtain retrospective indices scores and their validity was assessed using prospective scores as the gold standard. Analysis: Pearson’s product moment correlation coefficient(r), t-tests, kappa statistic, and intraclass correlation coefficient (ri). We also calculated sensitivity and specificity using pre-established cut-off points. Results: Mean retrospective scores were lower in all indices: Mex-SLEDAI (2.9 vs 3.8, p < 0.001, r = 0.87, ri = 0.31); SLEDAI (4.5 vs 5.7, p = 0.01, r = 0.77, ri = 0.30); and LACC (I vs 1.3, p = 0.005, r = 0.71, ri = 0.20). LACC Mex-SLEDAI SLEDAI 0.61 0.53 0.49 Kappa 0.71 0.69 0.75 Sensitivity 0.86 0.76 Specificity 0.91 0.89 0.88 0.84 + oredictive value - predictive value 0.74 0.65 0.64 Accuracy 81.1 75.8 75.5 Conclusions: Retrospective disease activity indices provided lower scores than prospective evaluations. They often missed patients with mildly active disease, but when positive they were good predictors of disease activity.
Ramesh C. Ahuja, M.K. Mitra, S. Sural, D. Saha, S. Mukherjee, A.K., A.R. Sircar, and C.G. Agrawal, CEU, King George’s Medical College, Lucknow, India. Objective: To estimate the comparative rate of changes in creatinine clearance (CC) ml/min/year and macro proteinuria in patients with NIDDM nephropathy treated with (E) and (M) for 2 years. Design: A randomized controlled trial. Setting: Patients attending Outpatient Diabetic Clinics of G.M. &a Associated Hospitals, Lucknow. Participants: Patients with diabetic nephropathy, NIDDM 35 years, BP. > 130/80, CC > 25 ml/min, no conrraindications co E and M and consenting to participate constituted our study sample (n = 242). Intervention: The study subjects were randomized to receive either E (5-20 mgm/day) or M (100-200 mgm/day). Diuretics were added in both E &a M groups to lower BP to <140/90 in hypertensive group and up to 110170 or to reduce DBP by at least IO mm Hg in normotensive group. Main Outcome Measures: Every 3 months for 2 years for fall in CC (primary outcome variable) and level of macro proteinuria (secondary outcome variable). The laboratory personnel estimating CC, macro proteinuria were blinded to the randomization code. Two hundred and two completed 2 years of follow up. Significance of differences in effects of interventions were tested by unpaired two tailed “t” test. Results: The study shows that for similar fall of BP and diabetes control in nvo groups , there was a lesser fall in CC/year at one and two years of follow up in patients receiving E (5.2 + 1.8 & 4.3 * 1.3) in comparison with those on M (8.1 r 1.5 &a 7.2 f 2.7) (p < 0.001). Further, E also had a superior antiproreinuric effect compared to M at 1 and 2 years of follow up (E-391 + 224 & -364 + 231; M 190 f 128 & 189 ? 134) (p < 0.01) Conclusion: Patients on E had a 38% (95% CL 33,43) lesser fall in CC/year at 2 years than those on M. Implication: If these relative differences persist in subsequent years, end stage renal disease would occur 4 years later in patients with advanced NIDDM nephropathy on E than those on M.
“HOW USEFUL HOSPITALIZED
OF RETROSPECTIVE DISEASE ACTIVITY IN SYSTEMIC LUPUS ERYTHEMATOSUS!’
IS THE CHEST ROENTGENOGRAM IN PATIENTS?” Juan J. Calva and Marina Rull, CEU,
“PRALIDOXIME A RANDOMIZED
IN ORGANOPHOSPHATE CONTROLLED TRIAL.”
POISONING-
A.M. Cherian, CEU, Christian Medical College & Hospital, Vellore, India. Introduction: Organophosphate are a group of compounds, of considerable interest and importance, by virtue of their widespread use as insecticides. They are the most common suicidal poison, especially in developing countries, due to easy availability and rampant use of pesticides, at home and in agriculture. The two antidotes used for poisoning are atropine and pralidoxime (PZAM). The dose and usefulness of PZAM defer widely in the literature. Our previous study had shown that a very low dose is as good as the conventional high dose. Objective: This study was aimed at determining the usefulness of PZAM in organophosphate poisoning (OPP). Design: Randomized placebo controlled Double blind Trial. Setting: A large tertiary care Institution, India. Participants: All patients admitted to the medical ICU with OPP, within 48 hours of their poisoning. Results: There were 100 cases, base line characteristics were similar Treatment Placebo Statistical Outcome Group significance Group 1. Mortality 28% p < 0.003 2. Number Ventilated 64% 3:; p < 0.004 3. Intermediate syndrome 64% 36% p < 0.005 There was a slightly increased number of cases of unconscious patients in the treatment group. After adjusting for the ‘Unconsciousness’ there was still a significant difference observed in mortality, number of patients ventilated and intermediate syndrome. Even in the unconscious group mortality is more in the treatment group (81% vs 11%). There was no significant difference between the two groups, in the unconscious patients as regards intermediate syndrome and number of patients ventilated. However in the conscious patients the intermediate syndrome (52% vs 25%) and the number of patients that needed ventilation (52% vs 25%) was significantly more in the treatment group. Conclusion: PZAM, an expensive drug for the treatment of OPP, does more harm than good co the patients.
Instituto National de la Nutricibn, Mexico City, Mexico. Objective: To assess the utility of the chest roentgenogram (CR) in hospitalized patients in terms of its influence on the diagnosis and on the therapeutic decisions made by the clinician. Design: A survey in a group of physicians. Two questionnaires were applied: one when a follow-up CR was ordered (inquiring about reasons for ordering the film, the likelihood that the CR would show changes and physician’s therapeutic plan); the second questionnaire was applied after the CR was obtained (inquiring about how unexpected the CR finding was and degree of influence on therapy). Setting: A tertiary care teaching hospital. Participants: Second-year residents in Internal Medicine. Intervention: N/A. Main Outcome Measure: Both questionnaires were analyzed in regard to the CR interpretation by a radiologist (Gold Standard). Results: One hundred surveys were analyzed. The CR ruled out the suspicion of a new pulmonary event (55% of cases) or of the worsening of a known lung disease (50% of cases) as predicted by the physician. In turn, the CR confirmed the absence of a new pulmonary event (92%) or the improvement/stabilization of the course of a known lung disease (92%), as predicted by the physician. Sixty-one percent of these CRs had a definite influence on patients’ treatment. Conclusion: CR in hospitalized patients is of practical benefit to physicians, mainly in avoiding over diagnosis and unnecessary treatment to their patients.
3s
0895-4356/96/$15.00 SSDI 0895-4356(95)00655-9
1996
ELSEVIER
CARE OF ADULTS “RETARDATION OF PATIENTS WITH TO NON-INSULIN (NIDDM)-A RCT OF
“VALIDITY ASSESSMENT
RENAL FUNCTION IMPAIRMENT IN ADVANCED NEPHROPATHY DUE DEPENDENT DIABETES MELLITUS ENALAPRIL (E) & METOPROLOL (M)!’
Mario H. Cardiel, Alejandro Arce-Salinas, Jaime Guzmin, and Jorge Alcocer-Varela, CEU, Instituto National de la Nutricibn, Mexico City, Mexico. Objective: To evaluate the validity of retrospective disease activity assessments derived from clinical charts. Design: Validation study. Setting: Hospital based, tertiary care center. Participants: Thirty five SLE patients were evaluated prospectively in 90 visits using Mex-SLEDAI, SLEDAI, and LACC to assess disease activity. Routine clinical notes were written by rheumatologists blind to indices scores. Notes were reviewed two years later to obtain retrospective indices scores and their validity was assessed using prospective scores as the gold standard. Analysis: Pearson’s product moment correlation coefficient(r), t-tests, kappa statistic, and intraclass correlation coefficient (ri). We also calculated sensitivity and specificity using pre-established cut-off points. Results: Mean retrospective scores were lower in all indices: Mex-SLEDAI (2.9 vs 3.8, p < 0.001, r = 0.87, ri = 0.31); SLEDAI (4.5 vs 5.7, p = 0.01, r = 0.77, ri = 0.30); and LACC (I vs 1.3, p = 0.005, r = 0.71, ri = 0.20). LACC Mex-SLEDAI SLEDAI 0.61 0.53 0.49 Kappa 0.71 0.69 0.75 Sensitivity 0.86 0.76 Specificity 0.91 0.89 0.88 0.84 + oredictive value - predictive value 0.74 0.65 0.64 Accuracy 81.1 75.8 75.5 Conclusions: Retrospective disease activity indices provided lower scores than prospective evaluations. They often missed patients with mildly active disease, but when positive they were good predictors of disease activity.
Ramesh C. Ahuja, M.K. Mitra, S. Sural, D. Saha, S. Mukherjee, A.K., A.R. Sircar, and C.G. Agrawal, CEU, King George’s Medical College, Lucknow, India. Objective: To estimate the comparative rate of changes in creatinine clearance (CC) ml/min/year and macro proteinuria in patients with NIDDM nephropathy treated with (E) and (M) for 2 years. Design: A randomized controlled trial. Setting: Patients attending Outpatient Diabetic Clinics of G.M. &a Associated Hospitals, Lucknow. Participants: Patients with diabetic nephropathy, NIDDM 35 years, BP. > 130/80, CC > 25 ml/min, no conrraindications co E and M and consenting to participate constituted our study sample (n = 242). Intervention: The study subjects were randomized to receive either E (5-20 mgm/day) or M (100-200 mgm/day). Diuretics were added in both E &a M groups to lower BP to <140/90 in hypertensive group and up to 110170 or to reduce DBP by at least IO mm Hg in normotensive group. Main Outcome Measures: Every 3 months for 2 years for fall in CC (primary outcome variable) and level of macro proteinuria (secondary outcome variable). The laboratory personnel estimating CC, macro proteinuria were blinded to the randomization code. Two hundred and two completed 2 years of follow up. Significance of differences in effects of interventions were tested by unpaired two tailed “t” test. Results: The study shows that for similar fall of BP and diabetes control in nvo groups , there was a lesser fall in CC/year at one and two years of follow up in patients receiving E (5.2 + 1.8 & 4.3 * 1.3) in comparison with those on M (8.1 r 1.5 &a 7.2 f 2.7) (p < 0.001). Further, E also had a superior antiproreinuric effect compared to M at 1 and 2 years of follow up (E-391 + 224 & -364 + 231; M 190 f 128 & 189 ? 134) (p < 0.01) Conclusion: Patients on E had a 38% (95% CL 33,43) lesser fall in CC/year at 2 years than those on M. Implication: If these relative differences persist in subsequent years, end stage renal disease would occur 4 years later in patients with advanced NIDDM nephropathy on E than those on M.
“HOW USEFUL HOSPITALIZED
OF RETROSPECTIVE DISEASE ACTIVITY IN SYSTEMIC LUPUS ERYTHEMATOSUS!’
IS THE CHEST ROENTGENOGRAM IN PATIENTS?” Juan J. Calva and Marina Rull, CEU,
“PRALIDOXIME A RANDOMIZED
IN ORGANOPHOSPHATE CONTROLLED TRIAL.”
POISONING-
A.M. Cherian, CEU, Christian Medical College & Hospital, Vellore, India. Introduction: Organophosphate are a group of compounds, of considerable interest and importance, by virtue of their widespread use as insecticides. They are the most common suicidal poison, especially in developing countries, due to easy availability and rampant use of pesticides, at home and in agriculture. The two antidotes used for poisoning are atropine and pralidoxime (PZAM). The dose and usefulness of PZAM defer widely in the literature. Our previous study had shown that a very low dose is as good as the conventional high dose. Objective: This study was aimed at determining the usefulness of PZAM in organophosphate poisoning (OPP). Design: Randomized placebo controlled Double blind Trial. Setting: A large tertiary care Institution, India. Participants: All patients admitted to the medical ICU with OPP, within 48 hours of their poisoning. Results: There were 100 cases, base line characteristics were similar Treatment Placebo Statistical Outcome Group significance Group 1. Mortality 28% p < 0.003 2. Number Ventilated 64% 3:; p < 0.004 3. Intermediate syndrome 64% 36% p < 0.005 There was a slightly increased number of cases of unconscious patients in the treatment group. After adjusting for the ‘Unconsciousness’ there was still a significant difference observed in mortality, number of patients ventilated and intermediate syndrome. Even in the unconscious group mortality is more in the treatment group (81% vs 11%). There was no significant difference between the two groups, in the unconscious patients as regards intermediate syndrome and number of patients ventilated. However in the conscious patients the intermediate syndrome (52% vs 25%) and the number of patients that needed ventilation (52% vs 25%) was significantly more in the treatment group. Conclusion: PZAM, an expensive drug for the treatment of OPP, does more harm than good co the patients.
Instituto National de la Nutricibn, Mexico City, Mexico. Objective: To assess the utility of the chest roentgenogram (CR) in hospitalized patients in terms of its influence on the diagnosis and on the therapeutic decisions made by the clinician. Design: A survey in a group of physicians. Two questionnaires were applied: one when a follow-up CR was ordered (inquiring about reasons for ordering the film, the likelihood that the CR would show changes and physician’s therapeutic plan); the second questionnaire was applied after the CR was obtained (inquiring about how unexpected the CR finding was and degree of influence on therapy). Setting: A tertiary care teaching hospital. Participants: Second-year residents in Internal Medicine. Intervention: N/A. Main Outcome Measure: Both questionnaires were analyzed in regard to the CR interpretation by a radiologist (Gold Standard). Results: One hundred surveys were analyzed. The CR ruled out the suspicion of a new pulmonary event (55% of cases) or of the worsening of a known lung disease (50% of cases) as predicted by the physician. In turn, the CR confirmed the absence of a new pulmonary event (92%) or the improvement/stabilization of the course of a known lung disease (92%), as predicted by the physician. Sixty-one percent of these CRs had a definite influence on patients’ treatment. Conclusion: CR in hospitalized patients is of practical benefit to physicians, mainly in avoiding over diagnosis and unnecessary treatment to their patients.
3s