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Factors associated with mortality in systemic lupus erythematosus (SLE). A nested case-control study
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J Clin Epidemiol, Vol. 50, Suppl. 1, pp. 3S-45S, 1997 Copyright 0 1997 Elsevler Science Inc. ELSEVIER
CARE OF ADULTS “ECPPA: RANDOMIZED TRIAL OF LOW DOSE ASPIRIN FOR THE PREVENTION OF MATERNAL AND FETAL COMS PLICATIONS IN HIGH RISK PREGNANT WOMEN.” Alvuro Nagib At&h. CEU, Escola Paulista de Medicina, Sao Paula, Brazil. Objective: To determine the effectiveness of low dose aspirin in women at high risk of adverse outcomes associated with pre-eclampsia. Design: A collaborative randomized trial comparing the effects of low dose aspirin (60 mg) with placebo on pre-eclampsia and other materno-fetal complications associated with hypertension. Setting: Twelve teaching maternity hospitals and 182 obstetrician’s offices in Brazil. Participants: One thousand and nine women considered to be at high risk for the development of pre-eclampsia, or its complications, entered the study between 12 and 32 weeks of gestation. They were randomly allocated to receive aspirin (498 women) or placebo (511 women) until delivery, and follow up was obtained for 96%. Results: There were no significant differences between the treatment groups in the incidence of proteinuric pre-eclampsia (6.7% aspirin-allocated compared with 6.0% placebo-allocated women), of preterm delivery (22.3% compared with 26.1”/0), of intrauterine growth retardation (8.5% compared with lO.l%), or ofstillbirth and neonatal death (7.3% compared with 6.0%), nor were there significant differences in the incidence of proteinuric preeclampsia in any subgroup of women studied, including those who had systolic blood pressures of 120 mmHg or above at entry (8.5% compared with 7.3%) or those who were chronically hypertensive (10.0% compared with 7.1%). Aspirin was not associated with a significant excess of maternal or fetal bleeding. Conclusion: The results of this study do not support the routine prophylactic administration of low dose aspirin in pregnancy to any category of high risk women (even those who have chronic hypertension or who are considered to be especially liable to early onset pre-eclampsia).
“FACTORS ASSOCIATED WITH MORTALITY IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE). A NESTED CASE-CONTROL STUDY.” Mario H. Cardiel, N. Tap& B. Hem&&, A. R. Villa, and E. Reyes. CEU, Institute National de la Nutrition, Mexico City, Mexico. Objective: To identify risk factors associated with mortality in Mexican patients with SLE. This would help to identify high risk patients for dying. Design: A nested case-control study. Setting: Hospital based, tertiary care center. Participants: All patients with SLE who died and had an autopsy study were selected as cases. They were identified from a registry book from 1960 to 1994. We matched one control per case by age, decade of SLE onset, disease duration (all three + 5 years). Main Outcome Measure(s): All clinical and pathological charts were reviewed by one trained Internist. She identified socio-demographic, clinical, therapeutical, pathological, disease activity (MEXSLEDAI) and severity variables with validated indices. Analysis: We compared cases and controls with uni and multivariate analysis. We calculated odds ratio and 95% confidence intervals. Significance was set at 0.05 level. Results: Seventy-six pairs are presented. Most important variables associated with mortality are depicted in table. Variable
“PREDICTORS OF ANTISOCIAL BEHAVIOR (ASB) IN ADOS LESCENCE AND EARLY ADULT LIFE.” Isabel A. S Bordin, Michael Boyle, and Dnn Offord. CEU, Escola Paulista de Medicina, Sio Pa&, Brazil. Objectives: Violence and crime are growing problems in our society, and effectiveness of prevention programs depends on the identification of early predictors. Study objectives: (1) to examine the magnitude of effect that violent and non-violent ASB before age 15 have on the prediction of ASB in adolescence and early adult life when taking into account 6 childhood events; (2) to identify gender differences in the prediction model. Design: Cross-sectional study (Ontario Health Survey Supplement). Setting: Residents in private dwellings from urban and rural areas of Ontario, Canada. Participants: 773 males and 878 females (N = 1651) aged 16-24 yrs. Sampling: multi-stage stratified cluster design. Main Outcome Measure(s): Outcome: 3+ ASB since age 15. Predicrors: 2+ non-violent ASB before age 15; l+ violent ASB before age 15; gender; physical abuse; sexual abuse; absence of a confiding relationship with an adult; parent marital discord; parent mental health; and parent with ASB or alcohol-drug problems. All data except child abuse gathered using an improved version of the Composite International Diagnostic Interview. Data on abuse obtained by a self-report questionnaire. Results: All predictors forced to enter logistic regression. In the presence of 6 childhood events, non-violent ASB before age 15 remained a highly significant predictor of ASB in adolescence and early adult life among males (OR = 8.7) and females (OR = 8.5). Violent ASB before age 15 remained significant only among males (OR = 3.7). In the presence of non-violent and violent ASB, parent mental health (depression, mania or psychotic episode) remained significant among males (OR = 2.8), and sexual abuse among females (OR = 7.6). When using mutually exclusive categories for ASB before age 15, the presence of both non-violent and violent ASB had greater prediction effect (OR = 35.8) than only non-violent ASB (OR = 13.6) or only violent ASB (OR = 6.7) overall. Conclusions: Non-violent ASB before 15 put children at greater risk for ASB in adolescence and early adult life than violent ASB before 15. Children with both violent and non-violent ASB before age 15 are at greater risk for ASB later in life than children with only one type of ASB. When considering early intervention strategies, attention should be paid to parent mental health (boys) and sexual abuse (girls).
Cases
Controls
OR (95% CI)
p
MEXSLEDAI P, tJ Severity Index
8.8,2.4
3.5,2
22,6.3
12.6,6.8
(mg/day) S&o; P? 0 Pancytopenia CNS Involvement Lune Involvement Infections Skin Involvement
89,18.4
20.4,24.7
368 60 53 60
: 16
::
0.001 62 (10-2511) 35.5 (8-312) 14 (6 -34) 11 (4.8-i6.2) 0.21 (0.05-0.7)
Conclusions: Active SLE with multi-organ damage, steroids, and infections were associated with mortality. Cutaneous involvement was protective. “THE HYPOGLYCEMIC EFFECTS OF ALOE VERA IN THAI DIABETIC PATIENTS.” Mont&i Chalaprawat. CEU, Chulalongkorn University, Bangkok, Thailand. Objectives: To evaluate the efficacy of the Aloe Vera juice as a hypoglycemic agent in Thai diabetic patients. Design: A two-period crossover, double-blinded, randomized, placebo-controlled trial comparing Aloe Vera juice against placebo juice. Setting: Tertiary-care hospital. Participants: Sixteen asymptomatic, normotensive, newly-diagnosed, noninsulin-dependent diabetes mellitus (NIDDM) patients, who are not taking other hypoglycemic agents, participated in the study from September 1995 to May 1996. Intervention: The Aloe Vera juice was prepared from the extract of the medicinal plant Aloe Vera. The placebo juice was identical in physical appearances and taste to the Aloe Vera. Both were administered in 15-ml bottle twice a day. Results: Mean plasma glucose levels for period 1 (placebo) and period Z(Aloe Vera) for the first group of patients (n = 8) were 251.5 and 255.9 mg/dl, respectively. Mean plasma glucose levels for period 1(Aloe Vera) and period 2 (placebo) for the second group (n = 8) were 228.6 and 239.0 mg/ dl, respectively. The analysis was done according to a statistical model proposed by Grizzle, J.E. Though plasma glucose levels tended to lower with the administration of the Aloe Vera juice, the lowering of plasma glucose levels resulting from the administration of the Aloe Vera juice did not differ significantly with those resulting from the administration of the placebo juice. Conclusion: This study did not demonstrate the hypoglycemic effect of Aloe Vera extract when compared with the placebo. However, the trend for the Aloe Vera juice to lower plasma glucose levels may warrant further investigation with some modifications of the present study.
3s
J Clin Epidemiol, Vol. 50, Suppl. 1, pp. 3S-45S, 1997 Copyright 0 1997 Elsevler Science Inc. ELSEVIER
CARE OF ADULTS “ECPPA: RANDOMIZED TRIAL OF LOW DOSE ASPIRIN FOR THE PREVENTION OF MATERNAL AND FETAL COMS PLICATIONS IN HIGH RISK PREGNANT WOMEN.” Alvuro Nagib At&h. CEU, Escola Paulista de Medicina, Sao Paula, Brazil. Objective: To determine the effectiveness of low dose aspirin in women at high risk of adverse outcomes associated with pre-eclampsia. Design: A collaborative randomized trial comparing the effects of low dose aspirin (60 mg) with placebo on pre-eclampsia and other materno-fetal complications associated with hypertension. Setting: Twelve teaching maternity hospitals and 182 obstetrician’s offices in Brazil. Participants: One thousand and nine women considered to be at high risk for the development of pre-eclampsia, or its complications, entered the study between 12 and 32 weeks of gestation. They were randomly allocated to receive aspirin (498 women) or placebo (511 women) until delivery, and follow up was obtained for 96%. Results: There were no significant differences between the treatment groups in the incidence of proteinuric pre-eclampsia (6.7% aspirin-allocated compared with 6.0% placebo-allocated women), of preterm delivery (22.3% compared with 26.1”/0), of intrauterine growth retardation (8.5% compared with lO.l%), or ofstillbirth and neonatal death (7.3% compared with 6.0%), nor were there significant differences in the incidence of proteinuric preeclampsia in any subgroup of women studied, including those who had systolic blood pressures of 120 mmHg or above at entry (8.5% compared with 7.3%) or those who were chronically hypertensive (10.0% compared with 7.1%). Aspirin was not associated with a significant excess of maternal or fetal bleeding. Conclusion: The results of this study do not support the routine prophylactic administration of low dose aspirin in pregnancy to any category of high risk women (even those who have chronic hypertension or who are considered to be especially liable to early onset pre-eclampsia).
“FACTORS ASSOCIATED WITH MORTALITY IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE). A NESTED CASE-CONTROL STUDY.” Mario H. Cardiel, N. Tap& B. Hem&&, A. R. Villa, and E. Reyes. CEU, Institute National de la Nutrition, Mexico City, Mexico. Objective: To identify risk factors associated with mortality in Mexican patients with SLE. This would help to identify high risk patients for dying. Design: A nested case-control study. Setting: Hospital based, tertiary care center. Participants: All patients with SLE who died and had an autopsy study were selected as cases. They were identified from a registry book from 1960 to 1994. We matched one control per case by age, decade of SLE onset, disease duration (all three + 5 years). Main Outcome Measure(s): All clinical and pathological charts were reviewed by one trained Internist. She identified socio-demographic, clinical, therapeutical, pathological, disease activity (MEXSLEDAI) and severity variables with validated indices. Analysis: We compared cases and controls with uni and multivariate analysis. We calculated odds ratio and 95% confidence intervals. Significance was set at 0.05 level. Results: Seventy-six pairs are presented. Most important variables associated with mortality are depicted in table. Variable
“PREDICTORS OF ANTISOCIAL BEHAVIOR (ASB) IN ADOS LESCENCE AND EARLY ADULT LIFE.” Isabel A. S Bordin, Michael Boyle, and Dnn Offord. CEU, Escola Paulista de Medicina, Sio Pa&, Brazil. Objectives: Violence and crime are growing problems in our society, and effectiveness of prevention programs depends on the identification of early predictors. Study objectives: (1) to examine the magnitude of effect that violent and non-violent ASB before age 15 have on the prediction of ASB in adolescence and early adult life when taking into account 6 childhood events; (2) to identify gender differences in the prediction model. Design: Cross-sectional study (Ontario Health Survey Supplement). Setting: Residents in private dwellings from urban and rural areas of Ontario, Canada. Participants: 773 males and 878 females (N = 1651) aged 16-24 yrs. Sampling: multi-stage stratified cluster design. Main Outcome Measure(s): Outcome: 3+ ASB since age 15. Predicrors: 2+ non-violent ASB before age 15; l+ violent ASB before age 15; gender; physical abuse; sexual abuse; absence of a confiding relationship with an adult; parent marital discord; parent mental health; and parent with ASB or alcohol-drug problems. All data except child abuse gathered using an improved version of the Composite International Diagnostic Interview. Data on abuse obtained by a self-report questionnaire. Results: All predictors forced to enter logistic regression. In the presence of 6 childhood events, non-violent ASB before age 15 remained a highly significant predictor of ASB in adolescence and early adult life among males (OR = 8.7) and females (OR = 8.5). Violent ASB before age 15 remained significant only among males (OR = 3.7). In the presence of non-violent and violent ASB, parent mental health (depression, mania or psychotic episode) remained significant among males (OR = 2.8), and sexual abuse among females (OR = 7.6). When using mutually exclusive categories for ASB before age 15, the presence of both non-violent and violent ASB had greater prediction effect (OR = 35.8) than only non-violent ASB (OR = 13.6) or only violent ASB (OR = 6.7) overall. Conclusions: Non-violent ASB before 15 put children at greater risk for ASB in adolescence and early adult life than violent ASB before 15. Children with both violent and non-violent ASB before age 15 are at greater risk for ASB later in life than children with only one type of ASB. When considering early intervention strategies, attention should be paid to parent mental health (boys) and sexual abuse (girls).
Cases
Controls
OR (95% CI)
p
MEXSLEDAI P, tJ Severity Index
8.8,2.4
3.5,2
22,6.3
12.6,6.8
(mg/day) S&o; P? 0 Pancytopenia CNS Involvement Lune Involvement Infections Skin Involvement
89,18.4
20.4,24.7
368 60 53 60
: 16
::
0.001 62 (10-2511) 35.5 (8-312) 14 (6 -34) 11 (4.8-i6.2) 0.21 (0.05-0.7)
Conclusions: Active SLE with multi-organ damage, steroids, and infections were associated with mortality. Cutaneous involvement was protective. “THE HYPOGLYCEMIC EFFECTS OF ALOE VERA IN THAI DIABETIC PATIENTS.” Mont&i Chalaprawat. CEU, Chulalongkorn University, Bangkok, Thailand. Objectives: To evaluate the efficacy of the Aloe Vera juice as a hypoglycemic agent in Thai diabetic patients. Design: A two-period crossover, double-blinded, randomized, placebo-controlled trial comparing Aloe Vera juice against placebo juice. Setting: Tertiary-care hospital. Participants: Sixteen asymptomatic, normotensive, newly-diagnosed, noninsulin-dependent diabetes mellitus (NIDDM) patients, who are not taking other hypoglycemic agents, participated in the study from September 1995 to May 1996. Intervention: The Aloe Vera juice was prepared from the extract of the medicinal plant Aloe Vera. The placebo juice was identical in physical appearances and taste to the Aloe Vera. Both were administered in 15-ml bottle twice a day. Results: Mean plasma glucose levels for period 1 (placebo) and period Z(Aloe Vera) for the first group of patients (n = 8) were 251.5 and 255.9 mg/dl, respectively. Mean plasma glucose levels for period 1(Aloe Vera) and period 2 (placebo) for the second group (n = 8) were 228.6 and 239.0 mg/ dl, respectively. The analysis was done according to a statistical model proposed by Grizzle, J.E. Though plasma glucose levels tended to lower with the administration of the Aloe Vera juice, the lowering of plasma glucose levels resulting from the administration of the Aloe Vera juice did not differ significantly with those resulting from the administration of the placebo juice. Conclusion: This study did not demonstrate the hypoglycemic effect of Aloe Vera extract when compared with the placebo. However, the trend for the Aloe Vera juice to lower plasma glucose levels may warrant further investigation with some modifications of the present study.
3s