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Biomedical subjects

A N Atallah

Publications and source records attributed to A N Atallah.

At least 19 recordsLinked to original sources

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: For more than a century the presence of bowel content during surgery has been related to anastomotic leakage. Mechanical bowel preparation has been considered an efficient agent against leakage and infections complications. This dogma is not based on solid evidence, but more on observational data and expert's opinions. OBJECTIVES: To determine the security and effectiveness of prophylactic mechanical bowel preparation for morbidity and mortality rates in colorectal surgery. The following hypothesis was tested: "The use of mechanical bowel preparation before elective colorectal surgery reduces the incidence of postoperative complications". SEARCH STRATEGY: All publications describing mechanical bowel preparation before elective colorectal surgery was sought through computerized searches of EMBASE, LILACS, MEDLINE, and Cochrane Library; by hand-searching in relevant medical journals, from major gastroenterological congresses, without limitation for date and language, using the search strategy described by the Colorectal Cancer Review Group. In addition, randomised clinical trials will be searched through personal communication with colleagues and from conference proceedings SELECTION CRITERIA STUDIES: All randomised, clinical trials, that were performed in order to answer the hypothesis. PARTICIPANTS: Patients submitted elective colorectal surgery. INTERVENTIONS: Any strategy in mechanical bowel preparation compared with no mechanical bowel preparation. PRIMARY OUTCOME MEASURES: 1. Anastomosis leakage- stratified for rectum and colon 2. Overall anastomotic leakage SECONDARY OUTCOME MEASURES: 3. Mortality 4. Peritonitis 5. Re operation 6. Wound Infection 7 Infectious extra-abdominal complication 8. Non-infection extra-abdominal 9. Overall surgical site infections DATA COLLECTION AND ANALYSIS: Data was independently extracted by two reviewers and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomisation (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up was recorded. The results of each RCT was summarised in 2 x 2 tables for each outcome. For analysis the Peto-Odds ratio was used as defaults (no statistical heterogeneity was observed) MAIN RESULTS: Of the 1159 patients with anastomosis (6 RCTs), 576 were allocated for mechanical bowel preparation (groups 1) and 583 for no preparation (groups 2) before elective colorectal surgery. Of 1204 patients totally enrolled 595 were in groups 1 and 609 in groups 2. PRIMARY OUTCOMES: 1) Anastomotic leakage - stratified:A) Low anterior resection: 12.5% (6 of 48 patients in 1) compared with 12% (6 of 50 patients in 2); Peto OR 1.17, 95% CI: 0.35 - 3.96 (non-significant) B) Colonic surgery: 1.16% (2 of 172 patients in 1) compared with 0.6% (1 of 166 patients in 2); Peto OR 1.75, 95% CI: 0.18 - 17.02 2) Overall anastomotic leakage: 5.5% (32 of 576 patients in 1) compared with 2.9% (17 of 583 patients in 2); Peto OR 1.94, 95% CI: 1.09 - 3.43 (P=0.02) SECONDARY OUTCOMES: 3) Mortality: 0.6% (2 of 329 patients in 1) compared with 0% (0 of 326 patients in 2); Peto OR 7.95, 95% CI: 0.49 - 128.34 (non-significant) 4) Peritonitis: 5.1% ( 13 of 254 patients in 1) compared with 2.8% (7 of 252 patients in 2); Peto OR 1.90, 95% CI: 0.78 -4.64) (non significant) 5) Reoperation: 3.3% ( 11 of 329 patients) compared with 2.5% (8 of 326 patients); Peto OR 1.40, 95% CI: 0.56 - 3.49) (non-significant) 6) Wound infection: 7.4% (44 of 595 patients in 1) compared with 5.7% (35 of 609 patients in 2); Peto OR 1.34, 95% CI: 0.85 - 2.13 (non-significant) 7) Infectious extra-abdominal complication: 8.3% ( 14 of 168 patients in 1) compared with 9.4% (15 of 159 patients in 2); Peto OR, 95%: 0.87 (0.41 - 1.87) 8) Non-infection extra-abdominal complication: 8.0% ( 20 of 250 patients in 1) compared with 7.0% (17 of 246 patients in 2); Peto OR 1.19, 95% CI: 0.61 - 2.32 (non-significant) - 9) Surgical site infection: 9.8% (31 of 325 patients in 1) compared with 8.3% (27 of 322 patients in 2); Peto OR 1.20, 95% CI: 0.70 - 2.05 (non-significant) - REVIEWER'S CONCLUSIONS: The results failed to support the hypothesis that bowel preparation reduces anastomotic leak rates and other complications. There was no a priori hypothesis that bowel preparation may increase anastomotic leak rates, so this was not stated. Thus, the routine use of mechanical bowel preparation in patients undergoing elective colorectal surgery is questioned.

Colorectal Surgery↗

Calcium supplementation to prevent pre-eclampsia--a systematic review.

BACKGROUND: Calcium supplementation during pregnancy may prevent high blood pressure and preterm labour. OBJECTIVE: To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child adverse outcomes. DESIGN: A systematic review of randomised trials that compared supplementation with at least 1 g calcium daily during pregnancy with placebo. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register (October 2001) and the Cochrane Controlled Trials Register (Issue 3, 2001) were searched and study authors were contacted. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed. Data were extracted and analysed. MAIN RESULTS: There was a modest reduction in the risk of pre-eclampsia with calcium supplementation (relative risk (RR) 0.68, 95% confidence interval (CI): 0.57-0.81). The effect was greatest for women at high risk of hypertension (RR 0.21, 95% CI: 0.11-0.39) and those with low baseline calcium intake (RR 0.32, 95% CI: 0.21-0.49). There was no overall effect on the risk of preterm delivery, although there was a reduction in risk among women at high risk of hypertension (RR 0.42, 95% CI: 0.23-0.78). There was no evidence of any effect of calcium supplementation on stillbirth or death before discharge from hospital. There were fewer babies with birthweight < 2,500 g (RR 0.83, 95% CI: 0.71-0.98). In one study, childhood systolic blood pressure > 95th percentile was reduced (RR 0.59, 95% CI: 0.39-0.91). CONCLUSIONS: Calcium supplementation appears to be beneficial for women at high risk of gestational hypertension and in communities with low dietary calcium intake. These benefits were confined to several rather small trials, and were not found in the largest trial to date, conducted in a low-risk population. Further research is required.

Calcium↗

Metoclopramide for migration of naso-enteral tube.

BACKGROUND: Enteral alimentation by feeding tube is a common problem and an efficient method of providing nutritional support to hospitalized patients with insufficient oral intake, but adequate gastrointestinal function. The use of metoclopramide, a prokinetic agent, has been recommended to achieve transpyloric placement, but its efficacy is controversial. OBJECTIVES: To determine the effect of intravenous metoclopramide on transpyloric passage of the naso-enteral tube. SEARCH STRATEGY: Relevant RCTs were identified by electronic search through MEDLINE, EMBASE, LILACS and the Cochrane Controlled Trials Register databases. SELECTION CRITERIA TYPES OF PARTICIPANTS: Adults needing enteral nutrition. Types of intervention: Intravenous or intramuscular metoclopramide compared to placebo or no intervention. Types of studies: Randomised controlled trials. Types of outcome measures: The success of migration of transpyloric intubation. DATA COLLECTION AND ANALYSIS: The reviewers evaluated the allocation concealment, which was classified as adequate, uncertain or inadequate. Two reviewers extracted the data independently. All analyses were performed according to the intention-to-treat method. MAIN RESULTS: Four studies were included and analysed. There was no statistically significant difference between intravenous or intramuscular metoclopramide administered to promote the tube migration (OR 0.65, 95% CI 0.33 to 1.28). Intravenous metoclopramide 10 mg (OR 0.68, 95% CI 0.37 to 1.23) and 20 mg (OR 0.27, 95% CI 0.01 to 10.84) were equally ineffective in facilitating transpyloric intubation. REVIEWER'S CONCLUSIONS: Four studies were included and analysed. There was no statistically significant difference between intravenous or intramuscular metoclopramide administered to promote the tube migration (OR 0.65, 95% CI 0.33 to 1.28). Intravenous metoclopramide 10 mg (OR 0.68, 95% CI 0.37 to 1.23) and 20 mg (OR 0.27, 95% CI 0.01 to 10.84) were equally ineffective in facilitating transpyloric intubation.

Antiemetics↗

Oral theophylline for chronic obstructive pulmonary disease.

BACKGROUND: Oral theophylline has, for many years, been used as a bronchodilator in patients with COPD. Despite the introduction of new drugs, and its narrow therapeutic index, theophylline is still recommended for COPD treatment. OBJECTIVES: To determine the effectiveness of oral theophylline when compared to placebo in patients with stable COPD. SEARCH STRATEGY: The Cochrane Airways Review Group and Cochrane Controlled Clinical Registers were searched. SELECTION CRITERIA: All studies were randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: Data were independently abstracted and the methodological quality assessed by two reviewers. MAIN RESULTS: Twenty RCTs met the inclusion criteria. Concomitant therapy varied from none to any other bronchodilator plus corticosteroid (oral and inhaled). The following outcomes were significantly different when compared to placebo. FEV1 improved with treatment: Weighted Mean Difference (WMD) 100 ml; 95% Confidence Interval (95%CI) 40, 160 ml. Similarly for FVC: WMD 210 ml 95%CI 100, 320. Two studies reported an improvement in VO2max; WMD 195 ml/min, 95%CI 113,27). At rest, PaO2 and PaCO2 both improved with treatment (WMD 3.2 mmHg; 95%CI = 1.2, 5., and WMD -2.4 mmHg; 95%CI = -3.5, -1.2, respectively). Walking distance tests did not improve (4 studies, Standardised Mean Difference 0.30, 95%CI -0.01, 0.62), neither did Visual Analogue Score for breathlessness isn two small studies (WMD 3.6, 95%CI -4.6, 11.8). The Relative Risk (RR) of nausea was greater with theophylline (RR 7.7; 95%CI 1.5, 39.9). However, patients' preference for theophylline was greater than that for placebo (RR 2.27; 95%CI = 1.26, 4.11). Very few patient withdrew from these studies for any reason. REVIEWER'S CONCLUSIONS: Theophylline has a modest effect on FEV1 and FVC and slightly improves arterial blood gas tensions in moderate to severe COPD. These benefits were seen in patients receiving a variety of different concomitant therapies. Improvement in exercise performance depended on the method of testing. There was a very low dropout rate in the studies that could be included in this review, which suggests that recruited patients may have been known by the investigators to be theophylline tolerant. This may limit the generalisability of these studies.

Administration, Oral↗

Vena cava thrombosis associated with nephrotic syndrome in the puerperal gestational cycle.

CONTEXT: The puerperal gestational cycle is accompanied by a state of physiological hypercoagulability. Thromboembolic phenomena may occur at this time. OBJECTIVE: To report on a clinic case involving a patient that presented a family history of thromboembolism and developed deep vein thrombosis in a lower limb and vena cava thrombosis during the puerperal gestational cycle, displaying nephrotic syndrome as the main complication. DESIGN: Case report.

Adult↗

Stapled versus handsewn methods for colorectal anastomosis surgery.

BACKGROUND: Randomized controlled trials comparing stapled with handsewn colorectal anastomosis have not shown either technique to be superior, perhaps because individual studies lacked statistical power. A systematic review, with pooled analysis of results, might provide a more definitive answer. OBJECTIVES: To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications. SEARCH STRATEGY: The RCT register of the Cochrane Review Group was searched for any trial or reference to a relevant trial (published, in-press, or in progress). All publications were sought through computerised searches of EMBASE, LILACS, MEDLINE, the Cochrane Controlled Clinical Trials Database, and through letters to industrial companies and authors. There were no limits upon language, date, or other criteria. SELECTION CRITERIA STUDIES: All randomized clinical trials (RCTs) in which stapled and handsewn colorectal anastomosis were compared. PARTICIPANTS: Adult patients submitted electively to colorectal anastomosis. INTERVENTIONS: Endoluminal circular stapler and handsewn colorectal anastomosis. OUTCOMES: a) Mortality b) Overall Anastomotic Dehiscence c) Clinical Anastomotic Dehiscence d) Radiological Anastomotic Dehiscence e) Stricture f) Anastomotic Haemorrhage g) Reoperation h) Wound Infection i) Anastomosis Duration j) Hospital Stay. DATA COLLECTION AND ANALYSIS: Data were independently extracted by the two reviewers (SASL, DM) and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomization (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up were recorded. The results of each RCT were summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by characteristics of the participants, the interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The Risk Difference method (random effects model) and NNT for dichotomous outcomes measures and weighted mean difference for continuous outcomes measures, with the corresponding 95% confidence interval, were presented in this review. Statistical heterogeneity was evaluated by using funnel plot and chi-square testing. MAIN RESULTS: Of the 1233 patients enrolled ( in 9 trials), 622 were treated with stapled, and 611 with manual, suture. The following main results were obtained: a) Mortality: result based on 901 patients; Risk Difference - 0.6% Confidence Interval -2.8% to +1.6%. b) Overall Dehiscence: result based on 1233 patients; Risk Difference 0.2%, 95% Confidence Interval -5.0% to +5.3%. c) Clinical Anastomotic Dehiscence : result based on 1233 patients; Risk Difference -1.4%, 95% Confidence Interval -5.2 to +2.3%. d) Radiological Anastomotic Dehiscence : result based on 825 patients; Risk Difference 1.2%, 95% Confidence Interval -4.8% to +7.3%. e) Stricture: result based on 1042 patients; Risk Difference 4.6%, 95% Confidence Interval 1.2% to 8.1%. Number needed to treat 17, 95% confidence interval 12 to 31. f) Anastomotic Hemorrhage: result based on 662 patients; Risk Difference 2.7%, 95% Confidence Interval - 0.1% to +5.5%. g) Reoperation: result based on 544 patients; Risk Difference 3.9%, 95% Confidence Interval 0.3% to 7.4%. h) Wound Infection: result based on 567 patients; Risk Difference 1.0%, 95% Confidence Interval -2.2% to +4.3%. i) Anastomosis duration: result based on one study (159 patients); Weighted Mean Difference -7.6 minutes, 95% Confidence Interval -12.9 to -2.2 minutes. j) Hospital Stay: result based on one study (159 patients), Weighted Mean Difference 2.0 days, 95% Confidence Interval -3.27 to +7.2 days. REVIEWER'S CONCLUSIONS: The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis, regardless of the level of anastomosis.

Adult↗

Musculoskeletal manifestations of bacterial endocarditis.

CONTEXT: The incidence of staphylococcal infection has been increasing during the last 20 years. OBJECTIVE: Report a case of staphylococcal endocarditis preceded by musculoskeletal manifestations, which is a rare form of clinical presentation. DESIGN: Case report. CASE REPORT: A 45-year-old-man, without addictions and without known previous cardiopathy, was diagnosed as having definitive acute bacterial endocarditis due to Staphylococcus aureus. Its etiology was community-acquired, arising from a non-apparent primary focus. In addition, the musculoskeletal symptoms preceded the infective endocarditis (IE) by about 1 month, which occurred together with other symptoms, e.g. mycotic aneurysms and petechiae. Later, the patient showed perforation of the mitral valve and moderate mitral insufficiency with clinical control.

Endocarditis, Bacterial↗

Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems.

BACKGROUND: Calcium supplementation may prevent high blood pressure through a number of mechanisms and may help to prevent preterm labour. OBJECTIVES: The objective of this review was to assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child adverse outcomes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register and we contacted study authors. SELECTION CRITERIA: Randomised trials comparing at least one gram daily of calcium during pregnancy compared to placebo. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality were assessed. Data extraction was carried out independently by two reviewers. MAIN RESULTS: Nine studies were included, all of good quality. There was a modest reduction in high blood pressure with calcium supplementation (relative risk 0.80, 95% confidence interval 0.73 to 0.88). The effect was greatest for women at high risk of hypertension (relative risk 0.35, 95% confidence interval 0.21 to 0.57) and those with low baseline dietary calcium (relative risk 0.49, 95% confidence interval 0.38 to 0.62). There was also a modest reduction in the risk of pre-eclampsia with calcium supplementation (relative risk 0. 72, 95% confidence interval 0.60 to 0.86). The effect was greatest for women at high risk of hypertension (relative risk 0.22, 95% confidence interval 0.11 to 0.43) and those with low baseline calcium intake (relative risk 0.32, 95% confidence interval 0.21 to 0.49). There was no overall effect on the risk of preterm delivery, although there was a reduction in risk amongst women at high risk of hypertension (relative risk 0.42, 95% confidence interval 0.23 to 0. 78). There was no evidence of any effect of calcium supplementation on stillbirth or death before discharge from hospital. REVIEWER'S CONCLUSIONS: Calcium supplementation appears to be beneficial for women at high risk of gestational hypertension and in communities with low dietary calcium intake. Optimum dosage requires further investigation.

Calcium↗

Fixed dose subcutaneous low molecular weight heparins versus adjusted dose unfractionated heparin for venous thromboembolism.

BACKGROUND: Low molecular weight heparins have been shown to be effective and safe for prevention of venous thromboembolism. There is accumulating evidence that these new anticoagulants are also effective and safe for treatment of venous thromboembolism. OBJECTIVES: The objective of this review was to determine the effect of fixed-dose, subcutaneous low molecular weight heparins compared with adjusted-dose, intravenous or subcutaneous, unfractionated heparin for initial treatment of acute deep venous thrombosis or pulmonary embolism. SEARCH STRATEGY: Trials were identified from the Cochrane Peripheral Vascular Diseases Group trials register and LILACS. The reviewers contacted colleagues and representatives of pharmaceutical companies for additional information about trials. SELECTION CRITERIA: Randomised trials comparing fixed-dose, subcutaneous low molecular weight heparin with adjusted-dose, intravenous or subcutaneous, unfractionated heparin in patients with venous thromboembolism. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trials for inclusion and quality, and extracted data independently. MAIN RESULTS: Fourteen studies with a total of 4754 patients were included. By the end of follow up in ten trials, thrombotic complications occurred in 86 (4.3%) of the 1998 patients treated with low molecular weight heparin, compared with 113 (5.6%) of the 2021 patients treated with unfractionated heparin (odds ratio 0.76, 95% confidence interval 0.57 to 1.01). In eight trials a reduction in thrombus size was shown by 60% treated with low molecular weight heparin and 54% treated with unfractionated heparin (odds ratio 0.77, 95% confidence interval 0.61 to 0.97). At the end of the initial treatment period, in all 14 of the trials, major haemorrhages occurred in 30 (1.3%) of the 2353 patients treated with low molecular weight heparin, compared with 51 (2.1%) of the 2401 patients treated with unfractionated heparin (odds ratio 0.60, 95% confidence interval 0.39 to 0.93). By the end of follow up in 11 trials, 135 (6.4%) of the 2108 patients treated with low molecular weight heparin had died, compared with 172 (8.0%) of the 2137 patients treated with unfractionated heparin (odds ratio 0.78, 95% confidence interval 0.62 to 0.99). Five studies with a total of 1636 patients examined proximal (above the knee) thrombosis; 814 treated with low molecular weight heparin and 822 with unfractionated heparin. A sub-analysis of these trials showed statistically significant reductions favouring the action of low molecular weight heparin in three areas: thrombotic complications; major haemorrhages; and overall mortality. By the end of follow up 39 (4. 8%) patients treated with low molecular weight heparin had thrombotic complications, compared with 64 (7.8%) treated with unfractionated heparin (odds ratio 0.60, 95% confidence interval 0. 40 to 0.89). Major haemorrhages occurred in 8 (1.0%) treated with low molecular weight heparin, compared with 68 (8.3%) treated with unfractionated heparin (odds ratio 0.44, 95% confidence interval 0. 21 to 0.95). By the end of follow up, 44 (5.4%) treated with low molecular weight heparin had died, compared with 68 (8.3%) treated with unfractionated heparin (odds ratio 0.64, 95% confidence interval 0.43 to 0.93). REVIEWER'S CONCLUSIONS: Low molecular weight heparin is at least as effective as unfractionated heparin in preventing recurrent venous thromboembolism, and significantly reduces the occurrence of major haemorrhage during initial treatment and overall mortality at the end of follow-up. It can be adopted safely as the standard therapy for deep venous thrombosis, and studies comparing individual low molecular weight heparins are merited.

Heparin↗

Antibiotics for preventing leptospirosis.

BACKGROUND: Leptospirosis is an infectious disease transmitted by animals. Death occurs in about five per cent of the patients. In clinical practice, doxycycline is widely used for prevention. OBJECTIVES: To evaluate the effectiveness and safety of any antibiotic regimen versus placebo or other antibiotic regimens in the prophylaxis of leptospirosis. SEARCH STRATEGY: The sources used were: EMBASE, LILACS, MEDLINE, SCISEARCH, The Cochrane Controlled Trials Register, The Cochrane Hepato-Biliary Group Controlled Trials Register, bibliographies of published papers, and personal communication with authors. There were no language or date restrictions in any of the searches. SELECTION CRITERIA STUDIES: All randomised clinical trials in which antibiotics were used as prophylactic regimen for leptospirosis. PARTICIPANTS: People potentially exposed to leptospirosis, such as people in endemic areas during the rainy season, health professionals and other professionals with high risk of infection. INTERVENTION: Any antibiotic regimen compared with a control group (placebo or another antibiotic regimen). OUTCOMES: Infection (primary outcome) and adverse events (secondary outcome). DATA COLLECTION AND ANALYSIS: Data were independently extracted and methodological quality of each trial was assessed by two reviewers as well as cross-checked. Details of the randomisation (generation and concealment), blinding, and the number of patients lost to follow-up were recorded. The results of each trial were summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. MAIN RESULTS: Two trials comparing doxycycline with placebo met the inclusion criteria. We did not find trials comparing doxycycline versus other antibiotics, or other antibiotics versus placebo. One of the trials had excellent methodological quality. In the other trial, the allocation concealment process, generation of allocation sequence, and blinding methods were not described. Of the 1022 participants enrolled, 509 were treated with doxycycline and 513 with placebo. Of these, 940 participants were soldiers included in one trial. The patients assigned to the antibiotics group compared with the ones assigned to the placebo group showed: Symptomatic, verified leptospirosis: 0.6% (3/509) versus 4.9% (25/ 513); risk difference (random effects model) -4.1%, 95% confidence interval -5.9% to -2.3%. Number needed-to-treat 24 (95% confidence interval 17 to 43). Adverse effects: 3% (13/469 participants) versus 0.2% (1/471 participants); random effects model 2.6%, 95% confidence interval 1.0% to 4.1%. Number needed-to-harm 39 (95% confidence interval 25 to 100). REVIEWER'S CONCLUSIONS: Prophylaxis of leptospirosis may be achieved by administrating doxycycline to soldiers training in endemic areas with a high risk of exposure to leptospirosis. Whether these findings apply to other scenarios or not remains to be proven.

Anti-Bacterial Agents↗

Antibiotics for treating leptospirosis.

BACKGROUND: Leptospirosis is a parasitic disease transmitted by animals. Severe leptospirosis may result in hospitalisation and about five per cent of the patients die. In clinical practice, penicillin is widely used for treating leptospirosis. OBJECTIVES: To evaluate the effectiveness and safety of antibiotics versus placebo or other antibiotic regimens in treating leptospirosis. We addressed the following clinical questions: a) Are treatment regimens with antibiotics more efficient than placebo for leptospirosis? b) Are treatment regimens with antibiotics safe when compared to placebo for leptospirosis? c) Which antibiotic regimen is the most efficient and safest in treating leptospirosis? SEARCH STRATEGY: Electronic searches and searches of the identified articles were combined. SELECTION CRITERIA STUDIES: Randomised clinical trials in which antibiotics were used as treatment for leptospirosis. Language, date, or other restrictions were not applied. PARTICIPANTS: Patients with clinical manifestations of leptospirosis. INTERVENTIONS: Any antibiotic regimen compared with a control group (placebo or another antibiotic regimen). DATA COLLECTION AND ANALYSIS: Data and methodological quality of each trial were independently extracted and assessed by two reviewers. The random effects model was used irrespective of significant statistical heterogeneity. MAIN RESULTS: Three trials met inclusion criteria. Allocation concealment and double blind methods were not clearly described in two. Of the patients enrolled, 75 were treated with placebo and 75 with antibiotics: 61 (81.3%) penicillin and 14 (18.6%) doxycycline. The patients assigned to antibiotics compared to placebo showed: a) Mortality: 1% (1/75) versus 4% (3/75); risk difference -2%, 95% confidence interval -8% to 4%. b) Duration of hospital stay (days): weighted mean difference 0.30, 95% confidence interval -1.26 to 1.86. c) Prolonged hospital stay (> seven days): 30% (7/23) versus 74% (14/19); risk difference -43%, 95% confidence interval -70% to -16%. Number needed-to-treat 3, 95% confidence interval 2 to 7. d) Period of disappearance of fever (days): weighted mean difference -4.04, 95% confidence interval -8.65 to 0.58. e) Leptospiruria: 5% (4/75) versus 40% (30/75); risk difference -46%, 95% confidence interval -88% to -3%. Number needed-to-treat 2, 95% confidence interval 1 to 33. REVIEWER'S CONCLUSIONS: Antibiotic regimens for treatment of leptospirosis is a form of care for which the evidence is insufficient to provide clear guidelines for practice. The randomised trials suggest that antibiotics could be a useful treatment for leptospirosis. Because of the questionable quality of two of the three trials, the indication for general use of antibiotics is uncertain. However, the evidence suggest that penicillin may cause more good than harm.

Anti-Bacterial Agents↗

Cyclophosphamide versus methylprednisolone for the treatment of neuropsychiatric involvement in systemic lupus erythematosus.

BACKGROUND: Neuropsychiatric involvement in systemic lupus erythematosus is complex and several clinical presentations are related to this disease such as: convulsions, chronic headache, transverse myelitis, vascular brain disease, psychosis and neural cognitive dysfunction. OBJECTIVES: To assess the efficacy and safety of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of systemic lupus erythematosus on mortality and side effects. SEARCH STRATEGY: We searched EMBASE, LILACS, Cochrane Controlled Trials Register and MEDLINE up to and including December 1999, additional articles were sought through handsearching in relevant journals, using the search strategy described in the Cochrane Handbook [Dickersin 1994]. There were no language restrictions. SELECTION CRITERIA: All randomized controlled trials which compared cyclophosphamide to methylprednisolone were to be included. Patients of any age and gender were included if they fulfilled the criterion of the American Rheumatology Association for the diagnosis of systemic lupus erythematosus and presented with any one of the following neuropsychiatric events; convulsions, organic brain syndrome; cranial neuropathy. Outcome measures included the following: a) Overall mortality (primary event); b) Motor and psychiatric deficit (primary event); c) Clinical improvement (secondary event). DATA COLLECTION AND ANALYSIS: The analysis planned was to do the following: Data would be independently extracted by the two reviewers and cross-checked. The methodological quality of each trial would be assessed by the same two reviewers. Details of the randomisation (generation and concealment), blinding, and the number of patients lost on follow-up would be recorded. The results of each RCT would be summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity would be defined by characteristics of the participants, the interventions and the outcomes. If appropriate, RCTs would be stratified based on control group and category of disease in accordance to the clinical homogeneity (external validity). The results obtained from these different methods are very similar, and therefore, only the results from the Risk Difference method, with the corresponding 95% confidence interval would be presented in this review. The fixed effects model would be used if there was no significant statistical heterogeneity. MAIN RESULTS: We found no randomised controlled trials comparing cyclophosphamide versus methylprednisolone for the treatment of neuropsychiatric involvement in the systemic lupus erythematosus. REVIEWER'S CONCLUSIONS: Cyclophosphamide regimen treatment is a form of care in neuropsychiatric involvement in systemic lupus erythematosus with no evidence to prove better effectiveness and safety when compared with methylprednisolone. This systematic review found no randomised controlled trials and its findings must be interpreted as 'no evidence of effect' and not as 'evidence of no effect'.

Antirheumatic Agents↗

Prospective assessment of the risk of postoperative pulmonary complications in patients submitted to upper abdominal surgery.

OBJECTIVE: To investigate associations between preoperative variables and postoperative pulmonary complications (PPC) in elective upper abdominal surgery. DESIGN: Prospective clinical trial. SETTING: A tertiary university hospital. PATIENTS: 408 patients were prospectively analyzed during the preoperative period and followed up postoperatively for pulmonary complications. MEASUREMENTS: Patient characteristics, with clinical and physical evaluation, related diseases, smoking habits, and duration of surgery. Preoperative pulmonary function tests (PFT) were performed on 247 patients. RESULTS: The postoperative pulmonary complication rate was 14 percent. The significant predictors in univariate analyses of postoperative pulmonary complications were: age >50, smoking habits, presence of chronic pulmonary disease or respiratory symptoms at the time of evaluation, duration of surgery >210 minutes and comorbidity (p <0.04). In a logistic regression analysis, the statistically significant predictors were: presence of chronic pulmonary disease, surgery lasting >210 and comorbidity (p <0.009). CONCLUSIONS: There were three major clinical risk factors for pulmonary complications following upper abdominal surgery: chronic pulmonary disease, comorbidity, and surgery lasting more than 210 minutes. Those patients with three risk factors were three times more likely to develop a PPC compared to patients without any of these risk factors (p <0.001). PFT is indicated when there are uncertainties regarding the patient's pulmonary status.

Abdomen↗