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Vancomycin Plus Rifampicin Effective in Treatment of Nosocomial MRSA Pneumonia
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These InfoPOEMs® are selected by JNMA InfoPOEMS Editor Gregory E. Gilbert, MSPH, (Gregory.E.Gilbert@ gmail.com) and Associate InfoPOEMS Editor Amy H. Wahlquist, MS, from www.infopoems.com. InfoPOEMs® are created by experts who continuously survey medical journals worldwide. They identify and summarize valid and clinically applicable new evidence. For more information or to subscribe to e-mail alerts of InfoPOEMs®, please visit www.infopoems.com. STUDY LEVELS OF EVIDENCE (LOE) From the Centre for Evidence-Based Medicine, Oxford. For the most up-todate levels of evidence, see www.cebm. net/levels_of_evidence.asp) Therapy/Prevention/Etiology/Harm: 1a: Systematic reviews of randomized controlled trials 1b: Individual randomized controlled trials 1c: All or none randomized controlled trials 2a: Systematic reviews of cohort studies 2b: Individual cohort study or lowquality randomized controlled 2c: “Outcomes” research, ecological studies Diagnosis: 1a: Systematic review of level-1 diagnostic studies 1b: Independent blind comparison of an appropriate spectrum of consecutive patients, all of whom have undergone both the diagnostic test and the reference standard, or a clinical decision rule not validated on a second set of patients 1c: Absolute SpPins and SnNouts 2a: Systematic review of level >2 2b: Independent blind or objective comparison, study confined to a narrow spectrum of study individuals, or a diagnostic clinical rule not validated in a test set Prognosis: 1a: Systematic review of inception cohort studies 1b: Individual inception cohort study with >80% follow-up, or a clinical rule not validated on a second set of patients 1c: All or none case series 2a: Systematic review of either retrospective cohort studies or untreated control groups in RCTs 2b: Retrospective cohort study or followup of untreated control patients in an RCT, or clinical rule not validated in a test set 2c: “Outcomes” research Copyright © 1995–2010 John Wiley & Sons, Inc. All rights reserved. www.infopoems.com.
Vancomycin Plus Rifampicin Effective in Treatment of Nosocomial MRSA Pneumonia Clinical Question Is vancomycin plus rifampicin more effective than vancomycin alone in the treatment of nosocomial methicillin-resistant Staphylococcus aureus (MRSA) pneumonia? Bottom Line The addition of rifampicin to vancomycin increases the clinical cure rate of nosocomial MRSA pneumonia. (LOE = 1b) Study Design Randomized controlled trial (nonblinded) Funding Government Allocation Uncertain Setting Inpatient (intensive care unit only) Synopsis Vancomycin is the primary therapy for MRSA pneumonia but may lead to treatment failure because of its poor activity in the lungs. Rifampicin is a bactericidal drug against gram-positive organisms with excellent lung penetration that has been used as an adjunct to vancomycin for the treatment of staphylococcal infections. In this Korean study, investigators recruited patients in a medical intensive care unit with clinical, radiographic, and culture evidence of gram-positive pneumonia that developed at
356 JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
least 48 hours after admission to the hospital. Of 183 eligible patients, almost half were excluded for reasons, including liver dysfunction, recent use of vancomycin, or refusal to participate. The remaining 93 patients were randomized to receive 14 days of either intravenous 1 g of vancomycin plus 300 mg of oral rifampicin every 12 hours or 1 g of intravenous vancomycin alone every 12 hours with dose adjustments for renal function and age, as needed. Of the 93 patients, 10 were later excluded, as they had no confirmation of MRSA or had bacteria resistant to rifampicin, leaving 83 patients in the modified intention-to-treat group. The treatment and control groups were well matched for baseline characteristics, including age, sex, comorbidities, and disease severity. All patients underwent daily clinical assessments and chest radiographs, as well as respiratory and blood cultures on study enrollment and at day 14. Adding rifampicin to vancomycin increased the clinical cure rate of nosocomial MRSA pneumonia, defined by resolution of clinical signs and symptoms of pneumonia and improvement in chest radiography at 14 days (53.7% vs 31%, P = .047). You would have to treat 4 patients with vancomycin plus rifampicin to cure 1 additional case of nosocomial MRSA pneumonia. No difference was detected in overall mortality at 28 days, but the mortality rate at 60 days was lower in the vancomycin plus rifampicin group (26.8% vs 50%, P = .042). Despite these findings, the microbiological eradication rate did not differ between the 2 groups. There was no significant difference in total number of adverse events between the 2 groups; however, almost VOL. 102, NO. 4, APRIL 2010
INFOPOEMS
15% of patients in the vancomycin plus rifampicin group developed hyperbilirubinemia.
Reference
Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial methicillin-resistant Staphylococcus aureus pneumonia. Crit Care Med. 2010;38(1):175-180.
Soy Associated With Less Risk of Breast Cancer Recurrence and Death Clinical Question Does soy food consumption reduce the risk of breast cancer recurrence and mortality among adult women with breast cancer? Bottom Line Among women with breast cancer, increased soy food consumption is associated with a reduced risk of breast cancer recurrence and mortality. This study was done in China, which may limit its generalizability to the United States. (LOE = 1b) Study Design Cohort (prospective) Funding Government Setting Population-based Synopsis The estrogen-like effect of isoflavones in soy foods may influence the risk of breast cancer recurrence and subsequent mortality. These investigators prospectively followed 5042 women, aged 20 to 75 years with documented breast cancer who were recruited as part of the Shanghai Breast Cancer Survival Study. Medical charts and vital statistic registries were reviewed to verify clinical outcomes. Dietary intake was assessed using a validated food frequency questionnaire designed to measure soy food consumption.
Complete follow-up occurred for 88.2% of study patients. Multivariate analyses were performed to control for other known clinical prognosis factors (eg, age, tumor stage, type of treatment, menopausal status, tamoxifen use, and estrogen receptor [ER] status). A total of 534 recurrences or breast cancer– related deaths and 444 total deaths were documented during the study period. Women consuming increasing amounts of soy protein had an inversely reduced risk of mortality and breast cancer recurrence. Adjusted 4-year mortality rates were 10.3% and 7.4%, and the 4-year recurrence rates were 11.2% and 8.0%, respectively, for women in the lowest and highest quartiles of soy protein intake. Mortality and recurrence risk followed a linear dose-response pattern until soy protein intake reached 11 g per day. The reduced risk from soy food intake was similar among women with either ER-positive or ER-negative breast cancers and did not vary by menopausal status, tamoxifen use, or cancer stage. Women whose soy food intake was in the highest quartile did not appear to receive any additional survival or recurrence benefit from tamoxifen use.
Reference
Shu XO, Zheng Y, Cai H, et al. Soy food intake and breast cancer survival. JAMA. 2009;302 (22):2437-2443.
Maternal Blood Testing Accurate for Fetal Sex Clinical Question Is maternal blood testing late in the first trimester accurate to determine fetal sex? Bottom Line Test results of maternal plasma for fetal DNA late in the first trimester to determine fetal sex are accurate. The main current indication of this testing is to avoid invasive testing of the female fetus for
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
X-linked congenital disorders. (LOE = 1b)
Study Design Diagnostic test evaluation Funding Other Setting Outpatient (specialty) Synopsis The presence of cell-free fetal DNA originating from the placenta in the plasma of pregnant women was discovered in the 1990s. Early knowledge of fetal sex can be helpful; for example, to avoid invasive testing of female fetuses for X-linked conditions. A polymerase chain reaction (PCR) test of maternal plasma can determine the presence or absence of sequences specific to the Y chromosome or paternal alleles present in the father, but absent in the mother. These Dutch authors report the results of 201 cases tested from 2003 to 2009. Fetal sex was ascertained by karyotyping, ultrasound, or after birth in 98% of cases. Ultrasound prior to PCR testing was performed to confirm viable singleton gestation. The researchers used a minimal gestational age of 7 weeks for indication of risk for congenital adrenal hyperplasia and 9 weeks for all others to reduce the likelihood of false-negative results due to low levels of fetal DNA. Testing for presence of paternal sequences absent in the mother was also performed to confirm the presence of fetal DNA. There were no cases of misclassification of boys and girls. In all cases of inconclusive results (n = 10), the sex of the newborn was female. Reference
Scheffer PG, van der Schoot CE, Page-Christiaens GC, Bossers B, van Erp F, de Haas M. Reliability of fetal sex determination using maternal plasma. Obstet Gynecol. 2010;115(1):117-126.
VOL. 102, NO. 4, APRIL 2010 357
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These InfoPOEMs® are selected by JNMA InfoPOEMS Editor Gregory E. Gilbert, MSPH, (Gregory.E.Gilbert@ gmail.com) and Associate InfoPOEMS Editor Amy H. Wahlquist, MS, from www.infopoems.com. InfoPOEMs® are created by experts who continuously survey medical journals worldwide. They identify and summarize valid and clinically applicable new evidence. For more information or to subscribe to e-mail alerts of InfoPOEMs®, please visit www.infopoems.com. STUDY LEVELS OF EVIDENCE (LOE) From the Centre for Evidence-Based Medicine, Oxford. For the most up-todate levels of evidence, see www.cebm. net/levels_of_evidence.asp) Therapy/Prevention/Etiology/Harm: 1a: Systematic reviews of randomized controlled trials 1b: Individual randomized controlled trials 1c: All or none randomized controlled trials 2a: Systematic reviews of cohort studies 2b: Individual cohort study or lowquality randomized controlled 2c: “Outcomes” research, ecological studies Diagnosis: 1a: Systematic review of level-1 diagnostic studies 1b: Independent blind comparison of an appropriate spectrum of consecutive patients, all of whom have undergone both the diagnostic test and the reference standard, or a clinical decision rule not validated on a second set of patients 1c: Absolute SpPins and SnNouts 2a: Systematic review of level >2 2b: Independent blind or objective comparison, study confined to a narrow spectrum of study individuals, or a diagnostic clinical rule not validated in a test set Prognosis: 1a: Systematic review of inception cohort studies 1b: Individual inception cohort study with >80% follow-up, or a clinical rule not validated on a second set of patients 1c: All or none case series 2a: Systematic review of either retrospective cohort studies or untreated control groups in RCTs 2b: Retrospective cohort study or followup of untreated control patients in an RCT, or clinical rule not validated in a test set 2c: “Outcomes” research Copyright © 1995–2010 John Wiley & Sons, Inc. All rights reserved. www.infopoems.com.
Vancomycin Plus Rifampicin Effective in Treatment of Nosocomial MRSA Pneumonia Clinical Question Is vancomycin plus rifampicin more effective than vancomycin alone in the treatment of nosocomial methicillin-resistant Staphylococcus aureus (MRSA) pneumonia? Bottom Line The addition of rifampicin to vancomycin increases the clinical cure rate of nosocomial MRSA pneumonia. (LOE = 1b) Study Design Randomized controlled trial (nonblinded) Funding Government Allocation Uncertain Setting Inpatient (intensive care unit only) Synopsis Vancomycin is the primary therapy for MRSA pneumonia but may lead to treatment failure because of its poor activity in the lungs. Rifampicin is a bactericidal drug against gram-positive organisms with excellent lung penetration that has been used as an adjunct to vancomycin for the treatment of staphylococcal infections. In this Korean study, investigators recruited patients in a medical intensive care unit with clinical, radiographic, and culture evidence of gram-positive pneumonia that developed at
356 JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
least 48 hours after admission to the hospital. Of 183 eligible patients, almost half were excluded for reasons, including liver dysfunction, recent use of vancomycin, or refusal to participate. The remaining 93 patients were randomized to receive 14 days of either intravenous 1 g of vancomycin plus 300 mg of oral rifampicin every 12 hours or 1 g of intravenous vancomycin alone every 12 hours with dose adjustments for renal function and age, as needed. Of the 93 patients, 10 were later excluded, as they had no confirmation of MRSA or had bacteria resistant to rifampicin, leaving 83 patients in the modified intention-to-treat group. The treatment and control groups were well matched for baseline characteristics, including age, sex, comorbidities, and disease severity. All patients underwent daily clinical assessments and chest radiographs, as well as respiratory and blood cultures on study enrollment and at day 14. Adding rifampicin to vancomycin increased the clinical cure rate of nosocomial MRSA pneumonia, defined by resolution of clinical signs and symptoms of pneumonia and improvement in chest radiography at 14 days (53.7% vs 31%, P = .047). You would have to treat 4 patients with vancomycin plus rifampicin to cure 1 additional case of nosocomial MRSA pneumonia. No difference was detected in overall mortality at 28 days, but the mortality rate at 60 days was lower in the vancomycin plus rifampicin group (26.8% vs 50%, P = .042). Despite these findings, the microbiological eradication rate did not differ between the 2 groups. There was no significant difference in total number of adverse events between the 2 groups; however, almost VOL. 102, NO. 4, APRIL 2010
INFOPOEMS
15% of patients in the vancomycin plus rifampicin group developed hyperbilirubinemia.
Reference
Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial methicillin-resistant Staphylococcus aureus pneumonia. Crit Care Med. 2010;38(1):175-180.
Soy Associated With Less Risk of Breast Cancer Recurrence and Death Clinical Question Does soy food consumption reduce the risk of breast cancer recurrence and mortality among adult women with breast cancer? Bottom Line Among women with breast cancer, increased soy food consumption is associated with a reduced risk of breast cancer recurrence and mortality. This study was done in China, which may limit its generalizability to the United States. (LOE = 1b) Study Design Cohort (prospective) Funding Government Setting Population-based Synopsis The estrogen-like effect of isoflavones in soy foods may influence the risk of breast cancer recurrence and subsequent mortality. These investigators prospectively followed 5042 women, aged 20 to 75 years with documented breast cancer who were recruited as part of the Shanghai Breast Cancer Survival Study. Medical charts and vital statistic registries were reviewed to verify clinical outcomes. Dietary intake was assessed using a validated food frequency questionnaire designed to measure soy food consumption.
Complete follow-up occurred for 88.2% of study patients. Multivariate analyses were performed to control for other known clinical prognosis factors (eg, age, tumor stage, type of treatment, menopausal status, tamoxifen use, and estrogen receptor [ER] status). A total of 534 recurrences or breast cancer– related deaths and 444 total deaths were documented during the study period. Women consuming increasing amounts of soy protein had an inversely reduced risk of mortality and breast cancer recurrence. Adjusted 4-year mortality rates were 10.3% and 7.4%, and the 4-year recurrence rates were 11.2% and 8.0%, respectively, for women in the lowest and highest quartiles of soy protein intake. Mortality and recurrence risk followed a linear dose-response pattern until soy protein intake reached 11 g per day. The reduced risk from soy food intake was similar among women with either ER-positive or ER-negative breast cancers and did not vary by menopausal status, tamoxifen use, or cancer stage. Women whose soy food intake was in the highest quartile did not appear to receive any additional survival or recurrence benefit from tamoxifen use.
Reference
Shu XO, Zheng Y, Cai H, et al. Soy food intake and breast cancer survival. JAMA. 2009;302 (22):2437-2443.
Maternal Blood Testing Accurate for Fetal Sex Clinical Question Is maternal blood testing late in the first trimester accurate to determine fetal sex? Bottom Line Test results of maternal plasma for fetal DNA late in the first trimester to determine fetal sex are accurate. The main current indication of this testing is to avoid invasive testing of the female fetus for
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
X-linked congenital disorders. (LOE = 1b)
Study Design Diagnostic test evaluation Funding Other Setting Outpatient (specialty) Synopsis The presence of cell-free fetal DNA originating from the placenta in the plasma of pregnant women was discovered in the 1990s. Early knowledge of fetal sex can be helpful; for example, to avoid invasive testing of female fetuses for X-linked conditions. A polymerase chain reaction (PCR) test of maternal plasma can determine the presence or absence of sequences specific to the Y chromosome or paternal alleles present in the father, but absent in the mother. These Dutch authors report the results of 201 cases tested from 2003 to 2009. Fetal sex was ascertained by karyotyping, ultrasound, or after birth in 98% of cases. Ultrasound prior to PCR testing was performed to confirm viable singleton gestation. The researchers used a minimal gestational age of 7 weeks for indication of risk for congenital adrenal hyperplasia and 9 weeks for all others to reduce the likelihood of false-negative results due to low levels of fetal DNA. Testing for presence of paternal sequences absent in the mother was also performed to confirm the presence of fetal DNA. There were no cases of misclassification of boys and girls. In all cases of inconclusive results (n = 10), the sex of the newborn was female. Reference
Scheffer PG, van der Schoot CE, Page-Christiaens GC, Bossers B, van Erp F, de Haas M. Reliability of fetal sex determination using maternal plasma. Obstet Gynecol. 2010;115(1):117-126.
VOL. 102, NO. 4, APRIL 2010 357