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4.
Pediatrics ; 150(1)2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35921639

RESUMO

Every year in the United States, approximately 3500 infants die of sleep-related infant deaths, including sudden infant death syndrome (SIDS) (International Statistical Classification of Diseases and Related Health Problems 10th Revision [ICD-10] R95), ill-defined deaths (ICD-10 R99), and accidental suffocation and strangulation in bed (ICD-10 W75). After a substantial decline in sleep-related deaths in the 1990s, the overall death rate attributable to sleep-related infant deaths have remained stagnant since 2000, and disparities persist. The triple risk model proposes that SIDS occurs when an infant with intrinsic vulnerability (often manifested by impaired arousal, cardiorespiratory, and/or autonomic responses) undergoes an exogenous trigger event (eg, exposure to an unsafe sleeping environment) during a critical developmental period. The American Academy of Pediatrics recommends a safe sleep environment to reduce the risk of all sleep-related deaths. This includes supine positioning; use of a firm, noninclined sleep surface; room sharing without bed sharing; and avoidance of soft bedding and overheating. Additional recommendations for SIDS risk reduction include human milk feeding; avoidance of exposure to nicotine, alcohol, marijuana, opioids, and illicit drugs; routine immunization; and use of a pacifier. New recommendations are presented regarding noninclined sleep surfaces, short-term emergency sleep locations, use of cardboard boxes as a sleep location, bed sharing, substance use, home cardiorespiratory monitors, and tummy time. In addition, additional information to assist parents, physicians, and nonphysician clinicians in assessing the risk of specific bed-sharing situations is included. The recommendations and strength of evidence for each recommendation are published in the accompanying policy statement, which is included in this issue.


Assuntos
Transtornos do Sono-Vigília , Morte Súbita do Lactente , Asfixia , Roupas de Cama, Mesa e Banho , Leitos , Criança , Humanos , Lactente , Chupetas , Fatores de Risco , Sono , Morte Súbita do Lactente/etiologia , Morte Súbita do Lactente/prevenção & controle , Estados Unidos/epidemiologia
5.
Pediatrics ; 150(1)2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35726558

RESUMO

Each year in the United States, ∼3500 infants die of sleep-related infant deaths, including sudden infant death syndrome (SIDS) (International Classification of Diseases, 10th Revision [ICD-10] R95), ill-defined deaths (ICD-10 R99), and accidental suffocation and strangulation in bed (ICD-10 W75). After a substantial decline in sleep-related deaths in the 1990s, the overall death rate attributable to sleep-related infant deaths has remained stagnant since 2000, and disparities persist. The triple risk model proposes that SIDS occurs when an infant with intrinsic vulnerability (often manifested by impaired arousal, cardiorespiratory, and/or autonomic responses) undergoes an exogenous trigger event (eg, exposure to an unsafe sleeping environment) during a critical developmental period. The American Academy of Pediatrics recommends a safe sleep environment to reduce the risk of all sleep-related deaths. This includes supine positioning; use of a firm, noninclined sleep surface; room sharing without bed sharing; and avoidance of soft bedding and overheating. Additional recommendations for SIDS risk reduction include human milk feeding; avoidance of exposure to nicotine, alcohol, marijuana, opioids, and illicit drugs; routine immunization; and use of a pacifier. New recommendations are presented regarding noninclined sleep surfaces, short-term emergency sleep locations, use of cardboard boxes as a sleep location, bed sharing, substance use, home cardiorespiratory monitors, and tummy time. Additional information to assist parents, physicians, and nonphysician clinicians in assessing the risk of specific bed-sharing situations is also included. The recommendations and strength of evidence for each recommendation are included in this policy statement. The rationale for these recommendations is discussed in detail in the accompanying technical report.


Assuntos
Transtornos do Sono-Vigília , Morte Súbita do Lactente , Asfixia , Roupas de Cama, Mesa e Banho , Causas de Morte , Criança , Humanos , Lactente , Chupetas , Fatores de Risco , Sono , Morte Súbita do Lactente/epidemiologia , Morte Súbita do Lactente/etiologia , Morte Súbita do Lactente/prevenção & controle , Decúbito Dorsal , Estados Unidos/epidemiologia
6.
JMIR Pediatr Parent ; 4(4): e27297, 2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-34779783

RESUMO

BACKGROUND: Parenting practices are highly influenced by perceived social norms. Social norms and American Academy of Pediatrics (AAP) guidelines for infant safe sleep practices are often inconsistent. Instagram has become one of the most popular social media websites among young adults (including many expectant and new parents). We hypothesized that the majority of Instagram images of infant sleep and sleep environments are inconsistent with AAP guidelines, and that the number of "likes" for each image would not correlate with adherence of the image to these guidelines. OBJECTIVE: The objective of this study was to determine the extent of adherence of Instagram images of infant sleep and sleep environments to safe infant sleep guidelines. METHODS: We searched Instagram using hashtags that were relevant to infant sleeping practices and environments. We then used an open-source web scraper to collect images and the number of "likes" for each image from 27 hashtags. Images were analyzed for adherence to AAP safe sleep guidelines. RESULTS: A total of 1563 images (1134 of sleeping infant; 429 of infant sleep environment without sleeping infant) met inclusion criteria and were analyzed. Only 117 (7.49%) of the 1563 images were consistent with AAP guidelines. The most common reasons for inconsistency with AAP guidelines were presence of bedding (1173/1563, 75.05%) and nonrecommended sleep position (479/1134, 42.24%). The number of "likes" was not correlated with adherence of the image to AAP guidelines. CONCLUSIONS: Although individuals who use Instagram and post pictures of sleeping infants or infant sleep environments may not actually use these practices regularly, the consistent portrayal of images inconsistent with AAP guidelines reinforces that these practices are normative and may influence the practice of young parents.

7.
Breastfeed Med ; 16(10): 807-813, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34009013

RESUMO

Background: An individual's personal social network influences behavior; one is more likely to adopt behaviors consistent with norms within the network to avoid social stigma. Personal social network types, which are associated with individual behaviors, have been identified for new mothers: exclusive (kin centric) and expansive (not kin centric). Objective: To analyze the impact of personal social network type on breastfeeding practices in U.S.-born Black and White mothers. Methods: Mothers of infants <6 months old completed surveys about their personal social networks and feeding practices. Multinomial logit models examined how social network types moderated effects of sociodemographic factors on feeding practices. Results: Of 402 mothers, 67% self-identified as Black and 33% as White. Forty-six percent were exclusively breastfeeding; 26% were mixed breast and formula feeding. The likelihood of exclusively breastfeeding was positively associated with percentage of network members who had breastfed; this association was stronger for mothers with exclusive networks than those with expansive networks (ß = 2.74, p < 0.001 versus ß = 1.78, p = 0.03). Black race was positively correlated with exclusive breastfeeding or mixed feeding for mothers with exclusive networks (ß = 1.50, p = 0.046; ß = 1.86, p = 0.02, respectively). Lower educational level was negatively correlated with exclusive breastfeeding; this correlation was stronger for mothers with exclusive networks (ß = -1.91, p = 0.002 versus ß = -1.70, p = 0.04). Lower educational level was also negatively correlated with mixed feeding for mothers with exclusive networks (ß = -1.61, p = 0.02). Conclusions: Mothers' personal social network type likely moderates the relationship between sociodemographic variables and feeding practices. While the influence of having network members with breastfeeding experience is important, the magnitude of influence is stronger in exclusive networks.


Assuntos
Aleitamento Materno , Fatores Sociodemográficos , População Negra , Feminino , Humanos , Lactente , Mães , Rede Social , Estados Unidos
8.
PLoS One ; 16(2): e0246373, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33529239

RESUMO

BACKGROUND: Respondent driven sampling (RDS) is employed to recruit populations that are hard-to-reach, "hidden," or without a sampling frame. For new mothers (those with infants <6 months) in countries without national health care systems or registries, there is no sampling frame, and random samples may only be attained through costly strategies, e.g., random-dial calling. OBJECTIVE: To assess the feasibility of RDS to recruit new mothers. METHODS: In the initial study, we recruited 30 new mothers ("seeds") from a single birth hospital; each was given 3 referral coupons to give to other mothers ("referrals"). When our sample did not self-perpetuate with referrals, additional seeds were recruited. Demographics of seeds and referrals were compared. A subset of mothers participated in focus groups and were asked about their experience with RDS. We also conducted a second survey of new mothers to further assess feasibility of RDS in this population. RESULTS: Of the 402 mothers recruited in the initial study, 305 were seeds and only 97 were referrals. Referrals were more likely to be White, highly educated, older, and privately insured (all p≤0.001). Focus group participants indicated that the time required to meet other mothers was an important barrier. In the second survey we recruited 201 mothers; only 53.7% knew ≥1 mother whom they could invite to the study. CONCLUSIONS: New mothers are not easily recruited using RDS because they have a limited number of contacts who are also new mothers. Those recruited through RDS are more likely to be older, Caucasian and of high socioeconomic status, indicating it is not an effective way to recruit a representative sample of new mothers.


Assuntos
Mães , Adulto , Atenção à Saúde , District of Columbia , Feminino , Grupos Focais , Hospitais , Humanos , Lactente , Recém-Nascido , Masculino , Estudos de Amostragem , Inquéritos e Questionários , Adulto Jovem
9.
Soc Sci Med ; 269: 113585, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33333376

RESUMO

Despite public awareness campaigns, some parents continue to engage in infant sleep practices that are considered risky by health experts, such as bedsharing or placing their infants on their stomachs. This study examines the role their social networks play in shaping parents' responsiveness to new information and/or suggestions about how they should place their infants for sleep, paying attention to the respective effects of health professionals and their close interpersonal ties. We collected data from a sample of 323 new mothers in Washington, D.C., who described their infant sleep practices and perceived personal social networks. We find evidence that mothers' social networks play a significant role in the likelihood that they adjust their infant sleep practices within the first few months of their infants' lives. Mothers are more likely to change sleep practices when health professionals and/or (lay) family members advise them to do so. The influence of network members is not always positive. For mothers who initially follow safe practices, their probability of change increases if their network members substantially espouse unsafe practices. Among mothers with initially unsafe practices, network members' level of support for safe sleep practices is not predictive of the likelihood of sleep practice change. Implications for potential interventions are discussed.


Assuntos
Mães , Morte Súbita do Lactente , Criança , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Lactente , Cuidado do Lactente , Fatores de Risco , Sono , Rede Social , Washington
11.
J Pediatr ; 229: 26-32.e2, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33065115

RESUMO

OBJECTIVES: To examine whether patients with multisystem inflammatory syndrome in children (MIS-C) demonstrated well-defined clinical features distinct from other febrile outpatients, given the difficulties of seeing acute care visits during the severe acute respiratory syndrome coronavirus 2 pandemic and the risks associated with both over- and underdiagnosis of MIS-C. STUDY DESIGN: This case-controlled study compared patients diagnosed with and treated for MIS-C at a large urban children's hospital with patients evaluated for fever at outpatient acute care visits during the peak period of MIS-C. Symptomatology and available objective data were extracted. Comparisons were performed using t tests with corrections for multiple comparisons, and multivariable logistic regression to obtain ORs. RESULTS: We identified 44 patients with MIS-C between April 16 and June 10, 2020. During the same period, 181 pediatric patients were evaluated for febrile illnesses in participating outpatient clinics. Patients with MIS-C reported greater median maximum reported temperature height (40°C vs 38.9, P < .0001), and increased frequency of abdominal pain (OR 12.5, 95% CI [1.65-33.24]), neck pain (536.5, [2.23-129,029]), conjunctivitis (31.3, [4.6-212.8]), oral mucosal irritation (11.8, [1.4-99.4]), extremity swelling or rash (99.9, [5-1960]), and generalized rash (7.42, [1.6-33.2]). Patients with MIS-C demonstrated lower absolute lymphocyte (P < .0001) and platelet counts (P < .05) and greater C-reactive protein concentrations (P < .001). CONCLUSIONS: Patients treated for MIS-C due to concern for potential cardiac injury show combinations of features distinct from other febrile patients seen in outpatient clinics during the same period.


Assuntos
Assistência Ambulatorial , COVID-19/complicações , COVID-19/diagnóstico , Febre/diagnóstico , Febre/etiologia , Síndrome de Resposta Inflamatória Sistêmica/complicações , Síndrome de Resposta Inflamatória Sistêmica/diagnóstico , Adolescente , Fatores Etários , COVID-19/terapia , Criança , Pré-Escolar , Diagnóstico Diferencial , Feminino , Humanos , Masculino , Estudos Retrospectivos , Avaliação de Sintomas , Síndrome de Resposta Inflamatória Sistêmica/terapia
12.
Breastfeed Med ; 14(9): 640-647, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31433206

RESUMO

Background: Social networks and subjective norms (individuals' perceptions of what other people think) can be influential in decision-making. Although there are data about the importance of support in initiation and duration of breastfeeding, no studies have explored the influence of women's social networks and the norms within those networks on breastfeeding. Research Aim: To investigate, through qualitative methods, the influence of mothers' social networks and subjective norms, both within and outside of her network, with regard to breastfeeding practices. Materials and Methods: Twenty-eight mothers participated in focus groups or individual interviews. Probing questions concerning breastfeeding intent, initiation, continuation, and support with regard to social networks and subjective norms were asked. Themes were developed in an iterative manner from coded data. Matrix coding queries assessed patterns in the data and compared quotes based on the respondents' race and social network type. Results: General themes that emerged were the importance of breastfeeding experience within one's social network, the influence of the infant's father, handling disagreement within one's network, and the effects of social norms that exist outside of one's network. Mothers described support for breastfeeding from network members as especially important when breastfeeding was not the norm within the network. There were no differences in themes by race or social network type. Conclusion: Breastfeeding behavior is influenced by a mother's social network, regardless of her race or social network type. Even when breastfeeding is not normative within one's social network, by relying on one network member to support them, mothers may be able to resist the opposing norms of their social network. Since breastfeeding is known to be beneficial to infants and mothers, education or interventions to improve breastfeeding rates may be more effective if they include individual network members who can provide strong support to new mothers.


Assuntos
Aleitamento Materno , Mães/psicologia , Rede Social , Normas Sociais/etnologia , Apoio Social , Adulto , Negro ou Afro-Americano , Relações Familiares/psicologia , Feminino , Grupos Focais , Humanos , Entrevistas como Assunto , Pesquisa Qualitativa , População Branca , Adulto Jovem
13.
J Med Internet Res ; 21(7): e14289, 2019 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-31290403

RESUMO

BACKGROUND: Traditionally, guidance and support to new parents have come from family, friends, and health care providers. However, the internet and social media are growing sources of guidance and support for parents. Little is known about how the internet and social media are used by parents of young infants and specifically about parental perceptions of the internet and social media as sources of parenting and infant health information. OBJECTIVE: The aim of this study was to explore, using qualitative methods, parental perceptions of the advantages and disadvantages of the internet and social media as sources of parenting and health information regarding their infant. METHODS: A total of 28 mothers participated in focus groups or individual interviews. Probing questions concerning parenting and health information sources were asked. Themes were developed in an iterative manner from coded data. RESULTS: The central themes were (1) reasons that mothers turn to the internet for parenting and health information, (2) cautionary advice about the internet, and (3) reasons that mothers turn to social media for parenting and health information. Mothers appreciated the ability to gather unlimited information and multiple opinions quickly and anonymously, but recognized the need to use reputable sources of information. Mothers also appreciated the immediacy of affirmation, support, and tailored information available through social media. CONCLUSIONS: The internet and social media are rapidly becoming important and trusted sources of parenting and health information that mothers turn to when making infant care decisions.


Assuntos
Grupos Focais/métodos , Troca de Informação em Saúde/normas , Internet/normas , Mães/psicologia , Poder Familiar/psicologia , Mídias Sociais/normas , Adulto , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pesquisa Qualitativa , Adulto Jovem
14.
J Pediatr ; 212: 151-158.e2, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31201032

RESUMO

OBJECTIVE: To describe the structure of networks in a cohort of mothers and to analyze associations of social network characteristics and norms with infant sleep practices. STUDY DESIGN: We recruited a prospective cohort of mothers with infants <6 months of age from January 2015 to December 2016. Mothers completed a survey about their personal social networks and infant care practices. Latent class analysis identified unobserved network types. Binary statistics and path analysis were performed. RESULTS: Overall, 402 mothers were surveyed. Latent class analysis identified 2 a priori unknown social network types: "exclusive" (restricted) and "expansive." Mothers who were black, younger, unmarried, less educated, and of lower socioeconomic status were more likely to have exclusive networks than expansive networks. Mothers with exclusive networks were more likely to be exposed to the norm of soft bedding (P = .002). Exposure to norms of non-supine infant placement, bedsharing, and soft bedding use within one's network was associated with engaging in these practices (P < .0001 for each). First-time mothers were more likely to pay attention to a non-supine norm and place infants in a non-supine position. Black mothers and first-time mothers were more likely to pay attention to the norm and use soft bedding. CONCLUSIONS: Both the type of networks mothers have and the norms regarding infant sleep practices that circulate within these networks differed by race. Network norms were strongly associated with infant sleep practices and may partially explain the racial disparity therein.


Assuntos
Cuidado do Lactente , Comportamento Materno , Mães , Assunção de Riscos , Sono , Rede Social , Adulto , Feminino , Humanos , Lactente , Recém-Nascido , Estudos Prospectivos
15.
Clin Pediatr (Phila) ; 58(9): 985-992, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31018675

RESUMO

Background. Mothers often look to family members and friends (ie, their social network) for advice and support regarding infant care decisions. However, little is known about the process by which mothers' social networks are established and how mothers use these networks to make decisions regarding infant care. We thus conducted a qualitative analysis to explore how mothers choose individuals for their social networks, and how they use these for decision-making. Methods. Focus groups or individual interviews were conducted with 28 mothers. We asked probing questions about whom mothers turned to for advice and support, and how they made infant care decisions. Data were coded and analyzed iteratively for emerging themes. Results. Themes that emerged were changes in social networks once children are born, reasons for being in the mother's social network, importance of the pediatrician as a trusted source, and process of making infant care decisions. After an infant is born, mothers gravitate toward friends with children; trustworthiness of those whom mothers turn to is based on their perceived experience and knowledge. Pediatricians are valued for their professional and personal experience with children. Mothers use consensus and/or instinct to make infant care decisions, but continually seek reassurance that these decisions are correct. Conclusion. Mothers' social networks are important sources of infant care information. Because mothers rely on consensus and continued reassurance when making decisions, health care professionals have many opportunities to influence decision-making. Consistent health care messaging can enhance mothers' perceptions that there is consensus of opinion from trusted sources.


Assuntos
Tomada de Decisões , Conhecimentos, Atitudes e Prática em Saúde , Cuidado do Lactente/métodos , Mães/psicologia , Rede Social , Adulto , Estudos de Avaliação como Assunto , Feminino , Grupos Focais , Humanos , Lactente , Entrevistas como Assunto , Masculino , Mães/estatística & dados numéricos , Apoio Social , Adulto Jovem
16.
J Community Health ; 43(5): 977-985, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29637434

RESUMO

Sudden infant death syndrome (SIDS) rates in African-Americans are more than twice national rates, and historically, African-American parents are more likely than other groups to place infants prone, even when they are aware of supine sleep recommendations. Prior studies have shown African-Americans have low self-efficacy against SIDS but high self-efficacy against suffocation. This study aimed to determine the impact of a specific health message about suffocation prevention on African-American parental decisions regarding infant sleep position. We conducted a randomized controlled trial of 1194 African-American mothers, who were randomized to receive standard messages about safe sleep practices to reduce the risk of SIDS, or enhanced messages about safe sleep practices to prevent SIDS and suffocation. Mothers were interviewed about knowledge and attitude, self-efficacy and current infant care practices when infants were 2-3 weeks, 2-3 months and 5-6 months old. Analyses of covariance were conducted to estimate the change in knowledge, attitudes and practice in each group, and chi square tests were used to compare sleep position with each variable. Over the first 6 months, the proportion of African-American infants placed supine gradually decreased and was unchanged by enhanced education about SIDS, suffocation risk and sleep safety. While initially high self-efficacy against SIDS and suffocation correlated with supine positioning, by 5-6 months self-efficacy did not correspond to sleep position in either group.


Assuntos
Negro ou Afro-Americano/psicologia , Promoção da Saúde/métodos , Cuidado do Lactente/métodos , Autoeficácia , Morte Súbita do Lactente/etnologia , Morte Súbita do Lactente/prevenção & controle , Negro ou Afro-Americano/estatística & dados numéricos , Tomada de Decisões , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pais
18.
JAMA Pediatr ; 171(2): 175-180, 2017 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-27918760

RESUMO

Importance: Sudden infant death syndrome remains the leading cause of death in infants aged 1 month to 1 year in the United States. Observations: While its exact cause is unknown, sudden infant death syndrome is believed to be multifactorial, ie, occurs in infants with underlying biological vulnerability who experience an exogenous stressor, such as prone/side sleeping or soft bedding, during a critical developmental period. Much genetic and physiologic evidence points to impaired arousal responses to hypercarbia and hypoxia, which ultimately leads to asphyxia. Known risk factors for infants include prone and side sleeping, soft bedding, bed sharing, inappropriate sleep surfaces (including sofas), exposure to tobacco smoke, and prematurity; protective factors include breastfeeding, pacifier use, room sharing, and immunizations. Conclusions and Relevance: Despite our improved understanding of the physiologic mechanisms that cause sudden infant death, the mainstay of risk reduction continues to be a safe sleep environment, as most infants who die suddenly and unexpectedly do so in unsafe sleep environments.


Assuntos
Morte Súbita do Lactente/prevenção & controle , Humanos , Lactente , Recém-Nascido , Fatores de Risco , Morte Súbita do Lactente/epidemiologia , Estados Unidos/epidemiologia
19.
J Clin Oncol ; 32(33): 3723-8, 2014 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-25245447

RESUMO

PURPOSE: Arsenic trioxide (ATO) is a highly effective agent for the treatment of acute promyelocytic leukemia (APL). QT interval prolongation is common with ATO and can pose a barrier to effective administration. The objective of this study was to characterize the prevalence, management, and clinical consequences of QT prolongation in a large cohort of patients treated with ATO. PATIENTS AND METHODS: We analyzed 3,011 electrocardiograms from 113 patients with non-APL acute myeloid leukemia and myelodysplastic syndrome who were treated on a previously reported clinical trial. QT intervals were assessed using four different correction formulas, and data were correlated with clinical parameters and treatment with ATO. RESULTS: There were no clinically significant cardiac events in the study population. Of those receiving ATO therapy, 29 patients (26%) had rate-uncorrected QT values above 470 ms and 13 (12%) had values exceeding 500 ms. With the commonly used Bazett rate correction formula, 102 patients (90%) had QTc greater than 470 ms, including 74 (65%) above 500 ms. By using alternative rate correction formulas, only 24% to 32% of patients had rate-corrected QT intervals above 500 ms. CONCLUSION: QT interval prolongation is common with ATO treatment, but clinically significant arrhythmias are rare and can be avoided with appropriate precautions. Use of the Bazett correction may result in unnecessary interruptions in ATO therapy, and alternative rate correction formulas should be considered for routine electrocardiographic monitoring.


Assuntos
Antineoplásicos/efeitos adversos , Arsenicais/efeitos adversos , Eletrocardiografia/efeitos dos fármacos , Óxidos/efeitos adversos , Idoso , Trióxido de Arsênio , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência
20.
Cancer ; 113(9): 2504-11, 2008 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-18825661

RESUMO

BACKGROUND: Acute myeloid leukemia (AML) carries a dismal prognosis in older patients. In this study, the authors evaluated the safety and efficacy of arsenic trioxide combined with low-dose cytarabine in untreated patients aged >or=60 years with AML. METHODS: In a phase 1/2 design, arsenic trioxide was administered intravenously at a dose of 0.25 mg/kg on Days 1 through 5 and on Days 8 through 12, and low-dose cytarabine was given subcutaneously twice daily on Days 1 through 14 in escalating doses to a target of 10 mg/m(2) per dose. Of 64 patients who had pathologically confirmed AML, excluding patients with acute promyelocytic leukemia and using World Health Organization criteria, the median age was 71 years, 10 patients (16%) had treatment-related AML, 40 patients (63%) had an antecedent myelodysplastic syndrome or myeloproliferative disorder, and 35 patients (55%) had unfavorable cytogenetics. Thirty-four patients (53%) had an Eastern Cooperative Oncology Group performance status of 2 or 3. RESULTS: Complete remission was achieved in 21 of 61 patients (34%), including 15 of 50 patients (30%) who had secondary or treatment-related AML, 10 of 33 patients (30%) who had unfavorable cytogenetics, and 6 of 34 patients (18%) who had a poor baseline performance status. The mortality rate within the first 4 weeks was 8%. Neutropenic fever was observed in >80% of patients, and 41% of patients had bacteremia. Nonhematologic toxicity generally was mild and reversible and included fatigue, nausea, diarrhea, rash, peripheral edema, and elevated transaminases. There were no clinically significant cardiac arrhythmias. CONCLUSIONS: The addition of arsenic trioxide to low-dose cytarabine appeared to improve responses in elderly patients who had AML compared with either agent alone, and a randomized trial of the combination versus single-agent low-dose cytarabine is ongoing.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Leucemia Mieloide Aguda/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Trióxido de Arsênio , Arsenicais/administração & dosagem , Citarabina/administração & dosagem , Feminino , Humanos , Leucemia Mieloide Aguda/patologia , Leucemia Promielocítica Aguda , Masculino , Pessoa de Meia-Idade , Óxidos/administração & dosagem , Prognóstico , Indução de Remissão , Taxa de Sobrevida
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