Successful pregnancy and lactation outcome in a patient with Gaucher disease receiving enzyme replacement therapy, and the subsequent distribution and excretion of imiglucerase in human breast milk.


BACKGROUND:Enzyme replacement therapy (ERT) with imiglucerase is a well-established, effective treatment for Gaucher disease. However, there have been no published reports regarding the excretion of imiglucerase into human breast milk and its effects on the nursing infant. OBJECTIVE:This letter reports on the successful pregnancy and lactation of a patient with Gaucher disease receiving treatment with imiglucerase, and the subsequent distribution and excretion of imiglucerase in human breast milk. METHODS:A 39-year-old Japanese female (height, 164 cm; weight, 55 kg) with Gaucher disease had 2 successful pregnancies and continued ERT through both. The study was conducted 6 months after the first delivery. She was administered a 1-hour infusion of imiglucerase 60 U/kg that coincided with her regular every-2-week regimen. Serum and breast-milk samples were obtained before and up to 24 hours after administration. Breast-milk samples were also obtained from 10 nursing mothers with galactorrhea as controls. RESULTS:The preinfusion level of breast-milk β-glucocerebrosidase was 0.008 nmol/h/mL. The peak of serum β-glucocerebrosidase activity (0.119 nmol/h/mL) was obtained at the end of the 1-hour infusion period. Slightly increased enzymatic activity (0.016 nmol/h/mL) was observed in the first breast milk sampled after imiglucerase infusion. CONCLUSIONS:We report a case of successful pregnancy and breastfeeding in a Japanese patient with Gaucher disease. A small amount of imiglucerase was found to be excreted into human breast milk, but only in the first milk produced after infusion.


Clin Ther


Clinical therapeutics


Sekijima Y,Ohashi T,Ohira S,Kosho T,Fukushima Y




Has Abstract


2010-11-01 00:00:00














  • A 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and tolerability of combination therapy with rosiglitazone and sulfonylurea in African American and Hispanic American patients with type 2 diabetes

    abstract:BACKGROUND:Type 2 diabetes mellitus is twice as prevalent in African Americans and Hispanic Americans as in non-Hispanic whites. However, the effectiveness and safety profile of rosiglitazone maleate used as combination therapy with sulfonylureas in the management of diabetes and its effect on cardiovascular disease (C...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Davidson JA,McMorn SO,Waterhouse BR,Cobitz AR

    更新日期:2007-09-01 00:00:00

  • Effect of combined systemic and local morpholino treatment on the spinal muscular atrophy Δ7 mouse model phenotype.

    abstract:BACKGROUND:Spinal muscular atrophy (SMA) is a fatal motor neuron disease of childhood that is caused by mutations in the SMN1 gene. Currently, no effective treatment is available. One possible therapeutic approach is the use of antisense oligos (ASOs) to redirect the splicing of the paralogous gene SMN2, thus increasin...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Nizzardo M,Simone C,Salani S,Ruepp MD,Rizzo F,Ruggieri M,Zanetta C,Brajkovic S,Moulton HM,Müehlemann O,Bresolin N,Comi GP,Corti S

    更新日期:2014-03-01 00:00:00

  • Effect of multidrug resistance gene-1 (ABCB1) polymorphisms on the single-dose pharmacokinetics of cloxacillin in healthy adult Chinese men.

    abstract:BACKGROUND:Plasma concentrations of cloxacillin have been found to vary as much as 20-fold among individuals receiving the same oral dose. There is evidence that cloxacillin may be a substrate for P-glycoprotein, suggesting that polymorphisms in the ABCB1 gene may be a contributing factor to the observed variability in...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Yin OQ,Tomlinson B,Chow MS

    更新日期:2009-05-01 00:00:00

  • Progression to insulin for patients with diabetes mellitus using the Texas Medicaid database.

    abstract:BACKGROUND:Patients newly diagnosed with type 2 diabetes mellitus generally initiate therapy with either metformin [Met] or a sulfonylurea [SU] drug, followed by the addition of a second agent (Met, an SU drug, or a thiazolidinedione [TZD] drug) if the diabetes is not well controlled. If necessary, the usual third line...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Rascati KL,Richards KM,Lopez D,Cheng LI,Wilson JP

    更新日期:2011-12-01 00:00:00

  • Single- and multiple-dose pharmacokinetics of samidorphan, a novel opioid antagonist, in healthy volunteers.

    abstract:PURPOSE:Samidorphan (3-carboxamido-4-hydroxy naltrexone) is a novel opioid receptor antagonist that is currently in clinical development. The oral dose pharmacokinetics, safety, and tolerability of samidorphan were evaluated in 2 double-blind, placebo-controlled, randomized studies in healthy adults. METHODS:The first...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Turncliff R,DiPetrillo L,Silverman B,Ehrich E

    更新日期:2015-02-01 00:00:00

  • Comparison of hydroxychloroquine with zidovudine in asymptomatic patients infected with human immunodeficiency virus type 1.

    abstract::Hydroxychloroquine (HCQ), an antimalarial agent used to treat patients with autoimmune diseases, has been shown to suppress human immunodeficiency virus type 1 (HIV-1) replication in T cells and monocytes in vitro by inhibiting posttranscriptional modification of the virus. An initial randomized, placebo-controlled cl...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Sperber K,Chiang G,Chen H,Ross W,Chusid E,Gonchar M,Chow R,Liriano O

    更新日期:1997-09-01 00:00:00

  • Managing Procedural Pain in the Neonate Using an Opioid-sparing Approach.

    abstract:PURPOSE:Pain in the neonate is often challenging to assess but important to control. Physicians often must balance the need for optimal pain control with the need to minimize oversedation and prolonged opioid use. Both inadequate pain control and overuse of opioids can have long-term consequences, including poor develo...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Squillaro A,Mahdi EM,Tran N,Lakshmanan A,Kim E,Kelley-Quon LI

    更新日期:2019-09-01 00:00:00

  • Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers.

    abstract:BACKGROUND:Varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, has been developed specifically for smoking cessation. In Japan, 39.3% of men smoke and this is a major public health concern. OBJECTIVE:The primary objective of this study was to evaluate the efficacy and dose-response r...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Nakamura M,Oshima A,Fujimoto Y,Maruyama N,Ishibashi T,Reeves KR

    更新日期:2007-06-01 00:00:00

  • Health Behaviors in Cervical Cancer Survivors and Associations with Quality of Life.

    abstract:PURPOSE:Improvement in health behaviors following cancer diagnosis may contribute to better prognosis and well-being. This study examines the prevalence of health behaviors in cervical cancer survivors who have completed treatment, and associations between health behaviors and quality of life (QOL). METHODS:We recruit...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Iyer NS,Osann K,Hsieh S,Tucker JA,Monk BJ,Nelson EL,Wenzel L

    更新日期:2016-03-01 00:00:00

  • Current attitudes on cardiac devices in heart failure: a review.

    abstract:PURPOSE:Despite significant advances in optimizing drug therapy, heart failure-related mortality and morbidity remain high. There has been great progression with regard to device therapy in heart failure, and device use continues to increase. The aims of this review were to critically re-examine the evidence base and t...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Marangou J,Paul V

    更新日期:2015-10-01 00:00:00

  • Efficacy of oral long-term N-acetylcysteine in chronic bronchopulmonary disease: a meta-analysis of published double-blind, placebo-controlled clinical trials.

    abstract:OBJECTIVE:This meta-analysis was performed to assess the possible prophylactic benefit of prolonged treatment with oral N-acetylcysteine (NAC) in chronic bronchitis (CB) based on qualifying clinical trials. Treatment of acute exacerbations with NAC was not investigated. BACKGROUND:Prolonged treatment with oral NAC has...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析


    authors: Grandjean EM,Berthet P,Ruffmann R,Leuenberger P

    更新日期:2000-02-01 00:00:00

  • Rotavirus live, oral, pentavalent vaccine.

    abstract:BACKGROUND:On February 3, 2006, the US Food and Drug Administration (FDA) approved a live, oral, pentavalent (G1-G4, P1[8]) human-bovine reassortant rotavirus vaccine for the prevention of rotavirus gastroenteritis (RVGE) in infants in the United States. The Advisory Committee of Immunization Practices of the Centers f...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Tom-Revzon C

    更新日期:2007-12-01 00:00:00

  • Hypersensitivity reactions during therapy with the nucleoside reverse transcriptase inhibitor abacavir.

    abstract:BACKGROUND:Hypersensitivity reactions consist of a variable group of clinical findings and have been described for a wide variety of chemical compounds. OBJECTIVE:This review characterizes the clinical profile of hypersensitivity to the nucleoside reverse transcriptase inhibitor abacavir sulfate. METHODS:We performed...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Hetherington S,McGuirk S,Powell G,Cutrell A,Naderer O,Spreen B,Lafon S,Pearce G,Steel H

    更新日期:2001-10-01 00:00:00

  • New techniques for augmenting saliva collection: bacon rules and lozenge drools.

    abstract:PURPOSE:Saliva is a reliable, noninvasive, and cost-effective alternative to biomarkers measured in other biological fluids. Within certain populations, saliva sampling may be difficult because of insufficient saliva flow, which may compromise disease diagnosis or research integrity. Methods to improve flow rates (eg, ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Peres JC,Rouquette JL,Miočević O,Warner MC,Slowey PD,Shirtcliff EA

    更新日期:2015-03-01 00:00:00

  • Romiplostim in chronic immune thrombocytopenic purpura.

    abstract:BACKGROUND:Immune thrombocytopenic purpura (ITP) is characterized by platelet deficiency due to platelet destruction and/or inadequate production. Initial therapy consists of corticosteroids or intravenous immunoglobulin (IVIg). Patients with chronic refractory disease might undergo splenectomy. Although there is no tr...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Cersosimo RJ

    更新日期:2009-09-01 00:00:00

  • New LDL-cholesterol lowering therapies: pharmacology, clinical trials, and relevance to acute coronary syndromes.

    abstract:BACKGROUND:Reduction in plasma low-density lipoprotein cholesterol (LDL-C) is a fundamental treatment for the prevention of acute coronary syndromes (ACS). Although statin therapy confers significant protection against ACS in both primary and secondary prevention, a considerable residual risk remains after intensive th...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Sahebkar A,Watts GF

    更新日期:2013-08-01 00:00:00

  • Pneumococcal vaccination in Europe: schedule adherence.

    abstract::Nonadherence to recommended pneumococcal conjugate vaccine (PCV) schedules may have implications for protection against pneumococcal disease. In this commentary, we have assessed adherence to the recommended dosing schedules (the completion of the primary PCV and booster series) in different European countries. We fou...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Gervaix A,Ansaldi F,Brito-Avô A,Azzari C,Knuf M,Martinón-Torres F,Tuerlinckx D,Tin Htar MT,Syrogiannopoulos GA

    更新日期:2014-05-01 00:00:00

  • Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects.

    abstract:PURPOSE:Selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective mitogen-activated protein kinase 1/2 inhibitor with a short half-life, has shown activity across various tumor types. Before initiation of Phase III trials, the site, scale, and color (hypromellose shell from white [Phase II] to blue [Pha...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Tomkinson H,McBride E,Martin P,Lisbon E,Dymond AW,Cantarini M,So K,Holt D

    更新日期:2017-11-01 00:00:00

  • Review of the therapeutic uses of liraglutide.

    abstract:BACKGROUND:Glucagon-like peptide (GLP-1) is a neuroendocrine hormone that increases blood glucose and is a drug target for treatment of type 2 diabetes. Liraglutide, a subcutaneous, once-daily GLP-1 agonist, is approved for the treatment of type 2 diabetes in the United States and Europe. It also has been studied for w...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Ryan GJ,Foster KT,Jobe LJ

    更新日期:2011-07-01 00:00:00

  • The effect of ticagrelor on the metabolism of midazolam in healthy volunteers.

    abstract:BACKGROUND:In vitro studies have demonstrated that ticagrelor, an oral antiplatelet agent, is a substrate, activator, and inhibitor of cytochrome P450 (CYP) 3A. Thus, potential CYP3A-mediated drug-drug interactions may occur. OBJECTIVES:The goal of this article was to report study results on the effect of ticagrelor o...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Teng R,Butler K

    更新日期:2013-07-01 00:00:00

  • Microvascular Dysfunction as Opposed to Conduit Artery Disease Explains Sex-specific Chest Pain in Emergency Department Patients With Low to Moderate Cardiac Risk.

    abstract:PURPOSE:Chest pain is a common emergency department (ED) presentation that is often unexplained. Recent evidence suggests that disease of the microvessels (arterioles) as opposed to the coronary artery (conduit artery) could explain one third of these cases, particularly in women. Brachial artery reactivity (BAR) is a ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Safdar B,Ali A,D'Onofrio G,Katz SD

    更新日期:2016-02-01 00:00:00

  • Open-label, dose-ranging pilot study of 4 weeks of low-dose therapy with sodium phosphate tablets in chronically constipated adults.

    abstract:BACKGROUND:The tablet formulation of sodium phosphate (NaP) is a prescription osmotic purgative that has been marketed since 2001. The use of NaP tablets in patients with constipation has not been studied previously. OBJECTIVE:This study assessed the tolerability and efficacy of 28 days of therapy with NaP tablets (1....

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Medoff J,Katz S,Malik P,Pambianco D,Pruitt R,Poulos J,Rank J,Rose M

    更新日期:2004-09-01 00:00:00

  • Improving the management of patients after myocardial infarction, from admission to discharge.

    abstract:BACKGROUND:Recent developments in pharmacologic and device therapy, as well as initiatives to increase the use of standard orders and promote in-hospital communication, have improved the care of patients with myocardial infarction (MI). The increased presence of hospitalists, physicians who provide in-hospital care as ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Amin A

    更新日期:2006-10-01 00:00:00

  • Multi-indication Pharmacotherapeutic Multicriteria Decision Analytic Model for the Comparative Formulary Inclusion of Proton Pump Inhibitors in Qatar.

    abstract:PURPOSE:The formulary inclusion of proton pump inhibitors (PPIs) in the government hospital health services in Qatar is not comparative or restricted. Requests to include a PPI in the formulary are typically accepted if evidence of efficacy and tolerability is presented. There are no literature reports of a PPI scoring...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Al-Badriyeh D,Alabbadi I,Fahey M,Al-Khal A,Zaidan M

    更新日期:2016-05-01 00:00:00

  • Cost-analysis of imipenem-cilastatin monotherapy compared with clindamycin+aminoglycoside combination therapy for treatment of serious lower respiratory, intra-abdominal, gynecologic, and urinary tract infections.

    abstract::To determine the cost relative to efficacy and tolerability of two antimicrobial regimens, a prospective, multicenter study compared imipenem-cilastatin (I-C) monotherapy with clindamycin+aminoglycoside (C+A) in the treatment of serious lower respiratory, intra-abdominal, gynecologic, and urinary tract infections. The...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Kreter B

    更新日期:1992-01-01 00:00:00

  • Guidelines for dyspepsia treatment in Japan.

    abstract::Recently published guidelines for the treatment of dyspepsia have emphasized the importance of age, Helicobacter pylori infection, and alarm symptoms such as weight loss, anemia, and dysphagia in patient assessment. However, the currently available guidelines were not designed specifically for regions in which the inc...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Matsueda K

    更新日期:1998-01-01 00:00:00

  • Comparison of rofecoxib and oxycodone plus acetaminophen in the treatment of acute pain: a randomized, double-blind, placebo-controlled study in patients with moderate to severe postoperative pain in the third molar extraction model.

    abstract:BACKGROUND:Opiates, acetaminophen, nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2-selective inhibitors such as rofecoxib are used in the treatment of acute pain because of their anti-inflammatory and/or analgesic properties. Rofecoxib has demonstrated an improved gastrointestinal safet...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Korn S,Vassil TC,Kotey PN,Fricke JR Jr

    更新日期:2004-05-01 00:00:00

  • Comparison of once-daily cephalosporin regimens for community-acquired lower respiratory tract infections in patients with chronic lung disease.

    abstract::The efficacy of cefonicid and of ceftriaxone, administered once daily for the treatment of lower respiratory tract bacterial infections (pneumonia or bronchitis), was evaluated and compared in 118 patients with chronic lung disease. The patients were randomly assigned to receive 1 gm of either drug, intravenously or i...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: McCabe RE,Schlossberg D,Donowitz GR,Scheld WM,Zellner SR,Lindenberg LB,Armstrong JH,Ein ME

    更新日期:1989-05-01 00:00:00

  • Effects of dexamethasone in preventing postoperative emetic symptoms after total knee replacement surgery: a prospective, randomized, double-blind, vehicle-controlled trial in adult Japanese patients.

    abstract:BACKGROUND:Postoperative emetic symptoms (nausea, retching, and vomiting) are common following total joint replacement, with an incidence as high as 83% when no prophylactic antiemetic is provided. However, most antiemetics currently used in Japan, such as antihistamines (eg, hydroxyzine), butyrophenones (eg, droperido...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验,收录出版


    authors: Fujii Y,Nakayama M

    更新日期:2005-06-01 00:00:00

  • Materials to clinical devices: technologies for remotely triggered drug delivery.

    abstract:BACKGROUND:Technologies in which a remote trigger is used to release drug from an implanted or injected device could enable on-demand release profiles that enhance therapeutic effectiveness or reduce systemic toxicity. A number of new materials have been developed that exhibit sensitivity to light, ultrasound, or elect...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Timko BP,Kohane DS

    更新日期:2012-11-01 00:00:00