Short dosing intervals during oral challenge increase the risk of severe adverse reactions in children with milk allergy

Актуальность. Заместительная терапия иммуноглобулинами человека является ведущим патогенетическим методом лечения первичных иммунодефицитов с нарушением синтеза антител. В настоящее время в России доступно несколько препаратов иммуноглобулинов человека нормальных для внутривенного введения. Цель. Оценить эффективность и безопасность препарата Привиджен (10 раствор иммуноглобулина для внутривенного введения) в реальной клинической практике в течение 12 клинических месяцев. Материалы и методы. 20 взрослых с диагнозом общая вариабельная иммунная недостаточности и Х-сцепленная агаммаглобулинемия получали внутривенный иммуноглобулин Привиджен к интервалом 243 дня в течение 12 мес. Первичными критериями оценки была частота инфекционных осложнений и нежелательных явлений. Результаты. У большинства пациентов в ходе исследования достигнут удовлетворительный претранс-фузионный уровень IgG. Тяжелых нежелательных явлений, связанных с введением препарата, не зарегистрировано. Заключение. В ходе исследования препарат продемонстрировал высокую эффективность и безопасность у пациентов, нуждающихся в ежемесячной заместительной терапииRelevance. Replacement therapy with human immunoglobulins is the leading pathogenetic method of treatment of primary immunodeficiency with impaired antibody synthesis. Currently, several preparations of human immunoglobulins for intravenous administration are available in Russia. Purposes. Evaluation of the efficacy and safety of Privigen immunoglobulin intravenous 10 liquid in real clinical practice within 12 clinical months. Methods. Twenty adults diagnosed with common variable immunodeficiency or X-linked agammaglobulinemia received intravenous Privigen infusions (0.2-0.4 mg/kg) at 243 intervals over a 12-month period. The primary endpoint was the annual rate of infections and adverse events. Results. Sufficient level of IgG was achieved in most patients during the study. Severe adverse reactions during the treatment were not registered. Conclusions. High efficacy and safety of monthly replacement therapy in patients with primary immunodeficiency with impaired antibody synthesis has been demonstrated.

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Newer Quinolones in the Treatment of Continuous Ambulatory Peritoneal Dialysis (CAPD) Related Infections

Peritoneal Dialysis International ◽

10.1177/089686089001000202 ◽

1990 ◽

Vol 10 (2) ◽

pp. 127-133 ◽

Cited By ~ 10

Author(s):

Paul Nikolaidis

Keyword(s):

Peritoneal Dialysis ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Adverse Reactions ◽

Antimicrobial Agents ◽

Hospital Staff ◽

Gram Negative Bacteria ◽

Promising Alternative ◽

Gram Negative ◽

Dosing Intervals ◽

Good Oral Bioavailability

Newer fluoroquinolones such as ciprofloxacin, pefloxacin, ofloxacin, enoxacin, and fleroxacin are potent antimicrobial agents against many gram-negative bacteria, including Pseudomonas aeruginosa species and staphylococci-sensitive or resistant to methicillin. They are almost completely absorbed when given orally, reaching therapeutic plasma and dialysate concentrations, and their long half lives permit infrequent dosing intervals. Clinical studies on fluoroquinolones efficacy in continuous ambulatory peritoneal dialysis (CAPD) infections, although not extensive, demonstrate good results. They are well tolerated and the adverse reactions, consisting mainly of gastrointestinal disturbance, were uncommon, mild, and reversible. The fluoroquinolones offer a promising alternative to standard parenteral treatments in CAPD patients, while their good oral bioavailability makes them attractive and convenient for both patients and hospital staff. However, they must be used with caution until we have more information and gain further experience.

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Intravenous versus Oral iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial

American Journal of Perinatology ◽

10.1055/s-0041-1740003 ◽

2021 ◽

Author(s):

Adam K. Lewkowitz ◽

Molly J. Stout ◽

Emily Cooke ◽

Seon C. Deoni ◽

Viren D'Sa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Adverse Reactions ◽

Controlled Trial ◽

Oral Iron ◽

Deficiency Anemia ◽

Randomized Controlled ◽

Iv Iron ◽

Severe Adverse Reactions

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points

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Risk of Severe Adverse Reactions Related to Allopurinol and Febuxostat in Asians

Value in Health ◽

10.1016/j.jval.2018.07.801 ◽

2018 ◽

Vol 21 ◽

pp. S106

Author(s):

C Chen ◽

W Chung ◽

YJ Lin ◽

C Chang ◽

S Chang

Keyword(s):

Adverse Reactions ◽

Severe Adverse Reactions

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New Clinical Applications-sintilimab Combined with Albumin-bound Paclitaxel/cisplatin in Treatment of Relapsed or Refractory ES-SCLC

10.21203/rs.3.rs-429106/v1 ◽

2021 ◽

Author(s):

Lei Han ◽

Li Li ◽

Jinli Hao ◽

Yuanli Lu ◽

Shicheng Li ◽

...

Keyword(s):

Adverse Reactions ◽

Response Rate ◽

Objective Response ◽

Second Line ◽

Efficacy Evaluation ◽

Peripheral Neurotoxicity ◽

Extensive Stage ◽

Grade 3 ◽

Positive Effect ◽

Severe Adverse Reactions

Abstract Introduction: This study is aimed to evaluate the efficacy and safety of sintilimab combined with albumin-bound paclitaxel/ cisplatin as a second-line treatment in these patients with relapsed or refractory extensive-stage small cell lung cancer (ES-SCLC). Methods and Materials: ES-SCLC patients received a second-line regimen of sintilimab combined with albumin-bound paclitaxel/cisplatin. Albumin-bound paclitaxel/cisplatin can be used for up to 6 cycles. Sintilimab use was not stopped until the disease progressed or untolerable side effects occurred. After 2 cycles of chemotherapy or when the patient's condition progressed significantly, computed tomography was rechecked to observe the clinical curative effect and adverse reactions. Results: Totally 38 patients with recurrent SCLC were included for efficacy evaluation. The objective response rate and disease control rate were 26.3% and 84.2% respectively. The median PFS and OS were 6.5 months (95% CI: 3.8-7.8) and 10.8 months (95% CI: 8.5-16.2), respectively. The main adverse reactions are bone marrow suppression, alopecia, peripheral neurotoxicity, muscle and joint pain, gastrointestinal reactions, and fatigue. The severe adverse reactions (grade 3-4) are mainly leukopenia (21.1%), neutropenia (21.1%) and decreased hemoglobin (7.9%). No significant correlation was found between PD-L1 expression and efficacy.Conclusion: Sintilimab combined with albumin-bound paclitaxel/cisplatin has a positive effect on the treatment of ES-SCLC, and the adverse reactions are tolerable.

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Severe Adverse Reactions to Contrast Media

Southern Medical Journal ◽

10.1097/00007611-197712000-00019 ◽

1977 ◽

Vol 70 (12) ◽

pp. 1440-1441 ◽

Cited By ~ 2

Author(s):

E. JAMES ANDREWS

Keyword(s):

Contrast Media ◽

Adverse Reactions ◽

Severe Adverse Reactions

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Safety evaluation of SPF66 malaria vaccine in Brazil

Revista da Sociedade Brasileira de Medicina Tropical ◽

10.1590/s0037-86821996000500014 ◽

1996 ◽

Vol 29 (5) ◽

pp. 497-501 ◽

Cited By ~ 6

Author(s):

LM. Urdaneta ◽

A. Prata ◽

C.J. Struchiner ◽

C.E. Tosta ◽

P. Tauil ◽

...

Keyword(s):

Placebo Group ◽

Side Effects ◽

Malaria Vaccine ◽

Adverse Reactions ◽

Safety Evaluation ◽

Efficacy Trial ◽

Systemic Side Effects ◽

Local Reactions ◽

Severe Adverse Reactions ◽

Local Side

The frequency and description of side effects secondaiy to the subcutaneous application of SPf66 malaria vaccine and placebo are reported for each dose of application in the participants of the vaccine efficacy trial in Brazil. Side effects evaluated two hours after each application were detected in 8.0%, 30.2% and 8.8%, for the Is', and 3"' dose, respectively, in the SPf66group, and in 7.0%, 8.5% and 2.9% in the placebo group. Local reactions such as mild inflammation, nodule and pain or erythema frequently accompanied by pruritus were the most common reactions detected in both groups (3-8%, 29.1% and 8.5% in the SPf66 group and 4.0%, 7.6% and 2.5% in the placebo group). Among vaccinees, local side effects after the 2nd dose were more frequent in females. Systemic side effects were expressed mainly through general symptoms referred by the participants and were most frequent after the 1st dose in both groups (4.3% in the SPf66 group and 3-0% in the placebo group). Muscle aches and fever were refewred by few participants. No severe adverse reactions were detected for either dose of application or group.

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P14.128 Lack of development of Pneumocystis Jirovecii Pneumonia in a cohort of 103 Italian glioblastoma patients not receiving prophylaxis during post-surgical chemoradiotherapy

Neuro-Oncology ◽

10.1093/neuonc/noz126.363 ◽

2019 ◽

Vol 21 (Supplement_3) ◽

pp. iii99-iii99

Author(s):

N Rifino ◽

A Rigamonti ◽

F Guida ◽

C Bonato ◽

G De Nobili ◽

...

Keyword(s):

Adverse Reactions ◽

Early Death ◽

Infectious Complications ◽

Community Acquired Pneumonia ◽

Pneumocystis Jirovecii ◽

Pneumocystis Jirovecii Pneumonia ◽

Newly Diagnosed ◽

Institutional Review ◽

Tract Infections ◽

Severe Adverse Reactions

Abstract BACKGROUND Patients diagnosed with high grade gliomas (HGG) usually receive surgery, radiation, temozolomide (TMZ) and corticosteroids. A major concern in patients who receive chemoradiotherapy (CRT) is the risk of developing secondary myelosuppression and a related infection during treatment. CRT may also lead to a long-lasting reduction of WBC, associated with early death from tumor progression. Among treatment-related infections, Pneumocystis Jirovecii Pneumonia (PJP) has been reported, since then, PJP prophylaxis has been required by the FDA. However, evidence for PJP during CRT is very limited limited and the rate of PJP still low. MATERIAL AND METHODS We did a retrospective, Institutional Review Board-approved cohort study in 103 patients (60 men and 43 women), who were consecutively diagnosed with GBM in “A. Manzoni” Hospital in Lecco during the period May 2007 to December 2013. All of these patients were treated with CRT according to the Stupp protocol without PJP prophylaxis. Haematological toxicities of CRT were assessed according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0; November 27, 2017). The objective of our study was to investigate the association between CRT and myelosuppression and we evaluated the types of infection contracted on CRT and in particular if the absence of a proper PJP prophylaxis led to an increased rate of PJP. RESULTS In our cohort, among 103 patients receiving CRT, 18% developed severe lymphopenia. Among all the subjects enrolled, a total of 9 patients (8.7%) had documented infectious complications during the CRT. Three patients developed community acquired pneumonia. Moreover, we documented three cases of fever without source, two urinary tract infections, one herpes zoster, one herpes simplex 1, one phlegmon and one purulent otitis. However, no one of these patients was diagnosed as PJP despite PJP prophylaxis was not given. CONCLUSION In conclusion, our data seem to support a lack of undisputable evidence for a favorable risk/benefit profile in the use of PJP prophylaxis for all newly diagnosed GBM patients undergoing the CRT, also considering the rate of adverse reactions (15.2%) and severe adverse reactions (around 3%, mainly leukopenia) in non-HIV adults receiving trimethoprim/sulphametoxazole for prolonged periods.

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A Working Hypothesis Regarding Identical Pathomechanisms between Clinical Efficacy and Adverse Reaction of Clozapine via the Activation of Connexin43

International Journal of Molecular Sciences ◽

10.3390/ijms21197019 ◽

2020 ◽

Vol 21 (19) ◽

pp. 7019 ◽

Cited By ~ 3

Author(s):

Motohiro Okada ◽

Kouji Fukuyama ◽

Takashi Shiroyama ◽

Masahiko Murata

Keyword(s):

Monitoring System ◽

Clinical Efficacy ◽

Adverse Reactions ◽

Clinical Evidence ◽

Antipsychotic Agent ◽

World Health ◽

Treatment Resistant ◽

Global Database ◽

The World ◽

Severe Adverse Reactions

Clozapine (CLZ) is an approved antipsychotic agent for the medication of treatment-resistant schizophrenia but is also well known as one of the most toxic antipsychotics. Recently, the World Health Organization’s (WHO) global database (VigiBase) reported the relative lethality of severe adverse reactions of CLZ. Agranulocytosis is the most famous adverse CLZ reaction but is of lesser lethality compared with the other adverse drug reactions of CLZ. Unexpectedly, VigiBase indicated that the prevalence and relative lethality of pneumonia, cardiotoxicity, and seizures associated with CLZ were more serious than that of agranulocytosis. Therefore, haematological monitoring in CLZ patients monitoring system provided success in the prevention of lethal adverse events from CLZ-induced agranulocytosis. Hereafter, psychiatrists must amend the CLZ patients monitoring system to protect patients with treatment-resistant schizophrenia from severe adverse CLZ reactions, such as pneumonia, cardiotoxicity, and seizures, according to the clinical evidence and pathophysiology. In this review, we discuss the mechanisms of clinical efficacy and the adverse reactions of CLZ based on the accumulating pharmacodynamic findings of CLZ, including tripartite synaptic transmission, and we propose suggestions for amending the monitoring and medication of adverse CLZ reactions associated with pneumonia, cardiotoxicity, and seizures.

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