Intravenous Immunoglobulin G Therapy in Streptococcal Toxic Shock Syndrome: A European Randomized, Double-Blind, Placebo-Controlled Trial
| Autor: | Ewa Aufwerber, Jan Sjölin, Nahla Ihendyane, Jessica Darenberg, Per Follin, Sven Haidl, Anna Norrby-Teglund, Jan Andersson |
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| Rok vydání: | 2003 |
| Předmět: |
Adult
Male Microbiology (medical) medicine.medical_specialty Placebo-controlled study Placebo Immunoglobulin G law.invention Double-Blind Method Randomized controlled trial law Streptococcal Infections hemic and lymphatic diseases Internal medicine Clinical endpoint Humans Medicine Aged Aged 80 and over biology business.industry Mortality rate Immunoglobulins Intravenous Toxic shock syndrome Middle Aged medicine.disease Shock Septic Surgery Clinical trial Treatment Outcome Infectious Diseases biology.protein Female business |
| Zdroj: | Clinical Infectious Diseases. 37:333-340 |
| ISSN: | 1537-6591 1058-4838 |
| Popis: | The efficacy and safety of high-dose intravenous polyspecific immunoglobulin G (IVIG) as adjunctive therapy in streptococcal toxic shock syndrome (STSS) were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial. The trial was prematurely terminated because of slow patient recruitment, and results were obtained from 21 enrolled patients (10 IVIG recipients and 11 placebo recipients). The primary end point was mortality at 28 days, and a 3.6-fold higher mortality rate was found in the placebo group. A significant decrease in the sepsis-related organ failure assessment score at days 2 (P = .02) and 3 (P = .04) was noted in the IVIG group. Furthermore, a significant increase in plasma neutralizing activity against superantigens expressed by autologous isolates was noted in the IVIG group after treatment (P = .03). Although statistical significance was not reached in the primary end point, the trial provides further support for IVIG as an efficacious adjunctive therapy in STSS. |
| Databáze: | OpenAIRE |
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