PMID- 11459901 OWN - NLM STAT- MEDLINE DCOM- 20010927 LR - 20220408 IS - 0022-3050 (Print) IS - 1468-330X (Electronic) IS - 0022-3050 (Linking) VI - 71 IP - 2 DP - 2001 Aug TI - Intravenous immune globulins in patients with Guillain-Barre syndrome and contraindications to plasma exchange: 3 days versus 6 days. PG - 235-8 AB - Plasma exchange is contraindicated in 10 to 20% of patients with Guillain-Barre syndrome (GBS). The optimal schedule for intravenous immune globulin (IVIg) therapy has not yet been established in these patients. The objective was to compare the efficacy and safety of two IVIg treatment durations in patients with GBS with contraindications for plasma exchange. In this randomised, double blind, multicentre phase II trial conducted in seven French centres, patients with GBS with severe haemostasis, unstable haemodynamics, or uncontrolled sepsis were randomly assigned to 0.4 g/kg/day IVIg for 3 or 6 days. The primary outcome measure was the time needed to regain the ability to walk with assistance. Thirty nine patients were included from March 1994 to May 1997, 21 in the 3 day group and 18 in the 6 day group. Time to walking with assistance was non-significantly shorter in the 6 day group (84 (23-121) v 131 days (51-210), p=0.08); the difference was significant in ventilated patients (86 days (13-151) in the 6 day group v 152 days (54-332) in the 3 day group; p=0.04). The prevalence and severity of IVIg related adverse effects were comparable between the two groups. In conclusion, in patients with GBS and contraindications for plasma exchange, especially those who need ventilatory assistance, IVIg (0.4 g/kg/day) may be more beneficial when given for 6 days rather than 3 days. FAU - Raphael, J C AU - Raphael JC AD - Hopital Raymond Poincare, Service de Reanimation Medicale, 104 Boulevard Raymond Poincare, 92380 Garches, France. FAU - Chevret, S AU - Chevret S FAU - Harboun, M AU - Harboun M FAU - Jars-Guincestre, M C AU - Jars-Guincestre MC CN - French Guillain-Barre Syndrome Cooperative Group LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - J Neurol Neurosurg Psychiatry JT - Journal of neurology, neurosurgery, and psychiatry JID - 2985191R RN - 0 (Immunoglobulins, Intravenous) SB - IM MH - Aged MH - Contraindications MH - Double-Blind Method MH - Female MH - Guillain-Barre Syndrome/*drug therapy MH - Humans MH - Immunoglobulins, Intravenous/*adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Outcome Assessment, Health Care MH - Pilot Projects MH - *Plasma Exchange MH - Random Allocation MH - Sample Size MH - Time Factors PMC - PMC1737513 EDAT- 2001/07/19 10:00 MHDA- 2001/09/28 10:01 PMCR- 2004/08/01 CRDT- 2001/07/19 10:00 PHST- 2001/07/19 10:00 [pubmed] PHST- 2001/09/28 10:01 [medline] PHST- 2001/07/19 10:00 [entrez] PHST- 2004/08/01 00:00 [pmc-release] AID - 10.1136/jnnp.71.2.235 [doi] PST - ppublish SO - J Neurol Neurosurg Psychiatry. 2001 Aug;71(2):235-8. doi: 10.1136/jnnp.71.2.235.