Background: Intravenous immunoglobulin (IVIg) has been reported to reduce dise ase activity in patients with relapsingremitting multiple sclerosis. We assessed the effect of IVIg treatment in patients after the first ...Background: Intravenous immunoglobulin (IVIg) has been reported to reduce dise ase activity in patients with relapsingremitting multiple sclerosis. We assessed the effect of IVIg treatment in patients after the first neurological event sug gestive of demyelinative disease and evaluated the occurrence of a second attack and dissemination in time demonstrated by brain magnetic resonance imaging with in the first year from onset. Methods: We conducted a randomized, placebo con trolled, double blind study in 91 eligible patients enrolled within the first 6 weeks of neurological symptoms. Patients were randomly assigned to receive IVIg treatment (2 g/kg loading dose) or placebo, with boosters (0.4 g/kg) given onc e every 6 weeks for 1 year. Neurological and clinical assessments were done ever y 3 months, and brain magnetic resonance imaging was performed at baseline and t he end of the study. Results: The cumulative probability of developing clinicall y definite multiple sclerosis was significantly lower in the IVIg treatment grou p compared with the placebo group (rate ratio, 0.36 [95%confidence interval, 0 . 15 0.88]; P = .03). Patients in the IVIg treatment group had a significant red u ction in the volume and number of T2 weighted lesions and in the volume of gado lin ium enhancing lesions as compared with the placebo group (P = .01, P = .01 , and P = .03, respectively). Treatment was well tolerated, compliance was high, and incidence of adverse effects did not differ significantly between groups. C onclusions: Intravenous immunoglobulin treatment for the first year from onset o f the first neurological event suggestive of demyelinative disease significantly lowers the incidence of a second attack and reduces disease activity as measure d by brain magnetic resonance imaging.展开更多
Acute exacerbations may complicate the course of pregnancy and the postpartum period in patients with relapsing- remitting multiple sclerosis (RRMS). To evaluate relapse rate and the effect of immunomodulatory treatme...Acute exacerbations may complicate the course of pregnancy and the postpartum period in patients with relapsing- remitting multiple sclerosis (RRMS). To evaluate relapse rate and the effect of immunomodulatory treatment with intravenous immunoglobulin (IVIg) during pregnancy and the postpartum period we retrospectively analysed the data of 108 pregnant RRMS patients. Group I patients were not treated, Group II patients were treated with IVIg 0.4 g/kg body weight/day for 5 consecutive days within the first week after delivery with additional booster doses of 0.4 g/kg body weight/day at 6 and 12 weeks postpartum (defined as 12 weeks after labor), and Group III patients were treated continuously with IVIg during gestation and the postpartum period (0.4 g/kg body weight/day for 5 consecutive days within the 6- 8 weeks of gestation with additional booster doses of 0.4 g/kg body weight/day once every 6 weeks until 12 weeks postpartum). All patients underwent antenatal care and fetal ultrasonographic surveillance examinations. Relapse rate per woman per year during the pregnancy and the postpartum period as well as neonatal outcome data and IVIg related adverse events were analysed. Relapse rate per woman per year for patients treated with IVIg for the whole pregnancy and postpartum period (Group III, N = 28) compared with the untreated Group I patients (N = 39) were as follows: first trimester 0.43 vs. 0.72, second trimester 0.15 vs. 0.61, third trimester 0.0 vs. 0.41, and postpartum period 0.28 vs.1.33 (p< 0.05). Patients treated with IVIg only during the postpartum period (Group Ⅱ , N = 41) also showed a decrease in relapse rate compared with untreated Group I patients, 0.58 vs. 1.33 (p = 0.012). The mean maternal age, disease duration, gestational age at delivery and fetal delivery weight did not significantly differ between the three groups. Mode of delivery, obstetrical complications, the use of epidural analgesia and breast- feeding, did not affect postpartum relapse rate. No severe adverse events were associated with IVIg treatment either during the pregnancy or postpartum period for the patients and newborns. We conclude that in RRMS patients IVIg treatment could be considered as an optional treatment to reduce the incidence of pregnancy and postpartum- related relapses. Further randomized double- blind studies are needed to confirm our findings.展开更多
文摘Background: Intravenous immunoglobulin (IVIg) has been reported to reduce dise ase activity in patients with relapsingremitting multiple sclerosis. We assessed the effect of IVIg treatment in patients after the first neurological event sug gestive of demyelinative disease and evaluated the occurrence of a second attack and dissemination in time demonstrated by brain magnetic resonance imaging with in the first year from onset. Methods: We conducted a randomized, placebo con trolled, double blind study in 91 eligible patients enrolled within the first 6 weeks of neurological symptoms. Patients were randomly assigned to receive IVIg treatment (2 g/kg loading dose) or placebo, with boosters (0.4 g/kg) given onc e every 6 weeks for 1 year. Neurological and clinical assessments were done ever y 3 months, and brain magnetic resonance imaging was performed at baseline and t he end of the study. Results: The cumulative probability of developing clinicall y definite multiple sclerosis was significantly lower in the IVIg treatment grou p compared with the placebo group (rate ratio, 0.36 [95%confidence interval, 0 . 15 0.88]; P = .03). Patients in the IVIg treatment group had a significant red u ction in the volume and number of T2 weighted lesions and in the volume of gado lin ium enhancing lesions as compared with the placebo group (P = .01, P = .01 , and P = .03, respectively). Treatment was well tolerated, compliance was high, and incidence of adverse effects did not differ significantly between groups. C onclusions: Intravenous immunoglobulin treatment for the first year from onset o f the first neurological event suggestive of demyelinative disease significantly lowers the incidence of a second attack and reduces disease activity as measure d by brain magnetic resonance imaging.
文摘Acute exacerbations may complicate the course of pregnancy and the postpartum period in patients with relapsing- remitting multiple sclerosis (RRMS). To evaluate relapse rate and the effect of immunomodulatory treatment with intravenous immunoglobulin (IVIg) during pregnancy and the postpartum period we retrospectively analysed the data of 108 pregnant RRMS patients. Group I patients were not treated, Group II patients were treated with IVIg 0.4 g/kg body weight/day for 5 consecutive days within the first week after delivery with additional booster doses of 0.4 g/kg body weight/day at 6 and 12 weeks postpartum (defined as 12 weeks after labor), and Group III patients were treated continuously with IVIg during gestation and the postpartum period (0.4 g/kg body weight/day for 5 consecutive days within the 6- 8 weeks of gestation with additional booster doses of 0.4 g/kg body weight/day once every 6 weeks until 12 weeks postpartum). All patients underwent antenatal care and fetal ultrasonographic surveillance examinations. Relapse rate per woman per year during the pregnancy and the postpartum period as well as neonatal outcome data and IVIg related adverse events were analysed. Relapse rate per woman per year for patients treated with IVIg for the whole pregnancy and postpartum period (Group III, N = 28) compared with the untreated Group I patients (N = 39) were as follows: first trimester 0.43 vs. 0.72, second trimester 0.15 vs. 0.61, third trimester 0.0 vs. 0.41, and postpartum period 0.28 vs.1.33 (p< 0.05). Patients treated with IVIg only during the postpartum period (Group Ⅱ , N = 41) also showed a decrease in relapse rate compared with untreated Group I patients, 0.58 vs. 1.33 (p = 0.012). The mean maternal age, disease duration, gestational age at delivery and fetal delivery weight did not significantly differ between the three groups. Mode of delivery, obstetrical complications, the use of epidural analgesia and breast- feeding, did not affect postpartum relapse rate. No severe adverse events were associated with IVIg treatment either during the pregnancy or postpartum period for the patients and newborns. We conclude that in RRMS patients IVIg treatment could be considered as an optional treatment to reduce the incidence of pregnancy and postpartum- related relapses. Further randomized double- blind studies are needed to confirm our findings.
