Analysis of Relapse by Inflammatory Rasch-built Overall Disability Scale Status in the PATH Study of Subcutaneous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy
Journal of the peripheral nervous system : JPNS. 2022
BACKGROUND AND AIMS Clinical trials in chronic inflammatory demyelinating polyneuropathy (CIDP) often assess efficacy using the ordinal Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. Here, data from the PATH study was reanalyzed using change in Inflammatory Rasch-built Overall Disability Scale (I-RODS) to define CIDP relapse instead of INCAT. METHODS The PATH study comprised an intravenous immunoglobulin (IVIG) dependency period and an IVIG (IgPro10 [Privigen®]) restabilization period; subjects were then randomized to weekly maintenance subcutaneous immunoglobulin (SCIG; IgPro20 [Hizentra®]) 0.2 g/kg or 0.4 g/kg or placebo for 24 weeks. CIDP relapse was defined as ≥1-point deterioration in adjusted INCAT, with a primary endpoint of relapse or withdrawal rates. This retrospective exploratory analysis redefined relapse using I-RODS via three different cut-off methods: an individual variability method, fixed cut-off of ≥8-point deterioration on I-RODS centile score or ≥4-point deterioration on I-RODS raw score. RESULTS Relapse or withdrawal rates were 47% for placebo, 34% for 0.2 g/kg IgPro20 and 19% for 0.4 g/kg IgPro20 using the raw score; 40%, 28% and 15%, respectively using the centile score, and 49%, 40% and 27%, respectively using the individual variability method. INTERPRETATION IgPro20 was shown to be efficacious as a maintenance therapy for CIDP when relapse was defined using I-RODS. A stable response pattern was shown for I-RODS across various applied cut-offs, indicating that any could be used in future clinical trials.
Using of tranexamic acid (Tranexam) for prevention and correction of coagulopathy during brain tumors removal Russian
Anesteziologiia I Reanimatologiia [Anesthesiology and Intensive Care]. 2011;4:61-6.
The aim of the study is to estimate clinical effectiveness of fibrinolysis inhibitor Tranexam in neurosurgical patients with intracranial tumors. The medication was prescribed to 78 patients from 27 to 65 years old. The control group consisted of 57 patients. The following criteria were assessed to estimate the impact of the medication on hemostasis: APPT, PT index, TT, fibrinogen, ATIII activity, factor XII-derived fibrinolysis, spontaneous euglobulin lysis. Blood sampling was drawn at the following stages: after the induction of anesthesia, before Tranexam injection, 30 minutes after Tranexam injection, on the next day after the surgery. Blood from jugular and peripheral veins was analyzed simultaneously. The medication caused significant decrease of fibrinolytic activity. The use of Tranexam was followed by bleeding reduction in the wound. The duration of surgical hemostasis in the main group was 11,7 +/- 3,3 minutes which is significantly lower than in the control group (18,1 +/- 3,1 minutes) (p = 0,034). Drainage blood loss was lower in the main group (267 +/- 23 ml a day) than in the control group (340 +/- 28 ml a day). Medication injection during diffuse bleeding from small vessels led to quick and visible bleeding reduction. Thus Tranexam decreases the risk of intraoperative blood loss in the patients with brain tumors.