Whole blood flows into the cylindrical non-woven fabric. The Non-woven fabric removes leukocytes through filtration and adhesion.
Cellsorba has high adsorption capacity of leukocytes.
The effectiveness and adverse effects of LCAP were investigated in a controlled multicenter trial in Japan at 16 participating institutions. In the trial, enrollment of 76 active-stage UC patients was randomly divided into two groups. In the LCAP group (39 patients), weekly LCAP treatment for 5 weeks as an intensive therapy was performed. After that, LCAP treatment was performed once for every 4 weeks as maintenace therapy in additin to on-going drug therapy, while steroids were maintained but not increased. In the high prednisolone (h-PSL) group, the dose of steroids was increased at the start of the study according to patient's severity. Subjects and methods are shown in Fig.3 and Fig.4.
Fig.5 and Fig.6 show the change of Clinical Activity Index of Rachmilewitz et al*2 (R-CAI) and Lichtiger et al *3 (L-CAI). Where the CAI decreased by 4 points or more at week 7, evaluation of the treatment was considered to be effective. LCAP showed significantly higher effectiveness (64.1% vs. 40.5%; p<0.05, R-CAI) (61.5% vs. 35.1%; p<0.05, L-CAI) compared with h-PSL.
Average steroid (PSL) dosage given to each group is shown in Fig.7. The absolute dosage of PSL was lower in LCAP group than h-PSL group. Excellent efficacy was obtained in LCAP group with less PSL dosage.
Fig.8 shows improvement ratio for the clinical conditions and endoscopic findings. LCAP showed superior findings in all clinical symptoms.
Results of clinical examinations at pre and Week 7 are shown in Fig.9, 10 and 11. Statistically no change was observed in leukocyte counts and platelet counts, however, the values of ESR and CRP significantly decreased.
Table.1 shows adverse reactions occurred in the both treatments. LCAP shows lower incidence rate compared to that h-PSL group(24% vs. 68%; p<0.001). Adverse reactions observed in LCAP group tended to be transient and related to the extracorpreal nature of the treatment. However, in the h-PSL group, lipid & protein metabolism abnormalities and skin-related symptoms were observed.
|Incidence of adverse reactions||LCAP||PSL|
|Gastro - intestinal symptoms||Abdominal pain||1|
|Allergic reactions||Tongue and lip numbness||1|
|Respiratory & cardiovascular symptoms||Chest pain||1|
|Nervous system associated symptons||Headache||3|
Paraesthesia of limbs
|Back & lumber pain||Back pain||1|
|Psychological symptoms||Mental abnormality||2|
|Musculo - skeletal system associated symptoms||Osteoporosis||2|
|Decrease of bone salt||4|
|Lipid & protein metabolism abnormality||Moon face||14|
|Body fluid / electrolyte abnormality||Oedema||1|
|Skin adverse symptoms||Acne||12|
|Adrenal cortex / diabetes||Diabetes||1|
|Vascular symptoms||Haemorrhage subcutaneous||1|
|Others||Oedema of lower extremities||1|
(Accumulated number of occurrence)
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