| Objective:Toestablish a new mode of double filtration plasmapheresis(DFPP) combining centrifugal/membranous plasma separation techniques, and to observe its efficacy, safety and advantages with a comparison to traditional membranous DFPP(M-DFPP) through a prospective, nonrandomized controlled study.Methodology:Patients requiring DFPP treatment were screened for enrollment. They received DFPP due to renal diseases associated with anti-neutrophil cytoplasmic antibody (ANCA) or anti-glomerular basement membrane(GBM) antibody. After enrollment, patients who alreadyhad central venous catheter and had no contraindications for adequate systemic anticoagulant were assigned to receive M-DFPP, and the others were assigned to receive centrifuge/membrane hybrid DFPP (C/M-hybrid DFPP). For M-DFPP, plasma was separated by a plasma separator MPS07, and passed through a fractional plasma separator EC20W for a second filtration; while for C/M-hybrid DFPP, plasma was separated by a centrifugal apheresis system and was secondly filtrated through a EC20 W filter, which was as the same as in M-DFPP. The blood flow rate was 100-120ml/min and plasma flow rate was 20-30ml/min in M-DFPP, with anticoagulation using low molecular weight heparin(LMWH). In C/M-hybrid DFPP, blood flow rate was 30-50ml/min and plasma flow rate was 20-30ml/min, with anticoagulation using acid-citrate-dextrose(Formula A) combined with or without low dose of LMWH. For one session of DFPP, up to 1.5 fold of the total plasma volume was processed, with a supplement of 35-45g human albumin. Samples were collected in the first session of DFPP, at the time points including before and after session, and at the sites including blood, separated plasma, discarded plasma, for measurement of the concentrations of total protein, globulin, albumin, immunoglobulin G(IgG), IgA, IgM, titer of ANCA and anti-GBM antibody, counts of red blood cell, white blood cell and platelets. Clinical conditions in all sessions of DFPP were also recorded for further analysis.Results:Thirty-two patients(15 males) were enrolled,14 in M-DFPP and 18 in C/M-hybrid DFPP. A total of 79 sessions of DFPP were performed, with 27 sessions of M-DFPP and 52 sessions of C/M-hybrid DFPP. There was no significant difference between M-DFPP and C/M-hybrid DFPP in the regards of reduction ratio of IgG[(53.72±6.10)% vs. (54.08±10.13)%, P=0.908], IgA[(66.31±6.56)% vs (66.19±9.14)%, P=0.967], IgM[(80.19±12.22)% vs. (82.82± 11.54)%, P=0.698], as well as the amount of supplemented human albumin [(38.65±4.63)g vs. (41.32±4.63)g, P=0.1], reduction ratio of serum albumin [(-2.07±11.62)% vs. (-7.44±9.84)%, P=0.167] and platelets counts [(9.05±11.89)% vs. (17.00±14.91)%, P=0.114]. While for the reduction ratio of the titer of autoimmune antibodies, C/M-hybrid DFPP was higher than M-DFPP[(36.78±16.44)% vs.25.62±11.67)%, P=0.043]. The blood flow rate in M-DFPP was significantly higher than that in C/M-hybrid DFPP [(118.21±8.68)ml/min vs. (35.29±4.14)ml/min, P<0.001]. Vascular access in C/M-hybrid DFPP was as follows:13 patients using central venous catheters and 5 using peripheral vascular puncture; while in M-DFPP, all patients used central venous catheters in M-DFPP. The dosage of LMWH in C/M-hybrid DFPP was much lower than M-DFPP[(911.76±618.35)U vs. (5054.50±984.65)U, P<0.001]. During 79 sessions of DFPP, only a few of non-serious events occurred, including 5 episodes of hypotention(2 in M-DFPP and 3 in C/M-hybrid DFP, P>0.05); 4 hemolysis in M-DFPP; 1 hypocalcemia-associated symptom in C/M-hybrid DFPP.Conclusions:Compared with M-DFPP, C/M-hybrid DFPP had not only some apparent technical superiorities including lower requirements of blood flow rate and systemic anticoagulation, but also higher efficacy for removal of pathogenic autoimmune antibodies. Besides to these, its effect on platelet count was similar with M-DFPP, and avoided the technical complications associated with M-DFPP like hemolysis. |
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