Exploring the safety and effectiveness of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy in chronic urticaria: An observer-blind, randomized, controlled study.

BACKGROUND: Autologous serum therapy aims to supplement the existing pharmacotherapy in chronic urticaria by decreasing the antihistamine pill-burden and maintaining symptom-free interval. Subcutaneous autologous serum therapy further modifies the amount of serum (2 mL to 1 mL) and gauge of a needle (24G to 31G) to improve compliance and facilitate ease of application. OBJECTIVES: To assess clinical effectiveness and safety of subcutaneous autologous serum therapy versus conventional intramuscular autologous serum therapy and to compare the quality of life in the two treatment arms. METHODS: Institution-based, assessor-blind, prospective, randomized, parallel-group, active-controlled trial with 32 patients in each treatment arm and analyzed on a modified intention to treat principle. After baseline autologous serum skin test, autologous serum was injected as per randomization every week for 9 consecutive weeks. RESULTS: Among the study population, conventional intramuscular autologous serum therapy and subcutaneous autologous serum therapy had a comparable duration of disease (P = 0.164, Mann-Whitney U test), autoreactive status (P = 0.796), urticaria total severity score (P = 0.637) and urticaria activity score summed up over 7 days (P = 0.982). Both urticaria activity score summed up over 7 days and total severity score along with antihistamine pill-burden reduced significantly (P < 0.001, Friedman's analysis of variance) in both subcutaneous autologous serum therapy and conventional intramuscular autologous serum therapy from first follow-up onwards (P < 0.05, Post hoc Dunn's test). Significant improvement was noted in patient's as well as physician's global assessment of disease activity improvement scale (P < 0.001, Friedman's analysis of variance). Intergroup analysis showed that there was no significant difference in urticaria activity score summed up over 7 days either at baseline (P = 0.982, Mann-Whitney U test) or at study end (P = 0.398, Mann-Whitney U test). Similar comparable results were found in the total severity score at the end of the study (P = 0.345, Mann-Whitney U test). Dermatology life quality index showed marked improvement with both types of treatment (P < 0.0001, Wilcoxon test), and the intergroup comparison showed comparable dermatology life quality index values (P = 0.994, Mann-Whitney U test). The pain score at the injection site was more with conventional intramuscular autologous serum therapy than subcutaneous autologous serum therapy (P = 0.0115, Mann-Whitney test). Younger age and lower baseline total severity scores were associated with a better therapeutic response. Baseline urticaria activity score added up over a period of 7 days and total severity scores and the diameter of lesions showed a positive correlation with response pattern. LIMITATION: Basophil histamine release assay not done. Logistics could not support follow-up beyond the end of treatment. CONCLUSION: Subcutaneous autologous serum therapy is not inferior to conventional intramuscular autologous serum therapy with the additional advantage of less pain and operational feasibility.

Autologous serum therapy in chronic urticaria: old wine in a new bottle.

BACKGROUND: Chronic urticaria (CU) is one of the most challenging and frustrating therapeutic problems faced by a dermatologist. A recent demonstration of abnormal type 1 reactions to intradermal autologous serum injections in some CU patients has led to the characterization of a new subgroup of "autoimmune chronic urticaria". This has rekindled interest in the age-old practice of autologous blood injections as a theoretically sound treatment option in these patients. AIMS: To evaluate the efficacy of repeated autologous serum injections (ASIs) in patients with recalcitrant chronic urticaria. METHODS: A cohort of 62 (32 females) CU patients with a positive autologous serum skin test (ASST) (group 1) was prospectively analyzed for the efficacy of nine consecutive weekly autologous serum injections with a postintervention follow-up of 12 weeks. Another group of 13 (seven females) CU patients with negative ASST (group 2) was also treated similarly. In both groups, six separate parameters of disease severity and activity were recorded. RESULTS: Demographic and disease variables were comparable in both groups. The mean duration of disease was 1.9 +/- 0.3 years (range = 3 months to 32 years) in group 1 and 1.5 +/- 0.2 years (range = 3 months to 10 years) in group 2. In the ASST (+) group, 35.5% patients were completely asymptomatic at the end of the follow-up while an additional 24.2% were markedly improved. In the ASST (-) group, these figures were 23 and 23% respectively. The intergroup difference for complete subsidence was statistically significant (P < 0.05). In both groups, the most marked reduction was seen in pruritus and antihistamine use scores followed by the size and frequency of the wheals. CONCLUSION: Autologous serum therapy is effective in a significant proportion of ASST (+) patients with CU. A smaller but still substantial number of ASST (-) patients also benefited from this treatment.

Autoapheresis and intraoperative blood salvage in oncologic surgery.

Transfusion of predeposit or salvaged autologous blood has continued to grow since the 1980s. Issues such as the indications for use and cost effectiveness as well as the safety of autologous blood salvaged during cancer surgery have emerged and should be addressed. The concern for possible contamination of autologous RBC with cancer cells responsible for metastasis has limited the use of autologous salvaged blood in cancer patients. Nevertheless, clinical experience has been gained on the use of salvaged blood in patients with colorectal, gastric, renal, hepatic, breast, bladder and lung cancer. No evidence has been reported showing an increase in metastasis or a decrease in patient survival, in spite of the obvious demonstration that salvaged blood is contaminated with viable tumor cells which are not washed out of the RBC layer during intraoperative blood salvage (IOBS). However, a number of limitations have hampered the widespread use of IOBS in these patients and the technique is not well established. Increasing knowledge of the deleterious effects of allogeneic blood transfusion both in terms of the increased number of viral or bacterial infections and the down-regulation of the patient's immune system have recalled attention to IOBS and to the techniques such as filtration, which might reduce the risk of reinfusion of cancer cells, or totally eliminate the risks such as irradiation has been proposed by Hansen's group. This paper reviews the topic with some emphasis on our personal experience with gamma and X-ray irradiation of salvaged blood in a large reference hospital, where IOBS and filtration of salvaged blood were established for use in cancer patients in 1993 and 1996.