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The cleansing effects on pus and debris of streptokinase-streptodornase and of stabilized crystalline trypsin were compared in 40 patients (12 males, 28 females) with necrotic varicose or arteriosclerotic leg ulcers. Both preparations produced significant partial or total cleansing of the ulcers of necrotic material, and both enhanced the granulation and epithelialization of most of the ulcers. Streptokinase-streptodornase was significantly more effective in removing freshly formed damp and smearing pus and debris. Neither preparation prevented the formation of or removed very deep adherent necrotic areas, especially in arteriosclerotic leg ulcers. Trypsin caused significantly more pain than streptokinase-streptodornase during the treatment period and on changing dressings. Both enzymes indirectly reduced the bacterial flora of the ulcers, probably by removal of necrotic wet material.
The National Institute for Medical Research, London, was asked by the WHO Expert Committee on Biological Standardization to take steps to set up an international standard of streptokinase-streptodornase. This paper describes the nature and handling of the material and its establishment as the International Standard for Streptokinase-Streptodornase, with a defined potency of 3100 International Units of Streptokinase and 2400 International Units of Streptodornase per ampoule. The International Unit of Streptokinase is defined as the activity contained in 0.002090 mg of the International Standard for Streptokinase-Streptodornase. The International Unit of Streptodornase is defined as the activity contained in 0.002700 mg of the International Standard for Streptokinase-Streptodornase.
Streptokinase-streptodornase (SK-SD) induced immediate and delayed skin test reactions in a high proportion of patients with disorders in which beta-streptococcal infection may be involved. The P-K test and absorption experiments with antigen or anti-IgE suggested that the immediate reaction was mediated by specific IgE antibody against SK-SD. Furthermore, the ratio of specific IgE antibody against SK-SD to total IgE was roughly calculated to be 20 percent. Finally, the RAST technique was applied to detect specific IgE antibody against SK-SD which showed high radiocounts bound to SK-SD-coupled particles in the sera of nephrotic patients who had a strong immediate reaction against SK-SD and a severe disease state.
The clinical efficacy of dextranomer (Debrisan) and streptokinase-streptodornase (Varidase) was compared in a controlled randomized in-patient study. There were two patient groups: Group A consisting of 28 patients with a total of 31 venous leg ulcers and Group B consisting of 56 patients with other infected wounds (posttraumatic and postoperative wounds, amputation stumps, burn wounds, arteriosclerotic ulcers, decubital ulcers, ulcers due to bone disease, rheumatic ulcers, ulcers due to erysipelas and wounds of mixed aetiology). Both agents have a good cleansing effect as well as a good effect on infection and wet necrosis. Dextranomer stimulates the formation of granulation tissue faster than streptokinase-streptodornase.
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Necrotic materials most frequently found in leg ulcers, including crusts with fibrinogen, pus and blood clots, were exposed to solutions of streptokinase-streptodornase and stabilized crystalline trypsin respectively. The investigations were performed at the temperatures of 26 degrees and 33 degrees C, representing the extreme values of the temperature range found in leg ulcers (arteriosclerotic ulcers, stasis ulcers) and at the pH corresponding to that of the enzyme preparations in wet dressings. Streptokinase-streptodornase demonstrated in vitro a more potent proteolytic activity than crystalline trypsin on necroses, crusts of fibrinoid and purulent exudate, which were more rapidly and thoroughly broken up. Both enzyme preparations were, however, equally effective on three-day-old blood clots.
The immediate skin reaction (IR) with streptokinase-streptodornase (SK-SD) was found with a high incidence in children with renal disease and was confirmed to be mediated by a specific IgE antibody against SK-SD by means of the radioallergosorbent test (RAST). This test revealed high radiocounts in children with renal disease who showed the IR and there was a close correlation between the RAST counts and the intensity of the IR. Furthermore, the RAST counts in the severe nephrotic syndrome belonging to corticosteroid dependent and resistant group were far higher than those in the corticosteroid sensitive group. From these results, a determination of the RAST counts against SK-SD seemed to help evaluate the severity of some nephrotic syndromes and the specific IgE antibody may be involved in the pathogenesis of the disease.
We have evaluated whether neutralising anti-streptokinase IgG antibodies are produced following streptokinase-streptodornase therapy of leg ulcer patients. Serum anti-streptokinase IgG concentrations in 10 leg ulcer patients were determined before, and 1 week, 2 weeks, and 3 weeks following the treatment. We observed only a negligible increase in neutralizing anti-streptokinase IgG concentrations during the observation period, which was probably of no therapeutical significance.
Delayed skin reactor (DSR), the material in streptokinase-streptodornase responsible for eliciting delayed hypersensitivity reactions in man, is stable as a lyophilized powder or when stored at -70 degrees C. Storage at a pH above or below 6.0 leads to a decrease in the ability of DSR to stimulate lymphocyte proliferation in vitro. Its molecular weight is 30,000 as estimated by sodium dodecyl sulfate gel electrophoresis and it is composed of approximately 260 amino acid residues without apparent sulfhydryl-bridged subunits. The extinction coefficient of DSR (A 1% 280 nm) is 2.6.
Using the 3H-thymidine incorporation test, the lymphocyte-stimulating activity of streptokinase-streptodornase (SK-SD, Varidase) and its fractions were evaluated. The dose-response curves of all the preparations except the third fraction had two peaks with the maximum around 5 and 40 mug. The dialyzable fraction of Sk-SD (D-SK-SD) occupying approximately half of the original sample had almost no lymphocyte-stimulating activity; and conversely, it had a potent inhibitory effect on the 3H-thymidine incorporation into lymphocytes that normally occurs with non-dialyzable SK-SD (ND-SK-SD), PPD and PHA-P. Therefore, it will be desirable to remove the dialyzable fraction from the commercial SK-SD preparation when it is used for the determination of the capacity of cellular immunity against tsk-sd.
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