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CASE REPORT: During enzyme therapy with intramuscular injections of Wobe-Mugos over 3 weeks a female MS-patient developed a severe anaphylactic reaction. The problems of enzyme therapy are discussed.
Wobenzim, a drug for systemic enzyme therapy, was used in 26 children with lower orbital wall fractures as monotherapy in early periods (on days 1 to 7) after brain injury to improve healing conditions and to minimize the formation of scar tissues in the fractural area. A control group comprised 24 patients who received systemic dehydration and vessel-strengthening therapy. Systemic enzyme therapy with Wobenzim could reduce the attenuation time of inflammatory manifestations of injury, prevent complications, such as strangulation of the musculus rectus inferior in the fractural area and development of strangulated orbital soft tissue hernia, and substantially decrease the number of patients having indications for surgical plastic repair of the orbital wall, as compared with the control group.
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The treatment of autoimmune and immune complex diseases of the vascular bed consists--similarly as of immunopathologic processes of other systems--in the use of risky immunosuppressive agents and antiinflammatory as well as symptomatic therapy. In the article the author informs about the possibility to use in these indications (and in addition also in other angiologic diseases) the systemic enzyme therapy, residing in the oral application of high-dosed combinations of several animal and plant proteolytic enzymes. About four tens years of positive medical empirical experience have been supported by a concentrated sophisticated research and approximately 150 clinical studies according to GCP. These revealed in most autoimmune and immune complex diseases a surprisingly high effectiveness and complete harmlessness of the enzyme therapy. After the short introduction mentioning the important indications for enzyme therapy in the field of clinical immunology, the major attention is paid to the results of enzymotherapy in angiology. Strong evidence indicates that enzymotherapy ameliorates the disturbed composition and properties of blood and vessel walls, acts preventively as well as therapeutically in thromboses, thromboflebitides and consequences of venous insufficiency; it seems be prospective in afflictions of arterial bed, including vasculitides and glomerulonephritides, also. The key feature of enzymotherapy is the immunomodulatory activity. There exists a strong evidence for the favourable modulation of pathogenic autoantibodies, inhibition of the neogenesis of immune complexes and cleavage of their deposits, normalization of the T cell system, network of cytokines, adhesion molecules and inflammatory cascades. Besides the direct peptidolytic and proteolytic effects of hydrolases, the indirect effects realized in the course of interaction between the resorbed enzymes and their natural "partners"--antiproteases (mainly alfa-2-macroglobulin)--have become a topic of intensive research. The author feels, that systemic enzyme therapy should become a regular component of the treatment of immunopathologic processes in general and of angiologic diseases specially. (Ref. 42.).
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Gaucher disease type 1, a non-neuronopathic lysosomal storage disease, is caused by mutations at the acid beta-glucosidase locus. Periodic infusions of macrophage-targeted acid beta-glucosidase reverse hepatosplenomegaly, hematologic, and bony findings in many patients. Two patients receiving enzyme therapy developed neutralizing antibodies to acid beta-glucosidase that were associated with a lack of improvement or progressive disease. After initial improvement, case 1 had no additional response to 2 years of high-dose (50 U/kg every 2 weeks) enzyme therapy. Similarly, case 2 initially showed a favorable response to enzyme therapy that plateaued after 1 year of treatment. Both patients developed minor allergic reactions and antibodies to acid beta-glucosidase within the first 6 months of treatment. Enzyme therapy was discontinued in case 1, with resultant disease progression and need for splenectomy. An immunosuppression/tolerization protocol was initiated in case 2 because of disease progression and stable neutralizing antibody titers. The IgG neutralizing antibodies rapidly and completely inactivated the wild-type, but not the N370S, acid beta-glucosidase in vitro. Antibodies to human serum albumin and chorionic gonadotropin also developed. The finding of neutralizing antibodies to acid beta-glucosidase during enzyme therapy for Gaucher disease has significant implications for monitoring the therapeutic responses and for potential alternative future therapies for Gaucher disease.
The efficiency of the enzyme therapy was studied in patients with hemophthalmos concurrent with diabetes mellitus of different types. Sixty-eight patients received parabulbar injections of the hemase and collelizin enzymes and another 25 patients underwent the routine therapy comprising injections of dicynone, emoxipin and heparinum. The method of ultrasound B-scanning was used to determine the area of hemorrhage spread into the vitreous body. A high efficiency of the enzyme therapy, as used within the complex treatment of hemophthalmos in patients with diabetes mellitus, was demonstrated. Ultrasound B-scanning is a highly informative technique in evaluating the enzyme-therapy efficiency. The enzyme therapy can be recommended as the most effective method for the treatment of hemophthalmos in patients with diabetes mellitus.
BACKGROUND: Skeletal complications are responsible for significant morbidity in Gaucher patients. Plain radiographs have been unreliable in assessing bone marrow infiltration and activity. A way to assess bone marrow improvement is needed during enzyme therapy. OBJECTIVE: The purpose of this paper is to assess the usefulness of MR in following improvement of abnormal bone marrow in Gaucher patients on enzyme therapy. MATERIALS AND METHODS: Three patients aged 2, 7, and 24 years underwent serial MR scans of the lower extremities before and during treatment with Alglucerase (two patients) and Imiglucerase (one patient). T1-weighted, T2-weighted, STIR and FSE T2-weighted images were utilized. Two patients were imaged after 16 months of therapy, and one patient was imaged after 6 months of therapy. RESULTS: All patients had improvement in marrow signal consistent with partial reconversion to fatty marrow during treatment. The findings were more marked after prolonged therapy. T1-weighted images demonstrated findings most clearly. CONCLUSION: MR consistently showed improvement in marrow signal in Gaucher patients on enzyme therapy. As smaller doses of enzyme therapy are the trend, MR can be utilized to determine if therapy is effecting a change in the bone marrow.
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The authors present their experience with enzyme therapy--the preparation Wobenzym--in comprehensive treatment of supracondylar fractures of the humerus in children. On monitoring the condition of the extremity by Doppler ultrasound, where the flow through the radial artery was quantified they obtained better results in the group of patients treated by systemic enzyme therapy than in the control group. Systemic enzyme therapy is recommended as a suitable supplement in comprehensive treatment where the most important part is played by correct and early treatment along with precise monitoring of the extremity during the postoperative course.
Patients with chronic pancreatitis are at risk for poor nutritional status. The two major clinical features of chronic pancreatitis are abdominal pain and maldigestion, both resulting in malnutrition. Abdominal pain often results in decreased oral intake, and decreased enzyme production results in maldigestion. Enzyme therapy often is included in treating chronic pancreatitis. There is limited data on the nutritional assessment of outpatients with chronic pancreatitis, and the efficacy of the use of enzyme therapy remains controversial. Serum albumin level and measurement of ideal body weight are two simple measures of nutritional status that can be obtained by gastroenterology nurses. A retrospective chart review was done of patients seen in our outpatient clinic for management of chronic pancreatitis. Serum albumin levels, an indicator of protein calorie malnutrition, were reviewed for 34 patients. Thirty-three percent of these patients were found to have mild-to-moderate protein calorie malnutrition as evidenced by low serum albumin levels. Enzyme therapy information was reviewed for 33 patients. Patients receiving enzyme therapy had better nutritional status based on both serum albumin levels and percent of ideal body weight. Gastroenterology nurses can be instrumental in the recognition and treatment of nutritional deficiencies in chronic pancreatitis.
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Adenosine deaminase (ADA) deficiency results in a combined immunodeficiency brought about by the immunotoxic properties of elevated ADA substrates. Additional non-lymphoid abnormalities are associated with ADA deficiency, however, little is known about how these relate to the metabolic consequences of ADA deficiency. ADA-deficient mice develop a combined immunodeficiency as well as severe pulmonary insufficiency. ADA enzyme therapy was used to examine the relative impact of ADA substrate elevations on these phenotypes. A "low-dose" enzyme therapy protocol prevented the pulmonary phenotype seen in ADA-deficient mice, but did little to improve their immune status. This treatment protocol reduced metabolic disturbances in the circulation and lung, but not in the thymus and spleen. A "high-dose" enzyme therapy protocol resulted in decreased metabolic disturbances in the thymus and spleen and was associated with improvement in immune status. These findings suggest that the pulmonary and immune phenotypes are separable and are related to the severity of metabolic disturbances in these tissues. This model will be useful in examining the efficacy of ADA enzyme therapy and studying the mechanisms underlying the immunodeficiency and pulmonary phenotypes associated with ADA deficiency.
PURPOSE OF THE STUDY: The authors concentrate on the use of enzyme therapy in traumatology. They monitored SET efficiency in the treatment and prophylazis of swelling in the postoperative period after the internal fixation of fractures of long bones and compared it with the effect of standard antiswelling seu antioedematous drugs on the basis of aescin. MATERIAL: A group of 60 patients was followed after the fixation of long bones. The average age was 42 years (range, 12-79 years). Fractures were treated by intrameduilary fixation or by external fixators. The patients were split into two groups. In 30 patients only Phlogenzym was administered for the treatment and prevention of posttraumatic and postoperative swelling. Another 30 patients--the control group--were treated by standard antioedematic drugs on the basis of aescin. The same analgesics were applied in both groups. METHODS: The group of patients with systemic enzyme therapy were treated by Phlogenzym in the dosage 3 times 3 tablets in the first three days after operation and subsequently 3 times 2 tablets in the remaining follow-up period. In the postoperative period the changes of operated limb volume was monitored. The circumference of a limb was measured in the area of the largest oedema and 10 cm distally. Then the volume of this part of limb was calculated as the volume of conical frustum. The measurements were performed on postoperative days 1, 3, 5, 7, 10 and 14. The volume value of the 1st day was used as starting value (100%). The values of subsequent measurements were then compared to this starting value in both group of patients. Evaluation of the resorption of traumatic and postoperative haematoma and analgesis effect of Phlogenzym was also made. RESULTS: In the group of patients who were administered with Phlogenzym after operation the reduction of the posttraumatic and postoperative swelling was continuous and significantly faster in compared with patients of the control group. A remarkable difference was revealed by the measurement on 5th postoperative day--in patients treated by Phlogenzym the starting value of the volume of the operated in limb was reduced on average by almost 8%. In contrast, in the control group treated by standard drugs this value slightly increased above 100%. At the end of the first postoperative week the monitored volume was on average reduced by 12% in the SET group compared with 1.45% in the control group. At the end of the follow-up--on 14th postoperative day the volume was reduced in the SET group by almost 17% compared with 9% in the control group. There was also an evidently good analgesic effect of the drug. The total consumption of analgesics of patients in the SET group was significantly lower, particularly in the early postoperative period. In the course of the follow-up of both groups no marked differences were recorded in the changes of the volume of operated limbs in dependence on the method of fixation applied (intramedullary or external), sex of the patient or on the affected limb (lower or upper). The patients tolerated Phlogenzym very well, only one female patient suffered temporarily from poor digestion which, however, did not require to interrupt the administration of the drug. No other undesirable effects occurred. DISCUSSION: Fixation of long bones belongs to the most frequent operations in traumatological and orthopaedic departments of all levels. One of the factors which may have an unfavourable effect on the final result of fixation is a prolonged post-trauma or postoperative swelling. The results of the study prove a clearly positive effect of system enzymotherapy on the reduction of oedema accompanying the trauma and inflammation. The study proved a statistical significance of the acceleration of the reduction of oedema in patients treated by Phlogenzym as compared to the control group treated by a standard antioedematous drugs. CONCLUSION: The authors verified that systemic enzyme therapy could influence significantly the results of traumatological surgery. Simple administration per os, efficient oedema reduction and thus accelerated healing, antiophlogistic and analgesic effect--all these advantages justify the application of this therapeutic method what can be recommended as a part of the complex treatment in traumatology with both conservative and surgical approaches.
Enteric-coated proteolytic enzyme preparations like Wobenzym and Phlogenzym are widely used for the so-called 'systemic enzyme therapy' both in humans and animals. Numerous publications reveal that oral proteolytic enzymes are able to stimulate directly the activity of immune competent cells as well as to increase efficiency of some of their products. But origins of the immunostimulatory effects of oral proteolytic enzymes are still unclear. The hypothesis described here suggests that it may be proteolysis of intestinal microorganisms that makes the immune competent cells to work in the immunostimulatory manner. The hypothesis was largely formed by several scientific observations: First, microbial lysis products (lipopolysaccharides, muropeptides and other peptidoglycan fragments, beta-glucans, etc.) are well known for their immunostimulatory action. Second, a normal human being hosts a mass of intestinal microorganisms equivalent to about 1 kg. The biomass (mainly due to naturally occurring autolysis) continuously supplies the host's organism with immunostimulatory microbial cell components. Third, the immunostimulatory effects resulting from the oral application of exogenously acting antimicrobial (lytic) enzyme preparations, such as lysozyme and lysosubtilin, are likely to be a result of the action of microbial lysis products. Fourth, cell walls of most microorganisms contain a considerable amount of proteins/peptides, a possible target for exogenous proteolytic enzymes. In fact, several authors have already shown that a number of proteases possess an ability to lyse the microbial cells in vitro. Fifth, the pretreatment of microbial cells (at least of some species) in vitro with proteolytic enzymes makes them more sensitive to the lytic action of lysozyme and, otherwise, pretreatment with lysozyme makes them more susceptible to proteolytic degradation. Sixth, exogenous proteases, when in the intestines, may participate in final steps of food-protein digestion. The resulting food-borne peptides have recently been shown to be potential activators of microbial autolysis. The main question that needs to be answered in order to verify the hypothesis is whether oral proteases are able (and to what extent) to lyse/mediate lysis of intestinal microorganisms in situ. Methods based on up-to-date molecular biology techniques to allow investigation of the influence of exogenous proteases on microbial lysis processes in vivo (in the intestines) need to be developed. Research testing of this hypothesis may have an important impact in development of novel preparations for the systemic enzyme therapy.
Systemic enzyme therapy (SET) represents a specific therapeutic approach consisting in peroral application of blends of animal and plant hydrolytic enzymes. A significant part of the swallowed enzymes (about 25%) is resorbed in the intestine in functionally active form. After being complexed with natural antiproteases, enzymes set concentrated in wounds, inflammation sites and immunopathological foci. SET has many important indications in traumatologic, thrombotic, infectious, inflammatory, immunopathologic and even tumorous processes. Rheumatoid arthritis, Bechterew's disease, activated arthrosis and extraarticular rheumatism represent important and sensitive targets of SET. In situ and in vivo studies continue to elucidate selective interferences of absorbed proteolytic enzymes with the crucial pathogenic mechanisms of rheumatoid processes.
OBJECTIVE: There is increasing interest in the use of combination therapy for rheumatoid arthritis and in the possibility of combining the conventional drug approach with newer antirheumatic therapy. The present study investigates the efficacy of long-term prophylactic enzyme therapy and combination therapy with cyclosporin A in rats with collagen-induced arthritis. METHODS: Rats with collagen-induced arthritis were administered the following drugs: cyclosporin A (5 mg/kg/day and 10 mg/kg/day orally); a mixture of enzymes containing pure substances (bromelain, trypsin, rutin) in the same ratio as in Phlogenzym (PHL, 150 mg/kg, twice daily intrarectally); and a combination of 5 mg/kg/day cyclosporin A plus 300 mg/kg/day PHL for a period of 50 days from the immunization. Levels of serum albumin, serum nitrite/nitrate concentrations, changes in hind paw swelling and bone erosions were measured in the rats as variables of inflammation and destructive arthritis-associated changes. RESULTS: Treatment with 10 mg/kg cyclosporin A, as well as combination therapy with half dosages of cyclosporin A (5 mg/kg) plus PHL significantly inhibited both inflammation and destructive arthritis-associated changes. Significant differences in favor of combination therapy with 5 mg/kg CsA + 300 mg/kg PHL as compared to 5 mg/kg CsA alone were seen in hind paw swelling. Also, reduction of the radiographic scores was more significant in the combination therapy group. Five mg cyclosporin A or PHL alone reduced the disease markers studied to a lesser extent, and in the case of enzyme therapy this occurred at a later stage of arthritis development. CONCLUSION: Our results show the inhibitory effect of enzyme therapy on collagen-induced arthritis in rats, as well as the efficacy of cyclosporin A given in low doses in combination with enzyme therapy, which may be useful in the treatment of rheumatoid arthritis.
UNLABELLED: Pompe disease or glycogen storage disease type II (OMIM 232300) is a metabolic myopathy with a broad clinical spectrum. Generalised muscle weakness combined with cardiomegaly presents within the first 3 months after birth, if the lysosomal alpha-glucosidase (AGLU) deficiency is complete. Residual enzyme activity prevents cardiac involvement and delays onset of muscle weakness. Enzyme therapy, by intravenous administration of acid AGLU, aims to supplement the missing enzyme activity. At the SHS symposium on Glycogen Storage Diseases Type I and II, in Fulda, two interim accounts were given of studies on the efficacy of enzyme therapy for Pompe disease; one with recombinant human acid AGLU produced in Chinese hamster ovary cells and the other with the same enzyme produced in the milk of transgenic rabbits. CONCLUSION: this review focuses on the latter study, discusses the scientific, technological and commercial aspects of the enterprise, and addresses the prospects and challenges of enzyme therapy for Pompe disease.