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Antineoplastic effect of hydrogel dextran phosphate, hydrogel prospidin, and prospidin in an injectable preparation has been assessed using Seidel ascites hepatoma as a model. Injectable and hydrogel prospidin in doses from 250, 500 to 1000 mg/kg and hydrogel phosphate dextran in doses of 500 and 1000 mg/kg were administered to rats intraperitoneally in a single dose in a volume of 1 or 2 ml per each 100 g of animal body weight. The study has shown that irrespective of rats with Seidel ascites hepatoma and significantly increase in the dosage of prospidin preparations and hydrogel dextran phosphate results in a longer average life expectancy of rats Compared with its injectable variant, hydrogel prospidin appears to produce more than twice as high antineoplastic effect, and is found to provide prolonged therapeutic effects, as well as cure of animals in more than 60 % of cases.

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AIM: To compare clinical efficacy of methotrexate monotherapy and methotrexate combination with prospidin in patients with psoriatic arthritis (PA). MATERIAL AND METHODS: Sixty three patients (42 females and 21 males) with documented PA, generalized articular syndrome of the second-third degree of activity were divided into two groups. Patients of group 1 (n = 30) received combined therapy (i.v. prospidin 200-300 mg/week + i.m. methotrexate 10 mg/week). Maintenance consisted of prospidin in a dose 100-200 mg/week i.m., methotrexate dose was the same. Patients of group 2 (n = 33) were given methotrexate monotherapy in a dose 10 mg/ week i.m. RESULTS: In the first three months of the study and in maintenance therapy, combined treatment was more effective. By ACR criteria, 50-70% response was achieved after 12 months of treatment in 44 and 27.3% patients of groups 1 and 2, respectively. The number of side effects and drug-related withdrawals was 23.3 and 36.4%, 10 and 15.1% in groups 1 and 2, respectively. CONCLUSION: Combination of methotrexate with prospidin produced an earlier and more potent positive clinical effect than methotrexate alone in PA patients.

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Respiratory papillomatosis was studied clinically and morphologically in 35 children with immunohistochemical detection of human papilloma virus. More frequent detection of viral antigen in the superficial layers of the epithelium in children with frequent recurrences was observed. Correlation between clinical efficiency of prospidine and immunohistochemical findings was noted. Suggestion on the indirect link between viral damage and intranuclear inclusions (although viral antigen in these inclusion was not observed) was made.

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BACKGROUND: Primary cutaneous plasmacytoma (PCP) is a rare type of cutaneous B-cell lymphoma arising primarily in the skin and derived from clonally expanded plasma cells with a various degrees of maturation and atypia. The disease is rare with only 30 cases reported so far. METHODS: Two cases of PCP with long-term follow-up of 17 and 15 years are presented. RESULTS AND CONCLUSIONS: Both patients were men with nodular lesions on the face. Histologically, the lesions were composed predominantly of variably maturated plasma cells with monotypic expression of immunoglobulin (Ig) lambda chains. Polymerase chain reaction for IgH genes did not reveal clonal rearrangement. Our cases are discussed in the context of previously reported cases of PCP with a long-term follow-up. We also include a review of all cases of PCP with known tumor progression earlier in the course of the disease (local relapse or visceral spread) to determine the clinical course of this primary cutaneous lymphoma.

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A study was made of clinical effectiveness and mechanism of action of the inhibitor of the specific 3',5'-cAMP phosphodiesterase papaverine in a therapeutic complex of measures designed to treat RA patients involving an immunodepressive preparation free from any cytopenic effect prospidin as a basic mediator. It has been shown that the papaverine antiarthritic action is associated with its positive effects on the unspecific component of the immune-complex inflammation, viz. processes of lipid peroxidation, activity of the antioxidant system of defence as well as on the vascular tone and microcirculation. All this improves tissue metabolism, and in this way enhances efficiency of RA basic therapy.

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Efficiency of pulse-therapy with prospidin (500 mg for 5 days in hospital, 500-1000 mg for a month as maintenance) and methotrexate (30 mg a week i.v. in hospital, 7-10 mg a week as maintenance) was investigated in 93 patients with severe RA. The response to prospidin and methotrexate arose quickly (within 10-14 and 4-5 weeks, respectively) and occurred in 73 and 70% of patients, respectively. Withdrawal of the drug was caused by side effects of methotrexate (19.3%) and resistance to prospidin (23.2%).

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Basing on the results of long-term observational study of 200 patients with laryngeal papillomatosis the authors made a conclusion on cycle pattern of the disease course. Each cycle consists of two periods: active (rapid growth of the tumor) and passive (slow growth of the tumor, recurrences are rare, 1-3 years of remission). A case of a male patient is reported illustrating cycle course of transitional laryngeal papilloma. In the beginning of the third cycle, in active period, his papilloma underwent malignant transformation. Cryotherapy of papilloma is thought ineffective.

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Original immunological studies allowed the authors to design a combined treatment of laryngeal papillomatosis (LP) with administration of immunomodulators and cytostatics. Surgery was performed on demand. Thymic hormone preparation (T-activin, thymalin, thymogen) and prospidin served as immunomodulators and cytostatic, respectively. To create lymphotropism, prospidin was delivered by means of electrophoresis following subcutaneous introduction of 8--16 U lidase. Sensitivity of patients to thymalin was tested in vitro by thymalin-induced changes in the number of CD2--DR+ lymphocytes. Adjuvant modalities were age-adjusted dibasol as inductor of interferon genesis and adaptogens (eleutherococcal fluid extract, B and C vitamins). Such treatment was given to 39 children. Remission duration increased 1.6--2.6-fold, 6 of 7 children with primary LP achieved persistent remission. Positive changes in immunological indices occurred in 84% of children. The above treatment outcomes support the efficacy of the method in childhood LP.

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Clinical, biochemical and immunological findings in 12 children with recurrent laryngeal papillomatosis evidence for defects in hormonal--metabolic and immune profiles in terms of depressed sympathoadrenal, adrenocortical functions and secondary immunodeficiency. To correct the above disorders it is advisable to practice immunocorrective therapy and drugs (prospidin) stimulating adrenal function.

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Twenty-seven patients with highly active, refractory rheumatoid arthritis (RA) were treated with the new anti-rheumatic drug prospidine, in view of selecting the optimum pulse regimen and comparing its short-term use with methotrexate (MTX). Prospidine was administered intravenously 500 mg every 3-5 days in the hospital and then monthly. Fifteen patients received MTX (30 mg/week intravenously in hospital and then monthly. Fifteen patients received MTX (30 mg/week intravenously in hospital and then orally 7.5-15 mg/week). The randomisation code was 2:1. We assessed 7 clinical and 4 lab data. The clinical improvement was noticed statistically after 2-4 weeks in 85% prospidine-patients and sustained up to 6 months in 73% (cp. 40% and 57% by the MTX). Only in the prospidine patients were a significant reduction of the mean daily prednisolone dose and the levels of rheumatoid factor and immune complexes observed. Prospidine and MTX had a similar incidence of side effects (39% and 43%), but all drop-outs in prospidine pulse were due to lack of response (26%) and to initial intolerance (4%). Drop-outs in MTX pulse were connected both with drug toxicity (14%) and with lack of response (7%). Alternate prospidine pulse, as highly anti-inflammatory, rapidly acting and well-tolerated regimen, may be used in treating severe forms of RA.

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Prospidin and azathioprine were given to 28 and 12 SLE patients, respectively, in a controlled trial which implied subsequent clinical and immunological surveillance for 12 months. The data obtained in the trial provided evidence for true antilupus activity of prospidin in a total dose 3.0-9.8 g. Prospidin brought about improvement with a complete or partial remission of the lupus nephritis in 71%, serious side effects in 21%, lethality in 17.8%, secondary resistance in 10% of the patients treated. The clinical and immunocorrective effects conformed. Compared to azathioprine, prospidin can produce more pronounced and rapid effect, induced more marked immunodepression. It is better tolerated, has no cytopenia effect. The drugs mechanisms of action and criteria of the treatment efficacy are discussed. It is hold valid to use prospidin in long-term maintenance of SLE patients.

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The time course of in vitro cellular immune reactions by using cyclophosphane, prospidin , and methotrexate was examined in 39 patients with rheumatoid arthritis to make predictions of the efficacy of its cytostatic therapy. The agents were evaluated for effects on the expression of Ia-like antigens on the peripheral lymphocytes and synovial fluid of the patients. The optimal doses of the agents for this testing had been chosen in the lymphoid cells from MRL31 lpr mice. The active dosage forms of the cytostatics for the experiment were obtained by administering native agents into the retrobulbar plexus of Balb/c mice, followed by blood isolation of active metabolites . The Ia-like antigen pre-expression index which is the ratio of the proportion of Ia-positive lymphocytes in control cultures to that of the cells in the culture after drug addition was used as a marker of the baseline cellular immunity in the patients. The patients having the index more than 1.5 were considered to be sensitive, those with less than 1.5 were insensitive to the drug. Thus, the Ia-like antigen pre-expression index may be used as a predictor in the assessment of the expediency of prospidine use.

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During 1979-1987 269 patients with laryngeal cancer stage I-II were included into a cooperative randomized study: 111 patients had T1 and 158 patients, T2 tumor; 13% of patients showed cancer of the vestibular cord and 87% of them of the true vocal cord. 76 patients underwent surgery, 129 patients--radiotherapy, and 64 patients received combined treatment, i.e. radio- and chemotherapy (prospidine). The rate of relapses and regional metastases was 11.8 +/- 3.7% and 2.6 +/- 1.8% after surgery, 21.4 +/- 3.8% and 1.6 +/- 1.1% after radiotherapy, and 23.4 +/- 5.3% and 6.3 +/- 3.0% after combined treatment. In terms of the recurrence-free time surgical intervention showed the highest efficacy. With respect to the 5-year survival, measured in the above patients plus 42 patients operated on because of relapses and regional metastases, surgery of vocal cord cancer was effective in 100% in case of stage I, 97.4% in case of stage II; radiotherapy was effective in 91.7% in case of stage I, 88.8% in case of stage II, and combined treatment was effective in 100% in case of stage I and 70.3% in case of stage II; surgery of vestibular cord cancer stage II was effective in 100%, combined treatment in 88.9%, and radiotherapy in 68.6%. When vocal cord cancer involves the anterior commissure, ventricle, and space, preference should be given to surgery because relapses after radiotherapy were seen in 38-42%. Combined radio- and chemotherapy did not reduce the recurrence rate and therefore cannot be recommended for practical purposes.

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The effects of new antitumor drugs spirobromin and prospidin on acute (carraghenin-induced rat paw edema) and chronic ("pellet granuloma") inflammation in rats were studied. The drugs were found to exert the anti-inflammatory effect on the model of chronic proliferative inflammation but to produce no significant changes in the degree of the acute inflammatory reaction. Spirobromin is superior to prospidin by the power of the anti-inflammatory effect. The electron microscopic studies showed that spirobromin and prospidin decrease the activity of fibroblasts in the focus of chronic inflammation.

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The individual response to chemotherapy was investigated in 17 heterotransplants of human lung tumours of different histogenesis by the subcapsule test. It is established that the subcapsule test is of high informativity only when testing the individual resistance of lung tumours, especially adenocarcinomas, to cytostatics.

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The initial and final proliferative activity (PA) of heterografts of human lung and breast tumors were assayed in cultures grown under the renal capsule in mice with and without cytotoxic drugs. The PA values in the control group proved similar. Chemotherapy-induced changes in PA did not correlate with those in heterograft growth rate.

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