Antitumor agent (options)

 

(57) Abstract:

The invention relates to medicine, in particular for experimental and clinical Oncology, and can be used in the treatment of hormonecontaining cancer in women, and in advanced cases when the loss of tumors of harmonicoscillator. The proposed remedy consists of a mechanical mixture of 2 - 4 g L-valine and small non-therapeutic dose at 0.020 - 0.025 g of methyltestosterone when exposed to hormonetestosterone cancer in women and from mechanical mixture of 2 - 4 g L-valine, 0,005 - 0,010 g methandrostenolone and 0.3 - 0.5 g ftivazide when exposed to cancerous tumors without harmonicoscillator. The technical result of the proposed use of the funds is that even in advanced cases reduced the size of tumors, sometimes to complete resorption, completely eliminates the pain syndrome in incurable patients significantly extended life with satisfactory subjective state, and sometimes with resorption of tumors. The use of this equipment is not accompanied by any toxic effects: it increases the antitumor resistance of the organism in the form of normalization hem is t to apply it on an outpatient basis. 9 Il., table 4.

The invention can be used in the treatment of hormonecontaining cancer in women, and in advanced cases when the loss of tumors of harmonicoscillator. The proposed tool consists of a mechanical mixture L-valine and small non-therapeutic doses of methyltestosterone when exposed to hormonetestosterone cancer in women, and from a mechanical mixture L-WA Lina, methandrostenolone and ftivazide when exposed to cancerous tumors without harmonicoscillator.

The effectiveness of the proposed means is that even in advanced cases reduced the size of tumors, sometimes to complete resorption. reduced completely pain syndrome in incurable patients significantly extended life with satisfactory subjective state, and sometimes with resorption of tumors. The use of this equipment is not accompanied by any toxic effects: it increases the antitumor resistance of the organism in the form of the normalization of disorders, weight gain, a significant increase appetite and health. The absence of side effects allows you to apply it and outpatient basis.

Isobune treatment hormonecontaining cancerous tumors in women and in cases of cancer running process, when these tumors lose their harmonicoscillator.

Known means with the experiment in the experiments in vitri cytotoxic effects on cancer cells in animals and humans, in the form of a suspension of individual cells in culture medium or in the form of a monolayer in tissue culture.

This is a simple composition and obtaining a chemical synthetic L-amino acid possessing a wide spectrum of cytotoxic activity in individual cancer cells of humans and animals: L-alanine, L-leucine, L-phenylalanine, L-glycine, L-methionine, L-tryptophan and L-valine /2/.

Synthetic amino acid L-valine, in contrast to other in vitro experiments has on cancer cells mammalian strongest cytotoxic effect, without damaging non-cancerous cells.

However, a major and very significant drawback of the above funds, including L-valine is their property damage only individual cancer cells in suspension or in monolayer and not have this effect in experiments in vivo when these cells form a dense cancers in mammals. So visinity to master them.

Also known antitumor agents that have antibioticskin effect on hormonetestosterone cancers in women: breast cancer and ovarian cancer.

These synthetically produced steroid hormones are derivatives of a strong androgen is testosterone. Of these anticancer agents have found the widest application in clinkerisation propionate, microtitration (or 2 - methyldihydromorphine), protestan (mixture of esters of 2 - methyldihydrotestosteroni), in the treatment of hormonecontaining tumors breast cancer and ovarian cancer in women. Oil solutions of these drugs intramuscularly. In long-term care is sometimes prescribed another derivative of testosterone, methyltestosterone, with weaker antibioticskin action. Its advantage consists in oral (sublingual) introduction /1/.

These synthetic derivatives of testosterone, initially tested in the experiment, despite its antitumor activity on harmonously induced breast cancer in rats,showed a number of significant disadvantages.

1. When you keep multiple tumors breast cancer greegreece tumors in a large percentage of cases does not reach the end and on the background of the input product is only growth inhibition remission, which replaces the irreversible growth of the same tumors.

3. After complete regression of the tumor caused by androgen, often see the emergence of recurrence of tumor growth.

4. Reuse initially caused the regression synthetic androgen gives no antitumor effect, i.e., there is complete loss of sensitivity to this drug.

5. Three fat-soluble derivatives of testosterone: testosterone propionate, 2 methyldihydrotestosteroni propionate and 2a--- methyldihydromorphine more active than methyltestosterone, have a percentage of the total regression of all tumors, respectively: 40% 70% 80% percentage of full regression, i.e. complete disappearance of tumors only, respectively: 10% 50% 20%

In the clinic of all these hormones are usually administered in very large doses: 50 to 100 mg a day and is used mainly when running the process with metastatic breast cancer and ovarian cancer. The above-mentioned means being a derivative of testosterone, have a more or less pronounced androgenic effects on the female body, resulting in long-term use in high doses have serious side effects i.e. Romo the liver, renal, cardiac activity, gipercalziemicescoy syndrome and another complication, the most difficult migrated woman: to the phenomena of virilization, to a sharp increase libido.

The aim of the invention is an antitumor agent that provides high antibioticsbuy effect when the effect on cancer tumors with absence of adverse toxic effects, and with a simultaneous improvement of antitumor resistance of the whole organism.

This goal is achieved by the fact that 1) an antitumor agent used in the impact on hormonetestosterone tumors containing methyltestosterone, while further comprises L-valine in the following ratio of components:

methyltestosterone 0,01

L-valine 1,0

2) an antitumor agent used in the impact on cancer tumors that do not have harmonicoscillator, and containing L-valine, additionally contains methandrostenolone and ftivazid in the following ratio of components:

L-valine 1,0

methandrostenolone 0,01

ftivazid 0,1

For specific preclinical study properties represent antineoplastic agents, it was originally aprobirovany gland of rats the proposed tool consists of daily oral input mechanical mixture 500 550 mg of synthetic amino acids L-valine and small non-therapeutic dose 5 to 10 mg of methyltestosterone on 1 kg of weight of the animal; when the loss of harmonicoscillator the long growing tumors breast cancer in rats, a new antitumor agent consists of a mechanical mixture 500 550 mg L-valine, 20 25 mg anabolic hormone methandrostenolone and 45 to 50 mg ftivazide on 1 kg of weight of animal per day.

The boundary values of components of the mixture due to the degree of activity of all anti-cancer drugs. As shown by experimental studies, the optimal dose L-valine is 550 mg/kg, the reduction of which up to 500 mg/kg effects of the mixture does not affect, and further increase the dose of, for example,twice. Dose reduction L-valine below 500 mg/kg worsens antibioticsbuy effect of the mixture, and the dose is 2 times smaller than the optimal, i.e. 275 mg/kg effect regression disappears completely. Non-therapeutic dose of methyltestosterone 5 mg per 1 kg of weight of the animal in combination with L-valine gives optimal antibioticsbuy effect when the amount of induced cancer from 4.0 cm3to 6.0 cm3with still very high harmonicoscillator. With further growth of tumors harmonicoscillator is reduced and thus the volume above 6.0 cm3(up to 8,0 10,0 cm3

When exposed in the experiment on long growing similar tumor volume in 10 cm3and above that lost partially or completely their ontogenetically, is optimal mechanical mixture L-valine with another very weak androgen-methandrostenolone dose of 20 to 25 mg/kg weight of the animal. The reduction in 2 times (12.5 mg/kg) causes mixed with L-valine instead of regression slight inhibition of growth of these tumors, and the increase of the results no effect.

However, the regression academentia cancerous tumors in rats when exposed to a mixture L-valine with one methandrostenolone is very slow so within 30 days of the experiment, all tumors regressed only 30 of 71% of its original volume and average only 52% Ftivazid able to significantly increase the conductivity L-valine-methandrostenolone cells long growing solid tumors breast cancer in rats. The optimal dose ftivazide found empiricle even to intensify.

When all the effects of a new antitumor agents need a diet rich in protein and low in fat.

Thus, the data antitumor agent has antibioticsthe action only through close collaboration of the 2 components of a mechanical mixture of: amino acids L-valine, able cialisyou to act only on individual cancerous mammalian cells in vitro, and androgen able in a small non-therapeutic dose to act as the conductor of this acid in cells dense cancer mammals.

Suggested by the author antitumor agent is significantly different from the prototype and high efficiency antibioticheskih steps in the experiment:

1) if the animal has multiple tumors in the first place or simultaneously with the "incremental" undergo resorption General, under controlled size (4 cm3);

2) termination of the regression, remission and subsequent irreversible tumor growth during the treatment period, funds not see;

3) after complete resorption of tumor recurrence, their growth not see;

4) if you reuse n is th antineoplastic effect causes regression depending on the degree of harmonicoscillator tumors and dose of methyltestosterone: at the dose of 5 mg/kg percentage of the overall regression 82% 89% of all tumors (10% of the tumors did not regress) i.e. 2 1 the full regression (disappearance of tumors) in 65% of tumors (11 tumors from 17) and partial regression (53% to 85% of the initial tumor volume) in 21% of tumors, i.e., 4 tumors from 17 (see tab. 1); when the dose of methyltestosterone 10 mg/kg total regression in 100% of tumors, i.e., regressing all about 80% complete regression at 20% and 80% tumor regression reaches 30 days of experiment 61 93% of the initial volume of tumors because tumors larger regressing slower;

6) the proposed tool, unlike the prototype, has antitumor antibioticsthe action and long growing cancer, partially or completely lost their ontogenetically, which are an experimental model of the running of cancer in the clinic. When mixed with L-valine antitumor agent contains previously never used as anticancer agents: anabolic methandrostenolone and is known as anti-tuberculosis drug, ftivazid. In this part of the antitumor agent, acting antiblastic large total (2 3) and on a huge single experimental tumors (up to 24.0 cm3), causing their regression, accompanied by frequent necrosis. the group of healthy tissue (see table. 2).

Antitumor agent in contrast to the prototype and from other known drugs, capable along with absorbing effects on rice tumor to raise defenses, i.e., antitumor resistance of the organism of ofwholesale, as indicated by: a) stimulation of hematopoiesis, leading to its normalization during the regression of the tumors(see table. 3); b) a significant increase in the weight of the animal, the accompanying effect regression (see table. 4); C) a significant increase (2 to 3 times the life expectancy of animals in cases of minor antitumor effect.

Unlike other drugs, the proposed tool has the property during the process of regression of tumors to provide an analgesic effect, which was traced in the experiment as a significant increase in pain threshold of excitability and, consequently, reduced pain sensitivity in animals. If no effect regression analgesic action stops that can be used in the clinic when evaluating the effect of treatment (see Fig 1 8).

Morphological changes that occur in tumor tissue and causing its regression, also have their sh is expressed by fiberizing, while under the influence of the tool changes, caused mainly by the lysis of cells of the parenchyma and streamy tumor tissue, necroticism with subsequent resorption.

Given the complete harmlessness of a new antitumor agents, proven on healthy animals, and, based on the above experimental data, and found when the doses were calculated daily dose, we offer tools for clinical use in the treatment of patients volunteers. Mainly incurable volunteer patients in the clinic received data which distinguish the new cure all known drugs.

On direct, not related to previous treatment, antitumor activity of a new agent containing L-valine combined with a small non-therapeutic dose of methyltestosterone, said data cytological studies of aspirates obtained from the weave of the uterus in 9 women volunteers from ll stage III adenocarcinoma of the uterine body. The use of this equipment, they had the first stage of treatment within 1 month during preoperative preparation. All patients this treatment was accompanied by a significant decrease is tah, taken after various periods of treatment with a new tool: 10 days (g) week (b),4 weeks (C) was found degenerative changes in the cells of the adenocarcinoma with significant vacuolization of the cytoplasm, nuclei,"shadenet" outlines of nuclei lysis of individual nuclei and marked vacuolar degeneration (Fig.9).

In advanced cases when the full recognition of incurability patient using the new tools in the form of L-valine with methyltestosterone or methandrostenolone and ftivazidom leads to a significant extension of life of the patient with a satisfactory subjective state,and in some cases with antibioticskin action resorption tumors.

The impact of new anti-cancer drugs within the first 7 to 10 days completely relieves pain even in those cases where strong drugs help only for a limited time, for example, in advanced cases with metastases in bones, etc.

The impact of the new tool in the treatment process is not accompanied by any toxic effects: hemodynamic, technote, vomiting.

During treatment, a new tool, even in incurable patients rises antitumor increasing efficiency.

A significant advantage of this new anti-cancer drugs is the possibility of its successful use in the outpatient setting, which distinguishes a new tool from the majority of known drugs with severe side effects and therefore require a stationary conditions of use.

Side effects.

Due to the harmlessness of a new tool for significant complications are absent. Long-term (up to 2 months) taking methyltestosterone in small doses can give weak manifestations of virilization, which quickly disappear after cessation of the administration of methyltestosterone.

Excessive introduction of new drugs and non-compliance protein diet may cause slight nausea, reduced appetite, weight loss. This signs amino acid imbalance, which disappear after reduction of the daily dose L-valine and subject protein diet.

Contraindications.

1. Prior to androgenetica reduces the sensitivity of tumor tissue to androgens because of the used high doses. In this case, a small dose of methyltestosterone on the first treatment may not realize its effect provodnitsa use in this case L-valine according to the second scheme (methandrostenolone and ftivazidom).

2. The presence of metastases in the lungs, as well as the rapid regression of tumors can lead to defects in the walls of large blood vessels, causing life-threatening patient bleeding.

3. Various forms of stress on the patient's body and mechanical damage prior to treatment: recent surgery, burns, fractures, etc. that is associated with the property in the body preferential transport of amino acids (and L-valine) in healing to damaged tissues (but not to tumor tissue).

Therefore, the use of new anti-cancer agents is possible only after complete healing of the tissue (after 20 to 25 days after surgery) and the cessation of stress (with a temporary replacing it with a traditional chemotherapy). Blood transfusions (especially multiple) also affects the metabolic processes in the body, the impact is close to the stress. Therefore, the introduction of the new tools you need for this is a short (few days) time to stop.

4. Should be avoided during treatment with diuretics affecting salt metabolism in the body.

5. Should not be used during treatment with a new tool gradprogram, phytotherapy means of stimulating hematopoiesis and cardiac function.

The invention is illustrated by the following specific examples of the properties of this anti-cancer drugs.

1) Patient Melnikov, A. 75 years of history N 12763/A. Trial laparotomy was 31. 05. 77, Department of gynecology Rostov research Institute of Oncology health Ministry. On histogenesis 104847 -848 was taken metastasis of the greater omentum, conclusion: Telesistemy ovarian cancer.

Clinical diagnosis: ovarian r, St IV with invasive tumor growth and germination in the intestine, with metastasis to the omentum and liver, with accumulation of ascites in the abdominal cavity.

In the postoperative period was held chemotherapy (V/m Thio-TEF), which resulted in the ascites did not accumulate, but tumor growth was continued. In July, the patient was considered incurable and was discharged from hospital on symptomatic treatment.

Since the end of July 1977 as a volunteer, weight 54 kg, this patient started treatment new antitumor agent in the form of a mixture L-valine combined with methyltestosterone with strict adherence protein diet and split the daily dose L-valine 4 times a day, prinimaites after taking L-valine. The course of treatment for 2 months.

During this time, completely stopped the pain in the abdomen and the liver returned to normal function of the gastrointestinal tract, have a good appetite, gained 4.5 kg, restored power and performance. The tumor did not even royalty.

Thanks to this status, a month later he was again admitted to the 2nd course of chemotherapy (V/m Thio-TEF), the total dose 200 mg. Gynecological examinations tumors did not reveal.

In 1978, in March and in July oseltamivir was conducted 2 more course Thio-Tepa that caused severe intoxication and persistent leukopenia.

In August 1978, was held the 2nd course in 1 month, offer antitumor agent in the same plan. The blood was normal. Gynecological examination of the tumors did not reveal. Feeling good, gained weight, subsequent gynecological examination has revealed nothing.

In 1979, the end of April held may 5th preventive course (V/m Thio-TEF),satisfactorily.

In June 1979 conducted a 2-month course of the third preventive course of treatment with a new antitumor agent, but in another daily dose due to C is Aki virilization, which the patient was very distressed, because of the manifestation of libido at her age, in connection with which the patient refused further preventive receive new funds. So for 2 years (1977 to 79 years.) it took 3 courses of treatment with a new antitumor agent: 1 to treatment 2 with the preventive purpose.

In late 1979 in the spring and in the autumn of 1980 was held on 3 more preventive chemotherapy with cyclophosphamide. The patient endured difficult.

In February and March 1981, the patient underwent a 2 stroke.

From the second stroke, the patient died without any signs of tumor that was installed on gynecological examination in the month before death. From the opening relatives refused.

Conclusion. Extending the active life of the patient 4 years after the recognition of the full incurability its state cannot be attributed solely due to the success of eight courses of traditional cancer chemotherapy. This antitumor agent not only corrected the toxic side effects of chemotherapy, but also clearly contributed to the initial antibiotics.com effect, and also of his fixation. Carrying a large number of courses are highly toxic chemotherapy, nabor is Alina in a mixture with non-therapeutic dose of methyltestosterone, originally tested on ZZ-x patients with malignant tumors of the genitalia (volunteers), III lV stages of the disease and histological confirmation of cancer with the following localization of the tumor process: a malignant tumor of the ovary 9 people, a malignant tumor of uterine body 21 people, cancer of the fallopian tube - 1 man, cervical cancer 2 people.

By the time the new treatment remedy they were subjected to conventional treatment without any effect, having a large fixed tumor conglomerates in the pelvis or effusions in serous cavities. Part of them had recurrence of the disease after conducting an inefficient combination or the combined treatment.

Most of the patients from the 2-month course of treatment with a new tool were (tumor was resolved or satisfactory effect. They were applicable and were radically operated. No effect was observed only in 5 patients. Four of these tumors were clearly pharmaecuticals: cervical cancer, cancer of the pipe, sarcoma of the uterine body and 5-the patient has undergone rapid generalization process.

The proposed tool was tested on 5 incura vypisannyh from the hospital for symptomatic treatment in very serious condition after the effective conduct of radiation and 10 of the 12 courses of chemotherapy.

In one of these cases due to long-term inpatient treatment defeat metastases in the bones of the skull, pelvis, ribs led to predeterminately the situation of the patient and the stretcher was brought from the hospital. Severe pain in the entire skeleton, which is only 1.5 to 2 hours were stopped injected, began to subside with C-day treatment with a new tool (L-valine with methyltestosterone) and completely disappeared after 2 weeks. As a result, after a month the pain Naya began to rise and gradually included in the active life. Every 2 months had x-rays of the affected areas of the skeleton. In the bones of the skull and pelvis were observed phenomena beginning reparation of bone tissue. With small breaks in 1 to 1.5 weeks the patient has been treated with a new antitumor agent in the outpatient setting for 8 months until he died of thromboembolism as a result of prolonged uncontrolled intake of calcium chloride within three months. All this time the patient had an active life in the house or outside it.

In other cases, the treatment of these patients with a mixture L-valine methandrostenolone and ftivazide led to the temporary but well-marked subjective improvement, which finally Ionene treatment in the Department of chemohormonal.

Evidence of the positive properties of the proposed new anti-cancer drugs are presented in tables 1 to 4 in the charts in Fig. 1 9.

The effectiveness of the proposed new anti-cancer drugs is its high antibiotics.com the effect that is manifested even in advanced cases of tumoral process. A new tool has no adverse toxic effects on the entire body, along with antitumor effects, increasing its resistance as the normalization of disorders, weight gain, increase appetite and health, as well as significantly extend the life of incurable patients. Tool in the process of effective anticancer effects has a strong analgesic effect, which eliminates the need for hospital use drugs and can serve as an indicator for assessing the effectiveness of the treatment. The absence of side effects and ease of oral administration can be used in the outpatient setting.

1. M. D. Mashkovsky. Medicinal product. M. 1986, T. 1, p.602.

2. 2603898, A 61 K 31/70, 1983. TTT TTT TTT TTT 2 4

1. Antitumor agent, the attachment components: methyltestosterone L-valine 0.01 to 1.0 second.

2. Antitumor agent containing amino acid, characterized in that it additionally contains methandrostenolone and ftivazid, as well as amino acids - L-valine in the following ratio of components: L-valine: methandrostenolone:ftivazid 1,0:0,01:0,1.

 

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