RU2294224C2 - Method for photodynamic therapy of malignant neoplasms - Google Patents

Abstract

FIELD: medicine, oncology, ophthalmooncology.

SUBSTANCE: the present innovation deals with treating malignant neoplasms of skin and mucosa and, also, intraocular neoplasms. It is necessary to introduce a preparation followed by laser irradiation of a neoplasm. As a preparation one should perform the intake of porphyrin derivative of plant origin perorally to an empty stomach at the dosage of 10.0 mg/kg, and in 3-4 h it is important to carry out laser irradiation of the neoplasm at wave length being correspondent to absorption of light radiation with porphyrin derivative, at the dosage of 300-900 J/sq. cm. The innovation enables to achieve complete or partial tumoral regression, exclude invasive technique for preparation introduction, the onset of allergic reactions and the risk for being infected with viral diseases, increase survival rate and life duration in patients.

EFFECT: higher efficiency of therapy.

1 cl, 3 ex, 1 tbl

Description

The invention relates to medicine and can be used in oncology for the treatment of malignant neoplasms of the skin and mucous membrane, as well as in ophthalmic oncology for the treatment of intraocular neoplasms.

A known method of photodynamic therapy of malignant neoplasms (RF patent 2161053), including the introduction of the drug and laser irradiation of the neoplasm. The disadvantages of this method are: vascular injury with intravenous administration of the drug, the risk of contracting viral diseases (AIDS, syphilis, hepatitis), allergic reactions, and therefore, the inability to conduct repeated courses to achieve the desired therapeutic result, the high cost of the drug.

The objective of the invention is to provide an effective, safe and affordable method of photodynamic therapy of malignant neoplasms.

The technical result is the complete or partial regression of the tumor, the exclusion of the invasive route of administration of the drug, the absence of allergic reactions and the risk of infection with viral diseases, the possibility of repeated repetition of treatment courses, the affordable cost of treatment, increased survival and increased life expectancy of patients.

The technical result is achieved by the fact that in the method of photodynamic therapy of malignant neoplasms, including the introduction of the drug and laser irradiation of the neoplasm, according to the invention, the drug of plant origin is taken orally on an empty stomach at a dose of 10.0 mg / kg, and after 3-4 hours, a laser irradiation of the neoplasm with a wavelength corresponding to the maximum absorption by the porphyrin derivative of light radiation at a dose of 300-900 J / cm ² .

The technical result is achieved due to the fact that:

1. The drug is taken orally;

2. Used derivatives of porphyrin of plant origin are biologically active additives, do not cause allergic reactions, affordable;

3. A derivative of porphyrin of plant origin accumulates in the tumor cells, and when the substances contained in it interact with light quanta, radical structures such as singlet oxygen are formed, which causes the oxidation of the tumor cells, the destruction of their membrane and the membrane of the cells of blood vessels supplying the tumor, which leads to inhibition of the development of a cancerous tumor;

4. Used doses of the drug and laser irradiation are necessary and sufficient for the implementation of the photoinduced photochemical reaction to obtain the therapeutic effect necessary to achieve the specified technical result.

The claimed technical result can be obtained only by using the totality of the techniques proposed by us method.

The method is as follows.

On an empty stomach, the patient is given an orally derived porphyrin derivative of plant origin, for example, pheophytin, or pheophorbide, or methylpheophorbide, at a dose of 10.0 mg / kg, after 3-4 hours, laser irradiation with a wavelength corresponding to the maximum absorption of the porphyrin derivative of light radiation, for example , with a wavelength of 661 nm when using pheophytin, or pheophorbide, or methylpheophorbide, at a dose of 300-900 J / cm ² .

When choosing a dose of laser radiation should be guided by the fact that a dose of less than 300 J / cm ^{2 is} not effective; at doses of more than 900 J / cm ² damage to surrounding healthy tissues occurs, burns; in the treatment of tumors with a height of 1-1.5 mm, doses from 300 J / cm ^{2 are used} ; in the treatment of tumors with a height of 2-3 mm - up to 600 J / cm ² ; in the treatment of tumors up to 5 mm high - up to 900 J / cm ² .

The invention is illustrated by the following data from experimental studies conducted on mice (table 1), and clinical examples 1, 2.

Example 1. Patient S., 56 years old. Diagnosis: basal cell carcinoma of the skin of the right cheek of the I-II stage.

The patient is treated according to the proposed method.

On an empty stomach, pheophytin was taken orally at a dose of 10.0 mg / kg, laser irradiation was performed after 4 hours with a wavelength of 661 nm at a dose of 900 J / cm. During the follow-up examination after 1 month, the tumor disappeared, no allergic reaction was noted.

The cost of treatment according to the proposed method was 2 times less than the cost of traditional PDT with intravenous administration of FS. In the observation period of up to 1 year, the patient remained alive. Repeated courses of treatment were not required.

Example 2. Patient N., 60 years old. Diagnosis: basal cell carcinoma of the lower lip of stage II.

The patient is treated according to the proposed method. On an empty stomach, methylpheophorbide was taken orally at a dose of 10.0 mg / kg, laser irradiation was performed after 3 hours with a wavelength of 661 nm at a dose of 600 J / cm ² . During the follow-up examination after 1 month, the tumor disappeared, no allergic reaction was noted.

The cost of treatment according to the proposed method was 2 times less than the cost of traditional PDT with intravenous administration of FS. In the observation period of up to 1 year, the patient remained alive. Repeated courses of treatment were not required.

Example 3. Patient L., 63 years old. Diagnosis at admission: melanoma of the choroid (MX) of the right eye.

Visual acuity in the affected eye upon admission was 0.1 n / k. The diagnosis of MX was verified ophthalmoscopically, angiographically and according to ultrasound B-scan. The neoplasm was located in the paracentral region of the fundus. The size of the neoplasm, according to the ultrasound B-scan, was: base diameter - 5 mm, height of the prominence - 2.5 mm.

The patient was treated according to the proposed method. On an empty stomach, pheoforbide was taken orally at a dose of 10.0 mg / kg, laser irradiation was performed after 3 hours with a wavelength of 661 nm at a dose of 400 J / cm ² .

In the control ultrasound B-scan in the distant period, a significant regression of the neoplasm was noted, with a decrease in the tumor prominence - up to 2.0 mm by 3 months and up to 1.0 mm - by 6 months after treatment. During the observation period (up to 2 years), positive dynamics was noted in the form of further flattening of the scar. No signs of recurrence of the neoplasm and metastasis were detected.

The cost of treatment according to the proposed method was 2 times less than the cost of traditional PDT with intravenous administration of FS.

Thus, the claimed method allows to achieve complete or partial regression of the tumor, eliminates the invasive method of drug administration, allergic reactions, affordable, increases survival and increases the life expectancy of patients.

Claims (2)

1. A method for the photodynamic therapy of malignant neoplasms, comprising administering the drug and laser irradiation of the neoplasm, characterized in that the preparation of porphyrin of plant origin is taken orally at a dose of 10.0 mg / kg as an empty stomach and the laser irradiation is carried out after 3-4 hours with a length waves corresponding to the maximum absorption by the derivatives of the porphyrin of light radiation. 2. The method according to claim 1, characterized in that the dose of laser irradiation is 300-900 J / cm ² .