Method for treating gastric malt-lymphomas

FIELD: medicine, oncology.

SUBSTANCE: the present innovation deals with treating gastric Helicobacter pylori-associated MALT-lymphomas. For this purpose, one should perorally introduce "Vitaflor" preparation as a ferment at daily dosage being not less than 40 g for 4 wk to an empty stomach or in intervals between meals, and in case of no complete regress of lymphoma at monotherapy with "Vitaflor" it is necessary to conduct additional courses of chemotherapy. The method provides cytostatic impact directly upon the tumor and suppresses proliferation of tumoral cells in case of complete absence of chemotherapy-accompanying side effects.

EFFECT: higher efficiency of therapy.

3 cl, 4 ex

 

The invention relates to medicine, namely to Oncology, and can be used in the treatment associated with infection by microorganisms Helicobacter pylori (HP) is one of the variants of non-Hodgkin lymphoma - the so-called MALT lymphomas of the stomach.

MALT lymphoma (Mucosal-Associated Lymphoid Tissue Lymphoma or associated with the mucosa and lymphoid tissue lymphoma) is a malignant tumor from a group of non-Hodgkin lymphoma, other than slow, but with potency transition into a more aggressive form of diffuse type In-both lymphoma and therefore fatal. Despite the fact that MALT-lymphoma of the stomach is isolated tumor, rarely extending beyond the body, the clinic it is not very different from carcinoma of the stomach with the threat of bleeding in ulcer forms, anorexia, pain and other symptoms. It is important proven fact etiopathogenetic link MALT-lymphoma of the stomach with Helicobacter pylori infection detected in 72-98% of cases. It is believed that the hyperstimulation mucosal antigens Hp with the appearance of diffuse gastritis leads to the formation of MALT-lymphoma. (Arwin LI New international morphological classification of gastritis (Modified Sydney system)//Arch. pathology. - 1997. - N3. - P.3-7; Ivashkin V.T. "Helicobacter pylori: biological characteristics, pathogenesis, and prospects for eradication". Grew up with. Zhu is N. Gastroenterol. gepatol.,1997, Vol.7, No. 1, 21-23).

Evidence of the leading role of Hp in etiopatogenesis MALT-lymphoma of the stomach is its regression in 70-80% of patients under the influence of so-called Helicobacter eradication therapy derivatives nitrofurans (furazolidone), drugs for the treatment of protozoal infections (metronidazole), broad-spectrum antibiotics (clarithromycin, azithromycin, roxithromycin, amoxicillin, tetracycline), blockers histaminic H2receptors (ranitidine) or similar action with them medications that suppress the secretion, colloidal bismuth subcitrate (Grigoriev PA Medical standards effective diagnosis and rational treatment of diseases of the digestive system. - M., 1997. - P.8-9; Grigoriev PA, Yakovenko EP, Isakov V.A. Pathological effects of HP infection in humans and new in the treatment of peptic ulcer disease (based on European gastroenterology week 21-26 October; Kudryavtseva L.V. experience in the study of antibiotic-Russian strains of Helicobacter pylori//proceedings of the 7th session of the Russian group for the study of Helicobacter pylori. - Omsk, 1998. - Page 11-14).

MALT lymphomas of the stomach, thus, seems to be the only non-Hodgkin malignant lymphomas, the regression of which is possible in principle and without special anticancer treatment with cytostatics. However, eradication therapy all is not amenable to 20-30% of patients with MALT lymphoma of the stomach, which then shows a surgical intervention, radiation therapy (if feasible) or cytostatic therapy due to the risk of transition to an aggressive form of the disease.

Surgery, radiation therapy or chemotherapy cytotoxic drugs, forced to shows mentioned categories of patients and held still do the vast majority with MALT lymphoma of the stomach, inevitably leads to a significant number of complications.

In the case of surgery (Subtotal resection or removing with widespread process) there is a decrease in the volume of the stomach (the so-called "disease resected stomach")that leads to malabsorption of food, deficiency of vitamin B12and anemia, adhesive process, diarrhea, weight loss and other consequences.

Radiation therapy, bearing in principle local character (SOD about 3500 cGy on the stomach), however, is accompanied by nausea, vomiting, General weakness, diarrhea and the risk of bleeding or perforation in ulcerative forms of the disease. Although as a method of chemotherapy are often used sparing regimens alkylating agents of the type hlorambuzila (leukeran, hlorbutina), they are not everywhere will have the desired effect and require replacement on an intensive, including anthracyclines (CHOP, CHOEP) and thus soprovozhdayas the large number of known complications - leukopenia, thrombocytopenia, present, stomatitis, manifestations of dyspeptic syndrome and others Besides herself eradication of H. pylori therapy, including, usually, a combination of antibiotics and other antibacterial agents not indifferent to the body and is accompanied by the development of undesirable metabolicheskikh effects and, primarily, the development or worsening of symptoms of dysbiosis. Thus, the problem of adequate and effective treatment without consequences for patients with MALT lymphoma of the stomach cannot be considered solved, the development of new types of H. pylori therapy is of great importance and perspective.

The closest to the technical nature of the claimed method is a method of treatment of MALT lymphoma methods of eradication therapy with furazolidone, metronidazole, antibiotics and ranitidine. (Grigoriev PA Medical standards effective diagnosis and rational treatment of diseases of the digestive system. - M., 1997. - P.8-9).

The disadvantage of this method is that, when conducting eradication therapy, the resistance of Hp to metronidazole is observed in 30% of patients and to clarithromycin - 10% treated, which reduces the successful treatment of MALT lymphoma to 44-69%. In addition, even in the complete regression of MALT lymphoma of the stomach in the eradication of those who FIPA in 20% of patients relapse within the first six months of observation.

The task of the authors was to create a method of treatment of lymphoma, which can eliminate as the cause of the disease, and to ensure proper treatment of lymphoma.

This task is solved by the use of the drug on the basis of symbiotic strains of lactic acid bacteria "Picaflor", which, as it turned out, are able to suppress the activity and other functions Hp, as well as to prevent adhesion of Hp to the epithelial cells and their reproduction, to influence the severity of inflammation in the gastroduodenal mucosa. Also, apparently, the drug provided a direct cytostatic effect of lactobacilli on the tumor and inhibiting proliferation of tumor cells; enhancement of the cytotoxic actions of macrophages and CD8+ T cells; the induction of non-specific local inflammatory reactions and indirectly enhanced the immune response to the tumor.

The drug depending on the characteristics of the disease can be used as a therapeutic agent in treatment and monotherapy in patients with Hp-induced MALT lymphoma of the stomach as antihelicobacter funds, as well as drug that eliminates side effects when conducting chemotherapeutic courses indicated.

Treatment consists of taking the "Picaflor" daily, at least 40 g of yeast pre is Arata oral for at least 4 weeks. The use of smaller quantities of yeast and smaller deadlines reduces the effectiveness of treatment. The maximum number of accepted drug is determined on the basis of patient response to the drug. Typically, the drug take 1 tablespoon 3-10 times a day.

The drug is desirable to carry out on an empty stomach or between meals. With treatment it is advisable to be accompanied by monitoring of the stomach (Hp-test, CSF, CT scan and/or ultrasound examination of abdominal cavity organs and other studies in comparison with the original background). In the absence of positive dynamics treatment Vitafoam" complemented by the use of other traditional therapies, such as chemotherapy.

Preparation of the leaven of the drug is well-known scheme (Pat.№2169574, 2000; №2170023, 1997; Pat no.2160992, 1999; GR No. 14514, 2000).

For this purpose from the drug, produced in two dosage forms - in inflaton or sublingual tablets containing viable cells of acidophilic lactic acid bacteria, prepare primary ferment milk.

The contents of one vial or tablet dissolved in boiled and cooled to room temperature water. The resulting solution (suspension) pour 0.5 liters of boiled and cooled to 35-45°With milk. Fermented so the milk is poured into a thermos and OST is given for 10-12 hours. The primary ferment is a well-formed clot, resembling the consistency of sour cream. Leaven stored in a refrigerator at a temperature of +2-+8°With no more than 10 days.

Treatment Vitafoam" is used for patients with MALT lymphoma of the stomach, as well as for having tested positive for Hp after an unsuccessful eradication therapy, chemotherapy and/or radiation therapy. Side effects treatment Vitafoam" is.

Example 1. Held in the VCO of Oncology research Institute. You of the RF Ministry of health clinical studies to determine the effectiveness of the method was carried out on two groups of 12 patients with MALT lymphoma of the stomach. All the patients before treatment had positive tests for Helicobacter pylori.

In the first group of these patients (6) patients received standard eradication therapy with antibiotics, omeprazole, colloidal bismuth, metronidazole, and the second group of patients received only a "Picaflor" according to the described method of application.

As a result, in the control group regression of the tumor and only partially after three to four cycles of eradication by the described 4-component scheme was registered Protocol in a comprehensive clinical and laboratory examination in 4 people out of 6 (67%).

In the second group of patients with monotherapy vitafoam by the described methods is e complete regression of tumors was observed in all patients (100% efficiency) including when combined with ulcer disease forms with complete disappearance of the defect mucosa (gastric ulcers have a diameter of from 1 to 4 cm before treatment Vitafoam").

Specified efficiency "Vilaflor was observed after 2-4 months of starting treatment monitoring of patients through FGDs and staging of repeated tests on Hp. The causative agent of Hp in patients with regression of the tumor was not detected during the subsequent 6-month follow-up for such patients from the second group (monotherapy vitafoam), and in patients from the first group after 2 months of traditional therapy was again noted Hp.

The recurrence of Hp infection in the control group were detected in 3 patients out of 6 (50%), and in the group of patients receiving Vilaflor in 1 patient out of 6 (16.7 per cent). It should be noted that side effects from treatment courses of vitafoam not observed in the group of patients treated by standard traditional scheme of eradication of Hp, noted the development of dysbacteriosis and its associated symptoms in all 6 of the 6 observed patients (100%). All patients of both groups of patients were Protocol designed and implemented by clinicians.

Example 2. Ill Bo-VA SS (outpatient map No. 8844), 78 years with a diagnosis of MALT lymphoma, stenoziruyuschaya the lumen of the stomach, and stomach ulcers on the back wall with a diameter of 2.5 cm was received "Picaflor" in a dose of 40 ml / day for 8 weeks under the supervision of FGDs (fibrogastroduodenoscopy). After 6 weeks, the ulcer healed with the formation of 1.5 cm scar dynamic and gradual reg is the ECCA MALT-lymphoma. After 8 weeks showed complete regression of MALT lymphoma. Side effects of treatment were observed.

Example 3. Ill Cu-BA NN, 72 years (outpatient map No. 8963) has complained of heaviness and pain in the epigastric region, intermittent nausea and vomiting after eating. Data fibrogastroduodenoscopy (FGDs) 29.11.2002, found in the lower third of the stomach on the front wall infiltration with a diameter of 5 cm After histological examination of biopsy specimens and positive urease test was diagnosed with MALT lymphoma of the stomach.

Appointed: "Picaflor" oral monotherapy at a daily dose of 150 g (fermented milk) 8-10 times a day before meals, during the month.

Control EGD established regression of MALT lymphoma in the lower third of the stomach on the front wall up to 1×3 cm with a significant improvement of health and condition.

After the second course of therapy "Vitafoam on the results of FGDs noted the stabilization process.

Example 4. Patient Niva O.N., 49 years (outpatient map No. 4740). The diagnosis of MALT lymphoma high grade with metastatic ring Waldeyer. Was observed and treated with courses of cancer chemotherapy drugs in the course of two years.

According to FGDs, dated 23.04.2003, in the lower third of the body of the stomach on the posterior wall of the ulcer with a diameter of 4 cm, on the front wall 3.5 cm After four-month course of treatment "Vitafoam daily dose of 120 g noted in the FGDs, the reduction of the ulcer on the anterior wall of the stomach up to 1 cm, and on the back wall up to 3 cm in diameter.

After applying complex therapy completely regressed enlarged cervical lymph nodes and tumor formation in the field Baldeyrou rings. On the background of the application "Picaflor" noted the complete absence of concomitant chemotherapy side.

1. Method for the treatment of MALT lymphoma of the stomach, associated with Helicobacter pylori, including the introduction of the drug "Picaflor" orally at a daily dose of at least 40 g for 4 weeks.

2. The method according to claim 1, characterized in that Vilaflor" is used in the form of leaven.

3. The method according to claim 1, characterized in that, in the absence of complete regression of lymphoma in monotherapy "Vitafoam advanced courses of chemotherapy.

4. The method according to claim 1, characterized in that Vilaflor use on an empty stomach or in between meals.



 

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