RU2445100C2 - Non-surgical method for integrated treatment of acute and chronic anal fissures - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely coloproctology, and is applicable for non-surgical integrated treatment of acute and chronic anal fissures. For this purpose, anaerobic and aerobic flora is analysed. Then rectal suppositories of the following formulation are prescribed in mg per 1 suppositorium: antibacterial preparation 200-400 mg, bismuth 80-160 mg, titanium dioxide 80-160 mg, lidocaine hydrochloride monohydrate 8-16 mg, base (solid fat) 1236-2472 mg. As an antibacterial preparation, metronidazole or gentamycin are used win relation to the presence of anaerobic or aerobic flora as shown by the analysis. The suppositories are prescribed twice a day in the morning and in the evening for 7-14 days. The rectal introduction of the gentamycin suppositories is added with the daily rectal introduction of metronidazole gel for 7-14 days. Additionally, all the patients take detralex or venarus 500 mg 1 tablet twice a day for 60 days, as well as meloxicam 7.5 mg once a day for 7 days and no-spa 40 mg 1 tablet 2-3 times a day or duspatalin 200 mg 1 capsule twice a day for 7 days.

EFFECT: invention enables the treatment, including in cases where the methods of treating known to the moment are contraindicated.

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Description

The invention relates to medicine, namely to its colorectal area, and can be widely used for the conservative complex treatment of acute and chronic anal fissures.

The frequency of occurrence of anal fissure, according to reversibility, is 20-23 cases per 1000 adult population, women of young and middle age are more often sick (G. Vorobyev, Basics of Coloproctology. Rostov-on-Don. Phoenix, 2001, 414 pp. ), more than a third of patients are of working age (Babaev OG, Skobelkin OK, Khodzhanepesov K. - Treatment of anal fissures with laser photo-coagulation. Surgery. 1990, No. 6, p.21-24).

Today, therapeutic tactics are traditional, which depend on the stage of the disease. In acute and subacute fissure, a complex of conservative measures is prescribed aimed at eliminating pain and sphincterospasm. Pain relief in this case is not an end in itself, but a treatment principle: the degree of spasm of the sphincter muscles decreases and there is a hope to heal the fissure of the anal canal. Treatment of a chronic crack is usually surgical (Zhukov BN, Shabaev VN, Isaev VR, Lysov NA, Coloproctology. Samara, Samara State Medical University, 1999, p. 132).

A known method of treating cracks in the anus, including the use of rectal suppositories "Proctosan", having the composition:

Bufexamak 250 mg Bismuth subgallate 100 mg Titanium dioxide 100 mg Lidocaine hydrochloride monohydrate 10 mg The basis 1540 mg

These rectal suppositories are used twice a day.

Rectal suppositories "Proctosan" have significant side effects: allergic reactions: burning, itching, redness of the skin of the perianal zone, swelling, the formation of scales, vesicles are possible.

A known composition of rectal suppositories containing: a medicinal substance and a base, while suppositories contain a medicinal substance of not more than 40% of the total mass of suppositories, as a base they contain an alloy of a thickener and such three components as hydrophilic substances, lipophilic substances and a complex with polyethylene glycol previously obtained by mixing with polyethylene glycol weighing 200-6000 Yes lipophilic or hydrophilic substances, and these three components are taken in the following ratio, wt.%:

Hydrophilic substances 0.1-49.0 Complex with polyethylene glycol 0.1-50.0 Lipophilic substances rest

and as a medicinal substance, suppositories contain metronidazole in an amount of 0.001-0.5 g per 1 g of suppository (see patent RU No. 2322968, M. cl. A61K 9/02, published on April 27, 2008).

The objective of the known invention is the creation of suppositories of wide medical use through the use of a universal base that provides bioavailability of fat and water-soluble substances at the same time and allows you to enter into the basis of both water and fat-soluble medicinal substances, solutions, as well as obtaining an aggregatively stable composition of suppositories, which improves quality and presentation.

As you can see, the known invention does not aim to increase the effectiveness of the treatment of the claimed disease - acute and chronic anal fissures.

In the known invention there is no information about the use and effectiveness of this drug in the treatment of anal fissures (acute and chronic).

In addition, the claimed composition of the base is multicomponent, which technologically complicates the preparation of suppositories.

There is a method of complex conservative treatment of anal fissure, selected as the closest analogue, consisting of several components:

- normalization of the digestive tract;

- removal of pain and spasm of the internal sphincter;

- increased regeneration of damaged tissues;

(see http://www.treamentabroad.ru/diseasesintestine/analfissurecomplextherapy)

The goal of treating an anal fissure is to eliminate the pain syndrome, restore normal bowel function, relieve spasm of the internal sphincter, improve microcirculation in the area of the anal fissure and hemorrhoid plexus. Since an anal fissure occurs as a result of a violation of the digestive tract, manifested by functional disorders or intestinal irritation syndrome, which occurs in more than half of patients, antispasmodics and prokinetics are used to regulate motility.

Non-steroidal anti-inflammatory drugs (NSAIDs) have an effective effect on pain.

In order to improve the regeneration of cracks, according to the authors of the known method, it is most advisable to use candles and ointments (Posterisan-Forte, posterisan) (see ibid.).

The composition of 1 suppository (2 g) of Posterisan-forte is an extract and components of the cell membrane of 1000 million E. coli (Escherichia coli) and 5 mg of hydrocortisone in 387.1 mg of an aqueous suspension. Phenol as a preservative.

However, the suppositories used in the known method are used mainly in acute cases. In the acute period of the disease, suppositories of 2-3 pcs / day are used in the morning and evening, and after each toilet, the anus should be oiled.

After the removal of the subjective symptoms of the disease, the introduction of 1 suppository 1 time per day for another 2-3 weeks is required.

In addition, since the Posterisan-forte suppositories and the Posterisan ointment contain extract and components of the cell membrane of the Escherichia coli (Escherichia coli), these drugs are problematic for the treatment of anal fissures, with anaerobic bacterial growth syndrome.

The drug also has side effects: a dermatological reaction characteristic of glucocorticoids, and an allergic reaction due to the presence of phenol.

Thus, the known method is not recommended for the treatment of patients with chronic forms of anal fissures, which indicates its inefficiency for this form of the disease. In addition, the use of drugs containing phenol and glucocorticoids for treatment does not ensure the safety of the treatment of this category of patients, and in addition, the suppositories recommended in the known method are problematic for the treatment of patients with anal fissures with anaerobic bacterial growth syndrome.

The technical result, the solution of which the claimed invention is directed, is to create a method intended for the effective treatment of both acute and chronic forms of anal fissures, expanding the category of patients who are not shown the currently known treatment methods.

The specified technical result is achieved by the fact that in the known method of complex conservative treatment of acute and chronic anal fissures, including the use of antispasmodics, non-steroidal anti-inflammatory drugs and rectal suppositories, according to the invention, additionally, the patient is inoculated for the presence of anaerobic or aerobic flora, and rectal suppositories are prescribed composition in mg per 1 suppository:

Antibacterial drug 200-400 mg Bismuth subgallate 80-160 mg Titanium dioxide 80-160 mg Lidocaine hydrochloride monohydrate 8-16 mg Base (hard fat) 1236-2472 mg

where, as an antibacterial drug, depending on the presence of anaerobic or aerobic flora in the patient’s crops, respectively, metronidazole or gentomycin are used, while rectal suppositories with gentomycin are administered, additionally daily for 7-14 days in the interval between the introduction of suppositories, administration of rectal gel with metronidazole; in addition, Detralex or Venarus 1 tablet 500 mg 2 times a day for 60 days is used as an anti-inflammatory drug for all patients of non-steroidal and antispasmodic drugs, respectively, are prescribed meloxicam at a dose of 7.5 mg once a day and no-shpu 1 tablet 40 mg 2-3 times a day or duspatalin 1 capsule 200 mg 2 times a day, suppositories are prescribed 2 times a day in the morning and in the evening, for 7-14 days, the course of treatment with non-steroidal anti-inflammatory and antispasmodic drugs is 7 days. The authors experimentally established that the use of

as medicinal substances in rectal suppositories of the claimed ingredients in the claimed amounts, and as anti-inflammatory non-steroidal and antispasmodic drugs, respectively, of meloxil and no-shpa or duspatalin in the claimed doses, additional use of detralex or venarus in the claimed doses for all patients, administration of rectal suppositories 2 times day, for 7-14 days, and the course of treatment with non-steroidal anti-inflammatory and antispasmodic drugs for 7 days, allowed and to achieve the creation of effective complex therapy of both acute and chronic anal fissures, significantly expand the category of patients who are not shown well-known treatment methods, in particular patients who are contraindicated in surgical treatment: these are women with perineal tears during childbirth, patients with rectocele, patients old age, patients refusing surgical treatment.

The technical result set before the invention is confirmed by the treatment results of the claimed method of numerous patients on the basis of the NIH of the Road Clinical Hospital (DKB) of Chelyabinsk.

The inventive method is as follows. Treatment by the claimed method is carried out on an outpatient basis. A patient who visits a proctologist at the clinic for complaints of severe pain during defecation lasting for about 2 hours, or a patient with a previously diagnosed chronic anal fissure is examined for the presence of aerobic or anaerobic flora in the crops. For this, the patient after anesthesia of the anal fissure with lidocaine (spray) is taken with anaerobic or aerobic flora. If there is anaerobic flora in the crops, the patient is prescribed the following course of treatment:

1. Diet.

2. Detralex 1 tablet 500 mg 2 times a day for 60 days.

3. Meloxicam 1 tablet 7.5 mg 1 time per day for 10 days.

4. No-spa: 1 tablet 40 mg 2-3 times a day for 7 days or duspatalin 1 capsule 200 mg 2 times a day.

5. Apply rectal suppositories composition:

Metronidazole 200-400 mg Bismuth subgallate 80-160 mg Titanium dioxide 80-160 mg Lidocaine hydrochloride monohydrate 8-16 mg Solid fat 1236-2472 mg

In the presence of aerobic flora in crops, rectal suppositories of the composition are used:

Gentomycin 200-400 mg Bismuth subgallate 80-160 mg Titanium dioxide 80-160 mg Lidocaine hydrochloride monohydrate 8-16 mg Solid fat 1236-2472 mg

Cocoa butter is used as solid fat.

In the case of the use of suppositories with gentomycin, additionally daily for 7-14 days in the interval between the introduction of suppositories, the rectal gel is administered with metronidazole in the form of turundas moistened with gel. Turundas moistened with gel cannot be pulled out all day. Rectal suppositories are administered 1 suppository 2 times a day in the morning (after bowel movement) and in the evening before bedtime.

Suppositories are prepared according to the prescription of a proctologist in pharmacies, in any known manner, one of which is described below.

The weighted base is heated. After the base is completely melted, it is mixed with a stirrer. Then, medicinal substances are introduced into the base, taking into account their physicochemical properties. Metronidazole and lidocoin hydrochloride hydrate are dissolved in water. The resulting concentrated solutions are filtered and added to the base. Titanium dioxide, bismuth subgallate is crushed, mixed with an equal amount of base, heated to 40-50 ° C. The resulting suspension-concentrate is cooled and ground several times to obtain the required degree of grinding, added to the base. The suppository mass is mixed for 45 minutes, analyzed, packaged in molds, and then cooled.

The method is confirmed by examples of specific performance.

Example No. 1. Patient B., 22 years old. I went to the clinic to a proctologist complaining of severe pain during bowel movements, persisting for 2 hours after it, traces of blood on a napkin. Considers herself ill for 1 month. On examination (lidocaine analgesia, spray): at 12 hours, an anal fissure measuring 1.0 × 0.5 × 0.1 cm. The mucous membrane is hyperemic, the vascular pattern is not visible.

Diagnosis: Acute anterior anal fissure. Chronic proctitis.

After anesthesia, the patient was taken inoculation on anaerobic or aerobic flora. Anaerobic flora has been identified.

Prescribed treatment:

1) Diet.

2) Detralex 1 tablet 500 mg 2 times a day 60 days 1 tablet in the middle of the day and 1 tablet in the evening with meals.

Meloxicam 1 tablet 7.5 mg 1 time per day for 14 days with meals, without chewing.

3) No-spa, 1 tablet 40 mg 2 times a day for 7 days.

4) Rectal suppository composition in mg per 1 suppository:

Metronidazole 200 mg Bismuth subgallate 160 mg Titanium dioxide 160 mg Lidocaine hydrochloride monohydrate 16 mg Cacao butter 1236 mg

for 14 days 2 times a day in the morning after stool and in the evening before going to bed.

When re-examined after 1 week: the pain decreased significantly, there was no trace of blood. On examination: a crack measuring 0.4 × 0.2 × 0.1 cm. Treatment continued.

At the next examination after 1 week, the bowel movement is painless. The crack was epithelized.

Example No. 2. Patient A., 52 years old. I went to the clinic to a proctologist with complaints of sharp pain during bowel movements, persisting for several hours after it. Sick for 10 days, when the sharp pain first appeared during stool, scarlet blood blots on a napkin. A similar episode was in this patient 3 years ago. On examination: at 6 hours, an anal fissure measuring 1.2 × 0.5 × 0.2 cm, no signal tubercles. The mucous membrane is hyperemic, the vascular pattern is not traced.

Diagnosis: Chronic posterior anal fissure. Chronic proctitis. Sowing on flora revealed the presence of aerobic flora.

Prescribed treatment:

1) Diet.

2) Venarus 1 tablet 500 mg 2 times a day 60 days at noon and in the evening with meals.

3) Duspatalin 1 tablet 200 mg 2 times a day for 14 days 20 minutes before meals in the morning and evening.

4) Meloxicam, 1 tablet of 7.5 mg 1 time per day for 7 days with meals, without chewing.

5) Rectal suppositories composition in mg per 1 suppository:

Gentomycin 400 mg Bismuth subgallate 80 mg Titanium dioxide 80 mg Lidocaine hydrochloride monohydrate 8 mg Cacao butter 2472 mg

Rectal suppositories are administered 2 times a day - in the morning (after stool) and in the evening before bedtime.

Additionally, in the period between the administration of rectal suppositories, the rectal gel is administered with metronidazole in the form of turundas moistened with gel. Turundas moistened with gel cannot be pulled out all day.

On examination after 1 week: according to the patient, the pain stopped 3 days after the start of treatment, there were no blots of blood on a napkin. On examination: a crack measuring 0.5 × 0.3 × 0.1 cm. Continue treatment.

At the next examination after 1 week, the crack was epithelized, at 6 o'clock a red scar was determined.

Example No. 3. Patient M., 35 years old. He went to the clinic to a proctologist with complaints of moderate pain during bowel movements, persisting for 30 minutes after it. Sick for 14 days, when the pain first appeared during a stool, blotches of red blood on a napkin, with subsequent acts of defecation the pain was less. On examination: at 6 hours, an anal fissure measuring 1.2 × 0.5 × 0.2 cm. The mucous membrane is hyperiminated, the vascular pattern is smoothed.

Diagnosis: Chronic posterior anal fissure. Chronic proctitis. Sowing revealed the presence of anaerobic flora.

Prescribed treatment:

1) Diet.

2) Detralex 1 tablet 500 mg 2 times a day 60 days 1 tablet in the middle of the day, 1 tablet in the evening with meals.

3) Meloxicam 1 tablet 7.5 mg 2 times a day for 7 days with meals, without chewing.

4) No-spa, 1 tablet 40 mg 2 times a day for 7 days.

5) Suppositories composition in mg per 1 suppository:

Metronidazole 350 mg Bismuth subgallate 90 mg Titanium dioxide 90 mg Lidocaine hydrochloride monohydrate 9 mg Cacao butter 2156 mg

On examination after 10 days: no complaints. On examination: the crack is epithelized, a red scar is determined.

Claims (1)

A method of complex conservative treatment of acute and chronic anal fissures, including the use of antispasmodics, non-steroidal anti-inflammatory drugs and rectal suppositories, characterized in that the patient is additionally sown for the presence of anaerobic or aerobic flora, suppositories are prescribed as rectal suppositories, mg per 1 suppository:
Antibacterial drug 200-400 Bismuth subgallate 80-160 Titanium dioxide 80-160 Lidocaine hydrochloride monohydrate 8-16 Base (hard fat) 1236-2472
where, as the antibacterial drug, depending on the presence of anaerobic or aerobic flora in the patient’s crops, respectively, metronidazole or gentamicin are used, while rectal suppositories with gentamicin are administered additionally daily for 7-14 days in the interval between the administration of suppositories with rectal gel with metronidazole, in addition to all patients, Detralex or Venarus are used, 1 tablet 500 mg 2 times a day for 60 days, as an anti-inflammatory flax non-steroidal and antispasmodic drugs are prescribed, respectively, meloxicam at a dose of 7.5 mg 1 time per day and nospa 1 tablet 40 mg 2-3 times a day or duspatalin 1 capsule 200 mg 2 times a day, suppositories are prescribed 2 times a day in the morning and in the evening, for 7-14 days, the course of treatment with non-steroidal anti-inflammatory and antispasmodic drugs is 7 days.