RU2361595C1 - Method of treatment of complicated urogenital clamidiosis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: way concerns medicine, namely to urology, and concerns treatment of the complicated clamidiosis of a urogenital tract of women and men. For this purpose azithromycin is entered slowly intravenously driply in a dose of 500 mg during 2-2.5 h. Introduction of azithromycin is performed on 1, 7 and 14 days of treatment. The way provides high therapeutic efficiency and prevention of relapses of disease at use of azithromycin in small doses, and also allows avoiding complications from a GI tract.

EFFECT: provision of high therapeutic efficiency and the prevention of relapses of disease at use of azithromycin in small doses, and also reception of possibility to avoid complications from a GI tract.

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Description

The invention relates to medicine, namely to dermatovenerology, and can be used for the treatment of chlamydial infections of the urogenital tract.

Inflammatory diseases of the pelvic organs (PID) are characterized by ascending infection of the urogenital tract by various pathogens. Urogenital chlamydia is one of the most commonly reported sexually transmitted infections. According to far from complete data, more than 90 million cases of this disease are registered annually in the world. According to CDC estimates, in the United States 2.8 million people fall ill each year [1]. In the Russian Federation, registration of urogenital chlamydial infection began in 1993. Between 1993 and 2003, the incidence of urogenital chlamydia increased by more than 3 times (54813 and 166111 cases, respectively), and in 2004 and 2005 amounted to 102.0 and 95.9 cases per 100,000 population. The incidence of urogenital chlamydial infection in the Sverdlovsk region in 2005-2006 was 173.0 and 157.3 cases per 100,000 population, respectively. However, these figures reflect the incomplete registration of the disease rather than the actual incidence in the country. The number of unrecognized cases of chlamydial infection, which is associated with a low-symptom course, remains high [2]. Chlamydial infection is detected in 25-50% of patients with PID and in 34% of men with epididymitis [3, 4]. According to our data, chlamydial infection of the urogenital tract was diagnosed in 69.8% of women and 77.7% of men [5, 6].

The results of clinical studies by both foreign and domestic authors for the treatment of urogenital chlamydial infection have shown high efficacy of azithromycin and doxycycline [7, 8, 9, 10].

Moreover, azithromycin is preferable to doxycycline, because It has fewer side effects, has high compliance and can be used in pediatric practice and in pregnant women. It has a pronounced bactericidal activity against a wide range of PID pathogens and accumulates in high therapeutic concentrations in the focus of infection. Without creating high concentrations in the blood, azithromycin due to its high lipophilicity is well distributed in the body, penetrating into many organs, tissues and environments. It accumulates in them in very high concentrations (tens to hundreds of times higher than serum levels) and is retained for a long time. The volume of distribution of the antibiotic is approximately 31 l / kg [11].

It is known to use azithromycin (Sumamed) for internal infusion in the treatment of inflammatory diseases of the pelvic organs, administered intravenously 1 time per day for 2 days, then 500 mg orally for 5 days in combination with metronidozole, 500 mg intravenously 2 times per day for 2 days, then 500 mg orally 2 times a day for 12 days [12].

Azithromycin in the form of step therapy and in combination with metronidazole shows high clinical and bacteriological effectiveness, however, with this method, the patient takes a generally high dose of the drug and for a long time.

The closest is the use of azithromycin (Sumamed) for the treatment of chlamydial infection in gynecological practice. In the presence of chronic chlamydia, the course of treatment included taking 1.0 g (2 tablets of 500 mg) of azithromycin orally for 1-7-14 days of treatment or 500 mg (1 table) of the drug 1 time per day for 3 days three times with an interval 5 days [13] - prototype.

The high effectiveness of azithromycin in combination with safety ensures the effectiveness of the treatment of fresh uncomplicated chlamydia, regardless of the regimen, however, this method is not very effective for the treatment of complicated urogenital chlamydia and is quite long.

The objective of the invention is to increase efficiency and reduce the treatment time for complicated urogenital chlamydia.

The technical result is achieved by the fact that in the treatment of complicated urogenital chlamydia, azithromycin is administered at a dose of 500 mg slowly intravenously drip for 2-2.5 hours in 1-7-14 days of treatment.

The invention consists in the effective use of techniques and drugs that positively affect the patient.

Slow intravenous drip of azithromycin (Sumamed) for 2-2.5 hours allows you to create avoidance of undesirable effects from the gastrointestinal tract, quickly relieve pain and prevent the development of emergency conditions and surgical interventions.

From the analysis of scientific, technical and patent literature of the claimed combination of features that provide high treatment efficiency and the absence of side effects while reducing the total dosage of the drug for the treatment of the urogenital tract, it is not revealed, which allows us to conclude that the claimed technical solution meets the criteria of "novelty" and "inventive level".

The method is as follows.

Before treatment, patients were examined for other sexually transmitted infections and, if necessary, their rehabilitation in accordance with existing schemes and recommendations.

Example 1. (extract from an outpatient card). Patient B., 31 years old, came to the reception on 02.20.06 with complaints of pain in the lower abdomen of a “aching” nature, copious mucous discharge from the vagina. The patient considers himself since March 2005, when pain first appeared. Previously, the patient was prescribed treatment with antibacterial drugs of the tetracycline group (unidox-solutab). After the treatment, the pain disappeared, but in August 2005 appeared again. In November 2005, vaginal discharge appeared. During the examination, the patient revealed chlamydia by PCR and ELISA (antibodies of class G (Ig G) to the protein antigens of C.trachomatis were detected).

The menstrual cycle is regular, 28-30 days, last menstruation 02/11/07. Sexual life from 18 years old, married, denies casual sexual intercourse. Pregnancy - 1, childbirth - 1. Contraception - a condom. Genital status: external genitalia are formed correctly, female-type hair, no symptoms of peritoneal irritation, inguinal lymph nodes up to 0.5 cm, painless, mobile, elastic. The mucous vulva is pink. The cervix is cylindrical, the mucous membrane is not changed, the pharynx is punctate. From the cervical canal and in the posterior arch, abundant mucous discharge. The body of the uterus is located symmetrically, not enlarged, moderately painful on palpation. Ultrasound scan of OMT revealed signs of an inflammatory process: salpingoophoritis and endometritis. Diagnosed with chlamydial infection of the upper parts of the urogenital tract.

The drug "Sumamed" was administered slowly for 2 hours drip intravenously 1 time per day at 500 mg on the 1st, 7th and 14th days of treatment. Pain on palpation of the pelvic organs disappeared after 48 hours. A follow-up examination 4 and 8 weeks after the end of chlamydia therapy by PCR and culture were not detected on McSow cells, the titers of class G antibodies (Ig G) to C.frachomatis protein antigens decreased by half.

Example 2. Patient B., 37 years old. He came to the reception on July 24, 2006 complaining of moderate mucous discharge from the urethra, aggravated after hypothermia and alcohol consumption. Considers herself ill since January 2006. Previously received antibiotic treatment for chlamydial infection (the name of the drug does not remember). During the examination, chlamydia was detected by PCR and culture on McCow cells.

Genital Status: The external genitalia are formed correctly.

Male type hair.

The head freely leaves under prepuce. The skin of the glans penis is pale pink.

Scanty mucus discharged from the urethra. Inguinal lymph nodes - up to 0.6 cm. Painless, mobile, elastic. The skin of the scrotum is not changed. The prostate gland is normal in size, moderately painful on palpation. Ultrasound of the prostate gland: signs of parenchymal prostatitis.

The drug "Sumamed" was administered slowly for 2.5 hours, drip intravenously 1 time per day, 500 mg on the 1st, 7th and 14th days of treatment.

During the follow-up examination 4 and 8 weeks after the end of chlamydia therapy by PCR and culture, no McCow cells were detected on the McCow cells, the titers of class G antibodies (Ig G) against C. trachomatis protein antigens decreased by half.

To confirm the effectiveness of the treatment method, clinical and laboratory monitoring was conducted of 34 patients (17 men and 17 women) aged 17-51 years, who applied for admission to the outpatient department of the Federal State Medical University UrNIIDViI Rosmedtehnologii, who received parenteral therapy with azithromycin (SUMAMED, Pliva, Croatia ) The drug was administered intravenously in a dose of 500 mg per infusion on the 1st, 7th and 14th days of therapy. Azithromycin was administered strictly intravenously, in the form of an infusion solution, preparing a solution of the drug immediately before administration. Regardless of the concentration of the drug in solution (2 mg / ml per 250 ml of solvent or 1 mg / ml per 500 ml), the infusion duration was 2-2.5 hours.

One of the most significant criteria for the effectiveness of therapy was the most rapid relief of subjective sensations: the disappearance of pain and pathological discharge from the urogenital tract. Against the background of the therapy, 12 out of 14 patients of the first group who previously had complaints of pain in the lower abdomen, after 24 hours, the disappearance or decrease in the severity of this symptom was noted. In the second group, this indicator was slightly lower - 10 out of 15 patients. The disappearance of pathological discharge from the urethra or vagina was noted by 15 of 17 patients of the first group and 11 of 15 patients of the second group. Thus, the analysis of the data showed that the intravenous administration of the drug SUMAMED to patients with a complicated course of chlamydial infection of the urogenital tract leads to a pronounced and early positive clinical effect.

When analyzing the results of this study, one of the most significant criteria was the severity of laboratory signs of chlamydial infection: the results of the analysis of scrapings of epithelial cells of the urethra and cervical canal on C.trachomatis by molecular biological methods, the method of culture on McCaw cells and titers of specific antibodies to C.trachomatis. During laboratory examination, 4 and 8 weeks after the end of treatment, chlamydia was detected in 1 patient (2.9%) in group 1 and 1 patient (3.0%) in 2 groups. The same results were obtained in a culture study on Mccow cells. In a blood test, class G antibodies (Ig G) against Chlamydia trachomatis protein antigens three months after the end of treatment were detected in 14 (41.2%) patients of the 1st group and in 15 (45.5%). We regarded the therapy as effective in a two-, three-fold reduction in the amount of class G antibodies in the blood serum. Both in the first and in the second group, a decrease in titers of antibodies of class G (Ig G) to protein antigens of C.trachomatis was noted by two or more times. Thus, the clinical study showed a high degree of pathogen elimination from the patient’s body, which is confirmed by the study of scrapings of epithelial cells of the urogenital tract on C.trachomatis and the dynamics of titers of specific antibodies to C.trachomatis (Ig G) in blood serum.

Adverse reactions with the use of SUMAMED for intravenous administration were not observed in any of the treated patients. Most patients noted the tolerance of therapy as very good (94.1%). Two patients of the study group had mild dyspeptic symptoms that did not require discontinuation of the drug.

A general assessment of the effectiveness of treatment with SUMAMED for intravenous administration was regarded by both the doctor and patients as good.

Thus, the inventive method has allowed to increase the effectiveness of treatment while reducing the total dosage of the drug, the absence of allergic reactions and side effects.

Bibliography

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Claims (1)

A method of treating complicated urogenital chlamydia by administering azithromycin according to a 1-7-14 day schedule, characterized in that azithromycin is administered slowly intravenously in a dose of 500 mg for 2-2.5 hours.