Clinical experience with the use of the angioprotector Doxy-chem

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Angioprotector (capillary and venoprotector), affecting the vascular endothelium and normalizing metabolic processes in it. Under its action, vascular permeability is normalized, microcirculation improves, capillary stability increases, platelet aggregation and blood viscosity decreases, and hemorrhagic syndrome . The effect of the drug is associated with an increase in the activity of kinins in plasma.

Pharmacokinetics

Slowly adsorbed from the gastrointestinal tract. After 5-6 hours, the maximum concentration is determined in the blood; 20-25% of the substance binds to plasma proteins. It is excreted by the kidneys and intestines within 24 hours.

Indications for use

• increased capillary permeability (with diabetic retinopathy and nephropathy );
• varicose veins and venous insufficiency , accompanied by pain, congestive dermatosis , superficial phlebitis , trophic ulcers ;
• microangiopathy due to cardiovascular diseases.

Doxi-hem

Calcium dobesilate

Release form, composition and packaging

10 pieces. — cellular contour packages (3) — cardboard packs.

Registration No.:

• caps. 500 mg: 30 pcs. — P No. 012627/01-2001 01/26/01

pharmachologic effect

A drug that improves microcirculation. Angioprotector, affects the vascular endothelium. Normalizes increased permeability of the vascular wall, increases capillary resistance, improves microcirculation, inhibits platelet aggregation, reduces blood viscosity, reduces the activity of plasma kinins.

Pharmacokinetics

Absorption Calcium dobesilate is slowly absorbed from the gastrointestinal tract. Cmax in the blood after oral administration is observed after 5-6 hours. Distribution Plasma protein binding is 20-25%. Calcium dobesilate practically does not penetrate the BBB. Excretion T1/2 of calcium dobesilate is 24 hours. It is excreted mainly by the kidneys within 24 hours.

Indications

• vascular lesions with increased capillary fragility and permeability (including diabetic retinopathy and nephropathy);
• microangiopathies associated with various cardiovascular and metabolic diseases;
• venous insufficiency of varying severity and its consequences (including pre-varicose veins with tissue swelling, pain, paresthesia, congestive dermatosis; superficial phlebitis; varicose veins; trophic ulcers).

Dosage regimen The average recommended dose is 500 mg 3 times/day with meals for 2-3 weeks, then the dose is reduced to 500 mg 1 time/day. For retinopathy and microangiopathy - 500 mg 3 times / day for 4-6 months, then 500 mg / day.

Side effect

Rarely: allergic dermatosis, febrile reactions, headache, dizziness, gastrointestinal disorders.

Contraindications

• bleeding caused by taking anticoagulants;
• I trimester of pregnancy;
• hypersensitivity to calcium dobesilate.

Pregnancy and lactation

The drug is contraindicated for use in the first trimester of pregnancy. Data on the safety and effectiveness of using the drug Doxy-chem during lactation (breastfeeding) are not provided.

special instructions

In severe renal failure requiring dialysis, the dose of Doxy-chem should be reduced. The drug can be prescribed for the purpose of prevention. Use in pediatrics There are no clinical data on the effectiveness and safety of the drug Doxy-chem in children. Effect on the ability to drive vehicles and operate machines. The drug Doxy-chem does not affect the ability to drive vehicles and operate machines.

Overdose

Data on overdose of the drug Doxy-chem are not provided.

Drug interactions

To date, there is no data on clinically significant interactions of the drug Doxy-chem with other drugs.

Storage conditions and periods

The drug should be stored in a place protected from moisture, out of the reach of children, at a temperature of 15° to 25°C. Shelf life: 5 years. Conditions for dispensing from pharmacies The drug is dispensed with a prescription.

Doxy-Chem, instructions for use (Method and dosage)

Doxy-Chem capsules or tablets are taken orally with food. The average dose is 500 mg twice a day for 3 weeks, moving up to 500 mg per day. For retinopathy , 500 mg is prescribed three times a day for 4-5 months, with a transition to 500 mg per day. The drug is also prescribed for prophylactic purposes.

If your temperature rises, chills appear, pain when swallowing, or inflammation of the oral mucosa (symptoms of agranulocytosis ), you should consult a doctor.

Reviews of Doxy-Heme

Calcium dobesylate has a more pronounced effect on vascular permeability than ethamsylate . It is the drug of choice for diabetic retinopathy , as a therapeutic and prophylactic agent, as evidenced by patient reviews. The drug is a highly effective angioprotector , which was necessarily prescribed to patients with diabetes mellitus . As a result of treatment, retinal edema and, in general, the prognosis for diabetic retinopathy improved. Side effects were observed very rarely, the drug is easy to use and affordable.

Price for Doxy-Chem, where to buy

You can buy the drug Doxy-Chem in pharmacies in Moscow and other Russian cities. The cost of capsules 500 mg No. 30 ranges from 186 to 349 rubles.

• Online pharmacies in RussiaRussia

ZdravCity

• Doxy-Chem capsules 500 mg 30 pcs. Hemofarm A.D.
  Vršac, branch Production site Šabac RUR 305.order

V.V. AGAFONOVA, M.Z. FRANKOVSKA-GERLAK, A.V. SHATSKIKH, N.B. KHALUDOROVA, V.S. CHUBAR, P.E. BRIJAC

MNTK "Eye Microsurgery" named after. acad. S.N. Fedorov Ministry of Health of the Russian Federation", Moscow

Khaludorova Natalya Budaevna

ophthalmologist, graduate student

In order to study the prophylactic use of the drug "Doxy-chem" as a preoperative preparation for patients with cataracts and various ocular manifestations of pseudoexfoliation syndrome (PES), a comparative study of 60 eyes was conducted.
The nature of the course of the early postoperative period was studied in patients after cataract phacoemulsification with intraocular lens implantation (FEC + IOL) with the use of the drug "Doxy-chem" (30 eyes of 30 patients) and without its prescription (30 eyes of 30 patients). It has been established that in patients with deposits of pseudoexfoliative material in the anterior segment of the eye ( stage II PES according to the classification of Nesterov A.P., 2008), it is advisable to prescribe the drug “Doxy-chem” as a preoperative drug preparation to improve the state of microcirculation, reduce the number of complications and terms rehabilitation of patients.
Key words:
pseudoexfoliation syndrome, Doxy-chem.
V. V.
AGAFONOVA, M. Z. FRANKOWSKA- GIERLAK, A. V. SHATSKIKH, N. B. KHALUDOROVA, V. S. CHUBAR, P. E. BRIZHAK
IRTC Academician S.N. Fedorov's "Eye Microsurgery". Ministry of Health of RF, Moscow

Efficacy of prophylactic application of doxi-chem (calcium dobesilate) to patients with cataract and pseudoexfoliation syndrome

A comparative study of 60 patients (60 eyes) was conducted to study the application of Doxi-Chem (calcium dobesilate) as a preparation for phacoemulsification of patients' eyes with cataract and various ocular manifestations of pseudoexfoliation syndrome. The nature of the early post-operative period was studied after the patients

phacoemulsification
of the cataract together with implantation of IOL (intraocular lens) either by applying Doxi-Chem (30 eyes of 30 patients) or without using it (30 eyes of 30 patients).
It was found that for patients with deposits of pseudoexfoliative material in the anterior segment of the eye (RPE stage II according to classification of AP Nesterov, 2008) it is recommended to use Doxi-Chem as premedication in order to improve microcirculation, decrease the amount of deposits and the rehabilitation period. Key words:

pseudoexfoliation syndrome,
Doxi-Chem (calcium dobesilate ).
Relevance

Currently, pseudoexfoliation syndrome (PES) is the subject of close attention of researchers and practitioners. The reasons for such a high interest of clinicians in PES are its relationship with cataracts and glaucoma, the fairly high prevalence and development of various complications caused by the presence of this syndrome.

Currently, the mechanism of PES development is not clear, but, according to various authors, in the pathogenesis of PES development, a certain role is played by vascular damage due to the accumulation of pseudoexfoliative material (PEM) in the vascular wall, which causes vascular permeability and the blood-ocular barrier (BOB) [1]. Kuchle et al. indicate a violation of GOB permeability in PES. In their study, the authors found a significant increase in the amount of protein in the anterior chamber aqueous humor in pseudoexfoliation glaucoma compared with primary open-angle glaucoma [2]. It is known that with PES, the permeability of the GOB is higher, which is the cause of pronounced postoperative reactions of an inflammatory and fibrinous nature [3]. Data on the presence of increased vascular permeability of the anterior segment of the eye during PES were also obtained in a previous study using fluorescein iridoangiography [4].

Considering all of the above, an important component of the rehabilitation of patients with cataracts and PES after surgical interventions is an uncomplicated, non-reactive postoperative period, which necessitates the adoption of preventive measures in their preoperative preparation aimed at stabilizing the state of the vascular bed of the eye.

Data from various authors on the effective use of Doxy-chem (calcium dobesilate) in the treatment of diabetic retinopathy [5], the manifestations of which are similar to vascular damage in PES, as well as the pharmacological properties of calcium dobesilate (normalization of increased capillary permeability, reduction of their fragility, reduction of blood viscosity and platelet aggregation, its economic availability and ease of use) allowed us to use Doxy-chem to prevent the development of various vascular reactions after FEC + IOL in patients with PES. To date, no data have been found in the literature on the use of Doxy-chem in the presence of signs of PES in the eye.

The purpose of the work

was an assessment of the clinical effectiveness of the prophylactic use of the drug "Doxy-chem" in patients with cataracts and various ocular manifestations of PES.

Material and methods

The study group consisted of patients with cataracts and ocular signs of PES of varying severity. Patients with clinically calculated emmetropic refraction of the eye (anterior-posterior axis within 23.5-24.5 mm) were selected for the study.

The study did not include patients with diabetes mellitus, glaucoma, high myopia and hyperopia, uveitis, trauma, or a history of eye surgery.

The study patients were divided into two groups based on the signs of PES detected by biomicroscopy.

Group 1 consisted of 15 patients (15 eyes) aged from 49 to 73 years (average age - 63±3.1 years) with cataracts secondary to stage I PES (according to the classification of A.P. Nesterov, 2008), i.e. with pigment dispersion on the structures of the UPC and iris tissue and without the presence of PEM deposits in the anterior part of the eye.

Group 2 consisted of 15 patients (15 eyes) aged from 61 to 87 years (average age - 73±2.1 years) with cataracts secondary to stage II PES (according to the classification of A.P. Nesterov, 2008), in whom biomicroscopy showed pigment dispersion and TEM deposits on the structures of the anterior part of the eye were identified [6].

Each of the 30 patients in groups 1 and 2 was prescribed the following regimen as preoperative preparation for phacoemulsification of cataract with IOL implantation (FEC+IOL): Doxichem 500 mg after meals orally 3 times a day for 1 month.

All 30 patients underwent FEC+IOL 1 month after taking Doxy-chem.

The control groups included 15 patients (15 eyes with stage I PES, group 1A) and 15 patients (15 eyes with stage II PES, group 2A) who underwent FEC+IOL routinely without prior administration of Doxy-chem.

FEC+IOL in patients of all study groups was performed by the same surgeon.

The criterion for the effectiveness of the preoperative preparation was the nature of the early postoperative period.

Results and discussion

Visual acuity on the 2nd day after surgery in patients of all study groups ranged from 0.5 to 0.8 depending on the condition of the cornea, optic nerve and retina, and the level of ophthalmotonus was within normal values ​​(Table 1).

Table 1.

Visual acuity and IOP level in the studied patients in the early postoperative period (M±m)

Data on the nature of the early postoperative period in operated patients are presented in Table 2.

Table 2.

Complications and features of the postoperative period

*p<0.05

Epithelial local edema of the cornea, not accompanied by an increase in ophthalmotonus, was diagnosed in 2 patients (13.3% of cases) of group 2 and resolved on the 2nd day after surgery, while in 5 patients (33.3%) from the control groups (in group 1A - 2 cases, in group 2A - 3 cases) corneal edema was more pronounced and diffuse in nature, which was accompanied by a decrease in the optical transparency of the cornea, an increase in its thickness in the optical section and the presence of folds of Descemet's membrane. In these patients, the swelling stopped on days 5–7.

In patients of all study groups in the early postoperative period, the presence of a cellular reaction of varying severity was noted (gradation of cellular reaction according to the classification of J. Kanski, 2006).

Cell reactions 1+ were more common in groups 1 and 2 and amounted to 46.7 and 40% of cases, respectively, while in the control groups they occurred with the same frequency and amounted to 13.3%. This difference between the groups was statistically significant (p<0.05).

The distribution of cases of 2+ cell reaction in all study groups was approximately the same: in group 1 - 5 patients (33.3%), in group 2 - 6 patients (40%). And in control groups: 1A - in 7 patients (46.7%), 2A - in 6 patients (40%).

Cell reactions 1+ and 2+ corresponded to the non-reactive course of the postoperative period.

A “4+” cellular response in patients taking Doxy-chem was noted in 3 patients in group 1 (20%) and 3 patients in group 2 (20%). In the control groups, without taking Doxy-chem in preparation for surgery, a 4+ cellular reaction occurred in 6 patients (33.3%) of group 1A and in 7 patients (46.7%) of group 2A, which was 2 times more compared with data from groups 1 and 2 (p<0.05).

A transudative reaction in the form of fibrin threads in the pupil area was noted in 2 patients (13.4% of cases) taking Doxy-chem in groups 1 and 2. In the control groups, a transudative reaction was detected in 3 patients (20% of cases) in group 1A and in 5 patients (33.3% of cases) in group 2A (p<0.05).

In patients with a 4+ cellular reaction and a transudative reaction, intensive anti-inflammatory therapy was carried out, including antibiotics, mydriatics, instillations of non-steroidal anti-inflammatory drugs, desensitizing drugs, and injections of corticosteroids under the conjunctiva. The period of relief of transudative and cellular reactions ranged from 2 to 7 days.

Cellular blood elements in the anterior chamber were noted in 5 patients of the control groups (group 1A - 1 patient (6.7% of cases), group 2A - 4 patients (26.7% of cases). The source of bleeding was the vessels of the pupillary edge of the iris.

There were no cases of macular edema.

The uncomplicated course of the postoperative period in patients of groups 1 and 2 with signs of PES, who took calcium dobesilate 500 mg 3 times a day for a month before surgery, served as the basis for transferring patients to outpatient observation.

Conclusion

Analysis of complications in the early postoperative period revealed a direct correlation between stage I PES and the occurrence of local epithelial edema, transudative reaction in the form of a fibrin thread, cellular reactions 4+, and in patients with stage II PES the occurrence of diffuse corneal edema, transudative reaction in the form of multiple fibrin threads, cellular reactions 4+ and local hemorrhagic phenomena.

The number of postoperative complications in patients with cataracts and stage II PES who did not take an angioprotector in the preoperative period was significantly higher.

Our study showed the effectiveness of the prophylactic use of Doxy-chem in patients with complicated cataracts against the background of both stages I and II PES; also, patients taking Doxy-chem were characterized by the absence of hemorrhagic phenomena in the early postoperative period.

Thus, our proposed medicinal preoperative preparation, which includes prescribing the drug “Doxy-chem” 500 mg 3 times a day for a month before surgery, can significantly reduce the number and severity of complications, shorten the time of treatment and rehabilitation of patients with cataracts on background of PES.

LITERATURE

1. Schlötzer-Schrehardt U., Kuchle M., Dorfler S. et al. Pseudoexfoliative material in the eyelid skin of pseudoexfoliation suspect patients: a clinic-histopathological correlation // Ger. J. Ophthalmol. - 1993. - Vol. 2. - P. 51-60.

2. Kuchle M., Amberg A., Martus P. et al. The blood aqueous barrier in eyes with pseudoexfoliation syndrome // Ophthalmic. Res. - 1995. - No. 27. - P. 136-142.

3. Podgornaya N.N., Namazova I.K., Dzemeshkevich V.V. Study of microcirculation of the iris in pseudoexfoliation syndrome and senile cataract using fluorescein angiography // Bulletin of Ophthalmology. - 1988. - No. 5. - P. 46-49.

4. Agafonova V.V., Kachalina G.F., Solomin V.A. and others. Assessment of vascular disorders and their correction in pseudoexfoliation syndrome // Bulletin of OSU. - 2011. - No. 14 (133). — P. 20-23.

5. Sobolevskaya N.V., Spasov A.A., Petraevsky A.V. and others. Complex therapy of diabetic microangiopathies using the drug “Doxy-chem” // Bulletin of VolSMU. - 2005. - No. 3. - P. 62-64.

6. Nesterov A.P. Glaucoma. — 2nd ed., revised. - M.: MIA, 2008. - 360 p.