In the thesis, an important problem of ophthalmology was solved – a therapeutic and diagnostic tactic was developed for the management of patients with diabetic macular edema and non-proliferative diabetic retinopathy against the background of type 2 diabetes mellitus using the combination of hyperbaric oxygen therapy (HBOT) with intravitreal administration of aflibercept.
The clinical study involved 91 patients (91 eyes) with diabetic macular edema (DME) and mild to moderate non-proliferative diabetic retinopathy (NPDR) at type 2 diabetes mellitus (DM) background, ages range from 45 to 60 years old, 56 males and 52 females. Using randomization method, all patients with DME were divided into two groups. The control group included 45, and the main group - 46 patients. To determine the factors that affect on the clinical course of DME in patients with type 2 diabetes, we performed a comprehensive assessment the features of sight in these patients using clinical ophthalmological and psychological, biochemical, statistical research methods, and also explored their impact on the quality of life of patients.
On the obtained scientific data we proposed the algorithm for diagnosis of NPDR-associated DME against the background of type 2 DM, which includes an assessment of clinical features (step 1) with consideration for the risk: duration of DM; clinical examinations: visiometry (with determination of visual acuity and photosensitivity of the retina), optical coherence tomography (with assessment of thicknesses and volumes of the central, parafoveolar, perifoveolar regions of the retina, volumes of the macular part d = 1 or 3 mm3). Neuro-ophthalmological assessment (step 2) involves the assessment of visual evoked potentials, namely amplitudes (P0-N0, P1-N1, N1-P2) and latencies (P0, P1, P2, N2, P3). Quality of life (QoL) assessment (step 3) consists of health-related QoL determining: emotional functioning and its role, pain, vitality, mental and general health. Assessment of psychological features (step 4) involves the determination of: E-independence-subordination, I-passivity-rigidity, N-flexibility-straightforwardness, M-pragmatic-luxuriance, Q1-radicalism-conservatism; anxious, neurasthenic, egocentric types of attitude to the disease. Assessment of biochemical and immunological features (step 5) should be carried out with the consideration of glycemia: blood sugar, concentration of glycated hemoglobin; lipidemia: total cholesterol, low- and high-density lipoprotein cholesterol; lipid peroxidation: superoxide dismutase, glutathione reductase, catalase; immunograms: Ig A, IL-8, IL-33; angiogenesis-related factors: VEGF, PLGF.
Patients in the control group with DME were treated with aflibercept (Eylea, Bayer) once a month intravitreally at a dose of 2 mg (50 μl) within five months (5 injections). Patients of the main group with DME were treated with aflibercept (Eylea, Bayer) once a month intravitreally at a dose of 2 mg (50 μl) within 5 months (3 injections) in combination with the two courses of 10 sessions of hyperbaric oxygen therapy before the first and third injection (45-minute exposure, atmospheric pressure 1.5 ATA, gas mixture with 95% medical oxygen). It has been shown that the effectiveness of combined treatment is comparable to the aflibercept (Eylea, Bayer) intravitreally at a dose of 2 mg (50 μl) within 5 months (5 injections).
The prognosis of the DME course in patients with type 2 diabetes is determined by the volume of the central region of the retina (-0.632), duration of diabetes (-0.296), blood glucose level (0.161), M-practicality- luxuriant imagination (-0.095), atherogenicity coefficient (AC) (-0.091). In DME patients the lowering of blood sugar level will contribute to the improvement of visual acuity, while the following will deteriorate: an increase in the volume of the central region of the retina, the duration of the DM, M-pragmatic-luxuriance imagination, and the atherogenicity coefficient.
The practical importance of the obtained results lies in the improvement of the diagnostic quality of NPDR-associated DME due to the implementation of the algorithm for the diagnosis of diabetic macular edema, which, in addition to the current standards, includes: determination of visual evoked potentials; immunograms, lipid peroxidation and angiogenesis factors; assessment of health-related quality of life; determination of the features of intrinsic pattern of the disease. A new therapy method for patients with DME in NPDR, which consists in a combination of treatment with aflibercept (Eylea, Bayer) once a month, intravitreally, at a dose 2 mg (50 μl) within three months (3 injections) with an additional two courses of 10 sessions hyperbaric oxygen therapy before the first and third injections, is significantly increases the quality of treatment and shortens the duration of the therapy.
