The “Phtisio-Biofon” apparatus clinical test report.

First stage, July 1, 2000

The clinical test program has been developed according to the existing schedule. The results log with the therapy effectiveness evaluation criteria and the clinical, hematology, and immunology monitoring data was prepared. Special attention was paid to the techniques of microbiological examination of the patients: 3 pre-treatment bacteriological tests by the irritant inhalation method with culturing onto two nutrient mediae (Levenstein-Jensen and Novaya) followed by luminescence bacterioscopy prior to start of treatment, and complete weekly microbiological examination during the exposure therapy. The parameters of the clinical roentgenology status and time of the check examination have been determined. The therapy schemes were developed taking into account the administered anti-TB medications. The “Phtisio-Biofon” device exposure frequency and duration schemes were developed for the patients, the instruction was drawn up: 1^st day – 4 exposures with 6-hours intervals; 2^nd day – 3 exposures with 8hours intervals; in the epriod from the 3d through 7^th day two exposures with 12 hours interval; one daily exposure starting on the 8^th and through the 30^th day. The exposures were administered to each patient individually. Each exposure period included 10 sessions.

The patient body was divided into the experimental (31 persons) and the check (30 persons) groups. The selection of patients was carried out by clinicians after a comprehensive examination and with due regard to laboratory results. With all patients receiving a standard antibacterial therapy, exposure was administered to the patients of the experimental group only.

To study the effect of exposure to the “Phtisio-Biofon” device emission on the hematological and immunology parameters, blood tests were carried out before start of the exposure administration and then every decade. The methods employed in determining the hematology parameters: hemoglobin by the unified hemoglobincyanide method; the erythrocyte and leukocyte counts by the unified method in the Goryaev chamber; ERS – by the unified Panchenkov micromethod; leukogram with staining after Romanovski. The immunogram was appraised by the main parameters: the relative and absolute numbers of T-lymphocytes and their subpopulations (the theophylline-sensitive and resistant ones) by the spontaneous rosette formation with ram erythrocytes method, the relative and absolute numbers of B-lymphocytes by the spontaneous rosette formation with mouse erythrocytes method; phagocytic activity of neutrophils in the NST test by latex incubation method; circulating immune complexes in the blood serum by the precipitation method in 3.5% solution of polyetheleneglycol with subsequent colormetering in spectrophotometer.

Biochemical data provide an important tool characterizing the basic physiological functions of the system and are indispensable parameters helping to monitor the safety of the patient exposure to the electromagnetic radiation. The following biochemical parameters helping to monitor the condition of the liver and kidneys were adopted - total blood serum protein determination by the Biuret method (“Rajchem” reagents); determination of the globulin-thymol-lipids content through a standard thymol turbidity test in veronal buffer; determination of blood serum protein fractions by standard paper electrophoresis method; determination of ÀlÀÒ and ÀCÀÒ ferment activity with “Rajchem” reagents; bilirubin determination by the unified L. Jendrassjk, R. Cleghom daizoreaction method; urea and creatinine determination by standard methods.

Total number of tests carried out: microbiological tests – 4158; hematology tests –2835; immunology tests - 2905; biochemical tests – 3969.

The obtained data are shown in Table 1.

Table 1 TB patients biochemical data

Table 2 TB patients immunology data

Table 3 TB patients hematology data

The “Phtisio-Biofon” exposure effectiveness was monitored on a monthly basis. 560 in-vitro tests were performed with use of laboratory strains.

Throughout the entire treatment period the laboratory control was backed-up by clinical X-ray examination. The result registers were filled out for both the exposure and the check groups of patients. The obtained data are being used in statistical analysis, the examination plan is being adjusted and additional evaluation criteria are selected.

Y.Y. Khokhlova