I.M. Sechenov Moscow Medical Academy

Research Institute of Phthisiopulmonology

Medical Test Log for the prototype of the “Phthisio – Biofon” apparatus

Basis: Decision by the Commission on the instruments and apparatuses used in pulmonology, Ministry of Health, minutes ¹2 of 02/07/2000

1. During the time period from November 1, 2000 till March 1, 2001 medical tests of the “Phthisio-Biofon” apparatus, developed at the Government-owned enterprise “Izhevsky Mekhanichesky Zavod” were conducted. The tests were carried out in accordance with the program and methods for medical tests.
2. Supplied for the tests were:

1. Test specimen of the "Phthisio-Biofon” apparatus – 3 pieces.
2. Report by the Research Institute for Medical Equipment VITA on the results of the official acceptance test of the “Phthisio-Biofon” IR-therapy appliance prototype, developed by the State Enterprise “Izhevsky Mekhanichesky Zavod”. As a result of the positive acceptance test it was recommended to subject the appliance to medical tests.

3. Brief technical characteristic of the apparatus

The “Biofon” series apparatuses are electronic appliances generating information-modulated electromagnetic radiation of non-thermal intensity in the IR range with the 0.8-30m m wavelength and 0,1-1mWt emissive power (hereinafter referred to as IRR). The IRR effect is based on changes of the electrostatic potential at the cell membranes of microorganisms. This dosage radiation of high selectivity has a capability to inhibit activity of pathogenic microorganisms.

The appliance received a positive decision by the Research Institute for the State Patent Inquiry about the patentability of the apparatus and the advisability of its production.

The examination run by the State Research Center for the Applied Microbiology and the Research and Production Enterprise “Bionix” revealed that the IRR of the “Biofon” devices has a suppressive effect on the viability of microorganisms. The most pronounced effect the IRR had on the barrier function of the microorganism membrane. Use of the luminoindependent chemiluminiscence method attested to growth in the rate of penetration of non-specific substances from the surroundings into the affected microbial cell. The appliances of this series are effectively employed in treatment of urogenital infections.

4. Indications – a device for complex treatment of infections caused by mycobacteria tuberculosis (in combination with usual chemotherapy efforts).
5. Contraindications – not found
6. The medical tests were conducted in accordance with the program and methods for medical tests.
1. To conduct the tests a group of 30 newly revealed pulmonary patients was formed. The bacteriostatic blood activity determination method was used. The said method is built around culturing the patient’s isolated culture onto his own blood plasma. The blood samples were taken after the patient had taken a usual single dose of ÃÈÍÊ. Several blood plasma dilutions were used for culturing. The patients were receiving usual doses of tubazide for at least two days prior to tests. On the test day 6ml of blood was taken from the elbow vein in three hours after a per os admission of a tubazide test dose. The blood sample was taken before exposure to the “Biofon” device emission and immediately after the exposure session. The blood from the syringe was put into a centrifugal tube containing 0.6ml of 6% sodium citrate solution and centrifuged. Then 2ml of the obtained plasma was transferred into a tube with 2ml of Shkolnikova nutrient – 1 dilution. After that 1:4 and 1:8 dilutions were prepared. The check tube was the tube where 1.8ml of nutrient medium was mixed with 0.2ml of a horse serum.

To get a bacterial suspension the mycobacterial culture of a patient was rubbed in a mortar and nutrient medium was added to obtain the emulsion density 500mln microbial bodies by the GKI turbidity standard. Then 0.2ml of bacterial emulsion was added into each tube with plasma. The cultured tubes were parafined and kept in thermostat at 37° C for 10 days after whoosh the sediment was used to prepare smears with subsequent Cille-Nilsen staining. The results were evaluated by microscopic growth picture and comparison against the check. The latter revealed a multitude of colonies. In the smears prepared from the test samples the culture was evaluated as growing not only during a mass growth but also with the presence of a considerable number of isolated braids and bundles in each field of view. With presence of only 3-4 colonies the culture was not considered as growing.

The tubazide resistance of the patients’ MBT cultures was also determined for the 0.1; 0.2; 0.5; 1.0; 5.0 and 25.0m g/ml concentrations

The obtained results are shown in the table below.

With absence of MBT growth in all three or first two dilutions the test was considered positive. With lack of growth only in the first dilution the test was characterized as on the verge of being negative. With growth evident in all the three dilutions the test was registered as positive.

As a result of the examination in 12 patients of total 30 (40%) the tuberculostatic test was found positive prior to exposure. Four patients in this group released mycobacteria tuberculosis sensitive to tubazide, four patients revealed cultures resistant to 0,2m g/ml of tubazide. In 12 more patients the results of the tuberculostatic test were found being on the verge of negative.

The mycobacteria cultures released by these patients were resistant to 0.5m g/ml of tubazide (5 cultures) and to 1.0m g/ml of tubazide (1 culture). The tuberculostatic test was negative in 6 persons with the cultures demonstrating a variety of tubazide resistance (0.5m g/ml, 1.0m g/ml and 5.0m g/ml).

In 8 cases of the 12 patients who initially tested on the verge of negative, no growth was found in first two plasma dilutions after the “Biofon” exposure session had been administered, which corresponds to a positive result. Thus the total number of the patients with a positive tuberculostatic test result after the “Biofon” exposure treatment grew to 20 cases which amounts to 67% of the total number of examined patients.

Table. The tuberculostatic test results in the pulmonary TB patients prior to and after the “Biofon” exposure treatment