Izhevsk State Medical Academy

Phthisiology Chair

CLINICAL TEST STATEMENT

For IR-therapy device “Phtisio-Biofon”

Head Phthisiology Chair Ph.D., Professor Å. Å. Polushkina

Grounds for carrying out the test

Agreement Nr. 2090 of 06/01/2000 between the State unitary enterprise “Izhevsky Mekhanichesky Zavod” and VTK.

The Decision by the Ministry of Health Committee for Innovative Medical Equipment (Excerpt from minutes ¹1 of 02/18/2000, sitting of the Pulmonology Apparatus and Appliances Commission)

Place and time of the test

1. Premises of the Republic Clinical TB Hospital, Department of Pulmonology, Izhevsk, Botkinskoye shosse 1.
2. Start of test 06/01/1999
3. Completion of test 07/31/2000

Brief characteristic of the tested device

1. The “Phtisio-Biofon” IR-therapy device is designed for physical treatment of TB of a variety of localization.
2. The device is designed for both institutional and out-patient therapy
3. The device is powered by an internal 2.8-3.2V power source (two 1.5V “Energizer” type elements);
4. Draw current 0.1A;
5. Weight 0.3kg;
6. Overall dimensions 156 x 82 x 30mm
7. The device contains an IR radiation source with emission in the 0.8 – 30mkm wavelength band.
8. The IR emission power is within the 0.1 – 1mWt range.
9. Duration of a single therapy session 24+1 sec.
10. The IR emission is generated within the first 12+1 sec.
11. Exposure distance between the device and the patient 0.005 – 0.5m
12. The device ensures indication by means of a built-in digital indcator showing:

• duration of a session
• number of sessions administered
• discharge of the power elements

13. The device has a power-on light, session start and session end sound indication and emission termination indicator.
14. The operation after power on delay setting does not exceed 1 sec.

Clinical test procedures

The “Phtisio-Biofon” IR-therapy device was tested in a complex treatment of pulmonary TB patients with various case duration.

All the patients received a standard tuberculostatic therapy in accordance with the case gravity and length taking into account mycobacteria sensitivity to antibiotics izoniazid (10mg/kg), rifadin (10mg.kg), pirazidamid (20-25mg/kg), streptomycin (canamycin) 15mg/kg, etambuctol, pathogenetic and symptomatic therapy, aerosol therapy.

The “Phtisio-Biofon” treatment was administered by the basic method individually adjusted depending on the intensity of the process and bacteria discharge. There were administered group and individual exposure sessions with no apparent difference in the results.

During an individual session the device was located opposite the TB process location at a 0.5m distance. During a group session 4-5 patients were sat in a semicircle with the backs turned to the therapist (dorsal locality of the TB process being the most common case) and again about 0.5m away from the device.

The observed patients were subject to a comprehensive clinical, laboratory and X-ray examination. Laboratory tests were carried out monthly (blood, biochemical examination of liver functioning, direct bacterioscopy of the sputum smear, luminescent bacterioscopy of the sputum smear, sputum culturing), X-ray examinations were performed once in two months.

Patient body characteristics

During the clinical test of the “Phtisio-Biofon” IR-therapy apparatus treatment was administered to 70 patients with spread destructive forms of TB with a variety of case duration. The number of male patients was 62, the number of females – 8. Average age of the patients was 36 years.. The overwhelming majority of the cases provided newly diagnosed cases, 80% patients belonged to socially disadvantaged walks of life.

All the patients revealed pronounced symptoms of the tuberculosis intoxication (subfebrile temperature, weight deficit, breathing deficiency, night sweating). In 83% cases clinical examination revealed dry rales of various intensity, breathing delays in the affected side. Pale skin integument and peripheral acrocyanosis was diagnosed in 58% cases. All patients underwent laboratory examination prior to treatment: total blood count with the leukocytic formula, urianalysis, blood biochemistry (liver tests ALT, bilirubin). Sputum was examined for mycobacteria tuberculosis by luminescent microscopy and culturing onto nutrient medium three times prior to treatment and then every month after withdrawal of bacteriostatic preparations.

Localization and spread of the process was appraised by X-raying and tomography once in two months. Respiratory disorders were evaluated with the help of the “Eton” automatic pneumotachometer. All the patients of the main group (volunteers) were briefed in an easy-to-understand form on the operating principle of the device.

The check group was formed similarly. It also included 70 patients with the spread destructive forms of TB. The patients of the check group received standard tuberculostatic and pathogenic treatment without IR-therapy.

As a result of the clinical test it has become apparent that that employment of exposure to the IR emission from the “Phtisio-Biofon” device does not affect the main parameters of the human system, i.e. pulse rate, arterial pressure (the measurements were performed prior and after the exposure sessions remaining within the limits of an individual norm).

Biochemical parameters of the liver test did not change during “Phtisio-Biofon” therapy either which attests to lack of hepatotoxic effect. The parameters of the hemogram remained stable too.

Two female patients noted a sensation of warmth in the location of the device projection during the first 2-3 exposure sessions which afterwards disappeared while other patients did not feel anything at all. The intoxication syndrome in the patients of the main group diminished or ceased in 1-2 months (in the patients of the check group in 2-3 months). 80% patients of the test group stopped revealing presence of mycobacteria in sputum in a month after enhancing the standard tuberculostatic treatment with the IR-therapy while the majority of the check group patients (unexposed to the “Biofon” IR-emission) stopped revealing mycobacteria in sputum only in the third months after start of treatment. Noteworthy is percentage of stubborn cases in both the groups (21.4% in the check group and 10% in the main group). These were the patients who had been undergoing long and irregular treatment and had developed poliresistance to tuberculostats.

The comparative therapeutic results.

Parameter	Groups
	The check group 70 persons	The main group 70 person
1	2	3
1. Males	62(89%)	62(89%)
2. Females	8(11%)	8(11%)
3. Average age	38	36
4. Number of patients releasing mycobacteria resistant to tuberculostats	15(43%)	15(43%)
5. Cessation of mycobacteria release, (persons):
- in 1 month time	7(10%)	56(80%)
- in 2 months time	14(20%)	6(9,3%)
- in 3 months time	34(48,6%)	1(0,7%)
- persistent cases	15(21,4%)	5(10%)

The basic method of administering the “Phtisio-Biofon” device IR-therapy to pulmonary TB patients

Spread of lesion	First 2-3 days	2 weeks	1 month	2 months	3 months
Limited process (1-2 segments)	4-6 twice a day	4-6 once a day	2 – 3 once a day	1-2 every other day	1-2 once a day
Spread process (over 2 segments)	6-10 twice a day	6-10 twice a day	6-10 once a day	4-6 once a day	2-4 once a day

 

Spread of lesion	4 months	5 months	6 months	7 months
Limited process (1-2 segments)	Once a week	once every other week	Once a month	–
Spread process (over 2 segments)	2-4 every other day	2-4 every other day	2x2 once a week	once in a fortnight

Clinical test results

Sputum tests for presence of mycobacteria were run monthly. The tests were performed by culturing and luminescent microscopy. 80% patients (56 persons) of the main group stopped revealing presence of mycobacteria in sputum in a month after enhancing the standard tuberculostatic treatment with the IR-therapy while the peak of mycobacteria release cessation in the check group (48.6% - 34 persons) patients (unexposed to the “Biofon” IR-emission) happened only in the third months after treatment start.

No side effects or complications were observed during treatment. The IR-therapy did not affect the main functioning parameters of the human system. Destruction cavity closure rate in the main and the check groups was similar and happened in the 4-5 months from the start of treatment.

Conclusion

The IR-therapy “Phtisio-Biofon” device proved effective as a part of complex treatment effort aimed at various forms of pulmonary TB. Indications for employment of the apparatus are all forms of tuberculosis regardless of the case duration. No contra-indications for the IR-therapy have been found.

Augmenting the institutional tuberculostatic effort with the IR-therapy permits to shorten the mycobacteria suppression period in bacillus releasing patients. “Phtisio-Biofon” is especially recommended for complex treatment of the patients releasing drug-resistant forms of mycobacteria tuberculosis.

The “Phtisio-Biofon” IR-therapy apparatus is a compact, easy-to-use, easy-to-master device. The virtues of the device are short therapy session time (24+1 sec.), noninvasive treatment methods, a possibility to administer group therapy.

Resulting recommendations

The IR-therapy device “Phtisio-Biofon” provides an effective means of complex institutional and out-patient treatment of a variety of pulmonary TB forms. No contra-indications were found for IR-therapy.

We deem it necessary to develop a stationary IR-radiation source capable of automatic operation 2-4 times a day for installation in TB wards.

The IR-therapy device “Phtisio-Biofon” can be recommended for batch production and use in therapeutic practice as a part of complex pulmonary TB treatment.

To add to handiness of use one could recommend introduction of an emission light indication.

E.E Polushkina, Ph.D., Professor, Head Phthisiology Chair, Izhevsk State Medical Academy
E.A. Tyulkina, Asistant Phthisiology Chair
S.Yu. Beresgova, Registrar, Republic Clinical TB Hospital