Clinical evidence of efficacy

Therapeutic effect of lysozyme in Lysobact® on pathological conditions of the oral mucosa, such as pharyngitis (inflammation of the throat), tonsillitis (inflammation of the tonsils), stomatitis (inflammation of the mucous membranes of the mouth), gingivitis (inflammation of the gums), condition after tonsillectomy…., is studied in several clinical studies with the primary aim of checking anti-inflammatory and antimicrobial activity. Clinical trials have been conducted in a few countries.

– Topić B., Čokorilo N., Arifhodžić F.: “Klinička evaluacija preparata Lyso-6®* u tretmanu aftoznog stimatitisa (Clinical evaluation of Lyso-6® * in the treatment of aphthous stimatitis)“

At the Clinic for Oral Diseases of the Faculty of Dentistry in Sarajevo, in a double-blind, placebo-controlled clinical trial, the efficacy and safety of long-term use of Lysobact® oriblet in patients diagnosed with stomatitis aphtosa recurrens was proven.

The results of a study involving 60 patients for 8 days were as follows:

  • the inflammation was cured on the fifth day of therapy
  • the pain disappears by the fifth day of therapy, which is significantly faster compared to the control placebo group
  • Healing of aphthous mucosal damage is almost complete on the fifth day, while in the control placebo group mucosal damage is still present at 40% of its baseline size
  • signs and symptoms caused by reactive lymph node inflammation are significantly milder in patients treated with Lysobact® oriblets compared to the placebo group
  • Lysobact® effectively reduces the intensity of pain and inflammation, promotes healing of the mucosa at the site of damage and relieves symptoms of inflammation of regional lymph nodes
  • drug tolerability was outstanding, and no toxic or allergic events were observed

* earlier trademark of the Lysobact®

– Kapidžić A. et al.: „Otvoreno multicentrično kliničko ispitivanje efikasnosti i sigurnosti primjene lijeka Lysobact® u liječenju i prevenciji postoperativnih komplikacija nakon tonzilektomije“ (Open multicenter clinical trial of the efficacy and safety of Lysobact® in the treatment and prevention of postoperative complications after tonsillectomy)

At the Clinic for ENT in Clinical Center of University Sarajevo, in an open, parallel, controlled multicenter study, which included 160 patients aged 16 to 40 years, the efficacy of Lysobact® was examined compared to standard therapy (analgesic and antibiotic).

The test results for Lysobact® showed:

  • significant difference in the formation of fibrin deposits (temporary whitish cover, necessary for easier healing of damage)
  • greater reduction in pain sensation
  • faster postoperative wound healing, starting from the second postoperative day
  • less need for analgesic therapy in patients treated with Lysobact®

– Bašić-Đulizarević D., Bajraktarević A., Obradović E: „Evaluacija praktične upotrebe lijeka Lysobact® u periodu 1976 – 2006.“ (Evaluation of the practical use of Lysobact® in the period 1976 – 2006)

A meta-analysis of nine prospective clinical trials, reports from the National Center and the Sarajevo Drug Center, a review of the professional literature and many years of experience in the use of the drug shows that Lysobact® has proven excellent efficacy in rapidly healing oral mucosal damage and reducing inflammation, as well as reduction of the subjective pain and burning sensation of the oral mucosa.  Lysobact® has proven to be a safe and effective drug with anti-inflammatory and antibacterial, antifungal, antiviral properties with a positive therapeutic effect on bacteria present in dental plaque.

– Zabolotnyj DI., Zaricvaja IS.: „Otvorena studija o efikasnosti i podnošljivosti lijeka Lysobact® u liječenju inflamatornih bolesti farniksa“ (Open study on the efficacy and tolerability of Lysobact® in the treatment of inflammatory diseases of the pharynx)

An open-label, comparative, parallel study involving 180 patients diagnosed with acute and chronic pharyngitis (pharyngitis) showed that Lysobact® was more effective in relieving symptoms faster than combination therapy with antibiotics and the furacillin solution used for pharyngeal lavage.  Lysobact® has shown antibacterial and anti-inflammatory effects and is recommended in patients with acute and chronic pharyngitis.

– Zabolotnyj DI., Mironjuk BM.: „Otvorena studija s ciljem procjene podnošljivosti preparata Lysobact® u postoperativnom tretmanu nakon tonzilektomije i kriohirurškom zahvatu na palatalnim tonzilama kod djece“ (Open study to assess the tolerability of Lysobact® in postoperative treatment after tonsillectomy and cryosurgery of the palatal tonsils in children)

An open, comparative, parallel study after tonsil surgery, which included 60 children, boys and girls aged 3 to 7 years, showed that Lysobact® is well tolerated and contributes to faster postoperative wound healing.

– Andrejčin MA., Borak VP., Išćuk IS., Gospodarska HO. „Efikasnost lijeka Lysobact® u tretmanu grlobolje“ (Efficacy of Lysobact® in the treatment of sore throat)

A follow-up study that included 42 patients diagnosed with laryngitis aged 19 to 48 years, in which patients were divided into two groups (one group receiving antibiotic therapy, antiseptic and vitamin and the other group receiving additional Lysobact®).  In patients who also received Lysobact®, the test results showed:

  • faster reduction of fever
  • faster normalization of laboratory tests
  • faster disappearance of pus accumulations
  • faster healing of patients with sore throat

Lysobact® has been shown to be a safe and well-tolerated drug.

– Burmak i sar. „Kliničko iskustvo sa terapijom preparatom Lysobact® kod djece sa respiratornim virusnim oboljenjem“ (Clinical experience with Lysobact® therapy in children with respiratory viral disease)

The results of a follow-up study involving 45 children aged 7 to 14 years with a diagnosis of acute respiratory disease, of whom almost 20% had tonsillitis, showed that improvement in inflammation symptoms and recovery were significantly faster in the group of subjects who received Lysobact® compared to a control group receiving conventional therapy (inhalations and teas).  Lysobact® has been shown to be an effective and safe drug in the treatment of acute respiratory diseases.

– Kuznecov et al. „Efikasnost preparata Lysobact® u liječenju djece sa dijagnozom akutnog tonzilitisa“ (Efficacy of Lysobact® in the treatment of children diagnosed with acute tonsillitis)

The results of a study involving 63 children diagnosed with acute tonsillitis (inflammation of the tonsils) showed that Lysobact® leads to faster clinical recovery and faster normalization of laboratory findings.  Lysobact® demonstrates the ability to activate immunobiological forces by reducing the action of antigens on immune cells.  Eradication of the pathogen was achieved in all subjects who received Lysobact® compared to the group who received antibiotic therapy, oral antiseptic, and vitamins.

– Gorbunov EN., Umanec NP.: „Iskustvo sa primjenom preparata Lysobact® kod peritonzilarnog apscesa“ (Experience with the use of Lysobact® in peritonsillar abscess)

Lysobact® has been shown to be very successful in patients with peritonsillar abscess who were included in a control study involving 40 subjects with a diagnosis of peritonsillar abscess. Patients were divided into two groups, one who would receive Lysobact® and antibiotic therapy and the other who would receive only Lysobact® without antibiotics.  In both groups, there was an improvement in the clinical picture, and in the group receiving Lysobact® alone, a significantly higher number of children did not show the need for additional antibiotic therapy.  Lysobact® has been shown to be a safe drug without side effects.

Other references:

  • Čopjak V., Gavriljak G. The experience of use of Lysobact in treatment of chronic tonsillitis and/or pharyngitis.
  • Burmak J.G. et al. The experience with use of Lysobact in treatment of acute respiratory virus diseases in children.
  • Katravenkova N. P. Use of Lysobact in treatment of infective mononucleosis.
  • Gorbuzov Z.N., Umanec N.P. The experience with use of Lysobact in treatment of paratonsillar abscessus.
  • Djumin O.V.,Tagunova I.K. The experience with use of Lysobact in the practice work of otorhinolaryngologist.
  • Gricaj S.O. Efficacy of Lysobact in treatment of acute and chronic oral candidiasis.
  • Sideljkova L.F. Report on clinical investigation of efficacy of Lysobact and Stomatidin in treatment of parodontal disease.
  • Kucevljak V.F. The experience with Lysobact in clinic for therapeutic stomatology.
  • Arifhodžić F. Expert report on the clinical documentation of Lysobact 2000.
  • Gospodarski I.J., Govda O.V. Use of Lysobact as complex treatment of chronic subatrophic pharyngo-laryngitis in patients with AIDS.
  • Dedišin L.P., Njanjkovski S.L., Sekretar L.B., Senik L.R., Galapač O.S. Use of Lysobact in prevention of acute respiratory virus infections in children.
  • Prohorov et al. The experience with use of Lysobact in children with bronchial asthma and chronic sore throat.
  • Garjuk G.I. Timošenko J.V., Ševčenko A.M., Čuvakov A.M. Efficacy of Lysobact use after tonsillectomy and surgical opening of paratonsillar abscessus.
  • Lesovaja et al. Clinical and mycrobiological efficacy of Lysobact in treatmetn of diseases of maxilloafacial area.
  • Parpalej E.A., Novickij A.V. Preventive therapy with Lysobact in treatment of dental caries in children.
  • Romanenko I.M., Afonjin S.L. Efficacy of treatment with Lysobact in treatment of different diseases of oral cavity in patients with dermatosis of different etiology.
  • Kosenko K.N., Zaporožec N.N. Clinical and immunological aspects ofuse of Lysobact in treatment of lateral gingivitis in children.
  • Kucevljak V.F., Babić E.M., Ciganova N.B. Lysobact in pharmacotherapy of inflammatory parodontal diseases.

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