EFFICACY AND SAFETY OF USE OF IODIXOL MEDICINE

УГК 616.322+616.31]-002-053.3/.5:615

EFFICACY AND SAFETY OF USE OF IODIXOL MEDICINE, MANUFACTURED BY «MICROPHARM» LLC AT TREATMENT O STOMATITIS, ACUTE TONSILITIES (ANGINA), RECRUDESCENCE OF CHRONIC TONSILITIES IN CHILDREN
 

Mariya Evgenivna Fesenko, doctor of medicine sciences, professor, Liliya Yuriivna Ovsyuk, pharmaceutist, Tatyana Volodymyrivna Kabika, The Head of family practice outpatient clinic, Olena Volodymyrivna Gorolyuk, therapeutist.

Ukrainian medical stomatological Academy

Resume.

The dynamics of the course and of the end of the disease in 50 children with stomatitis, acute tonsillitis (tonsillitis), acute exacerbation of chronic tonsillitis, taking in the account the efficacy and safety of the use of iodixol in complex ethiotropic treatment is presented here.  The efficacy of the medication has been observed, depending on the nosological form of the disease. According to the data obtained, the efficacy of Iodixol has been observed starting from the second day of treatment in 38 (76%) children surveyed – improvement of the general condition, reduction of the sore throat and hoarseness, and decrease of the number of mouth ulcers were seen.  In 12 (24%) children with stomatitis and follicular tonsillitis, on the third day of treatment the temperature returned to normal, symptoms of poisoning became less severe, appetite improved, and mouth ulcers disappeared. On the 5th – 7th day, in 47 (94%) patients general condition became satisfactory, the temperature was normal; there were no complaints, which we considered a recovery. In three patients, which are 6%, after the combination therapy, the sub febrile temperature was observed which we interpreted as an improvement of the patient’s clinical condition. Evidence of the long-term effectiveness of Iodixol was catamnestic observation of children within six months after the treatment, compared with the similar period before treatment.

Keywords:  disease, treatment, Iodixol of "Micropharm" LLC production.

Introduction

The correct choice of medicines for children should be focused on drugs with the lowest risk of side effects. The widespread use of drugs in the form of sprays helps to avoid systemic effect and achieve long-term contact with the mucous membranes of the oral cavity and pharynx, which, of course, increases the safety of pharmacotherapy. Iodixol medicine produced by "Micropharm" is an antiseptic formulation for topical treatment of throat and mouth with angina (catarrhal, follicular, and streptococcal), tonsillitis, glossitis, aphthous stomatitis. The action of the medicine is based on the fact that when in contact with skin and mucous membranes releases the iodine, which exhibits antiseptic properties due to its high oxidizing power. Just thanks to this capability the medicine manifests bactericidal, fungicidal, sporocidal and selective antiviral activity, is active as related to the protozoans. The main active ingredients of the Iodixol medicine is povidone-iodine (30 g of the medicine contains 2.55 g of povidone iodine), a water-soluble complex compound of iodine with non-toxic synthetic polymer - povidone. Allantoin in Iodixol medicine exhibits anti-inflammatory and reparative action, enhancing the effect of povidone-iodine. In addition to ability to stop the growth of bacteria, allantoin softens mucosa, relieves irritation and stimulates cell regeneration as well. The combined effect of Iodixol medicine causes a rapid blocking of stomatitis and tonsillitis symptoms, as well as prevents the spread of infection on the respiratory tract and prevents the development of complications. For 6 to 10 years old children the Iodixol medicine can be used only on prescription o the doctor.  Treatment course depends on the nature and severity of the disease and is determined individually by your doctor.

Objective: Study of the efficacy and safety of the Iodixol medicine, manufactured by "Micropharm" in children.

Materials and methods. 50 children in the age of 6 years and over were studied. They were divided into two age groups: first - 6-17 years old, second - 17 years and over. The number of children in each group and their distribution according to gender are shown in Table 1.

Table 1. Distribution of children surveyed by age and gender

Treatment of children was carried out in outpatient conditions COD2 of Children's City Hospital of Poltava city. According to the past medical history the surveyed children were sickly. At the time of the survey in 10 (20%) patients was diagnosed stomatitis. Children complained of fever, oral pain, poor appetite, presence of ulcers on the oral mucous membrane. 18 (36%) children had manifestations of acute tonsillitis (angina), accompanied by sore throat, intoxication, fever up to 38 ° C, deterioration of appetite. Recrudescence of chronic tonsillitis was noted in 22 (44%) patients with the presence of low grade temperature and sore throat (Figure 1).

Figure 1. The structure of the surveyed children diseases.

Дети, находившиеся под наблюдением, получали базисную комплексную етиотропную терапию с учетом нозологических форм заболевания и общего состояния ребенка. Базисная терапия включала антибактериальное (антибиотики), противовирусное (виферон), витаминотерапию (витамины группы А, Е, В, С), препарат Йодиксол. При лечении ангины и тонзиллита, препарат Йодиксол применяли путем введения распылителя на 2-3 см в полость рта, закрывали рот, задерживали дыхание и нажимали до упора на распылитель указательным пальцем дважды так, чтобы одно орошение было осуществлено в правую сторону, а второе - в левый бок. При лечении афтозного стоматита подводили распылитель к пораженному участку и делали 1 - 3 распыления до тщательного увлажнения пораженного участка. Применяли препарат 2 - 4 раза в сутки, при необходимости - через каждые 4 часа. По показаниям назначались ферменты, биопрепараты, препараты кальция, антистафилококковая терапия.

Children under surveillance received basic ethiotropic comprehensive therapy taking into account nosological entity of the disease and general state of the child. Basic therapy included antibacterial (antibiotics), antiviral (viferon), vitamin therapy (vitamins of A, E, B and C groups), Iodixol medicine. When treating the angina and tonsillitis, Iodixol medicine was used through injection of the sprayer for 2-3 cm in the mouth, shut the mouth, hold the breath and pressed up to the stop at the dispenser with the forefinger twice so that one irrigation was carried out to the right side, and the second - to the left side. When treating aphthous stomatitis the sprayer was placed close to the affected area and 1 - 3 spray injections were made till the thorough wetting of the affected area. The medicine was used 2-4 times a day; if necessary - every 4 hours. According to the indications were prescribed enzymes, biological products, calcium supplements, antistaphylococcal therapy.

Clinical observations results and their discussion.

The efficacy of the treatment in children, treated with ethiotropic combined and  Iodixol drug, we evaluated taking into account the nosological form of the disease, especially its course, the percentage of improvement in general condition, recovery and the presence of complications. With regard to the characteristics of the disease, it can clearly be seen a positive trend during the combined therapy with the use of the Iodixol drug. In particular, in 38 (76%) of the surveyed patients on the second day of the disease has improved the overall state, decreased pain in the throat and hoarseness, decreased the number of ulcers in the mouth. In 12 (24%) children with stomatitis and follicular tonsillitis, on the third day of treatment the intoxication became less expressed, appetite improved and mouth ulcers disappeared. On the 5th – 7th day, in 47 (94%) patients the general condition became satisfactory, the temperature was normal, there were no complaints, which we considered a recovery. In three patients, which are 6%, after the combined therapy, the sub febrile temperature was observed which we interpreted as an improvement of the patient’s clinical condition (Figure 2).

Figure 2. The effectiveness of combined therapy at the treatment of stomatitis, acute tonsillitis (angina), exacerbation of chronic tonsillitis in children with the use of Iodixol drug on a background of basic therapy.

As an evidence of the long-term effectiveness of Iodixol became catamnestic observation of children within six months after the treatment, compared with the similar period during treatment. As an example, we give catamnestic observation for the three children in the treatment of which has been assigned Iodixol drug. The first patient, a girl N 17 years, in a history of which were noted frequent (3-4 times per year) diseases associated with exacerbation of chronic tonsillitis, accompanied by severe intoxication. In October 2013, the disease was accompanied by a rise in temperature to 38 ° C, sore throat, and headache. It was diagnosed with follicular tonsillitis and prescribed antibacterial therapy (antibiotics of penicillin range), rinse of throat with Furacilin, loratadine. On the fifth day of the disease the girl status deteriorated, the temperature rose to 39 ° C, increased pain in the throat and appeared intoxication. Otolaryngologist diagnosed paratonziliar abscess as a complication of the disease. The girl was hospitalized and operated with the prescription of infusion therapy and additional injection of metrogil. After the treatment the girl's condition improved and with satisfactory condition she was discharged home. For four months in 2013 - she was not sick. In October 2014, it was re-diagnosed follicular tonsillitis. The patient received treatment in outpatient conditions: antibiotics (ampicillin), rinse of throat, Claritin, additionally were prescribed Iodixol spray 4 times a day for 10 days. On the second day after prescription of the Iodixol drug in the combined therapy, the girl's state improved - reduced the manifestation of intoxication, the temperature dropped to 37.5 ° C. On the third day reduced the pain in the throat, appetite improved, the temperature gone, there were no complaints. On the fifth day the general state was satisfactory, the temperature normalized, there was a slight hyperemia of the throat, there was no intoxication, no complications were detected. At follow-up supervision within six months of 2014-2015, the patient was healthy. Here is also an example of follow-up observations over the patient S, 7 years old, with acute exacerbation of chronic tonsillitis o staphylococcal etiology, with comorbidity of the girl MARS, bend in the upper third of the gall bladder, alopecia areata. At examination, the girl's state was satisfactory - low-grade fever, but expressed intoxication, auditioned systolic murmur in the second intercostal space on the left, amygdalas were hypertrophied, loose, it was present congestion in the throat, in the hairy part of the frontal bone on the right it was manifestation of local alopecia with the size of 1, 5 cm by 1.5 cm. It was assigned the complex therapy, which included multi-vitamins, enzymes, biological products, antistaphylococcal therapy, as well as spray Iodixol 3 times a day for 7 days. Following the appointment of the complex therapy with the Iodixol drug, the girl's state improved on the second day, decreased toxicity, sore throat, congestion of oropharynx. On the third day of observation the temperature returned to normal, disappeared intoxication, sore throat. After 2 weeks of complex treatment with the inclusion o Iodixol drug, in a bacterial inoculation from nose and throat of a child the pathogenic flora, in particular Staphylococcus aureus was not detected. Over the next 6 months the girl was healthy; in addition it was noted presence of hair growth in the area of ​​alopecia. The following example of follow-up o the girls V, 13 years old, who is on the dispensary for diseases with frequent exacerbations of chronic sub compensated tonsillitis (up to 6 times a year) who came with complaints, accompanied by sore throat, hoarseness. On the second day of the treatment the general state of the girl has improved, decreased the pain in the throat and hoarseness. On the fifth day decreased congestion of oropharynx and recovered the voice (hoarseness disappeared). Following the complex therapy with multivitamins, biologic products and Iodixol spray, for 6 months in 2015, the girl was healthy. During the treatment of patients with follicular tonsillitis and stomatitis, children sometimes noted the presence of heartburn in the throat in the first days of treatment, which is probably due to the reaction of the damaged by inflammation of the mucous membrane on the effect of the drug. Deterioration of children's state during the treatment was not reported.

Conclusions

On the basis of observations of children after a combined treatment using Iodixol drug manufactured by "Micropharm" Company, according to catamnesis, we can conclude that the use of Iodixol drug in the causal treatment of children with stomatitis, tonsillitis and acute exacerbation of chronic tonsillitis was effective, long-term, without complications.