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health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
The lnfluence of Long-Term Treatment with Povidone-lodine on Thyroid Function
Nobukuni K., Hayakawa N., Namba R., Ihara Y., Sato K., Takada H., Hayabara T., Kawahara S.
Bibliographic source:
Dermatology 1997;195 Suppl 2:69-72.

Materials and methods

Study type:
medical screening
Endpoint addressed:
repeated dose toxicity: dermal
Principles of method if other than guideline:
The effect of long-term treatment with PVP-I on thyroid function was to be assessed. In 40 patients of the department of neurology, the status of the use of PVP-I preparations and their effects on serum inorganic iodine levels and thyroid functions were investigated.
GLP compliance:

Test material

Constituent 1
Reference substance name:
Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer
EC Number:
Molecular formula:
Reaction mass of iodine and 2-Pyrrolidinone, 1-ethenyl-, homopolymer
Details on test material:
- Purity: ≥ 92%- pH: ≥ 1 - ≤ 5 (aqueous preparation)
Specific details on test material used for the study:
- Name of the test material: Povidone-iodine (PVP-I)


Type of population:
Ethical approval:
not specified
Details on study design:
The subjects included 40 patients in the neurological ward of the National Sanatorium Minami-Okayama Hospital. Clinical symptoms and the status of the use of PVP-1 were examined. Serum level of total iodine, thyroxine (T2), triiodothyronine (T3), free thyroxine (FT4), free triiodolhyronine (FT3) and thyrotropin (TSH) were determined. The inorganic iodine level in the serum was obtained by subtracting T4 x 0.654 from the serum level of total iodine.Characteristics of the patients:Mean age (year): Treated with PVP-I: 59.0 ± 12.8 (n = 27), not treated with PVP-I 54.0 ± 14.3 (n=13) Sex: Treated with PVP-I Men 17 / woman 10, not treated with PVP-I men 10 / woman 3; In 27 out of 40 patients PVP-l was used continuously for 3 - 133 months (mean ± standard deviation 48.0 ± 33.2). Most underlying diseases in these patients were degenerative diseases of the central nervous system, such as amyotrophic lateral sclerosis, and spinocerebellar degeneration, and all were bedridden. PVP-I was applied on the tracheotomy site in 23 patients, on the external urethral meatus in 16 patients, on the insertion site of a central venous catheter in 3 patients, on the insertion site of a percutaneous gastric tube in 3 patients, the nasal mucosa in 3 patients and an ulcerated skin area in 2 patients. Except for the nasal mucosa and the insertion site of the central venous catheter, PVP-l was applied once a day. PVP-I was used three times a day for the nasal mucosa and twice a week for the insertion site of the central venous catheter.

Results and discussion

Clinical Symptoms and the Status of the Use of PVP-I: Clinical Symptoms considered to be attributable to thyroid dysfunctions were seen in none of the subjects, nor was goiter observed in any of the patients. Effects of treatment with PVP-I on serum levels of inorganic Iodine, TSH and Thyroid Hormones: Serum inorganic iodine level was significantly elevated in 27 patients treated with PVP-I. In 27 patients treated with PVP-I, levels of FT4 and T4 were significantly increased. In 8 out of 27 patients, the FT4 level was elevated over the normal range. In levels of TSH, T3 and FT3, no significant intergroup difference was seen. However, out of 27 patients with PVP-I treatment, TSH was elevated higher than the normal range in 3 patients, and decreased below the normal range in 1 patient, and FT3 showed an increase in 1 patient and a decrease in 6 patients.Evaluation of thyroid functions of patients treated with PVP-I: In 1 of 3 patients with an increase in TSH, a decrease in FT3 was observed. ln the other 2 patients, both FT4 and FT3 were normal. These 3 patients with increases in TSH are considered to have subclinical hypothyroidism. In 1 of 8 patients with increases in FT4, increases in FT3 and decreases in TSH were also observed. This patient was considered to have mild hyperthyroidism. In the remaining 7 patients, the TSH was normal. Although not conclusive, these 7 patients are suspected to have subclinical hyperthyroidism. In these 11 patients with abnormal changes in TSH or FT4, anti-thyroid-peroxidase antibody, ant-thyroglobulin antibody and TSH receptor antibody were determined. Negative results were obtained for all of them. It is highly possible that 5 patients with normal TSH and decreased FT3 have euthyroid sick syndrome.Correlation between duration of treatment with PVP-I, Serum inorganic iodine, TSH and Thyroid Hormones: In 24 patients out of 27 patients treated with PVP-I, a correlation between the length of time in which PVP-I was given and the levels of serum inorganic iodine TSH, FT4 and FT3, were determined. The other 3 patients were excluded, because an increase was seen in TSH. No indication of a reverse correlation between the duration of treatment with PVP-I and the TSH level was found. The duration of PVP-I treatment was significantly correlated with the serum FT4 level and also with the serum FT3 level. There was a significant correlation between the duration of treatment with PVP-I and the serum FT4 level. In addition the FT level was elevated above the normal range in 6 out of 11 patients treated with PVP-I for more than 40 months. No correlation was seen between serum levels of inorganic iodine and other parameters.

Applicant's summary and conclusion