Teadusartikli kokkuvõte:

• Selleks, et hinnata kloriini sisaldavate vee desinfitseerijate ohutust ja mõju inimesele, viidi läbi kontrollitud uurimistöö.
• Kliiniline ainete hindamine viidi läbi kolmes faasis, nagu uurimisjärgus olevate ravimite puhul enamasti tehakse.
• Esimeses faasis tehti ainete tolerantsuse katse, uurides akuutseid mõjusid progressiivselt kasvavate kloriini sisaldavate desinfitseerijate dooside korral vabatahtlikele meessoost tervetele isikutele.
• Teises faasis uuriti desinfitseerijate mõju oraalsel tarbimisel kontsentratsioonide korral 5mg/l kaheteistkümne järjestikuse nädala jooksul. Isikud, kel on madal “glucose-6-phosphate dehydrogenase”, võivad olla tundlikud oksüdatiivse stressi suhtes; seetõttu uurimistöö kolmandas faasis anti neid aineid kontsentratsioonis 5 mg/l igapäevaselt kahetesitkümne järjestikuse nädala jooksul väiksemale grupile vabatahtlikele, kes olid potensiaalses riskigrupis.
• Füsioloogilist mõju hinnati kvalitatiivsete ja kvantitatiivsete testide abil.
• Kolmefaasilised kontrollitud kliinilised uuringud kloordioksiidi ja selle võimalike metaboliitide kohta meessoost inimeste peal viidi läbi vahejuhtumiteta.
• Ei leitud ühtki ebasoovitavat kliinilist efeki ühegi katses osalenud vabatahtliku subjekti poolt ega ka katset jälgiva meditsiinilise meeskonna poolt.
• Mõnedel juhtudel avastati statistiliselt märkimisväärsed trendid teatud biokeemiliste või füsioloogiliste parameetrite suunas katse käigus; sellegipoolest, hinnati et ükski neist trendidest ei too kaasa füsioloogilisi tagajärgi.

• Katsest olenemata ei ole võimalik väita, et ei ole võimalust, et pikemate tarbimiseperioodide korral ei muutu trendid kliiniliselt oluliseks.
• Siiski, kuna katse käigus ei ilmnenud ühtegi kahjulikku füsioloogilist toimet, suhteline ohutus suukaudse kloordioksiidi ja selle metaboliitide tarbimise korral on demonstreeritud.

Teadustöö inglise keeles:

Controlled clinical evaluations of chlorine dioxide, chlorite and chlorate in man.

J R Lubbers, S Chauan, and J R Bianchine

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Abstract

To assess the relative safety of chronically administered chlorine water disinfectants in man, a controlled study was undertaken. The clinical evaluation was conducted in the three phases common to investigational drug studies. Phase I, a rising dose tolerance investigation, examined the acute effects of progressively increasing single doses of chlorine disinfectants to normal healthy adult male volunteers. Phase II considered the impact on normal subjects of daily ingestion of the disinfectants at a concentration of 5 mg/l. for twelve consecutive weeks. Persons with a low level of glucose-6-phosphate dehydrogenase may be expected to be especially susceptible to oxidative stress; therefore, in Phase III, chlorite at a concentration of 5 mg/l. was administered daily for twelve consecutive weeks to a small group of potentially at-risk glucose-6-phosphate dehydrogenase-deficient subjects. Physiological impact was assessed by evaluation of a battery of qualitative and quantitative tests. The three phases of this controlled double-blind clinical evaluation of chlorine dioxide and its potential metabolites in human male volunteer subjects were completed uneventfully. There were no obvious undesirable clinical sequellae noted by any of the participating subjects or by the observing medical team. In several cases, statistically significant trends in certain biochemical or physiological parameters were associated with treatment; however, none of these trends was judged to have physiological consequence. One cannot rule out the possibility that, over a longer treatment period, these trends might indeed achieve proportions of clinical importance. However, by the absence of detrimental physiological responses within the limits of the study, the relative safety of oral ingestion of chlorine dioxide and its metabolites, chlorite and chlorate, was demonstrated.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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