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Polyhexanide – Safety and Efficacy As an Antiseptic 707 – 11

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Polyhexanide – Safety and Efficacy As an Antiseptic 707 – 11 REVIEW ARTICLE Review article Polyhexanide – safety and efficacy as an antiseptic 707 – 11 BACKGROUND Polyhexamethylene biguanide hydrochloride/polyhexanide/polyaminopropyl Hilde Fjeld biguanide (PHMB) is used as a disinfectant and antiseptic. This article discusses the use of [email protected] Department of Infection Prevention the substance as an antiseptic. We summarise published data on its antimicrobial efficacy Oslo University Hospital in vitro and its clinical efficacy and safety when used on skin, wounds and mucosa. and RELIS South-East MATERIAL AND METHOD A literature search was conducted in PubMed for articles published Oslo University Hospital in the last five years. Articles available as of June 2014 were considered. Egil Lingaas RESULTS Of 332 articles identified, 27 were included. In vitro studies have demonstrated anti- Department of Infection Prevention Oslo University Hospital microbial efficacy on gram-negative bacteria, gram-positive bacteria and Candida albicans. The clinical trials are small-scale, not well controlled and frequently sponsored by industry. Few adverse effects from the substance were reported. INTERPRETATION Better designed, larger-scale clinical trials of efficacy and safety are MAIN MESSAGE needed in order to give recommendations on the use of polyhexanide on skin, wounds and The clinical efficacy and safety of poly- mucosa. hexanide is poorly documented. In vitro studies have shown antimicrobial In all hospital departments one comes into ment process is underway in the EU for efficacy on gram-negative bacteria, gram- contact with disinfectants (used for techni- approval of PHMB products as biocides positive bacteria and Candida albicans. cal disinfection) and antiseptics (used on (substances for combatting unwanted orga- skin and mucosa) on a daily basis. Chlor- nisms) (2). This assessment will probably Few adverse effects were reported in the hexidine is one of the most commonly used take several years. clinical studies. antiseptic solutions in Norway. It should be Little information is available on poly- Better documentation should be available used with caution in premature infants be- hexanide; however, it is important that before antisepsis with polyhexanide can be cause of the risk of skin irritation and chemi- health personnel have the best possible basis cal burns. This applies in particular to pre- for choosing an antiseptic. We therefore recommended. mature infants weighing less than 1000 aimed at conducting a literature search to grams during their first seven days of life summarise data on the antimicrobial effi- (1). There is thus a need for other antiseptics cacy of the substance in vitro, and its safety that are suitable for this group. and clinical efficacy for use on skin, wounds Disinfection of methicillin-resistant Sta- and mucosa. phylococcus aureus is also an area where more alternative antiseptics are needed – Material and method because of safety aspects in some patient Four searches were conducted in PubMed on groups, and because there are few topical 27 June 2014 with a filter for the previous substances to choose from in the event of five years (Fig. 1). First search: polyhexa- therapeutic failure. There is also a general methylene biguanide (supplementary con- need for antiseptics that are effective against cept). Second search: «Microbial Sensitivity naked viruses (e.g. the norovirus) and spore- Tests» AND «Anti-Infective Agents, Local». forming bacteria (e.g. Clostridium difficile). Third search: text search with «PHMB». In the light of increasing antibiotic resis- Fourth search: «Carrier state» AND «Methi- tance, antiseptics may come to play a greater cillin-Resistant Staphylococcus aureus» (fil- role in the health services. It is essential that ter Clinical Trials). the efficacy and adverse effects of any new The searches resulted in a total of 332 products to be introduced are well documen- hits. We found several review articles on the ted. clinical efficacy and safety of polyhexanide. Polyhexamethylene biguanide hydrochlo- We therefore did not extend the search ride/polyhexanide/polyaminopropyl bigua- further back in time. A review article from nide (PHMB) has been marketed in the USA 2013 was found which discussed the bio- for many decades as a disinfectant. In 2014, chemical mechanisms that are presumed to The Norwegian Medicines Agency approved form the basis for the microbial efficacy of certain products containing the substance as the substance (3), such that past findings in disinfectants for technical use in health care. this area were also well covered. This approval does not encompass antiseptic Review articles and original articles on use in the health services. Products contai- antimicrobial efficacy in vitro, and clinical ning polyhexanide are now increasingly efficacy and safety for use on skin and marketed as antiseptics, while a risk assess- mucosa were included, but case studies were Tidsskr Nor Legeforen nr. 8, 2016; 136: 707 – 11 707 REVIEW ARTICLE PubMed-search 27.6.2014 Filter: Last 5 years Polyhexamethylene biguanide ”Microbial Sensitivity Tests” PHMB ”Carrier state” (Mesh) (supplementary concept) (Mesh) and ”Anti-Infective (text search) and ”Methicillin-Resistant Agents, Local” (Mesh) Staphylococcus aureus” (Mesh) Tilleggsfilter: Clinical Trial n = 64 n = 155 n = 92 n = 21 (48 not included) (153 not included) (74 not included) (None included) Excluded: 305 articles 332 articles 6 due to language 3 not available electronically 287 due to relevance 9 due to overlap 27 articles included Figure 1 Search strategy and results excluded. We assessed their relevance based various materials, the effect of surfactants, excluded. The results of these types of stu- on title and/or abstract. Articles that prima- emulsions, presence of albumin and the effi- dies are frequently difficult to relate to the rily concerned the release of PHMB from cacy of the dressing material itself were overall clinical efficacy, and we did not con- sider them essential in this context. We also excluded articles that were not available electronically, and articles on the treatment of acanthamoeba keratitis and on preserva- tives in contact lens solution to prevent this. H H H ,HCl Articles in English and the Scandinavian lan- N N N guages were included – a total of 27 articles. Chemical properties NH NH n Polyhexamethylene biguanide hydrochlo- ride/polyhexanide/polyaminopropyl bigua- a nide is a biguanide, the molecules of which form a chain (polymer) (Fig. 2). Biguanides are strong bases, and PHMB substances are therefore highly positively charged at phy- siological pH. This is thought to be of con- H H H H H H siderable significance for their mechanism N N N N N N of action, which is not fully understood (3). (CH2)6 Antimicrobial efficacy in vitro NH NH NH NH Cl Cl Koburger and colleagues determined the minimum inhibitory concentration (MIC) and minimum bactericidal concentration b (MBC) of polyhexanide in relation to Ger- Figure 2 Structural formula for a) PHMB and b) chlorhexidine. The biguanide groups are marked. The chemi- man standards (4). The MIC value varied cal structure of PHMB is very similar to that of chlorhexidine. It is therefore possible that PHMB and chlorhexi- from 0.5 mg/l to 4 mg/l, the MBC value from dine have common features with regard to clinical efficacy and safety 1 mg/l to 32 mg/l for selected gram-negative 708 Tidsskr Nor Legeforen nr. 8, 2016; 136 REVIEW ARTICLE Table 1 Overview of the clinical trials, based on the checklist for reporting of randomised clinical trials (CONSORT 2010 Statement) (19). The table also has information on the impact factor of the journals First author (reference) Eberlein (20) Elzinga (21) Sibbald (22) Lenselink (23) Lee (24) Findlay (25) Gentile (26) Gerli (27) Industry-sponsored Yes – Yes Yes – Yes – – Randomised Yes – Yes – Yes Yes Yes Yes Blinding – – Yes – Yes – – Yes Baseline values – demo- Yes Yes Some Some Some Some Only clinically graphic and clinical data irrelevant for each group information Number of patients 38 20 45 28, but only 38 106 100 50 16 who com- pleted Follow-up time 28 days 14 days 5 weeks Max. 24 weeks 12 weeks 13 months 6 months 6 weeks Active treatment/ PHMB in PHMB in PHMB in PHMB in PHMB in PHMB/ PHMB PHMB pessa- control group dressing/ dressing dressing/ dressing dressing/ mupirocine solution/ ries/chlorhexi- Ag dressing regular saline untreated dine pessaries dressing dressing Adverse effects 0 0 Minimal 4 0 The article 00 informs of both milder and more severe adverse effects Journal’s impact factor 2014 1.069 1.069 1.106 1.069 2.765 4.476 Not stated 1.213 and gram-positive bacteria. The results for tion unknown), 0.1 – 0.25 % PHMB and articles are published in journals with a low polyhexanide were somewhat better than for 0.2 % chlorhexidine gluconate had a similar impact factor or with none, and which seem chlorhexidine gluconate. They also compa- antimicrobial efficacy (potency and spec- to show a lack of critical assessment of the red the antimicrobial efficacy of several anti- trum) in an in vitro study of common oral studies discussed. Two of the articles are septics on Staphylococcus aureus, Pseudo- microorganisms (9). industry-sponsored (15, 16), and one of monas aeruginosa and Candida albicans in It has been demonstrated that polyhexa- them lacks information on the authors’ place relation to European standards for the quan- nide in concentrations used for disinfection of work (16). The fourth article (18) reports titative suspension test. For polyhexanide a of swimming pools (50 ppm) does not that one of the authors has applied for a very long exposure time or very high concen- inactivate the adenovirus (10). We have patent for medical equipment with poly- tration was necessary to adequately reduce found few data on the antimicrobial efficacy hexanide as its active agent. the number of bacteria in this test, but the of the substance on mycobacteria in vitro, Selected variables in the clinical trials substance had a somewhat better efficacy fungi other than C.
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