title: Clinical experience with spiramycin in bisphosphonate-associated osteonecrosis of the jaw.
abstract: Bisphosphonate-related osteonecrosis of the jaw (BRONJ) consists of an exposure of the jaw bone that persists for over 8 weeks in patients with positive history for bisphosphonates. Symptomatology is characterized by dull and ceaseless pain, and in advanced stages, the exposure of necrotic bone is evident, which is frequently associated with purulent secretions and faetor oris. Despite many different studies on BRONJ, there are no general guidelines to treat this disease. In this work, the authors present their experience in BRONJ conservative therapy with spiramycin by comparing the results achieved with amoxicillin and clavulanic acid. From January 1, 2008 to June 30, 2008, our department received 25 patients who were affected by osteonecrosis secondary to bisphosphonates. Thirteen had taken bisphosphonates for osteoporosis and 12 for malignancies. We divided the 25 patients into two groups: those who had not received any treatment and those who had received treatment. The first group of 13 patients had been treated only with spiramycin (S). The results from this group were only evaluated to test the efficacy of spiramycin and were not considered in the study. The second group of 12 patients had not undergone any previous treatment. This group was further divided in two groups of 6 patients each; one group was treated with spiramycin and the other with amoxicillin and clavulanic acid (ACA). The following criteria were used to evaluate the results of the study: pain, sensibility deficits, purulent secretion and bone exposure. All group results were evaluated according to the criteria chosen, and positive results were achieved in both groups S and ACA, such as reduction or disappearance of pain, sensibility deficits and purulent secretion and healing of bone exposition, although spiramycin showed itself to be more effective than the combination of amoxicillin and clavulanic acid. Spiramycin is a macrolide antibiotic with a wide spectrum of activity against Streptococci, Pneumococci, Diplococci, Gonococci and Staphylococci, which are typical in BRONJ. No resistance was indicated. Administration of the antibiotics can be intravenous, intramuscular, rectal or oral, which remains the most frequently used since spiramycin elimination also occurs with saliva and the antibiotic reaches high concentrations in the oral cavity where BRONJ is situated. Good compliance to the spiramycin regimen was observed in all three groups, with a general improvement in all of the parameters considered. In only two cases did patients have to undergo surgical curettage. The results showed that spiramycin can be a first choice drug in the treatment of BRONJ, and it should be strongly considered for patients where previous antibiotic therapy did not prove to be effective.
authors.affiliation: Maxillo-Facial Surgery, Complesso Integrato Columbus, Catholic University Medical School, Rome, Italy. giulio.gasparini@rm.unicatt.it
authors.forename: G
authors.initials: G
authors.lastname: Gasparini
authors.forename: G
authors.initials: G
authors.lastname: Saponaro
authors.forename: F
authors.initials: F
authors.lastname: Di Nardo
authors.forename: A
authors.initials: A
authors.lastname: Moro
authors.forename: R
authors.initials: R
authors.lastname: Boniello
authors.forename: D
authors.initials: D
authors.lastname: Cervelli
authors.forename: T M
authors.initials: TM
authors.lastname: Marianetti
authors.forename: G
authors.initials: G
authors.lastname: Palazzoni
authors.forename: S
authors.initials: S
authors.lastname: Pelo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019818:Clavulanic Acid / Q000008:administration & dosage; D004164:Diphosphonates / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007571:Jaw Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010020:Osteonecrosis / Q000188:drug therapy*; D015572:Spiramycin / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D004164:Diphosphonates; D019818:Clavulanic Acid; D015572:Spiramycin; D000658:Amoxicillin