Given the possibility of ERR associated with third molar impaction, the prophylactic removal of these impacted teeth could be considered especially for those patients with over 35 years and mesially and horizontally impacted teeth.
Spontaneous malignant transformation in craniomaxillofacial fibrous dysplasia (FD) is extremely rare and its clinicopathological characteristics remain largely unknown. Here, we aimed to characterize the epidemiology and clinicopathological features of malignancies arising from preexisting FD by presenting data from a Chinese tertiary referral hospital and review of English and Chinese literatures. The craniomaxillofacial disease registry of Shanghai Ninth People's Hospital was searched and reviewed to collect relevant information for patients diagnosed as malignant transformation in craniomaxillofacial FD between January 1993 and December 2010. An English and Chinese literature review was conducted to retrieve pertinent cases published in the past 2 decades with preset inclusion criteria. All included cases were further analyzed with regard to associated clinical and pathological variables. Three cases with osteosarcoma arising from previous craniomaxillofacial FD were found at our institution and 35 other cases were identified by literature review. These uncommon entities usually occurred in adults with a mean age of 39.8 years and equal gender preponderance. Maxilla remained the most common sites for malignancies followed by mandible and zygoma. Most malignancies were diagnosed as osteosarcoma followed by fibrosarcoma, chondrosarcoma, and malignant fibrous histiocytoma. Radical resection alone or with postoperative radiotherapy/chemotherapy remains the main treatment strategy with unfavorable prognosis due to local recurrence and distant metastasis. Taken together, our findings might for the first time provide the comprehensive information regarding the epidemiology, clinicopathological features, treatment, and prognosis of malignancies in craniomaxillofacial FD. Further investigations are warranted to improve early diagnosis and proper treatment for these uncommon entities.
IntroductionHydroxychloroquine (HCQ), 4-aminoquinoline, is an antimalarial drug and has become a basic therapy for rheumatic disease treatment. It can stabilize the condition of SLE patients and reduce the chances of patient relapse through its immunosuppressive function and antiinflammatory effects. This drug was absorbed completely and rapidly by oral administration, but has a prolonged half-life for elimination. The objective of this study was to evaluate the pharmacokinetic parameters and relative bioequivalence of a new generic (test) formulation with the branded (reference) formulation of HCQ in healthy Chinese male volunteers. This study was designed to acquire regulatory approval for the test formulation.MethodsThis study was conducted with a randomized, single-dose, two-period, and crossover design. The male subjects were randomly assigned to two groups at a 1:1 ratio to receive 0.2 g hydroxychloroquine sulfate tablets (0.1 g/piece) of the two formulations after a 3-month washout period then administered the alternate formulation. Study drugs were administered after overnight fasting (over 10 h). Plasma concentrations of hydroxychloroquine were measured by a validated LC-MS/MS method. The following pharmacokinetic properties were determined by a noncompartmental pharmacokinetic method: Cmax, Tmax, AUC0–t, AUC0–∝, and t1/2. The bioequivalence between the test and reference products was assessed based on the following parameters: Cmax, AUC0–60d, and AUC0–∝ using the ANOVA method. If the 90% CI for AUC0–t was within 80–125% and for Cmax was within 70–143% of the statistical interval proposed by the SFDA, the two formulations were assumed bioequivalent. Concerning the main pharmacokinetic charateristics of hydroxychloroquine, a long half-life drug, the pharmacokinetic parameters of 0–72 h were determined according to the FDA. Furthermore, a comparison was made between the parameters at 0–60 days and 0–72 h to evaluate whether a truncated AUC method can be applied to estimate the relative bioavailability of HCQ. Tolerability was assessed by monitoring vital signs and laboratory tests and by questioning subjects about adverse events.ResultsThe 90% CI of Cmax for HCQ is 103.8–142.3%; the AUC0–60 is 100–114.2% and AUC0–∝ 100–115.5%. Both met the criteria according to the SFDA’s guidelines for bioequivalence. The relative bioavailability was 109.5% (according to AUC0–60d) and 110.7% (according to AUC0–∝). No serious or unexpected adverse events were observed.ConclusionsIn this study, the pharmacokinetic studies and results were conducted so that the test and reference formulations of HCQ met the Chinese criteria for assuming bioequivalence. Both formulations were well tolerated in the population studies.
BackgroundEctopic mandibular third molar is a rare clinical entity with incompletely known etiology. Here, we sought to delineate its epidemiological, clinical and radiographic characteristics, and therapy by integrating and analyzing the cases treated in our institution together with previously reported cases.MethodA new definition and classification for ectopic mandibular third molar was proposed based on its anatomic location on panoramic images. Thirty-eight ectopic mandibular third molars in 37 patients and 51 teeth in 49 patients were identified in our disease registry and from literature (1990–2016), respectively. These cases were further categorized and compared according to our classification protocol. The demographic, clinicopathological and radiographic data were collected and analyzed.ResultsThese ectopic teeth were categorized into four levels, 33 in level I(upper ramus), 32 in level II (middle ramus), 15 in level III (mandibular angle) and 9 in level IV (mandibular body). The common clinical presentations included pain, swelling and limited mouth opening, although sometimes asymptomatic. Most teeth were associated with pathological lesions. Treatments included clinical monitor and surgical removal by intra- or extraoral approach with favorable outcomes. Clinical presentations and treatment options for these teeth were significantly associated with their ectopic locations as we classified.ConclusionsEctopic mandibular third molars are usually found in patients with middle ages and in upper and middle ramus of mandible. Surgery is preferred to remove these ectopic teeth and associated pathologies when possible.
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