青蒿琥酯皮肤擦剂在小鼠和兔体内的药代动力学研究

将青蒿琥酯溶于苯二甲酸二甲酯,加适量氨酮制成皮肤擦剂。给兔脱毛后,皮肤涂抹此擦剂25mg/kg后,血药浓度达峰时间平均为2 h,峰浓度平均为1.80μg/ml。药物在兔体内平均驻留时间为3.54 h,清除半衰期约为2.46 h。给小鼠脱毛皮肤涂抹擦剂6.7,31.3和71.4 mg/kg,血药浓度在给药后0.5～4 h达高峰,峰浓度分别为0.82,2.05和7.11μg/ml,体内药物平均驻留时间为3.39,2.79及3.54 h,清除半衰期为2.35,1.93及2.45 h。可见,给兔及小鼠皮肤擦剂后,青蒿琥酯吸收良好,血药浓度维持时间较长。     

Graded Pneumatic Dilation using Rigiflex Achalasia Dilators in Patients with Primary Esophageal Achalasia

Pneumatic dilation is the initial therapy for primary esophageal achalasia. Recently, polyethylene balloon (Rigiflex) dilators have been used with varying success and complication rate. We performed a total of 47 dilations in 29 consecutive patients with achalasia using the Rigiflex dilators. The 3.0-cm balloon was always used first. If there was no symptomatic response, a 3.5-cm balloon was used after 4–8 wk. If there was still no symptomatic response after 4-8 wk, a 4.0-cm dilator was used. Eighteen (62%) patients were successfully dilated with a 3.0-cm balloon only. Of 11 patients not responding to a 3.0-cm balloon, five were dilated successfully with a 3.5-cm balloon. Of six patients not responding to a 3.5-cm balloon, four were successfully dilated with a 4.0-cm balloon dilator. Two patients eventually required surgery. The overall success with Rigiflex balloon dilator was achieved in 27 of 29 (93%) patients. There were no complications. We conclude that pneumatic dilation for esophageal achalasia performed in a graded fashion starting with Rigiflex 3.0-cm balloon dilator has a high success rate without complications in patients with achalasia.     

Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018

BackgroundThe prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants.Materials and methodsThe US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature.ResultsAmong 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion.ConclusionOur study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants.Level of evidenceLevel IV; Case Series from Large Database Analysis; Treatment Study.