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OBJECTIVE@#Taking artificial hip joint test as the object, integrating ISO/IEC 17025 and GLP, and establishing a new set of management requirements for test influence factors.@*METHODS@#The requirements of ISO/IEC 17025 and GLP regulations for influencing factors were compared and analyzed, the similarities and differences were found, and the two were integrated to formulate new management requirements for each influencing factor.@*RESULTS@#From the personnel, equipment, materials, methods, reports, filing and other factors, a set of management requirements in line with ISO/IEC 17025 and GLP was formulated, so that the laboratory can provide the objective, real and accurate test data for medical equipment manufacturers and regulatory authorities.@*CONCLUSIONS@#It can improve the test quality of the laboratory and ensure the authenticity and reliability of the test data and conclusions.
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Reproducibility of Results , Laboratories , Hip JointABSTRACT
Objective@#A retrospective research was made to summarize the clinical characteristics, treatment methods, results of the adult cases with sagittal fracture of mandibular condyle (SFMC).@*Methods@#One hundred and fifty-one cases of hospitalized patients were enrolled. The age, sex, etiology, level of fracture, degree of displacement, associated facial fractures, treatment methods and results were retrospectively analyzed.@*Results@#The patient′s age ranged from 16 to 81 years old, with a median age of 38.5 years. The male to female ratio was 2.97∶1. The most involved age group was 20-29 years old [35.1% (53/151)]. Falls [53.6% (81/151)] were the most common cause. According to the classification of He (2009) and Duan (2011), the most common type of SFMC was type A [60.5% (130/215)] and the displacement type [80.9% (174/215)]. Eighty-six point zero percent (185/215) of SFMC were treated by surgery. The surgical rates of type A, B and M fractures were 91.5% (119/130), 79.6% (43/54) and 88.5% (23/26), with significant differences between the groups (P<0.05). The surgical rates of the displacement and dislocation type were 89.7% and 100%, with significant differences. The differences between the fixations of type A, type B and type M fractures were statistically significant. The follow-up results showed that, 78.7% (59/75) of patients treated with surgery had normal occlusion, no joint symptoms and no limited mandibular movement. Patients treated with conservative therapy had good occlusion and an average maximum mouth opening of 36.25 mm with malunion occurred in 5/6 of the condyles.@*Conclusions@#Under appropriate surgical indications, surgical treatment of SFMCs could achieve significantly better outcomes than conservative treatment.
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Objective: To evaluate the clinical results of intermaxillary fixation screws used in the management of oral and maxillofacial bone fracture. Methods: The clinical and imaging data of 166 cases of oral and maxillofacial bone fractures treated by intermaxillary fixation screws were analyzed retrospectively with the implant location,numbers and the complications of the treatment. Results: 668 intermaxillary fixation screws were used in the 166 cases,at an average of 4 screws per case. The occlusal relationship of the patients was perfect after 1 week traction. Radiographs showed 105 screws (15. 7％) reached the superficial layer of dentin,middle or deep layer in 14 cases (2. 1％),and root canal injury in 2 cases(1. 2％). No intermaxillary fixation screw was broken,loosened or fallen off. Conclusion: Intermaxillary fixation screws can be effectively used in the management of oral and maxillofacial bone fracture. For the most cases,4-6 screws can meet the needs. Root injuries and other complications should be avoided.
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Objective To evaluate the wound healing efficacy of negative pressure wound therapy (NPWT) combined with topical oxygen therapy ( TOT ) on the traumatic chronic wounds , and to explore new conception and method for traumatic chronic wounds . Methods Sixty-four patients with traumatic chronic wounds were randomized into two groups ( n=32 ) .Patients in the control group were treated by NPWT , and those in the intervention group were treated by NPWT and NPWT with TOT 3L/min.The treatment time lasted 12 days, and the dressing and tubes were changed every three days in the two groups .After 12 days, all the pa-tients were treated by standard moist therapy or surgery until healing or three months .Indicators of observation: The pressure ulcer scale for healing (PUSH) scores and granulation covered rate at 0, 3, 6, 9, and 12 days were measured, and healing rate and healing time during three months were calculated in the two groups . Results The PUSH scores were declined with intervention time during 12 days in the two groups , indicating the treatment was effective , but there was no significant difference between the two groups ( P>0 .05 ) .The granulation covered rate was increased with intervention time , and the granulation covered rate was higher in the intervention group than in the control group(P<0.001).The healing rate was higher in the intervention group than in the control group (87.50%vs 59.38%, P<0.05 ).The healing time of 14 days was shortened in the intervention group compared with the control group (P<0.001). Conclusion NPWT combined with TOT is an effective and feasible method for complicated traumatic chronic wounds , which can en-hance granulation growth , rise healing rate and shorten healing time .
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Objective To investigate the bacteria identification and clinical features of brucellosis in Qingdao City.Methods A retrospective analysis was performed on the clinical data,including general situation,clinical symptom,bacterial culture and laboratory findings,etc of 34 patients with brucellosis in the Affiliated Hospital of Qingdao University from April 2010 to November 2014.Results Among the 34 patients,24 were male and 10 were female,aged from 12 to 71.The main clinical manifestations included fever,diaphoresis and arthralgia,and merged multiple organ symptoms.After cultured for 3 to 5 days,16 blood samples were positive,6 tissue samples were positive,with 2 positive in both samples.Thirty-four cases were identified Brucella species.Besides liver parameters abnormality and anemia,elevation of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were the most common laboratory findings.Patients got better prognosis after antibiotic combination therapy.Conclusions With increasing numbers of brucellosis cases in non-endemic areas,we should pay attention to bacteriological culture and other confirmation tests.On the other hand,techniques such as morphology and growth characteristics of Brucella should be mastered to prevent laboratory infection.
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Objective Pressure Ulcer Scale for Healing ( PUSH) was published in 1998 by National Pressure Ulcer Advisory Panel ( NPUAP) as a tool to evaluate the effects of pressure ulcer care.This study aimed to verify the reliability and validity of the Chi-nese version of PUSH in order to provide an efficient and reliable tool for evaluating the effects of pressure ulcer care. Methods Using the Brislin translation model, we translated the English version of PUSH into Chinese and finalized the Chinese version through modifica-tion by an advisory panel, pretests, and verification of its reliability and validity in the care of 126 cases of stage-Ⅱ-Ⅳpressure ulcers. We analyzed the reliability and validity of the scale based on its item scores, content validity, construct validity, Cronbach′s αcoeffi-cient, and test-retest reliability. Results The correlation coefficient value of the total and individual item scores was 0.616-0.963 (P0.85 and the test-retest reliabili-ty coefficients of individual items were 0.826, 0.885, and 0.958, re-spectively ( P<0.01) . Conclusion The Chinese version of PUSH, with its high validity and reliability, can be used to evaluate interven-tion effectiveness of Chinese patients with pressure ulcers.
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Objective To describe the clinical application of microvascular anastomotic device in head and neck reconstruction.Methods From July,2013 to November,2013,microvascular free flaps were transferred to reconstruct the defects simultaneously after tumor resection of head and neck region in 12 cases in Department of Oral and Maxillofacial Surgery,Peking University School of Stomatology.Microvascular anastomotic coupling devices (MACD) were used in vascular anastomosis.The clinical data were collected and analyzed,including the selection of free flap,diameter of donor and recipient vessels,type of MACD,time of anastomosis,instant patency of anastomosis.The flap was monitored closely after operation and the final survival rate was calculated.Results Twelve microvascular free flaps were done in this series,including 6 fibula flaps,4 forearm flaps and 2 anterolateral thigh flaps.Totally 17 MACD were used by end-to-end anastomosis in this series,including 5 arterial anastomosis and 12 venous anastomosis.The anastomose time using MACD was from 4 to 10 minutes,with a median time 6.8 minutes.The instant patency rate of anastomosis was 100％.There were some blood leakages near the anastomotic stoma in 1 arterial anastomosis using MACD.It was resolved successfully by changing a new MACD.Conclusion Our primary clinical experience showed that the MACD was well suited to the microvascular reconstruction of head and neck defect.The feasibility and reliability was confirmed by our clinical cases.It should be recommended as a safe,fast and reliable adjuvant anastomotic instrument for free tissue transfer.
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ABSTRACT: Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice (GCDMP). Meanwhile, the data management plan (DMP) is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture (EDC) and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors: designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.
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Objective To compare the efficacy and safety of tranexamic acid(TA)and norethisterone(NET)for the treatment of patients with ovulatory menorrhagia in China. Methods Onehundred and thirty one patients with proven ovulatory menorrhagia from gynecologic clinics of 5 teaching hospitals located in 4 different cities in China were enrolled during Jul 2004 to Dec 2006.Ameng them 128 completed the study.Patients were randomly divided into two therapeutic regimen groups:TA 1g thrice daily during menstrual cycle days(D)1-5,69 cases;or NET 5 mg twice daily on D19-26.59 cases.The drugs were administered for 2 consecutive cycles,then withdrawn and patients were followed-up for 1 more cycle.Data on menstrual blood loss [ estimated by pictorial blood assessment chart(PBAC)],length of menstrual periods,quality of life(QOL)evaluated by a 6 item health-related questionnaire were collectedbefore,during each cycle and were compared.Results Both treatments led to significant decreases of mean PBAC scores and shorter duration of menstrual periods,and improved the QOL ranking during the twotreatment cycles.The mean percentages of PBAC decrements in the TA first and second cycles were significantly greater than those in the NET corresponding cycles(35%VS 17%,P=0.004;4J4%VS 34%,P=0.04 respectively).The success rate of TA second cycle was higher than that of the NET second cycle (41%VS 24%,P=0.04).Improvement of QOL ranking in the TA first cycle was also significantly better than those in the NET first cycle ( P=0.03).The percentage of patients with at least 1 adverse event in TA group(19%)was significantly lower than that in NET group(35%,P=0.04).Patients'willingness tocontinue the treatment in the TA second and follow-up cycles(94%,79%respectively)were significantly higher than those in the corresponding cycles of NET groups(79%,59%respectively;P=0.01,P=0.02).Conclusion The regimen of TA 3 g daily during menstrual days 1-5 is a more effective and tolerable treatment than luteal phase norethisterone for patients with ovulatory menorrhagia.