空军医学杂志
空軍醫學雜誌
공군의학잡지
MEDICAL JOURNAL OF AIR FORCE
2014年
3期
159-161
,共3页
闫小彬%孙鹏%周华%李晓舒%胡立晓
閆小彬%孫鵬%週華%李曉舒%鬍立曉
염소빈%손붕%주화%리효서%호립효
医疗器械%临床试验%数字化摄影
醫療器械%臨床試驗%數字化攝影
의료기계%림상시험%수자화섭영
Medical device%Clinical trial%DR
目的:总结数字化医用诊断X射线摄影系统(TFDR-20)的临床初期应用经验,验证其有效性及安全性。方法应用数字化医用诊断X射线摄影系统(TFDR-20)对270例患者进行胸部正位90例(含10例正侧位)、腹部平片90例、骨与软组织90例(头部正侧位、腰椎正侧位、骨盆/髋关节正位)X射线检查,之后按照图像质量评判标准对每个投照部位的每张图像进行临床诊断要求符合率评价,以及设备在使用操作过程中的便捷性、稳定性及安全性满意度评价。结果胸部临床诊断要求符合率为100%(90/90)、腹部临床诊断要求符合率为100%(90/90)、骨与软组织临床诊断要求符合率为95.18%(79/83),机器使用便捷性、稳定性及安全性满意度均为100%。结论数字化医用诊断X射线摄影系统(TFDR-20)在临床初期应用过程中,其有效性及安全性结果满意,可广泛应用于临床。
目的:總結數字化醫用診斷X射線攝影繫統(TFDR-20)的臨床初期應用經驗,驗證其有效性及安全性。方法應用數字化醫用診斷X射線攝影繫統(TFDR-20)對270例患者進行胸部正位90例(含10例正側位)、腹部平片90例、骨與軟組織90例(頭部正側位、腰椎正側位、骨盆/髖關節正位)X射線檢查,之後按照圖像質量評判標準對每箇投照部位的每張圖像進行臨床診斷要求符閤率評價,以及設備在使用操作過程中的便捷性、穩定性及安全性滿意度評價。結果胸部臨床診斷要求符閤率為100%(90/90)、腹部臨床診斷要求符閤率為100%(90/90)、骨與軟組織臨床診斷要求符閤率為95.18%(79/83),機器使用便捷性、穩定性及安全性滿意度均為100%。結論數字化醫用診斷X射線攝影繫統(TFDR-20)在臨床初期應用過程中,其有效性及安全性結果滿意,可廣汎應用于臨床。
목적:총결수자화의용진단X사선섭영계통(TFDR-20)적림상초기응용경험,험증기유효성급안전성。방법응용수자화의용진단X사선섭영계통(TFDR-20)대270례환자진행흉부정위90례(함10례정측위)、복부평편90례、골여연조직90례(두부정측위、요추정측위、골분/관관절정위)X사선검사,지후안조도상질량평판표준대매개투조부위적매장도상진행림상진단요구부합솔평개,이급설비재사용조작과정중적편첩성、은정성급안전성만의도평개。결과흉부림상진단요구부합솔위100%(90/90)、복부림상진단요구부합솔위100%(90/90)、골여연조직림상진단요구부합솔위95.18%(79/83),궤기사용편첩성、은정성급안전성만의도균위100%。결론수자화의용진단X사선섭영계통(TFDR-20)재림상초기응용과정중,기유효성급안전성결과만의,가엄범응용우림상。
Objective We planned to demonstrate the effectiveness and safety of Digital Radiography (TFDR-20) in primary clinical application. Method We used Digital Radiography (TFDR-20) to have an X-ray checked in 270 cases, including chest PA radiograph in 90 cases (including 10 chest PA& LAT within it), plain abdominal radiograph in 90 cases, bone and soft-tissue radiograph in 90 cases (including skull AP & LAT, L-spine AP & LAT, pelvis and hip AP), the coincidence rate of the clinical diagnose of each X-ray image was assessed according to the evaluation criteria of image quality, and the satisfaction evaluation of convenience, stabilization, safety in the process of device used. Results Chest coincidence of clinical diagnose was 100% (90/90), plain abdominal coincidence of clinical diagnose was 100% (90/90), bone and soft-tissue coincidence of clinical diagnose was 95.18% (79/83), and the satisfaction evaluation of convenience, stabilization, safety of device were 100%.Conclusion The effectiveness and safety are satisfied by the primary clinical application of Digital Radiography (TFDR-20); therefore, it can be widely applied clinically.