In this paper, we analyse the general information of medical equipment clinical trials by clinical trial process management experience to elaborate the characteristics of the medical equipment clinical trials and the existent problems in our hospital in 10 years. We propose corresponding countermeasures to ensure the quality of medical tests, and improve the management of medical equipment clinical trials in hospital.
Clinical Trials as Topic ; Equipment and Supplies, Hospital ; Humans

Objective:To evaluate the diagnostic efficiency of contrast-enhanced magnetic resonance angiography (CE-MRA), T 1WI and three-dimensional thin-layer T 1WI sequences (3D-T 1WI) in evaluating the blood supply of brain tumors, so as to improve the enhanced magnetic resonance imaging (MRI) scanning scheme of brain tumors. Methods:After the contrast agent was injected, 29 patients with brain tumors were scanned with CE-MRA, T 1WI and 3D-T 1WI. The imaging manifestations of " observing the enhancement of tumor substance" , " observing the small vessels in the tumor body" and " observing the small vessels around the tumor" were qualitatively classified, and the diagnostic differences of the three sequences were analyzed by McNemar test. Results:⑴ In the aspect of " observing the contrast medium in the tumor body" , CE-MRA, T 1WI and 3D-T 1WI sequences diagnosed as grade A1 were 0 cases, 8 cases (27.59%) and 19 cases (65.52%) respectively. The diagnostic efficiency of 3D-T 1WI sequences was better than that of T 1WI sequence ( P<0.05), and T 1WI sequence was better than that of CE-MRA sequence ( P<0.05). ⑵ In the aspect of " observing the small vessels in the tumor" , CE-MRA, T 1WI and 3D-T 1WI sequences diagnosed as grade B1 were 8 cases (27.59%), 5 cases (17.24%) and 16 cases (55.17%), respectively. The diagnostic efficiency of 3D-T 1WI was better than that of T 1WI and CE-MRA ( P<0.05). ⑶ In the aspect of " observing the small vessels around the tumor" , CE-MRA, T 1WI and 3D-T 1WI sequences diagnosed as grade C1 were 18 cases(62.07%), 5 cases (17.24%) and 14 cases (48.28%) respectively. The diagnostic efficiency of CE-MRA and 3D-T 1WI wre better than that of T 1WI ( P<0.05). Conclusions:The combination of 3D-T 1WI and CE-MRA sequence can comprehensively evaluate the blood supply of the tumor, which is of great significance for the localization, characterization and treatment of brain tumors.

Objective To investigate the accuracy for absolute quantification of brain creatine (Cr) concentration using long time echo (TE) point resolved spectroscopy (PRESS) sequence performed with an external standard and postprocessed with the linear combination of model spectra (LCModel).Methods Ten swine (3.1±0.6 kg) and an external standard phantom containing detectable compounds of known concentration were investigated in this study by using 1.5 T GE Signa scanner and a standard head coil. The single-voxel proton magnetic resonance spectroscopy (1H-MRS) data were acquired from the two ROIs (2 cm×2 cm×2 cm) placed in swine brain and external standard solution using PRESS sequence with TE 135 ms,TR 1500 ms,and 128 scan averages.The in vivo quantification of Cr was accomplished by LCModel.After 1H-MRS examination,each animal was sacrificed immediately.In vitro Cr concentration was analyzed by high performance liquid chromatography (HPLC).Results In the 1H-MRS group,the Cr concentration was (9.37±0.14)mmol/kg.In the HPLC group,the Cr concentration was (8.91±0.13)mmol/kg.Good agreement was obtained between these two methods (t=9.038,P=0.491).Conclusion The long echo time PRESS sequence performed with an external standard and processed with LCModel iS proven to be an accurate technique to detect the in vivo brain Cr concentration.

Objective:To investigate the stability of Liuwei Qiangu cataplasms. Methods:The active ingredient( naringin) in the samples was determined by HPLC. Meanwhile, the other indices including character, identification, ointment content, adhesion, mi-crobial limit and so on were detected as well. Results:The results of the accelerated test and long term test showed that Liuwei Qiangu cataplasms were stable. No significant change in each index was found before and after the tests. Conclusion: Liuwei Qiangu cata-plasms are stable at room temperature. The designs of preparation process and package are rational to keep the stability of the prepara-tion.

Objective To assess the dignosis value of CT three-dimensional reconstruction with Fisher discriminant model in small solitary pulmonary nodules before operation.Methods CT data of 40 cases with SPN were retrospectively analyzed and divided into into malignant pulmonary nodules (25 cases),squamous cell carcinoma (4 cases),adenocarcinoma (13 cases),lung cancer (4 ca-ses),small cell lung cancer (2 cases),large cell carcinoma (1 case),metastases tumor (1 case),benign nodules (1 5 cases,6 cases of tuberculosis,2 cases of hamartoma,and 7 cases of non-specific inflammatory nodules)by pathology and follow-up results.The CT features of pulmonary nodules were evaluated through multi-planar reformation (MPR),curved-planar reformation (CPR),volume rendering (VR),maximum intensity proj ection (MIP)and other three-dimensional reconstruction.The three-dimensional data were divided into benign and malignant groups.In each of the two groups,the significant signs of morphological signs of discrimination indicators were adminstrated Fisher discriminant,and the probalitiy of false positives were estimated using cross-validation method. Results The positive features of pulmonary nodules in there-dismensional images were much more than in two-dimensional images. Fisher discriminant formula of solitary pulmonary nodules in three-dimensional images was Z=1.143X1 + 0.454X2+1.606X3-0.262X4+0.04X5+0.483X6+1.611X7-2.164.Discriminant boundary value Zc was-0.516.When Zcgreater than -0.516,nodules were proneed to considere as malignant nodules.In 25 cases of malignant nodules,4 cases mistook for benign.When Zc less than -0.516,nodules were proneed to considere as benign nod-ules.In 1 5 benign nodules,2 cases mistook for malignant.The total misdiagnosis and accuracy rate were 15 % and 85% respec-tively.Conclusion CT three-dimensional reconstruction combined with Fisher discriminant model have a high clinical value in dif-fereiating diagonsis of pulmonary nodules were proneed to considere as malignant nodules.In 25 cases of malignant nodules,4 cases mistook for benign.When Zc less than -0.516,nodules were proneed to considere as benign nodules. In 15 benign nodules,2 cases mistook for malignant.The total misdiagnosis and accuracy rate were 15 % and 85% respec-tively.Conclusion CT three-dimensional reconstruction combined with Fisher discriminant model have a high clinical value in differeiating diagonsis of pulmonary nodules.