We found that the number of institutions made use of the undocumented in vitro diagnostic reagent in the survey. The phenomenon poses some risks and problems. In use this paper, we analyzed the situation and the reasons for the use of the undocumented in vitro diagnostic reagents, and put forward the corresponding measures.
Humans ; Indicators and Reagents ; standards

Objective Analyse the causes,diagnosis and treatment for delayed hemorrhage after distal radical gastrectomy.Methods Retrospective study on 45 patients combined with intro-abdominal hemorrhage after distal radical gastrectomy from January 2008 to June 2013.Results Thirteen patients combined with delayed hemorrhage in these 45 patients,all of 13 patients had intro-abdominal hemorrhage in 1week to 4 weeks after operation.And 5 of the 13 patiens were intermittent intro-abdominal hemorrhage 1 week after operation,these patients were demonstrated the blood come from gastroduodenal artery pseudoaneurysm fracture by CT and DSA examine,and they were cured by interventional embolization.Other 8 patients were marginal ulcer hemorrhage diagnosed by gastroscope,and they stoped bleeding with the help of gastroscope.Conclusions The causes of delayed hemorrhage after distal radical gastrectomy were complicated,and CT,DSA and endoscope can use for diagnosis.What was more,interventional embolization and endoscope were helpful for curing the intro-abdominal hemorrhage,avoiding re-operation.

Objective To explore the effect of clinical pathway in surgical treatment for patients with mandibular fracture.Methods 80 patients with mandibular fracture were randomly divided into the conventional therapy group(the control group) (n =40） and the clinical pathway therapy group (CP group) (n =40).The hospitalization time,medical expenses,satisfaction for the treatment,health awareness,and incidence of complications were compared between two groups.Results The results of hospitalization time,medical expenses,satisfaction for the treatment,and health awareness of the CP group were (11.86 ± 3.05) d,(9 115.43 ± 1 689.84) yuan,(91.19 ± 1.02) ％,(95.18 ±4.11)points,respectively,which were significantly better than those of the control group [(17.53 ± 2.98)d,(12 066.75 ±2 513.22)yuan,(89.39 ±1.35)％,(82.83 ± 6.56) points] (t =8.41,6.16,6.73,10.01,all P ＜0.05).The complication rate of the two groups was 2.5％,7.5％,respectively,which had no significant differences (χ2 =0.26,P ＞ 0.05).Concltsion The clinical pathway for mandibular fracture surgery is worthy of promotion.

Objective: To evaluate the surgView-RFT electromagnetic navigation system in radiofrequency thermocoagulation(RFT). Methods: 6 foramen ovales of 3 cadavers were punctured by 3 beginners. Every one tried 5 times by free-hand and 5 times by SurgView-RFT electromagnetic navigation-guidance. After each puncture, CT scans were used as golden standard to measure the distance between the tip of needle and the anterior margin of the foramen ovale. T test and variance of SAS 6.12 statistical software was used to do the statistic analysis. Results: The punctures by free-hand failed, and the distances between the tip of needle and the anterior margin of the foramen ovale were 8-10.6 mm. The punctures by navigation guidance were successful, and the distances between the tip of needle and the anterior margin of the foramen ovale were 2.68-3.54 mm. The error of navigation system was 0.59 mm which was verified by CT scan. There was significant difference between free-hand puncture and navigation-guided puncture. Conclusion: The surgView-RFT electromagnetic navigation system is characteristic with high performance, high accuracy and minimal invasion, while it is applied in training or clinical using.

Objective:To explore the clinical value of T 1 mapping/indexed extracellular volume fraction (iECV) quantified with cardiac MR (CMR) parameters, and its correlation with traditional indicators of myocardial dysfunction in aortic insufficiency (AI) patients. Methods:A total of 36 patients clinically and radiologically diagnosed with chronic AI in our hospital between May 2012 and February 2016 were retrospectively selected. All AI patients underwent conventional CMR protocol, native and post T 1 mapping. CMR parameters, such as aortic regurgitant fraction (RF), late gadolinium enhancement (LGE) mass fraction, myocardial extracellular volume fraction (ECV) and iECV. Based on the values of aortic RF, AI patients were divided into mild AI group (9 cases), moderate AI group (14 cases) and severe AI group (13 cases). The clinical characteristics were teased from the patients′ electronic medical records. Univariate analysis of variance was used to compare the measurement data of native T 1 mapping, post-contrast T 1 mapping, ECV, and iECV. LSD test was used for pair wise comparison between the mild AI, moderate AI and severe AI groups. Data about cardiovascular history, New York Heart Association (NYHA) heart function classification, and LGE were compared by chi-square test or Fisher exact test. The correlation between left ventricle ejection fraction (LVEF) and iECV was evaluated by Spearman correlation analysis. Results:There was no difference in age, sex, cardiovascular history among the three groups. Comparison of patients with different severity of AI in the three groups: (1) There was statistically significant difference in the LGE positive rate among the three groups ( P=0.023), while the myocardial replacement of fibrosis increased with the grade of aortic regurgitation. (2) There was no statistically significant difference in the measurement data of native T 1 mapping, post-contrast T 1 mapping, ECV among the three groups ( H=1.815, 0.929, 2.496, all P values>0.05), while the diffuse myocardial fibrosis tended to increase with the degree of aortic regurgitation. There was statistically significant difference in iECV among the three groups ( H=16.725, P<0.001). The measurement data of iECV in the severe AI group was significantly higher than those in the other two groups ( P<0.05). LVEF value was inversely correlated with iECV ( r=-0.649, P<0.001). Conclusions:Quantitative T 1 mapping/iECV can serve as a parameter to noninvasively identify diffuse myocardial fibrosis in AI patients of different severities. It changes with LVEF and can manifest the reversible stage of left ventricular decompensation.

Thirteen compounds were isolated from the stem bark of Bombax ceiba L. by silica gel, and Sephadex LH-20 column chromatography. Their structures were identified by spectroscopic analysis as: lupeol(1), lupeone(2), betulinic acid(3), zeorin(4), oleanolic acid(5), 3-oxooleanolic acid(6), cleomiscosin A(7), (±)-lyoniresinol(8), desmosterol(9), stigma-3, 6-dione(10), (+)-lasiodiploidin(11), aurantiamide acetate(12), and(2S, 3S, 4R, 10E)-2-［(2R)-2-hydroxytetracosanoylamino］-10-octadecene-1, 3, 4-triol(13). Among them, compounds 3, 4, 6, 7-13 were isolated from this plant for the first time.

Porcine interferon-alpha (pIFN-alpha) fermentative production by recombinant Pichia pastoris was carried out in a 10-L bioreactor to study its metabolism changes and effects on fermentation under different inducing strategies, by analyzing the change patterns of the corresponding metabolism and energy regeneration. The results show that the specific activities of alcohol oxidase (AOX), formaldehyde dehydrogenase (FLD) and formate dehydrogenase (FDH) largely increased when reducing temperature from 30 degrees C to 20 degrees C under pure methanol induction, leading significant enhancements in methanol metabolism, formaldehyde dissimilatory energy metabolism and pIFN-alpha antiviral activity. The highest pIFN-alpha antiviral activity reached 1.4 x 10(6) IU/mL, which was about 10-folds of that obtained under 30 degrees C induction. Using methanol/sorbitol co-feeding strategy at 30 degrees C, the major energy metabolism energizing pIFN-alpha synthesis shifted from formaldehyde dissimilatory energy metabolism pathway to TCA cycle, formaldehyde dissimilatory pathway was weakened and accumulation of toxic intermediate metabolite-formaldehyde was relieved, and methanol flux distribution towards to pIFN-alpha synthesis was enhanced. Under this condition, the highest pIFN-alpha antiviral activity reached 1.8 x 10(7) IU/mL which was about 100-folds of that obtained under pure methanol induction at 30 degrees C. More important, enhanced pIFN-alpha production with methanol/sorbitol co-feeding strategy could be implemented under mild conditions, which greatly reduced the fermentation costs and improved the entire fermentation performance.
Animals ; Energy Metabolism ; Fermentation ; Interferon-alpha ; biosynthesis ; genetics ; Methanol ; pharmacology ; Pichia ; genetics ; metabolism ; Recombinant Proteins ; biosynthesis ; genetics ; Sorbitol ; pharmacology ; Swine

Objective: To explore the application value of endoscope in probing the chronic wound with sinus tract in clinic. Methods: Twenty-eight chronic wounds with sinus tracts from 27 patients conforming to the inclusion criteria admitted to Outpatient Department of Wound Healing Center of Ruijin Hospital from December 2017 to March 2018 were investigated in a prospective and self-controlled trial. After being cleaned, the diameter of the opening of sinus tract was measured with a rule. A probe was used to measure the depth of a sinus tract according to the touch from the probe extremity in operation, and to measure the depth of a sinus tract that could be observed with naked eyes with the help of a pair of hemostatic forceps. Five minutes later, a probe was inserted deeply into the sinus tract to measure the depth under the endoscopic view combined with touch from the probe extremity in operation. Afterwards, the sinus tract was observed with endoscope, and the depth of the tract which could be observed under the endoscopic view was measured using a probe inserted deeply into the sinus tract. After completion of the above exploration, the sinus tract was infused with contrast agent Omnipaque 350 and scanned by computed tomography (CT) later to obtain its depth. The following indicators were calculated: the ratio of the depth of the sinus tract measured by CT to the diameter of the opening of the sinus tract (hereinafter referred to as the depth/diameter ratio of the sinus tract), the deviation rate comparing the depth of the sinus tract measured by conventional method (measured by probe only) and by endoscope (measured by probe under the endoscope view) with the depth of the sinus tract measured by CT (hereinafter referred to as the deviation rate of the measured depth of the sinus tract), the deviation rate comparing the depth of the sinus tract that could be observed measured by conventional method and by endoscope with the depth of the sinus tract measured by CT (hereinafter referred to as the deviation rate of the depth of the sinus tract that could be observed). Data were processed with paired t test. Pearson correlation analysis was applied to analyze the correlation between the depth/diameter ratio of the sinus tract and the deviation rate of the measured depth of the sinus tract and the deviation rate of the depth of the sinus tract that could be observed by conventional method and by endoscope. Results: The depth/diameter ratio of the sinus tract of this group of wounds was 1-32 (8±7). The deviation rate of the measured depth of the sinus tract and the deviation rate of the depth of the sinus tract that could be observed by conventional method were (19±14)% and (79±18)%, respectively, both obviously larger than (9±9)% and (25±25)% by endoscope (t=3.837, 13.626, P<0.01). Positive correlation existed between the depth/diameter ratio of the sinus tract and the deviation rate of the measured depth of the sinus tract by conventional method, and between the depth/diameter ratio of the sinus tract and the deviation rate of the depth of the sinus tract that could be observed by conventional method and by endoscope (r=0.514, 0.585, 0.651, P<0.01). However, there was no obvious correlation between the depth/diameter ratio of the sinus tract and the deviation rate of the measured depth of the sinus tract by endoscope (r=0.113, P>0.05). Conclusions Compared with the conventional method, application of endoscope is able to get more accurate data of chronic wounds with sinus tracts and observe the wounds with wider range.

Objective:To investigate the clinical feasibility of three-dimensional contrast-enhanced ultrasound (3D-CEUS) in the quantitative assessment of blood perfusion of hepatocellular carcinoma (HCC).Methods:Between January 2020 and August 2021, 36 HCC patients (39 lesions in total) confirmed by pathology and clinical diagnosis without any treatment from Zhongshan Hospital, Fudan University were enrolled and underwent both 2D-CEUS and 3D-CEUS examinations. Each examination last for 150 s and all images were recorded, and then the data were analyzed. A region of interest was manually drawn along the margin of the whole tumor and then the time-intensity curve (TIC) generated. The following perfusion parameters were extracted: peak intensity (PI), peak time (TTP), ascending slope (AS), mean transit time (MTT) and area under the curve (AUC). After calculating the quality of fit (QOF) of the curve, the intraobserver agreement of the 3D-CEUS quantitative parameters obtained by the same doctor between two times were assessed, and the consistency of the 3D-CEUS and 2D-CEUS quantitative parameters was evaluated when QOF>75%. The differences of the quantitative parameters between different groups (divided by depth of 8 cm and necrosis rate of 50%, respectively) in 3D-CEUS were compared.Results:There were 38 lesions (97.4%, 38/39) with QOF>75% in 3D-CEUS. The intraobserver agreement was excellent, the intraclass correlation efficient(ICC) values was 0.85-0.99. The consistency of the time quantitative parameters (TTP and MTT) were high (the ICC values of 0.87 and 0.91), and the correlation of intensity quantitative parameters were substantial, the rs values were 0.71, 0.72 and 0.71. The differences in 3D-CEUS quantitative parameters of the two groups of lesions with different depths were statistically significant (all P<0.05); but there were no significant differences in quantitative parameters between the two groups with different necrosis rate (all P>0.05). Conclusions:Quantitative 3D-CEUS is an useful and creditable tool in evaluating the blood perfusion of HCC, especially when the depth of lesion was less than 8 cm.

The correct thoughts and principles of diagnosis and treatment of chronic refractory wounds need to be formulated. Through the relevant domestic and international consensus and based on clinical experience, the Thoughts and principles of diagnosis and treatment of chronic refractory wounds in China is proposed. It is considered that in the diagnosis and treatment of chronic refractory wounds, in the case of fully understanding the patient′s medical history, the following thoughts and principles should be complied in order. (1) Pay attention to the cleanliness of the wound after being cleaned. (2) Reasonably perform debridement to avoid being " excessive" or " not thorough". (3) Reasonably perform examination, diagnosis, and differential diagnosis of pathogenic factors. (4) Treat according to etiology. (5) Find comorbidities and prevent adverse outcomes. (6) Select the correct wound treatment method reasonably and timely. When the conservative wound care treatment is considered, pay attention to embodying the concept of etiological treatment, treat the wound according to the principles of safety, phase, selectivity, and effectiveness, and make a reasonable choice of continuing conservative treatment or surgical treatment in time after completing the preparation of the wound bed. When surgical treatment is considered, pay attention to the selection of reasonable surgical method and donor site, pay attention to the healing rate of surgical wound site and the outcome of donor site, and give reasonable protection to the wound site after surgery. (7) Carry out rehabilitation treatment after wound healing and related health education.