Objective: To help medical device registration applicant understand the content of clinical evaluation, guided on the clinical evaluation method, and also putted forward several suggestions of the improvement scheme for our country registered clinical assessment and review of the work. Methods:Described the Global Harmonization Task Force (GHTF) medical device registration guidance for clinical evaluation, combined with the status quo of supervision in China, and made some specific scheme on China's medical device of clinical evaluation work. Results: Introduced the contents of the clinical evaluation and the relationships between the factors, in order to help the medical device registration applicant and Chinese regulators to do clinical evaluation work of scientific and reasonable. Conclusion:The definition of medical device registration clinical evaluation should clear the clinical evaluation, and to develop guidance for clinical evaluation of the corresponding.

The definition of rehabilitation should reflect the connotation and extension of rehabilitation medicine system,moreover,special attention should be paid to the process of translation,applications and promotion due to its derivation from Latin.The fourth edition of rehabilitation medicine textbook which published by People's Medical Publishing House described the definition of rehabilitation inaccurately,although integrated the foreign authority definitions.The definition of ‘ re-learning’has been described by the textbook without considering logical sequence,which caused difficulty in explaining and comprehending between teachers and students in class.Besides,application of another term of rehabilitation medicine in the textbook is imprudence.

Objective: To understand the survival status and influencing factors of HIV/AIDS patients with highly active antiretroviral therapy ( HAART ) among drug users in Yili Prefecture, Xinjiang from 2005 to 2019, so as to provide references for reducing AIDS mortality. Methods : The demographic information, clinical stage, baseline CD4+T lymphocyte ( CD4 ) level and treatment status of HIV/AIDS patients with HAART in Yili Prefecture from 2005 to 2019 were collected through AIDS Antiretroviral Therapy Information System. The survival rate was calculated by the life table method. The influencing factors for survival time were analyzed by Cox proportional hazard regression model. Results: Totally 1 935 patients were recruited, the median age receiving HAART was 37 years old and the median CD4 counts was 293/μL. The cumulative survival rates at 1, 5, 7 and 10 years were 97%, 78%, 73%, and 66%, respectively. The multivariate Cox proportional hazards regression analysis showed that the patients with body mass index of 18.5-<28.0 kg/m2 ( HR: 0.391-0.656, 95%CI: 0.234-0.958 ), baseline CD4>200/μL ( HR: 0.354-0.667, 95%CI: 0.232-0.841 ) , or missed medication in the last 7 days ( HR=0.009, 95%CI: 0.001-0.061 ) had lower risk of death; the patients with WHO clinical stage of Ⅱ-Ⅳ ( HR: 1.479-2.311, 95%CI: 1.004-3.288 ) or treatment delay ≥1 years ( HR: 1.287-1.388, 95%CI: 1.029-1.826 ) had higher risk of death. Conclusions The 5-year cumulative survival rate of HIV/AIDS patients with HAART in Yili Prefecture is 78%. Body mass index, baseline CD4 level, WHO clinical stage, treatment delay and missed medication in last 7 days were the influencing factors for survival time.

Animals ; Biological Specimen Banks ; utilization ; Humans ; Specimen Handling ; methods ; Tissue Fixation ; methods

Animals ; Hypertension ; metabolism ; physiopathology ; Male ; Myocardium ; metabolism ; Peptidyl-Dipeptidase A ; genetics ; metabolism ; Proto-Oncogene Proteins ; genetics ; metabolism ; RNA, Messenger ; genetics ; metabolism ; Rats ; Rats, Inbred SHR ; Rats, Inbred WKY ; Receptor, Angiotensin, Type 1 ; genetics ; metabolism ; Receptors, G-Protein-Coupled ; genetics ; metabolism

ObjectiveTo assess the value of the area of ground glass opacities (GGOs) in lungs displayed by high-resolution computed tomography (HRCT) in paraquat (PQ) poisoned patients in evaluating prognosis. Methods Clinical and imaging data of 137 patients with acute PQ poisoning admitted to Affiliated Hospital of the Medical College of Chinese People's Armed Police Forces from January 2012 to August 2014 were analyzed retrospectively. The plasma concentration of PQ on admission and the area of GGOs were compared between two groups. The lung HRCT within 10 days of poisoning was performed every 3 days, and the areas of GGOs were evaluated on five levels, including aortic arch, aortic pulmonary window, left upper lobe bronchial, right inferior pulmonary vein, and left diaphragmatic dome. Receiver operating characteristic curve (ROC) was plotted to evaluate the value of all the parameters for prognosis.Results Among 137 patients, 45 died within 28 days after poisoning, with the mortality rate of 32.85%. The plasma PQ level in the non-survivors was significantly higher than that in the survivors (mg/L:7.06±0.67 vs. 3.51±0.34,t = 5.280,P = 0.000). The areas of GGOs at three time points in the non-survivors were significantly higher than those in the survivors [1-3 days: (32.0±5.0)% vs. (2.5±0.4)%,t = 7.860,P = 0.000;4-6 days: (45.5±5.7)% vs. (2.8±0.5)%,t = 12.420,P = 0.000; 7-10 days: (68.0±4.8)% vs. (3.0±0.6)%, t = 23.950,P = 0.000]. ROC analysis demonstrated that the area under the ROC curve (AUC) of GGOs in 7-10 days was 1.000, which could be used to determine the prognosis, but it was too late for the treatment. The AUC of GGOs in 4-6 days was 0.979, with the threshold of> 12.0%, the specificity of 96.15%, the sensitivity of 85.19%, the positive predictive value of 88.46%, and the negative predictive value of 94.94%, which presented good effect in predicting prognosis in the early stage of acute PQ intoxication. But plasma PQ concentration was relatively poor for determining prognosis, AUC was 0.821, with the threshold of> 1.95 mg/L, the specificity of 34.52%, the sensitivity of 88.64%, the positive predictive value of 41.49%, and the negative predictive value of 85.29%.Conclusions The area of GGOs displayed by HRCT can be used to evaluate the fully developed acute PQ lung injury, and it is superior to plasma PQ concentration. The area of GGOs displayed by HRCT 4-6 days after intoxication can be used for the evaluation of PQ induced pulmonary injury in the early stage and the evaluation of clinical prognosis.

Acute Disease ; Adult ; Aged ; Humans ; Male ; Middle Aged ; Pesticides ; poisoning ; Young Adult

Objective To analyze the epidemiological characteristics of overseas imported malaria reported in Chongqing City from 2011 to 2015,so as to provide the evidence for improving the imported malaria control strategies. Methods The epi-demiological data of overseas imported malaria cases were collected and analyzed descriptively for the species,original coun-tries,diagnosis and treatment in Chongqing City from 2011 to 2015. Results A total of 148 overseas imported malaria cases were reported in Chongqing City from 2011 to 2015,in which 96(65.54%)cases were falciparum malaria,and 37(24.32%) cases were vivax malaria;125(84.46%)cases were infected in Africa,and the rest of 23(15.54%)cases were infected in Southeast Asia. Most of the patients were 30 to 50 years old male workmen,and the ratio of male to female was 11.42:1. There was no obvious seasonal distribution among the reported timelines of the cases;however,there were two small peaks from June to August and from January to February. The median interval time of imported malaria cases from malaria onset to see a doctor was 1 day and from seeing the doctor to get malaria diagnosis was 2 days. The patients'first selected institutions were county medical institutions(50 cases,33.78%),then provincial medical institutions(36 cases,24.325%)and private doctors(20 cases,13.51%),and only 79(53.38%)patients got malaria diagnoses in their first selected institutions. The standard treatment were provided to 142(95.54%)cases. There were 43(29.05%)patients had serious complications and three patients were dead. Conclusion It is very important to enhance the multi-sector's collaboration to establish the collaborative investigation mechanism for screening malaria patients,and strengthen malaria health education for overseas workers and training courses in primary care medical institutions.

Objective To study the effect of back-pressurized corset in incision pressure dressing after posterior lumbar surgery. Methods Seventy-eight patients who received posterior lumbar surgery during December 2013 to December 2014 in our hospital, were set as the control group and treated by incision dressing using common corset. Another 80 patients receiving the same posterior lumber surgery during January to December 2015 were set as the experiment group and treated with incision pressure dressing using the pressured-corset. After surgery, the two groups were compared in terms of incisive bleeding, completeness of the dresses and waist comfort level at day 7. Results The rate of incisive bleeding in the experiment groups was significantly lower and the comfort level at the lumbar was significantly higher than that of the control group (P < 0.001). There was no significant difference in the completeness of incisive dresses (P>0.05). Conclusion The incision pressure dressing for the patients after posterior lumbar surgery can remarkably improve the effect of compression fixation on the incision and increase comfort level.

Objective To compare the differences between measured resting energy expenditure calculated by the indirect calorimetry with the resting energy expenditure calculated by the Harris-Benedict formula and weight formula in the mechanically ventilated surgical critically ill patients in SICU.Methods Patients mechanically ventilated in SICU of Xuanwu Hospital,from April 2014 to April 2015 were measured resting energy expenditure by the indirect calorimetry with the resting energy expenditure calculated by the Harris-Benedict formula and weight formula in the 1st,the 3rd and the 5th day.There were twenty-nine patients enrolled,thirteen males and sixteen females,measured the resting energy expenditure 188 times.The distribution of metabolism level was studied,and the resting energy expenditure measured by three methods were calculated and evaluated by paired sample t test.Results There were 177 times(62.24％)of low metabolism level,59 times(31.38％)of normal metabolism level,and 12 times(6.38％)of high metabolism level.Eighteen patients used these three methods to calculate the energy expenditure on 1st,3rd and 5th day:indirect calorimetry (1 627.11 ± 323.63) kcal,(1 614.67± 308.93) kcal,(1 576.11 ± 263.96) kcal;Weight formula (1 479.44 ± 200.24) kcal,(1 488.40 ± 227.72) kcal,(1434.14 ± 216.56) kcal;Harris-Benedict formula (1 777.43 ± 253.00) kcal,(1 730.08 ± 265.18) kcal,(1 689.33 ± 236.69) kcal.The results calculated from Harris-Benedict formula and the weight formula were significantly different fiom calculated from indirect calorimetry (P ＜ 0.05).Resting energy expenditure by Harris-Benedict formula was significantly higher than calculated from indirect calorimetry (All P ＜ 0.05).Resting energy expenditure by weight formula was significantly lower than calculated from indirect calorimetry(All P ＜ 0.05).Conclusions Although Harris-Benedict formula and weight formula is convenient in clinical use,while the results calculated by them is significant different from the results calculated by indirect calorimetry.So clinical nutrition support should rely on indirect calorimetry as far as possible.