This article introduces the classifications of medical devices by FDA and EU and compares them with the situation in China. Towards the problems found, several reasonable advices are put forward.
China ; Durable Medical Equipment ; classification

Objective To compare the effects of different moist environment for treating severely burned patients.Methods From November 2009 to December 2014 in the Burn Unit of Hainan General Hospital, 170 hospitalized patients with severe burns were randomly equally divided into observation group and control group.The patients of control group were treated with the traditional wet therapy treatment, while of the observation group were given the closed moist therapy treatment.The wound healing, pain relief and adverse reactions were observed.Results All patients completed the treatment,and the cure rates at the 7th and 14th day of treatment in the treatment group were 80.0％ (68/85) and 97.6％ (83/85), significantly higher than those of the control group (52.9％ (45/85), 89.4％ (76/85), x2 =8.344,4.111, P ＜ 0.05).The number of dressing changes((7.44±2.39) times), cumulative dressing time ((45.98 ± 13.29) min) and wound healing time ((14.98±4.33)d) in the observation group were significantly less than those in the control group((11.76 ±3.14) times, (87.03 ± 14.99) min), (18.87 ± 5.13) d)), the differences were statistically significant (t =6.349,6.540,3.111, P＜0.05).After treatment, the pain scores were showed clear downward trend, with had significant difference compared before treatment (P＜0.05), while the pain scores at the 7th day((3.10± 1.34) scores) and 14th day((1.76±0.67) scores) of treatment in the treatment group were significantly lower than the control group((4.09±0.89) scores, (3.11±0.56) scores, P＜0.05).The incidence of adverse events during treatment in both groups were 5.9％, obviously improved after symptomatic treatment.Conclusion The moist environment conducive to the treatment of severely burned patients, and safety.Conclusion to traditional wet therapy, closed moist therapy has better cure rate of severe burns, can promote wound healing, relieve pain and shorten the dressing cycle time.

BackgroundBoth accommodative abnormality and higher order wavefront aberrations associated with near work are interrelated with blurry retinal image.It is very important to investigate the higher order wavefront aberrations in stable and progressive myopic eyes before and after near work. ObjectiveThe present study wasto observe the high order aberration change of myopic eyes before and after computer work upon near work stimulation as well as the relationship of high order aberration changes to types of myopia. MethodsThe case-controlled design was used in this clinical study.Sixty right eyes of 60 subjects were enrolled,including 30 progressive myopias and 30 stable myopias with matched age and gender.Refractive errors of the subjects were completely corrected by the wearing of spectacles.The subjects remained the work for 1 hour in front of a computer monitor with 40 cm distance under the dark environment and nature pupil size,and the height of the eye and monitor center kept the same level.The changes of wavefront aberration in test eyes were measured with Complete Ophthalmic Analysis System before and after 1 hour of continuous computer work.The influences of computer-work and myopia types on wavefront aberration were analyzed in 3,4,5 mm pupil size.Root-mean-square (RMS) of aberrations was calculated as the index of higher order wavefront aberrations.ResultsThere were no significant differences in the higher order wavefront aberrations before and after computer work for the two types of myopic eyes under the 3,4,5 mm pupil.The RMS of higher order wavefront aberrations were similar between progressive myopia and stable myopia under the 3 mm pupil condition.Total higher order RMS,6th-order,5th-order and 3rd-order RMS were significantly higher in progressive myopic group compared with stable myopic group under the 4 mm pupil size ( RMS3:F =5.985,P =0.016 ; RMS5:F =3.975,p=0.049;RMS6:F=8.130,P=0.005:RMST:F=6.493,P=0.012) and 5mm pupil size(RMS3:F=13.132,P=0.000;RMS5:F =4.032,P=0.047 ; RMS6:F =4.393,P=0.038:RMST:F=10.508,P=0.002 ).The spherical aberrations were higher in progressive myopic group under the 3,4,5 mm pupil conditions in comparison with stable myopic group,but these alterations were insignificant between two types of myopias ( P＞0.05 ).Conclusions Higher order wavefront aberrations of progressive myopic eyes is comparable higher than the stable myopic eyes.Computer reading task dose not significantly impact the higher order wavefront aberrations on myopic eyes.

Objective:To estimate the organ doses and effective doses to different-age children during cardiovascular interventional radiological procedures under some specific exposure conditions, and explore the main influencing factors on the doses.Methods:Based on the paediatric reference computational phantoms recommended in the ICRP Publication 143, several specific exposure models of cardiovascular intervention were built, and the Monte Carlocook MCNPX 2.7.0, was used to calculate the organ doses and effective doses for 1-, 5-, 10- and 15-year-old children. To validate the simulation result , an experiment was implemented by putting the thermoluminescent dosimeters in a 5-y old phantom (ATOM 705-D) manufactured by the CIRS Inc. in the USA.Results:Both the height and weight of the reference children for 1-, 5- and 10-year-old provided for by Chinese national standards are nearly in consistency with those recommended by ICRP, and even for the 15-year-old, the maximum relative deviations of the height and weight are only -1.9% and -5.7%, respectively. Under the exposure condition where the focal spot to image receptor distance (SID) was 90 cm, the length of square field of view (FOV) was 30 cm with a dose area product (DAP) of 45 Gy·cm 2, the relative deviations between simulated and measured doses to main organs/tissues within the irradiation filed were within ±6.7%. Under the same exposure conditions, the younger the children, the larger the organ doses and effective doses, and the effective doses could vary by a factor of about 5 among the 4 age groups. The conversion coefficient between the organ dose and the value of DAP was not only closely related to the age of children, but also affected by the FOV. Conclusions:In combination with the paediatric reference computational phantoms and the exposure models of cardiovascular intervention, the Monte Carlo method can be used to calculate the doses to children undergoing cardiovascular interventional radiological procedures. The information on the values of DAP and FOV as well as the directions of projection are needed for more accurate estimation of the exposure doses.

Objective To analyze the misdiagnosis in extraovarian peritoneal carcinoma(EOPC). Methods The clinical manifestation, blood tumor marker, imaging examination, laparotomy, pathology, treatment and prognosis of 19 EOPC patients were retrospectively analyzed. Results The clinical symptoms were abdominal distention, abdominal pain and swelling. 17 cases were tested for blood CA-125 with 15 at abnormaly high level, and in 4 cases ascites was CA-125 positive ( ＞ 10 KU/L). Tumor cells were detected in the ascites in 12 cases. Three cases were misdiagnosed as of uterine origin, 13 cases misdiagnosed as adnexal tumor, 1 case was misdiagnosed as bladder and intestinal tumor. Only 2 cases were correctly diagnosed before the operation. All of the cases were pathologically proved as peritoneal carcinoma. The five-year survival rate was only 20 percent. Conclusions Abdominal distention and pain with unknown causes were the primary manifestations of EOPC, elaborate physical examination sometimes may provide with important information. The significant elevation of serum CA-125 and the ascites cytology may be helpul for the differential diagnosis of PPC. CT scan is valuable for the diagnosis of EOPC.

Objective To investigate and determine the dietary intake level and food source of elements in Kashin-Beck disease(KBD) and non-endemic KBD areas in parts of Aba Autonomous Prefecture , Sichuan Province. Methods Three KBD villages were selected from each county including the counties of Songpan , Jiuzhaigou and Ruoergai in Aba Autonomous Prefecture with multi stage random sampling method in 2010 , and 122 KBD patients who were diagnosed at county-level or higher-level hospitals were selected from villages. One non-KBD village was selected randomly from each county and 43 controls without KBD or other bone and joint disease were selected in proportion to the number of investigated KBD patients. Dietary intake of each object was recorded 24 hours before the survey using a 24 hour dietary survey method and intake of each kind of food(cooked food) was recorded. Three day dietary intake of each surveyed object was recorded in continuous and the average value was calculated. The local resident representative food samples were collected and 20 kinds of elements in these samples were determined with inductively coupled plasma mass spectrometry ( ICP-MS ) and inductively coupled plasma atomic emission spectrometry(ICP-AES), and daily elements intake was calculated and compared with the relevant intake standards. Results Daily intakes of vegetables and meat were 126.72, 28.25 g, respectively, in patients with KBD. More than 3 times of brick tea was drank by KBD patients than non-KBD people (P<0.05). Per capita daily intakes of Ca, Fe, Mg, K, Na, Zn, I, Cu and Co were less than recommended nutrient intake or allowable daily intake in both groups. More than 80% patients with KBD overtook more Al and Pb than tolerable upper intake levels. Conclusion There is a single dietary structure and a serious shortage of a variety of essential elements intake in parts of Aba Autonomous Prefecture, and the dietary intake level of elements is different between two groups.

Objective To compare the short-term efficacies of laparoscopic adjustable gastric banding (LAGB) and laparoscopic sleeve gastrectomy (LSG) in the treatment of obesity and type 2 diabetes mellitus,and to investigate the relationship between the body weight loss and the decrease of glucose of the 2 treatment methods.Methods The clinical data of 40 patients with obesity combined with type 2 diabetes mellitus who were admitted to the Changhai Hospital of the Second Military Medical University from January 2010 to December 2011 were retrospectively analyzed.There were 14 patients treated by LAGB (LAGB group) and 26 by LSG (LSG group).The body weight loss and the decrease of glucose at postoperative year 1 of the 2 groups were compared.The differences in the body weight and glucose before and after operation within groups were compared using the paired t test,and the differences in the body weight and glucose between the 2 groups were compared using the multiple analysis of variance.The correlation between the body weight loss and the decrease of glucose was analyzed using the linear regression analysis.Results Laparoscopic surgery was successfully done without conversion to open surgery or intraoperative complications.The operation time and volume of blood loss were (69 ± 16)minutes and (31 ± 14)mL in the LAGB group,(120 ± 15) minutes and (148 ± 48) mL in the LSG group.Complications including postoperative malnutrition,electrolyte disturbance,delayed gastric emptying,bleeding,anastomotic leakage did not occurr in the 2 groups.Two patients were complicated with abdominal incision fat liquefaction,and were cured by symptomatic treatment.(1) The body weight,body mass index (BMI) and waistline had a decrease trend.The body weight,BMI and waistline in the LAGB group were decreased from (117 ± 28)kg,(40 ± 8)kg/m2 and (118 ± 15) cm before operation to (94 ± 28) kg,(33 ± 8) kg/m2 and (92 ± 15) cm at postoperative week 48.The body weight,BMI and waistline in the LSG group were decreased from (119 ± 25)kg,(42 ± 6)kg/m2 and (123 ± 14)cm before operation to (74± 16)kg,(26± 4)kg/m2 and (86 ± 13)cm at postoperative week 48.The EWL had an increase trend in the 2 groups.The EWL in the LAGB group was increased from 7％ ± 2％ at postoperative week 1 to 53％± 24％ at postoperative week 48,and the EWL in the LSG group was increased from 11％ ± 4％ at postoperative week 1 to 90％ ± 20％ at postoperative week 48.There were significant differences in the changes of body weight,BMI,waistline and EWL between the 2 groups (F =60.660,74.490,57.650,90.020,P ＜ 0.05).(2) The levels of glycosylated hemoglobin,fasting glucose,fasting insulin,HOMA-IR,triglyceride,total cholesterol,low-density lipoprotein and high density lipoprotein in the LAGB group were decreased from 8.1％± 0.8％,(8.4±0.6)mmol/L,(21±8)μmol/L,7.9 ±2.9,(1.68±0.50)mmol/L,(6.0±1.1)mmol/L (4.1 ± 0.8) mmol/L,(1.09 ±0.15)mmol/L to 6.4％ ±0.8％,(6.3 ±0.3) mmol/L,(10 ± 3) μmol/L,2.7 ±0.9,(1.04 ± 0.09) mmol/L,(4.3 ± 0.8) mmol/L,(2.3 ± 0.4) mmol/L,(1.22 ± 0.09) mmol/L at postoperative week 48 ; the levels of glycosylated hemoglobin,fasting glucose,fasting insulin,HOMA-IR,triglyceride,total cholesterol,low-density lipoprotein and high density lipoprotein in the LSG group were changed from 7.9％ ± 1.0％,(9.0±1.0)mmol/L,(21 ±9) μ mol/L,8.5 ±3.5,(2.09 ± 0.70) mmol/L,(6.0 ± 1.2)mmol/L,(3.9 ± 1.1) mmol/L,(1.06 ± 0.21) mmol/L before operation to 5.1％ ± 0.8％,(5.2 ± 0.4) mmol/L,(4 ± 1)μmol/L,0.9±0.2,(1.22±0.17)mmol/L,(4.2±0.8)mmol/L,(2.3 ±0.6)mmol/L,(1.30±0.13)mmol/L at postoperative week 48.There was a decrease trend of the glycosylated hemoglobin,fasting glucose,fasting insulin,HOMA-IR,trigluceride,total cholesterol and low density lipoprotein and a increase trend of the high density lipoprotein in the 2 groups.There were significant differences in the levels of glycosylated hemoglobin,fasting glucose,fasting insulin,HOMA-IR,triglyceride,total cholesterol,low-density lipoprotein and high density lipoprotein between the 2 groups (F =57.650,74.270,36.750,42.960,10.870,30.650,32.560,11.490,P ＜0.05).The levels of glucose of the LAGB group at postoperative month 1 and 3 were influenced by BMI (b =0.543,0.753,P ＜ 0.05),while the levels of glucose of the LAGB group did not be influenced by BMI at postoperative month 6 and year 1 (b =0.130,0.222,P ＞0.05).The levels of glucose of the LSG group did not be influenced by BMI at postoperative month 1,3,6 and year 1 (b =0.185,0.035,0.212,0.126,P ＞0.05).Conclusions The efficacy of LSG is superior to LAGB for the treatment of obesity combined with type 2 diabetes mellitus.The efficacy of LAGB is correlated with the change of body weight,while the efficacy of LSG does not correlated with the change of body weight.

Objective To investigate the efficacy of imatinib combining with allogeneic hematopioetic stem cell transplantation or chemotherapy for bcr-abl positive acute lymphoblastic leukemia (ALL). Methods 12 cases were diagnosed on morphology, cytochemistry, immunophenotype and bcr-abl fusion gene. The induction is imatinib (400 mg/d) combining chemotherapy. 8 cases accepted allogeneic hematopoietic stem cell transplantation after complete remission (CR). If bcr-abl became positive, the patient was treated with imatinib (400～600 mg/d). 3 cases were tested with imatinib alternating chemotherapy after cr. Results 11 patients gained CR, CR rate 91.7 %; 5 patients (41.7 %) became bcr-abl negative through 2 courses induction. 3 cases relapsed after transplantation. 2 cases relapsed in imatinib combining chemotherapy group. The median remission interval is 16 months (imatinib combining transplantation group) and 10 months (imatinib combining chemotherapy group) (P <0.01) respectively. The median survival time is 18 months (imatinib combining transplantation group), and the other group (imatinib combining chemotherapy) is 12 months (P <0.01). Conclusion Imatinib combining chemotherapy achieved high CR rate for the bcr-abl positive ALL. Imatinib combining allogeneic hematopoietic stem cell transplantation is superior to imatinib combining chemotherapy for CR patients.

Objective To evaluate neurodevelopmental outcome of very preterm(gestational age ＜ 32 weeks) and very low birth weight infant (VLBWI) (weight ＜ 1 500 g) and to examine the effectiveness of an early intervention program till 12 months corrected age.Methods Seventy followed-up very preterms and VLB-WI in Jinan Maternity and Childcare Hospital were enrolled in this study from January 2012 to and were divided into two groups by birth weight.All infants received 20 items of behavioral neurological assessment at 1 to 12 months corrected age and tested mental and psychomotor development with the use of CDCC at 6,12 months corrected age.The preterms who were abnomal in the 20 items of behavioral neurological assessment would receive early intervention (including kinesitherapy, physiotherapy, cereal circulation therapeutic equipment) by physiotherapists and their parents who received an intervention program training and were strongly encouraged to participate in the intervention sessions.The intervention method was adjusted according to the neurological assessment.The SPSS statistical software package for Windows, version 15.0, was used to run Fisher's exact test and t-test on the data presented,and P value of less than 0.05 was regarded as statistically significant.Results The average gestational age of infants was (30.4 ± 1.8) weeks,and average birth weight (1 463.7 ± 307.5) g.The incidence of extrauterine growth restriction was 57.1％ at first follow-up.The incidence of neurodevelpmental impairment NDI) and cerebral palsy tendency at 6 corrected months were 14.3％ ,8.6％ respectively.At 12 months corrected age,the incidence of NDI decreased to 2.9％ and cerebral palsy to 2.9％.There was significant difference in the incidence of NDI between 6 and 12 corrected months.There was no significant difference in the incidence of psychomotor developmental index ＜ 70, mental developmental index ＜ 70, NDI and cerebral palsy between the two groups.Conclusion The early intervention program can improve VLBWI neurodevelopmental outcomes at 12 months' corrected age and reduce the incidence of cerebral palsy.

Objective To construct and screen effective shRNA expression vectors targeting human AQP1 gene ,and evaluate the interference efficiency of the AQP1 shRNA recombinant plasmids ,thus provide basis for further exploration on the effect and mechanism of AQP1 gene on human breast cancer cells .Methods Four pairs of shRNA sequences targeting human AQP1 gene were designed and synthesized ,and then inserted into the GV115 vector .AQP1 shRNA and control shRNA plasmids were trans‐fected into human breast cancer MCF‐7 cells .The expression of AQP1 mRNA and protein were detected by real time PCR(RT‐PCR) and Western blot to evaluate the interfering efficiency .Results RT‐PCR demonstrated that AQP1 was expressed in human breast cancer MCF‐7 cells .Sequencing showed that the shRNA vectors targeting AQP1 were successfully constructed .48 h after the AQP1 shRNA transfection ,AQP1 mRNA and protein expression levels in MCF‐7 cells were reduced to a significant degree ,and the AQP1 shRNA 4 plasmid vector could inhibit the AQP1 most efficiently .Conclusion The AQP1 shRNA recombinant plasmids vectors were successfully constructed and can significantly inhibit the expression of AQP1 in MCF‐7 human breast cancer cells .