For the preparation of implementing IEC 60601-1 Ed. 3.1 in advance, this paper analyzes the main difference between IEC 60601-1 Ed. 3.1 and GB 9706.1-2007, and discusses the possible influence to medical device designing and testing.
Equipment Design ; standards ; Equipment and Supplies ; standards

Objective To investigate the clinical effects and safety of combination of open and laparoscopic surgery in treatment of elderly patients with gallbladder stones combined with common bile duct stones. Methods 140 elderly patients with gallbladder stones combined with common bile duct stones from May 2014 to May 2015 were randomly divided into control group (65 patients) with traditional open surgery and observation group (65 pa﹣tients) with combination surgery; then compared the perioperative clinical indicators, the total removal rate of stone, the postoperative analgesic used rate and postoperative complications incidence of the two groups. Results The oper﹣ation time, intraoperative blood loss volume, the exhaust time for first time and hospital staying time of observation group was significantly better than control group (P< 0.05). There was no significant difference in the total removal rate of stone between the two groups (P> 0.05). The postoperative analgesic used rate of observation group was sig﹣nificantly lower than control group (P< 0.05). The postoperative complications incidence of observation group was significantly lower than control group (P< 0.05). Conclusion Compared with traditional open surgery, combination surgery in treatment of elderly patients with gallbladder stones combined with common bile duct stones can efficient﹣ly shorten the operation time, speed up the recovery process, reduce the degree of trauma and postoperative pain and helpful to prevent the postoperative complications.

Objective To investigate the protective effects of hyperbaric oxygen(HBO)against brain dam- age from hypoxic ischemia(HIBD)in neonatal rats.Methods One hundred and seventeen 7-day-old Sprague- Dawley rats were randomly divided into 4 groups:a control group(n=32),a hypoxic ischemia brain damage group (HIBD group,n=30),a hyperbaric air group(HBA group,n=27),and a hyperbaric oxygen group(HBO group, n=28).The HIBD model was established by permanent occlusion of the left common carotid artery followed by expo- sure to a mixture of 8% oxygen/92% nitrogen for 2 h(at 37℃).HBO therapy was administered to the HBO group after the hypoxia exposure once a day for 7 d,as was HBA therapy to the HBA group.Apoptotic cells in the cortex and hippocampus(A_(CH)cells)were measured using TUNEL at 9 d after birth,and the ratios of left and right cerebral hemisphere weight(R_(L/R))and rate of weight gain(GRW)were recorded 14 d after birth.A radial arm maze acquisi- tion test(RAMAT)was administered at 30 to 35 days.Lastly,the neuron density in the CA_1 subfield of the rats' hip- pocampi(ND_(CAI)was measured with Nissl staining.Results R_(L/R)and GRW in the HIBD group were significantly lower than in the control group(P＜0.01),while R_(L/R)was increased in the HBO and HBA groups,especially in the HBO group(P＜0.01),although there was no significant difference in GRW between the groups.Compared with the control group,A_(CH)cells were increased and ND_(CAI)was decreased in the HIBD group(P＜0.01),while A_(CH)cells were decreased and ND_(CAI)was elevated in the HBO group in comparison with the HIBD group(P＜0.01).There was no change in A_(CH)cells or ND_(CAI)in the HBA group.The RAMAT results for the HIBD group,including the time to find the arms baited with water,average times of working errors and reference memory errors,were significantly high- er than those of the control group,while these values for the HBO group were obviously lower than for the HIBD group,and there was no change for the HBA group(P＞0.05).Conclusion HBO therapy might increase the re- covery of learning and memory function by attenuating HIBD in neonatal rats.

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

A sensitive, rapid and specific liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method for quantification of gabapentin in human plasma has been developed. After a single plasma protein precipitation with methanol, gabapentin and metformin (internal standard) were chromatographed on a Inertsil ODS-3 column (50 mm x 2.1 mm ID, 3 microm) with mobile phase consisting of methanol-0.2% formic acid aqueous solution (80:20, v/v) at a flow-rate of 0.2 mL x min(-1). Electrospray ionization (ESI) source was applied and operated in the positive ion mode. Multiple reaction monitoring (MRM) mode with the transitions of m/z 172 --> m/z 154 and m/z 130 --> m/z 71 were used to quantify gabapentin and metformin, respectively. The run time was 2.2 min. The linear calibration curve was obtained in the concentration range of 40.8-8.16x10(3) ng x mL(-1). The lower limit of quantification was 40.8 ng x mL(-1). The intra- and inter-day precision (RSD) was less than 12%, and the accuracy (RE) was within +/-6.4% calculated from quality control (QC) samples. The method was used to determine the concentration of gabapentin in human plasma after a single oral administration of 600 mg gabapentin capsule to 20 healthy male Chinese volunteers. The method was proved to be selective, sensitive, rapid and suitable for pharmacokinetic study of gabapentin in human plasma.

Antipsychotic Agents ; poisoning ; Clozapine ; poisoning ; Drug Industry ; Humans ; Male ; Middle Aged ; Occupational Exposure ; statistics & numerical data

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.

Objective To investigate the effect of gemcitabine, paclitaxel combined with nedaplatin in treatment of locally advanced nasopharyngeal carcinoma. Methods 40 patients diagnosed as locally advanced nasopharyngeal carcinoma from May 2012 to August 2014 were randomly divided into observation group and control group. Patients in the observation group received gemcitabine plus nedaplatin chemotherapy, while those in the control group received paclitaxel plus nedaplatin chemotherapy. Then chemotherapy effect, adverse reactions, survival time and tumor marker contents were compared. Results The effective rate of the observation group was 65 % (13/20), which was higher than that (30 %, 6/20) of the control group (χ2 = 4.912, P< 0.05), however, there were no statistically differences in gastrointestinal reactions, bone marrow suppression, liver damage, kidney damage between groups (P> 0.05). Before chemotherapy, the SCCAg and CYFRA21-1 content of the control group were (2.30 ±0.31) ng/L and (18.27±2.19)μg/L, and the observation group were (2.34±0.27) ng/L and (18.48±2.25)μg/L, and there was no significant difference between the groups (P>0.05). After chemotherapy, the SCCAg and CYFRA21-1 content of the control group were (1.92±0.22) ng/L and (13.72±1.74) μg/L, and the observation group were (1.20 ±0.15) ng/L and (8.49 ±0.91) μg/L (P= 0.000). Conclusion Gemcitabine combined with nedaplatin chemotherapy can improve the chemotherapy effect and reduce tumor marker content, without increasing more adverse reactions, which is an ideal chemotherapy regimen for advanced nasopharyngeal carcinoma.

Objective To analyse effects of the serum levels of thyroid peroxidase antibodies (TPOAb) on antithyroid drugs (ATD) treatment in patients with incipient Graves disease (GD). Methods A total of 121 patients with incipient GD, who were used anti thyroid drugs for 12 months, were included in this study. Patients were dvided into two groups:TPOAb negative group (TPOAb≤35 IU/mL, n=49) and TPOAb positive group (TPOAb>35 IU/mL, n=72). According to the degree of TPOAb drops the TPOAb positive group was sub-divided into low level positive group (35 IU/mL1 000 IU/mL, n=20). The ATD total dosage for 12 months and thyroid-stimulating hormone (TSH), which returned to normal rate after treatment of 3, 6 and 12 months, were compared between groups. Results ATD total dose was lower in TPOAb positive group (1 743.82±265.38) mg than that of negative group (1 889.18 ±125.51) mg. The ATD total dosages were (1 759.71±230.29) mg, (1 793.75±299.02) mg, (1 731.54± 236.44) mg and (1 710.00 ± 290.73) mg for low level TPOAb positive group, medium level TPOAb positive group, high level TPOAb positive group, and very high level TPOAb positive group respectively. The recovering ratio of TSH was significantly higher in TPOAb positive group than that of TPOAb negative group after 3-month treatment (P<0.05). Conclusion TPOAb positive serum can lead to shorten the course of ATD treatment and reduce the total amount of ATD treatment in GD patients.

Objective: To learn the epidemiological characteristics of infectious disease related public health emergencies in Zhejiang Province from 2010 to 2018 for the prevention and control. Methods: The surveillance data was extracted from National Public Health Emergency Management Information System. Descriptive epidemiology method was used to analyze main diseases as well as distribution characteristics of time and places. Results: A total of 445 events were reported, which caused 14362 cases and 34 deaths, with a attack rate of 0.69% and mortality rate of 0.24%. There were 298 events with less than 30 cases, accounting for 66.97%. The event classification was dominated by general events ( 242 events, 54.38% ) and ungraded events ( 201 events, 45.17% ). The main diseases were chickenpox ( 134 events, 30.11% ), hand foot mouth disease ( 59 events, 13.26% ) and other infectious diarrhea ( 51 events, 11.46% ). The incidence peaked from April to June ( 129 events, 28.99% ) and from November to December ( 131 events, 29.44% ). Ningbo ranked the top in the number of reported events ( 141 events, 31.69% ). Most events ( 322 events, 72.36% ) occurred in schools. Conclusions The infectious disease related public health emergencies in Zhejiang Province from 2010 to 2018 were mainly caused by chickenpox, hand-foot-mouth disease and other infectious diarrhea. The two peaks of the emergencies occurred from April to June and from November to December. Ningbo was the main area reporting infectious diseases, and schools were the main places.