OBJECTIVE:To provide suggestions for the development of training mode for pharmaceutical monitoring personnel in China.METHODS:The training mode of Office of Regulatory Affair University(ORA U) was introduced to analyze the difference of training mode for pharmaceutical monitoring personnel between China and America.RESULTS & CONCLUSIONS:America has established a systematic,continuous and uniform pharmaceutical monitoring personnel training system,which is more flexible and advanced than that in China.Our country could draw experiences from the training mode of FDA personnel to develop uniform and diversified training system with suitable budget mechanism.

Objective To evaluate the reference value of NGAL in sepsis patients with AKI to choose the timing of continuous renal replacement therapy (CRRT)treatment.Methods 62 sepsis patients with AKI were enrolled in this study.Within 24 hours after the diagnosis,the patients'urine samples were collected,the urinary NGAL levels were measured by ELISA.At the same time,the clinical parameters were collected,such as serum creatinine, blood urea nitrogen,blood leukocytes,etc.Depending on whether patients need to receive CRRT,the patients were divided into sepsis CRRT group and septic non CRRT group,the clinical data of the two groups were compared.ROC analysis was performed to evaluate the reference value of NGAL in sepsis patients with AKI to choose the timing of CRRT treatment.Results Total 62 sepsis patients with AKI were enrolled in this study.Ultimately,27 patients received CRRT treatment.Within 24 hours after the diagnosis,the clinical parameters of the two groups,such as serum creatinine,blood urea nitrogen and blood leukocytes showed no significant differences (all P >0.05);but the urinary NGAL level of sepsis CRRT group[(7.9 ±2.5)pg·mL -1 ·cr -1 ]was significantly higher than sepsis non CRRT group[(4.1 ±1.3)pg·mL -1 ·cr -1 ](t =12.912,P <0.01).ROC analysis showed that the area under the curve (AUC)for the value of NGAL in sepsis patients with AKI to choose the timing of CRRT treatment was 0.892(95%CI:0.775 ~0.898,P <0.01).Conclusion Urinary NGAL has a certain reference value in sepsis patients with AKI to choose the timing of CRRT treatment,could contribute to early intervention CRRT treatment.

Objective To investigate the effects of intrathecal (IT) gabapentin on the analgesic efficacy of morphine in a rat model of incisional pain. Methods Forty-eight male SD rats in which IT catheters were successly inserted according to the method described by Yaksh were randomly divided into 6 groups ( n = 8 each): Ⅰ sham operation group, Ⅱ incisional pain group, Ⅲ GBP 50 μg group, Ⅳ morphine 2.5 μg group, Ⅴ morphine 5 μg group, and Ⅵ morphine 2.5 μg + gabapentin 50 μg group. In group Ⅰ , IT artificial cerebrospinal fluid (ACSF)10 μl was injected and then 1.4% isoflurane was inhaled for 5 min. IT ACSF 10 μl, gabapentin 50μg and morphine 2.5 and 5 μg were injected 30 min before the establishement of the model in group Ⅱ -Ⅴ respectively. Paw withdrawl threshold (PWT) to mechanical stimulation and paw withdrawal latency (PWL) to a thermal nociceptive stimulus were measured at 2 h after the establishement of the model. Results Compared with group Ⅰ , MWT was significantly decreased and TWL was significantly shortened in group Ⅱ , Ⅲ and Ⅳ ( P ＜ 0.05), but no significant change in MWT and TWL was found in group Ⅴ and Ⅵ (P＞0.05). Compared with group Ⅱ , MWT was significantly increased and TWL was significantly prolonged in group Ⅴ and Ⅵ (P ＜ 0.05), but no significant change in MWT and TWL was found in group Ⅲ and Ⅳ/ ( P ＞ 0.05). MWT was significantly decreased and TWL was significantly shortened in group Ⅲ and Ⅳ compared with group Ⅵ ( P ＜ 0.05). Conclusion IT gabapentin enhances the analgesic efficacy of morphine in a rat model of incisional pain.

Objective To select the optimal registration method for on-line kilovoltage cone-beam CT (KVCBCT) guided lung cancer radiation and evaluate the reproducibility of the selected method. MethodsSixteen patients with non-small cell lung cancer were enrolled into this study.A total of 96 pre treatment KVCBCT images from the 16 patients were available for the analysis.Image registration methods were bone-based automatic registration,gray-based automatic registration,manual registration and semi-auto matic registration.All registrations were accomplished by one physician.Another physician blindly evaluated the results of each registration,then selected the optimal registration method and evaluated its reproducibili ty.Results The average score of the bone-based automatic registration,gray-based automatic registration, manual registration and semi-automatic registration methods was 2.4,2.7,3.0 and 3.7,respectively.The score of the four different groups had statistics significant difference (F = 42.20,P < 0.001).Using the semi-automatic registration method,the probability of the difference between two registration results more than 3 ram in the left-right,superior-inferior,and anterior-posterior directions was 0,3% and 6% by the same physician,0,14% and 0 by different physicians,and 8%,14% and 8% by physician and radiation therapist.Conclusions Semi-automatic registration method,possessing the highest score and accepted re producibility,is appropriate for KVCBCT guided lung cancer radiation.

Objective To assess the rotational set-up errors in patients with thoracic neoplasms. Methods 224 kilovohage cone-beam computed tomography (KVCBCT) scans from 20 thoracic tumor pa-tients were evaluated retrospectively. All these patients were involved in the research of " Evaluation of the residual set-up error for online kilovohage cone-beam CT guided thoracic tumor radiation". Rotational set-up errors, including pitch, roll and yaw, were calculated by 'aligning the KVCBCT with the planning CT, using the semi-automatic alignment method. Results The average rotational set-up errors were -0.28°±1.52°, 0.21°± 0.91° and 0.27°± 0. 78° in the left-fight, superior-inferior and anterior-posterior axis, respective-ly. The maximal rotational errors of pitch, roll and yaw were 3.5°, 2.7° and 2.2°, respectively. After cor-rection for translational set-up errors, no statistically significant changes in rotational error were observed. Conclusions The rotational set-up errors in patients with thoracic neoplasms were all small in magnitude. Rotational errors may not change after the correction for translational set-up errors alone, which should be e-valuated in a larger sample future.

Objective To compare the diagnostic performance of multi-contrast atherosclerosis characterization (MATCH) and magnetization-prepared rapid acquisition gradient-echo (MPRAGE) for the detection of IPH with histologic analysis as the reference standard.Methods Thirty individuals were collected in this study.They were diagnosed to have carotid stenosis＞50％ by ultrasound and scheduled for carotid endarterectomy from 2014 to 2015.3 T carotid MR examinations using MPRAGE,MATCH and 3D TOF were performed in these patients.Axial images covered all plaques and centered at the bifurcation of the carotid artery.All image data sets were processed on a semi-automatic software (MRI-Plaque View,VPDiagnostics,US) to analyze the component of IPH for vulnerable plaques.The consistency between MATCH and MPRAGE was analyzed by using Cohen Kappa analysis.Comparison of the two sequences to the pathological results was performed in a similar manner.The sensitivity and specificity of the two sequences were obtained.The SNR,CNR and contrast ratio(CR) of the two regions of interest were calculated and Wilcoxon rank sum test was used to compare the difference between the two methods.Results Among 30 patients,a total of 602 available sections and 95 correponding histology specimens were included in the analysis.When all 602 available sections were included in the analysis,MATCH yielded good agreement with MPRAGE(Kappa=0.773) on the detection of IPH.With pathological specimens as the gold standard,moderate to good agreement was shown for both MATCH and MPRAGE (Kappa=0.778,0.685).The sensitivity and specificity for the detection of IPH was 93.2％ (68/73) and 90.9％ (20/22) for MATCH.For MPRAGE,the sensitivity and specificity was 87.7％(64/73) and 90.9％(20/22) respectively.The difference between MATCH and MPRAGE was statistically significant for SNR,CNR and CR.That is to say,SNR and CNR of MPRAGE were higher than those of MATCH(P＜0.05),while CR of MATCH was higher than that of MPRAGE(P＜0.05).Conclusion Compared to the MPRAGE sequence,MATCH technique demonstrates similar diagnostic performance for the detection of IPH.

Objective Analyze the genetic characteristic of Hemagglutinin(H) gene of measles viruses isolated in Henan Province in 2017. Methods Swab samples collected from 7 lab confirmed measles cases,and we got the measles virus by Vero/Slam inoculation. Fragment of H genes were amplified by reverse transcription polymerase chain reaction(RT?PCR), then the PCR products were sequenced and analyzed. Results The age of the 7 measles confirmed cases were between 1 and 50 years old,and all of them were males. All the 7 measles viruses were identified as H1a genotype,and the average distance of the nucleotides and the amino acids was 0.005, respectively. Compared with the Shanghai?191/China?vaccine, there were some changes in isolated virus,such as 240th, 397th and 381st sites in the amino acid sequence. Conclusion The measles genotype which isolated in Henan Province in 2017 was H1a. There were some difference from Shanghai?191/China?vaccine in the nucleotides sequence of H gene,which suggested that it's necessary to strengthen the monitor the variation of measles virus.

Objective Analyze the genetic characteristic of Hemagglutinin(H) gene of measles viruses isolated in Henan Province in 2017. Methods Swab samples collected from 7 lab confirmed measles cases,and we got the measles virus by Vero/Slam inoculation. Fragment of H genes were amplified by reverse transcription polymerase chain reaction(RT?PCR), then the PCR products were sequenced and analyzed. Results The age of the 7 measles confirmed cases were between 1 and 50 years old,and all of them were males. All the 7 measles viruses were identified as H1a genotype,and the average distance of the nucleotides and the amino acids was 0.005, respectively. Compared with the Shanghai?191/China?vaccine, there were some changes in isolated virus,such as 240th, 397th and 381st sites in the amino acid sequence. Conclusion The measles genotype which isolated in Henan Province in 2017 was H1a. There were some difference from Shanghai?191/China?vaccine in the nucleotides sequence of H gene,which suggested that it's necessary to strengthen the monitor the variation of measles virus.

Objective To observe the incidence of malnutrition, the therapeutic effect of nutritional support and the prognosis of patients with chronic obstructive pulmonary disease (COPD) under mechanical ventilation (MV) in patients with different traditional Chinese medicine (TCM) syndrome types and discuss the relationships between these indicators and the differentiation of cold-heat/deficiency-excess syndrome. Methods One hundred and three patients with COPD and MV admitted to Zhuji Hospital of TCM from September 2015 and July 2017 were enrolled, according to the different TCM syndromes, they were divided into an excess-heat syndrome group 42 cases and an asthenia-cold syndrome group 61 cases, and the differences in nutrition indexes and prognosis between the two groups were compared. Results The acute physiology and chronic health evaluationⅡ (APACHE Ⅱ) score, nutritional risk screening 2002 (NRS2002) score and the incidence of malnutrition in excess-heat syndrome group were significantly lower than those in the asthenia-cold syndrome group, while the body mass index (BMI) in excess-heat syndrome group was obviously higher than that in the asthenia cold syndrome group [APACHE Ⅱ score: 20.1±5.4 vs. 22.0±3.4,NRS2002 score: 5.2±0.6 vs. 6.2±0.8, incidence of malnutrition: 61.9% (26/42) vs. 80.3% (49/61), BMI (kg/m2): 22.6±3.8 vs. 19.9±4.8, all P < 0.05]. The levels of albumin (Alb), prealbumin (PA) and transferrin (TF) of the excess-heat syndrome group were higher than those in the asthenia-cold syndrome group, and the differences between the two groups were statistically significant on the 7th day under MV [Alb (g/L): 36.14±2.97 vs. 34.40±3.37, PA (mg/L): 237.67±28.01 vs. 185.34±30.86, TF (g/L): 2.13±0.38 vs. 1.95±0.12, all P < 0.05]. In the excess-heat syndrome group, the percentage of weaning from MV was higher than that of the asthenia-cold syndrome group [85.7% (36/42) vs. 65.6% (40/61)], the 28-day mortality [14.3% (6/42) vs. 31.1% (19/61)] and ICU stay time (days: 9.21±2.96 vs. 11.13±3.96) were lower than those of the asthenia cold syndrome group (all P < 0.05). Conclusion The analysis of TCM differentiation of cold-heat/deficiency-excess syndrome has a certain reference value to realize the changing rules in nutritional status and prognosis of patients with COPD under mechanical ventilation.

Objective: Analyze the genetic characteristic of Hemagglutinin(H) gene of measles viruses isolated in Henan Province in 2017. Methods: Swab samples collected from 7 lab confirmed measles cases, and we got the measles virus by Vero/Slam inoculation. Fragment of H genes were amplified by reverse transcription polymerase chain reaction(RT-PCR), then the PCR products were sequenced and analyzed. Results: The age of the 7 measles confirmed cases were between 1 and 50 years old, and all of them were males. All the 7 measles viruses were identified as H1a genotype, and the average distance of the nucleotides and the amino acids was 0.005, respectively. Compared with the Shanghai-191/China-vaccine, there were some changes in isolated virus, such as 240^th, 397^th and 381^st sites in the amino acid sequence. Conclusion The measles genotype which isolated in Henan Province in 2017 was H1a. There were some difference from Shanghai-191/China-vaccine in the nucleotides sequence of H gene, which suggested that it′s necessary to strengthen the monitor the variation of measles virus.