1.The Continuous Improvement Practice of Ethics Quality Management in Drug Clinical Trial
Chinese Medical Ethics 2015;(5):769-771
The authors through the analysis on the state food and drug administration for clinical drug agency qualification , the ethics committee to run the problem:ethics committee incomplete management system and SOP;Familiar with work system and review process to be;Track review is not standard;Pilot project information manage-ment confusion;Ethics committee hardware substandard housing .And puts forward the following measures to solve these problems , reasonable adjustment of organization structure , strengthen the system construction , standard re-view process , establish 3 levels training model and improve office conditions .
2.Opportunities and challenges for the laboratory medicine in the era of precision medicine
Cong WU ; Chaoping FANG ; Jinglong YU ; Shanrong LIU
Chinese Journal of Laboratory Medicine 2017;40(1):14-16
Precision medicine is an emerging approach for disease treatment and prevention , which attempts to explore the effective means for protecting human health by synthetical consideration of individual variability in genes , environment and life style.Precision medicine has the prominent property of multidisciplinary intercrossing and fusion , the development of which claims rapid clinical application of advanced technology in the research of basic medical science.What kind of development opportunities are laboratory medicine confronted with under the novel medical mode? How can laboratory medicine and its researchers do to seize these opportunities and meet the challenges of precision medicine ? These questions are preliminary discussed in this paper.
3.Comprehensive treatment of hand post-burn scars
Fuli CHEN ; Jianying ZHU ; Juncheng WU ; Xianlei ZONG ; Jinglong CAI
Chinese Journal of Medical Aesthetics and Cosmetology 2013;19(5):351-354
Objective To investigate the value of combined therapy for hand post-burn scars.Methods We retrospectively analyzed 78 hands post-burn scars in 46 cases from 2007 to 2011.A mong them,scar contracture releasing,scar excision,free skin grafting and fixation with Kirschner's pins were performed in 38 hands,scar excision and regional flat transfer were performed in 18 hands,scar excision and skin grafting were performed in 18 hands,abdominal expanded flap transplantation and scar excision were performed in 4 hands.All patients received elastic sleeve pressure therapy,sili cone gel for external application and function training.Within six months after the operation,52 hands received drug delivery by wax therapy,16 hands incision with scar proliferation received drug injection into scar.We followed up all patients from half a year to three years after the treatment to observe the recovery of the appearance and function of the hands.Results We mainly chose surgery,elastic sleeve pressure therapy,silicone gel for external application,drug injection into scar,wax therapy,function training and so on treating the hand post-burn scars and found that the joins deformities caused by scar contracture were largely or totally corrected.The function and appearance were satisfying.Conclusions It is a good method to treat hand scars by surgery and post-surgery combined physical rehabilitation therapy,which deserves to popularization.
4.Application of combined saphenous nerve-great saphenous vein flap and cutaneous branches of posterior tibial artery flap in repair of chronic ulcer in foot
Yongxin HUANG ; Xinhua ZHAN ; Jianxian ZHU ; Jianchong CHEN ; Zuhuang WU ; Jinglong CAI
Chinese Journal of Medical Aesthetics and Cosmetology 2011;17(4):254-256
Objective To evaluate the efficacy of the combined saphenous nerve-great saphenous vein flap and cutaneous branches of posterior tibial artery flap in repairing refractory wounds. Methods Eighteen cases of pedal chronic ulcers were treated with the combinedsaphenous nervegreat Saphenous vein flap and cutaneous branches of posterior tibial artery flap, in which the wounds were treated with vacuum suction techniques before the operation in 6 cases. Wounds were from 8 cm× 13 cm to 1 cm× 17 cm in zine after debricement, and the designed size of the flaps was from 8 cm× 14 cm to 11 cm× 18 cm. Results After the treatment, 18 cases were evaluated as excellent in 10 cases, and good in 8 cases, in which the primary sealing of the wounds was achieved in 17 cases, but one case presented with focal necrosis of smaal size owing to vein drainage disturbance in a distallypedicled flap, and was healed after flap transplantation. Follow-up for 6 months to 2 years showed that all the patients were satisfied with the results. Conclusions The combined flap has reliable blood supply, skin pedicle of the flap is longer, superior texture and satisfied appearance, and incisive area of the flap is larger. It is particularly useful in repairing refractory wound in foot.
5.Effect of docosapentenoic acid on the neurite outgrowth in PC12 cells
Guanghui WANG ; Ming ZHONG ; Minna ZHANG ; Tingting WANG ; Yuting LIANG ; Dongrui LIANG ; Yan REN ; Chen ZHONG ; Jiantu CHE ; Jinglong WU
Chinese Journal of Behavioral Medicine and Brain Science 2017;26(5):390-394
ObjectiveTo explore the inductive action of docosapentenoic acid(DPA) on neurite outgrowth in PC12 cells in vitro.MethodsNeurite outgrowth in PC12 cells was examined after the treatment with different concentration of DPA using Motic Zamges Plus software mapping cell image system.Western blot was performed to detect the expression of β Ⅲ-tubulin regulated protein kinase,a neuronal marker as well as ERK and protein kinase B (Akt) phosphorylation.ResultsPC12 cell neurite formation rate was increased in a concentration dependent manner in the induction of DPA,increased by 2.4% (DPA 10 μg/ml,P>0.05),18.6% (DPA 30 μg/ml,P<0.05) and 25.0% (DPA 50 μg/ml,P<0.05) compared with that in the control group.DPA promoted the expression of β Ⅲ-tubulin (P<0.05) and the phosphorylation level of ERK and Akt (P<0.05,P<0.01).ConclusionDPA promotes PC12 cell neurites growth and its mechanism may be related to the activation of ERK and Akt signaling pathways.
6.Value of dual energy CT parameters combined with serum procollagen Ⅰ N-terminal propeptide and beta C-terminal cross-linked telopeptide of type Ⅰ collagen in differential diagnosis of spinal bone metastasis from lung cancer and myeloma
Erfeng WU ; Jianping ZHANG ; Jinglong WU ; Xingwei WANG ; Jinlu GUO ; Ningning HAN
Chinese Journal of Postgraduates of Medicine 2022;45(3):257-262
Objective:To analyze the value of dual energy CT parameters combined with serum procollagen Ⅰ N-terminal propeptide (PⅠNP) and beta C-terminal cross-linked telopeptide of type Ⅰ collagen (β-CTX) in differential diagnosis of spinal bone metastasis from lung cancer and myeloma.Methods:The clinical data of 54 patients with spinal bone metastasis from lung cancer and 50 patients with myeloma in Jincheng People′s Hospital from October 2019 to March 2021 were analyzed retrospectively. All patients were examined by dual energy CT on the day of admission, and the CT values at the energy levels of 40 to 80 keV (energy interval of 10 keV) were recorded. The serum PⅠNP and β-CTX levels were detected by chemiluminescent assay before treatment. The pathological examination results were taken as gold standard, and the CT values at the energy levels of 40 to 80 keV by dual energy CT and serum PⅠNP and β-CTX levels were compared between 2 groups. Receiver operating characteristic (ROC) curve was used to analyze the differential diagnosis value of the CT values at the energy levels of 40 to 80 keV, serum PⅠNP and β-CTX levels alone and combination.Results:The CT values at the energy levels of 40 to 80 keV by dual energy CT and serum PⅠNP and β-CTX levels in patients with spinal bone metastasis from lung cancer were significantly higher than those in patients with myeloma: 79.86 (61.20, 116.32) HU vs. 58.29 (46.92, 64.03) HU, 64.48 (50.27, 90.08) HU vs. 45.78 (38.59, 56.75) HU, 57.35 (43.31, 78.04) HU vs. 43.62 (36.91, 54.06) HU, 52.05 (42.98, 75.79) HU vs. 41.26 (32.84, 51.76) HU, 45.52 (38.55, 63.59) HU vs. 36.68 (28.72, 49.83) HU, 66.35 (31.15, 81.97) μg/L vs. 31.38 (27.76, 34.50) μg/L and 0.61 (0.48, 0.67) μg/L vs. 0.49 (0.47, 0.52) μg/L, and there were statistical differences ( P<0.05 or <0.01). ROC curve analysis result showed that the sensitivity of the combination of the CT values at the energy levels of 40 to 80 keV by dual energy CT was higher than those alone (83.33% vs. 59.26%, 61.11%, 62.96%, 64.81% and 66.67), the area under the curve (AUC) was also higher than those alone (0.882 vs. 0.798, 0.811, 0.817, 0.801 and 0.773), and there were statistical differences ( P<0.01 or <0.05); the sensitivity of the combination of serum PⅠNP and β-CTX levels was higher than those alone (81.48% vs. 57.41% and 62.96%), the AUC was higher than those alone (0.829 vs. 0.753 and 0.729), and there were statistical differences ( P<0.01 or <0.05); the sensitivity of all indexes combined in the differential diagnosis of spinal bone metastasis from lung cancer and myeloma was higher than those of the combination of the CT values at the energy levels of 40 to 80 keV by dual energy CT, the combination of serum PⅠNP and β-CTX levels (98.15% vs. 83.33% and 81.48%), the same as AUC (0.976 vs. 0.882 and 0.829), and there were statistical differences ( P<0.01); there were no significant differences in the specificity of each index alone and combination ( P>0.05). Conclusions:Compared with myeloma, the CT values at the energy levels of 40 to 80 keV by dual energy CT, serum PⅠNP and β-CTX levels in patients with spinal bone metastasis from lung cancer are increased, and the combination of the above indexes has ideal value in differential diagnosis of the two diseases.
7.Neurofeedback technique based on mismatched negativity in improvement of cognitive function
Guangying PEI ; Shujie WANG ; Zhongyan SHI ; Tiantian LIU ; Ruoshui YANG ; Guoxin GUO ; Jinglong WU ; Tianyi YAN
Chinese Journal of Neuromedicine 2020;19(4):330-336
Objective:To explore effective schemes for improving cognitive function in patients with subjective cognitive decline (SCD) by EEG neurofeedback (NF) technique.Methods:Ten SCD patients recruited in Department of Neurology, Xuanwu Hospital, Capital Medical University from April 2019 to August 2019, were chosen in our study; all patients were subjected to neuro-regulation of mismatched negativity (MMN) for 5 times in 2 weeks by EEG NF technique. By using the midlines of frontal zone (Fz), central zone (Cz) and peak zone (Pz) as training electrodes, auditory tones (1000 Hz as standard stimulus, individual hearing discrimination threshold as deviation stimulus) were used to induce MMN characteristics of event-related potential (ERP) via Oddball paradigm. SCD patients received visual disc stimulation feedback with dynamic neural signal activity. ERP waveforms and standard MMN characteristics (amplitude and latency) before and after training were used to evaluate the changes in neural activity of these patients; nine N-Back working memory tasks (three types×three gradients) and hearing discrimination ability tests were used in these patients to evaluate the improvement of cognitive competence.Results:ERP analysis showed that the MMN waveforms in SCD patients after training were obviously different as compared with those before training; their standard stimulus and deviant stimulus in the point-by-point paired t-test analysis were significant different ( P<0.05). The MMN amplitudes at the Fz, Cz and Pz electrodes in these patients after training were significantly higher than those before training ( P<0.05). The accuracy of auditory tone 3-Back task in SCD patients was statistically significant before and after training ( P<0.05). Conclusion:NF based on MMN can significantly improve the MMN amplitude and accuracy of auditory working memory task in patients with SCD, which might provide a potentially effective cognitive intervention method for patients with early AD and the elderly with normal memory decline.
8.Application of Neurofeedback for Parkinson's Disease (review)
Guangying PEI ; Tianyi YAN ; Boyan FANG ; Jinglong WU
Chinese Journal of Rehabilitation Theory and Practice 2018;24(12):1413-1416
Neurofeedback may improve cognitive function and behaviour by regulating the cerebral neural activities. Neurofeedback works as a kind of therapy for patients with Parkinson's disease, primarily based on electroencephalogram signals and hemodynamic signals. It regulates abnormal neuronal rhythm oscillations in the cortical-spinal system by electroencephalogram neurofeedback and sensory motor rhythm as the main adjustment frequency band, and modulates activation in the cortical-basal ganglia-thalamic-cortical network of brain with the supplementary motor area as the target area via functional magnetic resonance imaging neurofeedback. Neurofeedback effectively improves the motor symptoms of Parkinson's patients, both dynamic and static. However, the number of samples is limited in these researches, and the assessments before and after neurofeedback training are not yet comprehensive. Neurofeedback technology might be a potential effective rehabilitation for patients with Parkinson's disease.
9.A surgical classification system for the management of axial primary malignant and aggressive benign tumors and its application in multiple tertiary centers
Nanzhe ZHONG ; Feng LI ; Jinglong YAN ; Tongwei CHU ; Jian YANG ; Chen YE ; Shaohui HE ; Minglei YANG ; Jian JIAO ; Wei XU ; Haifeng WEI ; Tielong LIU ; Jian ZHAO ; Zhipeng WU ; Cheng YANG ; Xinghai YANG ; Jianru XIAO
Chinese Journal of Orthopaedics 2020;40(11):689-699
Objective:To propose and verify a surgical classification system for the axial primary malignant and aggressive benign tumor.Methods:The CZH surgical classification system was originally developed for the axial primary malignant and aggressive benign tumor. The CZH surgical classification system includes seven types, according to the anatomic features and the extension of tumor violation. A total of 136 patients (79 males and 57 females) with axial primary malignant and aggressive benign tumor from multiple tertiary centers who received surgery from July 2006 to July 2019 were included. The average age was 44.40±17.55 years (8-83 years) old. There were 99 malignant tumors and 37 aggressive benign tumors included. The number of patients with each classification was presented as followed, Type I 13, Type II 15, Type IIIa 3, Type IIIb 20, Type IVa 43, Type IVb 12, Type Va 21, Type Vb 3, Type VI 2, Type VIIa 3 and Type VIIb 1. Surgical procedures were selected according to different types in classification. The inter- and intra-observer consistencies were evaluated by the Kendall's W test. The VAS, Frankel score, overall survival and recurrence free survival were recorded during the follow-up. Results:The inter- and intra-observer consistent coefficient was 0.973 and 0.996, respectively ( P<0.05). The single posterior approach was adopted for the Type II tumors. Other patients underwent surgery by the combined antero-posterior approach. The majority in anterior approach (113 cases) was the modified submandibular approach. The reconstruction modes included anterior "T" shape titanium mesh (112 cases) or the 3D printed prothesis (7 cases) combined with the posterior occipto-cervical fusion (92 cases) or the pedicle screw system (44 cases). The average surgical duration and the volume of intraoperative bleeding was 348.40±136.14 min (60-760 min) and 1 225.69±859.40 ml (80-4 000 ml), respectively. The operation duration and volume of intraoperative bleeding among each type were with statistical difference. The patients with Type IV, V tumors had longer operation duration than those with Type II tumors. Those with Type V and VII tumors had longer operation duration than those with Type I tumors. The patients with Type V tumors had more intraoperative bleeding than those with Type I-IV tumors. The average preoperative VAS score was 4.15±2.25 and then was reduced significantly to 0.62±0.71 and 0.38±0.59 at one and three months after operation, respectively. The Frankel score was also significantly ameliorated at one and three months postoperatively. There were 22 postoperative complications (16.2%). The complications included cerebral spinal fluid leak (12.5%), dysphagia and/or dysphonia (7.4%), dyspnea (5.1%), wound infection (3.7%), wound hemorrhage (2.2%) and pharyngeal dehiscence (1.5%). The incidence of postoperative complication was 25.9% in Type IV-VII tumors, while 11.8% in Type I-III tumors. Conclusion:CZH surgical classification system was verified with high observer consistency. This classification system could assist surgeons to select proper surgical approaches, resection modes and reconstruction modes, and thus ensure the safety of surgery and reduce the recurrence. The tumors in Type IV, V and VII may be with more challenging for surgeons. The incidence of postoperative complication in Type IV-VII tumors may be higher than that in Type I-III tumors.