Objective To observe the influence of α-lipoic acid on nerve conduction velocity in the treatment of type 2 diabetes with peripheral neuropathy,to provide a theoretical basis for clinical treatment.Methods 90 type 2 diabetes patients with peripheral neuropathy were included in this study.The patients were randomly divided into the observation group and the control group,45 cases in each group.The control group was given conventional therapy,containing hypoglycemic comprehensive intervention and neurotrophic treatment.The observation group was given αt-lipoic acid treatment,600mg/d,21d for a course of treatment.The motor and sensory nerve conduction velocity were measured by EMG after a course,and the peripheral neuropathy symptoms (limb pain,numbness,fever,cold,hypoesthesia) before and after treatment were observed,the clinical efficacy was evaluated.Results The motor nerve conduction velocity (median nerve,tibial nerve,peroneal nerve) and sensory nerve conduction velocity (median nerve,peroneal nerve) of the observation group after treatment were significantly higher than before treatment (t =3.946,4.175,3.887,3.915,4.034,all P ＜ 0.05),but the median nerve sensory conduction velocity of the control group had no significant difference before and after treatment(P ＞ 0.05).The motor nerve conduction velocity (median nerve,tibial nerve,peroneal nerve) and sensory nerve conduction velocity (median nerve,peroneal nerve) of the observation group after treatment were significantly higher than the control group (t =3.488,3.585,3.362,3.246,3.505,all P ＜ 0.05).The efficacy of limb pain,numbness,fever,cold,feeling diminished of the observation group were 71.43％,78.95％,62.5％,61.54％,59.26％,which were significantly higher than 36.36％,43.24％,21.4％,29.17％,28％ of the control group(all P ＜0.05).The total effective rate of the observation group was 84.44％,which was significantly higher than 64.44％ of the control group (x2 =6.925,P ＜ 0.05).Conclusion α-lipoic acid can improve the motor nerve conduction velocity and sensory nerve conduction velocity of type 2 diabetes patients with peripheral neuropathy,significantly relieve the positive symptoms of DPN and improve clinical efticacy,which is worthy of clinical use.

Objective To investigate the effect of C-erbB-2 shRNA on chemosensitivity of mouse lung adenocarcinoma cells and its mechanism,and to find new therapy method for non-small cell lung cancer,especial lung adenocarcinoma.Methods The mouse lung adenocarcinoma Lewis cells were cultured regularly and divided into non-transfected group, pGPU6/RFP/Neo-shNC group and pGPU6/RFP/Neo-erbB-2 group. The plasmids were synthesized and transfected into Lewis cells in each group by Lipofectamine 2000.The expression levels of C-erbB-2 mRNA and protein in the cells in various groups were tested by RT-PCR and Western blotting method, respectively. The Lewis cells were divided into non- transfected group, pGPU6/RFP/Neo-shNC group, carboplatin group, pGPU6/RFP/Neo-erbB-2 group, pGPU6/RFP/Neo-shNC+carboplatin group and pGPU6/RFP/Neo-erbB-2+ carboplatin group. The apoptotic rates of the cells in each group were detected by flow cytometry;the expression levels of Bcl-2 and Bax proteins in each group were determined by Western blotting method.Results The expression levels of C-erbB-2 mRNA and protein in pGPU6/RFP/Neo-erbB-2 group were lower than those in non-transfected group and pGPU6/RFP/Neo-shNC.The apoptotic rate of the cells in pGPU6/RFP/Neo-erbB-2+carboplatin group was the highest in all of the groups (P<0.01);compared with the others, the expression of Bax protein in pGPU6/RFP/Neo-erbB-2+carboplatin group was increased, while the expression level of Bcl-2 protein was decreased.Conclusion C-erbB-2 shRNA can increase the Lewis cells’sensitivity to carboplatin.The mechanism may be that it can enhance the Lewis cells’apoptosis induced by carboplatin through increasing the expression of Bax protein and decreasing the expression of Bcl-2 protein.

Objective To analyze the influence of liraglutide intervention combined percutanous coronary intervention(PCI) therapy on acute myocardial infarction( AMI) with type 2 diabetes( T2DM) patients'myocardial injury, ventricular remodeling( VR), and cardiac function. Methods Eighty patients with AMI and T2DM were included in the study, and they were randomly divided into observation group and control group according to the random number table, each with 40 patients. The patients in the control group received metformin and conventional insulin combined PCI treatment, and the patients in the observation group received metformin and liraglutide combined PCI treatment. The changes in the values of ventricular remodeling indexes, cardiac function and serum related indexes were compared after 3 months treatment between the two groups. Results ( 1) The body weight and fasting blood glucose levels of the observation group were significantly lower than those of the control group( P＜0.05), and fasting insulin levels were significantly higher than those of the control group(P＜0.01). (2)The levels of N-terminal-pro-B- type natriuretic peptide ( NT-proBNP ), creatine kinase isoenzymes-MB ( CK-MB), and troponin I ( TnI) in the observation group 3 months after treatment were significantly lower than those in the control group(P＜0.05). (3)The levels of serum hypersensitive C-reactive protein(hs-CRP), tumor necrosis factor-α(TNF-α), and interleukin-6(IL-6) in the observation group were significantly lower than those in the control group 3 months after treatment( P＜0. 05). ( 4) The values of left ventricular end systolic diameter ( LVESD ), left ventricular end diastolic diameter (LVEDD), interventricular septum thickness ( IVST), left ventricular posterior wall thickness ( LVPWT), left ventricular mass index ( LVMI), left ventricular end systolic volume ( LVESV), and left ventricular end diastolic volume(LVEDV) in the observation group were lower than those in the control group; the values of left ventricular fraction shortening(LVFS), left ventricular ejection fraction(LVEF), and mitral valve early diastolic blood flow rate (VE)/atrial systolic flow velocity ( VA), all were higher than those of the control group ( P＜0. 05). Conclusion Lraglutide intervention combined with PCI therapy on AMI with T2DM patients may reduce myocardial injury, induce ventricular remodeling, enhance cardiac function, and improve prognosis.

Objective: To evaluate the application effect of the medication management training based on Precede-Proceed Model in schizophrenic inpatients. Methods: In this self-control study, 60 schizophrenic inpatients were chosen for this investigation and were undergoing the medication management training on Precede-Proceed Model with conventional nursing care. By using Insight and Treatment Attitudes Questionnaires (ITAQ), The Brief Psychiatric Rating Scale (BPRS) and Nurses′ Observation Scale for Inpatient Evaluation (NOSIE) after the first 3 months and 6 months of the intervention, in order to evaluate their results with their initial readings. Results: The total scores of ITAQ, the total scores of BPRS, lacking in activity factor, reaction factor, hostile-suspiciousness factor, the total scores of NOSIE, total positive and negative factors before the intervention were (183.3±15.0) points, (71.7±10.9) points and (13.6±8.8) points; three months after intervention were (189.0±15.8) points, (75.3±11.1) points and (11.6±7.2) points; six months after intervention were (193.8 months after intervention were15.2) points, (71.8 ±9.6) points and (10.1±7.0) points. There were significant differences between the total score and the total negative factor score before and after treatment (F=43.244, 23.060, P<0.05). Conclusion The Precede-Proceed Model on medication management training in schizophrenic inpatients plays a positive role in promoting recovery and it is worth extending in clinical practice.

Objective To evaluate the long-term safety of sentinel lymph node biopsy mapped by combination of indocyanine green and methylene blue in breast cancer patients.Methods 198 breast cancer patients with clinical negative axillary lymph node received sentinel lymph node biopsy mapped by combination of indocyanine green and methylene blue.Patients were followed up and regional lymph node recurrence,disease free survival(DFS) and overall survival(OS) were analyzed.Results After a median follow-up of 70 months,2 patients had ipsilateral lymph node recurrence with a regional lymph node recurrence rate of 1％ (2/198).14 patient had recurrence or metastasis and 6 patients died of distant metastasis.The estimated 6 years DFS was 94.4％ and OS was 96.5％.The incidence of arm lymphoedema within patients who received axillary lymph node dissection was 4.5％ and it was 2.5％ in patients who received sentinel lymph node biopsy.Conclusions The sentinel lymph node biopsy mapped by combination of indocyanine green and methylene blue was safe and reliable method for further staging axillary lymph node stastus.

OBJECTIVE： To provide references for improving the standard operating procedures of drug management in clinical trials and drug management in clinical trials. METHODS： According to Good Clinical Practice （GCP）， Data On-site Verification Points of Drugs Clinical Trial， Qualification Examination Rules of Drug Clinical Trial Institution， based on the quality control project carried out in our hospital since July 2016， the matters needing attention in the non-standard operation and key process of drug management in clinical trial were summarized， and the improvement measures were discussed. RESULTS & CONCLUSIONS： Non-standard drug management is a high-incidence link of non-standard operation in the trial process. Among them， the acceptance， distribution and use of drugs are the three links with the highest incidence of non-standard operation of drug management in the trial process. Therefore， when formulating the relevant management system， each institution should pay attention to it according to its own situation； such as， when accepting drugs in clinical trials， attention should be paid to checking the intact degree of drug packaging； drugs transported in cold chain should also be checked for temperature records and rejected in case of over-temperature； the copies of the waybill should be kept in file with the original to avoid fading of the thermosensitive paper； whether the relevant characteristics of the control drugs and placebos meet the requirements. Institutions can standardize the key links of drug management in the trial process， the time of project establishment， project start-up， quality control and supervision， formulate and constantly improve the relevant drug management system and standard operating procedures （SOP）. For example， when starting a project， attention should be paid to the participation of drug administrators in the training and signature of start-up meeting， whether the design of the form is complete， standardized and operable. It is necessary for clinical trial institutions to pay attention to the standardization and precision of drug management and the key links in clinical trials.

OBJECTIVE To provide a reference for improving the relevant standard operating procedures （SOP） and biological sample management in drug clinical trials. METHODS According to Good Clinical Practice， Data On-site Verification Points of Drugs Clinical Trials， Human Genetic Resources Management Regulations Implementation Rules， Qualification Examination Rules of Drug Clinical Trials Institution， based on the experience of managing clinical trials programs， the irregularities in biological samples management were analyzed by using statistical quality control tables and protocol deviation （PD） reported by sponsors， in the context of the quality control of drug clinical trials projects managed by the author from July 2016 to May 2023. The precautions in various aspects of sample management were put forward. RESULTS & CONCLUSIONS A total of 101 biospecimen- related irregularities were found in the 60 drug clinical trials projects. Biological sample collection， preservation， and handling were the aspects with the highest incidence of irregular operations in biological sample management， accounting for 37.62%， 25.74%， and 21.78%， respectively. Regulating the management of biospecimens requires multiple efforts. The institutional office and the ethics committee carefully reviewed the consistency of the protocols， informed consent， and genetic office application involving biospecimen collection and handling when the project was initiated. Institutional office quality controllers should pay attention to the attendance and training of authorized personnel at project initiation. The principal investigator， research nurse， collector， handler， transporter， relevant personnel of the central laboratory， and institutional office quality controller have their roles during the project implementation phase. On this basis， all parties involved in the management of biological samples should do a good job of effective communication， find problems and report them in time， and conduct special studies on key aspects.

OBJECTIVE To learn the common proto col deviation （PD）in the process of drug clinical trials and discuss the methods and precautions for preventing and reducing PD so as to provide reference for the standardization of drug clinical trials. METHODS According to Good Clinical Practice ，Notice on Issuing Guidelines for Planning and Reporting of Data Management and Statistical Analysis of Drug Clinical Trials ，Guidelines for Ethical Review of Drug Clinical Trials ，ICH E 3，ICH E 6（R2）and other regulations ，the PD reported in the relevant projects managed by the author from March 2017 to February 2022，as well as the PD found in the submission materials and project quality control ，were sorted out and statistically analyzed. RESULTS & CONCLUSIONS A total of 39 drug clinical trials were included ，and 212 subjects were selected. In all projects ，258 PDs were reported，including 28 major PD （accounting for 10.85％）and 230 ordinary PD （accounting for 89.15％）. The report of PD mainly included missed inspections/tests （93 reports，accounting for 36.05％），lack of visits （36 reports，accounting for 13.95％）， inspection/testing out-of-window （29 reports，accounting for 11.24％），dosage and usage of test drugs （28 reports，accounting for 10.85％），drug over-temperature/missing temperature （21 reports，accounting for 8.14％），etc. Avoiding and reducing the occurrence of PD requires the efforts of multiple parties ：the sponsor designs a reasonable protocol with appropriate interview rate and window period after listening to the opinions of multiple parties ；the investigators and clinical research coordinator should strengthen their own learning and training ，and be familiar with the protocol ，Good Clinical Practice and corresponding regulations；the compliance education of the subjects should be strengthened ；the institutional offices and ethics committees should conduct multi-angle and whole-process supervision and management when a drug clinical trial is approved ，in progress ，and jsyj- concluded，to ensure the safety rights and interests of the zdcxX0079） subjects and the quality of clinical trials. On this basis ，all parties should communicate effectively and timely ，report PD in time ，and conduct special studies on major PD that have com occurred and key links that are prone to PD.