Objective To compare the effects of Jianpi Shengxue Granule and Hexue Capsule in treating patients with iron deficiency anemia. Methods All 120 patients with iron deficiency anemia were randomly recruited into group A (treated with Jianpi Shengxue Granule) and group B (treated with Hexue Capsule), with 60 patients in each group. The levels of serum iron (Fe), total iron binding capacity (T IBC), transferrin saturation (TS), transferrin (Tf), ferritin (SF), hemoglobin (Hb) and serum soluble transferrin receptor(sTIR) were observed in both groups. Results Jianpi Shengxue Granule showed better results in treating patients with iron deficiency anemia than Hexue Capsule with significant difference (P<0.05). Conclusion Jianpi Shengxue Granule is effective in treating iron deficiency anemia.

Objective To evaluate the effect and safety of the intermittent deferoxamine therapy on relieving iron overload caused by transfusion in senile. Method Twenty-three senile with iron overload caused by transfusion were administered in a total daily dose of 20 - 50 mg/ ( kg·d ) for 5 - 6 days per week every 4 -6 weeks,the maximal dose was 2000 mg/d, add in 0.9％ sodium chloride 500 ml, continuous intravenous drip for 6 h. Result Nine months after therapy, serum ferritin fell from (2771.5±735.3)μg/L to (2483.7 ±724.4) μg/L (P＜0.01), and urine ferritin elevated from (9.68 ±5.39)μg/L to (12.14±5.50) μ g/L (P＜0.01 ). Conclusion It shows that intermittent deferoxamine therapy can reduce the serum ferritin with no significant toxicity.

Objective To explore the clinical application and curative effect of iron removal treatment with week-therapy in chronic iron overload related to blood transfusion.Methods Twenty patients who were diagnosed as chronic iron overload were retrospectively studied.The amelioration of liver and pancreatic fanctions in patients with chronic iron overload treated with week-therapy of iron chelating agent through intravenous drip.Results The changes in the level of serum ferritin [2693.7±709.9) μg/L] were not significant after treatment at six months,hut the cilinical symptoms were relieved obviously.The levels of serum ferritin in patients after the treatment at twelve months were significantly different from the level before treated [(2083.7±714.4) μg/L vs (2771.5±725.2) μg/L,t =3.35,P ＜ 0.01],and the decreases were significant in sixteen patients.The liver functions in seven patients were improved and pancreatic functions were better in five patients.Conclusion The study suggests that iron removal treatment with week-therapy is effective for chronic iron overload,and improves the functions of damaged organs.

Objective To explore the pathogenesis of myelodysplastic syndrome (MDS)transformation, JAK2V617F mRNA expression levels were compared in peripheral blood of MDS-RA(refractory anemia,RA)and MDS-RAEB(RA with excess blasts,RAEB)patients.Methods JAK2V617F mRNA expression level was detected by fuorescent quantitative polymerase chain reaction(FQ-PCR),and this research reviewed 22 patients diagnosed with MDS,including outpatient and hospitalized patients.20 cases of normal control group were healthy ones.FQ-PCR method was applied to monitor JAK2V617F mRNA expression level in peripheral blood of MDS-RA and MDS-RAEB patients.Results The JAK2V617F gene was not expressed or expressed in healthy subjects,and the copy number was (3 851.96 ±470.46).The patients with MDS-RA(4 631.11 ±3 851.96)was significantly higher than that in healthy subjects(t =3.61,P <0.01);MDS-RAEB patients was (22 545.98 ±11 084.17),and was significantly higher than that in MDS-RA patients(t =4.87,P <0.01).Conclusion JAK2V617F signal transduction can play a role in the pathogenesis and transformation of MDS,and the detection of JAK2-V617F mRNA expression level is use-ful for monitoring progression,judging prognosis and gene regulation therapy of MDS.

Objective To discuss the clinical application of using trimmed latissimus dorsi free muscle flap together with skin grafting to resurface soft tissue defects on the dorsum of the foot. Methods From June 2005 to October 2011,eleven patients (8 males and 3 females,aged from 4-46 years) with large soft tissue defects of the foot dorsum were treated in our department. The size of the defects after debridement ranged from 5.0 cm × 6.0 cm-8.0 cm × 12.0 cm,all with exposed tendons or bones.Trimmed free latissimus dorsi muscular flap with split thickness skin grafting was used for reconstruction for all the 11 patients. Results All the flaps survived with no complications after surgery.During 3-10 months' follow-up,the appearance and walking function were satisfying, no further debulking procedures were needed. Conclusion Trimmed latissimus dorsi free flap with skin grafting is a good option for dorsal defect reconstruction.

Objective : To study the effect of lipopolysaccharide ( LPS) -induced immune system activation on syn- aptic structure and DISC1. Methods : 40 rats were divided into 4 groups，which were PBS group，PBS + MK-801 group，LPS group and LPS + MK-801 group．The rats in LPS group and LPS + MK-801 group were administrated with LPS solution (0. 2 mg / kg，i．p．BIW) for 6 times in total， the rats in PBS group and PBS + MK801 group were administrated with PBS．At the third time when the rats were administrated with LPS solution，the rats in PBS + MK-801 group and LPS + MK-801 group were administrated with MK-801 solution (0. 5 mg / kg，i．p．BIW) for a total of 4 times，the rats in PBS group and LPS group were adminis- trated with saline．The head shaking and the open field tests were then evaluated in the rats．Immediately，the rats were sacrificed，and their brain were saved for testing. RT-qPCR , Golgi staining，immunohistochemistry and ELISA kits were used to detect DISC1 gene expression，dendritic spine status，microglia activation and inflammatory cytokine content in cortex，respectively. gene expression in the cortex of rats with schizophrenia． Results : Compared with the PBS group，the expression of DISC1 gene of the rats in the PBS + MK-801 group increased (P ＜0. 01) ，the score of head shaking increased (P ＜0. 01) ，and the distance of the open field increased (P ＜0. 000 1) ; As well as the LPS + MK-801 group，compared with the LPS group，the expression of DISC1 gene increased (P＜0. 000 1) ，the head shaking score and the distance of the open field increased (P＜0. 000 1) . In addition，compared with the PBS + MK-801 group，the expression of DISC1 gene， the shaking head score and the open field distance of the LPS + MK-801 group further improved (P ＜0. 000 1) . Furthermore，compared with PBS group and PBS + MK-801 group，the content of iba1 in the cortex of LPS group and LPS + MK-801 group significantly increased (P ＜0. 05 ) ，the content of inflammatory cytokines significantly increased (P＜0. 05) ，and the length and density of dendritic spines significantly decreased (P＜0. 05) ． Conclusion The activation of the immune system induced by LPS can contribute to the susceptibility of schizophrenia model， and the possible mechanism is that it cooperates with MK-801 to increase the expression of DISC1 gene，which ulti- mately leads to abnormal mental behavior in rats.

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.

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 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.