Protocol design and implementation are important steps for clinical trial . This article discussed key issues on effect of live birth rate by polycystic ovary syndrome ( PCOS ) treatment with acupuncture combined with clomiphene citrate in the randomized controlled trial ( RCT ) process . For example , the trial designs ( i . e . , trial design characteristics , selection of featured therapeutic effect index ) , clinical trial implementation ( i . e . , or-ganization construction , quality control , and etc . ) . This summarization provided references for the design and implementation of clinical trial plan .

Four genotypic mice were constructed, by ovary transplantation, with body leptin receptor (LR) + and ovary LR - in Group A, body LR + and ovary LR + in Group B, body LR - and ovary LR + in Group C, as well as body LR - and ovary LR - in Group D respectively. Mice in C and D groups showed significant differences in glucose and fat metabolism as well as ovarian function as compared with A and B groups. Leptin signal transducting system exists in the ovary. Ovarian failure was induced by hyperlipidemia and lowered gonadotropin levels, but not by defective leptin signal within ovaries in the db/db mice.

Objective:To explore the treatment of iatrogenic injury to the medial collateral ligament (MCL) in total knee arthroplasty (TKA).Methods:From January 2009 to December 2016, 14 patients were treated at Department of Arthropathy, Zhengzhou Orthopedics Hospital for iatrogenic MCL injury in primary TKA (injury group). They were 3 males and 11 females with an age of (72.6±3.9) years. The MCL injury was body rapture in 9 cases and avulsion of femoral insertion in 5 ones. Interlacing suture was used for body rapture and reparative reconstruction with wire anchors or nails was performed for avulsion of femoral insertion. A restrictive condylar prosthesis was used instead in the 4 patients whose medial stability failed to be restored after repair of body rapture. A control group of 21 cases was enrolled who had suffered from no iatrogenic MCL injury in primary TKA at the corresponding period. There were 5 males and 16 females with an age of (73.2±3.9) years. The 2 groups were compared in terms of American Knee Society Score (KSS) and knee flexion.Results:There was no significant difference between the 2 groups in preoperative general data, showing comparability between groups ( P>0.05). The injury group was followed up for 18 to 36 months (mean, 33 months). Joint loosening was observed at 18 months after operation in 3 patients with nonrestrictive prosthesis who had to receive secondary revision. At the 36-month follow-up of the remaining 11 patients, normal knee extension and flexion was observed, the stress test of valgus showed no inner relaxation, their KSS increased significantly from preoperative 50.0±22.7 to 93.3±4.7, and their knee flexion was improved significantly from 90.4°±10.3° to 110.7°±8.8° ( P<0.05). There were no significant differences in KSS score or knee flexion between the 2 groups at 3, 6, 12 or 36 months after operation ( P>0.05). Conclusion:Iatrogenic MCL injury in primary TKA should be repaired and reconstructed by one-stage surgery because the patients can achieve curative results similar to those for the patients free from iatrogenic MCL injury in primary TKA.

OBJECTIVETo explore the possible mechanism and protective effect of BMSCs (bone mesenchymal stem cells) carrying superoxide dismutase (SOD) gene on mice with paraquat-induced acute lung injury.

METHODSTo establish the cell line of BMSCs bringing SOD gene, lentiviral vector bringing SOD gene was built and co-cultured with BMSCs. A total of 100 BALB/c mice were randomly divided into five groups, namely Control group, poisoning group (PQ group) , BMSCs therapy group (BMSC group) , BMSCs-Cherry therapy group (BMSC-Cherry group) , BMSCs-SOD therapy group (BMSC-SOD group) . PQ poisoning model was produced by stomach lavaged once with 1 ml of 25 mg/kg PQ solution, and the equal volume of normal saline (NS) was given to Control group mice instead of PQ. The corresponding BMSCs therapy cell lines were delivered to mice through the tail vein of mice 4h after PQ treatment.Five mice of each group were sacrificed 3 d, 7 d, 14 d and 21 days after corresponding BMSCs therapy cell lines administration, and lung tissues of mice were taken to make sections for histological analysis. The serum levels of glutathione (GSH) , malondialdehyde (MDA) , SOD, and the levels of transforming growth factor-β (TGF-β) and tumor necrosis factor-α (TNF-α) in lung tissue were determined. The level of SOD was assayed by Westen-blot.

RESULTSCompared with Control group, the early (3 days) levels of SOD protein in lung tissue of PQ group obviously decreased, and the late (21 days) levels of SOD obviously increased, while in therapy groups, that was higher than that in PQ group, and the BMSCs-SOD group showed most obvious (all P<0.05) . Compared with Control group, the levels of plasma GSH and SOD of PQ group and each therapy group wae significantly lower than those in Control group, while in therapy groups, those were higher than those of PQ group, and the BMSCs-SOD group showed most obvious (all P<0.05) .Compared with Control group, the level of plasma MDA, TNF-α and TGF-β in PQ group and therapy groups were significantly higher, while in therapy groups, that was lower than that in PQ group, and the BMSCs-SOD group showed most obvious (all P<0.05) . Lung biopsy showed that, the degree of lung tissue damage in each therapy group obviously reduced.

CONCLUSIONSOD is the key factor of the removal of reactive oxygen species (ROS) in cells, that can obviously inhibit the oxidative stress damage and the apoptosis induced by PQ, thus significantly increasing alveolar epithelial cell ability to fight outside harmful environment.

Acute Lung Injury ; chemically induced ; therapy ; Animals ; Antioxidants ; metabolism ; Cell Line ; Glutathione ; blood ; Lung ; pathology ; Malondialdehyde ; blood ; Mesenchymal Stem Cell Transplantation ; Mice ; Mice, Inbred BALB C ; Oxidative Stress ; Paraquat ; poisoning ; Superoxide Dismutase ; blood ; genetics ; Transforming Growth Factor beta ; metabolism ; Tumor Necrosis Factor-alpha ; metabolism

Objective To investigate the prognostic value of echocardiography indicators combined with se-rum recombinant human arginase 1(ARG1)and glucose-6-phosphate dehydrogenase(G6PD)in children with sepsis.Methods A total of 116 children with sepsis admitted to the hospital from May 2022 to June 2023 were enrolled in the study as the sepsis group.According to the severity of sepsis,the children were further divided into general sepsis group(52 cases),severe sepsis group(38 cases)and septic shock group(26 cases).Ac-cording to the prognosis of the children,the children with sepsis were divided into good prognosis group(84 cases)and poor prognosis group(32 cases).A total of 116 healthy children who underwent physical examina-tion in the hospital during the same period were enrolled as the control group.The left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD),left ventricular end-diastolic volume(LV-EDV)and early diastolic mitral flow peak velocity(E)were detected by using color Doppler ultrasound.Ser-um ARG1 and G6PD levels were detected by using enzyme-linked immunosorbent assay(ELISA).The echo-cardiographic indexes and serum ARG1 and G6PD levels were compared between the sepsis group and the con-trol group,and among sepsis children with different disease severity and different prognosis.The receiver op-erating characteristic(ROC)curve was used to analyze the predictive value of echocardiographic indexes com-bined with serum ARG1 and G6PD for poor prognosis in children with sepsis.Results Compared with the control group,the sepsis group had significant reductions in LVEF,E,and G6PD(P＜0.05)and significant increases in LVEDD,LVEDV,and ARG1(P＜0.05).With the aggravation of sepsis,the levels of LVEF,E,and G6PD in children with sepsis gradually decreased(P＜0.05),while the levels of LVEDD,LVEDV,and ARG1 gradually increased(P＜0.05).Compared with the good prognosis group,the poor prognosis group had significantly lower levels of LVEF,E,and G6PD(P＜0.05)and significantly higher levels of LVEDD,LV-EDV,and ARG1(P＜0.05).ROC curve analysis showed that the AUC of echocardiographic indexes com-bined with serum ARG1 and G6PD in predicting poor prognosis of children with sepsis was 0.971,and the sensitivity and specificity were 84.4％and 83.2％,respectively.Conclusion The levels of LVEF,E,and G6PD in children with sepsis significantly decreases,and the levels of LVEDD,LVEDV,and ARG1 signifi-cantly increases.Echocardiographic parameters combined with serum ARG1 and G6PD have high predictive value for poor prognosis in children with sepsis.