Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective:To analyze the immune reconstitution after BTKi treatment in patients with chronic lymphocytic leukemia(CLL).Methods:The clinical and laboratorial data of 59 CLL patients admitted from January 2017 to March 2022 in Fujian Medical University Union Hospital were collected and analyzed retrospectively.Results:The median age of 59 CLL patients was 60.5(36-78).After one year of BTKi treatment,the CLL clones(CD5+/CD19+)of 51 cases(86.4％)were significantly reduced,in which the number of cloned-B cells decreased significantly from(46±6.1)× 109/L to(2.3±0.4)× 109/L(P=0.0013).But there was no significant change in the number of non-cloned B cells(CD19+minus CD5+/CD19+).After BTKi treatment,IgA increased significantly from(0.75±0.09)g/L to(1.31±0.1)g/L(P＜0.001),while IgG and IgM decreased from(8.1±0.2)g/L and(0.52±0.6)g/L to(7.1±0.1)g/L and(0.47±0.1)g/L,respectively(P＜0.001,P=0.002).BTKi treatment resulted in a significant change in T cell subpopulation of CLL patients,which manifested as both a decrease in total number of T cells from(2.1±0.1)× 109/L to(1.6±0.4)× 109/L and NK/T cells from(0.11±0.1)× 109/L to(0.07±0.01)× 109/L(P=0.042,P=0.038),both an increase in number of CD4+cells from(0.15±6.1)× 109/L to(0.19±0.4)× 109/L and CD8+cells from(0.27±0.01)× 109/L to(0.41±0.08)× 109/L(both P＜0.001).BTKi treatment also up-regulated the expression of interleukin(IL)-2 while down-regulated IL-4 and interferon(IFN)-γ.However,the expression of IL-6,IL-10,and tumor necrosis factor(TNF)-α did not change significantly.BTKi treatment could also restored the diversity of TCR and BCR in CLL patients,especially obviously in those patients with complete remission(CR)than those with partial remission(PR).Before and after BTKi treatment,Shannon index of TCR in patients with CR was 0.02±0.008 and 0.14±0.001(P＜0.001),while in patients with PR was 0.01±0.03 and 0.05±0.02(P＞0.05),respectively.Shannon index of BCR in patients with CR was 0.19±0.003 and 0.33±0.15(P＜0.001),while in patients with PR was 0.15±0.009 and 0.23±0.18(P＜0.05),respectively.Conclusions:BTKi treatment can shrink the clone size in CLL patients,promote the expression of IgA,increase the number of functional T cells,and regulate the secretion of cytokines such as IL-2,IL-4,and IFN-γ.BTKi also promote the recovery of diversity of TCR and BCR.BTKi treatment contributes to the reconstitution of immune function in CLL patients.

Objective: To explore the feasibility and safety of the gasless transoral vestibular robotic thyroidectomy using skin suspension. Methods: The clinical data of 20 patients underwent gasless transoral vestibular robotic thyroidectomy in the Department of Otorhinolaryngology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University from February 2022 to May 2022 were retrospectively analyzed. Among them, 18 were females and 2 were males, aged (38.7±8.0) years old. The intraoperative blood loss, operation time, postoperative hospital stay, postoperative drainage volume, postoperative pain visual analogue scale (VAS) score, postoperative swallowing function swallowing impairment score-6 (SIS-6), postoperative aesthetic VAS score, postoperative voice handicap index-10 (VHI-10) voice quality, postoperative pathology and complications were recorded. SPSS 25.0 was used for statistical analysis of the data. Results: The operations were successfully completed without conversion to open surgery in all patients. Pathological examination showed papillary thyroid carcinoma in 18 cases, retrosternal nodular goiter in 1 case, and cystic change in goiter in 1 case. The operative time for thyroid cancer was 161.50 (152.75, 182.50) min [M (P₂₅, P₇₅), the same below] and the average operative time for benign thyroid diseases was 166.50 minutes. The intraoperative blood loss 25.00 (21.25, 30.00) ml. In 18 cases of thyroid cancer, the mean diameter of the tumors was (7.22±2.02) mm, and lymph nodes (6.56±2.14) were dissected in the central region, with a lymph node metastasis rate of 61.11%. The postoperative pain VAS score was 3.00 (2.25, 4.00) points at 24 hours, the mean postoperative drainage volume was (118.35±24.32) ml, the postoperative hospital stay was 3.00 (3.00, 3.75) days, the postoperative SIS-6 score was (4.90±1.58) points at 3 months, and the postoperative VHI-10 score was 7.50 (2.00, 11.00) points at 3 months. Seven patients had mild mandibular numbness, 10 patients had mild cervical numbness, and 3 patients had temporary hypothyroidism three months after surgery and 1 patient had skin flap burn, but recovered one month after surgery. All patients were satisfied with the postoperative aesthetic effects, and the postoperative aesthetic VAS score was 10.00 (10.00, 10.00). Conclusion: Gasless transoral vestibular robotic thyroidectomy using skin suspension is a safe and feasible option with good postoperative aesthetic effect, which can provide a new treatment option for some selected patients with thyroid tumors.
Male ; Female ; Humans ; Adult ; Middle Aged ; Thyroidectomy/adverse effects* ; Robotic Surgical Procedures/adverse effects* ; Retrospective Studies ; Blood Loss, Surgical ; Hypesthesia/surgery* ; Neck Dissection/adverse effects* ; Thyroid Neoplasms/surgery* ; Pain, Postoperative/surgery* ; Postoperative Complications/etiology*

Objective:To investigate the clinical characteristics, diagnosis and treatment of mycoplasma pneumoniae(MP) pneumonia in children with pseudo-macrocytic erythrocytes.Methods:The clinical data of 50 children with mycoplasma pneumoniae pneumonia with pseudo-macrocytic erythrocytes in the Department of Pediatrics at Shengjing Hospital of China Medical University from January 2019 to August 2020 were analyzed retrospectively.Results:Among the 50 cases, there were 32 boys and 18 girls.The blood routine examination showed that pseudo-macrocytic erythrocytes, red blood cells decreased significantly, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration increased significantly, as well as MP-IgM was positive.Sixteen cases were complicated with herpes simplex virus infection, one with Epstein Barr virus infection, and six with both herpes simplex virus and Epstein Barr virus infection at the same time.All 50 cases were MP pneumonia, pulmonary imaging showed lobar pneumonia, and 25 cases were complicated with pleural effusion, including 32 cases of refractory MP pneumonia.The clinical symptoms of three cases were extrapulmonary manifestations, hemolytic anemia and diagnosed with cold agglutinin syndrome.In 36 children with D-dimer more than 252 μg/L, one case had femoral vein thrombosis and one case had pulmonary embolism.Conclusion:Pseudo-macrocytic phenomenon may play important roles in clinical etiological diagnosis, severity of disease and refractory MP pneumonia.The children with hemolytic anemia suggest cold agglutinin syndrome, and the hypercoagulable state of MP infection may be related to the aggregation of red blood cells caused by cold agglutinin in MP infection.

Background:Clinical outcomes of undifferentiated arthritis (UA) are diverse,and only 40 ％ of patients with UA develop rheumatoid arthritis (RA) after 3 years.Discovering predictive markers at disease onset for further intervention is critical.Therefore,our objective was to analyze the clinical outcomes of UA and ascertain the predictors for RA development.Methods:We performed a prospective,multi-center study from January 2013 to October 2016 among Chinese patients diagnosed with UA in 22 tertiary-care hospitals.Clinical and serological parameters were obtained at recruitment.Follow-up was undertaken in all patients every 12 weeks for 2 years.Predictive factors of disease progression were identified using multivariate Cox proportional hazards regression.Results:A total of 234 patients were recruited in this study,and 17 (7.3％) patients failed to follow up during the study.Among the 217 patients who completed the study,83 (38.2％) patients went into remission.UA patients who developed RA had a higher rheumatoid factor (RF)-positivity (42.9％ vs.16.8％,x2=8.228,P=0.008),anti-cyclic citrullinated peptide (CCP) antibodypositivity (66.7％ vs.10.7％,x2 =43.897,P ＜ 0.001),and double-positivity rate of RF and anti-CCP antibody (38.1％ vs.4.1％,x2 =32.131,P ＜ 0.001) than those who did not.Anti-CCP antibody but not RF was an independent predictor for RA development (hazard ratio 18.017,95％ confidence interval:5.803-55.938;P ＜ 0.001).Conclusion:As an independent predictor of RA,anti-CCP antibody should be tested at disease onset in all patients with UA.

ObjectiveTo explore the inhibitory effect of polyphyllin Ⅰ (PPⅠ) on the proliferation of castration-resistant prostate cancer PC3 cells and its molecular mechanism.

METHODSWe cultured human prostate cancer PC3 cells in vitro and treated them with PPⅠ at the concentrations of 0 (blank group), 0.4, 0.8, 1.2, 1.6, 2.0, and 2.4 μmol/L for 24, 48, and 72 hours, respectively. Then we detected the proliferation of the cells by MTT assay, measured their apoptosis by flow cytometry, and determined the expressions of p-ERK1/2, ERK1/2, NF-κB/p65 and DNMT1 proteins as well as the level of NF-κB/p65 in the cells additionally treated with the ERK1/2 inhibitor SP600125 by Western blot.

RESULTSCompared with the blank control group, the PPⅠ-treated PC3 cells showed a concentration- and time-dependent reduction of the survival rate (1.00 ± 0.00 vs 0.85 ± 0.05, P < 0.01) at 0.4 μmol/L after 48 hours of intervention, concentration-dependent early apoptosis at 0.8 μmol/L (4.83 ± 0.95 vs 13.83 ± 2.97, P < 0.01), time-dependent increase of the expressions of p-ERK1/2 (1.00 ± 0.00 vs 1.73 ± 0.17, P < 0.01) and ERK1/2 (1.00 ± 0.00 vs 1.36 ± 0.12, P < 0.01) at 2 hours, and concentration-dependent decrease of the expressions of NF-κB/p65 and DNMT1 at 1.2 μmol/L (1.00 ± 0.00 vs 0.78 ± 0.10 and 0.63 ± 0.06, P < 0.01) and 1.6 μmol/L (1.00 ± 0.00 vs 0.67 ± 0.11 and 0.52 ± 0.09, P<0.01). Inhibition of ERK1/2 phosphorylation with PD98059 markedly reversed PPⅠ-induced decrease of the NF-κB/p65 expression as compared with that in the PPⅠ group (0.86 ± 0.18 vs 0.43 ± 0.09, P < 0.05).

CONCLUSIONSPPⅠ induces the early apoptosis and suppresses the proliferation of PC3 cells, probably by activating the ERK1/2 pathway and inhibiting the expressions of the NF-κB/p65 and DNMT1 proteins.

Apoptosis ; Cell Proliferation ; drug effects ; DNA (Cytosine-5-)-Methyltransferase 1 ; metabolism ; Diosgenin ; analogs & derivatives ; pharmacology ; Flavonoids ; metabolism ; Humans ; MAP Kinase Signaling System ; Male ; Mitogen-Activated Protein Kinase 1 ; metabolism ; Mitogen-Activated Protein Kinase 3 ; metabolism ; NF-kappa B ; metabolism ; PC-3 Cells ; Phosphorylation ; Prostatic Neoplasms, Castration-Resistant ; drug therapy ; metabolism ; pathology ; Signal Transduction ; Transcription Factor RelA ; metabolism

OBJECTIVETo assess the value of preoperative neutrophil-lymphocyte ratio (NLR) for prognosis in patients with colorectal cancer after radical operation.

METHODSClinical data of 140 patients with colorectal cancer undergoing radical operation in the Department of General Surgery of General Hospital of PLA from July 2005 to July 2011 were analyzed retrospectively. According to preoperative NLR, patients were divided into the low NLR group (NLR<5, n=105) and the high NLR group (NLR≥5, n=35). The overall 5-year survival rates of two groups were compared and the independent risk factors were examined by univariate analysis and Cox model.

RESULTSThe overall 5-year survival rates of the low and high NLR groups were 74.8% and 54.7% respectively with significant difference (P=0.03). Univariate analysis revealed depth of tumor, lymph nodes metastasis, TMN stage and NLR were associated with survival (P<0.05, P<0.01). Cox model showed that NLR was independent risk factor of prognosis (RR=1.068, 95%CI:1.009-1.129, P=0.02).

CONCLUSIONPreoperative NLR≥5 predicts poorer prognosis of colorectal cancer patients.

Aged ; Colorectal Neoplasms ; blood ; diagnosis ; pathology ; Female ; Humans ; Lymphatic Metastasis ; Lymphocytes ; pathology ; Male ; Neutrophils ; pathology ; Prognosis ; Proportional Hazards Models ; Retrospective Studies ; Survival Rate

OBJECTIVETo explore the prognostic factors of anorectal malignant melanoma (ARMM).

METHODSMedical records and follow-up data of 34 patients with ARMM treated in the Chinese PLA General Hospital from March 1993 to November 2011 were analyzed retrospectively.

RESULTSThere were 26 abdominoperineal resections(APR) and 8 wide local excisions (WLE). Twenty patients underwent postoperative adjuvant therapy, including chemotherapy in 14 cases, radiotherapy in 2 cases, traditional Chinese medicine therapy in 4 cases and immunotherapy in 16 cases. Postoperative follow-up was carried out in all the patients and the mean follow-up period was 27 months. The 1-, 3- and 5-year overall survival rates were 76.3%, 39.6% and 20.6% respectively, while the 1-, 3- and 5-year disease-free survival rates were 60.6%, 30.8% and 12.8% respectively. APR and postoperative immunotherapy could significantly reduce the local recurrence rate. According to the Kaplan-Meier method, gross type of tumor, mural involvement, lymph metastasis, and clinical staging had significant effects on overall survival, while lymph metastasis and postoperative immunotherapy on disease-free survival. Cox proportional hazards model indicated that the clinical staging and postoperative immunotherapy were significant predictive factors.

CONCLUSIONSEarly diagnosis and correct choice of surgical method are the keys to the treatment. Postoperative immunotherapy can prolong disease-free survival.

Disease-Free Survival ; Humans ; Lymphatic Metastasis ; Melanoma ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Prognosis ; Survival Rate

OBJECTIVETo synthesize cyclin-dependent kinase (CDKs) inhibitors and assay their antitumor activities.

METHODSA series of pyrimidines containing different arylamino and 1-(methylsulfonyl)piperidin moieties were designed by combining the segments 1-(methylsulfonyl)piperidin and pyrimidine heterocycles according to the super-position principle of the reinforcement of biological activities.

RESULTSTheir structures were characterized by MS and 1H NMR spectra and all the synthesized compounds were screened for their antimicrobial activity with MTT assay.

CONCLUSIONThe preliminary bioassay showed that compound 3 b displayed good antitumor activity (IC(50)=13.6 µmol/L). The preliminary structure activity relationship analysis of these analogues suggest that the steric factor may have important impact on the anti-tumor activity.

Antineoplastic Agents ; chemical synthesis ; chemistry ; pharmacology ; Cell Line, Tumor ; Drug Screening Assays, Antitumor ; Humans ; Pyrimidines ; chemical synthesis ; chemistry ; pharmacology ; Structure-Activity Relationship

Objective To study the acceptability of pre-exposure prophylaxis (PrEP)program on prevention of human immunodeficiency virus (HIV)infection among female sex workers (FSWs) in Guangxi of China.Methods A cross-sectional survey using convenience sampling was administered among 405 FSWs in Nanning,Liuzhou and Beihai cities of Guangxi,China.Self-designed questionnaire,face to face interviews were used to collect HIV-related risk behaviors,knowledge and acceptability of PrEP.Results After an introduction on PrEP,presuming that it was effective,safe and free of charge,85.9％ of the 405 FSWs said they would use it.Data from logistic regression analysis showed that significant factors of intent to use PrEP would include the followings:workplace (OR=2.256,P=0.009),monthly income (OR=0.257,P=0.004),family closeness (OR＝0.338,P＝0.012),knowledge on HIV/AIDS (OR＝2.802,P=0.028),HIV/AIDS risk was introduced from a strange client (OR＝0.363,P＝0.049),whether the gatekeeper ordering the use of condom (OR＝0.432,P=0.010),whether consistent using condom with clients (OR＝3.010,P＝0.002),whether ever using drugs to prevent STD infection (OR=3.570,P=0.049) etc.Conclusion Awareness on HIV/AIDS knowledge and self-protection seemed the main influential factors while health education might promote the acceptability of PrEP.