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 explore the stem cell collection rate and efficacy and safety of patients aged 70 and below with newly diagnosed multiple myeloma (MM) treated with the VRD (bortezomib, lenalidomide and dexamethasone) regimen followed by autologous stem cell transplantation (ASCT). Methods: Retrospective case series study. The clinical data of 123 patients with newly diagnosed MM from August 1, 2018, to June 30, 2020, at the First Affiliated Hospital of Soochow University and Suzhou Hopes Hematology Hospital, who were eligible for VRD regimen sequential ASCT, were collected. The clinical characteristics, efficacy after induction therapy, mobilization regimen of autologous stem cells, autologous stem cell collection rate, and side effects and efficacy of ASCT were retrospectively analyzed. Results: Of the 123 patients, 67 were males. The median patient age was 56 (range: 31-70) years. Patients with IgG, IgA, IgD, and light-chain types accounted for 47.2% (58/123), 23.6% (29/123), 3.2% (4/123), and 26.0% (32/123) of patients, respectively. In addition, 25.2% (31/123) of patients had renal insufficiency (creatinine clearance rate<40 ml/min). Patients with Revised-International Staging System (R-ISS) Ⅲ accounted for 18.2% (22/121) of patients. After induction therapy, the rates of partial response and above, very-good partial response (VGPR) and above, and complete response (CR)+stringent CR were 82.1% (101/123), 75.6% (93/123), and 45.5% (56/123), respectively. Overall, 90.3% (84/93) of patients were mobilized with cyclophosphamide+granulocyte colony-stimulating factor (G-CSF) and 8 patients with G-CSF or G-CSF+plerixafor due to creatinine clearance rate<30 ml/min and one of them was mobilized with DECP (cisplatin, etoposide, cyclophosphamide and dexamethasone)+G-CSF for progressive disease. The rate of autologous stem cell collection (CD34⁺cells≥2×10⁶/kg) after four courses of VRD regimen was 89.1% (82/92), and the rate of collection (CD34⁺cells≥5×10⁶/kg) was 56.5% (52/92). Seventy-seven patients treated with the VRD regimen sequential ASCT. All patients had grade 4 neutropenia and thrombocytopenia. Among the nonhematologic adverse events during ASCT, the highest incidence was observed for gastrointestinal reactions (76.6%, 59/77), followed by oral mucositis (46.8%, 36/77), elevated aminotransferases (44.2%, 34/77), fever (37.7%, 29/77), infection (16.9%, 13/77) and heart-related adverse events (11.7%, 9/77). Among the adverse events, grade 3 adverse events included nausea (6.5%, 5/77), oral mucositis (5.2%, 4/77), vomiting (3.9%, 3/77), infection (2.6%, 2/77), elevated blood pressure after infusion (2.6%, 2/77), elevated alanine transaminase (1.3%, 1/77), and perianal mucositis (1.3%, 1/77); there were no grade 4 or above nonhematologic adverse events. The proportion of patients who achieved VGPR and above after VRD sequential ASCT was 100% (75/75), and the proportion of patients who were minimal residual disease-negative (<10^-4 level) was 82.7% (62/75). Conclusion: In patients aged 70 and below with newly diagnosed MM treated with VRD induction therapy, the collection rate of autologous stem cells was good, and good efficacy and tolerability were noted after follow-up ASCT.
Male ; Humans ; Female ; Multiple Myeloma/diagnosis* ; Hematopoietic Stem Cell Transplantation/adverse effects* ; Retrospective Studies ; Creatinine ; Hematopoietic Stem Cell Mobilization ; Transplantation, Autologous ; Dexamethasone/therapeutic use* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Heterocyclic Compounds/therapeutic use* ; Bortezomib/therapeutic use* ; Cyclophosphamide/therapeutic use* ; Stomatitis/etiology*

Objective:To summarize the patient profiles and therapeutic efficacies of ABO-incompatible living-related kidney transplantations at 19 domestic transplant centers and provide rationales for clinical application of ABOi-KT.Methods:Clinical cases of ABO-incompatible/compatible kidney transplantation (ABOi-KT/ABOc-KT) from December 2006 to December 2009 were collected. Then, statistical analyses were conducted from the aspects of tissue matching, perioperative managements, complications and survival rates of renal allograft or recipients.Results:Clinical data of 342 ABOi-KT and 779 ABOc-KT indicated that (1) no inter-group differences existed in age, body mass index (BMI), donor-recipient relationship or waiting time of pre-operative dialysis; (2) ABO blood type: blood type O recipients had the longest waiting list and transplantations from blood type A to blood type O accounted for the largest proportion; (3) HLA matching: no statistical significance existed in mismatch rate or positive rate of PRA I/II between two types of surgery; (4) CD20 should be properly used on the basis of different phrases; (5) hemorrhage was a common complication during an early postoperative period and microthrombosis appeared later; (6) no difference existed in postoperative incidence of complications or survival rate of renal allograft and recipients at 1/3/5/10 years between ABOi-KT and ABOc-KT. The acute rejection rate and serum creatinine levels of ABOi-KT recipients were comparable to those of ABOc-KT recipients within 1 year.Conclusions:ABOi-KT is both safe and effective so that it may be applied at all transplant centers as needed.

Novel Coronavirus Pneumonia (NCP) is a class B infectious disease, which is prevented and controlled according to class A infectious diseases. Recently, children′s NCP cases have gradually increased, and children′s fever outpatient department has become the first strategic pass to stop the epidemic. Strengthening the management of the fever diagnosis process is very important for early detection of suspected children, early isolation, early treatment and prevention of cross-infection. This article proposes prevention and control strategies for fever diagnosis, optimizes processes, prevents cross-infection, health protection and disinfection of medical staff, based on the relevant diagnosis, treatment, prevention and control programs of the National Health and Health Commission and on the diagnosis and treatment experience of experts in various provinces and cities. The present guidance summarizes current strategies on pre-diagnosis; triage, diagnosis, treatment, and prevention of 2019-nCoV infection in common fever, suspected and confirmed children, which provide practical suggestions on strengthening the management processes of children′s fever in outpatient department during the novel coronavirus pneumonia epidemic period.

Objective To investigate the effects of the relationship between bone cement polymethyl methacrylate (PMMA) and endplate on the vertebral height loss after percutaneous vertebroplasty (PVP).Methods A retrospective analysis of 84 female patients with single segment osteoportic vertebral compression fracture who had undergone PVP between Jun.,2013 and May,2016 was conducted.According to the X-ray radiographs and CT scans,all subjects were divided into the doPMMA-endplate-contact group (40 cases,average age 76.88 years) and the non-PMMA-endplatecontact group (44 cases,average age 77.96 years).The volume of bone cement,operation time,fractured vertebral height restoration rate,3-month postoperative vertebral height loss rate,changes in local sagitta view Cobb angle and bone cement leakage rate were respectively recorded and compared.Results There were no significant difference in age,body mass index,the levels of serum calcium and phosphorus,bone mineral density and preoperative vertebral body compression rate between the two groups (P＞0.05).Postoperative vertebral height loss rate and changes in local sagitta view Cobb angle in the do-PMMA-endplate-contact group were significantly less than the non-PMMA-endplate-contact group (P＜0.05).However,there was no significant difference in bone cement leakage rate between the two groups (P＞0.05).Conclusions Making bone cement contact with endplate would reduce the height loss of cemented vertebrae without increasing the rate of cement leakage.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.

Objective:To analyze the prophylactic use of antibiotics during the perioperative period of typeⅠincision operation in a cancer hospital in order to promote the safe, effective and rational use of antibiotics. Methods:The rationality of 480 cases of typeⅠincision operation from January to December in 2013 and from January to December in 2014 was evaluated respectively, and the analy-sis and comparison were performed on the prophylactic use of antibiotics. Results: Through the pharmaceutical intervention including the special evaluation carried out by clinical pharmacists, the use of antibiotics gradually reached the rational level. Conclusion: The participation of clinical pharmacists in the use management of antibiotics in typeⅠincision operation can improve the rationality of the drugs used in clinic.

OBJECTIVETo determine the association between viral load of high risk human papillomavirus (HR-HPV) and cervical intraepithelial neoplasia (CIN).

METHODSCervical exfoliated cells were collected from 18 186 women aged 17 -59 from six urban areas and eight rural areas when they were screened in the cross-sectional population-based studies from 1999 to 2008. HR-HPV was detected by the Hybrid Capture 2 (hc2) system, and viral load was measured by the ratio of relative light units to standard positive control (RLU/PC). RLU/PC was categorized for analysis into four groups: negative [0, 1.00), low viral load [1.0, 10.00), moderate viral load [10.00, 100.00), and high viral load > or = 100.00. Cervical lesions were diagnosed by biopsies as normal, CIN 1, CIN 2, CIN 3 and squamous cervical cancer (SCC). Association between HR-HPV viral load and CIN was evaluated by unconditional multinomial logistic regression.

RESULTSThe HR-HPV infection rate of the population was 14.51% (2515/17334). 100.00% (29/29) of SCC, 97.63% (206/211) of CIN 3, 93.43% (199/213) of CIN 2, 75.04% (421/561) of CIN 1 and 10.17% (1660/16320) of normal women were positive for HR-HPV DNA. The median RLUs for the HR-HPV positive women with SCC, CIN 3, CIN 2, CIN 1 and normal were 320.85, 158.05, 143.70, 125.34 and 9.64, respectively. There were significant differences among the distributions of viral loads in each lesion (chi2 = 6190.40, P < 0.01). The severity of CIN increased with the viral load (chi2 = 5493.35, P <0.01). Compared with the risks of CINs in HR-HPV negative population, the risks of CINs in low, moderate and high viral loads were increased gradually [OR(95% CI) : CIN 1 : 9.01(6.31 - 12.87), 24.96(18.23 - 34.17) and 68.42(51.40 - 91.08); CIN 2 : 26.44(12.07 - 57.95), 98.53(49.54 - 195.98) and 322.88(168.62 - 618.27); CIN 3+ : 72.89(24.02-221.18); 343.58(121.81-969.09) and >999.99(473.38 - >999.99)], and there were obvious dose-response relationships (chi2trend was 3115.05, 2413.95 and 3098.57, respectively. P< 0.01). In each age group of the HR-HPV positive population,the risks of CIN 2 + in the women with moderate or high viral load were higher than the one with low viral load [OR(95% CI): <35 : 4.71(1.23 - 18.09) and 15.06(4.40 - 51.49); 35 -: 4.01 (1.62 -9.90) and 14.09(6.15 -32.28); 40 - : 3.06(1.52 -6.16) and 7.78(4.05 -14.95); > or =45: 3.50(1.36 -9. 01) and 7.57(3.13 - 18. 30)], and there was a positive correlation between the risk of CIN 2+ and the viral load (chi2trend was 51.33, 66.28, 53.64 and 51.00, respectively. P <0.01). The risk of CIN 2 + was highest among the women aged 40 - with high viral load [OR (95% CI) : 2.02 (1.15 - 3.52)].

CONCLUSIONThere is strong correlation between the HR-HPV viral load and the severity of CIN, and so is the correlation between the HR-HPV viral load and the risk of CIN 2 +. A moderate to high viral load of HR-HPV should be the major risk factor for the cervical cancer and CIN 2 and CIN 3, and there is a higher risk in the women aged 35 or older than the younger ones. Considering both the age and viral load could help the doctors to manage the screening women more effectively.

Adult ; Cervical Intraepithelial Neoplasia ; epidemiology ; pathology ; virology ; Cervix Uteri ; pathology ; virology ; Female ; Humans ; Middle Aged ; Papillomavirus Infections ; epidemiology ; pathology ; virology ; Risk Factors ; Uterine Cervical Neoplasms ; epidemiology ; pathology ; virology ; Viral Load

OBJECTIVETo observe the therapeutic effect of hyperbaric oxygen (HBO) on acute pancreatitis (AP) by downregulating hypoxia-inducible factor (HIF).

METHODSForty Wistar rats were randomly divided into 4 groups (n = 10): sham group, AP group, normo-oxygen group (NP) and HBO group. At 4 hours after taurocholate-induced AP, the rats of NP group and HBO group were respectively treated with oxygen or HBO for 90 min. Several parameters were measured to evaluate oxygen stress after treatment including oxygen saturation (SaO2), partial pressure of oxygen (PO2), pH, and serum LDH. Pancreatic tissues were subjected to histopathological analysis, immunostained, and homogenized for Western blotted analysis of HIF-1alpha and VEGF, and measuring myeloperoxidase activity. The serum TNF-alpha and pancreatic histopathological scores were evaluated the severity of AP.

RESULTSIt was proved by immunohistochemisty that HIF in acinar cell and polymorphonuclear leukocytes (PMNs) was activated and transferred from cytoplasm into nucleus in AP group, NP group, and HBO group, following upregulation of VEGF. HBO therapy elevated blood SaO2 (99.6% +/- 0.7% vs. 87.7% +/- 1.8% or 91.2% +/- 2.5%, P < 0.05) and PaO2 [(369.1 +/- 67.6) mm Hg (1 mm Hg = 0.133 kPa) vs. (86.6 +/- 5.6) mm Hg or (99.9 +/- 4.0) mm Hg, P < 0.05]. HBO therapy attenuated the severity of AP through inhibiting AP-induced upregulation of HIF-1alpha and VEGF, as evidenced by reducing histopathological scores (12.40 +/- 1.21 vs. 16.45 +/- 1.10 or 16.38 +/- 1.10, P < 0.05), dry/wet weight ratio of pancreatic tissues, and myeloperoxidase activity.

CONCLUSIONSHIF-1alpha plays a key role in the pathogenesis of AP. HBO therapy attenuates the severity of AP through downregulating the expression of HIF-1alpha.

Animals ; Hyperbaric Oxygenation ; Oxygen ; Pancreatitis ; therapy ; Rats, Sprague-Dawley ; Rats, Wistar

OBJECTIVETo detect sperm mitochondrial membrane potential (MMP) of varicocele patients and investigate its clinical significance.

METHODSSixty-seven varicocele patients were divided into a VC1 (grade 1, n = 26), a VC2 (grade 2, n = 21) and a VC3 group (grade 3, n = 20). And 29 normal fertile volunteers were included in a control group ( m = 29). Conventional semen analyses were performed by computer-assisted semen analysis (CASA). Semen samples were washed, followed by JC-1 staining to evaluate the sperm MMP (JC-1+ %) by flow cytometry.

RESULTSThe sperm MMPs of the VC1, VC2 and VC3 groups were siginificantly lower ([56.29 +/- 16.32]%, P < 0.05; [45.04 +/- 13.21]%, P < 0.01; [31.63 +/- 12.91]%, P < 0.01) than that of the control ([76.21 +/- 13. 96]%). There was a significant positive correlation between the percentage of JC-1+ and that of grade (a + b) sperm (r =0.693, P=0.000).

CONCLUSIONThe decreased MMP in the sperm of varicocele men might be one of the important causes of male infertility.

Adult ; Flow Cytometry ; Humans ; Male ; Membrane Potential, Mitochondrial ; Sperm Motility ; Spermatozoa ; physiology ; Varicocele ; metabolism ; physiopathology ; Young Adult