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 pathogen distribution and drug resistance in a tertiary hospital in Shenyang in 2022 and provide evi-dence-based guidance for this and other hospitals to formulate antibacterial drug application strategies.Methods In 2022,bacterial iso-lates collected from patients in a tertiary hospital in Shenyang were identified and subjected to drug sensitivity tests based on the require-ments of the national clinical laboratory operation procedures.The data were analyzed using Whonet 5.6 software.Results In total,4968 pathogenic strains were isolated from this hospital in 2022.The top five isolates were Escherichia coli,Klebsiella pneumoniae,Acineto-bacter baumannii,Enterococcus faecalis,and Pseudomonas aeruginosa.The resistance rates of Escherichia coliand Klebsiella pneumo-niaeto carbapenems were 1.9%and 17.7%,respectively.The resistance rates of Enterobacter cloacaeto imipenem and meropenem were 26.7%and 25.0%,respectively.The isolation rate of methicillin-resistant Staphylococcus aureus(MRSA)was 15.6%.The resistance rates of vancomycin-resistant Enterococcusand linezolid-resistant Enterococcus faecaliswere 7.1%and 11.6%,respectively.The resist-ance rates of tropical yeasts to fluconazole was>20%.Conclusion The distribution and drug resistance of pathogens in this hospital differed from those in other regions of China.The drug resistance of strains in this hospital should be closely monitored to understand the distribution and drug resistance of pathogens in a timely manner and to provide guidance for the diagnosis and treatment of infections.

Objective To analyze risk factors, cardiovascular complications, time of death, gestational age of delivery and offspring outcomes in the maternal deaths with cardiovascular diseases (CVD). Methods Totally 4 112 cases of pregnant women with CVD in Shanghai obstetric heart disease intensive care unit within 26 years (from January 1993 to December 2018) were collected, and 20 maternal deaths within these cases were analyzed retrospectively. Results (1) Among the 20 deaths, structural heart diseases accounted for 90% (18/20), pregnancy induced heart diseases was 10% (2/20) while there was no dysfunctional heart disease. The mortality of pregnant women with CVD was 0.486% (20/4 112). (2) The following risk factors were common in these women, getting pregnant without counselling (95%, 19/20), New York Heart Association classⅢorⅣcardiac function (70%, 14/20), complicated with pulmonary hypertension (75%, 15/20 ) and prior heart events (60%, 12/20). And 85% (17/20) deaths occurred in puerperium, 15% (3/20) occurred before labor , while no death occurred during labor. And 65% (13/20) deaths died due to heart failure, 20% (4/20) deaths were due to pulmonary hypertension crisis, 5% (1/20) died on sudden cardiac arrest, rupture of aortic dissection and sudden death, respectively. Conclusions Women with CVD should get pregnant after strict evaluation. Pulmonary hypertension is one of the most severe contraindications to pregnancy, especially in patients with moderate to severe pulmonary hypertension. The puerperium period is a critical period that threatens the safety of these patients. Since heart failure is the most common cause of death, it is necessary to prevent and treat heart failure and to monitor heart function dynamically, especially in those with structural abnormal heart diseases. Moreover, it is also of importance to standardize antenatal care and to identify the severity of heart diseases in time.

Objective: To analyze risk factors, cardiovascular complications, time of death, gestational age of delivery and offspring outcomes in the maternal deaths with cardiovascular diseases (CVD). Methods: Totally 4 112 cases of pregnant women with CVD in Shanghai obstetric heart disease intensive care unit within 26 years (from January 1993 to December 2018) were collected, and 20 maternal deaths within these cases were analyzed retrospectively. Results: (1) Among the 20 deaths, structural heart diseases accounted for 90% (18/20), pregnancy induced heart diseases was 10% (2/20) while there was no dysfunctional heart disease. The mortality of pregnant women with CVD was 0.486% (20/4 112). (2) The following risk factors were common in these women, getting pregnant without counselling (95%, 19/20) , New York Heart Association classⅢ or Ⅳcardiac function (70%, 14/20), complicated with pulmonary hypertension (75%, 15/20) and prior heart events (60%, 12/20). And 85% (17/20) deaths occurred in puerperium, 15% (3/20) occurred before labor,while no death occurred during labor. And 65% (13/20) deaths died due to heart failure, 20% (4/20) deaths were due to pulmonary hypertension crisis, 5% (1/20) died on sudden cardiac arrest, rupture of aortic dissection and sudden death, respectively. Conclusions Women with CVD should get pregnant after strict evaluation. Pulmonary hypertension is one of the most severe contraindications to pregnancy, especially in patients with moderate to severe pulmonary hypertension. The puerperium period is a critical period that threatens the safety of these patients. Since heart failure is the most common cause of death, it is necessary to prevent and treat heart failure and to monitor heart function dynamically, especially in those with structural abnormal heart diseases. Moreover, it is also of importance to standardize antenatal care and to identify the severity of heart diseases in time.

Objective To observe the clinical efficacy of ebastine combined with Runzao Zhiyang capsules in the treatment of patients with chronic urticaria. Methods A total of 126 patients with chronic urticaria admitted to Department of Dermatology of Tianjin Third Central Hospital from January 2015 to May 2017 were enrolled and they were divided into two groups by the random number table method. The patients in control group (62 cases) were given oral ebastine administration 10 mg once per day, and those in observation group (64 cases) received oral administration of ebastine 10 mg once per day combined with Runzao Zhiyang capsule 2 g, 3 times per day, the therapeutic course being 4 weeks. The changes of clinical efficacy and the symptom scores, including urticaria activity score (UAS) and dermatolo-gical disease life quality index (DLQI) scores of the two groups were observed after treatment of 4 weeks;the incidence of adverse reactions and the recurrence situation after drug withdrawal for 4 weeks at follow-up were analyzed. Results Compared with the control group, the total effective rate of the observation group was significantly increased [92.2% (59/64) vs. 79.0% (49/62), P ＜ 0.05]. After treatment, the overall UAS score and DLQI score in two groups were both significantly decreased, the degree of decrease in observation group were more siginificant than those in control group [UAS: 1.26 (0.52 - 7.35) vs. 1.68 (0.75 - 8.65), DLQI: 0.56±0.52 vs. 1.57±0.96, P ＜ 0.01]. In addition, the total decrease degree of symptom score reducing index (SSRI) in the observation group was significantly greater than that in the control group [(76±21)% vs. (69±23)%, P ＜ 0.05], the incidence of adverse reactions [7.8% (5/64) vs. 12.8% (8/62)] and recurrence rate [8.3% (3/64) vs. 23.8% (5/62)] in the observation group were obviously lower than those in the control group (both P ＜ 0.05). Conclusion The efficacy of ebastine combined with Runzao Zhiyang capsule in the treatment of patients with chronic urticaria is prominent and superior to that of using ebastine alone, the combined method is capable of elevating the therapeutic effect obviously and has less adverse reactions.

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 investigate the effect ofatorvastatin on angiogenesis of brain tissues in focal cerebral ischemia rats,and explore the corresponding mechanism.Methods Ninety male SD rats were randomly divided into sham-operated group,model group and treatment group (n=30);and then,each group was divided into three subgroups:1 d group,3 d group and 7 d group (n=10).The focal cerebral ischemia models were induced by middle cerebral artery occlusion (MCAO);3 h after MCAO,rats in the treatment group received a gavage of atorvastatin 4 mg/(kg.d),and others were given the same amount of normal saline at corresponding time.The nerve function defects were estimated at 3 h after MCAO and before being killed;the protein expressions of vascular endothelial cell markers CD105 and glucose-regulated protein 78 (GRP78) were analyzed by immunohistochemistry;the vascular endothelial growth factor (VEGF) mRNA expression was analyzed by real time-PCR;the caspase-12 protein expression was analyzed by Western blotting.Results (1) Nerve function defects scores:there was no significantly statistical difference between model group and treatment group at 3 h after MCAO (P＞0.05),but statistical differences at different time points before being killed were noted (P＜0.05).(2) Microvessel density (MVD):at all time points,that of model group was increased as compared with that of sham-operated group,that of treatment group was increased as compared with that of model group,and the differences were all statistically significant (P＜0.05).(3)The VEGF rmRNA expression gradually increased over time;at all time points,the VEGF mRNA expression of model group was significantly higher than that in the sham-operated group,and that of treatment group was significantly higher than that in the model group (P＜0.05).(4)The GRP78 and caspase-12 expressions were gradually decreased over time;at all time points,the GRP78/BiP and caspase-12 expressions in the model group were significantly higher than those in the sham-operated group;those in the treatment group were statistically lower than those in the model group,but obviously higher than those in the sham-operated group (P＜0.05).Conclusion The angiogenesis of brain tissues in MCAO rats is obvious,and atorvastatin can enhance this effect;the mechanism may be that atorvastatin can weaken the endoplasmic reticulum stress,and then,reduce the apoptosis of endothelial cells.

Objective To discuss a optimal culture method of primary hippocampal neurons and a more suitable method of mor-phological observation ,and provide basis to the study of synapse in Alzheimer′s Disease .Methods Postnatal 0 -1 days (P0 -1 ) C57BL/6J mice were decollated and bilateral hippocampus were separated .Low level concentration of trypsin and mechanical disso-ciation were adopted .And culture medium without serum was used to culture neurons .After 17 days culturing ,transfected neurons with Green Fluorescent Protein(GFP) by calcium phosphate precipitation ,and then observed neurons and spines by fluorescence mi-croscope .Results The neurons looked good and healthy by using this method .And the axons ,dendrites and spines which were typ-ical structure of neurons were observed clearly after transfected with GFP .Conclusion The cultured hippocampal neurons look good by this method .And the morphological characteristics of neurons and spines are observed much more clearly after transfected GFP by calcium phosphate precipitation .

OBJECTIVETo perform a retrospective cohort study in order to determine the differences in short-term curative effect of ribavirin in combination with interferon alfa (IFNa)-2a vs. pegylated (Peg)-IFNa-2a in patients with chronic hepatitis C (CHC).

METHODSOne-hundred-and-eighty-eight treatment of the CHC patients who were administered combination therapy of ribavirin with IFNa from 2010 to 2012. One-hundred-and-thirty-three of the patients received the therapy with IFNa-2a and the remaining 55 received Peg-IFNa-2a. Hepatitis C virus (HCV) load and levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured at treatment weeks 4, 12, 24, and 48. Adverse reactions were recorded. Differences between the groups were assessed by statistical analysis.

RESULTSThe patients in the Peg-IFNa-2a group and the IFNa-2a group showed no significant difference in sex distribution, age, smoking habits, or drinking habits at baseline (all P more than 0.05). Both antiviral therapies significantly reduced the HCV load and levels of ALT and AST (baseline levels vs. all treatment weeks examined, P less than 0.05); however, the reduction in the HCV load at week 4 was significantly more robust with the Peg-IFNa-2a therapy (2.96 ± 0.66) log10 IU/ ml vs. (3.47 ± 1.42)1og10 IU/ml; F =4.14, P=0.04). The Peg-IFNa-2a group also showed a significant higher rate of rapid virological response (RVR) than the IFNa-2a group (72.72% vs .57.14%; x²=4.37, P=0.04), but there were no statistically significant differences found between the two groups for early virological response rate (EVR), endpoint antiviral treatment virologic response rate (ETR), biochemical response rate, or rate of adverse reactions (all P more than 0.05).

CONCLUSIONRibavirin in combination with Peg-IFNa-2a produces a better RVR than in combination with IFNa-2a .Yet, the EVR, ETR, biochemical response rate, and rate of adverse reactions is similar for the two forms of IFNa-2a. Further studies are required to determine the potential superiority of Peg-IFNa-2a for a long-term curative effect.

Adolescent ; Adult ; Aged ; Antiviral Agents ; therapeutic use ; Child ; Child, Preschool ; Drug Therapy, Combination ; Female ; Hepatitis C, Chronic ; drug therapy ; Humans ; Infant ; Infant, Newborn ; Interferon-alpha ; therapeutic use ; Male ; Middle Aged ; Polyethylene Glycols ; therapeutic use ; Recombinant Proteins ; therapeutic use ; Retrospective Studies ; Ribavirin ; therapeutic use ; Treatment Outcome ; Young Adult

Objective To design technique of local flap transposition to refine the aesthetic appearance of reconstructed fingers by toes transfer.Methods Nine cases with 21 reconstructed finger were included,which involved 6 males and 3 females with an average age of 21.8 years(range,18-34years).A lingual contour flap with a lateral pedicle Was shifted from the inflated distal pulp to the narrow middle part of the"finger"to refine the aesthetic appearance.Overall results were evaluated in terms of the survival of the flap,the appearance improvement and the functional influence of the reconstructed finger.Results All of the flaps survived and healed perfectly.After a mean follow-up of 9.3 months(range,6-12months),the appearance of the reconstructed fingers were impmved apparently.There was little influence on the function of the finger.The results showed that all the patients gained more acceptable fingers.Conclusion From our experience,local flap transposition is a useful method for remolding of reconstructed fingers by toes transfer.