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Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

BACKGROUND:How to improve the accuracy of puncture,reduce surgical damage,and improve surgical efficiency during vertebroplasty is currently one of the focuses of exploration and improvement in vertebroplasty techniques. OBJECTIVE:To explore the clinical significance of application of mixed reality technology in percutaneous vertebroplasty for spinal fractures. METHODS:Two patients with osteoporotic vertebral compression fracture in Dalian Second People's Hospital in June 2023 were selected.Before operation,128-row CT scanning of the lumbar spine was performed and the original data of digital imaging and communications in medicine(DICOM)were obtained.Visual Volume software was used to build the three-dimensional network model of vertebral compression fracture.Holographic imaging glasses were used to accurately map 3D network model images to the real world,assist the surgeon in completing preoperative simulation,explaining preoperative conditions and treatment plans,and guiding puncture and bone cement injection during surgery. RESULTS AND CONCLUSION:(1)Precise puncture was achieved with the assistance of a mixed reality technology.Postoperative imaging examination showed good bone cement filling and no obvious leakage.The postoperative symptoms of the patient were alleviated well,and they were able to move to the ground on the same day after surgery.(2)It is concluded that a mixed reality technology is helpful for preoperative surgical design and communication efficiency with patients and their families.Assisting with precise puncture during surgery,shortening surgical time,and reducing side injuries is a new and effective clinical diagnosis and treatment model,which has development potential in minimally invasive,precise,and personalized treatment of spinal surgery.

Objective To evaluate the clinical efficacy and safety of CT-guided percutaneous osteoplasty(POP)in the treatment of osteolytic metastases of the pelvis.Methods The clinical data of a total of 40 patients with pelvic osteolytic metastases,who received CT-guided POP at the Affiliated Zhongda Hospital of Southeast University between October 2011 and December 2021,were collected.Visual analogue scale(VAS)score was used to evaluate the clinical pain relief degree at one week,one month,3 months,6 months and 12 months after POP,and the joint function and the used dose of analgesic drugs were recorded.The preoperative and the postoperative 3-month,6-month and 12-month extents of the pelvic tumor destruction were compared.Based on the progression of local lesions within 12 months of follow-up,the patients were divided into controlled group and progression group.The proportion of using systemic anti-tumor therapy,the size of lesion,the amount of bone cement injected,and the cement filling ratio were compared between the two groups.Results Successful surgical procedure was accomplished for 57 lesions in 40 patients.The mean amount of bone cement injected was(4.56±2.25)mUpoint.In the 40 patients,the preoperative and the postoperative one-week,one-month and 3-month VAS score were(8.00±0.85)points,(2.05±0.96)points,(2.08±0.94)points and(2.18±0.84)points respectively,the difference in VAS score between preoperative value and postoperative one-week value was statistically significant(P＜0.01).In 37 patients,the postoperative 6-month VAS score was(2.35±0.54)points;and in 28 patients,the postoperative 12-month VAS score was(2.43±0.79)points.The differences in VAS score between postoperative one-week value and postoperative one-month,3-month,6-month,and 12-month values were not statistically significant(all P＞0.05),while the differences in VAS score between preoperative value and postoperative values were statistically significant(F=316.3,P＜0.01).The postoperative 3-month,6-month,and 12-month local control rates were 96.49％,85.19％,and 78.12％respectively,the differences between each other among the above three values were statistically significant(P=0.026).No statistically significant differences in the proportion of using systemic anti-tumor therapy,the lesion size and the amount of bone cement injected existed between the controlled group and the progression group(all P＞0.05).The cement filling ratio in the controlled group and the progression group was(81.26±9.17)％and(68.40±12.98)％respectively,and the difference between the two groups was statistically significant(P＜0.01).Conclusion For the treatment of pelvic metastases,CT-guided POP is clinically safe and effective.The injected bone cement can control the progression of local lesions for a longer time.(J Intervent Radiol,2023,32:1197-1201)

Bone tissue plays an important role in maintaining physical activity and health. The study of the biological functions of bone tissue cells and their application in tissue engineering is of great significance for clinical prevention and treatment of orthopedic-related diseases. Tea polyphenols are the main components of tea, with natural antioxidant, scavenging free radical activity and anti-inflammatory effects. Research results indicated that tea polyphenols can promote the bone remodeling process mainly by enhancing the formation of osteoblasts and reducing the occurrence of osteoclasts. In addition, tea polyphenols can also be used as surface modification molecules of artificial bone materials and are widely used in the field of bone tissue engineering. In this paper, the regulatory effects of tea polyphenols in bone tissue cells and its application in tissue engineering were reviewed, and related research contents were summarized and prospected, in order to provide reference and theoretical basis for subsequent research work.

Objective:To describe the COVID-19 epidemic and its characteristics in Heilongjiang province, and provide evidence for the further prevention and control of COVID-19 in the province.Methods:The information of COVID-19 cases and clusters were collected from national notifiable disease report system and management information system for reporting public health emergencies of China CDC. The Software’s of Excel 2010 and SPSS 23.0 were applied for data cleaning and statistical analysis on the population, time and area distributions of COVID-19 cases.Results:On January 22, 2020, the first confirmed case of COVID-19 was reported in Heilongjiang. By March 11, 2020, a total of 482 cases domestic case of COVID-19, The incidence rate was 1.28/100 000, the mortality rate was 2.70% (13/482) in 13 municipalities in Heilongjiang. There were 81 clusters of COVID-19, The number of confirmed cases accounted for 79.25% (382/482) of the total confirmed cases and 12 cases of deaths. The family clusters accounted for 86.42% (70/81). Compared with the sporadic cases, the mortality rate, proportion of elderly cases aged 60 or above and severe or critical cases of clinical classification were all higher in the clusters especially the family clusters, but the differences were not significant ( P>0.05). There were 34 clusters involving more than 5 confirmed cases accounted for 41.98% (34/81) of the total clusters, the involved cases accounted for 68.31% (261/382) of the total cases of clusters. There were significant differences in age distribution of the cases among the case clusters with different case numbers. In the clusters involving 6-9 cases, the proportion of cases aged 65 years or above was more (26.53%, 39/147). Conclusions:The incidence rate of COVID-19 was relatively high and the early epidemic was serious in Heilongjiang, The number of cases was large in clusters especially family clusters.

Objective To investigate the differences in the survival time and the occurrence of complications between esophageal cancer patients treated with fully-covered segmented esophageal internal irradiation stent and esophageal cancer patients treated with conventional esophageal internal irradiation stent.Methods The clinical data of 66 esophageal cancer patients,who had received esophageal internal irradiation stents placement,were retrospectively analyzed.The patients were divided into the study group (using fullycovered segmented esophageal internal irradiation stent,n=30) and the control group (using conventional esophageal internal irradiation stent,n=36).The postoperative complications,including restenosis,stent migration,chest pain,etc.,and the survival time of the two groups were recorded.The results were analyzed,and P＜0.05 was considered to be statistically significant.Results No statistically significant difference in the restenosis rate existed between the study group and the control group (20.0％ vs.30.6％,P=0.403);although the median time of restenosis in the study group was longer than that in the control group (161.5 d vs.138 d,P=0.025).The stent migration rate in the study group was higher than that in the control group (33.3％ vs.8.3％,P=0.014).The difference in the median time of stent migration between the two groups was not statistically significant (91.5 d vs.166 d,P=0.236).No statistically significant difference in the median survival time existed between the two groups (186 d vs.178 d,P=0.486).No statistically significantly differences in the incidence of other stent-related complications existed between the two groups.Conclusion Fully-covered segmented esophageal internal irradiation stent can delay the occurrence of restenosis,although it can increase the stent migration rate to a certain degree.

ObjectiveTo dynamically assess the regular pattern of both bone quantity and bone quality by means of MR spectroscopey and Micro-CT scanning in an osteoporosis rabbit model induced by ovariectomy and glucocorticoid, so as to explore the advantage of combining MRS with Micro-CT. MethodsSixty 8-month-old,mature female New Zealand white rabbits were allocated into three groups. Group B ( n =20 ) underwent bilateral ovariectomy (OVX)and Group C (n =20 )underwent OVX combining with daily i. m.injections of methylprednisolone sodium succinate (MPS). Group A ( n =20 ) were used as sham controls. Bone marrow fat fraction (FF) and bone microstructure parameters were detected by MR spectroscopy and Micro-CT scanning at 2,4,8, and 10 weeks ( 5 rabbits at each time point every group) after operation in three groups. ResultsLumber spine bone marrow FF in Group C was significantly increased over the time course of osteoporosis development with significant difference between Group C and Group A at 4,8,and 10 weeks after operation( all P＜0. 01 ). Bone mineral density(BMD) in Group C at 8 and 10 weeks after OVX was significantly decreased compared with Group A ( P＜0. 0l ). A moderately significant negative correlation between marrow fat content and bone microstructure parameters such as BMD, bone volume fraction, trabecular thickness, connectivity density, and trabecular plate number was found, while FF was positively correlated with structure model index and trabecular spacing( all P＜0. 01 ). ConclusionsMRS and MicroCT scanning noninvasively evaluate the bone marrow changes of osteoporosis in the field of pathophysiology and microstructure. Combination of both modalities seems to be valuable in the early, comprehensive assessment of bone quality and bone mass in osteoporosis.

Objective To study the changing of vertebral body marrow fat fraction(FF) in different age and sex and the relation-ship between FF and bone mineral densities (BMD). Methods Eighty-five healthy volunteers aged from 21 to 70 years old and twenty patients with osteoporosis based on T score after dual X-ray absorptionmetry examination underwent proton magnetic reso-nance spectroscopy (MRS) in L_3 vertebral bodies. The volunteers were divided into five groups according to the age(10 years and 16～18 cases in each group). Results The FF values in 21～30 years group,31～40 years group,41～50 years group,51～60 years group , >60 years group and the osteoporotic group were 30.7%±4.4%, 35.5%±6.8% , 41.9%±6.6%, 46.8%±5.5%, 51.7%±5.2% and 59.2%±7.4%, respectively. The FF values in L_3 vertebral bone marrow in men were high than that in women in the same age group (P<0.05) except >60 years group. There was negative correlation between marrow fat content and T score in osteoporotic group(γ=-0.6, P<0.01). Conclusion The vertebral marrow fat content in healthy adults was significantly in-creased with the aging. MRS may be used as a new way to evaluate the physiological and pathological process of bone marrow.