OBJECTIVE To develop a long-acting light-protective nanogel with both physical barrier and chemical clearance functions， and evaluate its performance. METHODS The photoprotective nanogel composed of mussel mucin and sodium hyaluronate was constructed based on a fullerenol-cerium oxide composite nano system， namely fullerenol-cerium oxide nanogel （FCN）， and was characterized. The antioxidant capacity of FCN was evaluated using in vitro free radical scavenging experiments； its UV shielding ability was assessed by using an SPF value detector； its biosafety was assessed according to the requirements of the Guidelines for Drug Safety Evaluation； skin adhesion was assessed using small animal 3D live imaging technology； its sun protection ability was assessed through skin sunscreen detection and histopathological observation. RESULTS The average particle sizes of cerium oxide and fullerenol nanoparticles in FCN were about 20 and 10 nm， respectively， and FCN exhibited good UV absorption and free radical scavenging abilities. SPF value of FCN was 58.95±0.82， and the ultraviolet A protection level value was 6.21±0.15. No pathogenic colonies such as Staphylococcus aureus， were detected in the nanogel， and the contents of lead， arsenic， mercury and cadmium all met the standards for pharmaceutical excipients； FCN group did not show any irritating reactions such as erythema， edema， or desquamation； blood biochemical indicators of the FCN group were within the normal reference range. The material clearance rate of mice in the artificial sweat flushing group was less than 30%， while the material clearance rate of mice in the dry cleaning group reached about 92%. The mice in the protective group did not show obvious erythema or ulcer formation throughout the experiment. Histopathology showed that the fibers were arranged in an orderly manner， and the number of collagen fibers was close to that of the control group. CONCLUSIONS The FCN formulation constructed in this study meets the relevant requirements of the Chinese Pharmacopoeia， has good safety and skin compatibility， and achieves dual synergistic protection of UV shielding and free radical scavenging.

OBJECTIVE: To compare the effectiveness of early versus delayed closed reduction and percutaneous Kirschner wire fixation in the treatment of pediatric supracondylar humerus fractures. METHODS: A retrospective analysis was conducted on 468 children with supracondylar humerus fractures, who were admitted between January 2020 and December 2023 and met the inclusion criteria. Among them, 187 children were treated during 12 hours after injury (early operation group) and 281 were treated after 12 hours (delayed operation group). There was no significant difference between the two groups ( P>0.05) in the gender, age, injury mechanism, fracture side and type, while there was significant difference in interval from injury to operation ( P<0.05). The operative outcomes, including the operation time, intraoperative blood loss, the length of hospital stay, fracture healing time, elbow function assessed by Flynn criteria at 3 months after operation, and complications, were compared. RESULTS: Compared to the delayed operation group, the early operation group demonstrated significantly shorter operation time and less intraoperative blood loss ( P<0.05). There was no significant difference in the length of hospital stay between the two groups ( P>0.05). All children were followed up 3-12 months. The follow-up time was (6.7±2.9) months in the early operation group and (6.9±2.8) months in the delayed operation group, showing no significant difference between the two groups ( P>0.05). There was no significant difference in the fracture healing time between the two groups ( P>0.05). At 3 months after operation, the early operation group exhibited superior Flynn elbow functional outcomes to the delayed operation group ( P<0.05). In the early operation group, there was 1 case of fracture non-union and 3 cases of cubital varus deformity after operation. In the delayed operation group, there was 1 case of nerve injury, 7 cases of fracture non-union, and 12 cases of cubital varus deformity after operation. There was significant difference in the incidence of complications between the two groups ( P<0.05). One case of the early operation group and 10 cases of the delayed operation group underwent secondary operation, showing no significant difference in the incidence of secondary operation between the two groups ( P>0.05). CONCLUSION For pediatric supracondylar humerus fractures, early closed reduction and percutaneous Kirschner wire fixation can reduce operation time, minimize intraoperative blood loss and postoperative complications, and improve the functional recovery compared to delayed operation.
Humans ; Humeral Fractures/surgery* ; Bone Wires ; Retrospective Studies ; Male ; Female ; Child ; Fracture Fixation, Internal/instrumentation* ; Child, Preschool ; Treatment Outcome ; Operative Time ; Fracture Healing ; Length of Stay ; Closed Fracture Reduction/methods* ; Blood Loss, Surgical ; Time Factors ; Time-to-Treatment ; Postoperative Complications/epidemiology*

With the normalization and institutionalization of national centralized drug procurement(NCDP)policy,a large number of generic drugs have been included in the clinical frontline,benefiting hundreds of millions of patients.At the same time,real-world studies(RWS)on generics and innovator drugs have been carried out successively,providing evidence-based support for the promotion and optimization of NCDP policy.Thispaper systematically reviewed the RWS of generic drugs in the past fiveyears of the NCDP policy,discussed and summarized the evidence of clinical efficacy,safety and cost-effectiveness of major generic drugs such as anti-infective drugs,cardiovascular drugs,neuropsychotics,hypoglycemic drugs,and anti-tumor drugs,and analyzed the current RWS status of generic drugs.Overall,the clinical effectiveness and safety of domestic generic drugs are basically the same as that of the innovator drugs,and there is no statistically significant difference,while generic drugs are more cost-effective.Current research still reveals shortcomings in in data quality and integrity,standardization and rigor of research methods,study coverage and population diversity,pharmacoeconomic evaluation and long-term safety monitoring,which point out the direction for later research in this field.Throughsystematic integration and analysis of the RWS of generic drugs,this review is expected to improve public awareness and recognition of NCDP policy,and provide an important reference for promoting the in-depth implementation of NCDP policy.

Objective To explore the clinical effect of Busshenqiangji decoction combined with adalimumab(Adam)in patients with ankylosing spondylitis.Methods A total of 114 patients with ankylosing spondylitis were included and randomly divided into the Adam group and the combined group,with 57 cases in each group.Patients in the Adam group were given adalimumab by subcutaneous injection,40mg/time,once every other week.Patients in the combined group were treated with Bushenqiangji decoction(1 dose/day)on the basis of the above,and both groups were treated continuously for 12 weeks.The efficacy,Traditional Chinese Medicine(TCM)syndrome score,spinal function,clinical index,serological index and adverse reactions were evaluated between the two groups.Results The total effective rate was 92.98%(53/57)in the combination group,which was higher than that of the Adam group(75.44%,43/57,P＜0.05).After treatment,the total score of TCM syndromes,Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)and Bath Andylosing Spondylitis Function Index(BASFI)scores were decreased in the combination group,and which were lower than those of the adalimumab group(P＜0.05).After treatment,the finger-to-floor distance and occipital bone-to-wall distance were decreased in the combination group,and which were smaller than those in the Adam group(P＜0.05).The chest range of motion increased,and which was greater than that in the Adam group(P＜0.05).After treatment,serum levels of sclerostin and 25 hydroxyvitamin D were significantly increased in the combination group than those in the Adam group(P＜0.05).There were no significant differences in the total incidence rates of adverse reactions,such as skin rash and gastrointestinal reactions between the two groups[10.53%(6/57)vs.14.04%(8/57),P＞0.05].Conclusion Bushenqiangji decoction combined with adalimumab can play a synergistic role in the treatment of patients with ankylosing spondylitis,significantly improving the symptoms of pain and morning stiffness.The mechanism of action may be related to improving the expression of osteosclerosis protein and the increase of 25-hydroxyvitamin D.

Objective To explore the clinical effect of Busshenqiangji decoction combined with adalimumab(Adam)in patients with ankylosing spondylitis.Methods A total of 114 patients with ankylosing spondylitis were included and randomly divided into the Adam group and the combined group,with 57 cases in each group.Patients in the Adam group were given adalimumab by subcutaneous injection,40mg/time,once every other week.Patients in the combined group were treated with Bushenqiangji decoction(1 dose/day)on the basis of the above,and both groups were treated continuously for 12 weeks.The efficacy,Traditional Chinese Medicine(TCM)syndrome score,spinal function,clinical index,serological index and adverse reactions were evaluated between the two groups.Results The total effective rate was 92.98%(53/57)in the combination group,which was higher than that of the Adam group(75.44%,43/57,P＜0.05).After treatment,the total score of TCM syndromes,Bath Ankylosing Spondylitis Disease Activity Index(BASDAI)and Bath Andylosing Spondylitis Function Index(BASFI)scores were decreased in the combination group,and which were lower than those of the adalimumab group(P＜0.05).After treatment,the finger-to-floor distance and occipital bone-to-wall distance were decreased in the combination group,and which were smaller than those in the Adam group(P＜0.05).The chest range of motion increased,and which was greater than that in the Adam group(P＜0.05).After treatment,serum levels of sclerostin and 25 hydroxyvitamin D were significantly increased in the combination group than those in the Adam group(P＜0.05).There were no significant differences in the total incidence rates of adverse reactions,such as skin rash and gastrointestinal reactions between the two groups[10.53%(6/57)vs.14.04%(8/57),P＞0.05].Conclusion Bushenqiangji decoction combined with adalimumab can play a synergistic role in the treatment of patients with ankylosing spondylitis,significantly improving the symptoms of pain and morning stiffness.The mechanism of action may be related to improving the expression of osteosclerosis protein and the increase of 25-hydroxyvitamin D.

With the normalization and institutionalization of national centralized drug procurement(NCDP)policy,a large number of generic drugs have been included in the clinical frontline,benefiting hundreds of millions of patients.At the same time,real-world studies(RWS)on generics and innovator drugs have been carried out successively,providing evidence-based support for the promotion and optimization of NCDP policy.Thispaper systematically reviewed the RWS of generic drugs in the past fiveyears of the NCDP policy,discussed and summarized the evidence of clinical efficacy,safety and cost-effectiveness of major generic drugs such as anti-infective drugs,cardiovascular drugs,neuropsychotics,hypoglycemic drugs,and anti-tumor drugs,and analyzed the current RWS status of generic drugs.Overall,the clinical effectiveness and safety of domestic generic drugs are basically the same as that of the innovator drugs,and there is no statistically significant difference,while generic drugs are more cost-effective.Current research still reveals shortcomings in in data quality and integrity,standardization and rigor of research methods,study coverage and population diversity,pharmacoeconomic evaluation and long-term safety monitoring,which point out the direction for later research in this field.Throughsystematic integration and analysis of the RWS of generic drugs,this review is expected to improve public awareness and recognition of NCDP policy,and provide an important reference for promoting the in-depth implementation of NCDP policy.