Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging. Further technical evaluation after market introduction should be carried out on safety, health function and other aspects of those widely used commercial scale production products. According to the analysis report on the consumption situation of post-marketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago, the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support. Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence, this paper analyzes the post-marketing evaluation content, evidence source construction, evidence classification and classification of functional food, and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points, so as to provide insights into evidence system research in this field in the future.
组织工程的提出、建立和发展,为最终实现脊髓损伤的修复和真正意义上的结构、形态与功能重建开辟了新的途径。支架的生物活性、三维结构和表面微观结构,材料的降解性等众多因素都对细胞增殖,分化和组织形成有明显影响。组织工程的发展也将改变传统的医学模式,使得再生医学得以进一步发展,并最终用于疾病的治疗。
ObjectiveTo compare the strength difference between the interfacial screw and the interfacial screw combined with bone tunnel crossing technology to fix the tibial end of ligament during anterior cruciate ligament (ACL) reconstruction through the biomechanical test.MethodsTwenty fresh frozen pig tibia were randomly divided into two groups (n=10) to prepare ACL reconstruction models. The graft tendons in the experimental group were fixed with interfacial screw combined with bone tunnel crossing technology, and the graft tendons in the control group were fixed with interfacial screw. The two groups of specimens were fixed in the high-frequency dynamic mechanics test system M-3000, and the length change (displacement), ultimate load, and stiffness of graft tendons were measured through the reciprocating test and load-failure test.ResultsThe results of reciprocating test showed that the displacement of the experimental group was (3.06±0.58) mm, and that of the control group was (2.82±0.46) mm, and there was no significant difference between the two groups (t=0.641, P=0.529). The load-failure test results showed that the stiffness of the experimental group and the control group were (95.39±13.63) and (91.38±14.28) N/mm, respectively, with no significant difference (t=1.021, P=0.321). The ultimate load of the experimental group was (743.15±173.96) N, which was significantly higher than that of the control group (574.70±74.43) N (t=2.648, P=0.016).ConclusionIn ACL reconstruction, the fixation strength of tibial end with interface screw combined with bone tunnel crossing technology is obviously better than that of interface screw alone.
ObjectiveTo explore the causes and management of the complications in diabetic foot treated with tibial transverse transport (TTT). MethodsBetween September 2015 and September 2019, 196 patients with diabetic foot were treated with TTT. There were 109 males and 87 females, with an average age of 67.6 years (range, 45-86 years). According to Wagner’s classification, there were 124 cases of grade 3, 62 cases of grade 4, and 10 cases of grade 5; the course of disease was 1-12 months, with an average of 2.6 months. All patients underwent the minimally invasive tibial osteotomy. The osteotomy site was the middle and lower tibia in 62 cases and the middle and upper tibia in 134 cases. The area of osteotomy was 20 cm2 in 83 cases and 7.5 cm2 in 113 cases. The osteotomy block was moved back and forth once in 92 cases and twice in 104 cases. The complications were recorded, including secondary fracture at tibial osteotomy, skin necrosis in osteotomy area, and pin tract infection. ResultsAmong 196 patients, 41 cases (20.9%) had complications. Nine cases (4.6%) had secondary fracture at tibial osteotomy, among which 6 cases (9.6%) of middle and lower segment osteotomies and 3 cases (2.2%) of middle and upper segment osteotomies. The incidence between the patients with different osteotomy sites was significant (χ2=5.354, P=0.021). The area of osteotomy was 20 cm2 in 5 cases (6.0%) and 7.5 cm2 in 4 cases (3.5%). There was no significant difference in the incidence between patients with different areas (χ2=0.457, P=0.499). Skin necrosis occurred in the osteotomy area in 12 cases (6.1%), all of which were moved back and forth once. There was a significant difference in the incidence between patients who were treated with transport once and twice (P=0.001). There were 18 cases (9.1%) with pin tract infection, including 12 cases (6.1%) with mild infection and 6 cases (3.0%) with severe infection. There was no significant difference in the incidence between the patients with mild and severe infections (P=0.107).ConclusionTTT is an effective method to treat diabetic foot, but there are complications such as secondary fracture at tibial osteotomy, skin necrosis in osteotomy area, and pin tract infection during transport. Preoperative evaluation of indication, standardization of osteotomy mode, size and position of osteotomy block, establishment of individualized removal plan, and strengthening of pin track nursing after operation can effectively reduce complications.
ObjectiveTo explore the effectiveness of a new point contact pedicle navigation template (referred to as “new navigation template” for simplicity) in assisting screw implantation in scoliosis correction surgery. MethodsTwenty-five patients with scoliosis, who met the selection criteria between February 2020 and February 2023, were selected as the trial group. During the scoliosis correction surgery, the three-dimensional printed new navigation template was used to assist in screw implantation. Fifty patients who had undergone screw implantation with traditional free-hand implantation technique between February 2019 and February 2023 were matched according to the inclusion and exclusion criteria as the control group. There was no significant difference between the two groups (P>0.05) in terms of gender, age, disease duration, Cobb angle on the coronal plane of the main curve, Cobb angle at the Bending position of the main curve, the position of the apical vertebrae of the main curve, and the number of vertebrae with the pedicle diameter lower than 50%/75% of the national average, and the number of patients whose apical vertebrae rotation exceeded 40°. The number of fused vertebrae, the number of pedicle screws, the time of pedicle screw implantation, implant bleeding, fluoroscopy frequency, and manual diversion frequency were compared between the two groups. The occurrence of implant complications was observed. Based on the X-ray films at 2 weeks after operation, the pedicle screw grading was recorded, the accuracy of the implant and the main curvature correction rate were calculated. ResultsBoth groups successfully completed the surgeries. Among them, the trial group implanted 267 screws and fused 177 vertebrae; the control group implanted 523 screws and fused 358 vertebrae. There was no significant difference between the two groups (P>0.05) in terms of the number of fused vertebrae, the number of pedicle screws, the pedicle screw grading and accuracy, and the main curvature correction rate. However, the time of pedicle screw implantation, implant bleeding, fluoroscopy frequency, and manual diversion frequency were significantly lower in trial group than in control group (P<0.05). There was no complications related to screws implantation during or after operation in the two groups. ConclusionThe new navigation template is suitable for all kinds of deformed vertebral lamina and articular process, which not only improves the accuracy of screw implantation, but also reduces the difficulty of operation, shortens the operation time, and reduces intraoperative bleeding.
Objective To investigate the effectiveness of using 3 hollow compression screws combined with 1 screw off-axis fixation under the guidance of three-dimensional (3D) printed guide plate with mortise-tenon joint structure (mortise-tenon joint plate) for the treatment of Pauwels type Ⅲ femoral neck fractures. Methods A clinical data of 78 patients with Pauwels type Ⅲ femoral neck fractures, who were admitted between August 2022 and August 2023 and met the selection criteria, was retrospectively analyzed. The operations were assisted with mortise-tenon joint plates in 26 cases (mortise-tenon joint plate group) and traditional guide plates in 28 cases (traditional plate group), and without guide plates in 24 cases (control group). There was no significant difference in the baseline data of gender, age, body mass index, cause of injury, and fracture side between groups (P>0.05). The operation time, intraoperative blood loss, frequency of intraoperative fluoroscopy, incision length, incidence of postoperative deep vein thrombosis of lower extremity, pain visual analogue scale (VAS) score at 1 week after operation, and Harris score of hip joint at 3 months after operation were recorded and compared. X-ray re-examination was taken to check the quality of fracture reduction, fracture healing, and the shortening length of the femoral neck at 3 months after operation, and the incidences of internal fixation failure and osteonecrosis of the femoral head during operation. Results Compared with the control group, the operation time, intraoperative blood loss, and frequency of intraoperative fluoroscopy reduced in the two plate groups, and the quality of fracture reduction was better, but the incision was longer, and the differences were significant (P<0.05). The operation time and intraoperative blood loss were significantly higher in the traditional plate group than in the mortise-tenon joint plate group (P<0.05), the incision was significantly longer (P<0.05); and the difference in fracture reduction quality and the frequency of intraoperative fluoroscopy was not significant between two plate groups (P>0.05). There was 1 case of deep vein thrombosis of lower extremity in the traditional plate group and 1 case in the control group, while there was no thrombosis in the mortise-tenon joint plate group. There was no significant difference in the incidence between groups (P>0.05). All patients were followed up 12-15 months (mean, 13 months). There was no significant difference in VAS score at 1 week and Harris score at 3 months between groups (P>0.05). Compared with the control group, the fracture healing time and the length of femoral neck shortening at 3 months after operation were significantly shorter in the two plate groups (P<0.05). There was no significant difference between the two plate groups (P>0.05). There was no significant difference in the incidences of non-union fractures, osteonecrosis of the femoral head, or internal fixation failure between groups (P>0.05). Conclusion For Pauwels type Ⅲ femoral neck fractures, the use of 3D printed guide plate assisted reduction and fixation can shorten the fracture healing time, reduce the incidence of postoperative complications, and be more conducive to the early functional exercise of the affected limb. Compared with the traditional guide plate, the mortise-tenon joint plate can reduce the intraoperative bleeding and shorten the operation time.
Objective To assess the effectiveness of a novel minimally invasive Achilles tendon suture instrument in the treatment of fresh closed Achilles tendon rupture. Methods A retrospective study was conducted on 150 patients who underwent surgical intervention for fresh closed Achilles tendon rupture. Eighty patients were treated with the novel minimally invasive Achilles tendon suture instrument (minimally invasive group) and 70 patients with traditional open surgery (traditional group). The two groups were comparable in terms of gender, age, injured side, cause of injury, the interval between injury and operation, and the distance from the fracture end to the calcaneal tuberosity (P>0.05). The operation time, intraoperative blood loss, incision length, hospital stays, hospitalization expenses, and complications were recorded and compared. At 1 year after operation, the ankle joint function was evaluated by the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score. Results The minimally invasive group demonstrated significantly shorter operation time, smaller incision length, and lower intraoperative blood loss when compared with the traditional group (P<0.05). However, there was no significant difference in terms of hospital stays and hospitalization expenses between the two groups (P>0.05). All patients were followed up 12-24 months after operation (mean, 15.5 months). In the traditional group, 6 cases of incision necrosis and 7 cases of Achilles tendon adhesion occurred, while in the minimally invasive group, all incisions healed at first intention and no Achilles tendon adhesion occurred. The differences in the incidences of the two complications between the two groups were significant (P<0.05). At 1 year after operation, the AOFAS ankle-hindfoot score in the minimally invasive group was superior to that of the traditional group (P<0.05). Conclusion In comparison with traditional open surgery, the use of self-designed novel minimally invasive Achilles tendon suture instrument proves to be an ideal technique for treating fresh closed Achilles tendon ruptures. This approach offers the benefits of smaller incisions, fewer complications, and better postoperative functional recovery, without increasing hospital costs.