Objective To evaluate the effectiveness and safety of implanted sustained-release fluorouracil in gastric cancer surgery. Methods Literature search was conducted in the following databases: PubMed, EMbase, The Cochrane Library (Issue 6, 2012), CNKI, VIP and WanFang Data from inception to June, 2012. Randomized controlled trials (RCTs) or quasi-randomized controlled trials on implanted sustained-release fluorouracil for gastric cancer were included. Two reviewers independently identified the literature according to the inclusion and exclusion criteria, and then extracted the data and assessed the quality of the included studies. Then, meta-analysis was conducted using RevMan 5.1 software. Results A total of 7 studies involving 742 patients were included. The results of meta-analysis showed no significant difference in the rate of postoperative complications between the two groups (OR=0.93, 95%CI 0.54 to 1.59, P=0.79), while a significant reduction was found in the recurrence rate in the sustained-release fluorouracil group during 1 to 3 year follow-up (1 year after surgery: OR=0.32, 95%CI 0.22 to 0.46, P=0.02; 2 years after surgery: OR=0.19, 95%CI 0.08 to 0.42, Plt;0.001; 3 years after surgery: OR=0.40, 95%CI 0.24 to 0.67, P=0.004). As for the survival rate, no significant difference was found between the two groups 1 year after surgery (OR=1.98, 95%CI 0.92 to 4.25, P=0.08), while it was significantly higher in the sustained-release fluorouracil group than in the control group 2 to 3 years after surgery (2 years after surgery: OR=2.63, 95%CI 1.17 to 5.91, P=0.02; 3 years after surgery: OR=2.42, 95%CI 1.53 to 3.83, P=0.002). Adverse reaction rates in the sustained-release fluorouracil group were lower than those in the control group, but without significantly differences between the two groups (OR=1.22, 95%CI 0.49 to 3.07, P=0.67). Conclusion Compared with the control group, implanted sustained-release fluorouracil for gastric cancer can significantly reduce the recurrence rate 1 to 2 years after surgery and improve the overall survival rate 2 to 3 years after surgery without increasing the incidences of the postoperative complications and adverse reaction. However, due to the limitation of quantity and quality of the included studies, this conclusion should be further confirmed by more high quality, larger sample and multi-center RCTs.
Objective To design a novel stentless porcine aortic bioprosthesis and test the feasibility and its function in vitro after the valve was implanted by a modified method. Methods Six stentless porcine aortic bioprosthesis were divided into two groups according to different implantation, single layer suture group: new improvement stentless porcine aortic bioprosthesis sutured with single layer was implanted; double layer suture group: stentless porcine aortic bioprosthesis developmented by our laboratory used double layer suture was implanted. Each group contained three scales: 23 mm ,25 mm and 27 mm. Analogue ex vivo aortic valve replacement was performed , the feasibility of the new implantation was detected. Effective orifice area, transvalvular pressure gradient and regurgitation ratio were recorded at the cardiac output of 2.0 L/min, 3.5 L/min, 5.0 L/min and 7.0 L/min under the guideline of International Organization for tandardization （ISO）5840. Results The average aortic valve implantation time used for single layer suture and tradition double layer suture were 50 min and 70 min respectively. The transvalvular pressure gradient in the single layer suture group were significantly lower than those in double layer suture group under the flow of 5.0 L/min in 23 mm valve and 27 mm valve （13.51±0.51 mm Hg vs. 14.44±0.99 mm Hg, 7.36±0.19 mm Hg vs. 7.53±0.28 mm Hg；P＜0.01）;and the effective orifice area in the single layer suture group were larger than those in double layer suture group in the same case(1.87±0.06 cm2 vs. 1.76±0.08 cm2, 2.26±0.07 cm2 vs. 2.16±0.05 cm2；P＜0.01). There was no statistically difference in other parameters between both groups. Conclusion The novel design of new improvement stentless porcine aortic bioprosthesis used single layer suture has good hemodynamic characteristics as the nature structure . The modified suture method decrease the implantation time.Nemerical data of the evaluation in vitro show that the difference between single layer suture group and double layer suture group in effective orifice area,transvalvular pressure gradient and regurgitation ratio haveno statistical significance. This experiment is the foundation of the animal and clinical experiment in the future.
Objective To investigate the influence of infarcted myocardial construction by umbilical cord blood mesenehymal stem cells（MSC） with induced to myo-derived stem cells and implanted into infarcted myocardium. Methods Thirty-six adult mongrel canines were randomly divided into MSC transplant group and control group （18 each group）. Transplant group： the umbilical cord blood MSC differented to myo-derived stem cells induced by 5-azacytidine（5-aza） were implanted into the acute myocardial infarct site via the ligated left anterior descending （LAD） artery. Control group： administer the same volume of IMDM culture medium containing 0. 02% 4,6- diamidino-2-phenylindone （DAPI）. At 2, 4, 8 weeks after implantation, the change of basic myocardial construction and the distribution of desmin were observed by using Nagar-Olsen staining and immunohistology respectively. Results With less fusing, the arrangement of gelatine fibers and elastic fibers were in order in transplant group,and they were partly fused in control group by Nagar-Olsen staining. The expression of desmin of infarcted myocardial cell in transplant group was much higher than those in control group （P〈0. 01）. No significant difference was detected in the expression of desmin in normal site of both groups （P〉0. 05）. Conclusion There is an protective effect on the basic myocardial construction in infarcted myocardium after the umbilical cord blood MSC was differented to myo-derived stem cell by induced with 5-aza in vitro and implanted into the acute myocardial infarction.
Objective To introduce a new type of bileaflet mechanical prosthetic heart valve （GK bileaflet valve）and evaluate clinically the early hemodynamic effect and short term follow-up after its replacement. Methods Sixty-one patients with heart valve diseases were operated upon. The mitral valve replacement was performed in 34 patients, aortic valve replacement in 16 patients and double valve replacement in 11 patients. A total of 72 GK bileaflet mechanical valves were implanted, 45 in mitral position, and 27 in aortic position. Blood consistency and hemodynamics were monitored. Follow-up was carried out routinely to check whether there were some valve-related complications. Results There was no early mortality （〈30 d）. Only one patient died of trauma 2 months after the operation. Follow-up was 100% and extended 1 to 2. 5 years. Without valve-related complications all patients had lived for more than 1 to 2.5 years. In 98% （60/61） of survivors heart functional performance had improved to New York Heart Association class Ⅰ or Ⅱ . Conclusion Early clinical results and short term follow up demonstrate that GK bileaflet prosthetic heart valve exhibits excellent hemodynamic properties, satisfied blood consistency and a low incidence of valve-related complications. Midterm and long-term results should be observed further.
Objective To review the research progress of promoting the bone formation at early stage by components of the extracellular matrix (ECM). Methods Recent literature concerning the influence of these components on new bone formation and bone/implant contact was extensively reviewed and summarized. Results Coating of titanium or hydroxyapatite implants with organic components of the ECM (such as collagen type I, chondroitin sulfate, and Arg-Gly-Asp peptide) offers great potential to improve new bone formation and enhance bone/implant contact, which in turn will shorten recovery time and improve implant stability. Conclusion The increasing knowledge about the role of the ECM for recruitment, proliferation, differentiation of cells, and regeneration of tissue will eventually deal to the creating of an artificial ECM on the implant that could allow a defined adjustment of the required properties to support the healing process.
Objective To evaluate the effect of the local del ivery of basic fibroblast growth factor 2 (bFGF-2) on the osseointegration around titanium implant of diabetic rats. Methods The bFGF-2-loaded poly (lactic-co-glycol ic acid) microspheres were prepared by water/oil/water (W/O/W) double-emulsion solvent evaporation method. Thirty-five male SPF level Sprague Dawley rats, weighing 220-250 g and aged 9 weeks, were selected as experimental animals. Ten rats were fedwith the routine diet as normal control group. The other 25 rats were made the diabetic animal model by giving high fat-sugar diet and a low dose streptozotocin (30 mg/ kg) intravenously; 20 rats were made the diabetic animal model successfully. Then 20 rats were randomly divided into diabetic control group (n=10) and bFGF-2 intervention group (n=10). A hole was drilled in the right tibia bone of all rats, and the titanium implant treated by micro-arc oxidation surface was planted into the hole. Simultaneously, the previously prepared microspheres and blood were mixed and were loaded on the surface of the implant before it was implanted into the rats of the bFGF-2 intervention group. At 4 and 8 weeks, the tibia containing implants was harvested, embedded with resin and made undecalcified tissue sl ices to compare the osseointegration. Results At 4 weeks, the implants of the normal control group were surrounded by new lamellar bone with continuity; whereas the tissue around the implants of the diabetic control group contained l ittle woven bone and some fibrous tissue; and obvious new formed bone with continuity was observed in bFGF-2 intervention group. At 8 weeks, the results of 3 groups were similar to those at 4 weeks. At 4 weeks, the percentage of bone-implant contact (BIC) in diabetic control group was significantly less than those in normal control group (P lt; 0.05) and in bFGF-2 intervention group (P lt; 0.05); the BIC in bFGF-2 intervention group was less than in normal control group, but showing no significant difference (P gt; 0.05). After 8 weeks, the BIC in normal control group and in bFGF-2 intervention group were significantly greater than that in diabetic control group (P lt; 0.05), but there was no significant difference between bFGF-2 intervention group and normal control group (P gt; 0.05). Conclusion Local del ivery of bFGF-2 around titanium implants may improve the osseointegration in diabetic rats.
To explore the histological and the hematological change of rabbits after implanting novel injectable artificial nucleus prostheses, and to evaluate the biological safety. Methods In accordance with Biological Evaluation of Medical Devices, materials of polyurethane, sil icone rubber and macromolecular polyethylene for medical use were made into short column 1 cm in length and 0.3 cm in diameter. Forty-eight SPF New Zealand white rabbits weighing 2.5-3.0 kg were used, and cavity 1 cm in depth was made in the area 2 cm away from the spinal midl ine by separating muscle.Then according to different material being implanted, the rabbits were divided into 3 groups (n=16): Group A, polyurethane; group B, sil icone rubber; group C, macromolecular polyethylene for medical use as negative control. General condition of the rabbits was observed after operation. Gross and histology observation were conducted 1, 4, 12 and 26 weeks after operation. Blood routine, biochemical function and electrolyte assays were performed 26 weeks after operation to observe pathological changes of organs. Meanwhile, physicochemical properties of the materials were detected, and the material in the same batch was used as negative control. Results All rabbits survived until the end of experiment, and all wounds healed by first intention. In each group, red swollen muscles were observed 1 week after operation and disappeared 4 weeks after operation, connective tissue around the implanted materials occurred 12 and 26 weeks after operation. At 26 weeks after operation, there were no significant differences among three groups in blood routine, biochemical function and electrolyte assays (P gt; 0.05). Organs had smooth surface without ulceration, ecchymosis, obvious swell ing, hyperemia or bleeding, and nodules. There were no significant differences among three groups in percentage weight of each organ (P gt; 0.05). Histology observation: granulation tissue prol iferation and inflammatory cell infiltration were observed in each group 1 week after operation, fibrous capsule formation around the materials and the disappearance of inflammatory cell infiltration were evident 4 weeks after operation, cyst wall grewover time and achieved stabil ity 12 weeks after operation. The inflammatory response and the fiber cyst cavity of groups A and B met the standard of GB/T 16175 and were in l ine with group C. No specific pathological changes were discovered in the organs 26 weeks after operation. For group A, no significant difference was evident between before and after material implantation in terms of weight average molecular weight, number average molecular weight, tensile strength at break and elongation at break (P gt; 0.05). For group B, no significant difference was evident between before and after material implantation in shore hardness (P gt; 0.05). Conclusion Novel injectable nucleus pulposus prostheses do not damage local tissue and function of organs, but provide good biocompatibil ity and biological safety.
Objective To study the immunological rejection occurred in different period after the in vivo implantation of vitreous-cryopreservation tissue engineered tendons for the repair of tendon defect and investigate its influences on the hepatic, renal, and cardiovascular function of rats. Methods Tenocytes obtained from tail tendon of one-weekold SD rats were cultured in vitro. The tenocytes at passage 2-4 (5 × 106 cells/mL) were co-cultured with 1.5 cm bio-derived tendon material to reconstruct tissue engineered tendon. The 21% DMSO was used as cryopreservation protection solution andthe Eurocoll ins solution served as basic solution for pre-frozen solution (4 ) and eluent. The cell-scaffold composites were vitreous-cryopreserved by self-designed method. Seventy-two healthy SD rats (male and/or female) weighing 210-230 g were randomly divided into three groups: group A (n=32), group B (n=32), and group C (n=8). The 0.5 cm tendon defect model was establ ished in the middle part of Achilles tendon in groups A and B. The defect in group A and B was repaired by the transplantation of tissue engineered tendon with and without vitreous-cryopreservation, respectively. At 2, 4, 6, and 8 weeks after transplantation, the general observation and the detection of hepatic function, renal function, and cardiovascular function were conducted. At 2, 4, and 6 weeks after transplantation, serum immunology test was conducted. Results There were no tissue necrosis, hydrops, and suppurative infection in groups A and B. The adhesion was evident in groups A and B 2 weeks after transplantation, improved gradually during 4-6 weeks, and disappeared at 8 weeks. The neonatal tissue had full integration and continuity, and the bridging region of the tendon healed and was similar to the normal tendon. For serum IgG and IgM content, there was no significant difference when group A or B was compared with group C, and between group A and group B 2, 4, and 6 weeks after transplantation (P gt; 0.05). Hepatic function: aspartate aminotransferase (AST) content of group A was less than that of group C 4 weeks after transplantation (P lt; 0.05); AST content of group B was less than that of group C 4 and 6 weeks after transplantation (P lt; 0.05); but there was no significant difference when group A or B was compared with group C in terms of other indexes 8 weeks after transplantation (P gt; 0.05). Renal function: serum albumin and creatinine in groups A and B were decreased obviously, and significant difference was evident when compared with group C (P lt; 0.05). Cardiovascular function: there was no significant difference between group A and group C in terms of blood glucose, triglyceride, and cholesterol (P gt; 0.05);there was a significant difference between group B and group C in terms of triglyceride 8 weeks after transplantation (P lt; 0.05). Conclusion Repairing tendon defect with the implantation of vitreous-cryopreservation tissue engineered tendons results in no obvious immunological rejection and exerts no obvious influences on hepatic, renal, and cardiovascular function.
Objective To investigate the feasibility and characteristic of tissue engineered testicular prosthesis with highdensity polyethylene(HDPE，trade name: Medpor) and polyglycolic acid(PGA). Methods The chondrocytes were isolated from the swine articular.The PGA scaffold was incorporated with medpor which semidiameters were 6mmand 4mm respectively.Then, the chondrocytes (5×10 7/ml) were seeded onto Medpor-PGA scaffold and cultured for 2 weeks. The ten BALB／C mice were divided into two groups randomly(n=5). In the experimental group, the cell-scaffold construct was implanted into subcutaneous pockets on the back of nude mice. In the control group, the Medpor-PGA scaffold was implanted. The mice of two groups were sacrificed to harvest the newly formed cartilage prosthesis after 8 weeks. Macroscopy, histology and immunohistochemistry observations were made. Results The gross observation showed that on changes were in shape and at size, the color and elasticity were similar to that of normal cartilage and that the cartilage integrated with Medpor in the experimental group; no cartilage formed and fiberlike tissue was found in the control group. HE staining showed that many mature cartilage lacuna formed without blood vessel and some PGA did not degradated completely. Toluidine blue staining showed extracellular matrix had metachromia. Safranin O-fast green staining showed that many proteoglycan deposited and collagen type Ⅱ expression was bly positive. In the control group, Medpor was encapsulated by fiber tissue with rich blood vessel. Conclusion The newly formed complex of Medpor-PGA and cells was very similar to testicle in gross view and to normal cartilage in histology. This pilot technique of creating testicular prosthesis by incorporating tissue-engineered cartilage with Medpor demonstrated success.
Objective To investigate whether the implanted myoblasts with the soluble carriers can improve the repairing efficiency for theseverelycryodamaged tibialis anterior muscles. Methods The skeletal myoblasts were isolated from the newborn SD rats by the use of the enzyme digestion. They were purified and serially subcultivated; the subcultivated myoblasts of the 3rd generation were marked with BrdU. The severelycryodamaged tibialis anterior muscle models were established from 84 SD rats aged 5 months. They were randomly divided into 4 groups, including Group A1 (the implanted myoblasts with the carriersF12 containing 0.1% sodium hyaluronate), Group A2 (the implanted myoblasts, with the carriersF12 that did not contain 0.1% sodiumhyaluronate), Group B1 (the implanted carrier solution containing 0.1% sodium hyaluronate, but with no myoblasts), and Group B2 (with no carrier solution or myoblasts). Six rats were killed at the following time points: at 2, 5 and 9 days,and 2, 4, 8 and 12 weeks after operation; the immunohistochemical and the Mallory staining studies were performed for an evaluation on the repairing efficiencyfor the severelycryodamaged tibialis anterior muscles. By the imaging analysis, the number of the survived cells in each group was compared at 2 days, and the area ratio of the collagen fiber in each group was also compared at 8 weeks. Results The BrdU immunohistochemical staining showed that the number of the remaining implanted cells was significantly greater in Groups A1 than in Group A2, the migrating area of the myoblasts was greater, the distribution of the cells was more uniform, the cell differentiating potential was undestroyed, the repairing efficiency for the severelycryodamaged tibialis anterior muscles was significantly improved. There was no bluestained nucleus at each time point in Group B. The Mallory staining showed that the fibrous degeneration inthe tissue repairing process was significantly inhibited in Groups A1, A2 and B1; the inhibition was most obvious in Group A1, and next in Group A2. The imaging analysis indicated that at 2 days after operation, the number of the survived cells was significantly-greater in Group A1 than in Group A2 (Plt;0.05). At 8 weeks after operation, the collagen fiber was the least in Group A1, less in Group A2, more in Group B1,and the most in Group B2 (Plt;0.05). Conclusion The implanted myoblasts can significantly improve the repairing efficiency for the severelycryodamaged muscle tissues, and the implanted carrier solution containing 0.1% sodium hyaluronate can improve the implanting efficiency for the myoblasts.