ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
Objective To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters. Methods Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated. Results Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant. Conclusion The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
Objective To study the effect of sodium hyaluronate hydrogel in treating residual cavity on body surface after abscess drainage so as to provide new method to speed up the heal ing of residual cavity after body surface abscess drainageand reduce the frequency of dressing change and cl inic nursing workload. Methods From June 2007 to March 2008, 60 outpatients with body surface abscess drainage were randomly divided into hydrogel group (group A, 30 cases) and the control group (group B, 30 cases). In group A, there were 16 males and 14 females aged (49.5 ± 6.1) years, the disease course was (3.8 ± 0.6) days, and the volume of residual cavity was (4.19 ± 1.31) mL. In group B, there were 18 males and 12 females aged (50.2 ± 7.6) years, the disease course was (4.3 ± 0.5) days, and the volume of residual cavity was (4.04 ± 1.22) mL. There was no significant difference between two groups in gender, age, disease course and volume of residual cavity (P gt; 0.05). Residual cavity was smeared with 1 mL/cm2 sodium hyaluronate hydrogel in group A and drained by sal ine gauze in group B, the dressing was changed every two to three days. Residual cavity volume was recorded every four days, and the residual cavity volume, the frequency of out-patient dressing and the heal ing time residual of cavity were compared. Results The volume of residual cavity was (3.11 ± 1.12), (1.75 ± 0.95) and (0.55 ± 0.56) mL in group A, and was (3.39 ± 1.12), (2.64 ± 0.99) and (1.81 ± 0.81) mL in group B at 4, 8 and 12 days after treatment respectively, showing no significant differences at 4 days (P gt; 0. 05), but significant difference at 8 and 12 days (P lt; 0.01). Residual cavity heal ing time was (12.70 ± 2.78) days in group A and (20.27 ± 3.89) days in group B, and the frequency of dressing change was 5.53 ± 1.33 in group A and 9.13 ± 1.81 in group B, indicating significant differences between two groups (P lt; 0.01). Conclusion Sodium hyaluronate hydrogel can promote residual cavity heal ing, reduce the frequency of dressing change of out-patient and decrease the cl inic nursing care workload.
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.
Objective To explore effective substances and methods for prevention of peridural adhesion. Methods Laminectomy was performed on the 5th lumbar segment in 64 rabbits, which were equally divided into 4 groups. The duramater (12 mm×6 mm) was exposed. The exposed duramater was left uncovered in Group A; the exposed dura mater was covered with sodium hyaluronate jel (high molecular weight, 1 ml) in Group B; the lamina repair was performed with the autologous spinous process in Group C; the lamina repair was performed with the sodium hyaluronate jel filling and the autologous spinousprocess in Group D. The specimens were observed grossly and histologically at 2, 4, 6 and 8 weeks postoperatively. The computed imaging analysis on the epidural adhesion was also performed at 6 weeks postoperatively. Results ①The gross anatomical evaluation: Severe peridural adhesion was formed in Group A, less adhesion formed in Groups B and C, but no obvious adhesion formed in Group D. ②The area percentage of the epidural scar: The area percentage ofthe epidural scar was 15.89%±1.88% and 13.94%±1.89% in Groups C and D respectively, which were significantly lower than those in Groups A and B (22.66%±2.89% and 20.70%±2.82%,Plt;0.05). ③The density of epidural scar: Thedensity of the epidural scars were 42.03%±7.36% and 36.50%±9.08% in Groups B and D, which were significantly lower than those in Groups A and C (63.73%±6.06% and 52.11%±4.10%，Plt;0.05). Conclusion The high molecular weight sodium hyaluronate jel filling combined with the lamina repair using the autologous spinous process has the best preventive effect on the peridural adhesion after laminectomy.
Objective To investigate the effects of sodium hyaluronate solution on the proliferation and differentiation of myoblasts. Methods The 3rd subculture myoblasts from muscle of infant SD rat were cultured in four growth media, in which the concentrations of sodium hyaluronate were 0.05% (group A) , 0.1%( group B), 0.2% (group C)and 0 (group D, control group), respectively. The proliferation rate of myoblasts in each medium was observed through growth curves by means of count and MTT. At the same time, the subculture myoblasts were cultured in differentiated media in which the concentrations of sodium hyaluronate were 0 and 0.1%. The capacity of fusion of myoblasts was compared between two kinds of differentiated media. Results There were the nearly same proliferation curse in Groups A, B and C: increasing by logarithm at 2 days and reaching peak value at 4 days. The myoblasts in Group D increased slowly: increasing by logarithm at 3 days, doubling at 5 days and reaching peak value at 6 days. MTT has the similar curse to counting. The myoblast proliferation of Group B was more than that of the other groups. The peak value of myoblast fusion was 35% at 6 days in common differentiated media; slowly reached 11.7% at 7 days in the differentiated media in which the concentrations of sodiumhyaluronate was 0.1%.Conclusion Sodium hyaluronate at certain concentration can be a decent media for myoblasts, it can accelerate proliferation and differentiation of myoblasts.
Objective To investigate the effect of sodium hyaluronate (SH) intra-articular injection on the treatment of knee osteoarthritis (OA), andto compare the contents of free radicals and inflammatory factors in joint fluids of pre-and pro-treatment as to explore the treatment mechanism of SH. Methods Ninety-two patients (111 knees) with mild(51)，moderate(35) and serious(25) knee OA were treated with intra-articular injections of SH (20 mg once a week for 5 weeks). According to Lysholm scoring, clinical signs such aspain, swelling,and the ability to walk, squat, run, go upstairs and downstairs were assessed before and after the treatment, and the contents of nitric oxide (NO), superoxide dismutase(SOD), malonic dialdehyde(MDA) and IL-1β、TNF-α in joint fluids from the OA joints before 1st,2nd, and 5th injection and 3 months after each injection were observed. Results All cases were followed up for 3 months. The improvements in the signs and function of knees were excellent in 42 knees, good in 38 knees, fair in 21 knees and poor in 10 knees, with 72.1% excellent and good results. The lighter the illness was, the better the improvement was: the rate of the excellent and good was 92.1% in mild group, 68.6% in moderate group and 42.9% in serious group. The contents of oxygen free radicals and IL-1β、TNF-α of the patients with mild and moderate OA decreasedmarkedly after being treated with SH（Plt;0.05）, but these decreased lightlyin serious OA group（Pgt;0.05）. SH had mild effect on the contents of NO. Three months after treatment, only in mild OA group the contents of NO significantly decreased（Plt;0.05）, and no significant change in moderate and serious groups was observed（Pgt;0.05）. Conclusion SH intraarticular injection has a positive effect on the relief of clinical symptoms and on the improvement of articular function of knee OA. The therapeutical effect of SH on OA is achieved possibly by decreasing the contents of free radicals especially oxygen free radicals and inflammatory factors in joint fluids.
Objective To explore the relationship of the limited resource of the autologous bone marrow mesenchymal stem cells (MSCs) in articularcavity to the treatment results of full-thickness articular cartilage defect, and to investigate whether the extrogenous sodium hyaluronate(SH) promotes the migration of MSCs cultured in vitro tothe articular defect in vivo. Methods Sixty-six Japan rabbits were made the model of the full-thickness articular cartilage defect (5 mm width and 4 mm depth).The autologous MSCs were extracted from the rabbit femur, cultured in vitro, labeledby Brdu, and injected into the injured articular cavity with or without SH. Theexperiment was divided into 4 groups; group A (MSCs and SH, n=15); group B (MSCs, n=15); group C (SH, n=18); and group D (non-treatment, n=18). The morphologic observation was made by HE staining, Mallory staining and immunohistochemical staining after 5 weeks, 8 weeks and 12 weeks of operation. Results There were significant differences in the thickness of repairing tissue between group A and group B(Plt;0.01); but there were no significant differences between group A and group C, and between group B and group D(P＞0.05). Thehistological observation showed that the main repairing tissue was fibrocartilage in group A and fiber tissue in group B. Conclusion MSCs cultured in vitro and injected into the articular cavity can not improve the treatment results of the articular cartilage defect. Extrogenous SH has effect on repairing cartilage defect. The extrogenous SH has no effect on the chemotaxis of the MSCs, and on the collection of MSCs into the joint defect.
OBJECTIVE To evaluate the clinical effect of sodium hyaluronate (SH) intra-articular injection in treatment of degenerative osteoarthritis (DOA) of knees. METHODS One hundred patients (116 knees) suffered from DOA were treated by SH injection intra-articularly once a week for three times. According to Lysholm scoring, clinical signs such as pain, swelling, excludes, range of movement (ROM), and the ability of walking, going upstairs and downstairs, squatting, running, were assessed before and after treatment. RESULTS Ninety-six cases were followed up for 1 to 6 months. There were obvious improvements in the signs and function of knee in 39 patients (40.6%), only some improvements in 48 patients (50.0%), and no obvious improvements in other 9 patients (9.4%). The total effectiveness rate was 74.0%. No toxic or side effect was observed. CONCLUSION Intraarticular injection of SH has a positive effect in relief of clinical symptoms and in improvement of articular function of DOA of knee.
OBJECTIVE To investigate the effects of intra-articular injection of sodium hyaluronate in post-operation treatment of the knee. METHODS From January 1998 to February 2001, 4 ml of sodium hyaluronate injection was injected into the knee joint of the 134 cases at the end of arthroscope operation, or the 91 cases undergoing open operation of the knee at the time when the drain tube was removed (treatment group). Five days after operation, the hydrarthrosis was removed and 2 ml of sodium hyaluronate was injected into the knee joint. According to the patient’s condition, injection of sodium hyaluronate was performed once a week for several weeks. Clinical evaluation was made by evaluating pain visual analog scale (VAS) and painless range of movement (ROM) of the joint at every definite point of time. The 85 patients in control group used nothing at the same time. RESULTS The VAS score of patients in the treatment group was significant lower than that of the control group. The period to the maximal painless ROM of the joint was 6 days in the treatment group after open operation, while 9 days in the control group. CONCLUSION Sodium hyaluronate appears effective in relieving post-operation pain of the knee joint.