Objective To compare product standards of drug and medical device made from sodium alginate and calcium alginate between domestic and abroad, and to emphases on the process parameters monitoring based on different standards. Methods Sodium alginate and calcium alginate standards of both domestic and foreign were analyzed and summarized, and the differences and commonalities of various product standards among each standard were compared. Results Differences exist in product standards of sodium alginate and calcium alginate between domestic and abroad, whether drug or medical device, but the fundamental control points are concordant. Conclusion Companies should focus on product quality control requirements combined with its own unique manufacturing process characteristics to develop reasonable and controllable quality standards, which can ensure safe and effective clinical use.
Objective To review the research progress of the risk factors for slip progression and the pathogenesis of lumbosacral spondylolisthesis, and to discuss the value of Spinal Deformity Study Group (SDSG) classification system for lumbosacral spondylolisthesis. Methods Recent articles about the risk factors for slip progression and the pathogenesis of lumbosacral spondylolisthesis were reviewed and comprehensively analyzed with SDSG classification system of lumbosacral spondylolisthesis. Results Pelvic incidence (PI) is the key pathogenic factor of lumbosacral spondylolisthesis. The Meyerding grade of slip, PI, sacro-pelvic balance, and spino-pelvic balance not only are the fundamental risk factors of slip progression, but also are the key factors to determine how to treat and influence the prognosis. Therefore, compared with Wiltse, Marchetti-Bartolozzi, and Mac-Thiong-Labelle classification systems of lumbosacral spondylolisthesis, SDSG classification based on these factors mentioned above, has better homogeneity between the subjects of subgroup, and better reliability, moreover, could better guide operative plan and judge the prognosis. Conclusion It is suggested that the SDSG classification system should be the standard classification for lumbosacral spondylolisthesis for the clinical and research work.
Objective To summarize the injury characteristics of the whole hand degloving injury and to explore its classification and treatment. Methods Between December 1999 and May 2010, 41 cases of the whole hand degloving injury were admitted for treatment. There were 28 males and 13 females with an average age of 35 years (range, 18-58 years). The causesof injury included mangled injury in 28 cases and crush injury in 13 cases. The interval between injury and surgery was 1-10 hours (mean, 3 hours). According to self-made classification standard for whole hand degloving injury, 11 cases were rated as type I, 5 cases as type II, 4 cases as type III, 8 cases as type IV, and 13 cases as type V. Type I injury was treated by replantation surgery with vascular anastomosis, type II by reconstruction with thumb flap and the second toe containing dorsal skin flap, type III by reconstruction with the second toe containing dorsal skin flap of both feet, type IV by replantation surgery with vascular anastomosis, and type V by reconstruction with thumb flap containing dorsal skin flap (8 cases) or repairing with abdominal flap (5 cases). The size of the dorsal flap was between 9 cm × 6 cm and 17 cm × 11 cm and the dorsal donor site was covered with free skin grafting. Results After surgery, partial necrosis occurred at fingers in 6 patients with type I injury, and at fingers and palm skin in 6 patients with type IV injury; the flaps, the reconstructed fingers, and replanted skin all survived in the others. The grafted skin at donor sites successfully healed. Forty cases were followed up from 6 months to 7 years (mean, 14 months). The skin color and texture were close to normal hand in the cases undergoing replantation, who had the best function restoration with S2-S4 sensory recovery; the hand function was basically restored with S2-S3 sensory recovery in the cases undergoing finger reconstruction with thumb and toe flaps; and the restoration of the hand function was not satisfactory with S1-S2 sensory recovery in the cases undergoing abdominal flaps. Conclusion Whole hand degloving injury can be classified into different types according to injury degree and this will help choose the cl inical treatment plan. The appropriate treatment based on these types can obtain better cl inical effectiveness.
Objective To introduce the research progress in the immune of composite tissue allotransplantation. Methods The related articles were reviewed to summarize the immune characteristics, experimental developments, and cl inical experiences of composite tissue allotransplantation. Results Composite allogeneic tissue is on the body surface, including the composition of the complex with high antigenicity. There are a lot of differences in the immune responsesbetween composite tissue allotransplantation and organ transplantation, such as immunosuppressant protocol, rejectiondiagnosis, and chronic rejection. Conclusion In the next study, it is urgently needed to learn these experiences and toestabl ish the special standard of composite tissue allotransplantation in induction of immune tolerance, local medication, and rejection diagnosis.
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 USA government’s administrative system about medical device standards as well as the standard making. Methods The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. Results The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. Conclusion The USA’s administrative system about medical device standards as well as many standards can be referenced.
Fullfield electroretinalgraphy (ffERG) is an indispensablemeans in assessment of retinal disease; it is invasive, effective, objective, quantifiable, and reproducible. Currently ffERG has been extensively applied domestically, but it also has disadvantages such as too few detected diseases, nonstandardised methodology, and inaccurate description of the results. It is important to place more emphasis on the internationalization, standardisation, and normalization of the application; obtaining the differences of indication, detection techiniques, and description of the results among ffERG, multifocal ERG and pattern ERG; expanding the new fields and methods of clinical applications. So that ffERG could play an more important role in the diagnosis and management for the patients with retinal disease.
Objective To verify the effects of the treatment of krypton yellow laser for diabetic macular edema.Methods A total of 430 eyes in 251 cases of diabetic focal macular edema, diffuse edema and cystoid edema were treated with krypton yellow laser photocoagulation. Those with focal macular edema underwent the focal photocoagulation, and those with diffuse edema and cystoid edema underwent the grid photocoagulation.The visual acuity examination, fundus fluoresec in angiography and colour photography of the fundus were performed before and every 3 or 4 months after the treatment.The changes of macular edema after the treatment were analysed.The follow-up duration was 3 to 23 months (with an average of 15.5 months). Results After laser focal photocoagulation in 186 eyes with focal macular edema, visual acuity was improved or maintained in 183 eyes (98.39% ). Edema disappeared completely or partially in 184 eyes (98.93%). After laser grid photocoagulation in 175 eyes with diffuse macular edema, visual acuity was improved or maintained in 163 eyes (93.14%). Edema disappeared completely or partially in 164 eyes (93.71%). After laser grid photocoagulation in 69 eyes with cystoid macular edema, visual acuity was improved or maintained in 59 eyes (85.5% ). Edema disappeared completely or partially in 64 eyes (92.75%).Conclusion The linchpin of the treatment of krypton yellow laser for diabetic macular edema lies in the insurance of the effective laser macules and the adaptability of selecting the proper parameter of laser according to the degree and scope of the macular edema and the visual acuity. (Chin J Ocul Fundus Dis，2003，19：14-17)
Objective To investigate the clinical characteristics of prepapillary and preretinal vascular loops. Methods The clinical manifestation, results of the fundus fluorescein angiography, and the prognosis of 20 cases(24 eyes) with prepapillary and preretinal vascual loops were analyzed retrospectively. Results 66.7% of prepapillary and preretinal vascular loops were involved in one eye, and 95.8% of vascular loops were located within one optic disc diameter. There were different configuration types of the vascular loops. Among 20 cases(24 eyes) of the vascular loops, 70.8%(17 eyes) were arterial, 12.5%(3 eyes) were venous, and 16.7%(4 eyes) were both arterial and venous. 62.5% of eyes with prepapillary and preretinal vascular loops were associated with other congenital and developmental anomalies of retinal vascular vessels. Conclusion Most PRVL are arterial and superior to the optic disc. The serious distortion of the vascular loops may result in disturbance of blood flow in artery and retinal hemorrhage, which cause visual loss. (Chin J Ocul Fundus Dis, 1999, 15: 9-11)
Purpose To investigate the blood dynamic feature of choroid in normal eyes. Methods Indocyanine green angiography (ICGA) was performed in each of fifty consecutive normal eyes. Results The earliest fundus fluorescence emerged at the mean timiest fundus fluorescence emerged at the mean time of (14.25plusmn;3.59) seconds,it represented the beginning of filling of choroidal arteries located at the posterior pole.The irrigation of choroidal veins appeared at the mean time of (15.03plusmn;3.44) seconds.At the time threre was the overlapping imaging appearance of choroisal arteries and veins.The most hyperfluorescent areas appered at the mean time of(16.75plusmn;3.78) seconds with definite shapes located at the posterior pole,and this stood for the fluorescence stage of choroidal arteries,veins and capillaries.The fluorescence of choroidal vein began to weaken at 11prime;58Prime;15plusmn;2prime;39Prime;86,and revealed the imaging of late stage of choroidal veins.The latest stage of ICGA was at 22prime;13Prime;22plusmn;3prime;30Prime;55,and presented obscure fluorescence. Conclusion The measurement results and fluorescent features of ICGA of normal eyes can offer consulted bases for the clinical diagnosis of the choroidal diseases. (Chin J Ocul Fundus Dis,1998,14:68-71)