宫内节育器、皮下避孕埋植剂及输卵管避孕材料特点及避孕效果分析

背景：使用安全、效率可靠、持久、无不良反应的避孕材料对生殖健康有重要意义。 目的：概述宫内节育器的进展其使用效果,分析皮下避孕埋植剂的优点、不良反应,以及输卵管避孕材料性质特点。 方法：分别以“宫内节育器,皮下避孕埋植剂,输卵管避孕,材料,避孕”为检索词,检索重庆维普(VIP)全文数据库1992-01/2011-01有关文章。根据纳入排除标准最终选入26篇进入结果分析。 结果与结论：自宫内节育器问世以来,在结构、性能、材料等方面均有不少改进和发展,是中国人使用的最多的一种避孕方法。皮下避孕埋植剂具有恒释性和缓释性、生物活性高、使用方便等优点。输卵管避孕栓具有定位准确、微小、无创、安全、可靠、可复的优点。但每种方法也都因存在或多或少的不良反应或并发症而不被接受。文章从上述3种节育方法的进展、使用效果、不良反应及材料性质特点进行了相关探讨。 关键词：宫内节育器;皮下避孕埋植剂;输卵管避孕;材料;节育,避孕 doi:10.3969/j.issn.1673-8225.2012.12.037     

形状记忆输卵管避孕材料与其他输卵管避孕材料的特点分析

背景：输卵管绝育器对女性生殖功能及内分泌平衡干扰少,方法简单有效。 目的：阐述形状记忆输卵管避孕材料与其他输卵管避孕材料的优点及不良反应。 方法：应用计算机检索1996至2013年万方医学网、中国知网、PubMed数据库有关形状记忆输卵管避孕材料与其他输卵管避孕材料的文章。 结果与结论：目前应用的输卵管避孕材料主要有记忆金属生物材料、非降解高分子生物材料及可降解高分子生物材料。形状记忆输卵管避孕器植入后,对输卵管上皮具有短期炎性刺激作用,但其对上皮输卵管黏膜层的影响是暂时的,随着植入时间延长,输卵管上皮炎性反应逐渐减退,其管壁的绒毛逐渐修复,表明输卵管再通具有可复性的组织基础。聚乙烯材料具有高抗冲性、耐磨性、优良的对化学药品稳定性、吸水性、电绝缘性、生物惰性等,现在几乎是所有宫内节育器的支架材料。硅橡胶耐热、耐寒、无毒、耐生物老化,具有化学稳定性、生理惰性、物理机械性能,植入人体组织后不会引起异物反应。聚乳酸具有较好的化学惰性、易加工性和的生物相容性,植入体内5 年后仍可能存在。     

国产皮下埋植剂埋植5年妇女血液流变学变化的观察

目的了解国产长效皮下埋植剂避孕妇女血液流变学的变化。方法对４６例国产皮下埋植避孕满５年的妇女进行血液流变学检测、结果发现４０Ｓ~(－１)全血粘度、血浆粘度（ηｐ）、还原粘度（ηｒ）、血球压积（ＨＣＴ）、血栓长度（Ｌ）等与对照组比较明显升高，有非常显著差异。结论应埋剂置入５年后可造成部分妇女血液流变学某些指标的升高。当皮埋剂取出一段时间后，这些改变可随外源性药物作用的消失而恢复。     

皮下埋植Norplant Ⅰ 型避孕药囊妇女的细胞遗传学研究

对２９例皮下埋植ＮｏｒｐｌａｎｔⅠ型避孕药囊（芬兰产）已４年的妇女和１９例未埋药的正常妇女的外周血淋巴细胞培养后进行了细胞遗传学分析。研究结果分析表明：埋药组染色体畸变率明显高于对照组染色体畸变率，且有统计学意义（Ｐ＜０．０１）；埋药组ＳＣＥ频率平均值高于对照组ＳＣＥ频率平均值，且有统计学意义（Ｐ＜０．０５）；埋药组细胞微核率平均值虽高于对照组细胞微核率平均值，但无统计学意义（Ｐ＞０．０５）。研究结果提示：应引起对于长期皮下埋植ＮｏｒｐｌａｎｔⅠ型是否存在致突变作用问题的重视和研究。     

皮下埋植避孕剂引起尺神经刺激的解剖学因素

目的:探讨皮埋剂引起尺神经刺激的解剖学因素,并提出预防措施。方法:解剖40侧上肢标本,观测尺神经的解剖特点。结果:尺神经在肘后内侧沟及其上方6.7±0.4cm 处位置较为表浅。结论:皮下埋植术操作不当,可能造成尺神经的机械性刺激。     

生物陶瓷宫内节育器的应用与安全性

BACKGROUND: Intrauterine device (IUD), widely used for contraception, achieves contraceptive effect by mechanical stimulation or chemical interference. Biological ceramics have been reported to have good performance and biocompatibility, but its effect used for IUD is rarely reported. OBJECTIVE: To explore the contraceptive effect of biological ceramic IUDS. METHODS: Totally 90 female rats were randomly divided into three groups (n=30 per group). The biological ceramic IUD and the bare copper IUD were respectively implanted into the middle of rat uterus, and blank control group received no intervention. One month later, according to the male and female ratio of 3:1, 30 male rats were selected to mate with female rats in the three groups. At 14 days after mating, 10 female rats were randomly selected from each group to detect the number of embryos in the implanted side and the number of pregnant rats, and the contraceptive rate was calculated. Ten rats among the remaining rats in each group underwent removal surgery of IUD, and mated with male rats again. After 60 days, the remaining rats were sacrificed to observe the morphology of liver, kidney and uterus. RESULTS AND CONCLUSION: The number of uterine embryos and pregnant rats in the groups of biological ceramic and bare copper IUD was significantly lower than that in the blank control group (P < 0.05), and the contraceptive rate reached 100% in the former two groups. The number of uterine embryos of implanted side and pregnant rats, and fertility recovery rate in the blank control and biological ceramic IUD groups were significantly higher than those in the bare copper IUD group (P < 0.05), but no significant differences were found between blank control and biological ceramic groups (P > 0.05). In the biological ceramic IUD group, there existed mild gland expansion, and visible some neutrophils both inside and outside the uterine cavity, but these phenomena were milder compared with the bare copper IUD group. No abnormal changes occurred in the rat kidney and liver. These results show that the biological ceramic IUD and bare copper IUD both can obtain the ideal contraceptive effect but make no damage to the rat kidney and liver. Especially, biological ceramic IUD holds better reversible recovery of fertility ability with less endometrial stimulation.     

聚乳酸基形状记忆输卵管避孕器的制备与应用安全性分析

BACKGROUND: Shape-memory polymer materials can be used as intrauterine device materials, which have certain shape changes under the influence of external temperature, and have good biodegradation, and are harmless to human body. OBJECTIVE: To prepare a poly(D,L-lactide)-based shape-memory intrauterine device and to analyze its application features. METHODS: Poly(D,L-lactide)-based shape-memory intrauterine device was prepared in this experiment. Sixty female New Zealand rabbits were randomly divided into two groups, with 30 rabbits in each group: experimental group were bilaterally implanted poly(D,L-lactide)-based shape-memory intrauterine device, and control group had no intrauterine device. Gross observation, blood test and histological examination were conducted at different time after implantation. RESULTS AND CONCLUSION: After 4 weeks of implantation, the intrauterine device was smooth and thickened and shortened compared with before implantation; after 6 weeks of implantation, the device became thinned and further shortened and even disappeared partially. No significant difference was found in the leukocyte, erythrocyte, hemoglobin, platelet, creatinine and urea levels between the two groups at 6 weeks after implantation. In the experimental group, obvious edema and hyperemia in the tubal mucosa were visible at 4 weeks after implantation, and a very small amount of infiltrated lymphocytes were present at 6 weeks after implantation, and edema and hyperemia were improved significantly. These findings indicate that after implantation, the poly(D,L-lactide)-based shape-memory intrauterine device can deform and degrade, and result in a certain pressure on the oviduct wall, but has no cell toxicity and possesses good application security. 中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程     

不同类型脑血管支架材料的特点及临床应用

背景：随着基础研究、临床应用,以及血管支架材料的不断发展,血管内支架置入治疗已被广泛应用于脑血管疾病治疗中。 目的：综述这几种支架材料的特点及临床应用情况。 方法：应用计算机检索CNKI数据库、万方数据库、PubMed数据库从建库到2014年3月的相关文献,中文检索关键词为“脑血管病,支架,生物相容性”,英文检索关键词为“cerebrovascular disease,stents,biocompatibility”。 结果与结论：按释放方式可将脑血管支架分为球囊扩张式支架与自膨式支架。最初应用的支架材料主要为裸金属材料,由记忆合金、医用不锈钢、钽、钴、镍钛合金等制成。由于金属支架置入后会释放金属离子,易致血栓形成,再狭窄率高,后来对其表面进行改性,出现了涂层支架与覆膜支架。支架置入治疗的围手术期并发症主要有过度灌注综合征、急性血栓形成、血管破裂和远端血管栓塞、血管痉挛和穿刺相关并发症,远期并发症主要是支架置入后再狭窄问题。相信随着科技的进步,支架材料和制作工艺的不断改进,血管支架置入治疗将更加安全有效。中国组织工程研究杂志出版内容重点：生物材料;骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性;组织工程全文链接：     

米非司酮对皮下埋植后子宫内膜雌、孕激素受体含量的影响

皮下埋置避孕剂是置于皮下硅胶管中左炔诺孕酮通过低剂量恒定释放至血液，发挥长效避孕作用的埋植剂。因其应用方便、长效、安全、可逆和无雌激素副作用，而具有良好的应用前景。由于其干扰正常月经周期，引起不规则子宫出血，成为终止使用的主要原因。米非司酮防治皮下埋植避孕后异常出血具有明显的疗效，能够减少出血／滴血天数，我们研究米非司酮对皮下埋植避孕者子宫内膜形态学与雌、孕激素受体的影响，探讨米非司酮的作用机理。     

铜/低密度聚乙烯复合材料宫内节育器引起子宫异常出血与铜离子浓度和血管生成的相关性

BACKGROUND: To achieve excellent contraceptive effects, the copper wire on the copper-containing intrauterine device surface persistently releases copper ions, but ectopic intrauterine device, abnormal uterine bleeding, menostaxis and waist and abdominal pain are usually inevitable. OBJECTIVE: To investigate the correlation of abnormal uterine bleeding caused by copper/low-density polyethylene nanocomposite intrauterine device with copper ion concentration and expression of vascular endothelial growth factor in endometrial tissues. METHODS: Totally 60 female patients, aged from 25 to 40 years old, hospitalized for taking intrauterine devices were enrolled, and those patients were divided into abnormal uterine bleeding group (n=32) and non- bleeding group (n=28). In the meanwhile, another 20 women without intrauterine devices and with the normal menstrual cycle were selected as control group. Patients in the abnormal uterine bleeding group and non- bleeding group underwent the removal of intrauterine device and scraping endometrial tissues within 4-7 days after menstruation; patients in the control group underwent scraping endometrial tissues within 4-7 days after menstruation. The copper ion content in endometrial tissues was measured by atomic absorption method; expression of endometrial vascular endothelial growth factor detected by immunohistochemical staining and the microvessel density counted. Additionally, the corrosion ratio of copper ion in the simulated uterine fluid was detected using flame atomic absorption spectroscopy method. RESULTS AND CONCLUSION: The content and corrosion ratio of copper ion in the uterine abnormal bleeding group was significantly higher than those in the non-bleeding group (P < 0.05), and the copper ion content of no bleeding group was significantly higher than that of control group (P < 0.05). The amount of copper in the intrauterine device of abnormal uterine bleeding group was higher than that in non-bleeding group (P < 0.05). Compared with the control and non-bleeding groups, the vascular endothelial growth factor expression and microvessel density were significantly increased in the uterine abnormal bleeding group (P < 0.05); and the control group and non-bleeding group had no significant differences in the vascular endothelial growth factor expression and microvessel density. Furthermore, there was a positive correlation of the vascular endothelial growth factor expression with microvessel density and copper ion content. In conclusion, after implantation of copper/low-density polyethylene   nanocomposites intrauterine device, the higher copper ion concentration in endometrial tissues may lead to the over-expression of vascular endothelial growth factor that increases the endometrial microvessel density through a variety of ways, and promote microvessel expansion and congestion, finally resulting in abnormal uterine bleeding.     

Efficiency and acceptability of intrauterine contraceptive devices

The efficacy and side effects of 6 different IUDs used by 790 women during 22826 menstrual cycles is reported. The conclusion is that modern IUDs have a negligible effect on the health of users if properly followed by regular checkups.     

Instrumentation for preparation and placement of subcutaneous implants

An instrument has been designed for the preparation and placement of subcutaneous implants in small laboratory animals. The usefulness and applications of the instrument have been assessed, based on experiences from 260 implants inserted subcutaneously on guinea pigs with the aid of the described instrument.     

Stress distributions in maxillary central incisors restored with various types of post materials and designs

Different dental post designs and materials affect the stability of restoration of a tooth. This study aimed to analyse and compare the stability of two shapes of dental posts (parallel-sided and tapered) made of five different materials (titanium, zirconia, carbon fibre and glass fibre) by investigating their stress transfer through the finite element (FE) method. Ten three-dimensional (3D) FE models of a maxillary central incisor restored with two different designs and five different materials were constructed. An oblique loading of 100 N was applied to each 3D model. Analyses along the centre of the post, the crown-cement/core and the post-cement/dentine interfaces were computed, and the means were calculated. One-way ANOVAs followed by post hoc tests were used to evaluate the effectiveness of the post materials and designs (p = 0.05). For post designs, the tapered posts introduced significantly higher stress compared with the parallel-sided post (p < 0.05), especially along the centre of the post. Of the materials, the highest level of stress was found for stainless steel, followed by zirconia, titanium, glass fibre and carbon fibre posts (p < 0.05). The carbon and glass fibre posts reduced the stress distribution at the middle and apical part of the posts compared with the stainless steel, zirconia and titanium posts. The opposite results were observed at the crown-cement/core interface.     

Scanning electron microscopy, x-ray diffraction, and electron microprobe analysis of calcific deposits on intrauterine contraceptive devices

Deposits found intrauterine contraceptive devices (IUDs) were studied by scanning electron microscopy, x-ray diffraction, and energy dispersive x-ray microanalysis. All seven devices, including five plastic and two copper IUDs, were coated with a crust containing cellular, acellular, and fibrillar material. The cellular material was composed of erythrocytes, leukocytes, cells of epithelial origin, sperm, and bacteria. Some of the bacteria were filamentous, with acute-angle branching. The fibrillar material appeared to be fibrin. Most of the acellular material was amorphous; calcite was identified by x-ray diffraction, and x-ray microanalysis showed only calcium. Some of the acellular material, particularly that on the IUD side of the crust, was organized in spherulitic crystals and was identified as calcium phosphate by x-ray microanalysis. The crust was joined to the IUD surface by a layer of fibrillar and amorphous material. It is suggested that the initial event in the formation of calcific deposits on IUD surfaces is the deposition of an amorphous and fibrillar layer. Various types of cells present in the endometrial environment adhere to this layer and then calcify. Thus, the deposition of calcific material on the IUDs is a calcification phenomenon, not unlike the formation of plaque on teeth. Hum Pathol 16:732-738, 1985.     

Safety and cleaning of medical materials and devices

A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medical devices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medical devices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough cleaning procedure should precede sterilization or disinfection (with the exception of NaOCl bleach which also cleans).     

Intra-uterine contraception with a new antigon model, and investigation of the mechanism of action of intra-uterine devices

Based on a review of the literature, it was hypothesized that an IUD's effect is local and increases with the size of the area covered by the IUD. This hypothesis was tested by comparing clinical material on the plain Antigon IUD with the newly designed Antigon winged model; the newer design increases the contact area by 50%. Data for 1151 patients over 18,599 woman-months of observation were collected from 2 hospitals in Denmark and 1 in Sweden. Average age ranged from 27.1-29.2 years, with average parity ranging from 2.2-2.9. There were 6.8% pregnancies and expulsions, 10.1% removals, and an 80.3% acceptability rate. Because the pregnancy rate has been halved with the Antigon winged model, it is thought that an IUD effects the local obstruction of blastocyst nidation.     

Statistical design of unicompartmental tibial implants and comparison with current devices

This study defines, in the context of unicompartmental tibial replacement, the medial and lateral resection surfaces of 34 tibiae at a depth of 5 mm below the articular surface. Using statistical techniques, three optimal theoretical size and shape unicompartmental tibial designs, (i) implants of consistent shape in varying size (ii) implants symmetric about their ML axis; (iii) implants of varying size and shape, were constructed to best fit the population. Two currently available commercial implants, the Preservation Uni System (DePuy Orthopaedics Inc., Warsaw, IN) and the LCS Uni System (DePuy Orthopaedics Inc., Warsaw, IN), which were similar to types (i) and (ii) respectively, of the theoretical designs, were also included in the analysis. All implants, commercial and theoretical, were compared with one another to determine which implant designs gave the best cortical bone coverage on both the medial and lateral compartments. Of the commercial implants, the type (i) design fitted best, with an average of 67% of the implant edge lying on cortical bone, compared with 57% for the type (ii) implants. Of the theoretical implants, 72%, 67% and 76% of the implant edge lay on cortical bone for types (i), (ii) and (iii) designs, respectively, indicating that there is room for improvement in current implant designs to achieve better coverage in both the medial and lateral compartments combined.