自交联透明质酸钠凝胶预防中重度宫腔粘连分离手术后再粘连的前瞻性、随机、阴性对照临床研究

目的 评价自交联透明质酸钠凝胶预防中重度宫腔粘连分离手术后再粘连的有效性和安全性.方法 前瞻性、多中心、随机、阴性对照临床研究;对2011年11月至2012年11月中南大学湘雅三医院等医院符合入组标准的宫腔粘连患者,根据美国生育学会(AFS)宫腔粘连评分分级标准进行宫腔镜下的术前诊断分级,中重度宫腔粘连患者纳入本研究.随机入组120例患者(试验组和对照组各60例),对试验组患者在宫腔镜粘连分离术后应用Foley球囊导尿管结合自交联透明质酸钠凝胶防止术后再粘连;对照组患者在宫腔镜粘连分离术后只用Foley球囊导尿管防止术后再粘连.在术后3个月时进行第2次宫腔镜检查,再次对宫腔粘连进行分级.主要评价指标:术后3个月时防止宫腔粘连的有效率.次要评价指标:对宫腔粘连累及范围、粘连类型、月经模式的得分进行手术前后和组间比较.结果 完成本研究的患者共111例,其中试验组55例、对照组56例.试验组自交联透明质酸钠凝胶防止术后宫腔粘连的有效率(76％,42/55)明显高于对照组(48％,27/56),两组比较,差异有统计学意义(P=0.000 9).试验组应用自交联透明质酸钠凝胶显著减少了AFS总分,试验组为(2.1±1.1)分,对照组为(3.7±2.5)分,两组比较,差异有统计学意义(P=0.000 8);并对宫腔粘连累及范围得分[试验组(1.3±0.5)分,对照组(1.7±0.8)分]和月经模式得分[试验组(0.8±1.1)分,对照组(1.4±1.1)分]均有明显改善(P=0.037 8、0.0004).试验组应用自交联透明质酸钠凝胶减少了术后再粘连(中度和重度)的发生率,试验组术后3个月时中重度宫腔粘连的发生率为13％(7/55),而对照组为38％(21/56),两组比较,差异有统计学意义(P=0.000 6).未发生与材料相关的不良事件和并发症.结论 自交联透明质酸钠凝胶能够有效减少中重度宫腔粘连分离手术后的再粘连发生率并降低粘连严重程度,有利于改善患者的月经情况.     

止血凝胶封闭微创经皮肾通道的安全性及可行性研究

目的 研究止血凝胶封闭微创经皮肾通道的安全性及可行性.方法 采用MPCNL治疗的简单性肾结石及输尿管上段结石80例,对照组术后放置14 F肾造瘘管,实验组采用止血凝胶封闭微创经皮肾通道,不放置肾造瘘管,手术为单通道.统计学分析对照组与实验组术后患者疼痛需要应用镇痛药物的发病率和剂量、手术后患者血红蛋白下降情况、术后患者术后出现持续出血,感染及尿外渗等并发症发生情况以及手术后住院的时间.结果 两组患者均一期手术成功,对照组患者术后疼痛需要应用镇痛药物的发病率明显高于实验组(42.5％ vs 20％),而术后出现出血、感染等并发症的发病率以及手术后的住院时间,差异无统计学意义(P＞0.05).两组患者术后复查均未出现肾周围血肿,对照组患者出现7例拔出造瘘管后的漏尿.结论 止血凝胶封闭微创经皮肾通道的经皮肾碎石取石术降低了患者手术后的痛苦,避免手术后拔出肾造瘘管漏尿的发病率,对于简单的肾结石和输尿管结石患者是安全可靠的手术方式.     

Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?

Objectives

There is currently no information on whether products evaluated in HIV microbicide trials affect the detection of the semen biomarkers prostate-specific antigen (PSA) or Y chromosome DNA.

Study Design

We tested (in vitro) dilutions of tenofovir (TFV), UC781 and the hydroxyethylcellulose (HEC) placebo gels using the Abacus ABAcard and the quantitative (Abbott Architect total PSA) assays for PSA and Y chromosome DNA by real-time polymerase chain reaction.

Results

TFV gel and the HEC placebo adversely affected PSA detection using the ABAcard but not the Abbott Architect total PSA assay. UC781 adversely affected both the ABAcard and Abbott Architect total PSA assays. While there were some quantitative changes in the magnitude of the signal, none of the products affected positivity of the Y chromosome assay.

Conclusions

The presence of TFV or HEC gels did not affect quantitative PSA or Y chromosome detection in vitro. Confirmation of these findings is recommended using specimens obtained following use of these gels in vivo.

Implications

Researchers should consider the potential for specific microbicides or any products to affect the particular assay used for semen biomarker detection. The ABAcard assay for PSA detection should not be used with TFV UC781, or HEC.     

壳聚糖对甲硝唑凝胶体外促透作用研究

目的 考察壳聚糖(CS)对甲硝唑凝胶体外透皮速率的影响。方法 将1.0% CS作为吸收促进剂用于甲硝唑凝胶中,以泊洛沙姆p407为凝胶基质,以含2%氮酮的甲硝唑凝胶作为阳性对照,不含任何促渗剂的甲硝唑凝胶作为阴性对照,采用改良Franz扩散池进行大鼠体外皮肤渗透实验,反相高效液相色谱法（RP HPLC）法测定接受液中甲硝唑含量,计算累积透过量Q,得出Q t回归方程及稳态渗透速率J。结果 1.0%CS组和氮酮组J分别为2.841, 2.874 μg•（cm2） 1•h 1,两者差异无显著性(P＞0.05),而与阴性组相比均差异有显著性(均P＜0.05),其透皮吸收行为符合一级方程。结论 CS对甲硝唑凝胶的体外透皮吸收有较好的促进作用,值得进一步研究。     

青藤碱凝胶抗炎作用的研究

目的:研究青藤碱凝胶局部给药的抗炎作用。方法:考察青藤碱凝胶对大鼠角叉菜胶足跖肿胀作用,大鼠棉球肉芽肿作用,以及对佐剂性关节炎的预防和治疗作用。结果:青藤碱凝胶对急慢性炎症,大鼠佐剂关节炎的预防和治疗具有明显的作用。结论:青藤碱凝胶与口服给药同样具有抗炎作用。     

Swelling kinetics of poly(N-isopropylacrylamide) gel

In many gel applications the swelling and shrinking kinetics are very important, e.g. in controlled/slow release, where the kinetics determine the rate of out-diffusion of the active component, and in gel extraction where the gel is swollen and shrunk several times. In this study swelling kinetics of poly(N-isopropylacrylamide) gel (NiPAAm gel) was determined by monitoring the swelling process using a stereo microscope and a video camera. The swelling of spherical gel bodies could conveniently be studied after a temperature change. The results obtained were treated according to the approach of Tanaka and Fillmore, in which the swelling and shrinking of a gel is described as a motion of the gel network according to the diffusion equation. This was shown to be valid when the temperature changes are kept below the critical point of the gel. However, the model fails to describe the shrinking process when passing from below to above the critical temperature. The collective diffusion coefficient (D), defined as the osmotic bulk modulus divided by the friction factor, was determined by fitting to the experimental data. D was found to increase with temperature according to the Wilke–Chang relation D=2.0·10⁻¹¹ +7.6·10⁻¹⁷ ·T/μ. The results were used to simulate the swelling/shrinking process. The simulations show the importance of having sufficiently small gel bodies to achieve a short swelling time.     

优选精制蛇毒酶凝胶剂基质组成及制备工艺

目的室温条件下优选精制蛇毒酶凝胶剂基质组成及制备工艺。方法以凝胶剂的稳定性及外观性状为考察指标,以卡波姆-940、氮酮、丙三醇-丙二醇和吐温-80为可变因素,选用L9(34)表进行正交实验。结果最优的基质组成是:卡波姆-940 2.0g,氮酮1.0g,丙三醇-丙二醇为7g∶3g,吐温-80 1.5g。结论按该法制备的凝胶剂符合中国药典2005年版软膏剂的有关规定。     

眼用凝胶剂研究进展

凝胶剂因其优良的成型性、黏弹性、载药量、生物相容性好和眼部滞留时间长的优点,已广泛应用于眼部给药系统.根据国内外眼用凝胶剂的研究现状,本文简要综述了眼用凝胶剂的性质、分类、常用的聚合物及应用情况等.     

胶原蛋白凝胶体系中磷酸钙生成研究

目的：了解和认识生物矿化过程基质的作用。方法：在含磷酸钠并且ｐＨ为７．４的胶原蛋白凝胶上面复盖ＣａＣｌ＿２溶液，研究在界面附近凝胶中晶体生长。结果：在Ⅱ型胶原蛋白凝胶中磷酸钙成核受到抑制，并且生成以磷酸八钙为主的矿物相；Ｉ型胶原蛋白在矿化起始阶段具有富集Ｃａ￣（２＋）的能力，并可将磷酸八钙转化为羟基磷灰石。结论：Ｉ型胶原蛋白可调节磷酸钙矿化过程中的晶体生长。