BIOEQUIVALENCE BETWEEN rhGH FOR RECONSTITUTION AND READY-TO-USE rhGH IN TWO LIQUID FORMULATIONS

Objective To evaluate the bioequivalence between recombinant human growth hormone （rhGH） for reconstitution, and two dosages of liquid formulation of rhGH [ （151U） 5mg or （301U） lOmg per 3ml ]. Methods The study drugs were tested in a randomized, single-blind and three-period crossover studies in 24 healthy male subjects. The three drugs were administered by subcutaneous injection at a dose of O. 21U/kg body weight. A continuous somatostatin infusion was given in order to suppress the secretion of endogenous GH. The ve- nous blood samples were drawn at different time points to test the serum concentration of GH. The pharmacokinetic parameters were analyzed by statistical methods. Results 90% confidence intervals （CI） of AUC0-24h among three products were all within 80% - 125% interval （ 103. 4% - 116. 5%, 105. 7% - 119. 6% and 91.9% - 103. 7%, respectively）, and the Cls of C,~ among three products were all within 70% - 143% interval （91.9% - 114. 0%, 103. 7% -127. 2% and 81.6% -97. 4%, respectively）. There was no statisitical difference of tmax among all the three products. Conclusion These data demonstrate that there is bioequivalence between rhGH for reconstitution and two liquid formulations of rhGH.     

Developmental changes of glutamate acid decarboxylase 67 in mouse brain after hypoxia ischemia

Objective To study the developmental changes of glutamic acid decarboxylase-67 (GAD-67, a GABA synthetic enzyme) in normal and hypoxic ischemic (HI) brain. Methods C57/BL6 mice on postnatal day (P) 5, 9, 21 and 60, corresponding developmentally to premature, term, juvenile and adult human brain were investigated by using both Western blot and immunohistochemistry methods either in normal condition or after hypoxic ischemic insult. Results The immunoreactivity of GAD67 was up regulated with brain development and significant difference was seen between mature (P21, P60) and immature (P5, P9) brain. GAD67 immunoreactivity decreased in the ipsilateral hemisphere in all the ages after hypoxia ischemia (HI) insult, but, significant decrease was only seen in the immature brain. Double labeling of GAD67 and cell death marker, TUNEL, in the cortex at 8h post-HI in the P9 mice showed that (15.6±7.0)% TUNEL positive cells were GAD67 positive which was higher than that of P60 mice. Conclusion These data suggest that GABAergic neurons in immature brain were more vulnerable to HI insult than that of mature brain.     

重组2型腺相关病毒-转化生长因子β3对实验性肝纤维化大鼠肝脏组织病理学和Ⅰ型胶原表达的影响

Objective To investgate the effects of TGF β 3 on rat hepatic fibrosis. Methods The TGF β 3 cDNA was cloned into rAAV2 vector. Rats were randomly divided into four groups: normal control group, model group, negative control group and TGF β 3 group. Hepatic fibrosis was induced by hypodermic injection of 40% CCI4. Recombinant AAV2-TGF β 3 viral particles were injected via the vena caudalis one week before CCh treatment. Rats were executed 8 weeks after CCI4 treatment, global histological change was observed after HE staining, the distribution of the collagen fibers was observed after masson staining, his-tochemistry was done to observe the expression of collagen Ⅰ; The positive area rate of the collagen fibers and the average optical rate of collagen Ⅰ were quantified. Results HE staining indicated that collagen fibers were reduced in the TGF β 3 group. Masson staining shown that the collagen fibers were distributed around the blood vessel, in the portal area and disse space. Compared to the model group (13.2%±2.2%) and negative control group (12.3%±1.5%), the collagen fibers in liver tissues of TGF β3 group (7.7% ± 1.5%) were significantly decreased (q = 9.456, P < 0.01; q = 8.217, P < 0.01). Histochemistry indicated that the collagen fibers of liver tissues of TGF 15 3 group (0.185±0.033) were significantly higher than those in the model group (0.252±0.042) and the negative control group (0.230±0.029), (q = 6.228, P < 0.01; q = 4.346, P < 0.01). Conclusion TGF β 3 alleviates the damage to hepatic cell and the level offibrosis in CCI4 treated rats and inhibits the expression of collagen Ⅰ.     

Feasibility of cranio-spinal axis radiation with the Hi-Art tomotherapy system.

BACKGROUND AND PURPOSE: Helical tomotherapy can eliminate the need for junction lines. The goal of this study is to evaluate tomotherapy in the delivery of CSA radiation and measurement of plan quality using physical parameters in comparing conventional (CSA-RT) and helical tomotherapy (CSA-TOMO) plans. PATIENTS AND METHODS: CSA-TOMO and CSA-RT plans were created for dosimetric comparison. Integral dose values were calculated. The ratios D50% (dose received by 50% of the organ at risk's volume) and D10% (dose received by 10% of the organ at risk's volume) were calculated representing large volumes and small volumes of organs at risk receiving significant dose. RESULTS: When considering D50% and D10%, CSA-TOMO has a dosimetric advantage over CSA-RT for most organs at risk. The body integral dose was higher for the CSA-TOMO plan by approximately 6.5%. CONCLUSIONS: Tomotherapy is a feasible alternative for treatment of CSA. Analysis shows that tomotherapy improves dose ratios over conventional radiation for most organs at risk. The impact of a small increase in whole body integral dose is unknown. Long-term follow-up will be needed to answer this question as others have argued of the possibility of increased risk of secondary malignancies due to delivery of radiotherapy with IMRT.     

联合应用口服水剂和水灌肠肠道充盈法的MSCT研究

目的：评价口服水剂、水灌肠及两者联合应用充盈肠道后,使用MSCT显示成人正常肠道的能力。材料和方法：将43名非肠道病变志愿者分别采用口服水剂法(21例)、水灌肠法(12例)、双重法(口服水剂和水灌肠联合应用,10例)充盈肠道,然后行MSCT平扫和增强扫描并进行图像重建,对小肠和大肠各肠段充盈状态进行评价。结果：口服水剂法回肠充盈良好,水灌肠法大肠充盈良好,双重法回肠及大肠均充盈良好。口服水剂法小肠充盈优于水灌肠法,与双重法无显著差异,大肠充盈状态水灌肠法明显优于口服水剂法,与双重法无显著差异。结论：口服水剂和水灌肠联合应用可以在MSCT同时较好地充盈显示小肠和大肠,而两种方法单独使用则仅能分别充盈显示小肠和大肠,需要根据显示目的选择相应的充盈方法。     

南京市婚检的现状与对策

介绍了2002～2005年间南京市的婚检情况。新的《婚姻登记条例》实施后婚检人数急剧下降,未能通过婚检检出的一些疾病导致了妊娠合并症、新生儿缺陷和新生儿疾病发生数明显上升;提出当前开展婚前卫生保健工作有着积极的现实意义和深远的历史意义。南京市妇幼保健院为提高人口素质积极开展婚前卫生保健工作,并取得一定成效。     

内膜下血管成形术治疗下肢动脉硬化闭塞症的新进展

内膜下血管成形术是治疗下肢动脉硬化闭塞症的主要方法之一，本文详细叙述了近年来内膜下血管成形术的新发展，包括适应证的拓展，各项操作新技术的进展，在小腿动脉中的应用及并发症的正确处理。为今后此技术更加广泛地应用提供了思路。     

应力性骨折影像学诊断

应力性骨折(stress fracture)为一组骨骼损伤性疾病,可发生于所有年龄段.本病常见,常具有特殊的发病部位,并与活动有关,但多无明显外伤史.本文阐述应力性骨折的病因、发病机制、临床表现、影像学表现及鉴别诊断.     

阿奇霉素替代激素治疗婴幼儿喘息性支气管炎临床研究

目的评价阿奇霉素治疗婴幼儿喘息性支气管炎的疗效并探讨其作用机制。方法婴幼儿喘息性支气管炎60例,随机分为2组,各30例,A组用阿奇霉素治疗,B组用地塞米松治疗,分别观察3d后的临床疗效;2组均测定其外周血清IL-4,IFN-γ浓度变化,并与15例健康婴幼儿（对照组）血清IL-4,IFN-γ浓度对比。结果A组与B组临床总有效率差异无统计学意义;整个喘息性支气管炎组与正常对照组相比IFN-γ和IL-4值差异均有统计学意义,IFN-γ下降,IL-4升高;各组治疗前与治疗后相比差异均有统计学意义,A组治疗后血清IFN-γ浓度增高、IL-4浓度下降;B组治疗后血清IFN-γ浓度下降、IL-4浓度也下降,且2组IFN-γ/IL-4值均显著升高。结论阿奇霉素治疗婴幼儿喘息性支气管炎有较好的疗效,能与地塞米松有同样的调节TH1及TH2细胞因子使之趋于平衡,并且有更好的促进细胞免疫作用。