Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer.

PURPOSE: Docetaxel, a taxane previously approved for the treatment of breast cancer and non-small cell lung cancer, was approved by the United States Food and Drug Administration on May 19, 2004 for use in combination with prednisone for the treatment of metastatic androgen-independent (hormone-refractory) prostate cancer. The purpose of this summary is to review the database supporting this approval. EXPERIMENTAL DESIGN: In a randomized, global study enrolling 1,006 patients, two schedules of docetaxel were compared with mitoxantrone + prednisone as follows: MTZ q 3w, mitoxantrone 12 mg/m2 every 21 days + prednisone 5 mg twice a day for a total of 10 cycles; TXT q 3w, docetaxel 75 mg/m2 every 21 days + prednisone 5 mg twice a day for a total of 10 cycles; and TXT qw, docetaxel 30 mg/m2 days 1, 8, 15, 22, and 29 every 6 weeks + prednisone 5 mg twice a day for a total of 5 cycles. RESULTS: There was a statistically significant overall survival advantage shown for the TXT q 3w arm over MTZ q 3w (median survival 18.9 months versus 16.5 months, P = 0.0094). No overall survival advantage was shown for TXT qw compared with MTZ q 3w. The most commonly occurring adverse events included anemia, neutropenia, infection, nausea, sensory neuropathy, fluid retention, alopecia, nail changes, diarrhea, and fatigue. CONCLUSIONS: This report describes the Food and Drug Administration review supporting this first approval of a combination therapy for hormone-refractory prostate cancer based on demonstration of a survival benefit.     

EXPRESSION OF p16,CYCLIN D1 AND RB PROTEIN IN GASTRIC CARCINOMA AND PREMALIGNANT LESIONS

Gastric carcinoma is one of the most serious diseases in mankind. Its pathogenesis has not been understood very clearly. Recent researches suggested that oncogenes (such as cyclin D1), antioncogenes (ie., p16, Rb) and cell cycle played an important role in the pathogenesis of gastric carcinoma. But there are few reports about the relationship between these genes in gastric carcinoma and gastric premalignant lesions. In this study, we will discuss these problems. MATERIALS AND METHO…     

白细胞介素6和肿瘤坏死因子—α在分泌性中耳炎渗出液中表达及…

Using enzyme-linked immunosorbant assay (ELISA), we measured levels of interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in middle ear effusions (MEE) from patients with secretory otitis media (SOM) undergoing auripuncture to study the role of cytokines in the pathogenesis of the disease. Significant levels of IL-6 (> 62.5 ng/L) were found in 19 (86.36%) of 22 MEEs and those of TNF-alpha (> 37.5 ng/L) in 19 (70.37%) of 27 MEEs. The mean (+/- s) levels of IL-6 and TNF-alpha were 507.68 +/- 813.11 ng/L and 186.86 +/- 166.93 ng/L, respectively. It revealed that the shorter the course, the higher the concentration of IL-6 in MEE: the longer the course, the higher the concentration of TNF-alpha in MEE. These findings suggested that during the early stages of SOM, IL-6 might participate in the defensive reaction of organism, while TNF-alpha might be closely related to the persistence of SOM, resulting in an excessive inflammatory reaction with a potential for pathological changes. It is concluded that the immunological mechanisms probably play a significant role in the pathogenesis of SOM.     

尼尔雌醇作用下去势雌兔骨组织形态计量学改变

目的：评估尼尔雌醇对绝经后骨质疏松症的疗效，并探讨其机理。方法：将３０只雌性新西兰兔随机分成３组（每组１０只）：治疗组［摘除卵巢＋尼尔雌醇（每月２ｍｇ）］、模型组（摘除卵巢）和正常对照组（假手术），６个月后处死取材，并在处死前行四环素标记，ＶＩＤＡＳ图象分析系统下作骨组织形态计量学测定。结果：治疗组的单位体积骨小梁骨量（ＢＶ／ＴＶ）、相对类骨质量（ＯＶ／ＢＶ）、成骨细胞指数（ＯＢＩ）和组织水平的骨形成速率［ＢＦＲ（Ｔ）］明显高于模型组和（或）正常对照组。结论：尼尔雌醇能增加成骨细胞数量，可能是一种成骨细胞募集和（或）增殖的刺激剂。     

中药“二黄”滴耳剂治疗急慢性化脓性中耳炎的临床观察(附1000例分析)

本文总结了“二黄”滴耳剂治疗急慢性中耳炎1000例，结果表明总有效率为89％，尤其对急性化脓性中耳炎效果更为明显，与其它抗生素相比具有很多优点。抗菌谱广，对革兰氏阳性菌及革兰氏阴性菌、病毒都有一定作用，低浓度抑菌，高浓度杀菌，不易产生抗药性及过敏反应，对第八对脑神经无毒性，价格低廉应用方便优于任何一种抗生素。     

再次尿道成形术治疗先天性尿道下裂术后严重并发症

目的：了解先天性尿道下裂行各种尿道成形术失败后，利用膀胱粘膜行尿道成形术的疗效。方法：将严重狭窄和（或）无法修补的尿瘘瘢痕组织彻底切除，取膀胱粘膜片形成尿道，正位开口于龟头，新尿道内置多孔硅胶支架管作引流。结果：２８例中，２３例治愈，３例有小尿瘘需作尿瘘修补，２例完全失败，再次作粘膜尿道成形术治愈。结论：各种类型先天性尿道下裂尿道成形失败后，可用膀胱粘膜移植尿道成形，效果良好     

双特异性抗体治疗肿瘤的可行性研究

肽图分析是验证rhIL-2的重要手段之一.rhIL-2具有133个氨基酸,在其一级结构的序列中有四个甲硫氨酸切点,可用化学裂解的方法将甲硫氨酸肽键打开,进行肽谱分析,以对其进行验证.为了有效地对甲硫氨酸进行裂解,我们用70%甲酸溶解CNBr~2,保持CNBr的高浓度小体积,使rhIL-2在1.5mlEppedorf管中,室温条件下有效地打开甲硫氨酸肽键.同时比较了CNBr浓度、裂解时间以及在不同浓度的梯度胶中作SDS-PAGE对实验结果的影响,确定了最佳的实验条件,获得了良好的实验结果.本文虽以rhIL-2为例,但对所有带甲硫氨酸的细胞因子均可用本方法进行肽图分析.     

钢基Cu-5%Al激光熔覆层颗粒组织分布的定量分析

熔覆层中的颗粒相分布不仅影响材料性能，同时也是研究熔覆过程各种反应机制的主要依据。本文利用图像分析技术，定量分析了Ｑ２３５钢表面Ｃｕ５％Ａｌ激光熔覆层的富铁相颗粒分布情况。发现熔覆过程中在熔池中存在熔体对流环，熔池中的对流带动颗粒运动，是决定熔覆层颗粒分布的主要因素。     

金属支架联合立体定向适形放疗治疗肝门部胆管癌

目的评价金属支架联合立体定向适形放疗肝门部胆管癌的疗效。方法31例肝门部胆管癌患者行金属支架置入联合立体定向适形放疗,并与23例行单纯支架治疗者进行对比研究。结果联合治疗组生存时间平均为11.1个月;对照组为5.1个月,差异有显著性意义(P<0.01)。结论胆道金属支架置入联合立体定向适形放疗是不能手术肝门部胆管癌的一种有效治疗方法。     

针刺取穴与骨折愈合疗效关系初探

目的:初步探讨针刺取穴与骨折愈合疗效的关系,为临床研究和应用提供参考,方法选用48只体重2.0～2.5 kg的雄性纯种大耳白家兔,手术造成新鲜桡骨骨折模型,用区组随机法分为局部和邻近取穴组(A组)、远道和辨证取穴组(B组)、局部和邻近取穴加远道和辨证取穴组(C组)、空白对照组(D组)共四组,术后第一天开始对治疗组分别做电针治疗,于术后7 d、14 d、28 d取材做血液生化学、生物力学、放射学、组织学的观测.比较各组间上述指标的差别.结果:血清碱性磷酸酶含量14 d时A组和C组明显高于B组和D组(P＜0.01),骨折标本抗弯强度在28 d时A组和C组明显高于B组和D组(P＜0.01),X线量化评分14 d和28d时A组和C组明显高于B组和D组(P＜0.05),在各个时段各个指标A组与C组、B组与D组比较均无显著差异(P>0.05).结论:局部和邻近取穴能明显促进骨折愈合,而且具有操作简便,易于推广等优点,远道和辨证取穴则效果不明显,与前者合用也没有明显增强前者的疗效.