Islet Xenotransplantation: Are We Really Ready for Clinical Trials?

Four clinical trials of porcine islet transplantation have been reported, and there are verbal reports that clinical trials on much larger scales are continuing in centers in China and Russia. The four reported trials are briefly reviewed and, in the light of the present status of experimental islet xenotransplantation, consideration is given to whether such trials are currently justified. The Ethics Committee of the International Xenotransplantation Association has (1) emphasized the need for encouraging studies in non-human primates before clinical trials should be undertaken, (2) mandatory monitoring for the transfer of porcine microorganisms, and (3) careful regulation and oversight by recognized bodies. Other aspects of the topic, such as the need for informed consent, are briefly discussed. We conclude that, at the present time, more data documenting convincing efficacy, focused on clinically applicable immunosuppressive regimens, are needed to justify the initiation of closely monitored clinical trials. A clinical trial may then be justified even though the potential risk to the patients, and possibly for society, will not be zero.     

KGF在乳腺癌的表达与临床意义

目的:探讨KGF蛋白在人乳腺癌的表达与意义,与临床病理因素及生物学指标的相关性。方法: 采用免疫组化方法检测KGF在63例乳腺癌组织中的表达,并与正常乳腺组织对照。结果:63例乳腺癌组织中34例肿瘤细胞表达KGF(54．0％),正常乳腺上皮细胞未表达(P<0．01),在乳腺癌间质细胞和正常乳腺组织间质细胞表达率分别为34．9％和16．7％(P>0.05)。其在肿瘤细胞中的表达与低分化相关,与ER、PR呈负相关,与Ki-67呈正相关,与Ki-67的协同表达与淋巴结转移正相关。结论: KGF在乳腺癌肿瘤细胞的表达可能促进乳腺癌的发生发展,并且与低分化、预后不良有关。     

间断纵行缝扎硬化注射治疗直肠黏膜内脱垂68例临床分析

目的:观察和评价间断纵行缝扎硬化注射治疗直肠黏膜内脱垂的临床疗效。方法:将68例直肠黏膜内脱垂患者随机分成两组,治疗组(36例)采用经间断纵行缝扎硬化注射治疗,对照组(32例)采用单纯硬化注射治疗。并对临床资料进行分析总结。结果:术后3个月随访,治疗组与对照组的症状、体征总得分比较,治疗组均优于对照组。结论:纵行缝扎硬化注射治疗后症状消除快,近远期疗效佳。     

Ritanserin in the treatment of alcohol dependence – a multi-center clinical trial

Four hundred and twenty-three alcohol dependent subjects were enrolled into a 12-week randomized, double-blind, placebo-controlled study to determine the safety and efficacy of the 5-HT₂ receptor antagonist, ritanserin (2.5 mg/day or 5 mg/day), in reducing alcohol intake and craving. All subjects received 1 week of single-blind placebo prior to randomization into the 11-week double-blind phase. Additionally, all subjects received weekly individual sessions of manual-guided cognitive-behavioral therapy. Comparing the single-blind period with endpoint, there was approximately a 23% reduction in drinks/day; 34% fall in the total number of drinking days/week; 22% decrease in drinks/drinking day; and a 37% diminution in alcohol craving for all treatment groups. All treatment groups experienced a beneficial clinical outcome as assessed by the Clinical Global Impression Scale. There was, however, no significant difference between treatment groups on any of these measures of alcohol drinking, craving, or clinical outcome. Subjects were of relatively high social functioning at baseline, and this did not change significantly during treatment. Treatment groups did not differ significantly on either medication compliance or reported adverse events. Ritanserin treatment was associated with a dose-related prolongation of subjects’ QTc interval recording on the electrocardiogram. These results suggest that alcohol dependent subjects can show marked clinical improvement within a structured alcohol treatment program. These findings do not support an important role for ritanserin in the treatment of alcohol dependence. Received: 30 April 1996/Final version: 3 July 1996     

良性小脑出血13例分析

笔者对13例良性小脑出血的患者,从起病、临床表现进行了具体分析.总结出中老年良性小脑出血的6个特点,供临床工作者参考.     

Comparison of gas-liquid chromatography and EMIT assay for serum valproic acid

We describe a simple direct extraction method for the gas-liquid chromatography determination of serum valproic acid. The working range for the assay is 2-180 mg/L and our within-run precision was 5.8 and 4.3% at the 40 and 90 mg/L concentrations respectively. Hemolyzed and lipemic sera as well as samples from patients with hyperbilirubinemia and from patients with decreased renal function were put through the assay and no interfering peaks were noted. Interference occurred when teflon-lined screw caps were used during the extraction step. The method was proven to be accurate by linear regression analysis of samples containing weighed-in amounts of valproic acid. The above assay was compared to an enzyme immunoassay technique (EMIT). The working range for the latter is 10-150 mg/L and the with-run precision was 10.8 and 5.9% and 90 mg/L concentration respectively. Samples were run by both the gas-liquid chromatograph and enzyme immunoassay methods and gave very similar results over the range 16-139 mg/L.     

中西医结合治疗难治性原发性肾病综合征20例

目的 :探讨难治性原发性肾病综合征 ( PNS)的中西医结合治疗途径。方法 :选择 PNS患者2 0例 ,逐步撤减激素至停用 ,停免疫抑制剂 ,酌情给予降压、利尿、降脂、提高血浆胶体渗透压 ,自拟“健肾汤”、辨证辨病加减 ,治疗前后分别测定 2 4 h尿蛋白定量、血浆白蛋白、胆固醇、Scr(血肌酐 )、Ccr(肌酐清除率 )。结果 :治疗 8周后 2 4 h尿蛋白、血浆胆固醇显著下降 ,血浆白蛋白显著上升 ,肾功能明显改善 ( P<0 .0 1 )。病情完全缓解 40 % ,部分缓解 45 % ,无效 1 5 % ,总有效率 85 %。结论 :中西医结合治疗 PNS取得一定疗效 ,值得临床和实验进一步研究。     

原发性中枢神经系统恶性淋巴瘤27例临床病理分析

目的 :分析和探讨原发性中枢神经系统恶性淋巴瘤 (PCNSML)的临床与病理学特点。　方法 :总结经手术证实的 2 7例PCNSML患者的临床资料 ,并进行病理学及免疫组化研究 ;　结果 :患者以中年男性为多 ,临床表现无特异性 ,术前误诊率高。病理学显示 2 6例为B细胞淋巴瘤 ,绝大多数属弥漫性大B细胞淋巴瘤 ;1例为T细胞淋巴瘤。 81.3%B细胞淋巴瘤bcl 2呈阳性表达。术后行放、化疗者生存期优于单纯手术者。　结论 :PCNSML临床早期诊断困难 ,治疗方案应采取以手术加放化疗的综合治疗措施     

绝经前后T1期乳腺癌患者临床特征的分析

目的:分析T1期(肿瘤直径<2cm)原发性乳腺癌女性患者绝经前后在肿瘤大小、病理分类、淋巴结转移率和数目。方法:常规病理检验以及应用免疫组化、HE法分别测定绝经前乳腺癌患者和绝经后乳腺癌患者者的ER、PR。结果:两组患者在肿瘤大小上无明显差异,但绝经前乳腺癌患者浸润导管癌的百分比为 84. 7%,绝经后乳腺癌患者的浸润导管癌百分比为 62. 2%,经χ2 检验,P<0. 01。两组淋巴结转移率分别为 39. 3%和 25. 5%,经χ2 检验,P<0. 01。两组ER和PR阳性伴淋巴结转移的比例经χ2 检验,P<0. 05。结论:绝经前乳腺癌患者和绝经后乳腺癌患者在病理分类、淋巴结转移率及数目、ER、PR阳性伴淋巴结转移上有显著性差异。对于T1原发性乳腺癌患者不论有无淋巴结转移,均应行癌肿切除伴Ⅰ、Ⅱ级淋巴结清扫。     

从事全胃肠外营养工作的心得

目的:交流从事全胃肠外营养(TPN)工作的心得。方法:查阅近年来相关国内外文献,结合自己的工作实践进行回顾、总结和分析。结果与结论:从事TPN工作的临床药师应不断接受业务教育,凭借专业优势与临床加强联系,善于分析、总结临床信息,推动临床药学发展。