Clinical practice is very important in clinical pharmacology education. However, there are some deficiencies in this field in China. Clinical trial institutions in China are medical institutions that are qualified to undertake drug clinical trials. There are hardware and software for clinical pharmacology practice, and high-quality teaching personnel with medical, teaching, and scientific research backgrounds in the clinical trial institutions, which can be used as clinical pharmacology teaching practice bases. Therefore, this article discusses the practice of clinical pharmacology teaching reform using clinical trial institutions as a practical platform, and aims to put forward teaching reform ideas that combining students’ clinical pharmacology research practice on the basis of theoretical teaching.
目的 评价LB-SDS2.0型酸性氧化电位水生成机生成的酸性氧化电位水对皮肤（手）消毒的有效性和安全性。 方法 2006年2月－8月将90例健康志愿受试者随机分为3组，各组30例。A组用LB-SDS2.0型酸性氧化电位水生成机生成的酸性氧化电位水（试验产品）消毒2 min，B组用试验产品消毒4 min，C组（对照组）用聚维酮碘溶液擦拭3 min。检测消毒后菌落总数和致病菌，以及受试者不良反应情况。 结果 按照Ⅲ类区域工作人员洗手消毒标准，A、C组合格率均为100%，B组为96.7%；按照Ⅰ、Ⅱ类区域工作人员洗手消毒标准，A组合格率为86.7%；B组合格率为93.3%，C组合格率为100%。各组受试者试验后生命体征均无临床意义的改变，未出现任何不良反应。 结论 试验产品消毒手是安全有效的，可推荐用在Ⅲ类区域工作人员中使用，并进一步观察其安全性和有效性。建议扩大样本含量进一步评价其试验产品是否适用于Ⅰ、Ⅱ类区域工作人员洗手消毒。
【摘要】 目的 评价中药复方（益气养阴、清热活血方Yiqi Yangyin Qingre Huoxue decoction，YYQHD）联合放射疗法治疗鼻咽癌在减毒增效方面的疗效。 方法 采用Cochrane系统评价方法，电子检索Cochrane图书馆临床对照试验资料库（Cochrane Central Register of Controlled Trials，CENTRAL）、PubMed、EMBASE、中国生物医学文献数据库（CBM）、中文科技期刊全文数据库（CNKI）和中国期刊全文数据库（VIP）以及万方数据库等数据库2010年3月前所发表的相关文献。同时互联网检索Current Controlled Trial、Clinical Trials和中国临床试验注册网。手工检索部分肿瘤类核心期刊。采用Cochrane协作网推荐的 “偏倚风险评估”工具，评估纳入研究的质量，使用RevMan 5.0.23.0软件对纳入的研究进行定量系统评价。 结果 最终纳入符合标准的中文文献9篇共795例患者。定量分析结果显示:与单纯常规放射治疗相比较，中药复方（YYQHD）联合常规放射治疗能显著提高肿瘤近期疗效、生存率，并且能显著减少放射治疗常见毒副反应的发生，从而提高放射治疗按时完成率确保放射治疗疗效、改善患者生存质量。 结论 虽现有研究尚不能得出可以将中药复方（YYQHD）作为标准治疗手段辅助放射治疗的结论，但提示益气养阴、清热活血类中药联合放射治疗治疗鼻咽癌是值得继续探索的研究方向，期待设计科学合理、高质量的多中心、大样本、双盲、随机对照临床试验以进一步验证其疗效。【Abstract】 Objective To compare the efficacy of traditional Chinese medicine (TCM) plus radiotherapy (RT) with RT alone on nasopharyngeal carcinoma (NPC) by Yiqi Yangyin Qingre Huoxue decoction (YYQHD) through a meta-analysis of all available randomized controlled trials. Methods Literature retrieval was conducted using the Cochrane Library, PubMed, EMBASE, CBMdisk, CNKI, VIP, and Wanfang Database electronically. Relevant journals and conference proceedings were also hand-searched until March 31, 2010. The quality of included studies was assessed according to the criteria recommended by the Cochrane handbook, and the Meta-analysis was performed for homogeneous studies using RevMan 5.0.23.0 Software. Results Basing on our search criteria, we found nine trials (795 patients) which all published in Chinese. Our results showed that TCM (YYQHD) plus RT compared with RT alone, improved immediate tumor response, survival, completion rate of RT, quality of life, and alleviation of adverse effect of patients with NPC. Conclusions Considering the limitations related to this Meta-analysis, it nevertheless presents credible evidence that TCM (YYQHD) plus RT is worthy of additional study. Therefore, further large-scale, muti-center, randomized, and double-blind trials are warranted.
Objective To assess the tolerability and safety of Yinhuang injection in Chinese healthy volunteers. Methods Thirty-two healthy subjects were enrolled in the single-dose study. Each subject was administered one of the seven doses of 40, 120, 240, 320, 400, 480, and 560 mg, respectively, by intravenous injection. The sample sizes were 2, 4, 6, 6, 6, 4 and 4, respectively, for each dose group. Twelve healthy subjects were enrolled in the multi-dose study. The subjects in the lower dose group were administered 240 mg and the subjects in the higher dose group were administered 400 mg Yinhuang by intravenous injection once a day for consecutive 7 days. The sample sizes for both groups were 6. The safety was evaluated based on clinical symptoms, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests and adverse events. All analyses were performed by using the software package SAS version 9.1. T-test and analysis of variance were used for continuous variables. Chi-square test and Fisher’s exact test were used for categorical variables.Results A total of 44 healthy volunteers completed the tolerance test. No serious adverse event and clinically significant changes in vital signs, ECG and laboratory tests were found in both single-dose groups and multi-dose groups. Among two mild adverse events, dizziness occurred in one subject in 480 mg dose group in the single-dose trial, which was probably related to the experimental drug. Conclusion Yinhuang injection is safe and well-tolerated in Chinese healthy subjects after administration of single-doses (40-560 mg) and multi-doses (240-400 mg once a day for consecutive 7 days). The maximum-tolerated dose of Yinhuang injection is at 560 mg in the single-dose trial. The dose regimen of 240-400 mg a day is recommended for phase II study.