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.
【摘要】 目的 評價中藥復方（益氣養陰、清熱活血方Yiqi Yangyin Qingre Huoxue decoction，YYQHD）聯合放射療法治療鼻咽癌在減毒增效方面的療效。 方法 采用Cochrane系統評價方法，電子檢索Cochrane圖書館臨床對照試驗資料庫（Cochrane Central Register of Controlled Trials，CENTRAL）、PubMed、EMBASE、中國生物醫學文獻數據庫（CBM）、中文科技期刊全文數據庫（CNKI）和中國期刊全文數據庫（VIP）以及萬方數據庫等數據庫2010年3月前所發表的相關文獻。同時互聯網檢索Current Controlled Trial、Clinical Trials和中國臨床試驗注冊網。手工檢索部分腫瘤類核心期刊。采用Cochrane協作網推薦的 “偏倚風險評估”工具，評估納入研究的質量，使用RevMan 5.0.23.0軟件對納入的研究進行定量系統評價。 結果 最終納入符合標準的中文文獻9篇共795例患者。定量分析結果顯示:與單純常規放射治療相比較，中藥復方（YYQHD）聯合常規放射治療能顯著提高腫瘤近期療效、生存率，并且能顯著減少放射治療常見毒副反應的發生，從而提高放射治療按時完成率確保放射治療療效、改善患者生存質量。 結論 雖現有研究尚不能得出可以將中藥復方（YYQHD）作為標準治療手段輔助放射治療的結論，但提示益氣養陰、清熱活血類中藥聯合放射治療治療鼻咽癌是值得繼續探索的研究方向，期待設計科學合理、高質量的多中心、大樣本、雙盲、隨機對照臨床試驗以進一步驗證其療效。【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.
