从复黄片临床探究谈谈中药临床试验设计及质量控制.docVIP

从复黄片临床探究谈谈中药临床试验设计及质量控制 　 作者：陆金根，潘一滨，曹永清，杨巍，张鑫麟 【关键词】 ,复黄片 ［摘要］ 目的：通过临床试验评价复黄片治疗内痔出血的效果，并讨论其研究设计与质控。方法：144例内痔出血病例按双中心随机盲法阳性药物对照试验设计分成2组。复黄片治疗组72例，口服复黄片4粒/次，3次/d；痔宁片对照组72例，口服痔宁片4粒/次，3次/d。治疗第3和第7天时观察患者的症状体征等变化，评价其疗效。结果：治疗第3天时，复黄片组总有效率58.57%，痔宁片组总有效率27.78%，两者比较有统计学差异（P＜0.05)。治疗第7天时，复黄片组总有效率91.43%，痔宁片组总有效率81.94%，两者比较无统计学差异。两组治疗前后实验室指标及生命体征都在正常范围。结论：复黄片是一种治疗内痔便血安全、有效的口服制剂。 ［关键词］ 复黄片; 临床研究; 研究设计; 质量控制 Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study ABSTRACT Objectives: To assess the efficacy of Fuhuang Tablets in treating internal hemorrhoid hemorrhage and discussing the design and quality control of clinical trials of traditional Chinese medicine. Methods: According to twocenter, randomized, blinded and controlled study, 144 patients with internal hemorrhoids were divided into 2 groups. Seventytwo patients were treated with Fuhuang Tablets (4 tablets t.i.d. per os) and the other 72 patients were treated with Zhining Tablets (4 tablets t.i.d. per os). Symptoms and signs of the patients were recorded and evaluated at the third and seventh day of treatment respectively. Results: At the third day of treatment, the overall response rates of Fuhuang Tabletstreated group and Zhining Tabletstreated group were 58.57% and 27.78% respectively, with statistic difference between the two groups (Plt;0.05). At the seventh day of treatment, the overall response rates of Fuhuang Tabletstreated group and Zhining Tabletstreated group were 91.43% and 81.94% respectively, with no statistic difference between the two groups. The laboratory test results and life signs of the 144 patients were normal before and after the treatment. Conclusion: Fuhuang Tablets are effective and safe in treating internal hemorrhoid hemorrhage. KEY WORDS Fuhuang Tablets; clinical research; research design; quality control 痔是临床常见的肛肠疾病，是肛垫病理性肥大、移位及肛周皮下血管丛血流瘀滞形成的团块［1］。痔的主要临床表现是便血、便后肛门块物脱出及齿线上黏膜的充血糜烂。目前多数学者认为药物治疗是首选方案。复黄片是