摘要
统计了1994—2008年100篇静脉用鱼腥草注射液大组病例的临床研究报告,涉及病例8200例。其中有效病例7460例（有效率为90.98%）,发生不良反应40例（占0.49%）,未发生休克或死亡。对1992—2008年126篇不良反应个案报道进行分析,涉及不良反应的有201例（过敏性反应123例,占61.19%）,其中死亡6例。由于个案报道未说明用药病例总数,无法计算不良反应发生率;首次给药后30min内出现不良反应的有192例（占95.5%）。结果表明,静脉用鱼腥草注射液临床疗效确切、作用显著、起效快;不良反应发生率较低,其不良反应类型以急性类过敏性反应为主。因此,静脉用鱼腥草注射液二次研究与再评价的重点应以安全性评价为主,特别是对急性类过敏反应须进行有针对性的重点研究。
In this paper, 100 clinical research reports for Houttuynia Injection were collected and analyzed, including 8200 cases, among which 7460 cases were effective （with the effective rate of 90.98%）, 40 cases showed adverse reactions （with the rate of adverse reaction of 0.49%）, and no case of circulatory collapsed or dead. And also, 126 reports of individual cases about adverse reactions of Houttuynia Injection were collected, in which 201 cases showed adverse reactions, 123 cases showed allergic reactions （with the rate in the total cases of 61.19%）, and 6 cases were dead. Because there was no sum total of the cases for Houttuynia Injection, the rate of adverse reaction could not be calculated. An analysis of the adverse reactions of the 201 cases shows that in 192 cases, the adverse reactions appear within the 30 minutes of the first injection （with the rate in the total cases of 95.5%）. It is shown that Houttuynia Injection has a notable curative effect with rapid speed, and its rate and severity of adverse reaction are all lower than those of pharmaceutical chemicals and its injections. In addition, the adverse reactions of Houttuynia Injection are mainly acute anaphylactoid reactions. Thus, the re-evaluation of Houttuynia Injection should focus on its security, especially on the acute anaphylactoid reactions induced by Houttuynia Injection.
出处
《科技导报》
CAS
CSCD
北大核心
2010年第16期36-47,共12页
Science & Technology Review
关键词
鱼腥草注射液
临床研究
不良反应
Houttuynia Injection
clinical research
adverse reaction
