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参附注射液临床应用及其不良反应调查
引用本文:李廷谦,马建昕,周宇丹.参附注射液临床应用及其不良反应调查[J].中国循证医学杂志,2009,9(3):319-322.
作者姓名:李廷谦  马建昕  周宇丹
作者单位:1. 四川大学华西医院,成都,610041
2. 成都中医药大学,成都,610021
摘    要:目的调查参附注射液的临床应用情况及不良反应。方法以参附注射液为检索词,检索中国期刊全文数据库(1993.1~2008.12),国内期刊发表的参附注射液的临床研究,调查分析纳入文献中参附注射液的不良反应、用药剂量、适应病证、给药途径、溶媒及疗程等。结果共纳入576篇文献,包括21496例患者(不包括对照组病例)。除2例过敏性反应(1例过敏性休克)外,均为轻度不良反应。结论自1993年上市以来,参附注射液已在临床广泛应用。但由于缺乏规范的上市后评价,在选择目标病证、扩大病种、探索剂量、使用方法、观察药物不良反应等方面存在一定的问题和不足。因此,运用循证医学加强上市后药物评价,规范临床用药势在必行。

关 键 词:参附注射液  临床应用  不良反应

Investigation of Clinical Practice and Side Effects of Shenfu Injection
LI Ting-qian,MA dian-xin,ZHOU Yu-dan.Investigation of Clinical Practice and Side Effects of Shenfu Injection[J].Chinese Journal of Evidence-based Medicine,2009,9(3):319-322.
Authors:LI Ting-qian  MA dian-xin  ZHOU Yu-dan
Institution:1. West China Hospital of Sichuan University, Chengdu 610041, China; 2. Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China)
Abstract:Objective To investigate the status of clinical practices and side effects related to Shenfu injection. Method We searched the China National Knowledge Infrastructure (CNKI) database using the key word "Shenfu injection". Original clinical studies of Shenfu injection which were published from/anuary 1993 to December 2008 in Chinese magazines were included. Results A total of 576 relevant clinical studies were identified. There were 21 496 cases in the study group and excluding the control group patients. We investigated and analyzed the side effects of Shenfu injection. For cases with side effects, the medication dosage, the diseases for treatment, the method of medication, the menstruum, and course of treatment for the side effects were evaluated. All the side effects were mild except one case of anaphylactic shock. Condusion Shenfu injection has been widely used in clinical patients since it came into the market in 1993. However, systematic evaluation of its clinical application is lacking, and there are some unsolved problems and deficiency in selecting and expanding diseases for treatment, evaluating the dosage and treatment method, and investigating the side effects of the drug. Therefore, it is imperative to enhance the evaluation drugs and good clinical application after the drugs come into the market with evidence-based medicine.
Keywords:Shenfu injection  Clinical practice  Side effect
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