Ji Kunmei, Chen Jiajie, Li Meng, Liu Zhigang, Xia Lixin, Wang Chunbo, Zhan Zhengke, Wu Xuli
State Key Laboratory of Respiratory Disease for Allergy at Shengzhen University, School of Medicine, Shenzhen University, Shenzhen Guangdong 518060, PR China.
Regul Toxicol Pharmacol. 2009 Nov;55(2):134-8. doi: 10.1016/j.yrtph.2009.06.008. Epub 2009 Jun 24.
Reports describing severe allergic shock and fatality following treatment of a common cold or upper respiratory tract infection (URTI) with a Chinese herbal injection were collected. Our analysis of the risks associated with this treatment suggested that the potential risk of serious, or even lethal, anaphylaxis should preclude its use in treating common colds and URTIs. In light of our findings herein, we propose the following five suggestions for improving the clinical safety of delivering Chinese herbal injections as medical treatments. First, Chinese herbal injections should not be delivered in the clinic to treat patients in accordance with Bian zheng lun zhi (broad-spectrum application based on holistic Traditional Chinese Medicine (TCM) theory and methodology), but rather they should be administered to target specific indicated disease processes. Second, Chinese herbal injection indications should be based on the results of double-blind randomized controlled clinical trials. Third, Chinese herbal injections should be used only in cases involving severe disease or to rescue patients in critical condition; they should not be used to treat mild, relatively innocuous diseases, such as common colds and upper respiratory tract infections, given the risk of doing harm. Fourth, Chinese herbal injection formulas should include materials from only a single or a small number of plant sources in known quantities. Fifth, more studies examining the toxicology and allergenic potential of Chinese herbal injections are needed.
收集了关于使用中药注射剂治疗普通感冒或上呼吸道感染(URTI)后出现严重过敏反应和死亡的报告。我们对这种治疗相关风险的分析表明,严重甚至致命过敏反应的潜在风险应排除其在治疗普通感冒和上呼吸道感染中的使用。鉴于我们在此的研究结果,我们提出以下五条建议以提高中药注射剂作为医疗治疗手段的临床安全性。第一,中药注射剂不应按照辨证论治(基于整体中医理论和方法的广谱应用)在临床用于治疗患者,而应针对特定的明确疾病过程给药。第二,中药注射剂的适应症应基于双盲随机对照临床试验的结果。第三,中药注射剂仅应用于严重疾病或抢救危急患者的情况;鉴于有害风险,不应将其用于治疗轻度、相对无害的疾病,如普通感冒和上呼吸道感染。第四,中药注射剂配方应仅包含已知数量的单一或少量植物来源的材料。第五,需要更多研究来考察中药注射剂的毒理学和致敏潜力。