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中药虽取诸天然,但亦可含对人体有害的物质,因此,近年来中药的毒副作用越来越受到关注。中药毒副作用可以分为不可预期类、使用不当类、中药“污染”类、品种混乱类和中西药物相互作用类等。使用不当类包括处方不遵从中医药理论、过量使用、炮制及制剂方法不当和配伍不当等;中药“污染”类包括重金属、农残留及中药产品被化学药物成分“污染”。中药的毒副作用,必须明晰报告。过高或过低估计中药的毒副用,都会误导临床医生及患者。我们建议在中医药随机对照试验报告规范中,报告副作用时,应包括以下面:研究药物毒副作用的背景资料、针对副作用的特异性结局评估指标;毒副作用的详细内容及其诠释。
Although traditional Chinese medicines are used naturally, they may also contain substances that are harmful to the human body. Therefore, the toxic and side effects of traditional Chinese medicine have received increasing attention in recent years. The toxic side effects of Chinese medicine can be classified into unpredictable, improper use, Chinese medicine “pollution”, variety disorder, and Chinese and Western drug interactions. Improper use of prescriptions includes prescriptions that do not comply with Chinese medicine theory, overuse, concocting, improper preparation methods, and inappropriate compatibility; Chinese medicine “pollution” categories include heavy metals, agricultural residues, and traditional Chinese medicine products that are contaminated by chemical drug ingredients. The toxic side effects of Chinese medicine must be clearly reported. Too high or too low to estimate the toxic effects of traditional Chinese medicine can mislead clinicians and patients. We recommend that when reporting side effects in the RCT report specification, the following should be included: Background information on the toxic side effects of the drug, specific outcome assessment indicators for side effects, and details of toxic side effects and their interpretation.