Problems in the use of Chinese medicine injections

On October 6, 2008, Yunnan Province Honghe Prefecture 6 patients use “prickly five plus” injection after appear serious adverse reaction, cause 3 cases death. On the same month 19th, the Ministry of Health informs, Shaanxi Yan’an Zhidan County Hospital uses Shanxi Taihang Pharmaceutical Co., Ltd. produces ” Yin gardenia yellow ” after the injection, 4 newborn infants have the adverse reaction, one of them was born 9 days of newborn infants on October 11th death. In recent years, “fishy grass” injection, compound “dandelion” injection, “fish gold” injection, “inflammation poison Qing “injection,” a variety of Chinese medicine injection, due to serious adverse reactions in clinical applications, was called off by the State Food and Drug Administration. The reasons for the high number of adverse reactions to Chinese medicine injections are: 1. The active ingredients of Chinese medicine injections are all extracts of the active parts of Chinese herbs, and there are few monomers of the active ingredients. Some of them are difficult to remove certain proteins and other macromolecular substances that can easily cause adverse reactions during infusion. 2, at present, the domestic Chinese medicine injection preparation process is complex, the quality is not easy to control, the active ingredients of the preparations produced by different production processes have certain differences, and these differences not only affect the efficacy of the injection, but also may lead to the occurrence of adverse reactions. 3, accelerate the infusion rate of Chinese medicine injection and the concentration of the drug will produce adverse reactions, and adverse reactions may also occur when used in combination with other drugs. There has been a great deal of controversy in the medical community about Chinese medicine injection. According to a domestic survey report of as many as several thousand cases, there are currently more than one hundred types of Chinese medicine injections approved for production by the state, and Chinese medicine injections have been put into clinical application in large quantities. It has been proved that due to the complexity of the composition of Chinese medicine injections, the active ingredients are still unclear, etc., which brings certain difficulties to the preparation and quality control of Chinese medicine injections, and the safety of Chinese medicine injections is becoming more and more problematic. Chinese medicine injection, on the one hand, has a high proportion of adverse reactions, but on the other hand, enterprises are actively developing and producing. Some data show that Chinese medicine injection has covered more than 1000 hospitals in more than 20 provinces and cities in China, and among the 20 varieties with the highest purchasing amount of traditional Chinese medicine, injections account for 16, and the top 5 are all injections. Individual large-scale enterprises, the production of Chinese medicine injection accounted for more than half of the total output, becoming the leading product. Some industry insiders bluntly said that under the drug regulatory environment of the previous few years, solid preparations to injections, which is considered to be the declaration of new dosage forms, can be re-priced. Moreover, injections are mandatory medications in hospitals with large dosage and much larger profit margins than oral medications. Therefore, more and more traditional Chinese medicines are being developed into Chinese medicine injection. At present, experts agree that Chinese medicine injections are high-risk varieties and the improvement of quality standards is imperative. Government departments should strengthen their supervision, firstly, to strengthen clinical drug monitoring, use in strict accordance with the indications and contraindications, try to avoid mixing and preparing with other medicines, and avoid rapid infusion; secondly, to supplement the systematic clinical safety re-evaluation, eliminating varieties with poor safety and alternative therapies. And at the same time, hospitals are required to use Chinese medicine injections for intravenous infusion with caution.