Recently, traditional Chinese medicine injection safety problems again aroused widespread interest. So, what security Chinese medicine injection? what are the causes of traditional Chinese medicine injection of adverse reactions? recently, reporter with these questions visited Nycomed Pharma herbal chemistry branch of the new Member of the week Ngoc.
Reporter: Hello Professor, recent national ADR publishing shuanghuanglian injection adverse reaction notification, how do you think this thing?
Week Ngoc new (hereinafter referred to as "week"): first, the traditional Chinese medicine injection is an innovative new forms of traditional Chinese medicine, it is in the process of rescuing the severe crisis played other important dosage form the unique role of irreplaceable. Traditional Chinese medicine injection is a traditional Chinese medicine theory and modern technology combined products, breakthrough an important traditional ways, is the medical institutions of the major clinical drug dosage form.
Adverse drug reactions in humans and diseases resistance process costs, all drugs have side effects, the same drug reaction to different people. Some drugs on certain negative reaction of the crowd is normal, as some people eat eggs, milk or allergies. Adverse reaction itself also exist in other types of drugs, but other types of drug reactions do not like this was marketed to the public notice. We understand that some Western medicine injection in a period of 150 deaths, no impact and attention. Why Chinese medicine injection in reactions only a small number of cases, give rise to concerns of social so big? from the incidence of adverse reactions, traditional Chinese medicine injection to well below Western drug injections. People always tend to focus on bad news, plus some of the media, it actually shows up.
In fact, the bulletin does not indicate that the drug is substandard drugs. Some of the media and the public in understanding is still possible deviation, has been on important injections, make routine drug reactions become death of Chinese medicine injection.
We are fully confident that because of the history, culture, industry, people's livelihood, and many other reasons, the regulatory authorities have been in the development of traditional Chinese medicine injection, only to guarantee the safety of medication drug quality, and the promotion of industrial health development put forward higher requirements.
Did you mention to shuanghuanglian injection adverse reaction notification, as far as I know, shuanghuanglian injection water needles, infusion of fluids, spray dry lyophilized, dosage form, in these formulations, lyophilized powder for injection is the most stable quality and storage, transportation and more stable. Therefore, I suggest a small hospital, community health centers, health centers, clinics, especially in remote areas, medical facilities are relatively backward regions, using shuanghuanglian injection, use quality relatively stable frozen powder.
Reporter: you are right, what resulted in traditional Chinese medicine injection security incidents?
Week: as this bulletin shuanghuanglian injections of adverse reaction reports, clinical Department, is the product of fair use, and parts of irrational drug use problems had been caused by adverse reactions. Unreasonable use mainly: incompatibility medication, drugs mixed with or incompatibility of drugs have the same infusion drip, no other liquids interval; children; Super dose of medication allergies patients, etc.
Thus, it is unreasonable use of the clinical Chinese medicine injection itself. This briefing by Shuang injections in clinical adverse reactions, occurring on unreasonable use is one of the main reasons.
In fact, the clinical Chinese medicine injection reactions rate far lower than the Western, not fair use-induced adverse reactions accounted for 70%. For example this notification shuanghuanglian injections, clinical adverse reaction rate not exceeding 0.2% shuanghuanglian lyophilized powder for injection of adverse reaction rate is lower, because it is all in shuanghuanglian dosage form the highest level of dosage form, it is recommended that you use shuanghuanglian injections, more use of lyophilized powder for injection. Is the same name, different formulations of the incidence of adverse reactions are not the same.
Reporter: now that the irrational use of time result in traditional Chinese medicine injection produces reactions of primary factors, traditional Chinese medicine injection that awareness is high, but rather Western medicine but seldom?
Week: objectively speaking, "is a drug toxicity". So, Chinese medicine and Western medicine. Drug treatment of main and side-effects is destined to be together and hygiene.
China's production of Western medicine formulations are basically generic drugs, the manual is the reference drug Medicare drugs abroad, require a large amount of adverse reactions in clinical trials and post-marketing studies can be found, these foreign companies have already completed the domestic yaoqi copying. While Chinese medicine injection is China complete independent intellectual property products, no one to help us test, it is only through his studies and post-marketing testing, before gradually figuring out the traditional Chinese medicine injection "bottom", to make it better for our health services. In this process, discovered that adverse reaction is completely normal.
Reporter: in order to reduce the clinical Chinese medicine injection on the incidence of adverse reactions, you have a good experience and recommendations?
Week: after all, we should be scientific treatment of traditional Chinese medicine injection of adverse reactions, enhanced monitoring, strengthening clinical guidance, to better serve the people, while also promoting the healthy development of Chinese medicine industry.
In fact, some hospitals have begun trying to reduce the adverse effects of Chinese medicine injection. They have a strict indications, dialectical accurately, in strict accordance with the statement of use; the second is to streamline drug type, avoid interaction; third, to grope out a set of clinical practice, prevention of drugs mixed adverse reactions. There are hospitals to promote the use of filters with Terminal infusion tube, significantly reducing the complexity of some of the ingredients of traditional Chinese medicine injection reactions to occur.
In addition, as a production enterprise of Chinese medicine preparations, take aim at enhancing their product standards so that you can significantly reduce the system of traditional Chinese medicine
The occurrence of adverse reactions.Related links
Shenyang Pharmaceutical University Professor Wu Li-Jun, pointed out that the existing shuanghuanglian quality standard control indicator 18 items (not including preparation will be checked in General), on three main components are raw materials for high standards of content control, provides for minimum and, at the same time provides for 10 relevant harmful substances and safety indicators, the product has reached the safe, efficient and controllable. Whereas the quality standards shuanghuanglian injection and powder than there is a big difference. Shuanghuanglian injection current implementation of the standard specifications of 1994, control quality indicators only seven, only one content index baicalin, and limit is very low, low than powder injection 2.5 times, on resin, arsenic salts, harmful substances and General composition is not control and cannot guarantee their safety, effectiveness and controllability, cannot effectively controls the intrinsic quality of the product.
(1m1m responsible editor: dongdong)
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