Traditional Chinese medicine injection adverse reactions of 127000 cases last year: frequent safety accidents

August 4, 2015 23:09 HeXun

18 share add love print fonts decreases font domestic 2014 patients using traditional Chinese medicine injection adverse reaction events as much as 127000 times, 6.7% reported serious

The rule of law trainee reporters over the weekend Generation show fai

The rule of law interns jaddua cold over the weekend

 "barbaric" of traditional Chinese medicine injections

An average of 5 minutes in 1 case by traditional Chinese medicine injection adverse reaction caused by medical accidents.

This is the last 2014 years, the state food and drug administration (hereinafter referred to as the "national food drug administration) for domestic patients using traditional Chinese medicine injection adverse reactions monitoring results.

On July 17, national food drug administration issued the national adverse drug reaction monitoring annual report (2014) "(hereinafter referred to as the monitoring report) showed that 2014 patients using traditional Chinese medicine injection adverse reaction incidents across the country as much as 127000 times, 6.7% reported serious among them. Compared with 2013, adverse reactions report quantity grows 5.3%, including a 26% increase in the number of serious report.

TCM injections is extracted from herbs effective materials can be injected into the body of sterile powder or concentrated solution.

More than 30 years, TCM injections once is regarded as a symbol in the history of the development of TCM modernization.

More than accept the rule of law, however, reporters over the weekend of the personage inside course of study says, accompanied by because of TCM injections cause safety accidents occur frequently, the industry of traditional Chinese medicine injection is becoming more and more controversial.

"Traditional Chinese medicine (TCM) injections into our body in the form of a savage, and we don't know its potential ingredients will bring us what kind of risks." A pharmaceutical industry, said.

Cases of adverse reactions of 127000 cases in reality

Time of pointer back to three months ago.

On April 24, jiangsu China pharmaceutical group co., LTD. (hereinafter referred to as the China pharmaceutical) was caught out "life vein injection events".

National food, food and drug administration said the confrontation of pharmaceutical production raw pulse injection adverse events occurred in the southern province of guangdong, individual patients after symptoms of chills, fever.

That contain raw pulse injection, red ginseng, radix ophiopogonis and fructus schisandrae, also as a kind of traditional Chinese medicine injections.

Public information display, the confrontation of pharmaceutical production involved vein injection for the 37638, had already sold to jiangsu, zhejiang and other nine provinces (area), most patients with has been used.

Not only the security incident.

As early as 2006, a national heartleaf houttuynia herb injection events led to the deaths of six people in Beijing, wuhan.

Public data show that by the end of June that year, the national adverse drug reaction monitoring center received heartleaf houttuynia herb injection adverse reaction report 5488 cases, 258 cases of severe adverse drug reactions, killed 44 people.

In October 2008, "acanthopanax, wormwood Zhi yellow event" from happening again. The incident has caused many deaths around, including a babies born just nine days.

In this series of medical safety incident, TCM injections have played a leading role. Public data shows that the present Chinese each year about 400 million people use traditional Chinese medicine injections.

Monitoring report, Chinese medicine injection adverse reaction in 2014 ranked top 10 number of drugs are: qing ling injection, and mai injection, ShuangHuangLian injection, blood flux injection, shu ning blood injections, blood clots injection and salvia miltiorrhiza injection,, vein injection xiangdan injections, phlegm heat injection.

Of phlegm heat has more than 600 ten thousand people use all the year round, adverse reactions, about 3000 people in the sales and the number one cause of the qing ling injection quantity is about 5 times of phlegm heat.

"In fact, last year, 127000 cases of time just can monitor the statistical data." Shi Lichen analysis, an official with the Beijing ding minister medical consultation "due to the use of traditional Chinese medicine injection adverse reaction and cases in real life a lot more than that."

The size of the market more than 32 billion yuan

Frequent safety accidents in the chaos of the war of resistance of traditional Chinese medicine injection.

Around the year 1940, as a result of the war of resistance difficult, lack of medicines, radix bupleuri decocted into medicinal broth (used in the treatment of influenza, malaria) was further made into injection for the treatment of decoction distill way.

At this point, the world's first birth of TCM injections, namely "radix bupleuri injection".

20 years later, as a result of China's rural and remote areas diseases such as cholera, malaria epidemic, the country was vigorous mass movement to Chinese herbal medicine, traditional Chinese medicine (TCM) injections become the focus of the development.

Public information, the 70 s, China appeared a lot of varieties of traditional Chinese medicine injections, alone with data reported more than 700 kinds. Since then, traditional Chinese medicine injections to continue to heat up, in the last century the nineties to research and development.

"Now, many in traditional Chinese medicine injections are then developed." Shi Lichen of rule of law reporters over the weekend, so far, the production of traditional Chinese medicine injection drug companies on the market up there have been thousands of large and small.

According to statistics, traditional Chinese medicine (TCM) injection on the market the compound growth rate of about 22% in recent 5 years, despite a 30% growth rate fell before, but still higher than 15.78% and the proprietary Chinese medicine pharmaceutical market revenue growth rate of around 18.23%.

At present, there are 303 enterprises of our country has 134 varieties of traditional Chinese medicine injection dosage forms 1255 different specifications of the production approval, which commonly used in more than 50 varieties, Chinese medicine injection, and the market size of more than 32 billion yuan.

Among them, the forward-looking industry research institute "from 2014 to 2018 in China's traditional Chinese medicine injection industry development prospects and investment forecast analysis report, statistics show that in 2014 China's top ten Chinese medicine injection production enterprise is: tasly (43.23, 0.59, 1.35%) pharmaceutical, Harbin pharmaceutical group, jinling pharmaceutical (18.45, 0.15, 0.81%), compared to pharmaceutical, kunming pharmaceutical (33.83, 1.16, 3.55%), guizhou yi hundred cooperates, Shanghai, shanxi, jiangsu kang edge and KaiBao (14.890, 0.31, 2.04%).

"At present, the grass-roots medical institutions use has the highest percentage of TCM injections." Shi Lichen said.

The personage inside course of study introduces, at present the grassroots medical institutions use the cost of traditional Chinese medicine injection take medicine, and the highest percentage of the total expense accounts for about 15%, secondary hospitals accounted for about 7%, and tertiary hospitals accounted for only 3% to 3%.

"Doctors in some big cities such as Beijing is now rarely tend to use traditional Chinese medicine injections, is also the main problem is afraid of bear responsibility." Shi Lichen, said "TCM injections more serious adverse events occurred in the county under the hospital medical personnel at the grass-roots level is the major reason for the limited by quality and knowledge level, the phenomenon of irrational drug use is far more than big hospital."

"Moments occurred in patients, maybe yourself among them, the unconscious mind may be injected with traditional Chinese medicine (TCM) injections." Shi Lichen said, "it all depends on the doctor's drug choice."

"In fact, in addition to li injection abroad, is now only in Chinese market with TCM injections." Traditional Chinese medicine health care chamber of commerce, director of Yu Zhibin told the rule of law over the weekend.

With a mixture of chemicals at the grassroots level is common

With widely used in areas at the grass-roots level, TCM injections with a mixture of other chemicals is not standard phenomenon is more alarming.

Monitoring report shows that 2014 Chinese medicine injection adverse reaction report overall top 20 drugs (88.7% for the traditional Chinese medicine injection report) drug combination cases, involving the drug combination report (42.3%), severe report involving the drug combination was 57.0%.

"Mixed use increases the risk of the safety of TCM injections." Zhou Lei, director of the China association of traditional Chinese medicine herbs market professional committee told reporters said the rule of law over the weekend.

"TCM injections cannot be used mixed with western medicine injection, to use the words should be more than half an hour or 1 to 2 hours, because the reaction of western medicine is very clear, and traditional Chinese medicine (TCM) reaction is not clear." Zhou Lei explanation.

Shi Lichen told reporters over the weekend of rule of law, traditional Chinese medicine (TCM) injections is part of traditional Chinese medicine medicinal stewing epigenetic output for the purification of products. "In fact, the market of traditional Chinese medicine injection extraction accuracy is not high, this can make a lot of invalid impurities mixed in the ampoule. With the western medicine product mix, easy to cause uncertainty of chemical reactions."

"There are a number of medicinal composition is simple, can be recognized, mixed use." Zhou Lei said, "but most of the medicinal composition is complicated, difficult to identify, mixed use undeserved produce allergic reaction on the liver and kidney damage."

In fact, the rule of law reporters access to information found that over the weekend to the problem of TCM injections using countries have already aware of that. According to the traditional Chinese medicine injection in clinical using the basic principles of regulation, the clinician must pay attention to separate use of TCM injections, taboo mixed with other drug compatibility.

"Hybrid medication use is also associated with small hospitals do not strictly abide by the rules, and relative to character, traditional Chinese medicine (TCM) injections much lower cost compared with the western medicine chemical injection." Yu Zhibin admits.

Three factors to TCM injections

Frequent safety accidents

The rule of law trainee reporters over the weekend Generation show fai

The rule of law interns jaddua cold over the weekend

Entered since 2015, the spate of blood "shu ning event" "the life vein injection events" and spread to many industry "ginkgo biloba incident" has long been disputed for a long time of TCM injections security problem again on the waves of public opinion.

And told the rule of law over the weekend in a number of medical people's view, the state food and drug administration (hereinafter referred to as the national food drug administration) released by the national drug adverse reaction monitoring annual report (2014) "more reflects the status quo of TCM injections safety need to be addressed.

"Over the years, traditional Chinese medicine (TCM) injection on the one hand is regarded as a milestone of modernization of traditional Chinese medicine, and is considered to be drug category of 'blockbuster' dispute." For traditional Chinese medicine injections, one industry source said.

So, TCM injections safety accidents happen frequently, what are root cause?

Traditional Chinese medicine injection itself flawed

"Traditional Chinese medicine injection production process is not complicated, simple speak prescription of traditional Chinese medicines is the ancestral down boil soup made of the purification process." The Beijing minister, head of the medical consultation Shi Lichen explained to reporters over the weekend under the rule of law, "but in the process, purification technology is a key."

Shi Lichen is introduced, reality of purification technology has not reached the standard of ideal. "The present TCM injections in there are a lot of unknown composition."

"Although TCM injections in the last century has been widely and s, and a huge pharmaceutical market development to the present, but the quality of TCM injections, but technology has not been improved or enhanced." Zhou Lei, director of the China association of traditional Chinese medicine herbs market professional committee of rule of law also reporter said over the weekend.

"Especially is important to note that in the past a lot of Chinese traditional medicine prescription itself and there are big differences between western medicine therapy, such as some prescription of mercury and sulfur can be used as a medicine." Shi Lichen said, "but containing these substances of TCM injections if adopt the method of direct injection vein, it must be a risk."

In Shi Lichen point of view, from the Chinese traditional medicine extract multiple components due to its effectiveness and safety of still is unknown, if by intravenous injection, bypassing the gastrointestinal barrier, directly into the blood stream, is bound to pose a safety hazard.

Many medical professionals also to the rule of law reporters over the weekend, and frequent adverse reactions and even death in patients with just proved that TCM injections did not conform to the basic requirements of "safe, effective and inexpensive.

"Through oral Chinese medicine prescription, after stewing purification, in not sure whether the impurities harmful to the body have been injected into the body's blood is in itself a very rough thing." Shi Lichen thinks, started to take Chinese traditional medicine modernization of traditional Chinese medicine injection development train of thought have a problem, is also the root cause of frequent occurrence of safety accidents.

Production quality is uneven

With traditional Chinese medicine (TCM) injections composition uncertainty risk at the same time, each big drug firms production of traditional Chinese medicine injection product quality is uneven.

On February 17th, large state-owned pharmaceutical listed companies CRC san-jiu (30.22, 0.48, 1.56%) pharmaceutical co., LTD. (hereinafter referred to as the CRC san-jiu) was caught out "shu ning blood event".

Shu ning main ingredients for ginkgo biloba blood, complementary makings to glucose, ethanol, a kind of traditional Chinese medicine injections.

Beijing food drug administration documents released in the process of market supervision and inspection, China resources san-jiu China resources owned by Beijing high-tech natural medicine co., LTD. (hereinafter referred to as the CRC high-tech) production of blood shu ning injection (hereinafter referred to as the blood shu ning) a security risk.

Huarun san-jiu announcement, according to problems of shu ning blood involves two batches of unqualified products, and has set up a sales into the market.

Between drug exists security risks, Beijing food drug administration asked CRC tech centers on a security risk with batch extraction production of shu ning blood, and in accordance with the measures for the administration of the drug recall recall. During the recall, China resources high-tech blood shall not continue to shu ning production and sales.

Huarun san-jiu "shu ning blood event" is only part of the traditional Chinese medicine injection production quality problems existed in the corner on the ice.

Zhou Lei said, at present technical level is uneven, production can produce problems together. "The doctor is unable to meet the injection quality, because they only suit the medicine according to the specification."

"In fact, traditional Chinese medicine injection production existed problems in raw material purchasing." Zhou Lei said, "raw material existence question, the extract is more problematic."

Zhou Lei introduction, Chinese herbal medicine such agricultural products (16.20, 0.10, 0.61%) is high, heavy metal residues, pesticide residues and because the country is not the relevant procurement standards, causing quality grade fuzzy when trading in the market.

"Under the market economy, there is no unified procurement standards, true and false and inferior is difficult to identify. Do not conform to the standard of raw materials once in production line to form the finished product sales, so there are serious security risks." Zhou Lei said, "now has some big companies like tongrentang (30.05, 0.47, 1.54%) do is better."

At the same time, the personage inside course of study says, "pyrogen of TCM injections" problem also affects the quality of TCM injections.

Hot means can cause warm-blooded temperature anomalies caused by thermal material, usually bacterial metabolites bodies, bacteria, etc.

"If drug companies in the production of non-standard production, pyrogen can into finished products through raw materials, solvents, etc." In some areas in shandong hospital Ren Xuan engaged in the work of the doctors told the rule of law reporters over the weekend.

Public information, pyrogen is contained in traditional Chinese medicine injection quantity up to 1 micrograms/kg can cause adverse reactions of the body.

"The existence of pyrogen to for the use of intravenous injections of traditional Chinese medicines with clinical risk is very big." Ren Xuan said.

The existing national standards defects

Industry insiders told reporters over the weekend, rule of law country in view of the existing standards of TCM injections also flawed.

Zhou Lei told reporters over the weekend of rule of law, the current standard of TCM injections are actually set the standard with western medicine, but also has not fully follow.

"Standards of western medicine research and development is through animal experiments, and pharmaceutical composition is clear, is internationally recognised." Zhou Lei said, "but the Chinese medicine composition is very complicated, and in clinical trials is directly used to the person, no animal studies that link. Now has also been mentioned, animal experiment, to do first to use again."

Shi Lichen to the rule of law also confirmed over the weekend, and now for the development of traditional Chinese medicine injection is often based on ancient Chinese medicine effective prescription handed down in production. "Not tested animals link, direct use in people."

", in contrast, the ingredients of TCM injections is too complicated, in theory should take more stringent standards than western medicine research and development." Shi Lichen said.

"Current TCM injections more unpredictable factors, should be to ensure drug quality, composition, detailed research on clinical medication, continuous assessment, back into the market." Yu Zhibin said.

In fact, the country aiming at the existing problems of traditional Chinese medicine (TCM) injection has taken some measures.

The personage inside course of study to the rule of law reporters over the weekend, at present the country food drug administration on a regular basis for Chinese medicine injection safety evaluation work again.

"Be assure the quality of the raw material, extraction technology to guarantee, strict procedures, do a good job in animal experiments, clearly indicate the side effects. At the same time, more in need of a set of meet the TCM injections from r&d to production process of the range of the standard of TCM injections." Zhou Lei advice.

(source: the rule of law over the weekend)