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According to data from The Intranet, among the top 20 brands in the chemical drug market in China's urban public hospitals in 2020, dizocine injection ranked first, with sales of 5.4 billion yuan, and this data was close to 6.8 billion yuan in 2019.
According to the drug label, dizocin injection is suitable for the treatment of moderate to severe pain after surgery, visceral colic and pain in patients with advanced cancer.
However, when the Health Times reporter asked the director of the anesthesia department and the director of the pain department of many well-known third-class hospitals in China about the clinical use of dizocin, the answer was often "I don't have much experience with this drug", "I don't know much about this drug", "This drug did not enter our hospital".
A question: Is there reliable clinical data on analgesia?
"Last June, I was admitted to the hospital because of severe pancreatitis, the nurse injected me with 2 dizocin (5 mg / stick) every day, lasted half a month, after discharge found that there was dependence, when I did not take the drug, I felt very painful, after using it can be relieved, so I have been buying dizocin to use, starting three or four sticks a day."
Mr. Chen of Wuhan told the Health Times reporter that until November last year, he was again admitted to the hospital for surgery because of a pancreatic cyst, and the use of dizocine increased to seven or eight cigarettes per day, which lasted for about half a month.
"After I was discharged from the hospital, I found that the addiction to dezocin was more serious, I had to use 5 sticks a day, I tried to quit on my own, but I didn't succeed, it was too painful." Mr. Chen mentioned that in September this year, he had to go to the Wuhan Mental Health Center for treatment, and because of the serious degree of addiction, the doctor recommended that he be hospitalized.
Not only is dizoxine potentially addictive, but the effect is not satisfactory. Ji Lianmei, vice chairman of the Pharmaceutical Service Innovation Working Committee of the Chinese Pharmacists Association, told the Health Times reporter, "Last year, after my uncle's heart bypass surgery, he had been in severe pain in the icu, and I asked the pharmacist friend of the hospital to help check my uncle's medication, and found that dizocin was used for analgesia, but the effect was not very good." ”
"The main problem with dezocin is the lack of evidence-based medical evidence. It is said that it has good efficacy and good safety, all rely on the theory of basic research, and lack of scientifically designed large-sample human clinical trial research data. Ji Lianmei said.
Dezolamine belongs to the opioid analgesics, is a receptor agonist - antagonist and receptor agonist, mainly through the agonist receptor to produce a non-linear dose-dependent analgesic effect, can be applied to postoperative analgesia, combined application in surgical anesthesia and visceral and cancerous pain and other fields.
A deputy director of the department of anesthesiology of a third-class hospital introduced that dizocin has an opioid effect similar to morphine, but the analgesic effect will be capped, so it is rare to use dezocin alone for analgesia in the clinic, and generally use it in combination with other drugs.
Fan Bifa, president of the Pain Physician Branch of the Chinese Medical Doctor Association and director of the Pain Department of the China-Japan Friendship Hospital, told the Health Times reporter, "Dizoxin as an agitation-antagonist, after the dosage reaches a certain level, the analgesic effect will reach the upper limit, while the side effects will continue to accumulate." ”
The National Comprehensive Cancer Website's Guidelines for the Treatment of Adult Cancer Pain explicitly mention that dezoxine is not recommended for cancer pain treatment because re-use of desocine may produce withdrawal symptoms if the patient has used pure agonists such as morphine.
The Health Times reporter found that the "Expert Advice on Postoperative Analgesia of Dezocin" published in 2018 and the "Expert Consensus of Clinical Analgesia of Dezocin" published in 2020 were noted at the beginning: There are still not many large-scale, multi-center, strictly controlled literature, and there is still a lack of evaluation based on evidence-based medicine.
The Health Times reporter tried to contact the expert group members of the article "Expert Advice on Postoperative Analgesia of Dizocin" to understand the relevant situation of dizocin, and many experts said that they did not understand dizocine and declined.
Second question: Why is the sales of dezoxin so high?
According to intranet data, in recent years, the sales of dizocin injection has grown rapidly, the growth rate has remained in double digits, urban public hospitals and county-level public hospitals are the main sales channels of the product, sales exceeded 5 billion yuan in 2018, and sales in 2019 soared to 6 billion yuan, accounting for about 37% of the national public medical institution terminal painkiller market size.
"The clinical use of dezoxin has fewer side effects, everyone thinks that it is not addictive, and the WHO does not include it in the controlled drugs, non-anesthesiologists can also prescribe drugs, and the country also lists dezocin as a class II psychotropic drug, and the medication restrictions are relatively loose, these reasons may have a certain relationship with its ultra-high sales." The deputy director of the anesthesiology department said so.
Dezocin was developed by Wyeth Laboratories in the United States in 1986, and was approved for marketing by the US Food and Drug Administration in 1989, and less than 10 years later, AstraZeneca, a manufacturer of dizocin, voluntarily submitted an application to stop the production of the drug and withdrew from the US market in 2000.
In 2009, Yangtze River developed it as a new drug in China according to class 3.1, and after its exclusive listing, it quickly occupied the domestic analgesic drug market. Until 2019, Nanjing Youke Pharmaceutical was approved according to the application for the listing of 6 generic drugs, becoming the second domestic manufacturer of dezoxine injection.
When the Health Times reporter checked the China Judgment Documents Network, he found that in the past 6 years, there were 5 bribery cases related to Dizoxin.
According to the Criminal Judgment of the People's Court of Xiaoshan District of Hangzhou City ((2020) Zhejiang 0109 Xingchu No. 817) released by the Judgment Document Network on October 9, 2020, between June 2012 and August 2019, defendant Hu Shuangfei took advantage of his position to seek benefits for the sale and use of the narcotic drug "Dizocin" injection distributed by a company in the Zhejiang Provincial People's Hospital, with a rebate amount of 5 yuan per charge. Repeatedly accepted the company's pharmaceutical representative Ye Mou's property totaling 1250620 yuan.
According to the Criminal Judgment of the People's Court of Wuxing District of Huzhou City ((2015) Hu wu xing yi chu zi no. 761) published on the judgment documents network, "from 2011 to 2014, defendant Wang Weixing took advantage of his position to illegally accept bribes from Chang X, a salesman of a certain group, for a total of more than 181,000 yuan, totaling more than 181,000 yuan, while serving as the director of the anesthesia department of Huzhou Central Hospital. ”
In the Criminal Judgment of the People's Court of Wuxing District of Huzhou City ((2015) Huwu Xing Yi Chu Zi No. 467) issued on December 30, 2016, from 2006 to 2014, defendant Chang Dehe (a salesman of a pharmaceutical sales company of a group) paid bribes to Wang for his care and assistance in the introduction or administration of drugs such as "Dizoxin" of a certain group in order to obtain and thank Wang Mou, then director of the Pharmacy Department of Huzhou Central Hospital, for his care and assistance in the introduction or management of drugs such as "Dizoxin" of a certain group.
Three questions: Is there any drug abuse?
According to Ji Lianmei, from the "Expert Advice on Postoperative Analgesia of Dezocin" released twice to the "Expert Consensus of Clinical Analgesia of Dezocin" released in 2020, an important change is to adjust from the original "postoperative analgesia" to the current "clinical analgesia". The difference of 2 words has greatly broadened the scope of application of dizocin, and now many outpatient clinics and wards are using it, so it is difficult to ensure its standardized and reasonable use.
Although the instructions for dizocine injection clearly state "low addiction" in the pharmacological effect column, the Health Times reporter's inquiry found that the data in the "Clinical Analysis Report on 8 Cases of Dezoxin Dependence" published in the Chinese Journal of Drug Dependence 2020 showed that there was irrational use of dezosine in the clinic (especially surgery), and studies showed that dependence accounted for 0.23% of all adverse reactions (3/1290).
In recent years, due to people's insufficient understanding of drug dependence, the availability of some drugs and the influence of recreational drug abuse in Europe and the United States, the incidence of drug dependence has increased year by year, and there have been reports of dependence caused by dezoxine in China.
According to the Chinese Pharmacist Magazine "Survey on the Clinical Use of Dezoxin Injection in 12847 Patients in a Hospital", among the hospitalized patients in December 2015 and November 2016, a total of 12847 patients used dezocine, of which 11687 patients were due to the surgical use of dezocine injection, accounting for 90.97% of the total. The most used departments were orthopedics (12.70%), hand surgery (10.30%) and hepatobiliary surgery (9.39%). The single dose of 132 patients exceeded the recommendation of the instructions (1.03%), mainly concentrated in large operating departments (cardiac surgery).
"There are reports that in hospitals, there are cases where individual doctors and nurses inject dizocin themselves to relieve work fatigue and occupational pain, resulting in addiction, because some medical staff think that dizocin is not easy to become addictive, so they have relaxed their vigilance against it." Ji Lianmei told the Health Times reporter.
Ji Lianmei said that the same as the management of morphine, dizocin should be classified into the first class of psychotropic drugs and narcotic drugs, and the scope of application and course of clinical use should be strictly controlled. In addition, the drug label should be revised to clarify its indications and warn of possible addiction. Once the revision of the drug label is initiated, the drug regulatory authorities must require relevant enterprises to provide the trial data of large-sample-size clinical controlled studies of their efficacy and safety.
The Health Times reporter found that dizoxin is a drug included in the catalogue of the second class of psychotropic drugs in China. According to the Provisions on the Administration of Prescriptions for Narcotic Drugs and Psychotropic Substances, the prescription of injections for narcotic drugs and first-class psychotropic substances shall be one time; the prescription of other dosage forms shall not exceed 3 days; the prescription of controlled sustained-release preparations shall not exceed 7 days; and the prescription of class II psychotropic substances shall generally not exceed 7 days.
According to the incomplete statistics of public information, the Health Times reporter found that before and after the approval of dezoxine in 1989, according to the abuse potential of the drug in animal experiments, the Drug Abuse Advisory Committee of the US Food and Drug Administration has recommended it on the "List of Controlled Substances" twice.
"The principle of drug application is safe, effective and economical, and these three points of dizocine are not available, its safety and efficacy are not supported by reliable evidence-based medical evidence, and the price is dozens of times that of morphine." Ji Lianmei told the Health Times reporter, "What exactly is the treatment, what is the specific applicable population, and what indications are supported, we must come up with clear and reliable clinical trial data, rather than making it like a 'panacea'." ”
Source: Health Times