关注穿琥宁、炎琥宁注射剂的安全性问题（Pay attention to the problem of safety, Chuanhuning Injection Yanhuning）

关注穿琥宁、炎琥宁注射剂的安全性问题（Pay attention to the problem of safety, Chuanhuning Injection Yanhuning） 关注穿琥宁、炎琥宁注射剂的安全性问题(Pay attention to the problem of safety, Chuanhuning Injection Yanhuning) The ADR information notification system is a measure taken by the drug supervision and administration department in China to ensure the safety of public drug use. Since the publication of the information bulletin on adverse drug reactions (ADR) to the public, it has played an active role in promoting the monitoring of adverse drug reactions in China and ensuring the safety of drug use among the broad masses of the people. The majority of medical workers, in the foundation to improve the cognition for adverse drug reactions, combining with clinical varieties, dosage and duration of treatment and special populations, more actively ADR information collection and reporting work. Drug production and operation of enterprises and enhance the prevention of drug safety hazards of the high sense of responsibility, not only began to collect ADR cases, some enterprises still carry out needle active safety monitoring work to be informed of. This bulletin varieties and Yanhuning injection of Chuanhuning effective ingredients of two varieties, the in vivo metabolism of the same, the same indications, route of administration, there are security issues similar. For the two varieties of safety of medical workers, pharmaceutical production enterprises and the public understanding, reduce the risk of drug, with special form of notification, two varieties of Chuanhuning Injection yanhuning. Pay attention to the problem of safety of Chuanhuning Injection. The main component of Chuanhuning Injection for Dehydroandroandrographolide Succinate potassium single, mainly used for the treatment of viral pneumonia and viral infection of upper respiratory tract. A case report database of National Center for ADR monitoring, serious adverse reaction / event of Chuanhuning Injection problem is more prominent, mainly in systemic lesions. Clinical manifestations of severe cases The adverse reaction / system events as follows: systemic damage mainly as anaphylactic shock, anaphylactoid reaction, fever, chills, and allergic shock accounted for about 43% of the reported cases of serious respiratory damage; mainly manifested by dyspnea, chest tightness, shortness of breath; mucocutaneous lesions showed severe drug eruption; other damage includes thrombocytopenic purpura, acute renal failure, etc.. Typical case: patient, female, 28 years old, due to intravenous infusion of Potassium Dehydroandrograpolide Succinate Injection upper respiratory tract infection (dose unknown), after about 10 minutes, patients feel chest tightness, shortness of breath, and cyanosis, sweating, blood pressure can not be detected. Immediately stop infusion, give epinephrine and dopamine rescue treatment, 5 hours later, the patient symptoms gradually disappeared, blood pressure returned to normal. On November 2005, the National Bureau has issued a notice, request modification of Chuanhuning Injection instructions, increase the "clinical data" at present there is no adequate medication for children, remove the usage "pediatric reduction or compliance" etc.. But since 2006, the National Center has received a considerable number of serious cases of child drug use. Two, irrational drug use analysis The adverse reaction / National Center database of Chuanhuning Injection event report analysis shows that the product is not reasonable use of clinical phenomenon, mainly as follows: 1. over dose use Chuanhuning Injection instructions: intravenous infusion, day 400 ~ 800mg, 2 times drip, each no more than 400mg. Some of the cases received by the National Center were in excess dose. Typical case: the patient, male, 39 years old, because of more than 24 hours of heat temperature of 39 DEG C, intravenous injection of 800 mg, 5% Glucose Injection Chuanhuning Injection 500 ml infusion, dyspnea 10 minutes after the infusion was stopped immediately, and in patients with facial cyanosis, blood pressure 100/80mmHg, lung rales, no, immediately to 1 mg intramuscular injection of epinephrine and dexamethasone 10 mg were injected into the resuscitation room, patients gradually given continuous oxygen, irritability, unconsciousness, oxygen instability, blood pressure continued to decline, dopamine infusion can maintain normal blood pressure, transferred to the hospital to continue treatment. 2. use of hyper indications Chuanhuning Injection instructions, The product is mainly used for the treatment of viral pneumonia and viral upper respiratory tract infection. The National Center for receiving cases exist beyond the indications for the use of the situation, mainly for the treatment of mycoplasma infection, lobar pneumonia, tonsillitis, intestinal infection, and the other is not clear for the treatment of viral upper respiratory tract infection. Typical case: the patient, male, 37 years old, due to tonsillitis admission, intravenous drip of Potassium Dehydroandrograpolide Succinate Injection after 10 minutes, high fever, chills, pale, breathing difficulties and other symptoms. Immediately stop, give oxygen, phenergan 25mg intramuscular injection, subcutaneous injection of epinephrine 1mg, bolus injection of 5mg dexamethasone injection, after the rescue, symptoms gradually improved. Three, relevant suggestions 1. medical personnel should carefully read the product manual, strictly grasp the indications of Chuanhuning injection. 2. medical personnel should detailed allergy history before the medication, it is strictly prohibited to have allergy history of Chuanhuning Injection patients; it is prohibited to use with other drugs; during the drug to patients were closely observed, once the allergy symptoms, you should immediately stop or give appropriate treatment measures. 3., in view of the fact that there is not enough clinical data for children at present, it is suggested that doctors and nurses should weigh the advantages and disadvantages of drugs in a comprehensive way, strictly grasp the applicable population and be careful with children. 4., it is suggested that the production enterprises should strengthen the propaganda of rational drug use in clinic and strengthen the monitoring of adverse drug reactions. Study on the safety of production enterprises to carry out 5. suggestions, the occurrence mechanism of the adverse reaction of Chuanhuning injection. Pay attention to the problem of safety of Yanhuning injection Department of andrographolide injection Yanhuning Andrographis paniculata extract by esterification, dehydration, salt and refined dehydroandrographolide succinate potassium sodium salt. It is clinically used for viral pneumonia and viral upper respiratory tract infection. A case report database of National Center for ADR monitoring, serious adverse reaction / Event Injection Yanhuning problem is more prominent, mainly in systemic lesions. Clinical manifestations of severe cases The adverse reaction / system events as follows: systemic damage mainly as anaphylactic shock, anaphylactoid reaction, high fever, fatigue, allergic shock accounted for about 27% of the reported cases of serious respiratory damage; mainly manifested by dyspnea, asphyxia, respiratory failure; damage of skin and its accessories for stripping dermatitis, severe drug eruption; other damage including hypotension, coma, quadriplegia, drug-induced hepatitis etc.. In severe cases, 53% were children under the age of 14, children reported more cases of adverse reactions may be related to the population for indications of disease susceptibility Yanhuning crowd. The adverse reactions of children after drug use showed no significant difference with the adverse reactions in the overall case. Yanhuning injection death case report, the major causes of death were caused by drug anaphylactic shock (approximately 38% deaths), in addition to respiratory arrest, asphyxia, cardiac arrest. Typical case: patient, female, 28 years old, because has given clindamycin phosphate 0.9g, Potassium Sodium Dehydroandroandrographolide Succinate for Injection 0.2g intravenous infusion of upper respiratory tract infection. About 10 minutes Potassium Sodium Dehydroandroandrographolide Succinate for Injection infusion, patients appear pale, sweating, and trismus, delirious. Physical examination: the temperature of 36 DEG C, the heart rate of 100 beats per minute, breathing 28 times / min, blood pressure 60/40mmHg, mind is not clear, lungs are rough, weak heart sound. Immediately stop the drug, oxygen inhalation, dexamethasone, 20mg intravenous drip, intramuscular injection of adrenaline, 0.5mg, the symptoms gradually relieved, 1 hours later, the patient ruddy, smooth breathing. Two, irrational drug use analysis The National Center received Yanhuning injection serious adverse reaction / event report shows that the product has the phenomenon of irrational use, mainly as follows: 1. drug overdose: Yanhuning injection instructions: intravenous infusion, day 0.16 ~ 0.4g, 40 ~ 80mg intramuscular injection. Some of the cases received by the National Center were in excess dose. Typical case: patient, female, 11 years old, due to intravenous infusion of Yanhuning 2G upper respiratory tract infection, sudden cough, 2 minutes after choking, shortness of breath, nausea, vomiting and restlessness, facial expression, immediately given dexamethasone 5mg intramuscular injection of 10% calcium gluconate 10ml, the symptoms disappeared after 5 minutes. 2. indications of medication over: 11% case reports of serious adverse reactions are obvious indications of medication over the phenomenon, Yan Huning injection for viral pneumonia and viral infection of the upper respiratory tract, ultra indications is mainly used for the treatment of other viral infection or bacterial infections, such as diarrhea, mycoplasma pneumonia, lymphadenitis and cerebral infarction. Typical case: children, female, 1 years old, because of diarrhea and fever (37.8 C) given Yanhuning injection 80mg intravenous drip, about 1 minutes with cyanosis, lip cyanosis, dyspnea, cardiac arrest and other symptoms, immediately intramuscular injection of epinephrine, intravenous infusion of dexamethasone, sputum and artificial respiration rescue after treatment. The symptoms improved. The 3. part: for patients with allergic drug allergy, or history of drug allergy history, serious allergic reactions with Yanhuning injection. Typical case: patient, female, 72 years old, has a history of allergies Yanhuning injection. Due to intravenous infusion of Potassium Sodium Dehydroandroandrographolide Succinate for Injection upper respiratory tract infection, 2 minutes after administration, the patients of sudden respiratory arrest, bradycardia, cyanosis, skin bruising, blood pressure was not detected. Immediately give Adrealine Injection 1mg, 20mg dexamethasone intravenously, tracheal intubation and artificial ventilation, chest compressions, multiple injections of epinephrine (total 4mg), promethazine intramuscular injection of 25mg, 1.5 hours after the rescue invalid death. Three, relevant suggestions 1. medical staff should fully understand the risks of Yanhuning injection, strictly grasp the indications, weigh patients (especially children patients) in the treatment of the pros and cons, medication should be cautious. 2. medical personnel should be administered strictly in accordance with the usage instructions, shall not exceed the dose application, especially in pediatric patients during the treatment; close observation, abnormal timely discontinuation of Yanhuning injection, and take timely treatment. 3. medical staff should allergy history carefully before treatment, the use of injections had Yanhuning allergy patients should be banned, the other patient allergies (allergic reactions to drugs or other substances of patients) medication should be careful if you need medication, should close monitoring of patients in the treatment process. 4. production enterprises should strengthen drug safety drug promotion, with fully informed drug safety information, prompting clinicians about taboo and caution items in use, according to the physical condition of the patient adjust medication, reasonable use of the drug. Actively carry out in-depth study of adverse reactions occur, the interaction mechanism of Yanhuning injection and 5. production enterprises, the cause analysis of adverse reactions of comprehensive; strengthen the ADR monitoring work, promote the rational use of drugs.