Irrationality of ceftriaxone sodium

The unreasonable clinical use of ceftriaxone sodium was warned.

Statistics from the case report database of the National Adverse Drug Reaction Monitoring Center show that the proportion of adverse events reported by anti-infective drugs is close to 50% of the total reports; The total number of adverse events and serious reports of ceftriaxone sodium accounts for a high proportion in anti-infective drugs, and the number of deaths ranks first in anti-infective drugs. To this end, the US Food and Drug Administration recently held a press conference to warn the clinical unreasonable use of ceftriaxone sodium.

What are the main clinical manifestations of unreasonable use of ceftriaxone sodium? From the second half of 2007, the National Adverse Drug Reaction Monitoring Center began to conduct a comprehensive evaluation of this variety. The whole evaluation lasted for half a year. After a comprehensive and systematic evaluation, when ceftriaxone sodium is used reasonably, the benefits obviously outweigh the risks. Irrational drug use is common in the reports of adverse drug reactions/events, which significantly increases the risk of drug use and the number of adverse events. The reporter invited experts from the National Adverse Drug Reaction Monitoring Center to summarize the main problems existing in the unreasonable clinical use of ceftriaxone sodium and put forward corresponding suggestions.

Irrational drug use. Question 1: Over-indication drugs (drugs are not symptomatic)

Typical case: the patient, female, 17 years old, came to the hospital with a gastrointestinal cold, and her consciousness was blurred after using ceftriaxone sodium. Stop using ceftriaxone sodium immediately, and the symptoms improved after 10 minutes.

Expert analysis: Ceftriaxone sodium is not suitable for gastrointestinal cold, but generally suitable for serious infections, such as respiratory tract infection, septicemia, abdominal infection, pyelonephritis, pelvic inflammatory disease, bone and joint infection, skin and soft tissue infection, central nervous system infection and so on. According to the national center case report database, the over-indication drugs in severe cases account for about 10% of the total number of severe case reports.

Overdose problem 2: Children overdose.

Typical case: a 4-year-old boy, weighing 1 1kg, was given 2g of ceftriaxone sodium for bronchitis. 1 minute later, the child has a runny nose and white sputum in his mouth. He immediately shut off the infusion and carried out rescue. After 30 minutes, he died after being rescued.

Expert analysis: The drug instructions of ceftriaxone sodium clearly point out that the daily dose of intravenous administration for children is 20-80mg/kg body weight. The national center case report database shows that some children have overdosed.

Problem 3 of irrational drug use and mixed drug use: incompatibility (mixed use with other drugs)

Typical case: A 60-year-old female patient went to the local village health center because of upper respiratory tract infection and was given a mixture of ceftriaxone sodium, dexamethasone and ribavirin. After about 20 minutes, he suddenly felt difficulty breathing, and then his heart stopped. He died after eight hours of rescue.

Expert analysis: The drug instructions of ceftriaxone sodium clearly indicate that this product cannot be mixed with other drugs, because there may be incompatibility between drugs, so it should be used alone when combined drugs are needed. The national center case report database shows that serious cases have the problem of intravenous use of ceftriaxone sodium mixed with other drugs. Ceftriaxone sodium and dexamethasone are mostly used intravenously, followed by antiviral drugs such as ribavirin and/or traditional Chinese medicine injections. In a few cases, up to four drugs are mixed at a time.

Irrational drug use in people with drug allergy Problem 4: Contraindications (drugs used by people with drug allergy)

Typical case: patient, female, 35 years old, had a history of penicillin allergy. Ceftriaxone sodium is used for "secondary infection caused by mosquito bites". After about 2 minutes, the patient felt unwell and stopped infusion immediately. 15 minutes later, the patient's heart suddenly stopped, and he continued to be rescued and died.

Expert analysis: in the instructions of ceftriaxone sodium, it has been clearly stated that "this product is prohibited for patients who are allergic to cephalosporins." "Before using this product, the patient's allergic history should be inquired in detail, and any allergic patient should use this product with caution. People who are allergic to penicillin may have a cross-allergic reaction to this product and should be used with caution. " The analysis of the case report database of the National Center shows that patients who are allergic to ceftriaxone sodium and penicillin use drugs, which leads to serious consequences of patient death.

Unreasonable use of drinking during medication problem 5: drinking during medication.

Typical case: A 60-year-old male patient received ceftriaxone sodium once a day for upper respiratory tract infection. On the third morning, the patient suddenly had difficulty breathing after drinking alcohol, and was rescued immediately, and his symptoms gradually eased.

Expert analysis: Ceftriaxone sodium can affect ethanol metabolism and increase the concentration of acetylaldehyde in blood, showing facial flushing, headache, dizziness, abdominal pain, nausea, vomiting, shortness of breath, increased heart rate, decreased blood pressure, drowsiness, hallucinations and so on. Therefore, alcohol consumption, alcoholic drugs, beverages or intravenous drugs should be avoided during and after drug withdrawal 1 week.

Irrational medication during operation. Question 6: Irrational medication during operation.

Typical case: A 34-year-old male patient was treated with ceftriaxone sodium after kidney calculi operation. When the infusion reached 10ml, the patient felt sick and vomited, and stopped the infusion immediately. 10 minutes later, the patient developed dyspnea and closed teeth, and was transferred to the intensive care unit.

Expert analysis: Perioperative drug use should meet the requirements of the Guiding Principles for Clinical Application of Antibacterials and the Guidelines for Preventive Use of Antibacterials in Perioperative Period. According to the case report database of the National Center, 46 cases of serious cases used ceftriaxone sodium during perioperative period, which mainly had some problems, such as improper timing, high starting point or no indication, long-term medication and so on, which might lead to serious adverse events.

Drug treatment of neonatal hyperbilirubinemia

Unreasonable use problem 7: medication for neonatal hyperbilirubinemia

Typical case: a boy, born 9 days ago, was treated with ceftriaxone sodium for neonatal hyperbilirubinemia, once a day/kloc-0. At 8: 30 on the third morning, the child developed fever and shortness of breath. 12: 55, the child stopped breathing and the rescue was invalid. He was pronounced clinically dead on 14: 10.

Expert analysis: The instructions of ceftriaxone sodium clearly point out that ceftriaxone sodium can replace bilirubin from serum albumin, and neonatal jaundice may occur in hyperbilirubinemia (especially premature infants), so this product should be used with caution or avoided. However, according to the data of the National Center's case report database, the use of ceftriaxone sodium exists in neonatal hyperbilirubinemia.