Fluoroquinolones should be standardized for children
【Abstract】 Objective: To quinolones in children with problems in the application were discussed. Methods: The literature was reviewed, the more the authority of the newly published monograph of medicine and drug brochures on the use of quinolones for children to compare the safety warning, combined with our hospital for children's use of quinolones were analyzed. Results: The application of these drugs for children, short-term, there may be rash, nausea, headache
symptoms and no long-term impact of child development. Drug statement relating to the safety warning for children there is inconsistency, be standardized. Conclusion: Children should be used with caution in patients with clinical quinolone drugs
should be used with trade-offs, and make follow-up.
Key words quinolone; children; Security
Quinolones and other antimicrobial drugs the difference lies in the role of the bacterial DNA as a target, it can inhibit DNA enzyme turn impede DNA synthesis, resulting in
irreversible damage to bacterial chromosome leading to bacterial death. This kind of selective bacterial toxicity, determines that it does not have to many antimicrobial agents cross-resistance.
In recent years, with the quinolones and constantly develop new products, further expand the antimicrobial spectrum, clinical applications are more extensive. In my hospital, the number and type of drug use compared to other antibacterial drugs, among the best. However, such drugs in
the clinical application of the process, children with drug
safety issues remain the focus of attention.
An analysis of drug use in our hospital Quinolones
1.1 General Information
2005 total annual discharge passengers 1 125 cases, of which 632 cases of male and female 493 cases, 748 cases suffering from infectious diseases, accounting for 66.5% of the total number of cases. Which contained the first 4 bits of the disease are: upper respiratory tract infection in 351
cases, accounting for 46.9%; 116 cases of acute bronchitis, accounting for 15.5%; 98 cases of bronchopneumonia, accounting for 13.1%; 57 cases of diarrhea in infants, accounting for 7.1%. Patients with infectious diseases were 81 cases of
fluoroquinolones, accounting for 10.8%. 47 cases were male and female 34 cases, with an average age of 8.2 years. Drugs used mainly Levofloxacin Hydrochloride and Sodium Chloride Injection (Dino new) 31 cases, accounting for 38.3%; injection of ciprofloxacin lactate in 23 cases, accounting for 28.4%; 12 Levofloxacin Hydrochloride for Injection cases, accounting for 14.8%.
1.2 Adverse reactions
81 cases of fluoroquinolones in children after the rash in 5 cases, accounting for 6.2%; nausea, abdominal discomfort
on 3 cases, accounting for 3.7%; headache, insomnia in 2 cases, accounting for 2.5%; hip joint pain in 2 cases, accounting for 2.5 %, in all cases after stopping to alleviate the symptoms disappear within a short period. Discontinuation
follow-up six months, children with no developmental
2 Review of the Literature
2.1 Medical Books
The author reviewed the medical monograph on the application of quinolones for children set out security
issues. "Pediatric Infectious Diseases study" that fluoroquinolones in animal experiments that may affect the cartilage of immature animals, development, pregnant women and infants should be used with caution. In recent years, many scholars believe that the animal studies used in the drug dose was significantly higher than the dose of human applications, and the side effects of bones and joints of children have not been reported, it applies to children are relatively safe . "Practical Pediatrics," that: the early years have been found in animal experiments, development of small animal bones there are obstacles, but in recent years, many domestic and foreign clinical data show that children are not aware of many years of clinical application of small animal bones similar
obstacles to quinolones application in children is not consistent with the experimental animals has shown considerable security, that should not be banned for children quinolone drugs, but the indications should be strictly controlled, the dose should not exceed 10 ~ 15 mg / (kg * d), treatment not more than 7 days . "New Drug study" the view that this class of drugs can affect the cartilage growth, pregnant women, young children should be used with caution . "Clinical Guide to rational use of drugs," pointed out that, quinolones should not be used for pregnant women and skeletal systems are not fully developed in children, should not be used for a central nervous system diseases . "Clinical Guide to The People's Republic of China
Pharmacopoeia" and stated that quinolone drugs "in children, young people under 18 years of age, pregnant women, breast milk in the application of safety and efficacy has not been established, the drug should be avoided for 18 years of age Minors . " However, recently published in "Pharmacology" points out that the class of drugs due to the impact on the skeletal system, children, adolescents, pregnant and lactating women banned . "Guiding principles for clinical application of antimicrobial agents" in regard to the attention of
quinolones matters set out as follows: "18 years of age patients to avoid using this class of drugs, pregnancy and lactation patients to avoid the application of this class of drugs." Reposted elsewhere in the paper for free download
2.2 Drug Manual
I looked at the instructions on children's use of quinolones security alerts, the results in Table 1. Quinolone use in children, the safety warning, the mainly in the following situations: (1) unfit for use: This product is used in several kinds of young animals, can cause joint disease, it would be inappropriate for children under the age of 18 and youth; (2) Avoid use: This product is for pregnant women, lactating women, the efficacy and safety has not been
established, should be avoided so that the FDA; (3) Disabled: fluoroquinolones can occur in dogs permanent load-bearing
articular cartilage damages and claudication, in several other minor animals can also be caused by joint disease occurred in
patients below 18 years of age and therefore disabled; (4) No warnings. Table 1 shows that, for the same drugs, manuals, warnings, but some are different, such as norfloxacin, there is "not used", "disabled", no warnings of the situation; levofloxacin exist " patients below age 18 is disabled "," 16 years of age in patients with disabling "and so on. Thus, pharmaceutical instructions relating to the safety warning for children there is inconsistency, which makes the clinical and patient medication at a loss, it should be standardized.
Table 1 quinolone drugs instructions on the application of the safety warning for children (omitted)
Note: * In the warnings set out "by multi-resistant
infections caused by bacteria sensitive only to
fluoroquinolones present when the children may be on balance, the FDA."
In my opinion, a different drug manufacturers, different books, there should be the same or similar conclusions. "Caution", "disabled", "avoid using", although the difference
between just a few words, meaning is different. "Caution" means to remind the patient should be careful condition should
be closely observed during medication changes, if there is adverse reactions should be promptly discontinued. Does not
mean that can not be used with caution. "Disable" is no choice belongs to the absolute prohibition of the use of drugs, once the use of such drugs, there will be serious adverse reactions or poisoning. And "avoid using" is not the best, suggesting that patients should not be used or should avoid the use of these drugs. Some patients taking the drug may arise after the significant adverse drug reactions and adverse consequences.
As a medical worker, in the use of drug treatment of diseases at the same time, the body can not be ignored drugs may produce some adverse reactions, their medication based on professional literature and medicine mainly from the description, while patients can see only the specification of drugs . Drug description is by the State Drug Administration approval of a written document with legal effect. In Benwensuoyin more authority to use reference books and brochures quinolone drugs on children medication safety alerts, the "security", the "caution", the "disabled", the
"avoid" Therefore, the pharmaceutical drugs and even to the insert in the same class of drug safety alerts are different, so that medical professionals know what to do, patients know what to do. Despite the recent publication of some of the authority of the medical monographs that quinolones in children is safe, but some instructions on the medicine continue to mark "Disable." As the drug specification inconsistency, if the patient after a number of adverse drug reactions, even if it is completely unrelated to skeletal
development and impact of adverse reactions, patients are equally likely to intervene to the hospital, thus the occurrence of doctor-patient disputes, undermines the
inconvenience, but also is the use of such drugs in children in the legal pitfalls.
In summary, I believe that in the other quinolones antibacterial drugs ineffective or caused by a variety of drug-resistant infections, the bacteria showed only sensitive to fluoroquinolones, the children can be weighed against the
wise use of such drugs, but should be avoided the long-term
medication. At the same time pay close attention to the short-
term adverse reactions may occur, if necessary, can be used for follow-up, the relevant issues can explain to the patient's family. Quinolone allergy, liver and kidney
dysfunction, central nervous system diseases and epilepsy patients should be disabled.
How to make inconsistent with the view to a unified, coordinated, and arrive at a scientific conclusion is that the relevant departments in the collection, an abundance of information must first be done, This is to ensure safe and effective in patients with medication to prevent the occurrence of vital patient disputes important.
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