Preface
Infectious diseases caused by bacteria, viruses, mycoplasma, chlamydia and other pathogenic microorganisms are found in various clinical departments, among which bacterial infections are the most common, and therefore antibacterial drugs have become one of the most widely used drugs in clinical practice. While antimicrobial drugs have cured and saved many patients’ lives, there are also adverse consequences caused by the irrational application of antimicrobial drugs, such as the increase of adverse reactions, the growth of bacterial resistance, and the failure of treatment, which have a significant impact on patients’ health and even lives. The irrational application of antimicrobial drugs is manifested in many aspects: preventive drugs without indications, therapeutic drugs without indications, wrong selection of antimicrobial drug species and dosage, unreasonable route of administration, number of times of administration and course of treatment. In order to improve the level of antimicrobial treatment of bacterial infections, ensure the safety of patients’ medication and reduce bacterial resistance, the Guidelines for Clinical Use of Antimicrobial Drugs (hereinafter referred to as “Guidelines”) are formulated. The Guidelines elaborate on the principles of antimicrobial therapy for the most important bacterial infections in infectious diseases, the indications for the application of antimicrobial drugs for treatment and prevention, and the principles for the formulation of rational drug administration programs, and list the indications and precautions for commonly used antimicrobial drugs and the etiologic treatment of various common bacterial infections, with the aim of improving the level of antimicrobial therapy for infectious diseases in China, slowing down the development of bacterial resistance, and reducing The aim is to improve the level of antimicrobial therapy for infectious diseases, slow down the development of bacterial resistance and reduce the cost of medicine.
1, this “guideline” for the clinical application of antibacterial drugs to obtain the best efficacy, and to minimize the avoidance or reduction of adverse reactions and developed, not a textbook or reference book, and does not involve specific drug delivery program.
2.The Guidelines are mainly limited to antibacterial drugs for the treatment of infectious diseases caused by bacteria, mycoplasma, chlamydia, rickettsia, spirochetes, fungi and other pathogenic microorganisms, excluding drugs for the treatment of various viral diseases and parasitic diseases.
3, the basic principles of the clinical application of antibacterial drugs in the “Guidelines” must be followed in clinical treatment, the indications and precautions for various types of antibacterial drugs and the pathogenic treatment of various infections are for the reference of clinicians.
4. In order to strengthen the management of the clinical application of antibacterial drugs, this Guideline also puts forward requirements for the management of the application of antibacterial drugs, which should be followed.
5, the “Guidelines” only relate to some of the varieties of commonly used domestic clinical antibacterial drugs, focusing on the antibacterial effects of various drugs, indications and precautions, the details of the clinical application of antibacterial drugs should still refer to the relevant professional books.
6, the “guideline” involves some common and important infectious diseases in various clinical departments, other infections not involved should still refer to the relevant professional books.
7, in the medical work of clinicians should still be combined with the specific circumstances of patients, the development of individualized drug delivery program.
8, “pathogenic treatment” in addition to the “guidelines” listed in the usual choice of drug varieties, clinicians can choose the most appropriate antibacterial drugs according to the patient’s clinical situation, bacterial resistance and local drug supply.
Chinese Medical Association
Chinese Hospital Management Association Professional Committee of Pharmacy Management
Hospital Pharmacy Committee of the Chinese Pharmaceutical Society
Part I Basic principles of clinical application of antimicrobial drugs
The correct and rational application of antimicrobial drugs is the key to improving the efficacy, reducing the incidence of adverse reactions and reducing or slowing down the occurrence of bacterial drug resistance. Whether the clinical application of antimicrobial drugs is correct and reasonable is based on the following two aspects: (1) whether there are indications for the application of antimicrobial drugs; (2) whether the selected species and drug delivery scheme are correct and reasonable.
Basic principles of therapeutic application of antimicrobial drugs
A. If the diagnosis is bacterial infection, the party has the indication to apply antibacterial drugs
According to the patient’s symptoms, signs and blood, urine routine and other laboratory test results, the preliminary diagnosis of bacterial infection and the pathogenic examination confirmed the diagnosis of bacterial infection before the application of antibacterial drugs; fungal, Mycobacterium tuberculosis, non-tuberculous mycobacteria, mycoplasma, chlamydia, spirochetes, rickettsia and some protozoa and other pathogenic microorganisms caused by the infection also have indications to apply antibacterial drugs. In the absence of evidence of bacterial and above pathogenic microbial infections, the diagnosis cannot be established, as well as viral infections, there are no indications for the application of antibacterial drugs.
Second, the early identification of the cause of infection, according to the type of pathogen and the results of bacterial drug sensitivity test selection of antibacterial drugs
In principle, the selection of antimicrobial drugs should be based on the type of pathogenic bacteria and their sensitivity or resistance to antimicrobial drugs, that is, the results of bacterial drug sensitivity tests (hereinafter referred to as drug sensitivity). Therefore, medical institutions that have the conditions, inpatients must first take the corresponding specimens before starting antimicrobial therapy, and immediately send bacterial culture, in order to clarify the pathogenic bacteria and drug sensitivity results as soon as possible; outpatients can carry out drug sensitivity according to the needs of the condition.
In critical patients, before the pathogenic bacteria and drug sensitivity results are known, the most likely pathogenic bacteria can be inferred from the patient’s morbidity, site of onset, primary lesion and underlying disease, and the empirical treatment of antibacterial drugs can be given first in combination with the local bacterial resistance status.
Third, according to the characteristics of the antibacterial action of drugs and their in vivo process characteristics to select the use of drugs
The pharmacodynamics (antibacterial spectrum and antibacterial activity) and pharmacokinetics (absorption, distribution, metabolism and excretion processes) of various antibacterial drugs are different, so they have different clinical indications. Clinicians should select antimicrobial drugs according to their clinical indications (see “Indications and precautions for various types of antimicrobial drugs”) based on the above-mentioned characteristics of various antimicrobial drugs.
Fourth, antimicrobial drug treatment plan should be integrated with the patient’s condition, pathogenic bacteria and antimicrobial drug characteristics to develop
According to the pathogenic bacteria, the site of infection, the severity of infection and the patient’s physiological and pathological conditions to develop antibacterial drug treatment plan, including the choice of antibacterial drugs, dose, the number of doses, route of administration, the course of treatment and the combination of drugs. The following principles should be followed when formulating the treatment plan.
(A) species selection: select antibacterial drugs according to the type of pathogenic bacteria and drug sensitivity results.
(B) the dose: according to the therapeutic dose range of various antibacterial drugs. Treatment of severe infections (such as sepsis, infective endocarditis, etc.) and infections in areas not easily reached by antibacterial drugs (such as central nervous system infections, etc.), the dose of antibacterial drugs should be larger (therapeutic dose range high limit); while the treatment of simple lower urinary tract infections, because most drugs urine drug concentration is much higher than the blood concentration, the application of smaller doses (therapeutic dose range low limit).
(iii) Route of administration.
1, mild infections can receive oral administration, should be selected to use oral absorption of complete antibacterial drugs, without the use of intravenous or intramuscular injection of drugs. The initial treatment of patients with severe infection and systemic infection should be given intravenously to ensure the efficacy of the drug; when the condition improves and can be taken orally, the drug should be switched to oral administration as early as possible.
2, the local application of antibacterial drugs should be avoided as far as possible: after the local application of antibacterial drugs in the skin mucosa, they are rarely absorbed and cannot reach the effective concentration at the infection site, which is easy to cause allergic reactions or lead to the production of drug-resistant bacteria. Local application of antimicrobial drugs is limited to a few cases, for example, when it is difficult to achieve therapeutic concentration at the infected site after systemic administration, local administration can be added as an adjunctive treatment. This can be seen in the treatment of central nervous system infections where certain drugs can be administered intrathecally at the same time, the injection of antibacterial drugs into the abscess cavity of encapsulated thick-walled abscesses, and the local administration of drugs for ophthalmic infections. Certain infections of the skin surface and mucosal surfaces such as the oral cavity and vagina can be treated with topical application of antibacterial drugs or topical application, but topical application of species mainly for systemic application should be avoided. Topical medications should be used with bactericidal agents that are less irritating, less easily absorbed, less likely to cause drug resistance and less likely to cause allergic reactions. Aminoglycosides and other ototoxic drugs should not be used as local ear drops.
(iv) The number of doses: In order to ensure that the drug can maximize its efficacy in the body and kill the pathogenic bacteria at the foci of infection, the drug should be administered according to the principle of combining pharmacokinetics and pharmacodynamics. Penicillins, cephalosporins and other β-lactams, erythromycin, clindamycin and other drugs with short elimination half-life should be given several times a day. Fluoroquinolones, aminoglycosides, etc. can be given once a day (with the exception of severe infections).
(E) course of treatment: the course of antibacterial drugs varies depending on the infection, and it is generally advisable to use until the body temperature is normal, 72-96 hours after the symptoms subside, special circumstances, proper treatment. However, sepsis, infective endocarditis, septic meningitis, typhoid fever, brucellosis, osteomyelitis, hemolytic streptococcal pharyngitis and tonsillitis, deep fungal disease, tuberculosis, etc. require a longer course of treatment to completely cure and prevent recurrence.
(F) the combination of antibacterial drugs to have clear indications: a single drug can be effectively treated infections, do not need to combine drugs, only in the following cases when there are indications for the combination of drugs.
1, the original bacteria have not been identified serious infections, including serious infections of immunodeficient people.
2, single antibacterial drugs can not control the aerobic bacteria and anaerobic bacteria mixed infection, 2 or more pathogenic bacteria infection.
3.Serious infections such as infective endocarditis or sepsis that cannot be effectively controlled by a single antimicrobial drug.
4.Infections that require long course of treatment, but the pathogenic bacteria are prone to resistance to certain antibacterial drugs, such as tuberculosis, deep fungal disease.
5.Because of the synergistic antibacterial effect of drugs, the dose of antibacterial drugs with high toxicity should be reduced when combined with drugs, such as amphotericin B and flucytosine when combined with cryptococcal meningitis, the dose of the former can be reduced appropriately, so as to reduce its toxic reaction. The combination of drugs with synergistic or additive antibacterial effects is appropriate, such as the combination of penicillins, cephalosporins and other β-lactams with aminoglycosides, and the combination of amphotericin B with flucytosine. The combination of 2 drugs is usually used, and the combination of 3 and more drugs is only applicable to individual cases, such as the treatment of tuberculosis. In addition, it must be noted that the combination of drugs will increase the number of adverse drug reactions.
The basic principles of preventive application of antibacterial drugs
I. Preventive use in internal medicine and pediatrics
1, for the prevention of one or two specific pathogenic bacteria invasion of the body caused by infection, may be effective; if the purpose is to prevent any bacterial invasion, it is often ineffective.
2.Prevention of infections occurring over a period of time may be effective; long-term preventive medication often fails to achieve the purpose.
3.Preventive medicine may be effective if the patient’s primary disease can be cured or in remission. If the primary disease cannot be cured or remitted (such as immunodeficient patients), preventive medicine should be used as little as possible or not. For immunodeficient patients, it is advisable to closely observe their condition, and once the signs of infection appear, send the relevant specimens for culture at the same time, first give empirical treatment.
4, usually not suitable for routine preventive application of antibacterial drugs: common cold, measles, chickenpox and other viral diseases, coma, shock, poisoning, heart failure, tumors, the application of adrenocorticotropic hormones and other patients.
II. Preventive medication for surgical procedures
(A) surgical prophylaxis purpose: to prevent post-operative incision infection, as well as clean – contaminated or contaminated surgical site infection and post-operative systemic infection may occur.
(B) the basic principles of surgical prophylaxis: according to whether the surgical field is contaminated or contaminated may, decide whether to prevent the use of antibacterial drugs.
1, clean surgery: the surgical field is a sterile part of the human body, no local inflammation, no injury, and does not involve the respiratory tract, gastrointestinal tract, genitourinary tract and other organs of the human body with the outside world. The surgical field is free of contamination and usually does not require prophylactic antibacterial drugs. (4) High-risk groups such as those of advanced age or immunodeficient persons.
2. Clean – contaminated surgery: upper and lower respiratory tract, upper and lower gastrointestinal tract, genitourinary tract surgery, or surgery via the above organs, such as major transoral pharyngeal surgery, transvaginal hysterectomy, transrectal prostate surgery, and open fracture or trauma surgery. Because of the presence of a large number of human parasitic flora at the surgical site, infection may be caused by contamination of the surgical field during surgery.
3. Contaminated surgery: surgery that has caused serious contamination of the surgical field due to large spillage of body fluids from the gastrointestinal tract, urinary tract, biliary tract or open trauma without dilation. These surgeries need preventive antibacterial drugs.
Pre-operative bacterial infection surgery, such as peritonitis of perforated abdominal organs, abscess resection, gas gangrene amputation, etc., is the therapeutic application of antimicrobial drugs, does not belong to the scope of preventive applications.
4, the choice of antibacterial drugs for surgical prophylaxis and the method of administration: the choice of antibacterial drugs depends on the purpose of prevention. To prevent postoperative incision infection, the drug should be selected for Staphylococcus aureus (hereinafter referred to as Staphylococcus aureus). To prevent surgical site infections or systemic infections, drugs should be selected according to the type of contamination or possible contamination in the surgical field, such as antibacterial drugs that are effective against Escherichia coli and Bacteroides fragilis before colon or rectal surgery. The antimicrobial drugs chosen must be sure of their efficacy, safe, easy to use and relatively low in price.
Method of administration: For those who undergo clean surgery, the drug should be administered within 0.5 to 2 hours before surgery, or at the beginning of anesthesia, so that a drug concentration sufficient to kill the bacteria that invade the incision during surgery has been reached in the local tissues when the surgical incision is exposed. A second dose may be given intraoperatively if the duration of surgery exceeds 3 hours or if blood loss is high (>1500 ml). The effective duration of antimicrobial drug coverage should include the entire surgical procedure and 4 hours after the end of surgery, with the total duration of prophylaxis not exceeding 24 hours, which may be extended to 48 hours in individual cases.