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It is only for medical professionals to read and reference.
The guide covers the treatment of drug-resistant tuberculosis, the course of treatment, curative effect monitoring, surgery, and nursing care.
Drug-resistant tuberculosis is still a global public health problem.
Recent statistics show that [1] there were approximately 500,000 new cases of multidrug-resistant or rifampicin-resistant tuberculosis (MDR/RR-TB) in 2018.
The health care system caused significant losses.
The current treatment plan for MDR/RR-TB patients is not satisfactory, requiring longer treatment courses, using more toxic drugs, and worse treatment results.
Nearly 15% of MDR-TB patients died as a result.
To this end, the World Health Organization (WHO) issued the "Comprehensive Guidelines for the Treatment of Drug-resistant Tuberculosis (2020 Edition)" [2], which covers the treatment of drug-resistant tuberculosis, the course of treatment, efficacy monitoring, surgery, and nursing care.
.
Today, I would like to explain in detail the important recommendations and suggestions of this edition of the guide for your reference.
01 Treatment plan for rifampicin-sensitive and isoniazid-resistant tuberculosis ⭐ For rifampicin-sensitive and isoniazid-resistant tuberculosis (HR-TB) patients, it is recommended to use rifampicin, ethambutol, pyrazinamide and Levofloxacin treatment, the course of treatment is 6 months.
⭐ For rifampicin-sensitive and isoniazid-resistant tuberculosis patients, it is not recommended to add streptomycin or other injection drugs to the treatment plan.
It can be seen that for HR-TB patients, the guidelines recommend the addition of levofloxacin instead of streptomycin.
This is because studies have shown that the treatment success rate of adding fluoroquinolones to the (H) REZ regimen is higher than that Without the addition of fluoroquinolones (AOR 2.
8, 95% CL 1.
1 to 7.
3), the number of deaths was relatively reduced (AOR 0.
4, 95% CL 0.
2-1.
1).On the contrary, adding streptomycin to the (H)REZ regimen will reduce the treatment success rate (AOR 0.
4, 95% CL 0.
2-0.
7), and the addition of streptomycin does not reduce mortality.
As for other injections (kanamycin, amikacin, and capreomycin), the WHO guidelines do not recommend it because there is no relevant data for the treatment of HR-TB.
02 Short course treatment plan for multidrug-resistant or rifampicin-resistant tuberculosis (full oral regimen containing bedaquiline) ⭐ It is recommended that patients with MDR/RR-TB adopt a shorter full oral treatment regimen containing bedaquiline, The course of treatment is 9 to 12 months.
Such patients have ruled out resistance to fluoroquinolones and have not been exposed to the second-line tuberculosis drug treatment used in this regimen for more than 1 month.
Bedaquiline is the first-choice drug recommended by the WHO for the long-term treatment of MDR/RR-TB, and it has been included in my country's medical insurance list in 2020.
The WHO guidelines recommend a shorter course of treatment, aiming to reduce the economic burden of MDR/RR-TB patients and improve treatment compliance.
The recommended evidence comes from a study showing that the use of a shorter course of bedaquiline-containing oral regimens in MDR/RR-TB patients is associated with a higher treatment success rate (AOR 2.
1, 95% CI 1.
1-4.
0), And compared with the longer treatment regimen containing Bedaquinoline, the results were not significantly different.
The WHO guidelines emphasize that, in the following cases, for MDR/RR-TB patients who have been ruled out of fluoroquinolones resistance, the above-mentioned shorter course of treatment can be used as the first choice: there is no drug resistance in the shorter course of treatment (isoniazid Except for drug resistance); have not been exposed to the program using second-line drugs for more than 1 month (unless it is confirmed that they are sensitive to these drugs); there is no disseminated tuberculosis, and no serious extrapulmonary tuberculosis; no pregnancy; children ≥ 6 years of age.
03 Longer course of treatment for multidrug-resistant or rifampin-resistant tuberculosis ⭐ MDR/RR-TB patients using a longer course of treatment should include all three group A drugs and at least one group B drug to ensure that at least at the beginning of treatment There are four possible effective tuberculosis drugs.
If bedaquiline is discontinued, at least three drugs should be included in the remaining treatment plan (group C drugs can be added when the drugs in groups A and B are not enough to form a treatment plan).
Here are the three groups of anti-tuberculosis drugs A, B, and C, and I would like to briefly introduce you: Regarding the specific course of treatment for MDR/RR-TB patients using a longer course of treatment, the WHO guidelines make the following recommendations: ⭐ For using a longer course of treatment For patients with MDR/RR-TB, the recommended total treatment course is 18-20 months, and the treatment course can be adjusted according to the patient’s response to treatment.
⭐ For patients with MDR/RR-TB who use a longer course of treatment, it is recommended to treat them for 15-17 months after the tuberculosis culture returns.
The duration can be adjusted according to the patient's response to the treatment.
⭐ For patients with MDR/RR-TB who use a longer treatment regimen of amikacin or streptomycin, an intensive treatment period of 6-7 months is recommended, and the duration can be adjusted according to the patient's treatment response.
The WHO guidelines emphasize that if a shorter course of treatment for MDR-TB cannot be used, patients need to be re-evaluated to initiate a longer course of treatment for MDR-TB.
However, patients who have received a longer course of treatment for at least four weeks cannot switch to a shorter course.
04BPaL regimen for the treatment of fluoroquinolone-resistant multidrug-resistant tuberculosis A treatment plan consisting of linezolid (BPaL).
Such patients have never been exposed to bedaquiline and linezolid, or have been exposed for no more than 2 weeks.
Putomani is a new drug for the treatment of multi-drug-resistant tuberculosis.
It belongs to the nitrosimidazoxazine compound and has significant anti-tuberculosis activity and a unique mechanism of action.
For patients with extensive drug resistance (including fluoroquinolone resistance), there is an urgent need for more effective treatment options.
To this end, the Tuberculosis Alliance conducted a Nix-TB study to evaluate the safety, effectiveness, tolerability and pharmacokinetic properties of BPaL treatment options for a period of 6 months.
The results of the study showed that the adjusted odds ratio for successful treatment with the BPaL regimen was 3.
3 (relative to the combined result of failure and recurrence; 95% CI 0.
8-13.
7).
However, compared with the control group, the BPaL regimen was also associated with a higher incidence of adverse events.
Therefore, the WHO guidelines emphasize that despite the promising treatment success rate observed in the Nix-TB study, the use of BPaL regimens should be cautious and close monitoring of adverse reactions is required before more evidence of efficacy and safety is generated.
05 Use culture method to monitor patient response to treatment of MDR-TB ⭐ For patients with MDR or rifampicin-resistant tuberculosis (MDR/RR-TB) who use a longer course of treatment, it is recommended that in addition to sputum smear microscopy, you should Sputum culture is performed to monitor treatment response, and sputum culture is repeated every other month.
Achieving sustained bacteriological outcome from positive to negative is widely used to evaluate the response to treatment of drug-sensitive and drug-resistant tuberculosis.
The WHO guidelines state that culture is a more sensitive bacteriological confirmation test than direct microscopic examination of sputum and other biological specimens.
Although molecular techniques can provide rapid and reliable diagnosis, they cannot replace cultures or microscopes to monitor bacteriological status during treatment.
In addition, the WHO guidelines emphasize that doctors treating patients with multidrug-resistant tuberculosis should not only refer to the bacteriological results, but also make adjustments based on the treatment response or disease progression, such as the patient's general condition, weight changes, blood tests, and chest imaging.
.
06 AIDS patients receiving second-line anti-tuberculosis program start antiretroviral treatment as soon as possible ⭐ It is recommended that all drug-resistant tuberculosis patients with AIDS who need second-line anti-tuberculosis drugs, regardless of the number of CD4 cells, start anti-tuberculosis treatment as soon as possible (within 8 weeks) Receive antiretroviral therapy (ART).
AIDS patients are at high risk of tuberculosis infection.
The results of a longitudinal cohort study show that compared with patients who do not use ART, patients who use ART have a lower risk of death and a higher probability of curing and alleviating tuberculosis symptoms.
Therefore, the WHO guidelines further recommend that HIV-positive tuberculosis patients with severely suppressed immune function (for example, the number of CD4 cells <50/mm3), receive antiretroviral therapy within two weeks of starting tuberculosis treatment.
07 Surgical treatment of patients with multi-drug resistant tuberculosis ⭐ For patients with MDR/RR-TB, selective partial lung resection (lobectomy or wedge resection) can be combined with the recommended MDR-TB treatment plan.
In fact, surgery was used to treat tuberculosis patients long before the advent of chemotherapy.
In many countries, it is still one of the treatment options for tuberculosis, which can help reduce refractory foci, reduce bacterial load and improve prognosis.
A meta-analysis showed that patients who underwent partial lung resection and patients who underwent pneumonectomy had a higher rate of treatment success compared with patients who did not undergo surgery.
However, there was no significant difference in mortality between patients who received surgical treatment and those who received medical treatment.
08 Care and support for patients with multidrug-resistant or rifampicin tuberculosis ⭐ Health education and consultation on the disease and treatment compliance should be provided to patients receiving tuberculosis treatment.
Strengthening health education and providing necessary support is the key to improving compliance with tuberculosis treatment.
Intervention measures include social support, such as material support (such as food, financial incentives or transportation expenses), psychological support, follow-up, such as home visits, text messages or phone calls, and medication Monitoring and education, etc.
The WHO guidelines emphasize that the choice of intervention measures should be based on the assessment of patient needs, medical resources and implementation conditions.
The above are the important recommendations of the 2020 WHO Comprehensive Guidelines for the Treatment of Drug-resistant Tuberculosis.
If you are interested, please read the original text of the guidelines.
There are a lot of evidence-based medicine evidence analysis and more specific recommendations. References: [1]Global tuberculosis report 2019(WHO/CDS/TB/2019.
15).
Geneva World Health Organization;2019(https:// 29 May 2020 ).
[2]https://
The guide covers the treatment of drug-resistant tuberculosis, the course of treatment, curative effect monitoring, surgery, and nursing care.
Drug-resistant tuberculosis is still a global public health problem.
Recent statistics show that [1] there were approximately 500,000 new cases of multidrug-resistant or rifampicin-resistant tuberculosis (MDR/RR-TB) in 2018.
The health care system caused significant losses.
The current treatment plan for MDR/RR-TB patients is not satisfactory, requiring longer treatment courses, using more toxic drugs, and worse treatment results.
Nearly 15% of MDR-TB patients died as a result.
To this end, the World Health Organization (WHO) issued the "Comprehensive Guidelines for the Treatment of Drug-resistant Tuberculosis (2020 Edition)" [2], which covers the treatment of drug-resistant tuberculosis, the course of treatment, efficacy monitoring, surgery, and nursing care.
.
Today, I would like to explain in detail the important recommendations and suggestions of this edition of the guide for your reference.
01 Treatment plan for rifampicin-sensitive and isoniazid-resistant tuberculosis ⭐ For rifampicin-sensitive and isoniazid-resistant tuberculosis (HR-TB) patients, it is recommended to use rifampicin, ethambutol, pyrazinamide and Levofloxacin treatment, the course of treatment is 6 months.
⭐ For rifampicin-sensitive and isoniazid-resistant tuberculosis patients, it is not recommended to add streptomycin or other injection drugs to the treatment plan.
It can be seen that for HR-TB patients, the guidelines recommend the addition of levofloxacin instead of streptomycin.
This is because studies have shown that the treatment success rate of adding fluoroquinolones to the (H) REZ regimen is higher than that Without the addition of fluoroquinolones (AOR 2.
8, 95% CL 1.
1 to 7.
3), the number of deaths was relatively reduced (AOR 0.
4, 95% CL 0.
2-1.
1).On the contrary, adding streptomycin to the (H)REZ regimen will reduce the treatment success rate (AOR 0.
4, 95% CL 0.
2-0.
7), and the addition of streptomycin does not reduce mortality.
As for other injections (kanamycin, amikacin, and capreomycin), the WHO guidelines do not recommend it because there is no relevant data for the treatment of HR-TB.
02 Short course treatment plan for multidrug-resistant or rifampicin-resistant tuberculosis (full oral regimen containing bedaquiline) ⭐ It is recommended that patients with MDR/RR-TB adopt a shorter full oral treatment regimen containing bedaquiline, The course of treatment is 9 to 12 months.
Such patients have ruled out resistance to fluoroquinolones and have not been exposed to the second-line tuberculosis drug treatment used in this regimen for more than 1 month.
Bedaquiline is the first-choice drug recommended by the WHO for the long-term treatment of MDR/RR-TB, and it has been included in my country's medical insurance list in 2020.
The WHO guidelines recommend a shorter course of treatment, aiming to reduce the economic burden of MDR/RR-TB patients and improve treatment compliance.
The recommended evidence comes from a study showing that the use of a shorter course of bedaquiline-containing oral regimens in MDR/RR-TB patients is associated with a higher treatment success rate (AOR 2.
1, 95% CI 1.
1-4.
0), And compared with the longer treatment regimen containing Bedaquinoline, the results were not significantly different.
The WHO guidelines emphasize that, in the following cases, for MDR/RR-TB patients who have been ruled out of fluoroquinolones resistance, the above-mentioned shorter course of treatment can be used as the first choice: there is no drug resistance in the shorter course of treatment (isoniazid Except for drug resistance); have not been exposed to the program using second-line drugs for more than 1 month (unless it is confirmed that they are sensitive to these drugs); there is no disseminated tuberculosis, and no serious extrapulmonary tuberculosis; no pregnancy; children ≥ 6 years of age.
03 Longer course of treatment for multidrug-resistant or rifampin-resistant tuberculosis ⭐ MDR/RR-TB patients using a longer course of treatment should include all three group A drugs and at least one group B drug to ensure that at least at the beginning of treatment There are four possible effective tuberculosis drugs.
If bedaquiline is discontinued, at least three drugs should be included in the remaining treatment plan (group C drugs can be added when the drugs in groups A and B are not enough to form a treatment plan).
Here are the three groups of anti-tuberculosis drugs A, B, and C, and I would like to briefly introduce you: Regarding the specific course of treatment for MDR/RR-TB patients using a longer course of treatment, the WHO guidelines make the following recommendations: ⭐ For using a longer course of treatment For patients with MDR/RR-TB, the recommended total treatment course is 18-20 months, and the treatment course can be adjusted according to the patient’s response to treatment.
⭐ For patients with MDR/RR-TB who use a longer course of treatment, it is recommended to treat them for 15-17 months after the tuberculosis culture returns.
The duration can be adjusted according to the patient's response to the treatment.
⭐ For patients with MDR/RR-TB who use a longer treatment regimen of amikacin or streptomycin, an intensive treatment period of 6-7 months is recommended, and the duration can be adjusted according to the patient's treatment response.
The WHO guidelines emphasize that if a shorter course of treatment for MDR-TB cannot be used, patients need to be re-evaluated to initiate a longer course of treatment for MDR-TB.
However, patients who have received a longer course of treatment for at least four weeks cannot switch to a shorter course.
04BPaL regimen for the treatment of fluoroquinolone-resistant multidrug-resistant tuberculosis A treatment plan consisting of linezolid (BPaL).
Such patients have never been exposed to bedaquiline and linezolid, or have been exposed for no more than 2 weeks.
Putomani is a new drug for the treatment of multi-drug-resistant tuberculosis.
It belongs to the nitrosimidazoxazine compound and has significant anti-tuberculosis activity and a unique mechanism of action.
For patients with extensive drug resistance (including fluoroquinolone resistance), there is an urgent need for more effective treatment options.
To this end, the Tuberculosis Alliance conducted a Nix-TB study to evaluate the safety, effectiveness, tolerability and pharmacokinetic properties of BPaL treatment options for a period of 6 months.
The results of the study showed that the adjusted odds ratio for successful treatment with the BPaL regimen was 3.
3 (relative to the combined result of failure and recurrence; 95% CI 0.
8-13.
7).
However, compared with the control group, the BPaL regimen was also associated with a higher incidence of adverse events.
Therefore, the WHO guidelines emphasize that despite the promising treatment success rate observed in the Nix-TB study, the use of BPaL regimens should be cautious and close monitoring of adverse reactions is required before more evidence of efficacy and safety is generated.
05 Use culture method to monitor patient response to treatment of MDR-TB ⭐ For patients with MDR or rifampicin-resistant tuberculosis (MDR/RR-TB) who use a longer course of treatment, it is recommended that in addition to sputum smear microscopy, you should Sputum culture is performed to monitor treatment response, and sputum culture is repeated every other month.
Achieving sustained bacteriological outcome from positive to negative is widely used to evaluate the response to treatment of drug-sensitive and drug-resistant tuberculosis.
The WHO guidelines state that culture is a more sensitive bacteriological confirmation test than direct microscopic examination of sputum and other biological specimens.
Although molecular techniques can provide rapid and reliable diagnosis, they cannot replace cultures or microscopes to monitor bacteriological status during treatment.
In addition, the WHO guidelines emphasize that doctors treating patients with multidrug-resistant tuberculosis should not only refer to the bacteriological results, but also make adjustments based on the treatment response or disease progression, such as the patient's general condition, weight changes, blood tests, and chest imaging.
.
06 AIDS patients receiving second-line anti-tuberculosis program start antiretroviral treatment as soon as possible ⭐ It is recommended that all drug-resistant tuberculosis patients with AIDS who need second-line anti-tuberculosis drugs, regardless of the number of CD4 cells, start anti-tuberculosis treatment as soon as possible (within 8 weeks) Receive antiretroviral therapy (ART).
AIDS patients are at high risk of tuberculosis infection.
The results of a longitudinal cohort study show that compared with patients who do not use ART, patients who use ART have a lower risk of death and a higher probability of curing and alleviating tuberculosis symptoms.
Therefore, the WHO guidelines further recommend that HIV-positive tuberculosis patients with severely suppressed immune function (for example, the number of CD4 cells <50/mm3), receive antiretroviral therapy within two weeks of starting tuberculosis treatment.
07 Surgical treatment of patients with multi-drug resistant tuberculosis ⭐ For patients with MDR/RR-TB, selective partial lung resection (lobectomy or wedge resection) can be combined with the recommended MDR-TB treatment plan.
In fact, surgery was used to treat tuberculosis patients long before the advent of chemotherapy.
In many countries, it is still one of the treatment options for tuberculosis, which can help reduce refractory foci, reduce bacterial load and improve prognosis.
A meta-analysis showed that patients who underwent partial lung resection and patients who underwent pneumonectomy had a higher rate of treatment success compared with patients who did not undergo surgery.
However, there was no significant difference in mortality between patients who received surgical treatment and those who received medical treatment.
08 Care and support for patients with multidrug-resistant or rifampicin tuberculosis ⭐ Health education and consultation on the disease and treatment compliance should be provided to patients receiving tuberculosis treatment.
Strengthening health education and providing necessary support is the key to improving compliance with tuberculosis treatment.
Intervention measures include social support, such as material support (such as food, financial incentives or transportation expenses), psychological support, follow-up, such as home visits, text messages or phone calls, and medication Monitoring and education, etc.
The WHO guidelines emphasize that the choice of intervention measures should be based on the assessment of patient needs, medical resources and implementation conditions.
The above are the important recommendations of the 2020 WHO Comprehensive Guidelines for the Treatment of Drug-resistant Tuberculosis.
If you are interested, please read the original text of the guidelines.
There are a lot of evidence-based medicine evidence analysis and more specific recommendations. References: [1]Global tuberculosis report 2019(WHO/CDS/TB/2019.
15).
Geneva World Health Organization;2019(https:// 29 May 2020 ).
[2]https://
