A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in China
Abstract Background To verify the efficacy and safety of an inexpensive standardized regimen for multidrug-resistant tuberculosis (MDR-TB) with low resistance to isoniazid (INH), a multicenter prospective study was conducted in eastern China. Methods Patients diagnosed as MDR-TB with low concentrati...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2021-08-01
|
| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-021-06553-2 |
| _version_ | 1818600742729023488 |
|---|---|
| author | Wenwen Sun Zheyuan Wu Ying Zhou Fan Xia Qin Tang Jie Wang Jinghui Yang Fangyou Yu Hua Yang Heping Xiao Lin Fan |
| author_facet | Wenwen Sun Zheyuan Wu Ying Zhou Fan Xia Qin Tang Jie Wang Jinghui Yang Fangyou Yu Hua Yang Heping Xiao Lin Fan |
| author_sort | Wenwen Sun |
| collection | DOAJ |
| description | Abstract Background To verify the efficacy and safety of an inexpensive standardized regimen for multidrug-resistant tuberculosis (MDR-TB) with low resistance to isoniazid (INH), a multicenter prospective study was conducted in eastern China. Methods Patients diagnosed as MDR-TB with low concentration INH resistance and rifampicin resistance, second-line/injectable agents sensitive were prospectively enrolled, given the regimen of Amikacin (Ak)–Fluoroquinolones (FQs)–Cycloserine (Cs)–Protionamide (Pto)–PasiniaZid (Pa)–Pyrazinamide (Z) for 6 months followed by 12 months of FQs–Cs–Pto–Pa–Z, and then followed up for treatment outcomes and adverse events (AEs). Results A total of 114 patients were enrolled into the study. The overall favorable treatment rate was 79.8% (91/114). Among 91 cases with favorable treatment, 75.4% (86/114) were cured and 4.4% (5/114) were completed treatment. Regarding to unfavorable outcomes, among 23 cases, 8.8% (10/114) had failures, 8.8% (10/114) losing follow up, 0.9% (1/114) had treatment terminated due to intolerance to drugs and 1.8% (2/114) died. Treatment favorable rate was significantly higher in newly treated MDR-TB (91.7%, 33/36) than that in retreated MDR-TB (74.4%, 58/78, p 0.03). The investigators recorded 42 AEs occurrences in 30 of 114 patients (26.3%). Clinicians rated most AEs as mild or moderate (95.24%, 40/42). Conclusions The regimen was proved to be effective, safe and inexpensive. It is suitable for specific drug resistant population, especially for newly-treated patients, which could be expected to be developed into a short-course regimen. Clinical trials registration China Clinical Trial Registry ChiCTR-OPC-16009380 |
| first_indexed | 2024-12-16T12:40:20Z |
| format | Article |
| id | doaj.art-86f484f566154fb99c4dfb7fa4d8896e |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-16T12:40:20Z |
| publishDate | 2021-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-86f484f566154fb99c4dfb7fa4d8896e2022-12-21T22:31:26ZengBMCBMC Infectious Diseases1471-23342021-08-012111910.1186/s12879-021-06553-2A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in ChinaWenwen Sun0Zheyuan Wu1Ying Zhou2Fan Xia3Qin Tang4Jie Wang5Jinghui Yang6Fangyou Yu7Hua Yang8Heping Xiao9Lin Fan10Department of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai Clinical Research Center for Tuberculosis, Tongji University School of MedicineShanghai Municipal Center for Disease Control and PreventionShanghai Xuhui District Central HospitalDepartment of Pulmonary Disease, PLA 905 HospitalDepartment of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai Clinical Research Center for Tuberculosis, Tongji University School of MedicineShanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai Clinical Research Center for Tuberculosis, Tongji University School of MedicineDepartment of Clinical Laboratory, Shanghai Pulmonary Hospital, Tongji University School of MedicineDepartment of Clinical Laboratory, Shanghai Pulmonary Hospital, Tongji University School of MedicineShanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai Clinical Research Center for Tuberculosis, Tongji University School of MedicineDepartment of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai Clinical Research Center for Tuberculosis, Tongji University School of MedicineDepartment of Tuberculosis, Shanghai Pulmonary Hospital, Shanghai Clinical Research Center for Tuberculosis, Tongji University School of MedicineAbstract Background To verify the efficacy and safety of an inexpensive standardized regimen for multidrug-resistant tuberculosis (MDR-TB) with low resistance to isoniazid (INH), a multicenter prospective study was conducted in eastern China. Methods Patients diagnosed as MDR-TB with low concentration INH resistance and rifampicin resistance, second-line/injectable agents sensitive were prospectively enrolled, given the regimen of Amikacin (Ak)–Fluoroquinolones (FQs)–Cycloserine (Cs)–Protionamide (Pto)–PasiniaZid (Pa)–Pyrazinamide (Z) for 6 months followed by 12 months of FQs–Cs–Pto–Pa–Z, and then followed up for treatment outcomes and adverse events (AEs). Results A total of 114 patients were enrolled into the study. The overall favorable treatment rate was 79.8% (91/114). Among 91 cases with favorable treatment, 75.4% (86/114) were cured and 4.4% (5/114) were completed treatment. Regarding to unfavorable outcomes, among 23 cases, 8.8% (10/114) had failures, 8.8% (10/114) losing follow up, 0.9% (1/114) had treatment terminated due to intolerance to drugs and 1.8% (2/114) died. Treatment favorable rate was significantly higher in newly treated MDR-TB (91.7%, 33/36) than that in retreated MDR-TB (74.4%, 58/78, p 0.03). The investigators recorded 42 AEs occurrences in 30 of 114 patients (26.3%). Clinicians rated most AEs as mild or moderate (95.24%, 40/42). Conclusions The regimen was proved to be effective, safe and inexpensive. It is suitable for specific drug resistant population, especially for newly-treated patients, which could be expected to be developed into a short-course regimen. Clinical trials registration China Clinical Trial Registry ChiCTR-OPC-16009380https://doi.org/10.1186/s12879-021-06553-2MDR-TBTreatment regimenMICTreatment outcomeAdverse effects |
| spellingShingle | Wenwen Sun Zheyuan Wu Ying Zhou Fan Xia Qin Tang Jie Wang Jinghui Yang Fangyou Yu Hua Yang Heping Xiao Lin Fan A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in China BMC Infectious Diseases MDR-TB Treatment regimen MIC Treatment outcome Adverse effects |
| title | A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in China |
| title_full | A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in China |
| title_fullStr | A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in China |
| title_full_unstemmed | A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in China |
| title_short | A highly effective and inexpensive standardized treatment of multidrug-resistant tuberculosis: a multicenter prospective study in China |
| title_sort | highly effective and inexpensive standardized treatment of multidrug resistant tuberculosis a multicenter prospective study in china |
| topic | MDR-TB Treatment regimen MIC Treatment outcome Adverse effects |
| url | https://doi.org/10.1186/s12879-021-06553-2 |
| work_keys_str_mv | AT wenwensun ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT zheyuanwu ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT yingzhou ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT fanxia ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT qintang ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT jiewang ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT jinghuiyang ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT fangyouyu ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT huayang ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT hepingxiao ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT linfan ahighlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT wenwensun highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT zheyuanwu highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT yingzhou highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT fanxia highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT qintang highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT jiewang highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT jinghuiyang highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT fangyouyu highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT huayang highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT hepingxiao highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina AT linfan highlyeffectiveandinexpensivestandardizedtreatmentofmultidrugresistanttuberculosisamulticenterprospectivestudyinchina |