|Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese Tuberculosis Patients: A Prospective Study|
|Lv, Xiaozhen1,2,3; Tang, Shaowen1,4; Xia, Yinyin5; Wang, Xiaomeng6; Yuan, Yanli7; Hu, Daiyu8; Liu, Feiying9; Wu, Shanshan1; Zhang, Yuan1; Yang, Zhirong1; Tu, Dehua10; Chen, Yixin11; Deng, Peiyuan12; Ma, Yu13; Chen, Ru1; Zhan, Siyan1|
|WOS标题词||Science & Technology|
|研究领域[WOS]||Science & Technology - Other Topics|
|关键词[WOS]||ANTITUBERCULOSIS DRUGS ; RISK-FACTORS ; PULMONARY TUBERCULOSIS ; HOSPITALIZED-PATIENTS ; PYRAZINAMIDE ; MANAGEMENT|
Background: More than 1 million tuberculosis (TB) patients are receiving directly observed treatment strategy (DOTS) therapy in China every year. As to the profile of adverse drug reactions (ADRs) due to DOTS therapy, no consensus has been reached. There is no report regarding ADRs due to DOTS therapy with a large Chinese TB population. This study aimed to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in China.
Methods: A prospective population-based cohort study was performed during 2007-2008. Sputum smear positive pulmonary TB patients who received DOTS therapy were included and followed up for six to nine months in 52 counties of four regions in China. The suspected ADRs were recorded and reviewed by Chinese State Food and Drug Administration.
Results: A total of 4304 TB patients were included in this study. 649 patients (15.08%) showed at least one ADR and 766 cases in total were detected. The incidence (count) of ADR based on affected organ was: liver dysfunction 6.34% (273), gastrointestinal disorders 3.74% (161), arthralgia 2.51% (108), allergic reactions 2.35% (101), neurological system disorders 2.04% (88), renal impairment 0.07% (3) and others 0.05% (2). Most cases of ADRs (95%) had a good clinical outcome, while two with hepatotoxicity and one with renal impairment died. Compared with patients without ADRs, patients with ADRs were more likely to have positive smear test results at the end of the intensive phase (adjusted OR, 2.00; 95% CI, 1.44-2.78) and unsuccessful anti-TB outcomes (adjusted OR, 2.58; 95% CI, 1.43-4.68).
Conclusions: The incidence of ADRs due to DOTS therapy was 15.08%. Those ADRs had a substantial impact on TB control in China. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.
|项目编号||81072387 ; 7111006 ; TB07-030|
|资助机构||National Natural Science Foundation of China ; Beijing Natural Science Foundation ; China Program for the Global Fund|
|作者单位||1.Minist Hlth, Key Lab Mental Hlth, Beijing, Peoples R China|
2.Peking Univ, Hlth Sci Ctr, Sch Publ Hlth, Dept Epidemiol & Biostat, Beijing 100871, Peoples R China
3.Peking Univ, Inst Mental Hlth, Div Clin Res, Beijing 100871, Peoples R China
4.Nanjing Med Univ, Sch Publ Hlth, Dept Epidemiol & Biostat, Nanjing, Jiangsu, Peoples R China
5.Chinese Ctr Dis Control & Prevent, Natl Ctr TB Control & Prevent, Beijing, Peoples R China
6.Ctr Dis Control & Prevent Zhejiang Prov, Hangzhou, Zhejiang, Peoples R China
7.Ctr Dis Control & Prevent Jilin Prov, Changchun, Peoples R China
8.Ctr Dis Control & Prevent Chongqing Municipal, Chongqing, Peoples R China
9.Ctr Dis Control & Prevent Guangxi Zhuang Autonomo, Nanning, Peoples R China
10.Beijing Inst TB Control, Beijing, Peoples R China
11.Ctr Drug Reassessment State Food & Drug Adm, Beijing, Peoples R China
12.Beijing Ctr Drug Reassessment, Beijing, Peoples R China
13.Beijing TB & Thorac Tumor Res Inst, Beijing, Peoples R China
|Lv, Xiaozhen,Tang, Shaowen,Xia, Yinyin,et al. Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese Tuberculosis Patients: A Prospective Study[J]. PLOS ONE,2013,8(6).|
|APA||Lv, Xiaozhen.,Tang, Shaowen.,Xia, Yinyin.,Wang, Xiaomeng.,Yuan, Yanli.,...&Zhan, Siyan.(2013).Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese Tuberculosis Patients: A Prospective Study.PLOS ONE,8(6).|
|MLA||Lv, Xiaozhen,et al."Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese Tuberculosis Patients: A Prospective Study".PLOS ONE 8.6(2013).|