Evidence map›Paper›PMID 23750225›Full record

Trial reportPloS one2013

Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study.

Xiaozhen Lv, Shaowen Tang, Yinyin Xia, Xiaomeng Wang, Yanli Yuan, Daiyu Hu, Feiying Liu, Shanshan Wu, Yuan Zhang, Zhirong Yang and 6 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 104 citations in OpenAlex.

  1. A systematic review of clinical outcomes on the WHO Category II retreatment regimen for tuberculosis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2018
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  10. MedComm · 2024
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  16. Nutrients · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 1 country.

Xiaozhen LvDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China.
Shaowen Tang
Yinyin Xia
Xiaomeng Wang
Yanli Yuan
Daiyu Hu
Feiying Liu
Shanshan Wu
Yuan Zhang
Zhirong Yang
Dehua Tu
Yixin Chen
Peiyuan Deng
Yu Ma
Ru Chen
Siyan Zhan
Peking University · CNBeijing Center for Disease Prevention and Control · CNBeijing Chest Hospital · CNCenter for Tuberculosis Control of Guangdong Province · CNChinese Center For Disease Control and Prevention · CNGuangxi Center for Disease Prevention and Control · CNNanjing Medical University · CNNational Medical Products Administration · CNPeking University Sixth Hospital · CNZhejiang Center for Disease Control and Prevention · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMore 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.

methodsA 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.

resultsA 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).

conclusionsThe 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.

Indexed as

Asian PeopleAdultAntitubercular AgentsFemaleHumansMaleMiddle AgedPrognosisProspective StudiesTreatment OutcomeTuberculosisAntitubercular Agents

Identifiers

PMID23750225
PMCPMC3672195
OpenAlexW1995803983

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.