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沙特阿拉伯吉达市结核病患者的治疗结果:一项社区移动外展直接观察短程治疗(DOTS)项目的结果,与基于标准设施的DOTS比较:一项随机对照试验。

Treatment outcomes among tuberculosis patients in Jeddah, Saudi Arabia: Results of a community mobile outreach directly observed Treatment, Short-course (DOTS) project, compared to a standard facility-based DOTS: A randomized controlled trial.

作者信息

Al-Sahafi Abdullah, Al-Sayali Mashal M, Mandoura Najlaa, Shah Hassan B U, Al Sharif Khalid, Almohammadi Emad L, Abdul-Rashid Ola A, Assiri Muhammad, Buksh Mohammed F, Alali Mahmoud M, Al-Garni Abdullah, Al-Garni Fatima, Al-Zahrani Abdullah, Khalawi Alaa, Alawi Maha, Moawwad Abdulhamed L, Almalki Abdulrahim I A, Al-Osaimi Maataug M

机构信息

Ministry of Health, Directorate of Health Affairs for Public Health Division, Jeddah, Saudi Arabia.

Ministry of Health, General Directorate of Health Affairs, Jeddah, Saudi Arabia.

出版信息

J Clin Tuberc Other Mycobact Dis. 2020 Dec 31;22:100210. doi: 10.1016/j.jctube.2020.100210. eCollection 2021 Feb.

Abstract

INTRODUCTION

Tuberculosis (TB) remains a global public health threat affecting people in many developing countries, including the Kingdom of Saudi Arabia. Maintaining a long-term treatment regimen has always been the cornerstone of successful treatment outcomes among tuberculosis patients. In the Jeddah region, the National Tuberculosis Control and Prevention Program is now treating TB patients by means of a community mobile outreach team approach.The objective of this study was to compare the effectiveness of the community mobile outreach approach in improving treatment outcomes (success rate) among local tuberculosis patients with those being treated with a facility-based directly observed treatment, short-course (DOTS).

STUDY DESIGN

Our study consisted of a two-sample, parallel design [1:1], statistician -blind randomized control trial with 200 newly diagnosed, TB patients as subjects.

SETTING/PARTICIPANTS: The patients had all presented at the Madain Alfahd Primary Health Care Center, Jeddah. Between Nov 2017 and Nov 2018, a total of 221 TB patients were screened of whom 200 were randomly selected using randomly generated sequences.

INTERVENTION

Patients in the intervention sample group were treated by means of mobile outreach teams with oral anti-TB treatment under the DOTS, and control group patients were given the traditional facility-based DOTS treatment according to the WHO recommendations and national guidelines.

MAIN OUTCOME

The primary outcome was the level of overall treatment success rate. It was finally determined and compared in the two sample groups using chi-square analysis and relative risk assessment.

RESULTS

In the analysis stage, 97 patients were in the intervention group, while the control group consisted of 76. The overall response rate was 86.5% (173/200). We found that the percentage of overall treatment success rate among the patients served by the mobile outreach team was 97%, compared to 76% in the non-mobile team treated patients. The relative risk of treatment success rate among the intervention group was 1.27 (95% CI = 1.13-1.43) times greater than that amongst the control group. Log-rank test (log-rank statistics = 18.91; p < 0.001) identified a significant difference in the default rate after six months of treatment.

CONCLUSION

This study has shown that a mobile outreach DOTS approach is an effective and acceptable strategy for treating TB patients. It also provides important data on the efficacy of using mobile outreach teams to improve TB treatment outcomes in Jeddah. Our results provide evidence and highlight the positive and significant impact of mobile outreach teams in mitigating TB recurrence rates and in improving TB treatment outcomes.Clinical Trial Registration: Clinicaltrials.gov: NCT03787914.

摘要

引言

结核病仍然是全球公共卫生威胁,影响着包括沙特阿拉伯王国在内的许多发展中国家的人民。维持长期治疗方案一直是结核病患者成功治疗结果的基石。在吉达地区,国家结核病控制与预防计划目前正通过社区流动外展团队的方式治疗结核病患者。本研究的目的是比较社区流动外展方法与基于机构的直接观察短程治疗(DOTS)在改善当地结核病患者治疗结果(成功率)方面的有效性。

研究设计

我们的研究采用两样本平行设计[1:1],由统计学家设盲的随机对照试验,以200名新诊断的结核病患者为研究对象。

设置/参与者:患者均在吉达的马达因阿尔法德初级卫生保健中心就诊。在2017年11月至2018年11月期间,共筛查了221名结核病患者,其中200名通过随机生成的序列随机选取。

干预措施

干预样本组的患者通过流动外展团队在DOTS下接受口服抗结核治疗,对照组患者根据世界卫生组织的建议和国家指南接受传统的基于机构的DOTS治疗。

主要结果

主要结果是总体治疗成功率水平。最终使用卡方分析和相对风险评估在两个样本组中进行确定和比较。

结果

在分析阶段,干预组有97名患者,对照组有76名患者。总体缓解率为86.5%(173/200)。我们发现,流动外展团队服务的患者总体治疗成功率为97%,而非流动团队治疗的患者为76%。干预组治疗成功率的相对风险比对照组高1.27倍(95%置信区间=1.13-1.43)。对数秩检验(对数秩统计量=18.91;p<0.001)表明治疗六个月后的违约率存在显著差异。

结论

本研究表明,流动外展DOTS方法是治疗结核病患者的一种有效且可接受的策略。它还提供了关于在吉达使用流动外展团队改善结核病治疗结果有效性的重要数据。我们的结果提供了证据,并突出了流动外展团队在降低结核病复发率和改善结核病治疗结果方面的积极和显著影响。临床试验注册:Clinicaltrials.gov:NCT03787914。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9392/7809390/def0bebd1711/gr1.jpg

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