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同行评议开放获取伤寒新型冠状病毒感染登革热疟疾流行性和地方性斑疹伤寒恙虫病

Azithromycin with or without cefixime for suspected or culture-confirmed uncomplicated typhoid fever in Nepal, Bangladesh, and Pakistan (ACT-South Asia): a double-blind, parallel-group, randomised, placebo-controlled, phase 4 trial

The Lancet Infectious Diseases·

Buddha Basnyat, Sudeep Adhikari, Puja Shrestha, Saraswati Budhathoki, Md Shabab Hossain, Naveed Ahmed, Sabina Dongol, Nhukesh Maharjan, Olita Shilpakar, Damodar Gajurel, Dhruba Shrestha, Sanjib Kumar Sharma, Sadia Shakoor, Yuba Nidhi Basaula, Shiva Ojha, Lochan Karki, Evelyne Kestelyn, Marcel Wolbers, Guy E Thwaites, Tahmeed Ahmed, Farah Naz Qamar, Abhilasha Karkey, Christopher M Parry, Jyoti Acharya, Sharmila Acharya, Imran Ahmed, Sharmin Akter, Amit Arjyal, Milan Bajracharya, Stephen Baker, Sunil Baniya, Tran Nguyen Bao, Rohan Basnet, Adwoa Bentsi-Enchill, Dilli Bahadur Bhandari, Parmananda Bhandari, Pragya Bhandari, Pratik Bhattarai, Sonika Bhattarai, Urza Bhattarai, Renu Bhuju, Zulfiqar Bhutta, Durga Bishra, Sumit Bista, Bimal Kumar Bista, Probaha Biswas, Lalita Bokati, Bimal Kumar Chalise, Saheb Lal Choudhary, John Crump, Sadana Dahal, Ashata Dahal, Abul Faiz, Irum Fatima, Sumit Gami, Aastha Ghimire, Abhishek Giri, Rebecca Grais, Swornim Gyawali, Naheeda Haque, Caroline Harris, Ho Hien, Lan Le Thi Hoang, Md Mahbubul Hoque, Aneeta Hotwani, Mohsina Ibrahim, Shaumik Islam, Prachanda Japrel, Brajesh Kumar Jha, Rajesh Dhoj Joshi, Bimala Joshi, Juni Joshi, Manij Joshi, Subi Joshi, Laila Kabir, Md. Kamruzzaman, Bijaya Karanjit, Sushila Karki, Rinu Kayastha, Ashmita KC, Milan Khadka, Nisha Khadka, Ar-Rafi Khan, Basudha Khanal, Januka Khatri, Niraj Khatri, Sweta Koirala, Ranjit Kumar, Narayan Kunwar, Santosh Lamsal, Sue Lee, Sunil Limbu, Sangita Thapa Magar, Archana Maharjan, Shrawan Kumar Mandal, Suneeta Namdave, Nosheen Nasir, Bal Mukunda Neupane, Jenish Neupane, Nowrin Nusrat Nova, Shiva Krishna Pandey, Binod Panta, Nirmala Pariyar, Sushmita Pathak, Santosh Paudel, Shankar Paudel, Anupama Pokharel, Seema Poudyal, Buddhi Prasad Poudyal, Alisha Pradhan, Rajana Pyatha, Sonia Qureshi, Bhawana Rai, Mamit Rai, Manisha Rawal, Bijaya Rawat, Ajit Rayamajhi, Isabella Ribeiro, Samita Rijal, Santa Rokaya, Binita Rupakheti, G.K.M. Shahiduzzaman, Lubaba Shahrin, Ronas Shakya, Chandrama Sharma, Dibya Sharma, Karan Sharma, Upama Sharma, Bidhya Laxmi Shrestha, Basudha Shrestha, Divesh Shrestha, Medina Shrestha, Milan Shrestha, Raj Shrestha, Rajendra Shrestha, Sarita Shrestha, Shova Shrestha, Suchita Shrestha, Surendra Shrestha, Sushmita Shrestha, Keshab Raj Sigdel, Pawan Singh, Shraddha Subedi, Sapna Sunar, Anjana Tachamo, Afia Tariq, Devendra Singh Thagunna, Duy Thanh, Lich Bui Thanh, Jyoti Thapa, Rajkumar Thapa, Monika Thimi, Dikshya Sharma Timilsina, Thuan Dang Trong, Siddhartha Upadhaya, Nick White, Ram Babu Yadav, Ajay Kumar Yadav

DOI
10.1016/s1473-3099(26)00358-0
PMID
42624818
PMCID
OpenAlex
W7203820018
研究类型
Journal article
出版商
Elsevier BV
文章类型
journal-article
完整性状态
current

为何这项研究现在值得关注

研究结果支持WHO关于口服阿奇霉素单药治疗无并发症伤寒的建议,未提供证据支持加用头孢克肟。鉴于对双药耐药出现的担忧,这对抗菌药物管理具有重要意义。

01

结构化证据摘要

研究问题

该试验评估了阿奇霉素联合头孢克肟与单用阿奇霉素相比,能否降低无并发症伤寒的治疗失败率。

研究设计

这是一项在三个南亚国家开展的双盲、平行组、随机、安慰剂对照的4期临床试验。参与者按1:1随机分配接受阿奇霉素联合头孢克肟或阿奇霉素联合安慰剂治疗7天,所有人员和参与者对治疗分配均保持盲态。

人群与场景

研究在尼泊尔、孟加拉国和巴基斯坦的急诊和门诊招募了1847名2至65岁的成人和儿童,包括血培养确诊或临床疑似无并发症伤寒患者。纳入标准为急性未分化发热性疾病持续3至14天、C反应蛋白至少10 mg/L,且登革热、恙虫病、疟疾和COVID-19检测阴性。

主要发现

阿奇霉素-头孢克肟组和阿奇霉素-安慰剂组的治疗失败率均为5.1%,两组间无显著差异。在培养确诊病例中,联合治疗组失败率为11.2%,单药治疗组为16.0%,但差异无统计学意义。两组不良事件发生率相当,均为16%。

公共卫生意义

研究结果支持WHO关于口服阿奇霉素单药治疗无并发症伤寒的建议,未提供证据支持加用头孢克肟。鉴于对双药耐药出现的担忧,这对抗菌药物管理具有重要意义。

重要局限

本摘要仅依据所提供的单篇文章摘要和元数据。对试验局限性的完整解读,包括效力计算、依从率和亚组分析,需要查阅完整的发表手稿。

GIDS 解读

该文章在三个伤寒流行的南亚国家中按伤寒治疗进行索引,可通过疾病和地理分类器检索。文章关注临床管理问题,而非记录监测趋势或疫情特征。

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相关 GIDS 监测

文献背景不会验证、解释或改变监测信号;精确关系与背景关系会分开展示。

03

证据关系

本文与疾病、地区、主题及研究设计之间有 8 条可审计分类关系。

about diseaseaddresses topicevaluates interventionstudied instudied instudied instudied population settinguses study design