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索利霉素单药治疗社区获得性细菌性肺炎:一项随机对照试验的荟萃分析。

Solithromycin monotherapy for treatment of community-acquired bacterial pneumonia: A meta-analysis of randomised controlled trials.

作者信息

Wen Junlin, Chen Feng, Zhao Mengxin, Wang Xiaoping

机构信息

Department of Pain Management, The First Affliated Hospital, Jinan University, Guangzhou, China.

Department of Pharmacy, Yuebei People's Hospital, Shaoguan, China.

出版信息

Int J Clin Pract. 2019 May;73(5):e13333. doi: 10.1111/ijcp.13333. Epub 2019 Mar 14.

DOI:10.1111/ijcp.13333
PMID:30810253
Abstract

OBJECTIVES

Solithromycin is a new monotherapy option for community-acquired bacterial pneumonia (CABP) patients. However, the efficacy and safety of solithromycin monotherapy for the treatment of CABP remains controversial. The aim of this meta-analysis was to evaluate the role that solithromycin played in the treatment of CABP.

METHODS

We systematically retrieved randomised controlled trials (RCTs) compared solithromycin with other antibiotics in the treatment of CABP, which were published on PubMed, ScienceDirect, Cochrane libary and the Clinical Trials.gov before July 2018. Ultimately, a meta-analysis of all RCTs eligible for inclusion criteria was performed.

RESULTS

Three RCTs, comprising 1855 patients, were included in the meta-analysis. There were no statistically significant differences between patients given solithromycin and those given other antibiotics with regard to early clinical response (ECR) [1855 patients, odds ratio (OR) = 1.00, 95% confidence interval (CI) 0.80 to 1.24, P = 0.99] and clinical success rates at short-term follow-up (SFU) (1855 patients, OR = 0.78, 95% CI 0.60 to 1.01, P = 0.06) in the intention-to-treat (ITT) population, as were the ECR (787 patients, OR = 0.90, 95% CI 0.64 to 1.27, P = 0.55) and clinical success rates at SFU (358 patients, OR = 0.73, 95% CI 0.41 to 1.31, P = 0.30) in microbiological intention-to-treat population (mITT). Similarly, with regard to the occurrence of treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), serious AEs, serious drug-related AEs and mortality, no statistically significant difference between patients given solithromycin and those given other antibiotics was observed.

CONCLUSION

In the treatment of CABP, solithromycin monotherapy is an effective and safe antibiotic regimen. Other advantages (ie anti-inflammatory effect, potent activity against expected pathogens of CABP and convenient clinical use) of solithromycin may make it a more fascinating option compared with the currently used regimens.

摘要

目的

索利霉素是社区获得性细菌性肺炎(CABP)患者的一种新型单药治疗选择。然而,索利霉素单药治疗CABP的疗效和安全性仍存在争议。本荟萃分析的目的是评估索利霉素在CABP治疗中的作用。

方法

我们系统检索了2018年7月之前发表在PubMed、ScienceDirect、Cochrane图书馆和ClinicalTrials.gov上的比较索利霉素与其他抗生素治疗CABP的随机对照试验(RCT)。最终,对所有符合纳入标准的RCT进行荟萃分析。

结果

三项RCT(共1855例患者)被纳入荟萃分析。在意向性治疗(ITT)人群中,接受索利霉素治疗的患者与接受其他抗生素治疗的患者在早期临床反应(ECR)方面无统计学显著差异[1855例患者,比值比(OR)=1.00,95%置信区间(CI)0.80至1.24,P = 0.99],短期随访(SFU)时的临床成功率也无显著差异(1855例患者,OR = 0.78,95%CI 0.60至1.01,P = 0.06);在微生物学意向性治疗人群(mITT)中,ECR(787例患者,OR = 0.90,95%CI 0.64至1.27,P = 0.55)和SFU时的临床成功率(358例患者,OR = 0.73,95%CI 0.41至1.31,P = 0.30)同样无显著差异。同样,在治疗中出现的不良事件(TEAE)、药物相关不良事件(AE)、严重AE、严重药物相关AE和死亡率方面,接受索利霉素治疗的患者与接受其他抗生素治疗的患者之间未观察到统计学显著差异。

结论

在CABP治疗中,索利霉素单药治疗是一种有效且安全的抗生素治疗方案。与目前使用的治疗方案相比,索利霉素的其他优势(如抗炎作用、对CABP预期病原体的强大活性以及临床使用方便)可能使其成为更具吸引力的选择。

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