Lu Li-Chin, Lai Chih-Cheng, Chang Shen-Peng, Lan Shao-Huan, Hung Shun-Hsing, Lin Wei-Ting
School of Management, Putian University, Putian, China.
Department of Internal Medicine, Kaohsiung Veterans General Hospital, Tainan Branch.
Medicine (Baltimore). 2020 May;99(19):e19960. doi: 10.1097/MD.0000000000019960.
This meta-analysis assessed the efficacy and safety of novel β-lactam/β-lactamase inhibitor combinations in the treatment of complicated urinary tract infection (cUTI)/acute pyelonephritis (APN).
PubMed, Web of Science, EBSCO (Elton B. Stephens Co.), Cochrane Library, Ovid MEDLINE, and Embase databases were accessed until November 21, 2019. In this meta-analysis, only randomized controlled trials comparing the treatment efficacy of novel β-lactam/β-lactamase inhibitor combinations with other antibiotics for cUTI/APN in adult patients were included. The outcomes included the clinical and microbiological responses, and risk of adverse events (AEs).
Overall, the experimental group treated with a novel β-lactam/β-lactamase inhibitor combination and the control group comprised 1346 and 1376 patients, respectively. No significant difference in the clinical response rate at test-of-cure was observed between the novel β-lactam/β-lactamase inhibitor combination and comparators among the microbiological modified intent-to-treat population (89.1% vs 88.3%, OR, 1.04; 95% confidence interval [CI], 0.76-1.42; I = 28%) and the microbiologically evaluable population (95.2% vs 94.7%, OR, 1.12; 95% CI, 0.68-1.84; I = 0%). Additionally, the novel β-lactam/β-lactamase inhibitor combination was associated with a better microbiological response at test-of-cure than the comparators among the microbiological modified intent-to-treat population (74.4% vs 68.5%, OR, 1.34; 95% CI, 1.04-1.72; I = 45%) and microbiologically evaluable population (80.1% vs 72.5%, OR, 1.49; 95% CI, 1.06-2.10; I = 58%). Finally, the risk of AEs associated with the novel β-lactam/β-lactamase inhibitor combination was similar to that associated with the comparators (treatment-emergent adverse events [TEAE], OR, 1.04; 95% CI, 0.87-1.23; I = 19%; serious AEs, OR, 1.21; 95% CI, 0.82-1.76; I = 0%; treatment discontinuation for drug-related TEAE, OR, 077; 95% CI, 0.38-1.56, I = 5%). The all-cause mortality did not differ between the novel β-lactam/β-lactamase inhibitor combination and comparators (OR, 1.19; 95% CI, 0.37-3.81; I = 0%).
The clinical and microbiological responses of novel β-lactam/β-lactamase inhibitor combinations in the treatment of cUTI/APN are similar to those of other available antibiotics. These combinations also share a safety profile similar to that of other antibiotics.
本荟萃分析评估新型β-内酰胺/β-内酰胺酶抑制剂联合用药治疗复杂性尿路感染（cUTI）/急性肾盂肾炎（APN）的疗效和安全性。
检索了PubMed、Web of Science、EBSCO（艾尔顿·B·斯蒂芬斯公司）、Cochrane图书馆、Ovid MEDLINE和Embase数据库，检索截止至2019年11月21日。在本荟萃分析中，仅纳入比较新型β-内酰胺/β-内酰胺酶抑制剂联合用药与其他抗生素治疗成年患者cUTI/APN疗效的随机对照试验。结局指标包括临床和微生物学反应以及不良事件（AE）风险。
总体而言，接受新型β-内酰胺/β-内酰胺酶抑制剂联合用药治疗的试验组和对照组分别有1346例和1376例患者。在微生物学改良意向性治疗人群（89.1%对88.3%，比值比[OR]，1.04；95%置信区间[CI]，0.76 - 1.42；I² = 28%）和微生物学可评估人群（95.2%对94.7%，OR，1.12；95% CI，0.68 - 1.84；I² = 0%）中，新型β-内酰胺/β-内酰胺酶抑制剂联合用药与对照药物在治疗结束时的临床反应率上未观察到显著差异。此外，在微生物学改良意向性治疗人群（74.4%对68.5%，OR，1.34；95% CI，1.04 - 1.72；I² = 45%）和微生物学可评估人群（80.1%对72.5%，OR，1.49；95% CI，1.06 - 2.10；I² = 58%）中，新型β-内酰胺/β-内酰胺酶抑制剂联合用药在治疗结束时的微生物学反应优于对照药物。最后，新型β-内酰胺/β-内酰胺酶抑制剂联合用药相关的AE风险与对照药物相似（治疗中出现的不良事件[TEAE]，OR，1.04；95% CI，0.87 - 1.23；I² = 19%；严重AE，OR，1.21；95% CI，0.82 - 1.76；I² = 0%；因药物相关TEAE停药，OR，0.77；95% CI，0.38 - 1.56，I² = 5%）。新型β-内酰胺/β-内酰胺酶抑制剂联合用药与对照药物之间的全因死亡率无差异（OR，1.19；95% CI，0.37 - 3.81；I² = 0%）。
新型β-内酰胺/β-内酰胺酶抑制剂联合用药治疗cUTI/APN的临床和微生物学反应与其他现有抗生素相似。这些联合用药的安全性也与其他抗生素相似。
