补中益气汤治疗医院获得性肺炎多药耐药菌的临床疗效:一项前瞻性、随机、多中心对照试验。

X U Xiangru, Zhou Yi, Chen Gang, Lei Ming, Zhang Wen, W U Xinxin, P U Yuting, Chen Caiyu, Sun Yuting, Zhou Shuang, Fang Bangjiang
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引用次数: 0

摘要

目的:评价补中益气汤治疗医院获得性肺炎(HAP)合并多药耐药菌(MDRB)的疗效和安全性。将符合条件的患者按1:1的比例随机分为干预组(BZYQ加常规西医治疗)和对照组(常规西药治疗)。主要结果是临床反应、临床肺部感染评分(CPIS)和微生物学反应。次要结果为28天全因死亡率(ACM)、急性生理学和慢性健康评估Ⅱ(APACHEⅡ)评分、呼吸机停用率、机械通气时间(MV)、住院时间和感染指标变化。结果:干预组83例,对照组85例。干预组的临床成功率(48.2%)和病原体根除率(59.0%)均优于对照组(分别为32.9%和38.9%),差异有统计学意义(0.05),和APACHEⅡ评分无统计学意义(P>0.05)。干预组在第28天的白细胞计数、C反应蛋白、中性粒细胞百分比和降钙素原均较基线下降(结论:BZYQ可能是MDRB治疗HAP的有效治疗选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical efficacy of Buzhong Yiqi decoction in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial.

Objective: To evaluate the efficacy and safety of Buzhong Yiqi decoction (, BZYQ) in the treatment of hospital-acquired pneumonia (HAP) with multi-drug-resistant bacteria (MDRB).

Methods: This 28-day study was conducted at 5 clinical centers in Shanghai. The eligible patients were randomly assigned (1:1) into the intervention group (BZYQ plus conventional Western Medicine therapy) and control group (conventional Western Medicine therapy). The primary outcomes were the clinical response, clinical pulmonary infection score (CPIS), and microbiologic response. The secondary outcomes were the 28-day all-cause mortality (ACM), Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) score, ventilator weaning rate, length of mechanical ventilation (MV), length of hospital stay, and changes of infection indicators.

Results: Altogether 83 subjects in the intervention group and 85 subjects in the control group were analyzed. The clinical success rate (48.2%) and the pathogen eradication rate (59.0%) of the intervention group were all better than those of the control group (32.9% and 38.9%, respectively) with statistically significant differences (<0.05). The CPIS score of the intervention group (8.9 ± 1.7) was lower than that of the control group (9.6 ± 2.5) (<0.05). The length of MV in the intervention group [(13.7 ± 6.4) d] was significantly shorter than that of the control group [ (17.2 ± 7.2) d] (<0.05). The 28-day ACM of the intervention group (13.33%) was lower than that of the control group (21.2%) with no statistically significant difference (>0.05). The differences between two groups in ventilator weaning rate, length of hospital stay, and APACHE Ⅱ score were not statistically significant (> 0.05). The intervention group displayed decreases in white blood cell count, C-reactive protein, neutrophil percentage, and procalcitonin at day 28 compared with baseline (<0.05). No serious adverse events occurred in either group during the 28-day follow-up.

Conclusion: BZYQ may be an effective therapeutic option for the management of HAP with MDRB.

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