补中益气汤治疗多重耐药菌医院获得性肺炎的临床疗效：一项前瞻性、随机、多中心对照试验。
Clinical efficacy of Buzhong Yiqi decoction in the treatment of hospital-acquired pneumonia with multi-drug resistant bacteria: a prospective, randomized, multicenter controlled trial.
机构信息
Department of Emergency, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China.
School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
出版信息
J Tradit Chin Med. 2023 Oct;43(5):1010-1018. doi: 10.19852/j.cnki.jtcm.20230713.002.
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.
目的
评价补中益气汤（BZYQ）治疗多重耐药菌（MDRB）医院获得性肺炎（HAP）的疗效和安全性。
方法
本 28 天研究在上海的 5 个临床中心进行。合格患者被随机分配（1:1）到干预组（BZYQ 联合常规西医治疗）和对照组（常规西医治疗）。主要结局是临床反应、临床肺部感染评分（CPIS）和微生物学反应。次要结局是 28 天全因死亡率（ACM）、急性生理学和慢性健康评估Ⅱ（APACHE Ⅱ）评分、呼吸机撤机率、机械通气（MV）时间、住院时间和感染指标变化。
结果
干预组 83 例和对照组 85 例患者纳入分析。干预组的临床成功率（48.2%）和病原体清除率（59.0%）均优于对照组（32.9%和 38.9%），差异有统计学意义（<0.05）。干预组 CPIS 评分（8.9 ± 1.7）低于对照组（9.6 ± 2.5）（<0.05）。干预组 MV 时间[（13.7 ± 6.4）d]明显短于对照组[（17.2 ± 7.2）d]（<0.05）。干预组 28 天 ACM（13.33%）低于对照组（21.2%），差异无统计学意义（>0.05）。两组间呼吸机撤机率、住院时间和 APACHE Ⅱ评分差异无统计学意义（>0.05）。干预组在第 28 天与基线相比，白细胞计数、C 反应蛋白、中性粒细胞百分比和降钙素原下降（<0.05）。两组在 28 天随访期间均未发生严重不良事件。
结论
BZYQ 可能是治疗多重耐药菌医院获得性肺炎的有效治疗选择。
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