Clinical efficacy of Buzhong Yiqi decoction(补中益气汤)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(补中益气汤,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 allcause mortality(ACM),Acute Physiology and Chronic Health EvaluationⅡ(APACHEⅡ)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(P<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)(P<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](P<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(P>0.05).The differences between two groups in ventilator weaning rate,length of hospital stay,and APACHEⅡscore were not statistically significant(P>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(P<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.