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Effect of Kuanxiong Aerosol(宽胸气雾剂)on Patients with Angina Pectoris:A Non-inferiority Multi-center randomized controlled trial

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Chinese Journal of Integrative Medicine 2018年第5期24卷 336-342页

作者： YANG Qiao-ning BAI Rui-na DONG Guo-ju GE Chang-jiang ZHOU Jing-min HUANG Li HE Yan WANG Jun REN Ai-hua HUANG Zhan-quan ZHU Guang-li LU Shu XIONG Shang-quan XIAN Shao-xiang ZHU Zhi-jun SHI Da-zhuo LU Shu-zheng LI Li-zhi CHEN Ke-ji Cardiovascular Diseases Center Xiyuan Hospital China Academy of Chinese Medical Sciences Department of Cardiology Beijing Anzhen Hospital Beijing Institute of Respiratory Medicine Capital Medical University Department of Cardiology Zhongshan Hospital Fudan University Department of Cardiology China-Japan Friendship Hospital Department of Cardiology Longhua Hospital Shanghai University of Traditional Chinese Medicine Department of Cardiology Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine Department of Cardiology Zhejiang Hospital Department of Cardiology The First Affiliated Hospital of Zhejiang Chinese Medical University Department of Cardiology Guangxing Hospital Affiliated to Zhejiang Chinese Medical University Department of Cardiology Wuxi Traditional Chinese Medicine Hospital Nanjing University of Traditional Chinese Medicine Department of Cardiology People's Hospital Affiliated Fujian University of Traditional Chinese Medicine Department of Cardiology The First Affiliated Hospital of Guangzhou University of Chinese Medicine Department of Cardiology The 117th Hospital of People's Liberation Army of China

Objective： To evaluate the effect and safety of Kuanxiong Aerosol （宽胸气雾剂, KA） on patients with angina pectoris. Methods： Block randomization was performed to randomly allocate 750 patients into KA （376 cases） and control groups （374 cases）. During an angina attack, the KA group received 3 consecutive sublingual sprays of KA （0.6 mL per spray）. The control group received 1 sublingual nitroglycerin tablet （NT, 0.5 rag/tablet）. Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment （1,2, 3, 4, 5, and 〉5 min）. Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society （CCS） classes of angina. Results： The 5-min remission rates in the KA and control groups were not significantly different （94.41% vs. 90.64%, P〉0.05）. The angina CCS class significantly influenced the rate of remission （95% confidence interval = 0.483-0.740, P〈0.01）. In the CCS subgroup analysis, the 3- and 5-min remission rates for KA and NT were similar in the CCS I and IV subgroups （P〉0.05）, while they were significantly better for KA in the CCS Ⅱ and Ⅲ subgroups （P〈0.05 or P〈0.01）. Furthermore, the inciden0ce of adverse reactions was significantly lower in the KA group than in the control group for the CCS Ⅱ and Ⅲ subgroups （9.29% vs. 26.22%, 10.13% vs. 20.88%, P〈0.05 or P〈0.01）. Conclusions： KA is not inferior to NT in the remission of angina. Furthermore, in CCS Ⅱ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions. （Registration No. ChiCTR- IPR-15007204）

关键词： Kuanxiong Aerosol angina pectoris Canadian Cardiovascular Society classification of angina randomized controlled trial Chinese medicine

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Efficacy of Xuebijing Injection(血必净注射液)on Cardiopulmonary Bypass-Associated Pulmonary Injury:A Prospective,Single-center,Double Blinded,randomized controlled trial

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Chinese Journal of Integrative Medicine 2018年第11期24卷 815-821页

作者： GAO Wei LI Na CUI Xiao-guang Department of Anesthesiology the Second Affiliated Hospital of Harbin Medical University

Objective： To evaluate the efficacy of Xuebijing Injection（血必净注射液, XBJ） on the lung injury induced by cardiopulmonary bypass（CPB）. Methods： Fifty patients undergoing CPB were randomized to either the saline group or XBJ group according to a random number table（25 cases in each group）. The patients in the saline group received saline and patients in XBJ group received XBJ at 12 h prior to the operation, at the beginning of the operation, and at 12 h after the second injection. The PaO_2/Fi O2 at extubation 3 days post-operation, duration of ventilation in the intensive care unit（ICU）, and lengths of stay in the ICU and hospital were recorded. The levels of inflammatory mediators including interleukin（IL）-1β, IL-8, IL-10, and C-reactive protein（CRP） in bronchoalveolar lavage fluid（BALF） and plasma were measured. The neutrophil count and elastase neutrophil elastase in BALF were also measured. In addition, adverse events were monitored. Results： The PaO-2/FiO_2 in the XBJ group was higher than that in the saline group from 12 to 72 h post-operation（all P〈0.05）. The blood levels of IL-1β, IL-8, and CRP in the XBJ group from 12 to 72 h were all significantly lower than those in the saline group（all P〈0.05）. In contrast, the level of the anti-inflammatory cytokine IL-10 was significantly higher in the XBJ group than in the saline group（P〈0.05）. In addition, 4 patients presented with atelectasis in the saline group and none in the XBJ group. Ten patients experienced mild acute respiratory distress syndrome（ARDS） during hospitalization, and 5 patients with mild ARDS were in the XBJ group（P〈0.05）. Conclusion： XBJ shows protective potential against lung injury in patients who undergo CPB surgery, possibly through the downregulation of inflammatory mediators, reduction in neutrophil infiltration, and upregulation of IL-10（trial registry： Chi CTR-TRC-14004628）.

关键词： Xuebijing Injection cardiopulmonary bypass lung injury inflammation randomized controlled trial

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Zhengyuan capsule(正元胶囊)for the treatment of cancer-related fatigue in lung cancer patients undergoing operation:a study protocol for a randomized controlled trial

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Journal of Traditional Chinese Medicine 2021年第3期41卷 485-490页

作者： ZHANG Zhouji ZHANG Ming WU Xiaoting CUI Qing GUO Yijun Department of Integrated Chinese and Western Medicine Shanghai Chest Hospital Shanghai JiaoTong UniversityShanghai 200030China

OBJECTIVE: To evaluate the efficacy and safety of Zhengyuan capsule(正元胶囊) when treating Cancer-related fatigue(CRF) in lung cancer patients undergoing surgical ***/DESIGN: This is a single-center, double-blinded, prospective, and randomized controlled trial in the Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital Shanghai Jiao Tong University, Shanghai. Eligible participants will be randomly allocated into two groups: a treatment group receiving an 8-week Zhengyuan capsule regimen therapy and a control group receiving an 8-week placebo capsule regimen therapy. Evaluation will be carried out at four timelines: the participants' screening period, baseline period, the middle of the intervention period,and the end of the intervention period. The primary outcome assessment is fatigue scoring using the Cancer Fatigue Scale(CFS) measurement *** measurements include fatigue severity assessment using the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF) measurement system, Traditional Chinese Medicine syndrome pattern differentiation, levels of immunologic indicators(TNF-α, IL-6, IL-1, T lymphocytes subsets and B lymphocyte subsets), patient's pulmonary function, performance status scale(PS),self-rating scale of sleep(SRSS), and adverse events(AEs).DISCUSSION: The trial results can provide efficacy and safety data of Zhengyuan capsule when treating CRF in clinic. The data can also be imported into the management and treatment guidelines for CRF in lung cancer patients undergoing operation throughout China.

关键词： fatigue lung neoplasms postoperative period Zhengyuan capsule randomized controlled trial clinical trial protocol

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Gefitinib plus Fuzheng Kang'ai Formula(扶正抗癌方) in Patients with Advanced Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation:A randomized controlled trial

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Chinese Journal of Integrative Medicine 2018年第10期24卷 734-740页

作者： YANG Xiao-bing CHAI Xiao-shu WU Wan-yin LONG Shun-qin DENG Hong PAN Zong-qi HE Wen-feng ZHOU Yu-shu LIAO Gui-ya XIAO Shu-jing Department of Oncology Guangdong Provincial Hospital of Traditional Chinese Medicine

Objective： To evaluate the effect of Fuzheng Kang＇ai Formula （扶正抗癌方, FZKA） plus gefitinib in patients with advanced non-small cell lung cancer with epidermal growth factor receptor （EGFR） mutations. Methods： A randomized controlled trial was conducted from 2009 to 2012 in South China. Seventy chemotherapynaive patients diagnosed with stage ⅢB/Ⅳ non-small cell lung cancer with EGFR mutations were randomly assigned to GF group [gefitinib （250 mg/day orally） plus FZKA （250 mL, twice per day, orally）; 35 cases] or G group （gefitinib 250 mg/day orally; 35 cases） according to the random number table and received treatment until progression of the disease, or development of unacceptable toxicities. The primary endpoint [progression-free survival （PFS）] and secondary endpoints [median survival time （MST）, objective response rate （ORR）, disease control rate （DCR） and safety] were observed. Results： No patient was excluded after randomization. GF group had significantly longer PFS and MST compared with the G group, with median PFS of 12.5 months （95% CI 3.30-21.69） vs. 8.4 months （95% CI 6.30-10.50; log-rank P〈0.01）, MST of 21.5 months （95% CI 17.28-25.73） vs. 18.3 months （95% CI 17.97-18.63; log-rank P〈0.01）. ORR and DCR in GF group and G group were 65.7% vs. 57.1%, 94.3% vs. 80.0%, respectively （P〉0.05）. The most common toxic effects in the GF group and G group were rash or acne （42.8% vs. 57.1%, P〉0.05）, diarrhea （11.5% vs. 31.4%, P〈0.05）, and stomatitis （2.9% vs. 8.7%, P〉0.05）. Conclusion： Patients with advanced non-small cell lung cancer selected by EGFR mutations have longer PFS, MST with less toxicity treated with gefitinib plus FZKA than gefitinib alone.

关键词： non-small cell lung cancer gefitinib Chinese medicine combination therapy sensitizing effect Fuzheng Kang'ai Formula randomized controlled trial

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Change in Preoperative Nervousness: A randomized controlled trial in Gynecological Cancer Patients

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Health 2016年第3期8卷 219-229页

作者： Marianne K. Thygesen René De Pont Christensen Lone Hedemand Ole Mogensen Institute of Clinical Research Faculty of Health Sciences University of Southern Denmark Odense Denmark Department of Obstetrics and Gynaecology Odense University Hospital Odense Denmark Research Unit of General Practice University of Southern Denmark Odense Denmark

Patients are often nervous prior to surgery and females might suffer the most. Increased nervousness needs attention as it can negatively affect postoperative recovery. Support from nurses, i.e. being present, attentive, empowering and helpful to the patient, and talking about what is on the patient’s mind, might help to reduce nervousness. However, there is a lack of evidence as to the ideal level of attention and resources to reduce preoperative nervousness. The objective of the current study was to compare a range of care combinations with standard care to female patients prior to sedation and cancer surgery primarily on difference in change in nervousness from admission until sedation before cancer surgery, measured on a Visual Analouge Scale. Using simple randomization and numbers in sealed envelopes, adult gynaecological patients scheduled for open cancer surgery were allocated to care provided by a nurse anaesthetist and: A) a surgical nurse, B) no additional care, C) a known nurse , and D) a relative. Only the statistician was blinded. The trial stopped when the calculated numbers were included. In the full analysis set, compared to standard care A) (n = 61), we observed the following mean changes and [95% confidence intervals]: B) (n = 65) 1.05 [CI: 0.298 to 1.794] with p = 0.006, C) (n = 61): -0.38 [-1.140 to 0.385] with p = 0.330, D) (n = 71): 0.23 [-0.498 to 0.967] with p = 0.528. Female cancer patients will benefit from supportive care by a surgical nurse from the time of arrival on the operating ward plus supportive care from a nurse anesthetist from 5 - 10 minutes after entering the operating ward. It is not recommended at any time to rely fully on the support of relatives. The effect on adults of preoperative painful procedures and patients’ time alone on the operating ward should be further investigated.

关键词： Anxiety Cancer Perioperative Care randomized controlled trial Women’s Health

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Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury:A multicenter,double-blind,placebo-controlled,randomized trial

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Journal of Integrative Medicine 2024年第3期22卷 279-285页

作者： Jia-jia Wu Tian-yi Zhang Ying-hui Qi Min-yan Zhu Yan Fang Chao-jun Qi Li-ou Cao Ji-fang Lu Bo-han Lu Lu-min Tang Jian-xiao Shen Shan Mou Department of Nephrology Molecular Cell Lab for Kidney DiseaseShanghai Peritoneal Dialysis Research CenterUremia Diagnosis and Treatment CenterRenji Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai 200127China Department of Nephrology Shanghai Pudong New Area Punan HospitalShanghai 200125China Department of Nephrology Ningbo Hangzhou Bay HospitalNingbo 315336Zhejiang ProvinceChina

Background:Yiqi Peiyuan(YQPY)prescription,a composite prescription of traditional Chinese medicine,has been used to prevent or delay the continued deterioration of renal function after acute kidney injury(AKI)in some institutions and has shown considerable ***:This is the first randomized controlled trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with ***,setting,participants and interventions:This is a prospective,double-blind,multicenter,randomized,and placebo-controlled clinical trial.A total of 144 enrolled participants were randomly allocated to two groups according to a randomization ***,caregivers and investigators assessing the outcomes were blinded to group *** in the YQPY group received 36 g YQPY granules twice a day for 28 *** in the placebo group received a placebo in the same dose as the YQPY *** outcome measures:The primary outcome was the change in the estimated glomerular filtration rate(eGFR)between baseline and after 4 and 24 weeks of *** secondary outcomes were the change of serum creatinine(Scr)level between baseline and after treatment,and the incidence of endpoint events,defined as eGFR increasing by more than 25%above baseline,eGFR>75 mL/min per1.73 m2or the composite endpoint,which was defined as the sum of patients meeting either of the above ***:Data from a total of 114 patients(59 in the YQPY group and 55 in the control group)were *** mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two *** further subgroup analysis(22 in the YQPY group and 31 in the control group),the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m2in the YQPY group and 5.78 mL/min per1.73 m2in the placebo group,and the mean difference between groups was 21.61 mL/min per 1.73 m2(P<0.001).Thirteen(59.1%)patients in the YQPY group and 5(16.1%)in the placebo g

关键词： Chinese herbal medicine randomized controlled trial Acute kidney injury Renal function

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Anti-inflammatory treatment with colchicine in acute coronary syndrome:A meta-analysis of randomized controlled trial

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South China Journal of Cardiology 2020年第2期21卷 128-137页

作者：韦秋霞詹红古钎林吴冰璇黄素芬黄振华 Department of Emergency the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou 510080GuangdongChina

Background Inflammation has been identified as a central role in the pathogenesis of acute coronary *** is an inexpensive,potent anti-inflammatory properties drug which is suitable for treatment of acute coronary syndrome(ACS).Methods We systemically searched Pubmed,Embase,and the Cochrane library from their inception to November 19,*** inclusion criterion was published randomized controlled trials(RCTs)comparing difference between colchicine administration group and control group in ACS *** calculation was carried out by review manager *** Five eligible RCTs incorporating 5257 patients were *** patients in colchicine group toke colchicine 0.5 or 1 mg every single day in addition to standard treatment of *** was no difference in the C-reactive protein(CRP)level,neutrophils count,white blood cell count,rangeability of CRP level and neutrophil count between the colchicine and control group and their standardized mean difference(SMD)were-0.13(95%CI:-0.36 to 0.11,P=0.29),-0.14(95%CI:-0.35 to 0.07,P=0.20),-0.02(95%CI:-0.10 to 0.07,P=0.70),-0.15(95%CI:-0.56 to 0.27,P=0.49)and-0.50(95%CI:-1.1 to 0.10,P=0.10),*** with control group,colchicine group had a significant decrease in the morbidity of stroke(OR:0.27,95%CI:0.10-0.69,P=0.006)and revascularization(OR:0.50,95%CI:0.31-0.81,P=0.005).The incidence of gastrointestinal symptoms(OR:3.15,95%CI:1.11-8.98,P=0.03)obviously increased in colchicine group compared with control *** were no significant difference in all-cause death(OR:0.98,95%CI:0.65-1.49,P=0.93)and recurrent myocardial infarction(OR:0.55,95%CI:0.17-1.75,P=0.31)between colchicine and control *** Despite previous suggested colchicine therapy in coronary heart disease patients,our study did not lead to significant reduction in biomarkers of inflammation,all-cause death and recurrent myocardial infarction of ACS ***,colchicine may increase the adverse ***

关键词： colchicine acute coronary syndrome randomized controlled trial meta-analysis

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Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients:A 12-week randomized placebo-controlled phase III trial with long-term extension

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Chinese Medical Journal 2024年第10期137卷 1190-1198页

作者： Chen Yu Songmei Geng Bin Yang Yunhua Deng Fuqiu Li Xiaojing Kang Mingye Bi Furen Zhang Yi Zhao Weili Pan Zhongwei Tian Jinhua Xu Zhenghua Zhang Nan Yu Xinsuo Duan Shuping Guo Qing Sun Weiquan Li Juan Tao Zhijun Liu Yuanyuan Yin Gang Wang Department of Dermatology Xijing HospitalThe Fourth Military Medical UniversityXi’anShaanxi 710032China Department of Dermatology The Second Affiliated Hospital of Xi’an Jiaotong UniversityXi’anShaanxi 710004China Department of Dermatology Dermatology Hospital of Southern Medical UniversityGuangzhouGuangdong 510091China Department of Dermatology Tongji HospitalHuazhong University of Science and TechnologyWuhanHubei 430030China Department of Dermatology The Second Hospital of Jilin UniversityChangchunJilin 130041China Department of Dermatology People’s Hospital of Xinjiang Uygur Autonomous RegionUrumqiXinjiang 830001China Department of Dermatology Wuxi People’s Hospital of Wuxi CityWuxiJiangsu 214023China Department of Dermatology Shandong Provincial Hospital for Skin Diseases&Shandong Provincial Institute of Dermatology and VenereologyShandong First Medical University&Shandong Academy of Medical SciencesJinanShandong 250022China Department of Dermatology Beijing Tsinghua Changgung HospitalBeijing 102218China Department of Dermatology Zhejiang Provincial People’s HospitalHangzhouZhejiang 310014China Department of Dermatology The First Affiliated Hospital of Xinxiang Medical CollegeXinxiangHenan 453100China Department of Dermatology Huashan Hospital Affiliated to Fudan UniversityShanghai 200040China Department of Dermatology General Hospital of Ningxia Medical UniversityYinchuanNingxia 750000China Department of Dermatology Affiliated Hospital of Chengde Medical UniversityChengdeHebei 067000China Department of Dermatology The First Hospital of Shanxi Medical UniversityTaiyuanShanxi 030001China Department of Dermatology Qilu Hospital of Shandong UniversityJinanShandong 250012China Department of Dermatology Yuebei People’s HospitalShaoguanGuangdong 512026China Department of Dermatology Union Hospital Tongji Medical Collage Huazhong University of Science and TechnologyWuhanHubei 430022China Department of Dermatology and Venereal Diseases The First Affiliated Hospit

Background:There is a need for effective and safe therapies for psoriasis that provide sustained *** aim of this study was to assess the efficacy and safety of tildrakizumab,an anti-interleukin-23p19 monoclonal antibody,for treating moderate-to-severe plaque psoriasis in Chinese ***:In this multi-center,double-blind,phase III trial,patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned(1:1)to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and *** initially assigned to placebo were switched to receive tildrakizumab at weeks 12,16,and every 12 weeks *** in the tildrakizumab group continued with tildrakizumab at week 16,and every 12 weeks until week *** primary endpoint was the Psoriasis Area and Severity Index(PASI 75)response rate at week ***:At week 12,tildrakizumab demonstrated significantly higher PASI 75 response rates(66.4%[73/110]vs.12.7%[14/110];difference,51.4%[95%confidence interval(CI),40.72,62.13];P<0.001)and Physician’s Global Assessment(60.9%[67/110]vs.10.0%[11/110];difference,49.1%[95%CI,38.64,59.62];P<0.001)compared to *** 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups,reaching maximal efficacy after 28 weeks(86.8%[92/106]vs.82.4%[89/108])and maintained up to 52 weeks(91.3%[95/104]vs.87.4%[90/103]).Most treatment-emergent adverse events were mild and not related to ***:Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque *** registration:***,NCT05108766.

关键词： Tildrakizumab Interleukin 23 Plaque psoriasis Chinese randomized controlled trial

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Effectiveness of Zhuling decoction(猪苓汤) on diuretic resistance in patients with heart failure:a randomized,controlled trial

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Journal of Traditional Chinese Medicine 2022年第3期42卷 439-445页

作者： CHEN Yunhu FAN Lihua ZHANG Tao LIU Xueqian Department of Cardiovascular Taicang Hospital affiliated with Nanjing University of Traditional Chinese MedicineSuzhou 215400China Department of Cardiovascular Changzhou Hospital affiliated with Nanjing University of Traditional Chinese MedicineChangzhou 213003China

OBJECTIVE:To test the effects of Zhuling decoction(猪苓汤)on patients with diuretic resistance in heart failure compared with a group of patients undergoing conventional treatment ***:This research was a prospective,randomized,controlled *** July 2018 to August 2020,96 diuretic resistance patients from the Cardiovascular Research Center of Taicang Hospital affiliated with Nanjing University of Traditional Chinese Medicine(GradeⅢHospital of Traditional Chinese Medicine)were enrolled in the *** subjects were randomly divided into an observation group(48 cases)and a control group(48 cases).Patients in both groups received conventional *** addition,observation group patients received Traditional Chinese Medicine Zhuling *** primary endpoint was the urine output mean difference between Day 1 and Day 7 after *** endpoints were the changes over time in the N-terminal pro-B type natriuretic peptide(NTproBNP),New York Heart Association(NYHA)functional classification,and Minnesota Living with Heart Failure Questionnaire(MLHFQ).The safety and tolerability of the drug were comprehensively evaluated based on adverse drug reactions,as well as laboratory-assisted tests for liver and kidney function and ***:Significant improvements were demonstrated for urine output in the two groups at Day 7,with a 1325 vs 1045 mL difference in favor of the observation group(P=0.018).The observation group also had greater improvements in NT-proBNP and NYHA functional classification changes than the control *** the 30 th day of follow-up,a significant reduction in negative findings on the MLHFQ from baseline was observed in both groups,but the observation group demonstrated a significantly greater reduction than the control group(P<0.001).CONCLUSIONS:Zhuling decoction could be used in combination therapy for patients with diuretic resistance in heart failure in addition to standard treatment.

关键词： heart failure diuretic resistance urine output treatment outcome Zhuling decoction randomized controlled trial

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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

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中医杂志:英文版 2023年第5期43卷 1010-1018页

作者： XU Xiangru ZHOU Yi CHEN Gang LEI Ming ZHANG Wen WU Xinxin PU Yuting CHEN Caiyu SUN Yuting ZHOU Shuang FANG Bangjiang Department of Emergency Longhua Hospital Affiliated to Shanghai University of Traditional Chinese MedicineShanghai 200032China School of Basic Medical Sciences Shanghai University of Traditional Chinese MedicineShanghai 201203China Department of Intensive Care Medicine Seventh People’s Hospital of Shanghai University of Traditional Chinese MedicineShanghai 200137China Acupuncture and Massage College Shanghai University of Traditional Chinese MedicineShanghai 201203China Institute of Critical Care Shanghai University of Traditional Chinese MedicineShanghai 201203China

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 *** 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 *** 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 ***:Altogether 83 subjects in the intervention group and 85 subjects in the control group were *** 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(P0.05).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 ***:BZYQ may be an effective therapeutic option for the management of HAP with MDRB.

关键词： healthcare-associated pneumonia drug resistance multiple bacteria Buzhong Yiqi decoction randomized controlled trial

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