| ObjectiveThrough theoretical research,systematically understand the characteristics of multidrugresistant bacterial pneumonia and analyze the problems existing in the treatment process of the disease;adopt a method of systematic evaluation to comprehensively evaluate the therapeutic effect of oral administration of traditional Chinese medicine(TCM)on drugresistant bacterial pneumonia and clarify its therapeutic advantages;use a prospective,multicenter,randomized and parallel controlled clinical research method to evaluate the efficacy and safety of Buzhong Yiqi Decoction in the treatment of multidrug-resistant bacterial pneumonia,to explore the prevention and treatment strategy of multidrugresistant bacterial pneumonia and develop a new thought and method of diagnosis and treatment of TCM and integrated traditional Chinese and Western medicine.Methods1.Theoretical research: consult the ancient literature and modern research,explore the understanding of TCM and Western medicine on multidrug-resistant bacterial pneumonia,and systematically sort out its theoretical and practical basis.2.Systematic review: relevant keywords were formulated,the computer was used to search the articles from CNKI,Wan Fang Data,VIP,CBM,Pub Med,the Cochrane Library,Embase,and Web of Science up to February 2021.Randomized controlled clinical trials(RCTs)on the efficacy and safety of oral administration of TCM for drug-resistant bacterial pneumonia were collected.Articles were screened according to the inclusion and exclusion criteria.Methodological quality evaluation and data extraction were carried out for the included literature.Revman 5.3 and Stata 16.0 software were used for the meta-analysis of outcome indicators.3.Clinical study: 180 patients with multidrug-resistant bacterial pneumonia were divided into a control group(n=90)and an experimental group(n=90)by multicenter,randomized,and parallel controlled clinical research method.The control group received basic treatment,and the experimental group was treated with Buzhong Yiqi Decoction.After 14 days of observation,the inflammatory reaction,coagulation function,drug-resistant bacteria clearance rate,clinical pulmonary infection score(CPIS),TCM symptom score,single symptom disappearance rate and disappearance time of the two groups were evaluated at different time points.The adverse events during the study period were recorded,and the clinical efficacy and safety were evaluated.Results1.Systematic review: 25 studies involving 1908 patients with drug-resistant bacterial pneumonia were included.The results of meta-analysis showed that in terms of curative effect,Chinese medicinal formulae combined with western routine intervention could improve the clinical effective rate(RR = 1.30,95% CI [1.23,1.37],P < 0.000 01),improve the white blood cell(WBC)count(MD =-2.32,95% CI [-2.89,-1.75],P < 0.000 01),and reduce the CRP level(MD =-6.38,95% CI [-8.21,-4.55],P < 0.000 01),decreased CPIS(MD =-1.50,95% CI [-1.69,-1.32],P < 0.000 01),decreased PCT content(MD =-0.56,95% CI [-0.73,-0.40],P < 0.000 01),increased clearance rate of drug-resistant bacteria(RR = 1.49,95% CI [1.33,1.66],P < 0.000 01);in terms of safety,Chinese medicinal formulae did not increase the incidence of adverse events in the treatment of drug-resistant bacterial pneumonia(RR = 0.72,95% CI [0.48,1.07],P > 0.05).In addition,due to the limited number and low homogeneity of studies on the treatment of drug-resistant bacterial pneumonia by Chinese medicinal formulae compared with conventional western medicine,the results of descriptive analysis suggest that compared with conventional western medicine,oral administration of Chinese medicinal formulae has certain advantages in improving clinical efficiency,CPIS,WBC count and reducing adverse events.Subgroup analysis was based on different treatment principles of Chinese medicinal formulae.The results showed that Quxie group and Fuzheng group could improve the clinical effective rate of drug-resistant bacterial pneumonia(RR = 1.31,95% CI [1.21,1.40],P < 0.000 01;RR = 1.28,95% CI [1.19,1.39],P < 0.000 01),improve WBC count(MD =-2.02,95% CI [-2.75,-1.30],P < 0.000 01);MD =-2.83,95% CI [-3.94,-1.71],P < 0.000 01),decreased CRP level(MD =-8.39,95% CI [-11.44,-5.33],P < 0.000 01;MD =-4.76,95% CI [-7.24,-2.28],P < 0.05),decreased PCT content(MD =-0.72,95%CI [-1.08,-0.36],P < 0.000 01;MD =-0.43,95% CI [-0.58,-0.28],P < 0.000 01)The clearance rate of drug-resistant bacteria was increased(RR = 1.54,95% CI [1.32,1.80],P < 0.000 01;RR = 1.43,95% CI [1.22,1.67],P < 0.000 01).In terms of safety,the combination of Fuzheng Chinese medicinal formulae did not increase the incidence of adverse events(RR = 1.09,95% CI [0.67,1.77],P > 0.05),and the incidence of adverse reactions in combination with Quxie Chinese medicinal formulae was less than that in conventional western medicine alone(RR = 0.35,95% CI [0.16,0.74],P < 0.05).2.Clinical study: a total of 180 patients with multidrug-resistant bacterial pneumonia were included,including 5 cases in the control group and 7 cases in the experimental group.There was no significant difference in the baseline data between the two groups(P > 0.05).The results are as follows:(1)Compared with before treatment,the WBC count of the control group did not change significantly after 7 days of treatment(P < 0.05),WBC count of the experimental group decreased significantly after 3 days of treatment(P < 0.05),showing a downward trend at different time points.There was no significant difference between the two groups at different time points(P > 0.05).(2)Compared with before treatment,the percentage of neutrophils(NEUT%)in the control group did not change significantly at different time points(P > 0.05).After 7 days of treatment,the level of NEUT% in the experimental group decreased significantly(P < 0.05),showing a downward trend at different time points.There was no significant difference between the two groups at different time points(P > 0.05).(3)Compared with before treatment,the CRP content of the control group decreased significantly after 14 days of treatment(P < 0.05),and the CRP content of the experimental group decreased significantly after 7 and 14 days of treatment(P < 0.05).There was no significant difference between the two groups at different time points(P > 0.05).(4)Compared with before treatment,the FIB content in the control group had no significant change at different time points(P > 0.05).After 14 days of treatment,the FIB content in the experimental group decreased significantly(P < 0.05),showing a downward trend at different time points.There was no significant difference between the two groups at different time points(P > 0.05).(5)Compared with before treatment,the CPIS of the control group and the experimental group decreased significantly after 14 days of treatment(P < 0.05).Compared between the two groups,the experimental group was better than the control group in reducing CPIS,and the difference was statistically significant(P < 0.05).(6)After 14 days of treatment,the clearance rate of drug-resistant bacteria and the curative effect of TCM symptoms in the experimental group were better than those in the control group(P < 0.05),the disappearance rate of fever and expectoration symptoms in the experimental group were higher than those in the control group(P < 0.05),and the disappearance time of fever and expectoration symptoms was shortened(P < 0.05).(7)The results of full analysis set(FAS)for intention to treat(ITT)showed that there was no significant difference in the clinical effective rate between the two groups after 14 days of treatment(P > 0.05).According to the further investigation of the PPS population who fully complied with the research protocol,the clinical effective rate of the experimental group was higher than that of the control group(P < 0.05).But no matter which case,the clinical effective rate of the experimental group was higher than that of the control group(P < 0.05).(8)Logistic regression analysis showed that age,gender,and TCM syndrome score could influence the clinical efficacy grade(P < 0.05).Besides,there were no serious adverse events in both groups during the study period.Conclusion1.Oral administration of Chinese medicinal formulae or combined with western medicine conventional therapy in the treatment of drug-resistant bacterial pneumonia has better curative effect,and does not increase the incidence of adverse events.Quxie group and Fuzheng group,which derived from the therapeutic principle of detoxification and strengthening,can both improve the clinical efficacy,and there is no significant difference in efficacy,but still need high-quality clinical trials to verify.2.Buzhong Yiqi Decoction can improve the clinical efficiency of patients with multidrugresistant bacterial pneumonia,reduce the CPIS,improve the clearance rate of drugresistant bacteria,improve the TCM syndrome score,promote the disappearance of fever and expectoration symptoms,shorten the disappearance time,reduce the inflammatory reaction and correct the hypercoagulable state faster,which is conducive to the prognosis,no serious adverse events,and has good safety. |
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