| Objective:this study was to evaluate the clinical effects of Chinese Herbal Preparation Feiganfang for multi-drug resistant bacteria in respiratory tract infection with encephalopathy patients and determine the in vitro bacteriostatic effect of Feiganfang combined with three kinds of clinical commonly used antibiotics.Methods:1. Clinical study:we recruited43hospitalized patients with respiratory tract infection due to multidrug-resistant organisms and got Traditional Chinese Medicine (TCM) diagnosis as "Phlegm heat accumulate lung syndrome" from the department of TCM (Encephalopathy section), the First Affiliated Hospital of Guangxi Medical University, Guangxi, China. We performed a cohort study and divided participants into25cases in control group and18cases in treatment group. The control group was given conventional Western medicine to reduce intracranial pressure, improve blood circulation, nourish nerves and others base on the standard treatment of encephalopathy. The antibiotics base on antimicrobial susceptibility testing and doctors’experience, antispasmodic, expectorant, bronchodilator, Chinese medicine except Feiganfang, and other treatments according to all the patient’s relevant symptoms were accepted for respiratory tract infection management. Feiganfang group was given the same intervention as those in the control group and added Chinese medicine preparation Feiganfang (comprising baikal skullcap root, pinellia, fructus, cordate houttuynia, semen coicis, peach kernel, phragmites communis, zhejiang fritillary, rhubarb and others). The course of treatment was14days. Clinical signs and symptoms, sputum bacterial culture, antibiotic sensitivity test, PSI scores, TCM scores, routine blood test, CRP, immune globulin, T cell subgroup, chest CT-scan were compared before and after treatment in each group to evaluate the clinical effects of Feiganfang for multi-drug resistant bacteria in respiratory tract infection with encephalopathy patients.2. In vitro bacteriostasis experiment:(1) The minimal inhibitory concentrations (MICs) of Fei Gan Fang, cefoperazone-sulbactam, levofloxacin and piperacillin-tazobactam to against standard Staphylococcus aureus, multidrug-resistant strains of S. aureus, multidrug-resistant Acinetobacter baumannii, multidrug-resistant Klebsiella pneumoniae, multidrug-resistant Escherichia coli and multidrug-resistant strains of Pseudomonas aeruginosa were measured by two-fold dilution method.(2) Checkerboard dilution method was used to determine MICs of susceptibility of multi-drug resistant bacteria to combination therapies of Feiganfang and three kinds of antibiotics.Results:1. Clinical study:(1) TCM syndrome curative effect:there was no complete recovery case in both groups. The significant effective rate, improvement rate and total effective rate were16.67%,72.22%and88.89%in Feiganfang group in addition to12.00%,68.00%and80.00%respectively in control group. There was no significant difference after treatment between two groups (P>0.05).(2) Western medicine curative effect:there was no full recovery case in both groups. The improvement rate and total effective rate were88.89%and88.89%in Feiganfang group, as well as80.00%and80.00%respectively in control group. There was no significant difference after treatment between two groups (P>0.05).(3) Pathogen:Before-and-after treatment comparison showed no significant difference in bacteria constituent (P>0.05). However, we could culture a variety of gram-negative bacilli in control group after treatment. The comparison between two groups showed significant difference (P<0.05). The difference of bacterial clearance after treatment between two groups was not statistically significant (P>0.05).(4) PSI score:there were no significant differences of PSI score in two groups when compared a before and after treatment (P>0.05) as well as the scores after treatment between both groups (P>0.05).(5) Symptom score:scores of cough and sputum after treatment in both groups were significantly lower than those in before treatment (P<0.05). Though, the comparison between two groups after the trial was no significant difference (P>0.05). After giving Feiganfang comparing it with before, there was significantly lower in the fever score in the experiment group (P<0.05). On the other hand, there was no significant difference in control group comparing before and after treatment (P>0.05). Feiganfang group had antipyretic effect better than control group (P<0.05).(6) Blood test:there were no significant differences of leukocytosis and the percentage of neutrophils in two groups before and after treatment (P>0.05).(7) CRP:There were no significant differences in CRP growth structure in two groups before and after treatment (P>0.05).(8) Immune function:there were no significant differences in the ratio of IgG, IgA, IgM, total T cells, CD4+, CD8+and CD4+/CD8+before and after treatment in two groups (P>0.05). The difference values after treatment were no significant differences between two groups (P>0.05).(9) Chest CT scan:Full recovery case from pneumonia was0%. The most improvement, partial improvement and total effective rate were27.28%,44.44%and72.22%in experimental group and32.00%,40.00%, and72.00%respectively in control group. There was no significant difference in pneumonia recovery after treatment between two groups (P>0.05).2. In vitro bacteriostatic experiment:Feiganfang showed very obviously antibacterial effect on those six strains. MICs were between0.0195and0.1560g·ml-1, while minimum bactericidal concentrations (MBCs) were between0.1560-0.3125g·ml-1. Moreover, Feiganfang combined with antibiotics generated the selective effects and synergistic or additive effects by reducing the inhibitory concentrations of multi-drug resistant bacteria. Standard S. aureus and multidrug-resistant S. aureus were sensitive to Feiganfang combined with cefoperazone-sulbactam and levofloxacin while A. baumannii was susceptible to Feiganfang with levofloxacin. Moreover, there were additive effects of Feiganfang and cefoperazone-sulbactam to multidrug-resistant A.baumannii and Feigan fang combined with levofloxacin to P. aeruginosa.Conclusions:In vivo (clinical study) Feiganfang had an efficacy to partially inhibit the multi-drug resistant bacteria. There were selective, synergic or additive effects for multi-drug resistant bacteria when it combined with commonly used antibiotics. In clinic, the combination of Feiganfang and antibiotics showed the therapeutic effects for multi-drug resistant bacteria in respiratory tract infection with encephalopathy patients. It might have the properties of antipyretic, antitussive and expectorant effects and can improve the bacterial translocation of multi-drug resistant bacteria in respiratory tract infection patients. However, there was no obviously significant effect in bacterial clearance and patients’ immune function. Then, further studies will be needed to demonstrate the conclusion. |
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