Efficacy And Safety Evaluation Of Treatment Of CAP Patients With Lung Phlegm Heat Syndrome By Augmented Maxingshigan Decoction Iontophoresis

Background Community-acquired pneumonia(CAP)is a respiratory disease contracted outside the hospital and is characterized by fever,cough,sputum and chills as the main symptoms,lung consolidation and wet rales as the main clinical signs,and abnormal leukocyte counts and radiology changes.The high domestic and international prevalence and mortality rate makes CAP a target in the clinician’ s quest for Chinese and Western Medicine integration.Iontophoresis is an important,non-invasive,new drug delivery method that increases the permeability of the skin through physical or chemical means,and passes the ionized drug through the stratum corneum to act on local tissue or the entire body.Much research has been conducted on its principle and clinical application in recent years.Many attempts within the country have applied ionized Chinese medicines on acupoints in the treatment of various diseases and have demonstrated good safety.Maxingshigan Decoction is a classic decoction that can clear invading pathogens and release lung heat.Pharmacological studies have found that although it has no clear antibacterial effect,this decoction has obvious antipyretic effects and is commonly used to treat pneumonia,influenza,bronchitis and other respiratory diseases.However,when it comes to treating lung phlegm heat syndrome CAP,the decoction should be augmented.Therefore,there is a need to objectively evaluate the efficacy and safety of Chinese Medicinal Iontophoresis in the treatment of CAP.Clinical ResearchObjective:To evaluate the efficacy and safety of Augmented Maxingshigan Decoction Iontophoresis in the treatment of patients with the lung phlegm heat syndrome CAP.This study intends to provide a support for the rational formulation of a comprehensive treatment protocol in the treatment of CAP by integrating Chinese and Western medicine.Methods:79 patients diagnosed with CAP from the Respiratory Department at Beijing University of Chinese Medicine First Affiliated Hospital(Dongzhimen Hospital)from 2016 to 2018 were enrolled in a simple randomized manner.As per selection criteria,76 eligible patients were divided into treatment group and control group.Both groups received a 10-day course of treatment,with the former receiving conventional treatment together with Augmented Maxingshigan Decoction Iontophoresis on bilateral Lung Shu(BL-13)for 20 minutes daily and the latter receiving only conventional anti-infective therapy.Results:There was no significant difference in baseline data between treatment group and control group.In terms of efficacy,the therapeutic effect of Augmented Maxingshigan Decoction Iontophoresis on patients with lung heat phlegm CAP was superior to that of conventional treatment.Safety evaluation was good with no obvious adverse reactions.(1)Baseline Data:Baseline data included gender,age,height,weight,BMI,previous medical history,allergies,smoking history,sever:ity of illness,vital signs,routine blood test with CRP.There was no significant difference between treatment group and control group(P>0.05).(2)Efficacy Indicators:Primary Outcomes:Pneumonia Efficacy is.divided into clinical control,marked improvement,improvement and ineffective.The were no significant differences on days 3 and 10 between both groups(P>0.05).There was a significant difference on day 7 between both groups(P<0.05).In terms of total positive outcome(i.e.clinical control,marked improvement and improvement)between both groups,there were no significant differences on days 3 and 10(P>0.05)but there was a significant difference on day 7(P<0.05),indicating that efficacy of the treatment group was better than that of the control group on day.7.Combining the two groups of patients with four grades of efficacy,the.treatment group was significantly better than the control group on the seventh day.There was no significant differences in total efficacy between of the two groups have no significant difference on the 3rd,7 th and 10th day(P>0.05).Secondary Outcomes:There were significant differences in the routine blood test with CRP between both groups on days 3,7 and 10,namely,leukocyte count,neutrophil count and CRP levels.Body temperature was divided to 4 levels-normothermia and low,medium and high temperature.There were no significant differences in body temperature and proportion of normothermia on days 1,3 and 10 between both groups(P>0.05).There was a significant difference in body temperature and proportion of normothermia on day 7 between both groups(P<0.05).TCM syndrome scores was divided to 4 levels-healed,marked improvement,improvement,and ineffective.There were significant differences in syndrome distribution and total efficacy on days 3,7 and 10 between both groups.(3)Safety Evaluation:No adverse events were reported:no adverse drug reactions,no systemic allergic reactions with nither liver and kidney function damage nor abnormal electrocardiogram.Conclusion:(1)On the 3rd,7th,and 10th days:There were differences in the distribution of the efficacy levels of the two groups of TCM syndrome scores.Besides,the total effective rate of the TCM syndromes in the treatment group was better than that of the control group,the absolute value and scores of the WBC and NE were decreased obviously in the treatment group than the control group.(2)On the 3rd day:The treatment group decreased CRP on the third day better than the control group.(3)On the 7th day:There was a significant difference in the distribution of clinical efficacy scores between the two groups,and the total effective rate of the treatment group(good outcome)was better than that of the control group.There was a significant difference in the temperature classification between the groups,and the treatment group had better results in fever Control group.Treatment group was superior to control group in reducing CRP score.(4)The study shows good safety.Augmented Maxingshigan Decoction Iontophoresis combined with anti-infective therapy was superior to conventional anti-infective therapy alone in the treatment of lung heat phlegm syndrome CAP-it reduced the body temperature,leukocyte count,neutrophil count and CRP of pneumonia patients.The effect began from the day 3 of treatment and showed a significant difference in efficacy on day 7.Hence,Augmented Maxingshigan Decoction Iontophoresis is an effective and safe treatment for lung phlegm heat syndrome of CAP.