Clinical Study On Treatment Of Acute Upper Respiratory Tract Infection (Cold And Wind - Heat Syndrome) By Anti - Sensory Refractory Mixture

This thesis is mainly composed of two parts, which include the literature reviews and clinical research.The content of the literature reviews involves in Traditional Chinese Medicine (TCM) and Western Medicine. Then, the part of TCM literature review elaborates many fields about the common cold, such us the text of theoretical basis, the continuous development of the typing of syndrome differentiation and the process of some modern scientific research methods.The other part, the Western Medicine literature review summarizes the basic understanding of the acute upper respiratory tract infection, the updated diagnostic technology, the current treatment and some drugs’researches. Besides, the part of clinical research is based on subjects collected and observed in Bei Jing Dong Fang Hospital that accord with the Western Medicine and TCM diagnostic criteria of acute upper respiratory tract infection (wind-heat common cold). And then, according to the study’s results, we draw conclusions about the efficacy of Kanggantuireheji and make objective evaluation on its safety.Objective:Through the use of the treatment experience from the national well-known TCM doctors Zhongshan Gao and the product of modern research in TCM, the Kanggantuireheji was formulated by our team. The drug formulations can play a positive role in alleviating symptoms as fever, sore throat, cough. What’s more, in the treatment of acute upper respiratory tract infection (wind-heat common cold), it had obtained some good curative effect. Our research aimed to observe its effectiveness and assess the safety of the Kanggantuireheji, providing evidences to the promotion of clinical drug.Methods:The study collected 42 patients from the fever clinic of Dongfang Hospital during the period of December 2013 to January 2014.Both of them were in accordance with the western medicine diagnostic standards of acute upper respiratory tract infection and TCM criteria of wind-heat common cold. A randomized, placebo-controlled design method was used in this study.The patients were randomly divided into 3 groups, which contained low-dose group (Kanggantuireheji 20mL and Kanggantuirehej simulation regent 10mL,n= 14),high-dose group(Kanggantuireheji 30mL,n=14), placebo group(Kanggantuirehej simulation regent 30mL,n=14),each group was given oral 30 mL every time,4 times per day,and the treatment course was 5 days. To evaluate the clinical effect and safety of Kanggantuirehji in the treatment of acute upper respiratory tract infection (wind-heat common cold), disease efficacy, syndrome efficacy, ease of main symptoms, onset time about antipyretic effect and the changes of laboratory indexes were observed in the treatment.Results:This study selected patients meet the criteria for a total of 42 cases(falling 1 case), and the actual number of cases was 41, including 23 females,18 males, average age was 42.17 ± 11.958 years, the temperature range between 37.3 C°-38.5 C°,the average duration of time was 18.78 ± 5.561 hours.① The third day curative effect analysisIn terms of TCM syndrome efficacy, low-dose group effective rate was 92.3%, high-dose group was 85.7%,control group was 92.9%;the disease curative effect, low-dose group effective rate was 76.9%,high-dose group was 85.7%, control group effective rate was 85.7%. The three groups and even each two groups for multiple comparisons had no statistical significance (P> 0.05).In terms of symptomatic improvement, the differences among the three groups and multiple comparisons between two groups after the treatment of symptoms total score were not statistically significant (P> 0.05). Comparison between a single symptom, low dose group was in fever, sore throat, headache, aversion to wind, postnasal drip, thirst with ease(P<0.05); high dose group was fever, sore throat, aversion to wind, cough, thirst with ease(P<0.05); the control group except the symptom scores of sweating having no statistical significance (P> 0.05), the rest of symptoms there are statistical significance (P<0.05). The four symptoms of the three groups such us fever, sore throat, aversion to wind, thirsty were improved(P<0.05), and the symptom scores of sweating and stuffy nose having no statistical significance (P> 0.05),it meant the two of symptoms were not relieved.② The fifth day curative effect analysisIn terms of TCM syndrome efficacy, the efficiency of the three groups was 100%. The three groups and even each two groups for multiple comparisons had no statistical significance (P> 0.05). In terms of symptomatic improvement, the differences among the three groups and multiple comparisons between two groups after the treatment of symptoms total score were not statistically significant(P>0.05).Comparison between a single symptom,except the symptom scores of sweating having no statistical significance (P>0.05), the rest of symptoms among the three groups, such us sore throat, headache, aversion to wind, postnasal drip, coughing, stuffy nose, thirst and other symptoms,there are statistical significance (P<0.05), while the symptom scores of each group after the was significantly decreased.In addition, the symptom disappear rate, particularly fever in each group was 100%, but the disappear rate of cough symptoms in every group ranked last,which was46.2% in low dose group,50% in high dose and control group.③ Onset timeIn terms of onset time about antipyretic effect, the differences among the three groups and multiple comparisons between two groups were not statistically significant (P> 0.05). The study drug failed to play a role in quickly antifebrile action.④ Drug safetyAt the end of the course, the three groups of clinic testing outcomes(WBC#, NEUT%, LYM%, ALT, AST, Crea, Urea and ECG etc.), which were basically in the normal range. Based on the comparison of routine blood parameters (WBC#, NEUT%, LYM%), hepatic parameters(ALT,AST),renal function(Crea,Urea)and ECG, there were not statistical significance among the three groups (P> 0.05).At the same time,there was no serious adverse events in the study.That is to say, the Kanggantuireheji is a safe medicine for acute upper respiratory tract infection (wind-heat common cold).Conclusion:The research shows that Kanggantuireheji has good security.However,due to the less collected sample size, acquisition cases in short time and even other multiple factors, to a certain extent, it does not show the superiority of Kanggantuireheji in treatment of acute upper respiratory tract infection (wind-heat common cold). Therefore,we think that the later further study should be expanded the sample size, prolonged cases collected.