| Objective:A prospective, randomized, parallel controlled clinical trial was conducted to observe and evaluate curative effect and safety of oseltamivir and traditional Chinese medicine(TCM) treatment, based on guidelines for diagnosis and treatment of influenza(2011edition), in treating mild influenza.Methods:In this study, outpatients with influenza-like symptoms, visiting Chengdu Infectious Disease Hospital from December2012to January2013, and Guang’anmen Hospital, China Academy of Chinese Medical Sciences from December2012to January2013, December2013to February2013, were screened, and throat swab specimens of whom were collected for rapid antigen test of influenza A and B viruses. After informed consent, patients according with the inclusive and exclusive criteria were admitted to our study. All the cases included were randomly divided into experimental group and the control group at the ratio of1:1through central randomization system. The experimental group was treated with Chinese medicine on the basis of traditional Chinese medicine syndrome differentiation specified in guidelines for diagnosis and treatment of influenza(2011edition), while the control group were given oseltamivir, a kind of anti-influenza virus drug. Detailed information was collected and recorded in the case report form, including demographic data(age, gender, etc.), epidemiological characteristics(duration, temperature, symptom, history of contact with influenza suffers and influenza vaccination, etc.), laboratory test results(blood and urine routine examination, liver and kidney functions, myocardial enzyme level, electrocardiogram, chest CR, etc.) and pathogen detection outcome. Dynamic changes of disease on the first, second, third, fifth and seventh day, occurrence of adverse event and complication were observed throughout the study. Blood and urine routine examination, liver and kidney functions, myocardial enzyme level were rechecked when follow-up on the seventh day. We established a database with Epidata3.1and input all the valid data we got. Software SPSS19.0Version was used for statistical analysis.Result:(1)A total of43cases were included in our study,21of which were devided into experimental group, and the other22cases fell into control group.1case of control group fell off due to adverse effect, while1of experimental group and2of control group were eliminated for poor response to the treatment, respectively.(2)In the aspect of pyretolysis, the average of antifebrile onset time and fever disappearance time among patients treated with TCM treatment were9.16h and12.97h shorter than patients given oseltamivir. The rate of cases with no fever among experimental group were higher than that of control group both24h and48h after acceptance of the treatment(P<0.05).(3) When it comes to symptoms of influenza, the remission time of cough, expectoration, fever, headache, muscle ache among experimental group were shorter than control group(P<0.05), while other symptoms, such as rhinobyon, pharyngalgia, fatigue, thirsty had no statistical significance among two groups(P>0.05). Otherwise,3days,5days,7days after treatment, the average symptom integral of experimental group were lower than control group with great statistical significance(P<0.01), and the curative effect of symptom of experimental group was superior to control group.(4)There was significant difference in influenza comprehensive curative effect among two groups(P<0.01), experimental group had higher cure rate, markedly effective rate and effective rate, compared with control group. There was no invalid cases in experimental group, while31.6%of inefficiency in control group. Great effect can be observed among Chinese medicine treatment group on all three TCM syndromes, wind and cold attacking the exterior, wind and heat invading the lung, heat and toxin invading the lung. However, Oseltamivir seems to generate no therapeutic benefit to influenza of heat and toxin invading the lung.(5)In the respect of safety,1case of experimental group had mild diarrhea, which relieve itself several days later. In the control group,1case was seen suffering heart palpitation, dizziness and high blood pressure, which relieved after stopping the treatment, and another case turned out to be secondary pulmonary infection.Conclusion:(1)The average of antifebrile onset time and fever disappearance time among patients treated with TCM treatment of syndrome differentiation which was based on guidelines for diagnosis and treatment of influenza(2011edition)were obviously shorter than patients given oseltamivir. Therefore, we can infer that TCM therapy is more effective than oseltamivir in shortening antifebrile time.(2) The TCM therapy of our study was significantly superior to oseltamivir in alleviating symptoms, decreasing symptom integral, reflecting better curative effect of symptom with TCM therapy, compared with oseltamivir.(3) The TCM therapy of our study was of better influenza comprehensive curative effect than oseltamivir, with no invalid case and higher cure rate, markedly effective rate and effective rate.(4) The TCM therapy of our study was superior to oseltamivir in the aspect of safety. |
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