| ObjectiveTo observe the efficacy and safety of the TCM treatment of large dose of heat removing agent on postoperative fever with the design methodology of randomized control trial.To explore the law of the TCM treatment of large dose of heat removing agent on postoperative fever.To demonstrate the efficacy and safety of overdose of heat removing agent to cure for postoperative fever.MethodThe cases were selected from postoperative fever patients in the department of general surgery and department of orthopedics (spine, trauma, bone and joint) in Wangjing Hospital of China Academy of Traditional Chinese Medicine, during March2012to March2013.50standard clinical cases were divided into test and control groups at random. The test group, with26cases assigned to receive Chinese medicine (10grams of ginseng,30grams of bupleurum,30grams of notopterygium,30grams of buffalo horn powder), oral, once a day, and every time a small amount of taking, frequently until temperature decreaseed to the normal. The control group was24cases. The cases below38.5℃had no treatment, while, the cases above38.5℃assigned to receive Aspisol. All patients with case report form were treated for three days, and then followed-up for three days. According to the trial,to observe the changes on the temperature and the clinical symptoms etc of the cases after the treatment.Qualitative data is described by the percentage. If the data accord with normal distribution, we describe it by mean±standard deviation, while the data does not accord with, describe percentage. For hypothesis test, we rank sum test analysis.For calculation of the mean and standard deviation, we analyzed by the independent samples t-test. For counting data, we use the chi-squared test. All data is analyzed by statistics software of SPSS16.0, P<0.05is thought to have significant difference.Results1The result of baseline analysesThe comparison of baselines of two groups, including the age, sex, height, weight, systolic blood pressure, diastolic blood pressure, heart rate, pulse, respiratory rate, time of onset, the highest temperature, and the TCM symptom score, the difference between the two groups were not statistically significant (P>0.05).2The result of efficacy analyses2.1The improvement of TCM symptoms On the second day,the symptoms of fever, chills, mental (?)tigne,tired in the test group were more improved than the control group. The difference was statistically significant between two groups (P<0.05).On the third day, TCM syndrome total score and the symptoms of shortness of breath and lazy words in the test group are better than the control group. The differences in improvement of shortness of breath and TCM syndrome score were statistically significant between two groups (P<0.05), while the differences in improvement of lazy words and sweating were not (P>0.05).2.2Efficiency analysesThe differences had statistical significance in the total effect between two groups (P<0.05), the effect of test group was better than control group.2.3Temperature changesDuring the course of treatment and the first day of following-up, the average temperature of test group and control group was not statistically significant difference (P>0.05). From second days of following-up, the differences had statistical significance in the daily average temperature between two groups (P<0.05).3Safety analysesTwo groups are both safe, security level is one or two, the differences between the two groups was not statistically significant (P>0.05).ConclusionThe treatment of large dose of heat removing agent on relieving fever has a satisfactory curative effect. The fever is hard to rebound by steadily lowering the temperature. It is significant to improve some symptoms ofqi deficiency such as shortness of breath, fatigue, lazy words etc. It is showed that the treatment is safe, effective, and short of adverse reactions. |
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