Objective: To observe the clinical effect of Ganduqing Granules on the treatment of common cold(syndrome of qi deficiency and evil invasion)and its influence on serum IL-1 and TNF-? levels.Methods: In this clinical study,a randomized,double-blind,placebo-controlled clinical trial was designed to randomly divide 60 patients meeting the inclusion criteria into a treatment group(Ganduqing Granules group)and a control group(placebo group).In the treatment group,30 patients were given Ganduqing Granules for 3 times/day for 5 days.In the control group,30 patients were given placebo 3 times/day for 5 days.To observe the therapeutic effect and changes of serum IL-1 and TNF-? levels in the two groups.Result:(1)2 cases were excluded from the treatment group.In the control group,4 cases were removed and 1 case was shed.A total of 53 cases were completed.(2)There were no significant differences in age,sex and course of disease between the two groups.(3)The markedly effective rate of the treatment group was 89.29%,while that of the control group was 52.00%.The markedly effective rate of the treatment group was significantly better than that of the control group,and the difference was statistically significant(P < 0.05).After treatment,the total score of TCM syndromic symptoms in the treatment group decreased more significantly than that in the control group and the difference was statistically significant(P < 0.05).After treatment,the syndromic scores of the main symptoms(chill,runny nose,fatigue,shortness of breath,lazy speech,sore throat)and secondary symptoms(cough and sputum)in the treatmentgroup were significantly reduced compared with those before treatment,and the difference was statistically significant(P < 0.05),and at the same time,the scores of these symptoms after treatment were significantly lower than that of the control group and the difference was statistically significant(P < 0.05),it can be considered that Ganduqing Granules has a good effect in improving the symptoms of chill,runny nose,fatigue,shortness of breath,lazy speech,sore throat,cough and phlegm.(4)After treatment,there was no significant difference in serum IL-1 and TNF-? levels between the two groups(P >0.05).Serum IL-1 and TNF-? levels in the treatment group before and after treatment showed no statistically significant difference(P >0.05).Serum IL-1 and TNF-? levels in the control group before and after treatment showed no significant difference(P >0.05).(5)During the test,there were no abnormal changes in vital signs,physical examination,blood routine,liver and kidney function,and no special adverse reactions or adverse events occurred.Conclusion:(1)This study shows that Ganduqing Granules can effectively improve the overall TCM syndromic symptoms and shorten the course of common cold(syndrome of qi deficiency and evil invasion),and it has a good effect on relieving chill,runny nose,tiredness and weakness,shortness of breath,sore throat,cough and phlegm of the common cold(Syndrome of qi deficiency and evil invasion).The security is good,too.(2)In this study,it is difficult to draw a positive conclusion that the efficacy of Ganduqing Granules in the treatment of common cold(syndrome of qi deficiency and evil invasion)is achieved by reducing serum IL-1 and TNF-? levels,and more in-depth clinical and basic research is needed to explore its specific mechanism in the future. |