| Objective: The experiment is to observe whether Guizhi Decoction has acute adverse reactions and the outcome of acute adverse reactions in hospitalized patients who suffering from ostoporosis after zoledronic acid infusion,based on the theory of six meridians syndrome differentiation and parallel control design.In the future,use Six-channel differentiation,we can promote the application of traditional Chinese medicine instead of non steroidal anti-inflammatory drugs in the prevention and treatment of adverse reactions after the application of nitrogen-containing bisphosphonates,and explore the use of traditional Chinese medicine in the prevention and treatment of adverse reactions such as drug-induced fever.Methods:By way of randomized controlled,selected 108 patients who suffering from osteoporosis and visited Yunnan provincial hospital of TCM.And divided 36 of them who treated with Guizhi Decoction one day before zoledronic acid infusion into test group and 36 who treated with celecoxib one day before zoledronic acid infusion into control group.The rest there was no other drug given before zoledronic acid infusion into blank group.Record the number of cases of fever record of three groups of patients,adverse reactions and indicators such as the number of cases occurring,and then make statistical analysis of the relevant data.Results: During the treatment and observation period,4 cases in the text group and the control group each were removed,2 cases in the blank group,and 98 effective cases were finally collected.Statistics:(1)Comparison of fever rate among three groups,by chi-square test,there was no difference between the experimental group and the control group(P = 0.708),there was difference between the experimental group and the blank group(P = 0.006),and there was difference between the control group and the blank group(P = 0.039)(2)By one-way ANOVA,the VAS scores of the three groups were compared,P < 0.01,and there was statistical difference between the groups.By LSD test,compare with the blank groups,both of the text groups and the control groups were no difference.(3)According to Fisher’s exact probability test,the three groups had chills and fever,P =0.361,nasal congestion(P = 0.367),throat itching or swelling(P = 0.411),head and body pain(P = 0.322),There was no significant difference in TCM symptom score among the three groups(P = 0.246).(4)Safety indicators: by single factor analysis of variance,the three groups of intervention related indicators,P > 0.05,the difference was not statistically significant.Conclusion: harmonizing Ying Wei method can prevent and alleviate the adverse reactions of zoledronic acid in the treatment of acute osteoporosis,and can reduce the fever and muscle and joint pain caused by zoledronic acid injection,which is worthy of further study in clinic. |