| Objective: Through this clinical study,we observed and objectively evaluated the clinical effectiveness of reducing the south and reinforcing the north method with Yishen Decoction in the treatment of nasopharyngeal carcinoma patients with Yin-deficiency and fire-excess type insomnia after radiotherapy.This clinical study provides a treatment method and basis for the treatment of Yin-deficiency and fire-excess type insomnia after radiotherapy of nasopharyngeal carcinoma.Method: This study adopted a randomly and parallel controlled observation design.Sixty-six patients who met this clinical study were separated without any regular pattern.As a result,a treatment group and a control group were generated,with33 patients in each group.The treatment group was treated with Yishen Decoction,and the control group was treated with estazolam tablets.Each course of treatment was 7 days,and both groups received 2 courses of continuous treatment.Related indicators before and after treatment in both groups,such as the PSQI scores,quality of life scores,TCM syndrome scores,follow-up after 7 days of treatment and so on,were compared for statistical analysis.Result: A total of 66 cases were included in the clinical study.One case was excluded from the treatment group and the control group separately,so 32 cases left in each group.A total of 64 clinical studies were completed.1.The dissimilarities(P>0.05)between the two groups of general information before treatment were not fairly large.And the general information were comparable,such as gender,age,duration,PSQI score,TCM syndrome score,and QOL score.2.TCM syndrome scores: The scores of TCM syndromes after treatment in both groups were significantly lower than those before treatment(P<0.05).After treatment,as for the TCM syndrome scores,the treatment group were significantlylower than the control group.There were statistically significant differences in the TCM syndrome scores after treatment in both groups(P<0.05).3.PSQI scores: PSQI scores after treatment in the two groups were significantly lower than those before treatment(P<0.05).The dissimilarity of PSQI scores between the treatment group and the control groups was not statistically fairly large.(P>0.05).4.TCM syndrome effectiveness: The total effective rate was 93.75% in the treatment group and 78.13% in the control group.The difference between the two groups was statistically fairly large(P<0.05).5.Clinical effectiveness: The total effective percentage in the two groups were87.50% and 84.38%.Although the treatment group is a bit higher than the control group,there was no statistically fairly large dissimilarity in the two groups(P<0.05).6.Quality of life scores: The quality of life scores after treatment were significantly higher than those before treatment(P<0.05).As for the scores between the treatment group and the control group,the former were statistically higher.There were statistically significant differences in the quality of life scores after treatment in both groups(P<0.05).7.Follow-up 7 days after the end of treatment: In the treatment group,the dissimilarity in the PSQI score of 7 days after the end of treatment and after treatment was not fairly large(P>0.05).But in the control group,the PSQI score was higher than that after treatment(P<0.05).Seven days after the end of treatment,there was fairly large dissimilarity in the PSQI scores of the two groups(P<0.05).8.Safety indicator:There were no obvious abnormalities in the indicators before and after treatment in the two groups(P>0.05),such as blood routine,liver and kidney function.The indicators has no statistical meaning before and after treatment.No adverse events occurred in either group during the course of treatment.Conclusion: Yishen Decoction is effective in the treatment of Yin-deficiency and fire-excess type insomnia after radiotherapy of nasopharyngeal carcinoma,and has a fairly large effect in improving TCM syndromes.It can make patients sleep well and ameliorate the quality of their life.The drug is safe and effective,and no obvious side effects have been found. |