| Objective:Based on the theory of "sour and sweet herbs to nourish yin", this study was to explore the efficacy of dark plum spray in head and neck tumors patients with radiation-induced xerostomia, including the function of stimulating the secretion of salivary, relieving the feeling of dry mouth, improving the quality of life and the quality of sleep. Meanwhile, according to the clinical efficacy and feasibility, this study also evaluated the clinical potential of dark plum spray. So that, it could provide a valuable reference for the clinical treatment and nursing of radiation-induced xerostomia.Methods:In a randomized controlled trial,64 patients with head and neck tumors in accordance with the inclusion and exclusion criteria from Traditional Chinese Medicine Hospital of Guangdong Province from June 2014 to October 2015 were randomly divided into the experimental group (n=32) and the control group (n=32). All the subjects were received the conventional oral care of head and neck tumors. Meanwhile, the control group were given the pure water aerosol, while the experimental group were given the dark plum aerosol. And the spray were applied q2h with the exception of sleep time,0.3 ml at a time, about 5-8 ml at a day,14 days for a course of treatment. Then, the salivary flow rates and the scores of linear visual analog scale were assessed and compared between two groups before and after the first and last spray. The RTOG grades were collected twice before and after spray. The quality of life and quality of sleep were assessed at the end of this test.Results:In this study, the final valid cases were 59 including experimental group (n=29) and control group (n=30). Compared 5 abscission cases with all other 59 cases, there were no statistically significant differences (P>0.05)。(1) Salivary flow rates(SFR):there were no statistically significant differences (P>0.05) in SFR before the first spray between experimental group and control group. The SFR after the first spray of experimental group was about to two times of control group, and there were statistically significant of this two groups(P<0.01). The SFR before the last spray had no statistically significant differences (P>0.05) between experimental group and control group. The SFR after the last spray was just like the first spray, experimental group was about to two times of control group(P<0.01).(2) The scores of linear visual analog scale(VAS scores):there were no statistically significant differences (P>0.05) in VAS scores before the first spray between the two groups. The VAS scores after the first spray of the experimental group showed that there were 41.4% patients with mild dry mouth,48.3% patients with moderate dry mouth, and 10.3% severe dry mouth However, the percentages of the control group were 13.3%,56.7% and 30.0% respectively.it had a statistically significant difference(P<0.01). And it had no statistically significant differences between the two groups(P>0.05) of the VAS scores before the last spray. After the last spray, the percentages of mild, moderate, severe dry mouth were 34.5%,58.6%,6.9% in experimental group, and were 13.3%,53.3%,33.4% in control group, there were statistically significant differences of this two groups(P<0.01).(3) RTOG grades:it had no statistical significance (P>0.05) between experimental and control group in RTOG grades at the first and the last spray.(4) The quality of life (QOF):the total score (FACT-H&N) of experimental group was higher than the control group, and it had statistical significance (P>0.01). Among them, the scores of physiology and additional dimensions had statistical significance(P<0.01). However, the scores of social, family, functional, emotional dimensions had no statistical significance (P>0.05). What more, Some items belonged to additional dimension, for example, the related items of thirsty, swallowing and chew, communication had statistical significance (P<0.01) between the two groups, and the unrelated items had no statistical significance (P>0.05).(5) The quality of sleep (QOS):the QOS of experimental group is better than the control group. And there was a statistically significant difference (P<0.05) in QOS between experimental group and control group.Conclusions:(1) Dark plum spray could stimulate the secretion of saliva and alleviate the feeling of dry mouth at the first using, what’s more, the effect of the first using and the last using were the same.(2) Through alleviating the feeling of dry mouth, helping patients eating and communicating, dark plum spray has a function of improving the quality of life.(3) By reducing the water intake at night, the number of waking up and urination at night were being cut down, and the quality of sleep of patents were improved.(4) Dark plum spray was making in CTM granule which was nontoxic, cheap and easy taking. Through the local action of mouth, dark plum spray could relieve the radiation-induced xerostomia. And thanks to its feasibility and efficacy, dark plum spray could be a adjuvant medicine for long-term treatment of radiation-induced xerostomia. |
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