| ObjectiveGuided by the external treatment theory of "external medicine is internal medicine",this study applies the preparation process of ointment to prepare the traditional Chinese medicine internal prescription pig skin decoction as external ointment.The purpose of this study is that evaluates the quality of pig skin decoction ointment and its clinical effect on hemopenia wind dry type Senile Pruritus(SP).Guided by the classical theory of traditional Chinese medicine,this study applied the internal medicine prescription,innovating the external therapy of SP,inheriting and developing the theory of traditional Chinese medicine nursing.The clinical practice of this study laid a foundation for further exploring the mechanism of pig skin decoction ointment in the intervention of SP patients.MethodsThe research design of this study includes the preparation experiment of pig skin decoction ointment and the clinical application of pig skin decoction ointment in SP patients.The first stage: orthogonal experimental design was adopted in the preparation experiment of pig-skin decoction ointment,and the optimal extraction condition of pigskin lotion was investigated by taking the yield of pig-skin extract as the index,so as to select the optimal decoction condition of pig-skin.According to the matrix scoring criteria,the most suitable matrix type of pig skin decoction was selected from three kinds of commonly used ointment matrixes,and the best matrix prescription was further screened.The ointment base was mixed with the pig skin decoction to prepare pig skin decoction ointment.The quality of the pig skin decoction ointment was evaluated according to the quality evaluation standard of the ointment.The second stage: the clinical application of pig skin decoction ointment in SP patients with blood deficiency and wind dryness was designed as a multi-center randomized controlled trial.From December 2017 to April 2018,126 SP patients who met the admission criteria were continuously included in 5 nursing home in Yibin city.They were randomly assigned to the control group and the experimental group,with 63 patients in each group.Each group was given 4 weeks of health education including group lectures and individualized instruction.The group lectures are divided into 4 topics,including SP related knowledge,skin care,diet guidance,life guidance,etc.,once every 2 weeks,30-40 min each time.Individualized guidance was given face-to-face once a week for 10-20 min each time.On this basis,the control group was treated with urea ointment,and the experimental group was treated with pig skin decoction ointment.In both groups,the skin was cleaned with warm water and then a thin layer of ointment was applied to cover the itchy part of the skin.2 times a day,the interval between 2 times is 6h.Two weeks was one course of treatment,a total of two courses of intervention.Before the intervention and at the fourth weekend of the intervention,the "pruritus" standard in the "guidelines for clinical research on dermal venereal diseases" was used for scoring,and the efficacy was judged according to the "guidelines for clinical research on new drugs in China".Before the intervention and at the fourth weekend of the intervention,the comprehensive evaluation Scale of skin itching,Pittsburgh Sleep Quality Index(PSQI),negative emotion Scale of Chinese elderly,Chinese Dermatology Life Quality Index(DLQI),General self-efficacy Scale(GSES)were used to evaluate patients' pruritus,sleep quality,negative emotions,quality of life and self-efficacy.Results 1 Research results of preparation of pig skin decoction ointmentThe total amount of porcine skin extract was 6.089±2.7283.The best condition for pig skin decoction was the ratio of pig skin to water: 1:4,decocting 3 times,1.5h/ time.The most suitable ointment matrix type of pig skin decoction is emulsion ointment matrix,and the most suitable matrix prescription:(1)aqueous phase: glycerol 1.00 g,lauryl sodium sulfate 0.10 g,purified water 4.80ml;(2)Oil phase: yellow vaseline 1.00 g,liquid paraffin 1.25 g,stearic acid 1.05 g,glycerin monostearate 0.80g;(3)preservative: ethylparaben 0.01 g.The pig skin decoction ointment was light yellow,without particles and easy to be coated.No oil and water stratification was found in the centrifugal test,and no hardening,stratification and foaming were found in the cold and heat resistance test.According to the ointment quality evaluation standard score of 35 points,that the preparation of pig skin decoction ointment quality is well.2 Clinical application results of skin decoction ointmentAll the data of 120 patients were collected in the clinical study.There were 60 cases in the control group(2 cases fell out and 1 case was removed),and 60 cases in the experimental group(3 cases fell out).The results are as follows: 2.1 efficacy evaluation resultsThe total effective rate in the control group was 61.7%.The total effective rate in the experimental group was 76.7%.There was no statistically significant difference between the two groups in total effective rate(P>0.05).2.2 evaluation results of pruritusThe results of the intergroup comparison showed that there were statistically significant differences between the control group and the experimental group in pruritus degree,involved site,pruritus frequency item score and total score at the fourth weekend of intervention(P<0.05).The results of intra-group comparison showed that the score and total score of the three items of pruritus degree,involved site,and pruritus frequency of the patients in the two groups before intervention and at the end of the fourth week of intervention were statistically significant(P<0.05).2.3 evaluation results of sleep assessmentThe results of the intergroup comparison showed that there was no statistically significant difference in the score and total score of the 7 dimensions of PSQI sleep quality,time to fall asleep,sleep time,sleep efficiency,sleep disorder,hypnotic drug and daytime dysfunction among the patients in the control group at the fourth weekend of intervention(P>0.05).The results of intra-group comparison showed that the score of sleep quality,time to fall asleep,sleep time,sleep efficiency,sleep disorder,daytime dysfunction and the total scores of PSQI in the two groups before intervention and at the end of the fourth week of intervention were statistically significant(P<0.05),except the score of hypnotic drug.2.4 quality of life evaluation resultsThe results of the intergroup comparison showed that at the fourth weekend of the intervention,except for the difference in the symptom perception dimension scores between the control group and the experimental group(P<0.05),there was no statistically significant difference in the total DLQI score and the scores in the five dimensions of daily life,leisure,work and study,interpersonal relationship and treatment(P>0.05).The results of intra-group comparison showed that there were statistically significant differences between the two groups in the total DLQI score,symptom experience,daily life,leisure,work and study,interpersonal relationship and treatment before intervention and at the fourth weekend of intervention(P<0.05).2.5 negative emotional evaluation resultsThe results of the intergroup comparison showed that there was no statistically significant difference in negative emotional scores between the control group and the experimental group at the fourth weekend of intervention(P>0.05).The results of intragroup comparison showed that there were statistically significant differences in negative emotional scores between the two groups before intervention and at the fourth weekend of intervention(P<0.05).2.6 self-efficacy evaluation resultsThe results of the intergroup comparison showed that there was no significant difference in the self-efficacy scores between the control group and the experimental group on the fourth weekend of intervention(P>0.05).The results of intra-group comparison showed that there was no significant difference in self-efficacy scores between the two groups before intervention and the fourth weekend of intervention(P>0.05).2.7 results of safety evaluationNo adverse reactions were observed throughout the trial.ConclusionsBased on the theory that "the external medicine is the internal medicine" and combined with the modern preparation technology of western medicine,the classic internal medicine prescription pig skin decoction was prepared into ointment for external use,which can reduce the skin itching,sleep quality,negative emotions and life quality of blood deficiency and wind dryness SP patients.Drawing on the preparation technology of western medicine ointment,the new application of the ancient prescription promoted the inheritance and development of the traditional Chinese medicine classic prescription,which is worthy of further promotion and indepth discussion in clinical practice. 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