| This thesis consists of two parts:a literature review and a clinical observat ion.The first part is the literature review. It discussed the incidence, manifestations, laws of occurrence, evaluat ion and class ificat ion, the mechanism, the correlation of efficacy, prevention and treatment of the epidermal growth factor receptor inhibitors (EGFRIs) associated side effects of the skin, as well as traditional Chinese medicine’s understanding and treatment methods and other related aspects regarding to this side effect.The second part is a clinical research. Objective:To observe the clinical effects and the safety of "Pure TCM mostening cream" in treating EGFRIs associated skin dryness. Methods:20malignant tumors patients, confirmed by pathology or cytology diagnosis, had varied degrees of dry skin adverse reactions after using EGFRIs. This research used a self-control method:Right limbs are the treatment group and the left limbs are the control group. The treatment group was applied "Pure TCM mostening cream" evenly on the surface of the skin after cleansing up, twice daily. The preparation room of China-Japan Friendship Hospital streamlined an experiential effective recipe after tests, and then got "Pure TCM mostening cream", whose major components of traditional Chinese medicine are Salvia and Rhodiola. It is a pale brown cream that can clear heat, promote blood circulation, nourish and help regenerating the skin. The control group was given urea cream evenly on the surface of the skin after cleansing up, twice daily. The treatment group and the control group started at the same time and were taken photos as reference images weekly, which marked with image acquisition code.21days was a course of treatment and each case was evaluated after that, each was observed for level changing of skin side effects and associated symptoms after treatment, separate and total score changes, the relieving time and effective percentage as well. Moreover, compare the treatment group with the control group, all data was analyzed by paired Wilcoxon rank sum test and paired t-test of SPSS17.0statistical software. Results:The total effective percentage of "Pure TCM mostening cream" was55%while that of urea ointment was40%. The results showed that "Pure TCM mostening cream" had significant efficacy to alleviate skin dryness, scaling, peeling and rhagadia (p<0.05). The shortest time of symptoms relieving was2day and the longest was9days, and it has an average of6.55±2.86days and the mid-time is7days. It was obviously shorter than the control group (p<0.01), and the fastest improvement is in sealing as well as peel ing. Its efficacy for treating scaling, peel ing,rhagadia and itching was bet ter than urea cream (p<0.05), while eff icacy for treating skin dryness is no significantly different from the control group. Both the treatment group and the control group didn’t do well in improving the associated symptoms of pain. Conclusion:"Pure TCM mostening cream" had much better effects on ECFRIs associated skin dryness and effected significantly quicker than urea cream. Allergic reactions and other adverse reactions in the clinical course of the study were not found. Furthermore, it is easy and convenient to use and has good patient compliance. Therefore, it is worthy of clinical application widely. |
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