| This thesis consists of two parts:the literature review and the clinical observation.The literature review is made up of two parts:One is about the basic knowledge of epidermal growth factor receptor inhibitors,including its relationship with malignant tumors, the typical drugs,the side effects of the drugs and their mechanisms and the treating methods in western medicine. And in this part the author emphasizes on the epidermal growth factor receptor inhibitors(EGFRIs) related skin side effects. The other is about the viewpoints in traditional Chinese medicine(TCM) of epidermal growth factor receptor inhibitors related acneiform eruptions, including its TCM name, its pathological mechanism and cause and the treating methods of it.The clinical observation is about the therapeutic effects and the clinical safeties of Chinese herbs ZY-06in treating epidermal growth factor receptor inhibitors related acneiform eruptions and pruritus. Background:Skin toxicities are the most common side effects of targets drugs, especially epidermal growth factors receptors inhibitors (EGFRIs). Skin toxicities usually influence patients’ quality of life(QOL), and when sever, they can lead to the cessation of targeted therapy. Traditional Chinese medicine(TCM) plays an importmant part in the treatment of dermatological diseases, but it hasn’t been used in the skin toxici ties of EGFRIs. We carried out this clinical trial to test the therapeutic effect and the securities of the herbs ZY-06. Methods:To choose patients with EGFRIs related acneiform eruptions and pruritus, then devide them into two groups randomizely:one is the TCM group and the other is the western medicine group. Patients in the TCM group are given ZY-06for external use only, different methods according to the location of the rash. Observe the level changes of the acneiform eruptions and pruritus and the security of ZY-06after14days. Patients in the western medicine group are given erythromycin ointments for external use where there are rashs. The observations are the same with the TCM group, and the observe cycle is also14days. All patients enrolled are tested in blood regulation and liver and kidney functions of the blood. Results:120patients were enrolled between Sep.2010and Feb.2013, with KPS≥60and OS≥3months.80patients were devided into the TCM group and40into the western medicine group. There are no significant difference between the two groups in the age, sex, KPS and disease categories before observation. The grading of the EGFRIs related acneiform eruptions and pruritus are also similar with each other according to the MASCC grading systems and the VAS. When the observation ended after the14days cycle,the grading of EGFRIs related acneiform eruptions and pruritus differs in the two groups. Although all patients received release, the levels in the TCM group are obviously lower than the western medicine group. SPSS16.0shows statistical significances in the levels changing of " pruritus" and "acneiform eruptions"(P<0.05). The shortest time for symptoms reliefs is1day in the TCM group, and the longest is12days in the western medicine group. None of the120patients have untoward effects such as "allergy" of ZY-06.And the blood regulation test and liver and kidney functions test after the observation showed no abnormal!ties, too. Conclusions:ZY-06can reduce the levels of EGFRIs related" pruritus" and "acneiform eruptions" and it’s used safely so that it can make the using of EGFRIs more widely. |
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