RCTs Tyrosine Kinase Inhibitor Medical Treatment Related To The Rash Of Epidermal Growth Factor Receptor

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(EGF),epidermal growth factor receptor(EGFR),epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI),including the occurrence rate of the related rash after taking EGFR-TKI,the rash assessment and grading,the rash mechanism,its relationship with curative effect of malignant tumors,and the treating and nursing methods in western medicine.The other is about the understanding of ancient and modern Chinese medicine physician to acneiform eruptions,and the treatment experience on acne of traditional Chinese medicine(TCM) Various.Meanwhile in order to achieve the purpose of studying the ancient method healing the nowaday disease,the paper focuses on the understanding and treatment of TCM on the EGFR-TKI related acneiform eruptions.It is providing the new thinking that TCM treating EGFR-TKI related acneiform eruptions.The clinical observation is about observing the therapeutic effects and the clinical safeties of Chinese herbs ZNPZF in treating EGFR-TKI related acneiform eruptions.Purpose:observing the therapeutic effects and the clinical safeties of Chinese herbs ZNPZF in treating EGFR-TKI related acneiform eruptions.Observe the improvement of clinical symptoms by the basic Chinese herbs combining with ZNPZF,in addition to evaluating the clinical safeties.It is the purpose to further evaluate the Synthesized Traditional Chinese medicine in decreasing toxicity of targeted therapy.Object.To choose60patients diagnosed non-small-cell lung cancer(NSCLC) by pathology with EGFR-TKI(Gefitinib,Erlotinib,Icotinib) related acneiform eruptions.DOE(Design of experiments):The test is a prospective, randomized, controlled clinical study.Through the CHISS software generating random Numbers table,devide60patients into two groups randomly:one is the treatment group including30patients and the other is the control group including30patients.Treatment group of30patients are given on the basis of traditional Chinese medicine commonly loading treatment to invigorate the circulation and detoxification,dispelling wind and arresting itching as the main principle of the ZNPZF.Continuous administration for14days,that is two period of treatment.Operation of treatment group:taking ZNPZF half an hour after breakfast and dinner together with decoction,or taking it with warm water alone.During the medication may not use other medicines to treat skin rash.Follow-up every7days,14days after the end of entering groups conduct effect evaluation.Control group of30patients are given silicone emulsions on the basis of traditional Chinese medicine,continuous administration for14days similarly.Operation of control group:Clean the local rash with clean water,and smear silicone emulsions at least2times a day,Follow-up every7days,14days after the end of entering groups conduct effect evaluation. Before using medicine, record patients’ name, gender, age, contact information, diagnosis, merger disease, past medical history, vital signs, physical examination and general situation.At the same time,evaluate patients’health condition, clinical symptoms and quality of life.And according to the NCI-CTCAE3.0evaluates toxicity to the skin.Evaluate the rash remission rate,the rash relief time,patient’s clinical symptoms,body condition,and weight changes.And two groups of patients are needed to evaluate drug safety before and after medication routine blood and liver and kidney function.Results:Into the group of60cases of patients,Fall off in1case.Two groups of patients’KPS>70before treating.And gender, age, KPS score, ECOG score, lung cancer staging, a rash severity, the clinical symptoms were no statistical difference.After using medicine,Two groups of patients KPS score, ECOG score is still no statistical difference,Two groups of patients with acneiform eruptions are alleviated in different degrees.By comparing rash classification between the two groups of patients after one and two course of treatment,the results by SPSS16.0statistical software analysis that X2value are respectively18.45,17.25,P values are0.00,both are less than0.05,Statistic are different.By comparing the clinical symptoms improved between the two groups after one and two course of treatment,X2value are respectively0.89,2.12, P values are0.3445,0.1452,both>0.05,statistic are not different.Within treatment group and control group,the situation of clinical symptoms improvement are respectively compared before and after one course,their P values are less than0.05,they remain statistically significant;Two groups respectively compares the situation of Clinical Symptoms improvement between before medications and after the second course, P values are less than0.05,and there are statistical differences.It is compared with medications after the first course,P values are more than0.05,no statistical differences.Make statistics of two groups of rash ease for the first time,Z=-2.489, P=0.013<0.05,there exist statistical differences.After stopping the medicine of rash treatment,the rash of the control group relapses within the first week.However,the rash of the treatment group relapses within the second week.Through testing blood routine and liver and kidney function of two groups of patients before and after medication,there are no abnormities. And two groups of patients are not allergic related to medicine.Conclusion:first,the curative effect of treatment of the basic Chinese herbs combining with ZNPZF is better than combining with silicone emulsions,and as the extension of time,the curative effect of treatment group and control group are both improved.Second,with the using of the basic traditional Chinese medicine,the patient’s symptoms improved significantly,but there are no differences between treatment group and control group.It is very beneficial for the improvement of the patient’s clinical symptoms by the treatment of the basic Chinese herbs,but within the two groups there are no differences.Third,two groups of patients in the observation period,patients’physical condition,such as physical examination, KPS,ECOG,change of weight,there are no statistical differences.Fourth,two groups of patients that improve the symptom of rash after medications,time of treatment group for the first time of the rash ease is earlier than the control group’s.Fifth,after the two course and after stopping the medicine of rash treatment,the rash of the control group relapses within the first week.However,the rash of the treatment group relapses within the second week.Sixth,no matter either treatment group or control group,the medicine is very safe.