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A Multi-center, Double-blind, Randomized Control Clinical Trial Of Shencao Hand-foot Cream For Treatment Of Anti-tumor Drugs-induced Hand-foot Syndromes

Posted on:2016-11-25Degree:MasterType:Thesis
Country:ChinaCandidate:X J ZhuFull Text:PDF
GTID:2284330464455935Subject:Integrative Medicine
Abstract/Summary:
At present, malignant tumor is a major killer to threat human’s life and health, and the main treatment of cancer is operation, chemotherapy, radiotherapy, biological therapy, targeted therapy and Chinese medicine treatment. So far, although the biological target treatment has achieved unprecedented effect, radiation therapy and chemotherapy are still indispensable and classic means in the treatments of tumor. Nevertheless, side effects of chemotherapy often lead to handicaps during the recovery of social function after the clinical cure in patients. Among the toxic side effects, hand-foot syndrome caused by chemotherapy is the commonest, which has greatest impact on quality of life in patients. Besides, it also can lead to patients not tolerating further treatment, reducing quality of life, and even affecting daily life seriously. Hence, there is urgent need to find a reliable curative effect, little side effect and economic treatment method to treat these side effects.Hand-foot syndrome (HFS)also known as palmer-planter erythrodysesthesia syndrome (PPES), is the skin toxicity caused by anti-tumor treatment, and the chemotherapy drug such as capecitabine, cyclophosphamide, cytarabine, docetaxel and vinorelbine, etc, and especially,it is severe during the treatment in capecitabine. Nowadays, as the popularity of targeted therapy, it is reported that targeted therapy drugs such as Solafini, sunitinib, also can cause hand foot syndrome. The occurrence of HFS, not only affects the efficacy, but also seriously lowers the patient’s quality of life.Hand-foot syndrome is characterized by aggravating cutaneous lesions, and hands are more likely to be affected than feet. The first symptom is palm and plantar skin itching, and palm, finger and foot congesting, then the fingers or toes paining, hand/foot skin erythema, tension, sensation, numbness, rough skin and chapped. A small number of patients may have cut-finger skin damage, and appear blisters, peeling, exudation, even fester, and secondary infection. Patients with severe pain may be unable to walk, and serious ones even can lose the life ability. In most cases, these clinical responses are usually self-limiting, but after administration again HFS may relapse. This study is based on 2012 traditional Chinese medicine major science and technology project of Beijing Municipal Science and Technology Commission, radioactive skin injury etc. related to adverse reactions in malignant tumor treatment and treatment standardization research, with Shencao hand foot Cream for anticancer drugs caused hand foot syndrome, therapeutic effect of TCM External Treatment of hand foot syndrome. Research methods:in this study, a multi center, randomized double blind method, the blank control, Beijing Cancer Hospital, Academy of Medical Sciences Cancer Hospital, Guanganmen hospital, Xiyuan Hospital were involved.144 patients, according to the ratio of 1:1 were randomly divided into the treated group and the control group. Patients in treated group were applied to use "Shencao hand foot Cream" after they washed hands and feet with warm water, the control group was given matrix drug daub, dosage of two groups was 5g each time, twice a day. We observed the improvement of hand foot syndrome after two weeks, efficacy evaluation.Shencao hand foot Cream formula based on "huoxuejiedutang",which is widely used in the Department of Oncology Guang’anmen Hospital of Chinese Academy of Science. For the convenience of patients to carry and use, we change it into ointment. Shencao hand foot cream is consisted of Kushen, lopseed, baixianpi,etc.Results:134 patients were included in this trial, including 69 ones in the control group, while the other group was of 65 ones. The observation period was 14+2 days, After two weeks of medication test observation,we have confirmed that (1) Shencao hand foot Cream could effectively relieve the clinical symptoms of HFS, and the decrease of the grades of HFS in the treated group was significantly higher than the control group (Efficiency was 81.54% in treated group, and that of the control group was 37.81%); especially in the relief of paining, swelling, dry desquamation, ulcers and other aspects, Shencaohand-foot had better effect;(2)patients can improve<MDASI-TCM>symptoms such as "emotion, work (including housework), walk, life and fun",scores of test group are higher than the control group; (3) Shencao hand foot Cream can improve the quality of life of patients, and after two weeks of treatment, patients were observed in the somatic function role function, emotional function, whole life, improved;(4) The scores of KPS about patients in the treated group kept steady or improved.Conclusion:Shencao hand foot Cream could effectively alleviate the clinical symptoms of HFS, reduce the degree of toxicity induced by antitumor drugs and improve the quality of life of patients.
Keywords/Search Tags:chemotherapy, targeted therapy, hand-foot syndrome, Shencao hand foot Cream
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