| As one of the most important treatments of malignant tumors, radiotherapy usually results in many adverse side effects. Acute radiation-induced skin damage is one of the most common in variety of adverse reactions. According to research, approximately 85% of cancer patients receiving radiotherapy will suffer from a moderate-to-severe skin reaction. And 91.1% of radiation-induced skin damage will happen when the cumulative dose was below 40Gy. The symptoms range from a mild rash to severe ulceration. Acute radiation-induced skin damage often leads to itching and pain, delays in treatment, seriously affecting the treatment effects and subsequently leading to a decrease in quality of life. Therefore it is rather significant to select some effective drugs for prophylaxis and management of acute radiation-induced skin damage.This paper is divided into two parts. Part I is a literature review, and Part II is clinical research.Part I:Literature ReviewIn this part, we reviewed most of the clinical studies about the mechanism and the prophylaxis and management of acute radiation-induced skin damage in recent years, which include TCM therapy, the mechanism, modern medical researches and daily care.Part II:Clinical ResearchObjective:To evaluate the therapeutic efficacy and safety of "Erhuang Decoction" spray in treating radiation-induced skin damage, it is expected to provide the basis for further popularizing this designated treatment clinically.Methods:Three hospitals have participated in this research, that is, Guang’anmen Hospital China Academy of Chinese Medical Sciences, the 307th Hospital of Chinese People’s Liberation Army, and Xiyuan Hospital China Academy of Chinese Medical Sciences. We observed 166 patients from October 2013 to March 2015, who suffered from grade 2 or 3 skin reaction after radiotherapy (According to RTOG Grading Standards). They were divided into test group and control group according to center random principle. In test group,83 patients were treated with "Erhuang Decoction" Spray. In control group,83 patients were treated with Biafine. The therapeutic efficacy of the two groups was evaluated after two weeks of treatment. The evaluating indicators include the reduction of pain, the symptoms of skin damage (red rash, peeling skin, and edema), wound healing, clinical symptoms, karnofsky performance status, and quality of life scale.Results:Compared with patients in control group, those in the test group had a significantly higher alleviation rate of pain (P<0.001). The overall remission rates of pain in test group and control group were 80.52% and 54.55% respectively. There was a significant difference in the relief of edema in favour of "Erhuang Decoction" spray (88.31% vs.77.92%, P<0.05); however, there was no difference on the alleviation rate of other symptoms such as red rash (67.53% vs.61.04%, P>0.05) and peeling skin (53.25% vs.49.35%, P>0.05). Compared with Biafine, "Erhuang Decoction" Spray appears to be much better at improving clinical symptoms (P<0.001). And there was no difference on the variation of karnofsky performance status between test group and control group (P>0.05). As for the evaluation of quality of life scale, this article analyzed 15 entries one by one, but found no difference between two groups (P >0.05). There occurred three adverse events during the whole research project (test group:2 cases; control group:1 case). The incidence of adverse events of test group and control group were 2.6% and 1.3% respectively. The adverse events of test group seem to be related with the accumulative effects of radiation dosage, while the adverse event of control group seems like allergic reaction.Conclusion:Compared with Biafine, "Erhuang Decoction" spray had a better therapeutic efficacy in the pain, edema at the treat area, and clinical symptoms. There was no difference on other aspects between two groups, such as red rash, skin peeling, wound healing, karnofsky performance status, and quality of life scale. According to the results, it is worth it to make further development and researches. As it is a trend to study preventive medication for radiation-induced skin damage, "Erhuang Decoction" spray can be used as a prophylaxis. And we can also design a trial to testify its efficacy. Because the patients were just treated for two weeks and after that many patients were still receiving radiotherapy or just finished, it is difficult to evaluate the average time of wound healing. If another trial will be designed, it is necessary to extend the observation period. |
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