Xiaozheng Pain Topical Side Combined With Radiotherapy Clinical Studies Of Metastatic Bone Pain

Bone metastasis is one of the most common complications of advanced malignant carcinoma, with its incidence of 20% -90%, just next to the lung and liver metastasis. Bone metastasis is often seen in the malignant carcinoma such as breast cancer, lung cancer, prostatic carcinoma, gastric carcinoma, renal carcinoma, cancerous goiter, cervical carcinoma, bone and soft tissue sarcoma. The common manifestations of Bone metastasis include severe pain of bones, pathological fracture, spinal compression, severe constricted activities, hypercalcemia, which severely influence the Quality of Life of the patients. The treatments of bone metastatic pain are mainly relied on radiotherapy, pain-killer, bisphosphonate, and chemotherapy, which are different from treatments of other kinds of pain; among these treatments, radiotherapy has reliable clinical effects and has became routine and standard treatment. Traditional Chinese Medicine has accumulated abundant clinical experience about the treatment of carcinoma, formed its specific theoretic system,and now are accepted by more and more patients and medical scholars, gradually becomes one of the efficient methods of the malignant carcinoma. External Therapy is an important composition of TCM, with the advantages of convenience, less side effects, quick operation, without stimulus to gastrointestinal tract, without drug resistance and reliance. Xiao Zhen Zhi Tong formula for external use is the experiential formula towards pain syndromes of Feng Wu Duan, who was the famous doctor of Oncology department. Xiao Zhen Zhi Tong formula for external use has the functions of dissipating tumor, dissolving toxins, eliminating phlegm, dispersing accumulation, invigorating blood, and stopping pain. Clinical practice has showed that Xiao Zhen Zhi Tong formula for external could help relieve pain, decrease the dosage of pain-killer, improve the Quality of Life for those patients with bone metastatic pain. This study adopted randomized control trials and prospective clinical research method, and combined Xiao Zhen Zhi Tong formula for external use with radiotherapy to explore the efficacy of Xiao Zhen Zhi Tong formula for external use towards bone metastatic pain. Objective:To observe the clinical efficacy of Xiao Zhen Zhi Tong formula for external use combined with radiotherapy, and to explore its effects on enhancing the analgesic funtion of radiotherapy, shortening the onset time, easing adverse reactions, and improving Quality of Life.Methods:According to evidence-based medicine, This study adopted randomized control trials and prospective clinical research method, in the light of some diagnostic,included,exclude standards, the enrolled hospitalized patients were randomly divided into two groups, treatment group and control group. In these two groups, the basic treatments were almost the same, which included anti-tumor Chinese medicine by intravenous drip infusion, three-step pain-killer drugs taken orally, and nutrition supports according to patients'situations. The treatment group:besides the basic treatments above, radiotherapy and Xiao Zhen Zhi Tong formula for external use were included; the control group:only radiotherapy was included on the basis of the elementary treatments. Observe and compare the onset time, Quality of Life, variation of pain degree and adverse reaction of the two groups.Results:A total of 60 patients were enrolled in this study from 2009.3 to 2010.4, with treatment group 30cases, control group 30 cases. There was no evident difference (p>0.05) in pain-relieving between Xiao Zhen Zhi Tong formula for external use combined with radiotherapy and radiotherapy itself. In the treatment group,23 cases were efficient(77.7%)and control group 22cases(73.3%).But significant difference (p<0.001)was observed in the onset time,treatment group worked obviously fast than control group; Both of their KPS scores were increased, but without evident difference (p>0.05); In Quality of Life, the daily life,emotion,,sleep were significantly improved(p<0.05) in treatment group comparing with those in control group, especially in the improving of emotion and sleep, treatment group had obvious superior (p<0.001),which manifested that treatment group had better effects in improving daily life and emotion of patients. But no significant difference (p>0.05) was found in the aspects of patient'work, relationships and life appeals. In terms of side effects, the incidence of nausea, vomiting, dry mouth, constipation were higher (p<0.05) in control group than that in treatment group, especially nausea and constipation, there was significantly difference (p<0.001) between the two groups, whereas no evident difference was found in the incidence of headache,dizziness,somnolence, and hemogram.Conclusion:1 The Xiao Zhen Zhi Tong formula for external use plus the analgesic guidelines based on radiotherapy relieve pain. There was a trend the patients added the Xiao Zheng Zhi Tong Wai Yong Fang could gain the stable pain relief earlier and easier.2. The Xiao Zhen Zhi Tong formula for external use plus the analgesic guidelines based on radiotherapy relieve pain was more effective on improving the quality of live, with few side effect.