| Objective To observe the clinical curative effect of ambroxol and Qianjin Weijing decoction combined with glucocorticoid in the treatment of acute radiation pneumonitis(ARP), especially on the type of Tan Re Yu Fei in Chinese traditional medicine. Includeing alleviate the patient’s clinical symptoms, reduce the radiation induced lung injury(RILI), reduce the amount of glucocorticoid, improve the quality of life of the patients. It is the clinical research of integrated traditional Chinese and Western medicine therapy for treatment of acute radiation pneumonitis, in order to produce the guidance significance for clinical.Methods This is a randomized, small samples, double-blind and placebo-controlled clinical trial. In strict accordance with the inclusion criteria and exclusion criteria, selected in from 2012 December to 2014 November time range to the inpatients in Hubei Provincial Traditional Chinese Medical Hospital and cancer center of Wuhan Union Hospital treatment Tan RE YU FEI type of acute radiation pneumonitis. They Were randomly divided into treatment group(Treatment with Chinese and Western) and control group(pure Western medicine treatment), 30 patients in each group. Two groups of basic situation and condition through statistical analysis are comparable, there is no significant difference(P>0.05) between the groups. The control group treated by routine Western Medicine: Prednisone 40 mg, oral, 4 times per day, alleviating of symptoms after prednisone reduced gradually as the daily 10 mg, additional ambroxol 60 mg, intravenous drip, 2 times per day,treatment for 4 weeks; Combined with bacterial infection according to sputum culture and drug sensitive test of use of antibiotics; The treatment group at the basic of the control group was given by the Qianjin Weijing decoction, decocted in water to 200 ml, 2 clothes, one dose daily, the treatment course about 4 weeks. During the treatment, the two groups can be supportive treated according to the conditions of patients. After 4 weeks of treatment based on the criteria of curative effects were assessed, the comparison of treatment group and control group after treatment, the curative effect of TCM symptoms,the chest X-ray effect, the acute radiation lung injury in RTOG/EORTC grading, the glucocorticoid decrement the required time, and the KPS score improvement. And the data were analyzed by SPSS17.0 statistical software, draws the conclusion.Results ① The comparison of two groups of TCM symptom: in the treatment group, the score of cough symptom is 0.72 + 0.39,and 2.15 + 0.41 for the control group, there was a significant difference between them(P < 0.01); Shortness of breath symptom score of the treatment group is 0.69 + 0.63, and 1.66 + 0.68 for the control group, there was significant difference(P < 0.01); Fatigue symptom score of the treatment group is 1.38 + 0.47, and 1.66 + 0.68 for the control group, with significant difference(P < 0.05).② The comparison of two groups of Chest X-ray effect: the effective rate was 93.3% in the treatment group total,while 56.6% in the control group,and there was a significant difference between them(P < 0.01).③The comparison of the two groups of acute radiation lung injury in RTOG/EORTC grading: there was a significant difference between the treatment group and the control group(P < 0.05).The score was 1.57 + 0.90, 2.20 + 0.70 respectively.④The comparison of two groups of glucocorticoid reduction time required: The time of glucocorticoid decrement required for the treatment group is(5.18 + 1.52) d and(10.07 + 2.23) d of the control group. There was a significant difference between them(P < 0.01). And the control group of 4 patients treated with prednisone reduced symptoms after treatment, reduction and rebound phenomenon, once again increased the dose of glucocorticoid, the disease can be controlled. But, the rebound phenomenon is not found in the treatment group.⑤The comparison of the two groups of glucocorticoid decrement time required: The treatment group improved stability rate was 83.3%,the control group increased stability rate was 56.7%, with significant difference(P < 0.05).⑥The comparison of two groups of safety :The treatment group and the control group of patients with white blood cell decreased with no statistical difference(P > 0.05).Conclusion The result of the research shows that, the patients in the type of Tan Re Yu Fei of acute radiation pneumonitis, ambroxol and Qian Jin WeiJing decoction combined glucocorticoid therapy can significantly reduce the clinical symptoms and reduce the symptom scores, pulmonary inflammatory exudates absorption promoting, alleviate the lung injury induced by radiation therapy and the dose of glucocorticoid, improve the quality of patients,life. And no obvious toxicity side effects,good safety, strong operability, is worth the clinical promotion. |
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