Clinical Observation Of Prophylactic Effect With The Method Of Cooling Blood And Promoting Blood Flow On Radiation Pneumonia

[Object] According to the theory of traditional Chinese medical science and the study of modern pathology, we propose a standpoint that the cause of radiation pneumonia is "evil heat", and its syndrome is "heat impairing pulmonary collateral" and "stagnated blood blocking pulmonary collateral", so we apply traditional Chinese drug possessing the effect of "cool the blood and promoting blood flow" to prevent radiation lung injury. We start the prophylactic treatment by traditional Chinese drugs at the early stage of radiotherapy, observe the incidence of radiation pneumonia, the patient's whole status and evaluate the prophylactic effect and the safety of medicine.[Method] Adopting the prospective, randomized and controlled method for clinical trial, only the patients who have been finally diagnosed NSCLC (nonsmall-cell lung cancer) according to pathology and accepted radiotherapy, having more than 60 KPS scores and anticipating survival time longer than 6 months are eligible to be enrolled to clinical observation. We take a sample size of 46 cases according to the analysis of rate. All the 46 patients are randomly assigned to treatment group or control group, each group includes 23 patients. In the treatment group we use herbal medicine possessing the effect of "cool the blood and promoting blood flow" (such as Rehmannia dride rhizome, Cortex Moutan, Semen Persicae, Flos Carthami, Fructus Forsythiae, et al.) to radiotherapy. In control group we use common anticancer drugs (such as Radix Codonopsis, Radix Angelicae Sinensis, Fructus Ligustri Lucidi, Apricot seed, Rhizoma Atractylodis Macrocephalae, et al.). Then observe the symptoms (including cough, short breath, debility) and take lung CT scanning at every stage, compare the occurrence of radiation pneumonia in two groups, evaluate the quality of life, the status of dyspnea and the severity of acuteradiation lung injury by Watters score, KPS score and RTOG score. Also attempt to explore the prophylaxis mechanism by observation of cytokine IL-6 and TNF-α in serum. Finally, assess the safety of traditional Chinese medicine through the observation of adverse events and hematologic check of Liver function and renal function.[Result] At the end of trial, 30 cases are brought into statistical analyses, excluding 1 rejected case and 2 dropout cases in treatment group and 4 dropout cases in control group. The baseline data in two groups have comparability. Incidence rate between the two groups is different statistically (P= 0.0058). Comparing to control group, the Watters score in treatment group descended significantly (the P values at the 2^nd month, 3^rd month, 6^th month after treatment is 0.003, 0.028, 0.000 distinctively); the RTOG score also descended significantly (the P values at the 1^st month, 2^nd month, 3^rd month, 6^th month after treatment is 0.025, 0.016, 0.018, 0.001 distinctively); and the RTOG score increased significantly (the P values at the 2^nd month, 3^rd month, 6^th month after treatment is 0.001, 0.001, 0.000 distinctively). At the 1^st month after treatment we observed that the degree of cough, short breath and debility significantly lower than control group (P value is 0.003, 0.002 and 0.008 distinctively). The worst-case scenario analysis of the incidence between two groups shows highly significant statistic difference (P=0.0006).We only found one adverse reaction event that a patient experienced loose stools and disappeared after decreasing the dosage of Rehmannia dride rhizome. The results of the safety evaluation about the drugs such as hematologic check of liver function and renal function have no difference between two groups. The results of cytokine in blood serum show that only at the 1^st month after radiotherapy the level of cytokine IL-6 in control group statistically increased (P=0.035), while in treatment group the serum level of cytokine IL-6 and TNF-α at every observing point after radiotherapy has no significant difference.[Conclusion] Applying the method of "cooling blood and promoting bloodflow" early at the process of radiotherapy can decrease the incidence of radiation pneumonia, lessen the severity of acute radioaction lung injury, control the patients' symptoms, improve the quality of patients' life, and don't have obviously adverse reaction.