桔杏麦冬颗粒防治放射性肺损伤的临床研究

Clinical Study on Prevention and Treatment of Radiation-induced Lung Injury by Jie Xing Maidong Granules

【目的】观察桔杏麦冬颗粒防治放射性肺损伤的临床疗效。【方法】采用多中心、前瞻、双盲、随机对照的临床设计,将80例接受放疗的胸部肿瘤患者随机分为治疗组和对照组,每组各40例。2组患者均给予接受胸部放疗,在此基础上,治疗组给予服用桔杏麦冬颗粒治疗,对照组给予服用安慰剂治疗,疗程为4周。观察2组患者放射性肺损伤症状出现时间和相应的放射剂量及各观察时点放射性肺损伤的评分情况,比较2组患者治疗前后Karnofsky功能状态(KPS)评分和线性模拟自我评价量表(LASA)评分的变化情况,并评价2组的安全性。【结果】(1)脱落情况:研究过程中,有4例患者脱落(包括3例自愿退出和1例失访),最终有76例患者(对照组39例和治疗组37例)完成试验。(2)放射性肺损伤评分方面:随着放疗时间的推延,2组患者的放射性肺损伤评分均逐渐增加,但治疗组在治疗4周后的放射性肺损伤评分明显低于对照组,差异有统计学意义(P<0.05)。(3)放射性肺损伤症状出现时间和相应放射剂量方面:在76例入组患者中,有65例患者发生放射性肺损伤,其中对照组34例,治疗组31例。2组患者的肺损伤症状出现时间和相应放射剂量比较,差异均无统计学意义(P>0.05)。(4)治疗2周和4周后,2组患者的KPS评分均较治疗前降低(P<0.05),但治疗组在治疗4周后的KPS评分高于对照组,差异有统计学意义(P<0.01)。(5)治疗2周和4周后,2组患者LASA量表各维度评分及总分均无显著性变化(P>0.05),但治疗组在治疗4周后的食欲、睡眠、一般活动和总分情况优于对照组,差异均有统计学意义(P<0.05或P<0.01)。(6)试验过程中,2组患者的血常规、肝功能、肾功能和电解质等均无明显变化。【结论】持续服用4周后,桔杏麦冬颗粒可有效减轻放射性肺损伤级别,改善患者食欲、睡眠,增加患者体力,提高患者生活质量,且临床应用安全可靠。

Objective To observe the clinical effect of Jie Xing Maidong Granules in preventing and treating radiation-induced lung injury. Methods The multi-center, prospective, double-blind, randomized and controlled clinical design was adopted. The 80 patients with thoracic tumors undergoing radiotherapy were randomly divided into treatment group and control group,with 40 cases in each group. The two groups were given thoracic radiotherapy,and additionally,the treatment group was treated with Jie Xing Maidong Granules while the control group was treated with placebo granules for a course of 4 weeks. The time for the occurrence of the symptoms of radiation-induced lung injury and the radiation dosage at the corresponding time, the scores of radiation-induced lung injury at various time points,and the scores of Karnofsky Performance Status(KPS)and linear analogue self-assessment(LASA)scales for the quality of life before and after treatment in the two groups were observed. After treatment,the clinical safety of the two groups was also evaluated. Results(1)During the trial,4 cases dropped out,of which 3 cases quit the trial voluntarily and one case lost to follow-up. A total of 76 cases,39 cases from the control group and 37 cases from the treatment group,completed the trial finally.(2)With the prolongation of the time for radiotherapy,the scores of radiation-induced lung injury in the two groups increased gradually, but the scores of radiation-induced lung injury in the treatment group after 4 weeks of treatment were significantly lower than those in the control group,the difference being statistically different(P<0.05).(3)In respect of the time for the occurrence of the symptoms of radiation-induced lung injury and the radiation dosage at the corresponding time,65 cases of the 76 enrolled patients had the radiation-induced lung injury,of which 34 cases from the control group and 31 cases from the treatment group. The differences of the time for the occurrence of the symptoms of radiation-induced lung injury and the radiation dosage at the corresponding time between the two groups were insignificant(P>0.05).(4)After treatment for 2 and 4 weeks,the scores of KPS in the two groups were decreased in comparison with those before treatment(P<0.05),but the KPS scores in the treatment group after 4 weeks of treatment were higher than those in the control group,the difference being statistically different(P<0.01).(5)After treatment for 2 and 4 weeks,no obvious changes were found in the dimension scores of LASA and in the overall LASA scores in the two groups(P>0.05),but the scores of appetite,sleep,and general activities as well as the overall LASA scores in the treatment groups after 4 weeks of treatment were superior to those in the control group,and the differences were statistically different(P<0.05 or P<0.01).(6)During the trial,the results for the test of blood routine,liver function,kidney function and electrolytes in the two groups showed no abnormalities. Conclusion After medication for 4 continuous weeks,oral use of Jie Xing Maidong Granules can effectively reduce the degree of radiation-induced lung injury,improve the appetite and sleep of the patients,increase physical strength,and enhance the quality of life. And the granules are safe and reliable in the clinical application.