冻干人胎盘因子对肿瘤放化疗患者生活质量的影响

Effect of placenta factor on the quality of life of patients with solid tumors treated with chemotherapy and radiotherapy

目的探讨冻干人胎盘因子（PF）对放化疗患者生活质量的影响.方法①评价PF对放疗患者生活质量的影响：共收治实体肿瘤101例,随机分为试验组和对照组.试验组采用放疗加PF,从放疗开始之日起,PF 18 mg,肌注,隔日1次,直至放疗结束;对照组单用放疗.②评价PF 对化疗患者生活质量的影响：共收治100例患者,随机分为试验组（即化疗＋PF组）及对照组（单用化疗组）,化疗至少2疗程.试验组PF 18 mg肌注,隔日1次,持续3～4周.结果①与对照组相比,加PF后可使放疗患者的全身功能状态（PS）提高（P=0.001）,同时亦使食欲、精神状态、睡眠、疲乏和体重等生活质量指标均得到提高（P值分别为0.009、0.001、0.008、0.044、0.007）.②PF对试验组和对照组的化疗疗效无明显影响（P=0.529）.PF可使化疗患者的全身功能状态（PS）提高（P=0.002）.PF亦可改善化疗患者的生活质量,差异有显著性.结论PF具有提高放化疗患者生活质量的作用,不良反应轻微,值得进一步深入研究.

Objective To evaluate the effect of lyophilized human placenta factor（PF） on quality of life（QOL） of patients with solid tumor treated with radiotherapy or chemotherapy. Methods ①For evaluating the effect of PF on QOL of patients treated with radiotherapy, 101 patients with solid tumors were enrolled. All patients were randomized into study group （A） and control group （B）. Group A was treated with radiotherapy combined with PF and Group B was treated with radiotherapy alone. The PF was given intramuscularly at a dose of 18mg per person every two days from the beginning to the end of radiotherapy. ②For evaluating the effect of PF on QOL of patients treated with chemotherapy, one hundred patients were randomized into two groups （Group A and Group B）. Group A was treated with chemotherapy combined with PF and Group B was treated with chemotherapy alone. The PF was administered intramuscularly at a dose of 18mg per person every two days from the beginning of chemotherapy for three to four weeks. Eligible patients should be given at least 2 cycles of chemotherapy. Results ①Performance status （ECOG） of patients in group A was significantly improved after treatment with radiotherapy and PF（P =0.001 ）. Appetite, mental status, sleep, fatigue and body weight were also significantly improved （P = 0.009, 0.001, 0.008, 0.044 and 0.007, respectively）. The effect of PF on the efficacy of radiotherapy was not clarified in our study.②The effect of PF on the efficacy of chemotherapy was not observed in this study （ P = 0. 529）, and the performance status was significantly higher in Group A （P = 0. 002） treated with chemotherapy and PF. PF could improve QOL of solid tumor patients treated with chemotherapy. Conclusions Preliminary results of this multicenter clinical study showed that PF can improve QOL of the patients treated with radiotherapy or chemotherapy with mild toxicity. Further investigation is needed.