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目的探讨冻干人胎盘因子(PF)对肿瘤化疗患者免疫功能、生活质量、不良反应和客观疗效的影响。方法收治116例患者,随机分为试验组(A组,化疗+PF组)及对照组(B组,单用化疗组),化疗至少2个疗程。试验组第1日开始用胎盘因子,隔日一次,每次18mg肌注,持续3～4周。结果在免疫指标方面,除CD8外,治疗组CD3、CD4、CD4/CD8比值和NK细胞活性水平均有不同程度的升高,对照组则有不同程度的下降(均为P=0.000)。PF使纯蛋白衍生物皮试阳性率和强阳性比例明显增高(P=0.008)。治疗组腹泻、发热、并发感染的机会较少(P值分别为0.002、0.034、0.020),但注射部位疼痛则以治疗组较高(P=0.002)。PF对试验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提高(P=0.002)。PF可改善食欲、精神状态、睡眠、疼痛和体重等指标,从而提高患者的生活质量,均达到差异有统计学意义。迄今,国内外未见同类报告。结论PF的多中心临床随机对照研究初步表明,PF可改善化疗后患者细胞免疫功能,对癌症化疗患者有一定辅助治疗价值。同时它还具有减少化疗不良反应、提高化疗的耐受性和提高化疗患者的生活质量的作用,PF毒副反应轻微,值得临床进一步研究和推广应用。
Objective To investigate the effect of freeze-dried human placenta factor (PF) on immune function, quality of life, adverse reactions and objective curative effect in patients with tumor chemotherapy. Methods A total of 116 patients were enrolled and randomly divided into experimental group (group A, chemotherapy + PF group) and control group (group B, chemotherapy alone group) for at least 2 courses of chemotherapy. The experimental group started on the 1st day with placental factor, every other day, each 18mg intramuscular injection for 3 to 4 weeks. Results In terms of immune parameters, the levels of CD3, CD4, CD4 / CD8 and NK cell activity in the treatment group increased to some extent except CD8, while the control group decreased to some extent (all P = 0.000). PF significantly increased the skin test positive rate and strong positive rate of pure protein derivatives (P = 0.008). The treatment group had fewer chances of diarrhea, fever and concurrent infection (P values were 0.002, 0.034 and 0.020 respectively), but the injection site pain was higher in the treatment group (P = 0.002). PF had no significant effect on the efficacy of chemotherapy in the test and control groups (P = 0.529). PF increased the overall functional status of patients undergoing chemotherapy (P = 0.002). PF can improve the appetite, mental status, sleep, pain and weight and other indicators, thereby improving the quality of life of patients, reached a significant difference. So far, no similar reports at home and abroad. Conclusions The multicenter randomized controlled clinical trial of PF has shown that PF can improve the cellular immune function of patients after chemotherapy and has certain adjuvant therapeutic value in patients with cancer chemotherapy. At the same time, it also has the effect of reducing the adverse reaction of chemotherapy, improving the tolerance of chemotherapy and improving the quality of life of patients with chemotherapy. The side effects of PF are slight and it is worth further research and popularization and application.