冻干人胎盘因子对肿瘤化疗患者免疫功能影响的Ⅱ期临床研究

The Impact of Placenta Factor on Immune Function,Quality of Life for Patients with Solid Tumors Treated by Chemotherapy——A preliminary outcome of multicenter,prospective randomized controlled study

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。

Objectives To evaluate the impact of lyophilized human placenta factor （PF） on immune function, quality of life, toxicity and efficacy for patients with solid tumor treated by chemotherapy. Methods One hundred and sixteen patients were randomized into two groups. Study group （group A） was treated by chemotherapy combined with PF, and controlled group （group B） was treated by chemotherapy alone for at least 2 cycles. PF was administered intramuscularly at a dose of 18 mg per person every two days from the beginning of chemotherapy for three to four weeks. Results These were significantly higher level of CD3, CD4, the radio of CD4/CD8 and NK cell activity except CD8 in study group in comparison to control group （P=0.000）. The ratio of positive and strong positive rate of PPD skin test were significantly higher in study group. The incidence rates of infection, fever and diarrhea in the study group were lower than in the controlled group （P=0.002, 0.034, 0.020, respectively）, while the incidence of pain at injection site was higher in the study group （P=0.002）. The impact of PF on the effect of chemotherapy was not observed in both groups （P=-0.529）, and the performance status of patients also was significantly higher in the study group （P=0.002）. PF can improve the quality of life including appetite, sleep, emotional status, fatigue, pain and body weight in patients with solid tumor. Conclusions The preliminary outcome of this multiple center, randomized control clinical study showed：the cellular immune function could be improved by addition of PF in patients treated with chemotherapy. PF can also reduce some toxicity of chemotherapy. Furthermore, the PF can improve the patients＇ performance status and quality of life. PF plays valuable role in the adjuvant management for advanced carcinoma treated by chemotherapy. Further study is warranted.