Pfeifer Bernd L, Jonas Wayne B
University of Kentucky Medical Center, Lexington, Kentucky, USA.
Integr Cancer Ther. 2003 Jun;2(2):112-9. doi: 10.1177/1534735403002002003.
Immunoaugmentative therapy (IAT) is an unconventional therapy used by thousands of cancer patients that has not been systematically evaluated for safety and efficacy. The authors evaluated the toxicity and effects of this therapy in a series of consecutively treated cancer patients.
A sample of 46 consecutive patients treated at the Immune Therapy Clinic in Playas, Mexico, from April to December 1989 were evaluated for adverse reactions, tumor response, quality of life and immune status over 12 weeks of IAT treatment. Patients' blood was tested for HIV and hepatitis B antibody before and after treatment. Histological confirmation of cancer and staging was obtained in all patients, and the results of follow-up radiological examinations were judged in a blinded fashion by independent diagnostic radiologists.
There were no signs of toxicity (SWOG criteria) and no HIV or hepatitis B conversion attributable to IAT. None of the 46 patients showed tumor regression. Forty patients (87%) had disease progression, and 25 (55%) died within 6 months from disease progression. Thirty-five patients (76%) noticed a decline in their quality of life during IAT. Thirty-eight patients (83%) opted to continue with the IAT treatment, despite its lack of effectiveness.
No indication of toxicity or effectiveness was found in an uncontrolled, consecutively selected series of 46 cancer patients undergoing IAT treatment. In addition, the therapy did not appear to contribute to improved quality of life in most patients. This study does not justify its continued use.
免疫增强疗法（IAT）是一种数千名癌症患者使用的非传统疗法，尚未对其安全性和有效性进行系统评估。作者评估了该疗法在一系列连续治疗的癌症患者中的毒性和效果。
对1989年4月至12月在墨西哥普拉亚斯免疫治疗诊所连续治疗的46例患者样本，评估其在12周免疫增强疗法治疗期间的不良反应、肿瘤反应、生活质量和免疫状态。治疗前后检测患者血液中的HIV和乙肝抗体。所有患者均获得癌症的组织学确诊和分期，随访影像学检查结果由独立诊断放射科医生以盲法判断。
没有毒性迹象（SWOG标准），也没有因免疫增强疗法导致的HIV或乙肝血清学转换。46例患者中无一例出现肿瘤消退。40例（87%）病情进展，25例（55%）在疾病进展后6个月内死亡。35例（76%）患者在免疫增强疗法期间生活质量下降。38例（83%）患者尽管该疗法无效仍选择继续接受免疫增强疗法治疗。
在一组未经对照、连续入选的46例接受免疫增强疗法治疗的癌症患者中，未发现毒性或有效性迹象。此外，该疗法似乎并未使大多数患者的生活质量得到改善。本研究无法证明其继续使用的合理性。
