针灸防治化疗不良反应的随机对照试验研究方案制定方法探讨

Discussion on Methodoligies of Formulating Research Proposal for a Randomized Controlled Trial of Acupuncture and Moxibustion for Prevention and Treatment and Side Effects of Chemotherapy

在恶性肿瘤的化疗过程中,患者会出现不同程度不良反应,不但给患者带来痛苦,也影响治疗的顺利完成。因此,亟需探寻有效防治化疗不良反应的方法,这对确保化疗顺利进行及提高患者生活质量等具有重要的临床意义。近年来,国内外针灸防治化疗不良反应的临床研究报道逐渐增多,但部分研究临床设计不合理、质量及证据级别较低。本文依据临床试验设计的原则、方法,并结合化疗不良反应的临床特点对化疗不良反应的研究方案制定方法进行探讨,以期为此领域的针灸临床工作者提供参考借鉴。

Patients will have chemotherapy toxicity in varying degrees during the treatment course of malignant tumor. The side effects not only bring great suffering to the patient, but also lead to the failure of chemotherapy.Therefore, it is necessary to actively explore the treatment methods of effective prevention and treatment of side effects of chemotherapy. It will have important clinical significance to ensure the smooth progress of chemotherapy and improve the life quality of the patients. In recent years, clinical research reports on the prevention and treatment of side effects of chemotherapy by acupuncture and moxibustion have gradually increased at home and abroad.However, many clinical studies are not designed properly, and the quality and level of evidence are low. This article discussed a series of methods of formulating the research scheme of side effects of chemotherapy, according to clinical trial design principles, methods and clinical features of toxic side effects of chemotherapy, in order to provide references for acupuncture clinicians in this field.