针灸临床试验设计与质量控制解析.pptVIP

Haake M,et al. Arch Intern Med,2007. 举例 2 ： ? 导入期 3 周，以观察 IBS 患者对假针刺的应答情况，同时让患者体 ? 验针刺数量和针灸师的关注情况，以为随机分配时切换到真针刺做 ? 准备。 ? Lembo AJ et al. Am J Gastroenterol,2009. （三）对照组的设计 ? 1. 按临床研究设计方案的分类设置对照 ? 同期随机对照 ? 前后对照 / 交叉对照 ? 配对对照 ? 非随机对照 ? 历史对照 按照干预措施的性质设置对照 ? 安慰剂对照：非经非穴 ? 空白对照：等待治疗 ? 有效对照 / 阳性对照：西药对照 / 常规治疗 （ 1 ）安慰剂对照 - 非经非穴的选择 ? 真穴旁开（穴位旁开 3mm ）或两经之间（ 2 经中点）； ? 远端取穴，相对固定； 以上选取方式均需考虑非穴所在位置的神经节段、注意避开血管 和神经。 取法一：经穴旁开及两经之间取非穴 ? 梁教授团队的研究表明，在针刺偏头痛的临床研究中发现，与真穴 旁开取法比较，远端取非穴与真穴的疗效差异更显著。 ? Li Y,et al. Headache ， 2009. 远端取穴： ? Acupuncture for migraine prophylaxis ： a randomized controlled trial. CMAJ ， 2012. ? Randomised clinical trial ： an assessment of acupuncture on specific meridian or specific acupoint vs sham acupuncture for treating FD. Aliment Pharmacol Ther,2012. 远端取穴 Macklin EA.Hypertension,2006. 经穴旁开： The sham points were chosen by the following 4 rules: (1) Acupoints that were de?ned as unrelated to headache based on a vast amount of TCM reference books. (2) In order to avoid possible therapeutic effects from acupuncture, 30 acupoints in the vicinity of elbow and knee joints were selected while the acupoints in the head,hands, feet, and trunk were excluded. The actual sham points were located 3 mm apart from these selected acupoints. (3) The 30 sham points in the vicinity of elbow and knee joints were randomly assigned to 5 subgroups: B, C, D, E, and F, and were recorded in predetermined computer-made randomization sealed envelopes. Each subgroup has 2 points on the arms and 3 points on the legs. The patients in the control group were assigned into 1 of these 5 sub-groups. (4) The number of sham points in the control group was identical to that in the acupuncture group. All points were punctured perpendicularly with lifting, thrusting, and twirling to obtainDeQi. The details