METHOD FOR THE ANALYSIS OF PAIN CLINICAL TRIALS

该申请提出：1）开发一个计算机模拟， 理想药物剂量（输入）数据和患者反应测量 （输出）;剂量为阿片类镇痛药和/或三环类镇痛药 药物;产出将很快通过问卷工具进行评估 2）分析正在进行的试验的结果，比较 阿米替林与地昔帕明交替镇痛治疗癌痛 用阿片类药物治疗的患者;和3）进行前瞻性，盲法， veniafaxine与安慰剂连续治疗的随机研究 (to阿片类镇痛药）在癌症疼痛患者中的应用;阿片类药物治疗 首先，每个病人的病情都要稳定下来。 的 veniafaxine（或安慰剂，benztropine）剂量将向上滴定， 随着时间的推移，除非受到副作用的限制。 将随访患者 持续10周，每天、每周或每周对他们的状况进行评分， 每两周一次，由定义的调查问卷组合进行。 在此 在一段时间内，不仅会增加附加值， 向下，取决于副作用的投诉，而 阿片剂量将根据疼痛症状而变化。

The application proposes to: 1) develop a computer simulation of idealized drug dose (input) data and patient response measures (output); the doses are of opiate analgesic and/or tricyclic adjunctive drugs; the output is to be assessed by questionnaire instruments, soon to be tested; 2) analyze the results of an ongoing trail, comparing amitriptyline and desipramine adjunctive analgesia in cancer pain patients treated with opiates; and 3) conduct a prospective, blinded, randomized study of veniafaxine versus placebo adjunctive treatment (to opiate analgesia) in cancer pain patients; the opioid treatment regiment will first have been stabilized for each patient. The veniafaxine (or placebo, benztropine) dose will be titrated upward, over time, unless limited by side effects. Patients will be followed for ten weeks, their condition being scored at either daily, weekly or bi-weekly intervals by the defined questionnaire battery. Over this time period, not only will adjunct does be varied upward or downward, depending on the complaint of side effect, whereas the opiod dose will be varied in response to pain complaint.