Strum S B, McDermed J E, Opfell R W, Riech L P
JAMA. 1982 May 21;247(19):2683-6. doi: 10.1001/jama.247.19.2683.
An open-label clinical trial was conducted to test the safety and efficacy of intravenous metoclopramide monohydrochloride in preventing chemotherapy-induced nausea and vomiting. Thirty-eight patients received a total of 83 assessable courses of chemotherapy with cisplatin alone or in combination with other cytotoxic agents. In 19 of 38 patients (50%) or 40 of 83 courses (48%), nausea or vomiting did not occur ("total protection") and in six of 38 patients (16%) or 19 of 83 courses (23%), emesis occurred one of two times ("major protection"). Thus, 25 of 38 patients (66%) receiving 59 of 83 courses (71%) of cisplatin-containing chemotherapy attained either total or major antiemetic protection with metoclopramide. In those patients who received multiple courses of chemotherapy, antiemetic protection afforded by metoclopramide remained unabated. At this dosage, the drug was well tolerated with minimal side effects. Intravenous metoclopramide is consistently effective in preventing emesis associated with cisplatin when used either alone or in combination with other cancer chemotherapy agents that are in themselves emetogenic.
开展了一项开放标签临床试验，以测试静脉注射盐酸甲氧氯普胺预防化疗引起的恶心和呕吐的安全性和有效性。38名患者接受了总共83个可评估疗程的化疗，化疗药物为单独使用顺铂或与其他细胞毒性药物联合使用。在38名患者中的19名（50%）或83个疗程中的40个（48%），未发生恶心或呕吐（“完全预防”）；在38名患者中的6名（16%）或83个疗程中的19个（23%），呕吐发生一两次（“主要预防”）。因此，在接受含顺铂化疗的83个疗程中的59个（71%）的38名患者中的25名（66%），通过甲氧氯普胺获得了完全或主要的止吐保护。在接受多个疗程化疗的患者中，甲氧氯普胺提供的止吐保护作用并未减弱。在此剂量下，该药物耐受性良好，副作用极小。静脉注射甲氧氯普胺单独使用或与本身具有致吐性的其他癌症化疗药物联合使用时，在预防与顺铂相关的呕吐方面始终有效。
