Ritchie J A, Truelove S C
Br Med J. 1980 Nov 15;281(6251):1317-9. doi: 10.1136/bmj.281.6251.1317.
A previous therapeutic trial of factorial design showed that a combination of a psychotropic drug, a smooth-muscle relaxant, and a bulk former (lorazepam, hyoscine hydrobromide, and ispaghula husk) relieved symptoms of the irritable bowel syndrome more effectively than the same agents given singly. Another trial of similar design was undertaken to compare each of these three agents with another having the equivalent clinical actions--namely, Motival (fluphenazine/nortriptylene mixture), mebeverine, and bran. Ninety-six patients took part; all received three agents, one from each of the three pairs being compared, and no placebos were used. Fifty-six patients reported a sustained symptomatic improvement, which was a significantly higher incidence than in the previous trial, when placebos were used. Ispaghula was significantly more effective than bran. The combination of ispaghula, Motival, and mebeverine improved 11 out of 12 patients--significantly more than bran, Motival, and hyoscine (five improved), or bran, lorazepam, and mebeverine (four improved). Mebeverine was significantly more effective when combined with Motival (18 out of 24 improved) than with lorazepam (10 improved). These results confirm the value of a combined therapeutic approach to the relief of the irritable bowel syndrome and suggest the possibility of synergism between agents.
一项先前的析因设计治疗试验表明,一种精神药物、一种平滑肌松弛剂和一种容积性泻药(劳拉西泮、氢溴酸东莨菪碱和卵叶车前子壳)联合使用比单独使用这些药物更有效地缓解了肠易激综合征的症状。进行了另一项类似设计的试验,以比较这三种药物中的每一种与另一种具有等效临床作用的药物——即Motival(氟奋乃静/去甲替林混合物)、美贝维林和麸皮。96名患者参与;所有人都接受了三种药物,每种药物来自被比较的三对药物中的一对,且未使用安慰剂。56名患者报告症状持续改善,这一发生率显著高于先前使用安慰剂的试验。卵叶车前子壳比麸皮显著更有效。卵叶车前子壳、Motival和美贝维林的组合使12名患者中的11名病情改善——显著多于麸皮、Motival和东莨菪碱(5名改善),或麸皮、劳拉西泮和美贝维林(4名改善)。美贝维林与Motival联合使用时(24名中有18名改善)比与劳拉西泮联合使用时(10名改善)显著更有效。这些结果证实了联合治疗方法对缓解肠易激综合征的价值,并提示了药物之间协同作用的可能性。