沙利度胺改善癌症患者围化疗期失眠症的临床研究

Treatment of Peri-Chemotherapy Insomnia of Cancer Patients Using Thalidomide

目的探讨沙利度胺治疗癌症患者围化疗期失眠症的临床疗效及不良反应。方法采用随机对照的研究方法,将67例围化疗期间失眠的患者分为治疗组(35例)和对照组(32例)。治疗组:睡前服用沙利度胺,起始剂量为100 mg,疗效欠佳者可逐渐累加剂量(每晚增加50 mg)至400 mg;对照组:睡前服用地西泮,起始剂量为2.5mg,疗效欠佳者可逐渐累加剂量(每晚增加2.5 mg)至10.0 mg。睡眠不能改善者可采用其他治疗手段。采用国际通用的SPIEGEL睡眠量表检测疗效,并评价患者的Kamofsky评分变化、不良反应及总体自我评价。结果治疗组和对照组的有效率分别为97.1%和93.7%,两组有效率比较,差异无统计学意义(P>0.05)。两组患者恶心呕吐Ⅰ～Ⅳ级的发生率比较,差异有统计学意义(P<0.05)。两组腹泻、周围神经病变、白细胞、血小板、血红蛋白、便秘、黏膜炎、血栓、皮疹及瘙痒、肝肾功能Ⅰ～Ⅳ级的发生率比较,差异均无统计学意义(P>0.05)。两组患者生存质量及总体自我评价比较,差异均无统计学意义(P>0.05)。结论沙利度胺可有效改善癌症患者围化疗期失眠症状,进一步扩大了沙利度胺临床抗肿瘤治疗的适应证。

Objective To explore the therapeutic effects and adverse reactions of thalidomide in the treatment of peri-chemotherapy insomnia.Methods A total of 67 patients were randomly assigned into the treatment group（35 cases）and the control group（32 cases）.The treatment group was treated with thalidomide（oral administration at a dose of 100 mg nightly,the dose can be added by 50 mg daily untill the insomnia can be well treated,other measures can be taken after the top dose of 400 mg nightly）.The control group was treated with oral administration of diazepam in a way similar to that of the first group,with a starting dose of 2.5 mg and a top dose of 10 mg.All cases were examined using SPIEGEL scale.KPS scores,toxicity,and general self assessment were also obtained.Results The response rate was 97.1% in the treatment group and 93.7% in the control group（P0.05）.Incidence rates of nausea and vomiting（Ⅰ~Ⅳ） were significantly different between the two groups（P0.05）.No statistically significant differences between the two groups were noted in the incidence of diarrhea,peripheral neuropathy,leukocyte,platelet,hemoglobin,constipation,mucositis,thrombosis,skin rashes and itching,liver and kidney function（P0.05）.Quality of life and general self assessment were also similar between the two groups（P0.05）.Conclusion Thalidomide is effective for insomnia patients with cancer during peri-chemotherapy,which further enlarges the indication of the drug.