目的评价改良标准化疗方案治疗脊柱结核的临床疗效和药物安全性,明确常见副作用及其处理措施.方法收集2008年1月至2012年12月期间在昆明医科大学第一附属医院明确诊断为"脊柱结核"、接受改良标准化疗方案(2HRZE/4HRE/12-18HR;剂量为H 300 mg,R 450 mg,Z 750 mg,E 750 mg,晨起顿服)并完成至少2 a随访的患者资料,采用临床治愈率和复发率评估该化疗方案的疗效;通过药物副作用发生率和严重程度评估该化疗方案的安全性.对药物常见的副作用,按发生的类型、时间、严重程度、处理措施等进行统计和分析.结果共67例患者纳入本研究,其中男性32例,女性35例;年龄15-68岁,平均40.6岁.其中21例患者仅采用改良标准化疗方案,其余46例采用术前化疗+手术+术后化疗方案进行治疗.2 a临床愈合率95.52%,2 a内结核复发率1.50%.在整个化疗期间,药物副作用主要发生在前2个月的四联强化治疗期,主要涉及胃肠道反应(约为28.36%)、高尿酸血症(约为31.34%)、肝功能异常(约为31.34%)等;多数药物副作用较轻,部分较严重病例加用Vit B6、护肝药(如多烯磷脂酰胆碱、草甘酸二钠或还原性谷胱甘肽等)、碳酸氢钠和多饮水等措施得到控制;吡嗪酰胺的撤除可明显减少高尿酸血症的发生率.结论运用改良标准化疗方案治疗脊柱结核可获得良好的临床疗效并具有较高的安全性.
Objective To evaluate the efficacy and safety of modified standard chemotherapy in the treatment of spinal tuberculosis,and clarify the common side effects as well as corresponding treating measures. Methods From 2008 January to 2012 December,cases of spinal tuberculosis were collected in our hospital,received the modified standard chemotherapy(2HRZE/4HRE/12-18HR;H 300 mg R dose,450 mg,Z 750 mg, E 750 mg,meal served in morning),and followed up for at least 2 years. The chemotherapy efficacy was evaluated using the clinical cure rate and recurrence rate. Meanwhile, the chemotherapy safety was evaluated through the drug side effect incidence and severity. The drug side effects were analyzed by statistics according to the types, duration,severity,and treatment measures. Results A total of 67 patients were included in the study, including 32 cases of male, 35 cases of female; aged 15-68 years(mean, 40.6 years). 21 patients were treated with modified standard chemotherapy, the remaining 46 cases were treated with preoperative chemotherapy + operation +chemotherapy after surgery. The clinical healing rate within 2 years was 95.52%, and the recurrence rate after 2years was 1.50%. In the whole period of chemotherapy,drug side effects occurred mainly in intensive treatmentperiod in the first 2 months, mainly related to the gastrointestinal reaction(about 28.36%), hyperuricemia(about 31.34%) and abnormal liver function(about 31.34%), but most drugs had mild side effects. In some cases with serious liver injury, liver protecting drugs(such as polyene phosphatidyl choline,glyphosate acid two sodium or glutathione etc.),sodium bicarbonate and drinking more water measures were verified as effective. The removal of pyrazinamide might reduce the incidence of hyperuricemia. Conclusion The use of modified standard chemotherapy for the treatment of spinal tuberculosis has a good clinical curative effect with high security.