严重急性呼吸综合征患者肾上腺糖皮质激素使用的多因素COX回归分析

目的探讨SARS治疗中糖皮质激素(GCS)的疗效及使用方法.方法收集北京市SARS病历资料,对全部病例进行分析诊断,建立数据库,输入每日临床症状、体格检查及辅助检查.共1291例临床诊断病例资料完整,作为研究对象,分别进行单因素分析及COX多因素回归分析.GCS均换算为甲泼尼龙的剂量(mg/d).结果共1084例使用了GCS治疗,占总例数的83.96%,未使用GCS者为207例.两组年龄(t=-1.08,P>0.05)、住院距离发病的时间差异均无显著意义(P>0.05).多因素COX回归分析显示应用GCS组较未用组的病死危险性略高,RR为1.334(95%可信区间0.588～3.026).其中有基础病使用GCS者RR为2.086(95%可信区间0.694～6.267),无基础疾病者为0.536(95%可信区间0.146～1.970), P>0.05.无基础病患者,起始剂量、最大剂量、平均剂量、累积剂量与病死率均呈现"J"型关系,过低和过高均增加病死相对危险度,中间剂量病死危险略有降低,但差异均无显著意义(P＞0.05).病死相对危险度最低的起始剂量、最大剂量、平均剂量、累积剂量依次为80～160 mg/d、80～160 mg/d、<80 mg/d、1000～3000 mg.无基础病发病14 d以内开始使用GCS者病死RR均小于1,在15 d后使用者则RR值为1.415(95%可信区间0.195～10.257).在入院后不同时间使用的GCS,RR也呈现所谓的"J"型改变.入院后5～7 d使用RR最低,为0.282(95%可信区间0.043～1.828),8～14 d使用RR为1(95%可信区间0.150～6.654).结论 GCS治疗SARS可能有一定的疗效.在应用时,应控制剂量在适当范围内,并掌握恰当的使用时机,对有基础病的患者应慎重使用.

The COX regression analysis on the use of corticosteroids in the treatment of SARS

OBJECTIVE: To explore the effectiveness of corticosteroids (GCS) and to determine how to use it in the treatment of SARS. METHODS: All reported probable cases in Beijing were reviewed. Those who fulfilled the diagnostic criteria with an integrity clinical record were recruited in the study. A database was established and all the clinical data, including patients' personal information, epidemiological history, underlying diseases, clinical manifestations, laboratory tests and therapies after hospitalization, as well as the outcome of the disease, were inputted under a quality control. Unifactor and COX multifactor regression analysis were done. The dose of GCS was all expressed in that of methylprednisolone. RESULTS: 1291 cases were in consistence with the demands mentioned above. Among them, 1084 cases (83.96%) had used GCS and 207 did not in the course of SARS. There was no significant difference of average age (t = -1.08, P = 0.2808) and the time from SARS onset to hospitalization (P = 0.2797) between the two groups. COX regression showed that the risk of fatality in the GCS group was higher than that of those who did not use GCS (RR = 1.334, 95% of CI: 0.588 - 3.026). In the patients with comorbidities, RR was 2.086 (95% of CI: 0.694 - 6.267), and RR was 0.536 (95% of CI: 0.146 - 1.970) in the patients with no comorbidity. In those without any comorbidity, the initial doses, maximal doses, average doses and cumulative doses all showed a 'J' shape change. An appropriate dose could keep RR to be the lowest whereas the doses either higher or lower than it could increase RR. The initial dose with the lowest RR was 80 - 160 mg/d, the maximum 80 - 160 mg/d, the average < 80 mg/d and the cumulative one 1000 - 3000 mg although there was no statistical significance (all P > 0.05). RR was less than 1 in non-comorbidity patients who initiated GCS therapy before the 15th day of the disease. RR was 1.415 (95% of CI: 0.195 - 10.257) in the patients who began to use GCS over this period. Counting from hospitalization, the time of GCS use also showed a 'J' type change of RR. The initiation of GCS from day 5 to 7 had the lowest RR (0.282, 95% of CI: 0.043 - 1.828) and that from day 8 to 14 was 1 (95% of CI: 0.150 - 6.654). CONCLUSION: In the treatment of SARS, GCS seems to be effective. An appropriate dose and a right time of application decrease the risk of death. The use of GCS in SARS patients with comorbidities should be with caution.