国内吡柔比星与阿霉素为主的化疗方案治疗非霍奇金淋巴瘤疗效与安全性的Meta分析

E ectiveness and Safety of Chemotherapy Regimens Represented by Pirarubicin versus Adriamycin Hydrochloride for Non-Hodgkin Lymphoma in China's Mainland: A Meta-Analysis

目的系统评价国内以吡柔比星(THP)为主的化疗方案与以阿霉素(ADM)为主的化疗方案比较治疗非霍奇金淋巴瘤的有效性与安全性。方法计算机检索PubMed、CNKI、CBM、VIP和WanFang Data,查找THP和ADM比较治疗NHL的随机对照试验(RCT)。检索时限均为1989年1月至2012年9月,并手工检索所有纳入文献的参考文献。由2位评价员根据纳入和排除标准独立筛选文献、提取资料并评价纳入研究的方法学质量后,采用RevMan 5.0软件进行Meta分析。结果最终纳入15个RCT,共1 659例患者。Meta分析结果显示:①在总有效率方面,以THP为主的CTOP方案(C:环磷酰胺,T:吡柔比星,O:长春新碱,P:泼尼松)明显高于以ADM为主的CHOP方案(C:环磷酰胺,H:阿霉素,O:长春新碱,P:泼尼松),其差异有统计学意义[OR=1.07,95%CI(1.02,1.12),P=0.006]。②在安全性方面,以THP为主的CTOP方案在心脏、胃肠道、肝功损害等方面的副作用明显少于以ADM为主的CHOP方案,其差异均有统计学意义[心脏:OR=0.42,95%CI(0.30,0.57),P<0.000 01;胃肠道:OR=0.69,95%CI(0.56,0.85),P=0.000 5;OR=0.69,95%CI(0.48,1.00),P=0.05],但两种化疗方案在骨髓抑制方面差异均无统计学意义[血红蛋白减少:OR=0.83,95%CI(0.61,1.14),P=0.25;白细胞减少:OR=0.85,95%CI(0.68,1.07),P=0.17;血小板减少:OR=0.99,95%CI(0.70,1.39),P=0.95]。结论目前国内研究结果表明,与以ADM为主的CHOP方案相比,以THP为主的CTOP方案治疗非霍奇金淋巴瘤的总有效率更高,且副作用更小。受纳入研究质量和数量限制,上述结论尚需开展更多高质量、大样本的随机双盲对照试验加以验证。

Objective To evaluate the effectiveness and safety of chemotherapy regimens represented by pira- rubicin （THP） vs. adriamycin hydrochloride （ADM） for non-Hodgkin lymphoma （NHL） in China's Mainland. Methods The randomized controlled trials （RCTs） about THP vs. ADM for treating NHL were collected in the databases such as CNKI, CBM, VIP and WanFang Data, and the references of the included studies were also retrieved manually, with the retrieval time from January 1989 to September 2012. According to the inclusion and exclusion criteria, two reviewers in- dependently screened articles, extracted data, and assessed the methodological quality of the included studies. Then meta- analysis was performed using RevMan 5.0 software. Results A total of 15 RCTs involving 1 659 patients were included. The results ofmeta-analysis showed that： a） As for the total effective rate, the CTOP （C： cyclophosphamide, T： pirarubicin, O： vincristine, P： prednison） regimen was superior to the CHOP （C： cyclophosphamide H： adriamycin hydrochloride, O： vincristine, P： prednison） regimen with a significant difference （OR=1.07, 95%CI 1.02 to 1.12, P=0.006）; and b） As for the safety, there were significant differences between the two groups in the incidence of cardiac toxicity （OR=0.42, 95%CI 0.30 to 0.57, P〈0.000 01）, gastrointestinal tract response （OR=0.69, 95%CI 0.56 to 0.85, P=0.000 5） and liver damage （OR=0.69, 95%CI 0.48 to 1.00, P=0.05）. But no significant differences were found between the two groups in the incidence of mye 1 o- suppression： the decreased hemoglobin （OR=0.83, 95%CI 0.61 to 1.14, P=0.25）, leucopenia （OR=0.85, 95%CI 0.68 to 1.07, P=0.17）, and thrombocytopenia （OR=0.99, 95%CI 0.70 to 1.39, P=0.95）. Conclusion Based on the domestic evidences at current and compared with CHOP regimen represented by ADM, CTOP regimen represented by THP for treating NHL shows a higher total effective rate and less side effects. However, more high quality, large sample and double blind RCTs are required to prove this conclusion for the quality and quantity limitation of the included studies.