香菇多糖对晚期胃癌患者免疫功能的影响及临床疗效与安全性评估

目的系统评价不同香菇多糖联合治疗方案对晚期胃癌患者免疫功能的影响及临床疗效与安全性。方法按Cochrane工作手册,计算机检索MEDLINE(1969～2006)、EMBASE (1984～2006)、OVID(1969～2006)、CENTRAL(Cochrane Central Register of Controlled Trials)(Issue 4,2006)、CBM(1978～2006)、中国循证医学中心中文临床研究数据库、CNKI等数据库,同时手检相关杂志和参考文献,并与药厂联系,选择符合标准的随机对照试验。按Cochrane评价标准严格评价文献,纳入高质量研究。结果截至2006年,共纳入10个研究,786例患者。Meta分析显示,香菇多糖 FAM(5-Fu ADM MMC)方案比FAM方案治疗晚期胃癌近期疗效更有效[P<0．01,RR=1．70,95％CI(1．39,2．09)]。3个研究比较了CD_3 T、T_4／T_8、NK细胞作用前后数量变化,Meta分析提示香菇多糖 FAM可显著提高晚期胃癌患者上述三种免疫细胞的数量,且消化道反应明显低于FAM方案[RR=0．71,95％CI(O．55,O．91)]。另一个研究虽未描述近期疗效,但香菇多糖组毒副反应明显下降。其余3个研究由于对照药物均不同(ATP co- A Vc;DDP Epirubicin 5Fu;5Fu CF VP16),可能存在的异质性较大,故未做合并分析,仅对每一研究结果进行单独描述。该3个研究单独结果均提示香菇多糖组治疗晚期胃癌较对照组有效,前者可显著提高晚期胃癌患者以上三种免疫细胞的数量,且副作用明显低于对照组。结论本系统评价结果显示香菇多糖 FAM方案较FAM方案有效,但尚无充分证据表明香菇多糖联合其它化疗方案与单独使用化疗药物方案相比谁更佳。鉴于本系统评价纳入的研究大多质量低下,有必要进行更多方法学质量高,设计严谨,多中心的随机对照试验。

Lentinan for Patients with Advanced Gastric Cancer: A Systematic Review

Objective To evaluate the effectiveness and safety of lentinan on immune function in patients with advanced gastric cancer. Methods We searched MEDLINE (1969-2006), EMBASE (1984-2006), OVID (1969-2006), CENTRAL (Cochrane Central Register of Controlled Trials in The Cochrane Library) (Issue 4, 2006), the Chinese Biomedicine Database (1978-2006) and CNKI (1978-2006). We also handsearched relevant journals. Pharmaceutical companies were contacted to identify additional randomized controlled trials. We assessed the identified studies in order to include high quality studies. Results Ten studies (containing 786 patients) met the inclusion criteria. Six trials shown that lentinan FAM had significant efficacy upon patients with advanced gastric cancer compared with FAM in overall response [P<0.01, RR1.70, 95%CI (1.39,2.09)]. In three trials, a significant effect of lentinan FAM group compared with FAM group in quantity of CD_3 T, T_4/T_8, NK was found, but lower than FAM group in side- effect of digestive system [RR0.71, 95%CI (0.55,0.91)]. The other trail identified there were fewer side effects in lentinan FAM group compared with FAM group, though did not discribe the overall response. In case the significant heterogeneity, meta-analysis could not be used for the other three trails included, since the components of chemotherapeutic agents (ATP Co-A Vc; DDP Epirubicin 5FU; 5FU CF VP16) were not the same. In the three trials, overall response was statistically significant better in the lentinan group than in the control group, and lentinan group could significantly increase the quantity of CD_3 T, T_4/T_8, NK compared with control group. Conclusions The present meta-analysis suggested that addition of lentinan to standard chemotherapy provided a significant advantage over chemotherapy alone in terms of efficacy for patients with advanced gastric cancer. However, most of trials included in the review were of low quality, therefore, it is of necessity to conduct multi-center randomized-controlled trials of high quality.