27 5 2013 9 35 Meta /200032 Cochrane Cochrane CENTRAL PubMed Nature EMbase CNKI VIP Cochrane RevMan 5. 0. 24 Meta 6 369 192 177 Meta KPS risk ratio RR 95% CI 1. 92 1. 29 2. 85 RR 5% CI 1. 43 1. 08 1. 89 RR 95% CI 0. 35 0. 24 0. 52 RR 95% CI 1. 25 0. 97 1. 63 T NK 2 1 KPS Meta R730. 5 A 1008-861X201305-0035-06 bufalin 1 Cochrane Meta 1 2 3 4 5 1. 1 文 献 纳 入 标 准 6 7 8 France America and British FAB FAB WHO 2006BAI0 1 1 50% E-mailyang. yunke@ zs-hospital. sh. cn 1 2KPS 3
36 ACTA UNIVERSITATIS TRADITIO NIS MEDICALIS SINENSIS PHARMACO LO GIAEQ UE SHANGHAI Vol. 27 No. 5 Sep. 2013 4 5 1. 2 排 除 文 献 标 准 1 1. 5 统 计 学 分 析 Cochrane 2 2 RevMan 5. 0. 24 Meta 3 RR 95% Q I 2 1. 3 检 索 策 略 bufalin ANDtumor or cancer or carcinoma or oncology Cochrane Mantel-Haenszel 2012 1 PubMed 1980-2012. 2 Nature 1980-2012. 2 EMbase1980-2012. 2 or or or AND or DerSimonian and Laird DL CNKI1980-2012. 2 1990-2 2012. 2 VIP1989-2012. 2 2. 1 1. 4 文 献 筛 选 资 料 提 取 与 质 量 评 价 纳 入 研 究 的 基 本 情 况 406 396 PRISMA 9 10 Jadad 10 1 ~ 2 2 3 4 ~ 7 6 11-16 1 1 纳 入 研 究 的 基 本 情 况 及 方 案 比 较 B /C CR + PR KPS B vs. C B vs. C B vs. C B vs. C 9 /31 vs. 11 2002 31 /28 49 12 /31 vs. 4 /28 5 /28 32-64 12 2009 31 /31 13 30 /30 2007 56. 5 39-74 16 /31 vs. 14 /31 P > 0. 05 58. 30 ± 8. 5 10 /30 vs. 36-69 8 /30 55. 2 ± 6. 63 P > 0. 05 39-70 18 /31 vs. 12 /31 9 /30vs. 3 /30 25 /31 vs. 18 /28 B vs. C B CD C 26 /31 vs. 19 /31 CD3 CD4 CD8 CD4 /CD8 P < 0. 05 15 /30 vs. 6 /30 B C CD CD3 CD4 CD4 / CD8 C CD4 CD8 CD4 / CD8 P <0. 05
27 5 2013 9 37 1 B /C CR + PR KPS B vs. C B vs. C B vs. C B vs. C B vs. C B1 B2 20B1/ 14 34 2000 26B2/ 34 12/20B1vs. 51. 8B1 15 /34 27-72 49. 6B2 13 /26 24-69 B2vs. 52. 3C 15 /34 26-70 32 /46 B1 + B2vs. 23 /34 OKTH OKTS OKTH OKTS NK 85% 64. 4% C NK 29. 4% 15 30 /30 2005 10 /30 vs. 5335-65 8 /30 5133-64 P > 0. 05 13 /30 vs. 5 /30 B C IgG IgM IgA C3 C4 2 / 30 B 1 /30 10 /24 vs. 5 /24 9 /24 16 24 /24 2008 59 45-80 10 /24 vs. 6 /24 vs. 5 /24 7 /24 vs. 4 /24 18 /24 vs. 20 /24 Ⅱ 10 /24 vs. 1 /24 B vs. C vs. CR + PR CR PR 6 54 1 11 10 ml 6 5% 500 ml 2. 2 Meta 分 析 结 果 20 ml 5% 500 ml 2. 2. 1 6 Q = 0. 63 P = 0. 99 I 2 = 0% Meta KPS RR = 1. 25 95% CI 0. 97 1. 63 P = 0. 09 14 1
38 ACTA UNIVERSITATIS TRADITIO NIS MEDICALIS SINENSIS PHARMACO LO GIAEQ UE SHANGHAI Vol. 27 No. 5 Sep. 2013 1 Q = 1. 90 P = 0. 59 I 2 = 0% Meta 2. 2. 2 KPS 4 RR = 1. 43 95% CI 1. 08 3 Meta 2. 2. 4 9 RR = 1. 92 95% CI 1. 29 2. 85 P = 0. 001 KPS 2 Meta 2. 2. 3 10 Q = 23. 56 P = 0. 005 I 2 = 62% 1. 89P < 0. 001 Q = 8. 88 P = 0. 35 I 2 = 10% RR = 0. 35 95% CI0. 24 0. 52 P < 0. 001 4 Meta 2 KPS Meta 3 Meta 4 Meta
27 5 2013 9 39 2. 2. 5 KPS 5 6 5 KPS Meta 6 4 1 1 4 6 KPS 2. 2. 6 Meta 1 Meta 3 6 KPS 1 2 KPS 6 RCT 17
40 ACTA UNIVERSITATIS TRADITIO NIS MEDICALIS SINENSIS PHARMACO LO GIAEQ UE SHANGHAI Vol. 27 No. 5 Sep. 2013 1. M. 1982419. 2Yeh JY Huang WJ Kan SF. Effects of bufalin and cinobufaten on the proliferation of androgen Dependent and independent prostate cancer cells J. Prostate 2003 542 112-124. 3. HL-60 11. J. 2000 217 359-361. 31 J. 2002 243 163-165. 4. 12. + J. 2006 11 7 J. 2009 283697-99. 494-497. 13. 5. J. 2007 344 440-441. B16 J. 14. 2007 64 206-209. J. 2000 123 185-186. 6Numazawa S Inoue NNakura H et al. A cardiotonic steroid bufalin-induced differentiation of THP-1 cells. Involvement of Na + - K + -ATPase inhibition in the early changes in proto-oncogene expression J. Biochem Pharmacol 1996 522 321-329. 7Eeffrth T Davey M Olbrieh A. Activity of drugs from traditional Chinese medicine toward sensitive and MDRI-or MRPI-overexpressing multidurg-resistant human CCRF-CEM leukemia cellsj. Blood Cells Mol Dis 2002 282 160-168. 9Moher D Liberati A Tetzlaff J et al. Preferred reporting items for systematic reviews and meta-analysesthe PRISMA statementj. Journal of Clinical Epidemiology 2009 62101006-1012. 10Jadad AR Moore RA Carroll D. Assessing the quality of reports of randomized clinical trialsis blinding necessaryj. Control Clin Trials 1996 171 1-12. 8. J. 2008 221 63-68. 15. J. 2005 321 36-37. 16. J. 2008 61 57-58. 17. J. 2003 21026-27. 收 稿 日 期 : 2013-05-27 Effectiveness and Safety of Bufalin Praeparatum in the Adjuvant Therapy of Tumor: A Systematic Review and Meta-analysis ZHANG Zhou-Ji YANG Yun-Ke Zhongshan Hospital Affliated to Fudan University ABSTRACT Objective: To evaluate the efficacy and safety of Bufalin Praeparatum as an adjuvant therapy for the tumor patients underwent chemotherapy or radiotherapy. Methods: The databases such as Cochrane Library,Cochrane Central Register of Controlled Trails,PubMed,Nature,EMbase,CNKI,WanFang Data and VIP were searched by taking the Cochrane s systematic review method,and Chinese Journal of Oncology was searched by a manual retrieval operation. The data were extracted,the quality was assessed,and meta-analysis was conducted by using Revman 5. 0. 24 soft ware. Results: Six research literatures involving 369 participants ( 192 participants in treatment group and 177 participants in control group) were included. The meta analysis showed that active constituents in Bufalin Praeparatum for tumor patients increasing rate of KPS function scored of the effect of statistic risk ratio ( RR) and 95% confidence interval ( CI) being 1. 92[1. 29,2. 85],clinical symptoms to improve the rate of impact the effect of statistics of RR and its 95% CI being 1. 43[1. 08,1. 89]. The effects of the toxic effects of statistic RR and 95% CI caused by chemotherapy or radiotherapy are 0. 35[0. 24,0. 52]. Influences on these three outcome indicators were statistically significant. While there was no significant difference in tumor remission rate of the effect of statistic RR and 95% CI being 1. 25 [0. 97,1. 63]. During the period of treatment,this medicine adjusted helper T lymphocytes and suppressor T lymphocytes to tend to become a reasonable ratio remarkably and enhanced NK cell s viability,immunoglobulin, and complement in blood serum and so on. These secondary indicators of the differences were statistically significant. In addition, fewer reports of adverse events were associated with Bufalin Praeparatum. Only two cases with arrhythmia and one case with a rash existed,while without significant difference in the two symptoms. Conclusion: The existing evidence reveals that the Bufalin Praeparatum,as neoadjuvant chemotherapy for cancer,plays a certain part in raising rate of KPS function,improving clinical syndrome,decreasing chemotherapeutic and radiotherapeutic toxicities,and boosting up immunity. More high-quality trails were required to verify this conclusion due to the limitational quality and small scale of the included studies. KEY WORDS Bufalin Praeparatum; tumor; adjuvant therapy; randomized controlled trial; systematic review; meta-analysis