三氧化二砷治疗急性早幼粒细胞白血病疗效的系统综述和meta分析

doi:10.3736/jcim20090901

Abstract

Objective

To systematically review the efficacy and safety of arsenic trioxide (ATO) in treatment of acute promyelocytic leukemia (APL).
Methods

The Cochrane Library (Issue 1, 2009), Cochrane Central Register of Controlled Trials (from 1970 to January 2009), MEDLINE (from 1978 to October 2008), EMBASE (from 1950 to March 2009), Chinese Biological Medical Literature Database (from 1978 to December 2008), China National Knowledge Infrastructure (CNKI, from 1994 to December 2008), and China Medical Academic Conference Database (from 1994 to December 2008) were electronically searched. We also searched the Meta-Register of controlled trials, Conference Proceedings of American Society of Hematology (from 1946 to December 2008) and Conference Proceedings of American Society of Clinical Oncology (from 1946 to December 2008) on the internet for grey literature. The related journals in the library of Third Military Medical University were hand-searched. The randomized controlled trials (RCTs) of ATO in treatment of APL were included. We adopted complete remission, overall survival rate, disease free survival rate, time to complete remission, relapse rate, mortality and adverse reactions as outcome indicators. Data were entered and analyzed with the Cochrane review manager software 5.0 (RevMan 5.0).
Results

After merger of the included trials, five eligible RCTs with 328 cases were included. All the RCTs focused on the comparison of all-trans retinoic acid (ATRA) plus ATO regimen with ATRA monotherapy. Meta-analysis showed that the effect indexes for time to complete remission, two-year disease free survival rate, relapse rate, incidence of edema and incidence rate of QT interval prolongation were –1.20 [–1.68, –0.72], 8.64 [1.66,45.00], 0.21 [0.09,0.47], 4.16 [1.46,11.79] and 22.10 [2.75,177.49], respectively. The influences on other outcome indicators such as complete remission and leukocytosis were statistically non-significant.
Conclusion

ATO can prolong disease free survival and reduce the time to complete remission and relapse rate of newly diagnosed APL patients, and increase the incidence of edema and prolongation of corrected QT interval during the treatment. Due to limitation of the included trials, this conclusion needs to be validated by further studies.

Key words: Arsenic trioxide, Leukemia, Promyelocytic, Acute, Randomized controlled trial, Systematic review, Meta-analysis

Shuang-nian Xu , Jie-ping Chen, Jian-ping Liu, Yun Xia . Efficacy of arsenic trioxide for acute promyelocytic leukemia: A systematic review and meta-analysis. Journal of Chinese Integrative Medicine, 2009, 7(9): 801-808.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20090901

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Figures/Tables 6

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References 20

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Study	Cases*		Male/Female^△		Median age (years)^▲		White blood cell count ($\bar{x}$±s, 10⁹/L)		Treatment program
Study	ATO (–) group	ATO (+) group	ATO (–) group	ATO (+) group	ATO (–) group	ATO (+) group	ATO (–) group	ATO (+) group	ATO (–) group	ATO (+) group
Shen et al^[14]	20	21	12/8	9/12	30.5	34	Did not report	Did not report	ATRA 25 mg/(m²·d)	ATO 0.16 mg/(kg·d); ATRA 25 mg/(m²·d)
Su et al ^[15]	30	40	12/18	18/22	31	37.2	11.9±21.5	15.7±20.6	ATRA 25 mg/(m²·d)	ATO 0.16 mg/(kg·d); ATRA 30-40 mg/d
Ren et al ^[16]	52	43	30/22	23/20	32	34	11.9±21.5	13.6±23.9	ATRA 25 mg/(m²·d)	ATO 10 mg/d; ATRA 25 mg/(m²·d)
Yang et al^[17]	11	15	4/7	5/10	41	39	Did not report	Did not report	ATRA 30-60 mg/d	ATO 10 mg/d; ATRA 30-60 mg/d
Zhou et al ^{[9,10,11,12,13]}	48	48	30/18	28/20	23	21	7.8±3.0	8.2±2.5	ATO 0.16 mg/(kg·d), routine intravenous infusion (30-40 drops per minute)	ATO 0.16 mg/(kg·d), continuous slow intravenous infusion (8 drops per minute)

Efficacy of arsenic trioxide for acute promyelocytic leukemia: A systematic review and meta-analysis

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