Efficacy and safety of Compound E’jiao Jiang (复方阿胶浆) for treating leukopenia based: a systematic review and Meta-analysis

doi:10.19852/j.cnki.jtcm.2025.05.001

Abstract

Abstract:

OBJECTIVE: To systematically assess the safety and effectiveness of Compound E’jiao Jiang (复方阿胶浆, CEJ) for treating leukopenia.

METHODS: Four English and four Chinese databases were searched for randomized controlled trials (RCTs) on CEJ for treating leukopenia up to July 1, 2024. Two researchers independently screened the studies and extracted necessary data. Methodological quality and risk of bias were assessed using the Cochrane risk-of-bias tool. Articles eligible for Meta-analysis were analyzed using RevMan.

RESULTS: A total of 28 RCTs involving 2041 participants were included, with 1034 in the experimental group and 1007 in the control group. The Meta-analysis showed a significant effect of CEJ in treating leukopenia caused by tumor and immune diseases (three RCTs) [risk ratio (RR) = 1.17, 95% confidence interval (CI) (1.08, 1.27), P= 0.0002, I 2 = 35%]. The combination of CEJ and Western Medicine showed superior results in terms of white blood cell (WBC) counts (fifteen RCTs) [mean difference (MD) = 1.12, 95% CI(0.83, 1.42), P< 0.000 01, I 2 = 88%], Karnofsky Performance Status (KPS) levels (seven RCTs) [RR = 1.39, 95% CI(1.25, 1.55), P <0.000 01, I 2 = 36%], and mitigation of bone marrow toxicity (eleven RCTs) [RR = 0.61, 95% CI(0.54, 0.69), P < 0.00001, I 2 = 24%] compared to Western Medicine alone. Adverse events mainly included gastrointestinal and digestive reactions associated with chemotherapy drugs.

CONCLUSION: CEJ alone or in combination with Western Medicine for treating leukopenia caused by tumor and immune diseases improved WBC counts, clinical efficacy, and quality of life. It also reduced bone marrow toxicity-induced leukopenia, enhanced the efficacy of chemotherapy while reducing its toxicity, and alleviated symptoms. No significant adverse events were reported in the RCTs, indicating favorable efficacy and safety. The Grading of Recommendations Assessment, Development and Evaluation assessment indicated a low level of evidence for CEJ in improving leukocyte elevation efficacy, KPS levels, and myelosuppressive toxicity. Therefore, large-scale, high-quality, rigorous multicenter double-blind controlled trials are recommended to strengthen the evidence level.

Key words: nonprescription drugs, leukopenia, safety, treatment outcome, GRADE approach, Meta-analysis, Compound E’jiao Jiang

LU Zhenkai, TAN Chang, ZHI Yingjie, ZHANG Xuming, XIE Yanming. Efficacy and safety of Compound E’jiao Jiang (复方阿胶浆) for treating leukopenia based: a systematic review and Meta-analysis[J]. Journal of Traditional Chinese Medicine, 2025, 45(5): 941-953.

Figures/Tables 6

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No.	Study	Samples (No.)			Male/female		Age (years)		Treatment		Disease	Course of treatment (weeks)	Outcome
No.	Study	Experiment	Control	Total	Experiment	Control	Experiment	Control	Experiment	Control	Disease	Course of treatment (weeks)	Outcome
1	Fu L et al 2014¹⁴	64	55	119	49/15	Oct-45	≤ 50, 35 cases; 51-60, 46 cases; 61-70, 24 cases; > 70, 14 cases		CEJ+C	GP	Malignant tumor	6	②
2	Liu ZH, Shi JW 2007¹⁵	15	15	30	11月4日	10月5日	56	57	CEJ+C	Chemotherapy	Lung cancer	6	①⑤
3	Lu DR et al 2015¹⁶	33	33	66	N		15-75		CEJ+C	Folic acid tablets + ferrous succinate tablets	Malignant tumor	4	②
4	Zhou Y 2013¹⁷	34	34	68	20/14	12月22日	18-80		CEJ+C	Chemotherapy	Malignant tumor	3	②③
5	Zhou Y et al 2018¹⁸	65	70	135	80/55		50		CEJ+C	EP	Small cell lung cancer	6	②⑤
6	Zhou XT, Shen J 2014¹⁹	38	37	75	N		18-75		CEJ	Leucogen Tablets	Malignant tumor	-	②③
7	Song T et al 2016²⁰	33	30	63	12月21日	17/13	54/09±14.12	56.72±12.57	CEJ+C	Chemotherapy	Malignant lymphoma and breast cancer	6	②④
8	Zhang GZ, Chen HT 2017²¹	38	38	76	20/18	22/16	53.1±11.7	51.9±9.1	CEJ+C	Yi Bi Ao	Malignant tumor	6	②④
9	Zhang YH et al 2010²²	30	30	60	14/16	12月18日	61.97	65.52	CEJ+C	Chemotherapy	Malignant tumor	6月8日	②③
10	Zhang CH et al 2002²³	20	20	40	N		40±14.12	38.25±11.78	CEJ	Shark liver oil+VitB4	dry syndrome	6	②③
10	Zhang CH et al 2002²³	20	20	11	N		40±14.12	38.25±11.78	CEJ	Shark liver oil+VitB4	dry syndrome	6	②③	Li HB, Zhou JM 2017²⁴	44	44	88	N		44.2±10.3	43.8±10.2	CEJ+C	GP	Cervical cancer	8	②
12	Li ZB, Jiu SW 2016²⁵	25	25	50	7/43		43.22±7.13		CEJ	Shark liver oil+VitB4	dry syndrome	6	②③
13	Li N 2013²⁶	37	36	73	23/14	19/17	61±11	60±10	CEJ+C	Chemotherapy	Cancer-related fatigue	4	①②⑥
14	Yang KP et al 2015²⁷	25	25	50	7/43		43.22±7.13		CEJ	Shark liver oil + VitB4	dry syndrome	6	②③
15	Bu YQ et al 2013²⁸	30	30	60	12月18日	16/14	36-60	36-62	CEJ+C	XELOX	Advanced gastric cancer	8	①⑤
16	Xu NW et al 2014²⁹	51	46	97	24/27	29/17	51.97±2.35	55.20±3.63	CEJ+C	Chemotherapy	B-cell lymphoma	3	②③⑤
17	Tan QX et al 2009³⁰	15	15	30	10月5日	11月4日	51	49	CEJ+C	Chemotherapy	Malignant tumor	6	①⑤
18	Zhao JL et al 2011³¹	30	30	60	N		55.6	56.1	CEJ+C	TP	Advanced-stage gynecological tumors	3	②⑤
19	Lu JH et al 2002³²	26	20	46	2/44		23.6		CEJ	RhGM-CSF	Lupus nephritis	1	②③
20	Shao YY, Liu PM et al 2009³³	31	25	56	N		51.54±15.32	53.26±18.75	CEJ+C	AC	Breast cancer	6	⑤
21	Min XM 2012³⁴	41	41	82	62/58		50		CEJ+C	Ascend white amine tablets	Malignant tumor	8	②④
22	Chen M et al 2015³⁵	38	37	75	N		18-75		CEJ+C	Leucogen Tablets	Malignant tumor	4	②③
23	Gu YF et al 2012³⁶	46	48	94	13/33	22/26	57.1	59.4	CEJ+C	Chemotherapy	Stomach cancer	2	②⑤
24	Gu YF et al 2012(2)³⁷	80	79	159	32/48	36/43	58.8	60.4	CEJ+C	Chemotherapy	Malignant tumor	2	②
24	Gu YF et al 2012(2)³⁷	80	79	159	32/48	36/43	58.8	60.4	CEJ+C	Chemotherapy	Malignant tumor	2	②	25	Wei YS et al 2017³⁸	50	50	100	35/15	33/17	58	59	CEJ+C	XELOX	Late-stage rectal cancer	4	①⑤
26	Huang ZH et al 2016³⁹	24	25	49	5月19日	11月14日	55.39±9.89	58.54±10.74	CEJ+C	Chemotherapy	Malignant tumor	3	②③④	25	Wei YS et al 2017³⁸	50	50	100	35/15	33/17	58	59	CEJ+C	XELOX	Late-stage rectal cancer	4	①⑤
27	Li MC et al 2019⁴⁰	40	40	80	50/30		55		CEJ+C	EP	Small cell lung cancer	9	①⑤
28	Long D et al 2014⁴¹	31	29	60	11月20日	11月18日	51	48	CEJ+C	Chemotherapy	Malignant tumor	7月8日	①

No.	Study	Samples (No.)			Male/female		Age (years)		Treatment		Disease	Course of treatment (weeks)	Outcome
No.	Study	Experiment	Control	Total	Experiment	Control	Experiment	Control	Experiment	Control	Disease	Course of treatment (weeks)	Outcome
1	Fu L et al 2014¹⁴	64	55	119	49/15	Oct-45	≤ 50, 35 cases; 51-60, 46 cases; 61-70, 24 cases; > 70, 14 cases		CEJ+C	GP	Malignant tumor	6	②
2	Liu ZH, Shi JW 2007¹⁵	15	15	30	11月4日	10月5日	56	57	CEJ+C	Chemotherapy	Lung cancer	6	①⑤
3	Lu DR et al 2015¹⁶	33	33	66	N		15-75		CEJ+C	Folic acid tablets + ferrous succinate tablets	Malignant tumor	4	②
4	Zhou Y 2013¹⁷	34	34	68	20/14	12月22日	18-80		CEJ+C	Chemotherapy	Malignant tumor	3	②③
5	Zhou Y et al 2018¹⁸	65	70	135	80/55		50		CEJ+C	EP	Small cell lung cancer	6	②⑤
6	Zhou XT, Shen J 2014¹⁹	38	37	75	N		18-75		CEJ	Leucogen Tablets	Malignant tumor	-	②③
7	Song T et al 2016²⁰	33	30	63	12月21日	17/13	54/09±14.12	56.72±12.57	CEJ+C	Chemotherapy	Malignant lymphoma and breast cancer	6	②④
8	Zhang GZ, Chen HT 2017²¹	38	38	76	20/18	22/16	53.1±11.7	51.9±9.1	CEJ+C	Yi Bi Ao	Malignant tumor	6	②④
9	Zhang YH et al 2010²²	30	30	60	14/16	12月18日	61.97	65.52	CEJ+C	Chemotherapy	Malignant tumor	6月8日	②③
10	Zhang CH et al 2002²³	20	20	40	N		40±14.12	38.25±11.78	CEJ	Shark liver oil+VitB4	dry syndrome	6	②③
10	Zhang CH et al 2002²³	20	20	11	N		40±14.12	38.25±11.78	CEJ	Shark liver oil+VitB4	dry syndrome	6	②③	Li HB, Zhou JM 2017²⁴	44	44	88	N		44.2±10.3	43.8±10.2	CEJ+C	GP	Cervical cancer	8	②
12	Li ZB, Jiu SW 2016²⁵	25	25	50	7/43		43.22±7.13		CEJ	Shark liver oil+VitB4	dry syndrome	6	②③
13	Li N 2013²⁶	37	36	73	23/14	19/17	61±11	60±10	CEJ+C	Chemotherapy	Cancer-related fatigue	4	①②⑥
14	Yang KP et al 2015²⁷	25	25	50	7/43		43.22±7.13		CEJ	Shark liver oil + VitB4	dry syndrome	6	②③
15	Bu YQ et al 2013²⁸	30	30	60	12月18日	16/14	36-60	36-62	CEJ+C	XELOX	Advanced gastric cancer	8	①⑤
16	Xu NW et al 2014²⁹	51	46	97	24/27	29/17	51.97±2.35	55.20±3.63	CEJ+C	Chemotherapy	B-cell lymphoma	3	②③⑤
17	Tan QX et al 2009³⁰	15	15	30	10月5日	11月4日	51	49	CEJ+C	Chemotherapy	Malignant tumor	6	①⑤
18	Zhao JL et al 2011³¹	30	30	60	N		55.6	56.1	CEJ+C	TP	Advanced-stage gynecological tumors	3	②⑤
19	Lu JH et al 2002³²	26	20	46	2/44		23.6		CEJ	RhGM-CSF	Lupus nephritis	1	②③
20	Shao YY, Liu PM et al 2009³³	31	25	56	N		51.54±15.32	53.26±18.75	CEJ+C	AC	Breast cancer	6	⑤
21	Min XM 2012³⁴	41	41	82	62/58		50		CEJ+C	Ascend white amine tablets	Malignant tumor	8	②④
22	Chen M et al 2015³⁵	38	37	75	N		18-75		CEJ+C	Leucogen Tablets	Malignant tumor	4	②③
23	Gu YF et al 2012³⁶	46	48	94	13/33	22/26	57.1	59.4	CEJ+C	Chemotherapy	Stomach cancer	2	②⑤
24	Gu YF et al 2012(2)³⁷	80	79	159	32/48	36/43	58.8	60.4	CEJ+C	Chemotherapy	Malignant tumor	2	②
24	Gu YF et al 2012(2)³⁷	80	79	159	32/48	36/43	58.8	60.4	CEJ+C	Chemotherapy	Malignant tumor	2	②	25	Wei YS et al 2017³⁸	50	50	100	35/15	33/17	58	59	CEJ+C	XELOX	Late-stage rectal cancer	4	①⑤
26	Huang ZH et al 2016³⁹	24	25	49	5月19日	11月14日	55.39±9.89	58.54±10.74	CEJ+C	Chemotherapy	Malignant tumor	3	②③④	25	Wei YS et al 2017³⁸	50	50	100	35/15	33/17	58	59	CEJ+C	XELOX	Late-stage rectal cancer	4	①⑤
27	Li MC et al 2019⁴⁰	40	40	80	50/30		55		CEJ+C	EP	Small cell lung cancer	9	①⑤
28	Long D et al 2014⁴¹	31	29	60	11月20日	11月18日	51	48	CEJ+C	Chemotherapy	Malignant tumor	7月8日	①

Outcomes	Evaluation of evidence quality						Event occurrence rate (%)			RR [95% CI]	Level of evidence
Outcomes	Quantity	Limitations^a	Inconsistency^b	Indirectness^c	Imprecision^d	Publication bias^e		Experiment	Control	RR [95% CI]	Level of evidence
Efficacy of leukocyte elevation	8	Severe (－1)	Not severe	Not severe	Possible (－0.5)	Possible (－0.5)	257/307 (83.7)		209/295 (70.8)	RR [1.17 (1.08, 1.27)]	Level C
KPS levels	7	Severe (－1)	Not severe	Not severe	Possible (－0.5)	Possible (－0.5)	192/218 (88.1)		136/215 (63.3)	RR [1.39 (1.25, 1.55)]	Level C
Myelosuppressive toxic reaction (degree of leukopenia)	11	Severe (－1)	Not severe	Not severe	Possible (－0.5)	Possible (－0.5)	161/353 (45.6)		251/339 (74.0)	RR [0.61 (0.54, 0.69)]	Level C

Outcomes	Evaluation of evidence quality						Event occurrence rate (%)			RR [95% CI]	Level of evidence
Outcomes	Quantity	Limitations^a	Inconsistency^b	Indirectness^c	Imprecision^d	Publication bias^e		Experiment	Control	RR [95% CI]	Level of evidence
Efficacy of leukocyte elevation	8	Severe (－1)	Not severe	Not severe	Possible (－0.5)	Possible (－0.5)	257/307 (83.7)		209/295 (70.8)	RR [1.17 (1.08, 1.27)]	Level C
KPS levels	7	Severe (－1)	Not severe	Not severe	Possible (－0.5)	Possible (－0.5)	192/218 (88.1)		136/215 (63.3)	RR [1.39 (1.25, 1.55)]	Level C
Myelosuppressive toxic reaction (degree of leukopenia)	11	Severe (－1)	Not severe	Not severe	Possible (－0.5)	Possible (－0.5)	161/353 (45.6)		251/339 (74.0)	RR [0.61 (0.54, 0.69)]	Level C

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