Wenshen Jianpi recipe (温肾健脾方) induced immune reconstruction and redistribution of natural killer cell subsets in immunological non-responders of human immunodeficiency virus/acquired immune deficiency syndrome: a randomized controlled trial

doi:10.19852/j.cnki.jtcm.20220519.005

Journal of Traditional Chinese Medicine ›› 2022, Vol. 42 ›› Issue (5): 795-802.DOI: 10.19852/j.cnki.jtcm.20220519.005

• Research Articles • Previous Articles Next Articles

Wenshen Jianpi recipe (温肾健脾方) induced immune reconstruction and redistribution of natural killer cell subsets in immunological non-responders of human immunodeficiency virus/acquired immune deficiency syndrome: a randomized controlled trial

TAO Zhuang¹, WANG Jian², CHEN Xin³, LI Yonghong⁴, YAN Yuguang⁴, ZHANG Ao⁵, ZOU Wen²(), LIU Ying²()

1 Research Center of AIDS Treatment with Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China; Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
2 Research Center of AIDS Treatment with Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
3 Department of Integrated Traditional Chinese and Wetern Medicine, Kunming Hospital of Traditional Chinese Medicine, Kunming 650000, China
4 Department of Infection, No.6 People's Hospital of Shenyang City, Shenyang 110006, China
5 University of Chinese Academy of SoCIal SCIences, Beijing, 100102, China

Received:2021-05-11 Accepted:2021-08-20 Online:2022-10-15 Published:2022-05-19
Contact: ZOU Wen,LIU Ying
About author:LIU Ying, Research Center of AIDS Treatment with Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. liuying0516@163.com Telephone: +86-13552252730; +86-13021985109
ZOU Wen, Research Center of AIDS Treatment with Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. veven@yeah.net;
Supported by:
National Science and Technology Major Project of China During the 13th Five-year Plan Period: New Adjuvant Strategies of Traditional Chinese Medicine on Immune Reconstruction for Long-term ART-treated People Living with HIV(2017ZX10205501);Effects of Traditional Chinese Medicine on Intestinal Bacterial Community Structure of AIDS Patients(2017ZX10205501-001-010);National Natural Science Foundation of China: Immune Mechanism of Immunological Non-responders of HIV/AIDS Treated with Traditional Chinese Medicine from Immune Activation and Toll like Receptor Signal Pathway(81503571)

Abstract

Abstract:

OBJECTIVE: To evaluate the effects of the Wenshen Jianpi recipe (温肾健脾方, WJR) on immune reconstruction and natural killer (NK) cells in immunological non-responders (INRs) of people living with human immunodeficiency virus (HIV) (PLWH) and propose new therapeutic strategies for HIV.

METHODS: Based on Traditional Chinese Medicine treatment principle “invigorating Qi and warming Yang in the spleen and kidneys”, WJR combined with antire-troviral therapy (ART) therapy was performed in a randomized, double-blind, placebo-controlled study of 60 patients with non-responders. The randomized process was executed by the Clinical Evaluation Center of China Academy of Chinese Medical Sciences. Sixty patients who met the inclusion criteria obtained random numbers (that is the drug number) was randomly divided into a treatment group and a placebo control group according to a 1∶1 ratio. CD4+T cell counts and natural killer (NK) cells counts were evaluated at baseline and 12-week, 24-week follow-ups.

RESULTS: Four participants received random numbers and did not enter the group due to the patient's own reasons. A total of 56 patients were enrolled, including 28 in the treatment group and 28 in the control group. CD4+T cell counts in the treatment group were significantly increased at week 24 (P = 0.01 < 0.05), which were significantly higher than those in the control group (P = 0.01 < 0.05). Although no significant differences were observed between two groups, the CD56briCD16- NK cell counts in the treatment group were significantly increased after duration. and CD56dimCD16+ NK cell counts in the treatment group were significantly higher than those in the control group after 24 weeks of treatment (P = 0.025 < 0.05). As compared with the control group, the treatment group had significantly lower CD56negCD16+ NK cell counts after 24 weeks of treatment (P = 0.023 < 0.05).

CONCLUSIONS: WJR promotes the immune reconstruction of INRs and redistribution of NK cell subsets, notably decreasing CD56negCD16+ NK cell counts in INRs. However, the redistribution of NK cell subsets is not beneficial for immune reconstruction in INRs. Further large-scale RCTs are required to evaluate the effect of WJR on immune recovery in INRs and decipher the underlying mechanism.

Key words: HIV, acquired immunodeficiency syndrome, killer cells, natural, immunological non-responders, antiretroviral therapy, Wenshen Jianpi recipe, immune reconstruction, randomized controlled trial

TAO Zhuang, WANG Jian, CHEN Xin, LI Yonghong, YAN Yuguang, ZHANG Ao, ZOU Wen, LIU Ying. Wenshen Jianpi recipe (温肾健脾方) induced immune reconstruction and redistribution of natural killer cell subsets in immunological non-responders of human immunodeficiency virus/acquired immune deficiency syndrome: a randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2022, 42(5): 795-802.

Figures/Tables 6

References 32.

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Baseline information	Treatment group (n = 28)	Control group (n = 28)	Test	Statistic value	P value
Age			t	1.416	0.163
N (missing)	28 (0)	27 (1)
Mean ± SD	47.0±10.8	42.8±11.2
Sex			χ²	0.125	0.724
N (missing)	28 (0)	27 (1)
Male [n (%)]	24 (85.70 )	24 (88.90)
Female [n (%)]	4 (14.30 )	3 (11.11 )
Nationality			Fisher	-	0.236
N (missing)	28 (0)	27 (1)
Han [n (%)]	28 (100.00)	25 (92.59)
Minority [n (%)]	0 (0.00 )	2 (7.41 )
Allergy history			χ²	<0.001	1.000
N (missing)	28 (0)	28 (0)
Never [n (%)]	27 (96.43 )	27 (96.43)
Before [n (%)]	1 ( 3.57 )	1 (3.57 )
Marriage			Fisher	-	0.139
N (missing)	28 (0)	27 (1)
Never married [n (%)]	6 (21.43)	12 (42.90)
Married/cohabitation [n (%)]	21 (75.00)	14 (50.00)
Divorced/separated [n (%)]	1 (3.57 )	1 (3.57)
Smoking			Fisher	-	0.420
N (missing)	28 (0)	23 (5)
Always [n (%)]	5 (17.86)	1 (4.35)
Often [n (%)]	1 (3.57)	1 (4.35)
Seldom [n (%)]	22 (78.57)	21 (91.30)
Drinking			Fisher	-	1.000
N (missing)	28 (0)	22 (6)
Always [n (%)]	0 (0.00)	0 (0.00)
Often [n (%)]	2 (7.14)	1 (4.55)
Seldom [n (%)]	26 (92.86 )	21(95.45)
BMI			t	0.126	0.900
N (missing)	28 (0)	28 (0)
Mean ± SD	21.8 ± 2.3	21.7 ± 3.0
Transmission route			Fisher	-	0.470
N (missing)	28 (0)	27 (1)
Drug injection [n (%)]	3 (10.71 )	0 (0.00)
Homosexual sexual tranmission [n (%)]	21 (75.00 )	22(78.57)
Heterosexual sexual transmission [n (%)]	2 (7.14)	2 (7.14)
Other [n (%)]	2 (7.14)	3 (10.71)
Duration of ART			t	1.574	0.121
N (missing)	28 (0)	28 (0)
Mean ± SD	7.2±1.9	8.2±2.8
Baseline CD4+T cell counts			t	0.648	0.600
N (missing)	28 (0)	28 (0)
Mean ± SD	213.6 ± 67.8	224.5 ± 57.7

Baseline information	Treatment group (n = 28)	Control group (n = 28)	Test	Statistic value	P value
Age			t	1.416	0.163
N (missing)	28 (0)	27 (1)
Mean ± SD	47.0±10.8	42.8±11.2
Sex			χ²	0.125	0.724
N (missing)	28 (0)	27 (1)
Male [n (%)]	24 (85.70 )	24 (88.90)
Female [n (%)]	4 (14.30 )	3 (11.11 )
Nationality			Fisher	-	0.236
N (missing)	28 (0)	27 (1)
Han [n (%)]	28 (100.00)	25 (92.59)
Minority [n (%)]	0 (0.00 )	2 (7.41 )
Allergy history			χ²	<0.001	1.000
N (missing)	28 (0)	28 (0)
Never [n (%)]	27 (96.43 )	27 (96.43)
Before [n (%)]	1 ( 3.57 )	1 (3.57 )
Marriage			Fisher	-	0.139
N (missing)	28 (0)	27 (1)
Never married [n (%)]	6 (21.43)	12 (42.90)
Married/cohabitation [n (%)]	21 (75.00)	14 (50.00)
Divorced/separated [n (%)]	1 (3.57 )	1 (3.57)
Smoking			Fisher	-	0.420
N (missing)	28 (0)	23 (5)
Always [n (%)]	5 (17.86)	1 (4.35)
Often [n (%)]	1 (3.57)	1 (4.35)
Seldom [n (%)]	22 (78.57)	21 (91.30)
Drinking			Fisher	-	1.000
N (missing)	28 (0)	22 (6)
Always [n (%)]	0 (0.00)	0 (0.00)
Often [n (%)]	2 (7.14)	1 (4.55)
Seldom [n (%)]	26 (92.86 )	21(95.45)
BMI			t	0.126	0.900
N (missing)	28 (0)	28 (0)
Mean ± SD	21.8 ± 2.3	21.7 ± 3.0
Transmission route			Fisher	-	0.470
N (missing)	28 (0)	27 (1)
Drug injection [n (%)]	3 (10.71 )	0 (0.00)
Homosexual sexual tranmission [n (%)]	21 (75.00 )	22(78.57)
Heterosexual sexual transmission [n (%)]	2 (7.14)	2 (7.14)
Other [n (%)]	2 (7.14)	3 (10.71)
Duration of ART			t	1.574	0.121
N (missing)	28 (0)	28 (0)
Mean ± SD	7.2±1.9	8.2±2.8
Baseline CD4+T cell counts			t	0.648	0.600
N (missing)	28 (0)	28 (0)
Mean ± SD	213.6 ± 67.8	224.5 ± 57.7

Index	Treatment group (n = 28)	Control group (n = 28)	t value	P value
Baseline			-1.13	0.26
N (missing)	28 (0)	28 (0)
Mean ± SD	207±66	228±60
95% CI	177.97, 236.85	203.49, 253.06
After 12 weeks treatment			0.51	0.61
N (missing)	22 (6)	27 (1)
Mean ± SD	238±77	228±68
95% CI	205.96, 270.87	201.32, 254.91
After 24 weeks treatment			2.65	0.01^b
N (missing)	24 (4)	23 (5)
Mean ± SD	275±79^a	215±72
95% CI	240.76, 309.23	182.82, 247.08

Index	Treatment group (n = 28)	Control group (n = 28)	t value	P value
Baseline			-1.13	0.26
N (missing)	28 (0)	28 (0)
Mean ± SD	207±66	228±60
95% CI	177.97, 236.85	203.49, 253.06
After 12 weeks treatment			0.51	0.61
N (missing)	22 (6)	27 (1)
Mean ± SD	238±77	228±68
95% CI	205.96, 270.87	201.32, 254.91
After 24 weeks treatment			2.65	0.01^b
N (missing)	24 (4)	23 (5)
Mean ± SD	275±79^a	215±72
95% CI	240.76, 309.23	182.82, 247.08

Index	Treatment group (n = 28)	Control group (n = 28)	Z value	P value
CD56briCD16-
Baseline			-1.225	0.221
N (missing)	28 (0)	28 (0)
IQR	3.50 (2.00, 6.00)	4.00 (2.25, 8.00)
95% CI	2.51, 7.49	4.11, 7.31
After 12 weeks treatment			-1.514	0.130
N (missing)	26 (2)	27 (1)
IQR	6.50 (2.00, 11.50)	5.00 (2.00, 6.00)
95% CI	5.34, 10.81	3.44, 7.19
After 24 weeks treatment			-0.567	0.571
N (missing)	24 (4)	23 (5)
IQR	6.78 (3.25, 8.50)^*	5.50 (4.00, 8.00)
95% CI	5.21, 8.35	4.97, 8.19
CD56dimCD16+
Baseline			-0.387	0.699
N (missing)	28 (0)	27 (1)
IQR	197.00 (117.00, 359.00)	176.00 (119.50, 271.50)
95% CI	177.24, 309.13	160.48, 298.59
After 12 weeks treatment			-1.090	0.276
N (missing)	23 (5)	27 (1)
IQR	271.00 (151.25, 457.50)	247.00 (147.75, 275.50)
95% CI	227.88, 404.91	181.83, 311.64
After 24 weeks treatment			-2.246	0.025^b
N (missing)	24 (4)	23 (5)
IQR	342.00 (157.75, 412.75)	193.50 (135.75, 267.75)
95% CI	252.31, 432.47	164.47, 272.39
CD56negCD16+
Baseline
N (missing)	28 (0)	28 (0)	-1.787	0.074
IQR	250.00 (212.00, 363.75)	234.00 (186.00, 286.25)
95% CI	253.27, 369.66	203.77, 277.09
After 12 weeks treatment
N (missing)	26 (2)	27 (1)	-1.475	0.140
IQR	226.50 (180.25, 337.25)	203.50 (148.25,265.00)
95% CI	211.81, 287.84	179.32, 252.03
After 24 weeks treatment
N (missing)	24 (4)	23 (5)	-2.278	0.023^b
IQR	172.50 (133.00, 265.00)^a	295.50 (205.50, 334.75)
95% CI	174.11, 245.39	233.91, 323.23

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Wenshen Jianpi recipe (温肾健脾方) induced immune reconstruction and redistribution of natural killer cell subsets in immunological non-responders of human immunodeficiency virus/acquired immune deficiency syndrome: a randomized controlled trial

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