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
TAO Zhuang1, WANG Jian2, CHEN Xin3, LI Yonghong4, YAN Yuguang4, ZHANG Ao5, ZOU Wen2(), LIU Ying2()
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; +86-13021985109Supported by:
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.
Figure 1 Participants flowchart KHTCM: Kunming Hospital of Traditional Chinese Medicine; PHS: No. 6 People's Hospital of Shenyang City; INRs: immunological non-responders; ART: antiretroviral therapy; HIV: human immunodeficiency virus.
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 |
Table 1 Participants' characteristics
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 | 0.01b | ||
N (missing) | 24 (4) | 23 (5) | ||
Mean ± SD | 275±79a | 215±72 | ||
95% CI | 240.76, 309.23 | 182.82, 247.08 |
Table 2 CD4+T cell counts recovery before and after WJR treatment (cells/μL)
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 | 0.01b | ||
N (missing) | 24 (4) | 23 (5) | ||
Mean ± SD | 275±79a | 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 | 0.025b | ||
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 | 0.023b |
IQR | 172.50 (133.00, 265.00)a | 295.50 (205.50, 334.75) | ||
95% CI | 174.11, 245.39 | 233.91, 323.23 |
Table 3 Counts of NK cell subsets before and after WJR treatment (cells/mm3)
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 | 0.025b | ||
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 | 0.023b |
IQR | 172.50 (133.00, 265.00)a | 295.50 (205.50, 334.75) | ||
95% CI | 174.11, 245.39 | 233.91, 323.23 |
Figure 2 Correlation between the levels of NK cell subsets and CD4+T cell counts using Pearson correlation analysis A: correlation between CD56briCD16- NK cell counts and CD4+T cell counts (r2 = 0.006995, P = 0.2826); B: correlation between CD56dimCD16+ NK cell counts and CD4+T cell counts (r2 = 0.003117, P = 0.4736); C: correlation between CD56negCD16+ NK cell counts and CD4+T cell counts (r2 = 0.009078, P = 0.2193). Treatment group (n = 28): WJR (5.5 g/d, po, bid) + ART, control group (n = 28): simulant WJR (5.5 g/d, po, bid) + ART, the total treatment duration was 24 weeks for the two groups. NK: natural killer; WJR: Wenshen Jianpi recipe; ART: antiretroviral therapy.
Figure 3 Correlation between the levels of different NK cell subsets using Pearson correlation analysis A: correlation between CD56dimCD16+ NK cell counts and CD56negCD16+ NK cell counts (r2 = 0.18, P < 0.001); B: correlation between CD56briCD16- NK cell counts and CD56negCD16+ NK cell counts (r2 = 0.04, P = 0.01); C: correlation between CD56briCD16- NK cell counts and CD56dimCD16+ NK cell counts (r2 = 0.13, P < 0.0001). Treatment group (n = 28): WJR (5.5 g/d, po, bid) + ART, control group (n = 28): simulant WJR (5.5 g/d, po, bid) + ART, the total treatment duration was 24 weeks for the two groups. NK: natural killer; WJR: Wenshen Jianpi recipe; ART: antiretroviral therapy.
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