Effect of Hangeshashin-To (Japanese Herbal Medicine Tj-14) on Tolerability of Irinotecan: Propensity Score and Instrumental Variable Analyses
Abstract
:1. Introduction
2. Materials and Methods
2.1. Data Source
2.2. Patient Selection
2.3. Variables
2.4. Primary Outcomes
2.5. Statistical Analyses
3. Results
3.1. Patient Characteristics
3.2. Tolerability of CPT-11
3.3. Mortality during First Admission for Administration of CPT-11
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Conflicts of Interest
References
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Characteristic (Categorical) | All Patients | Patients after IPTW Estimation | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Control | TJ-14 | Control | TJ-14 | |||||||
(N = 83,198) | (N = 7239) | (N = 82,019) | (N = 7092) | |||||||
N | % | N | % | s.d. | N | % | N | % | s.d. | |
Sex (male) | 49,417 | 59.4 | 4347 | 60.1 | 0.012 | 48,732 | 59.4 | 4195 | 59.2 | 0.006 |
Cancer type a | ||||||||||
Colon cancer | 36,595 | 44.0 | 1937 | 26.8 | −0.37 | 34,958 | 42.6 | 3004 | 42.4 | −0.006 |
Lung cancer | 14,271 | 17.2 | 2438 | 33.7 | 0.39 | 15,165 | 18.5 | 1351 | 19.1 | 0.013 |
Gastric cancer | 11,078 | 13.3 | 571 | 7.9 | −0.18 | 10,560 | 12.9 | 914 | 12.9 | 0.000 |
Ovarian cancer | 4438 | 5.3 | 589 | 8.1 | 0.11 | 4586 | 5.6 | 408 | 5.8 | 0.006 |
Pancreatic cancer | 4421 | 5.3 | 317 | 4.4 | −0.044 | 4310 | 5.3 | 359 | 5.1 | −0.009 |
Cervical cancer | 4039 | 4.9 | 452 | 6.2 | 0.058 | 4074 | 5.0 | 356 | 5.0 | 0.002 |
Non-Hodgkin lymphoma | 1042 | 1.3 | 170 | 2.4 | 0.083 | 1093 | 1.3 | 100 | 1.4 | 0.006 |
Breast cancer | 311 | 0.4 | 28 | 0.4 | 0.005 | 300 | 0.4 | 23 | 0.3 | −0.007 |
Skin cancer | 88 | 0.1 | 26 | 0.4 | 0.051 | 105 | 0.1 | 9 | 0.1 | −0.000 |
Other cancer | 7098 | 8.5 | 736 | 10.2 | 0.057 | 7057 | 8.6 | 581 | 8.2 | −0.014 |
Activities of daily life (Barthel index) | ||||||||||
Independent (100) | 72,572 | 87.2 | 6293 | 86.9 | −0.007 | 71,717 | 87.4 | 6184 | 87.2 | −0.008 |
Dependent (≤95) | 7638 | 9.2 | 675 | 9.3 | 0.003 | 7463 | 9.1 | 676 | 9.5 | 0.015 |
Missing | 2988 | 3.6 | 271 | 3.7 | 0.009 | 2839 | 3.5 | 232 | 3.3 | −0.010 |
Characteristic (numerical) | Mean | S.D. | Mean | S.D. | s.d. | Mean | Mean | s.d. | ||
Age (years) | 64.5 | 10.9 | 64.0 | 11.3 | −0.004 | 64.4 | 64.6 | 0.015 | ||
Body mass index (kg/m2) | 21.9 | 3.7 | 22.1 | 3.8 | 0.063 | 21.9 | 21.9 | 0.001 |
All Patients | Patients after IPTW Estimation | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Control | TJ-14 | Control | TJ-14 | |||||||
(N = 83,198) | (N = 7239) | (N = 82,019) | (N = 7092) | |||||||
N | % | N | % | s.d. | N | % | N | % | s.d. | |
Chronic obstructive pulmonary disease | 2611 | 3.1 | 387 | 5.4 | 0.11 | 2725 | 3.3 | 236 | 3.3 | 0.001 |
Interstitial pneumonia | 477 | 0.6 | 66 | 0.9 | 0.041 | 492 | 0.6 | 43 | 0.6 | 0.000 |
Congestive heart failure | 1996 | 2.4 | 188 | 2.6 | 0.013 | 1347 | 2.4 | 117 | 2.4 | −0.003 |
Ischemic heart disease | 2571 | 3.1 | 278 | 3.8 | 0.040 | 2587 | 3.2 | 238 | 3.4 | 0.011 |
Tachycardia | 1937 | 2.3 | 209 | 2.9 | 0.036 | 1947 | 2.4 | 172 | 2.4 | 0.003 |
Chronic liver disease | 1554 | 1.9 | 134 | 1.9 | −0.001 | 1525 | 1.9 | 142 | 2.0 | 0.010 |
Chronic renal failure | 1224 | 1.5 | 123 | 1.7 | 0.020 | 1225 | 1.5 | 98 | 1.4 | −0.009 |
Autoimmune disease | 585 | 0.7 | 61 | 0.8 | 0.017 | 586 | 0.7 | 52 | 0.7 | 0.002 |
CPT-11 Administration | Generalized Linear Model | Instrumental Variable Analysis | ||||
---|---|---|---|---|---|---|
IRR | 95% CI | p | IRR | 95% CI | p | |
frequency | 1.34 | 1.31–1.38 | <0.001 | 1.11 | 1.05–1.17 | <0.001 |
amount | 1.16 | 1.14–1.19 | <0.001 | 1.12 | 1.11–1.12 | <0.001 |
All Patients | Patients after IPTW Estimation | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Control | TJ-14 | Control | TJ-14 | ||||||||
(N = 83,198) | (N = 7239) | (N = 82,019) | (N = 7092) | ||||||||
N | % | N | % | p | N | % | N | % | p | ||
In-hospital death | 3972 | 4.8 | 336 | 4.6 | 0.26 | 3936 | 4.8 | 280 | 4.0 | 0.001 | |
Generalized linear model | Instrumental variable analysis | ||||||||||
Odds ratio | 95% CI | p | Odds ratio | 95% CI | p | ||||||
In-hospital mortality of TJ-14 compared with the control | 0.81 | 0.71–0.93 | 0.002 | 0.42 | 0.22–0.80 | 0.009 |
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Urushiyama, H.; Jo, T.; Yasunaga, H.; Michihata, N.; Yamana, H.; Matsui, H.; Hasegawa, W.; Hiraishi, Y.; Mitani, A.; Fushimi, K.; et al. Effect of Hangeshashin-To (Japanese Herbal Medicine Tj-14) on Tolerability of Irinotecan: Propensity Score and Instrumental Variable Analyses. J. Clin. Med. 2018, 7, 246. https://doi.org/10.3390/jcm7090246
Urushiyama H, Jo T, Yasunaga H, Michihata N, Yamana H, Matsui H, Hasegawa W, Hiraishi Y, Mitani A, Fushimi K, et al. Effect of Hangeshashin-To (Japanese Herbal Medicine Tj-14) on Tolerability of Irinotecan: Propensity Score and Instrumental Variable Analyses. Journal of Clinical Medicine. 2018; 7(9):246. https://doi.org/10.3390/jcm7090246
Chicago/Turabian StyleUrushiyama, Hirokazu, Taisuke Jo, Hideo Yasunaga, Nobuaki Michihata, Hayato Yamana, Hiroki Matsui, Wakae Hasegawa, Yoshihisa Hiraishi, Akihisa Mitani, Kiyohide Fushimi, and et al. 2018. "Effect of Hangeshashin-To (Japanese Herbal Medicine Tj-14) on Tolerability of Irinotecan: Propensity Score and Instrumental Variable Analyses" Journal of Clinical Medicine 7, no. 9: 246. https://doi.org/10.3390/jcm7090246