No Significant Effect of Daikenchuto (TJ-100) on Peritoneal IL-9 and IFN-γ Levels After Pancreaticoduodenectomy

Figures & data

Figure 1 Peritoneal IL-9 and IFN-γ levels in patients between postoperative days 1 and 3. IL-9 (A) and IFN-γ (B) levels decreased between POD 1 and 3 in individual measurements. The peritoneal IL-9 levels accumulated in a narrow range (A), while variety of the levels were observed in IFN-γ. The patient having a high IL-9 level was different from the patient having high IFN-γ level. These two patients did not have sever postoperative complications or significant preoperative clinical features related to inflammation.

Table 1 Peritoneal Levels of IL-9 and IFN-γ Within the TJ-100 and Placebo Groups

	TJ-100 (n=91)			Placebo (n=89)			p-value
	n	Median (pg/mL)	[Min–Max] (pg/mL)	n	Median (pg/mL)	[Min–Max] (pg/mL)
Day 1
IL-9	91	27.6	[10.2–4855.6]	88	25.0	[10.2–738.2]	0.31
IFN-γ	91	274.8	[19–1862.7]	88	267.7	[20.6–608.2]	0.26
Day 3
IL-9	91	17.3	[10.2–2686.1]	89	18.4	[10.2–336.7]	0.74
IFN-γ	91	140.1	[6.5–1823.6]	89	134.6	[6.5–646.1]	0.67

Table 2 Univariate and Multivariate Regression Analyses for IL-9 Levels After Log Transformation

			Univariate		Multivariate
		n	Coefficient	p	Coefficient [95% CI]		p
Log IL-9, POD 1
Use of TJ-100	No	88	Reference			Reference
	Yes	91	0.09	0.43		0.060 [−0.168, 0.289]	0.60
Age (years)	<65	53	Reference			Reference
	65<70	50	0.279	0.06		0.260 [−0.030, 0.551]	0.08
	70<75	35	0.146	0.38		0.149 [−0.176, 0.473]	0.46
	75≤	41	0.108	0.50		0.098 [−0.215, 0.409]	0.54
BMI (kg/m^2)	<20	43	Reference
	20<22	51	−0.157	0.32
	22<25	52	−0.012	0.94
	25≤	33	−0.092	0.60
Surgical time (min)	<360	60	Reference			Reference
	360<420	42	−0.156	0.30		−0.152 [−0.45, 0.147]	0.32
	420<480	35	0.264	0.10		0.248 [−0.072, 0.568]	0.13
	480≤	42	0.128	0.40		0.102 [−0.198, 0.401]	0.51
Log IL-9, POD 3
Use of TJ-100	No	89	Reference			Reference
	Yes	91	0.005	0.97		−0.031 [−0.26, 0.199]	0.79
Age (years)	<65	54	Reference
	65–70	50	0.105	0.50
	70–75	35	−0.050	0.77
	75≤	41	0.098	0.55
BMI (kg/m^2)	<20	43	Reference			Reference
	20<22	51	−0.226	0.16		−0.234 [−0.547, 0.079]	0.14
	22<25	53	−0.322	0.05		−0.317 [−0.628, −0.007]	0.05
	25≤	33	−0.210	0.25		−0.332 [−0.694, 0.03]	0.07
Surgical time* (min)	<360	60	Reference			Reference
	360<420	42	−0.100	0.53		−0.111 [−0.416, 0.195]	0.48
	420<480	36	0.265	0.11		0.304 [−0.023, 0.63]	0.07
	480≤	42	0.187	0.23		0.205 [−0.105, 0.515]	0.19

Notes: *Surgical time for Log IL-9 of POD 3 was a component of the multivariate analysis although univariate analysis showed that the p-value for category 420<480 min was 0.11. We observed a significant effect of surgical time on POD 1 IL-9 levels and POD 1/3 IFN-γ levels, and thus, included surgical time as a variable for the multivariate analysis of POD 3 IL-9 levels.

Abbreviation: BMI, body mass index.

Table 3 Univariate and Multivariate Regression Analyses for IFN-γ Levels After Log Transformation

Log IFN-γ, POD 1
Use of TJ-100	No	88	Reference		Reference
	Yes	91	0.070	0.32	0.05 [−0.09, 0.19]	0.48
Age (years)	<65	53	Reference		Reference
	65<70	50	0.205	0.03	0.194 [0.015, 0.372]	0.03
	70<75	35	0.102	0.32	0.089 [−0.11, 0.288]	0.38
	75≤	41	0.160	0.10	0.185 [−0.007, 0.376]	0.06
Epidural anesthesia	No	53	Reference
	Yes	126	−0.057	0.464
Surgical time (min)	<360	60	Reference		Reference
	360<420	42	0.117	0.21	0.140 [−0.044, 0.323]	0.14
	420<480	35	0.139	0.16	0.140 [−0.056, 0.337]	0.16
	480≤	42	0.274	<0.01	0.274 [0.09, 0.458]	<0.01
Log IFN-γ, POD 3
Use of TJ-100	No	89	Reference		Reference
	Yes	91	0.064	0.53	0.035 [−0.162, 0.232]	0.73
Age (years)	<65	54
	65<70	50	0.046	0.73
	70<75	35	−0.093	0.53
	75≤	41	−0.062	0.66
Epidural anesthesia	No	54	Reference		Reference
	Yes	126	−0.184	0.09	−0.255 [−0.475, −0.034]	0.02
Surgical time (min)	>360	60	Reference		Reference
	360–420	42	0.161	0.23	0.218 [−0.049, 0.484]	0.11
	420–480	36	0.091	0.52	0.132 [−0.148, 0.413]	0.36
	<480	42	0.241	0.08	0.320 [0.048, 0.592]	0.02