A novel dose-adjustment protocol for interrupted subcutaneous immunotherapy in children with allergic rhinitis

Figures & data

Figure 1. The trial flow chart illustrates the novel dose-adjustment protocol and the conventional one for subcutaneous immunotherapy in allergic rhinitis due to delayed injection. Baseline: baseline before treatment; M0: the maintaining pretreatment baseline of the conventional group; R0: the maintaining pretreatment baseline of the novel dose-adjustment protocol group; M3: the end of 3-year treatment in the conventional group; R3: the end of 3-year treatment in the novel dose-adjustment protocol group.

Table 1. Demographic characteristics comparison between the novel group and the conventional group.

Demographic characteristics	The novel group	The conventional group	Z/t/χ^2	p-value
Age (years)	9.94 ± 2.28	9.76 ± 2.46	0.473	0.492
Gender (n, male/female)	112/82	82/63	0.047	0.829
Duration of delayed treatment (weeks)	13.32 ± 1.97	2.14 ± 1.36	3451.976	<0.001
Baseline before treatment
Nasal congestion	2.14 ± 0.94	2.05 ± 0.87	0.919	0.338
Itchy nose	2.31 ± 0.79	2.25 ± 0.79	0.499	0.480
Sneezing	1.95 ± 1.04	2.00 ± 0.91	0.144	0.704
Runny nose	1.97 ± 1.09	1.86 ± 1.08	0.780	0.378
TNSS	8.39 ± 2.26	8.17 ± 2.01	0.874	0.351
MS	2.75 ± 0.53	2.67 ± 0.54	1.779	0.183
CSMS	4.84 ± 1.04	4.71 ± 0.98	1.435	0.232
Baseline of the maintenance phase	R0	M0
Nasal congestion	1.44 ± 0.59	1.32 ± 0.58	3.434	0.065
Itchy nose	1.32 ± 0.58	1.28 ± 0.53	0.456	0.500
Sneezing	0.81 ± 0.68	0.68 ± 0.55	3.653	0.057
Runny nose	0.69 ± 0.75	0.57 ± 0.63	2.140	0.144
TNSS	4.23 ± 1.61	3.90 ± 1.58	3.397	0.066
MS	0.36 ± 0.78	0.30 ± 0.75	0.383	0.536
CSMS	1.41 ± 0.98	1.28 ± 0.90	1.636	0.202

CSMS: Combined symptom and medication score; MS: Medication score; TNSS: Total nasal symptom score.

Figure 2. Comparison of therapeutic effects between the novel dose-adjustment protocol group and the conventional protocol group in subcutaneous immunotherapy. (A) Nasal congestion score; (B) itchy nose score; (C) sneezing score; (D) runny nose score; (E) TNSS; (F) MS; (G) CSMS. Baseline: baseline before treatment; M0: the maintaining pretreatment baseline of the conventional group; R0: the maintaining pretreatment baseline of the novel dose-adjustment protocol group; M3: the end of 3-year treatment in the conventional group; R3: the end of 3-year treatment in the novel dose-adjustment protocol group.

CSMS: Combined symptom and medication score; MS: Medication score; TNSS: Total nasal symptom score.

Figure 3. Comparison of changes in TNSS, MS and CSMS before and after treatment between the novel dose-adjustment protocol group and the conventional group. (A) Change in TNSS; (B) change in MS; (C) change in CSMS. R3-R0: The change at the end of 3-year treatment compared with the pretreatment baseline of the re-maintenance in the novel dose-adjustment protocol group; M3-M0: the change at the end of 3-year treatment compared with the baseline of maintenance treatment in the conventional group; R3-Baseline: the change from baseline to the end of 3-year treatment in the novel dose-adjustment protocol group; M3-Baseline: the change from baseline to the end of 3-year treatment in the conventional group.

CSMS: Combined symptom and medication score; MS: Medication score; TNSS: Total nasal symptom score.

Table 2. The occurrence of SRs in the maintenance phase of children with allergic rhinitis in the novel dose-adjustment protocol group and the conventional group.

Values	The novel group	The conventional group	χ^2	p-value
Total number of patients (n)	194	145
Total number of injections (n)	5251	3934
Number of patients with SRs (n,%)	30 (15.46%)	21 (14.48%)	0.063	0.803
Number of injections with SRs (n,%)	43 (0.82%)	31 (0.79%)	0.027	0.870

SR: Systemic reaction.