Table 6.
Calcitriol n = 40 |
Placebo n = 40 |
Effect size | 95% CI | P value | |
---|---|---|---|---|---|
Mean duration of hospitalization (day) | 16.31 ± 7.17 | 15.25 ± 3.50 | 1.06* | −1.48 to 3.59 | 0.41* |
Mean number of anti-infectives in addition to usual care (n)§ | 2.63 ± 1.72 | 3.03 ± 1.25 | −0.40* | −1.07 to 0.27 | 0.24* |
Mean total dose of filgrastim (mcg)§ | 4920.0 ± 2626.61 | 4867.50 ± 2443.35 | 52.50* | −1076.73 to 1181.73 | 0.93* |
Mean total units of platelet (n)§ | 9.15 ± 10.77 | 10.35 ± 15.54 | −1.20* | −7.15 to 4.75 | 0.69* |
Median total units of packed cell (n)§ | 0.0 (0.0–5.0) | 0.0 (0.0–8.0) | N/A | N/A | 0.70† |
Median duration of TPN (day)¶ | 0.0 (0.0–8.0) | 0.0 (0.0–3.0) | N/A | N/A | 0.58† |
Incidence of OM | 24 (60.0%) | 27 (67.5%) | 0.89‡ | 0.64 to 1.24 | 0.49‡ |
Mean duration of OM (day) | 10.17 ± 5.20 | 7.85 ± 3.54 | 2.32* | −0.19 to 4.83 | 0.07* |
Incidence of OM grade 3–4 | 4 (10.0%) | 7 (17.5%) | 0.57‡ | 0.18 to 1.80 | 0.33‡ |
Mean duration of OM grade 3–4 (day) | 9.25 ± 6.08 | 5.67 ± 1.63 | 3.58* | −5.84 to 13.00 | 0.33* |
OM severity (WHO scale) | |||||
None | 16 (40.0%) | 13 (32.5%) | |||
Grade 1 | 10 (25.0%) | 11 (27.5%) | N/A | N/A | 0.88‡ |
Grade 2 | 10 (25.0%) | 9 (22.5%) | |||
Grade 3 | 2 (5.0%) | 4 (10.0%) | |||
Grade 4 | 2 (5.0%) | 3 (7.5%) | |||
Incidence of fever | 35 (87.5%) | 37 (92.5%) | 0.95‡ | 0.82 to 1.10 | 0.71‡ |
Mean duration of fever (day) | 3.54 ± 3.53 | 2.49 ± 2.23 | 1.06* | −0.32 to 2.44 | 0.13* |
Mean duration of severe neutropenia (day) | 8.78 ± 3.81 | 8.35 ± 3.31 | 0.43* | −1.16 to 2.01 | 0.60* |
*Independent samples t-test with mean difference
†Independent samples Mann-Whitney U test
‡Chi-square tests or Fisher’s exact test (if appropriate) with relative risk
§All the post-HSCT patients received oral fluconazole (100 mg q.12.h), oral acyclovir (200 mg q.8.h), oral nystatin (20 drops q.3.h), and subcutaneous filgrastim (5–10 μg/kg/day based on the neutrophil response) in the hospital. Additionally, according to the hospital protocol, transfusion of platelet for PC <10.0 × 103/μl or higher if clinical bleeding, and packed cell for HC <7.0 g/dl was indicated
¶One patient in the calcitriol group and two patients in the placebo group received TPN in the hospital
Abbreviations: CI confidence interval, HL Hodgkin’s lymphoma, HSCT hematopoietic stem cell transplantation, MM multiple myeloma, N/A not applicable, NHL non-Hodgkin’s lymphoma, OM oral mucositis, TPN total parenteral nutrition