ABSTRACT
Objective:To evaluate the efficacy by using domestic recombinant human thyroid-stimulating hormone (rhTSH) in patients with differentiated thyroid cancer (DTC) before or after 131I therapy. Methods:From May 2019 to November 2020, a total of 24 patients with DTC (5 males, 19 females, median age 41 years) in Peking Union Medical College Hospital and Affiliated Tumor Hospital of Zhengzhou University were enrolled into the open-label, dose escalation phase Ⅰ study. All patients were divided into 4 domestic rhTSH dose groups: 0.9 mg×1 d (group A), 0.9 mg×2 d (group B), 1.8 mg×1 d (group C), 1.8 mg×2 d (group D) in succession, with 6 patients in each group. Each patient underwent rhTSH phase and thyroid hormone withdrawal (THW) phase. The end point included safety, tolerability, the quality of life (hypothyroidism symptom and sign score (Billewicz score), profile of mood states (POMS)), effectiveness (thyroid-stimulating hormone (TSH) and thyroglobulin (Tg) levels, diagnostic whole-body scan (Dx-WBS)) and pharmacokinetic characteristics (peak time, peak concentration) of rhTSH. Paired t test and Wilcoxon signed rank test were used for statistical analysis. Results:There were no dose-limiting toxicities, serious adverse events, or no grade ≥3 adverse events reported. The quality of life in rhTSH phase was significantly better than those in THW phase, including the lower Billewicz score (-53.00(-53.00, -53.00) vs -39.50(-47.00, -23.00); S=119.50, P<0.001) and the lower POMS score (91.92±12.06 vs 99.67±19.13; t=0.95, P=0.025). Serum TSH level was increased from 0.04(0.02, 0.11) mU/L (baseline) to 150.00(105.20, 173.31) mU/L 24 h after the last rhTSH administration, which was increased along with the elevation of rhTSH doses. In the THW phase, patients′ TSH levels were≥30 mU/L after 23 d (median) of THW, with the median of 73.51(57.22, 106.22) mU/L. Median Tg level of baseline was 0.10(0.10, 0.41) μg/L, which reached a peak of 0.85(0.12, 3.01) μg/L at 48 h after rhTSH administration. The peak Tg level in the THW phase was 0.88(0.15, 8.04) μg/L. The Dx-WBS consistency rate between rhTSH and THW phase was 95.8%(23/24). Conclusion:rhTSH is a safe and effective method to stimulate the serum Tg level and radioiodine uptake in patients undergoing post-operation or post- 131I assessment for DTC, as well as maintain a higher quality of life in comparison to THW phase.
ABSTRACT
OBJECTIVE： To compare the cost-effectiveness of long-effect and short-effect granulocyte stimulating factor in prevention and treatment of bone marrow suppression induced by chemotherapy for lung malignancies， and to provide reference for rational drug use in the clinic. METHODS： A retrospective analysis was conducted for 132 cases who used granulocyte stimulating factor to prevent and treat bone marrow suppression induced by chemotherapy for lung malignancies in the Affiliated Tumor Hospital of Zhengzhou University during Jan. 2017 to Jun. 2018. Among them， 60 cases were treated with Recombinant human granulocyte stimulating factor injection （short-effect， group A）， and 72 cases were treated with Polyethylene glycol recombinant human granulocyte stimulating factor injection （long-effect， group B）. Clinical efficacies， the occurrence of bone marrow suppression and ADR were compared between 2 groups. Cost was calculated， and cost-effectiveness analysis was conducted. Sensitivity analysis was conducted by down-regulating 20％ drug price. RESULTS： The total response rates of group A and B were 71.7％ and 75.0％， without statistical significance （P＞0.05）. There was no statistical significance in the incidence and duration of bone marrow suppression or the incidence of ADR （P＞0.05）. Average treatment costs of the two groups were （335.91±180.34） and （1 982.75±603.15） yuan； the cost of group A was significantly lower than that of group B （P＜0.05）. The cost-effectiveness ratio of them were 4.69 and 26.44， while group A as a reference， incremental cost-effectiveness ratio of group B was 494.55. The sensitivity analysis results were in agreement with the cost-effectiveness analysis. CONCLUSIONS： The effectiveness of Recombinant human granulocyte stimulating factor injection is similar to that of Polyethylene glycol recombinant human granulocyte stimulating factor injection for the prevention and treatment of bone marrow suppression induced by chemotherapy for lung malignancies. But the cost-effectiveness ratio of the former is lower than that of the latter.