Examination of the Dose-Effect Relationship of Radiation-Induced Hypopituitarism: Results of a Case-Control Study

Vakilian, Siavosh; Thebaut, J; Ruo, R.; Marcovitz, Sorana; Panet-Raymond, Valérie; Shenouda, George; Sultanem, Khalil; Souhami, Luís

doi:10.1016/j.adro.2021.100693

Cited by 2 publications

(2 citation statements)

References 15 publications

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“…For most drugs, within a certain dose range, the dose of drugs is directly proportional to the effect ( Qian et al, 2021 ; Zhang et al, 2021 ). However, due to the influence of multiple factors (including constitution, age, and gender) in the population, there are individual differences in the patient’s response to drugs, which makes the existing dose-response relationship research deviate in clinical practice ( Collet et al, 2021 ; Vakilian et al, 2021 ). It is necessary to establish a new study model of the dose-effect relationship for TCM.…”

Section: Introductionmentioning

confidence: 99%

Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials

Zhou

Zheng

et al. 2021

Front. Pharmacol.

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Traditional Chinese medicine (TCM) prescriptions lack standardization due to the complex composition of the prescribed herbs, the unclear mechanism of the formulas, and a lack of scientific data to support the dose-response relationship. Here, we proposed a new clinical strategy of dosage modification for TCM prescriptions to evaluate the clinical efficacy and guide the clinical medication. This study used two TCM prescriptions for the treatment of newly diagnosed type 2 diabetes mellitus (T2DM) to explore the key indications and the most appropriate critical values of dosage modification by analyzing two randomized controlled trials (RCTs). In this study, the indications refer to a change in the indicators from baseline at a certain time point (week 4, week 8, week 12), which could predict the change in outcome indicators, and the critical values refer to the change ranges closely related to the decrease in HbA1c at week 12. In Study 1, the correlation analysis between the change range of indicators at three time points (weeks 4, 8, and 12) from baseline and the decrease in HbA1c at week 12 from baseline (HbA1c 012) was carried out to screen the related indications. Next, we evaluate the related indications and the respective critical values to determine the key indicators, indications, and the most appropriate critical value. We conducted a correlation between the change range of key indicators (obtained from the result of Study 1) at three time points from baseline and HbA1c 012 to screen the key indications in the drug group, high-dose group, and low-dose group in Study 2. Key indications with critical values were determined to investigate the most appropriate critical value in the three groups separately. In Study 1, the key indicator was FBG, the key indication was FBG 04, and the most appropriate critical value was 0.5 mmol/L. In Study 2, the key indication was FBG 04 and the most appropriate critical value was 0.6 mmol/L in the drug group. In the high-dose group, the key indication was FBG 04, and the most appropriate critical value was 0.3 mmol/L. In the low-dose group, the key indication was FBG08, and the most appropriate critical value was 0.1 mmol/L. In addition, we summarized a verification strategy for dosage modification.

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Section: Introductionmentioning

confidence: 99%

Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials

Zhou

Zheng

et al. 2021

Front. Pharmacol.

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“…There is a well-characterized dose-dependent sequence of pituitary derangements, with the somatotrophs more likely to be affected first at even low radiation doses; gonadal, adrenal, and thyroid axes are more likely to become dysfunctional with higher radiation doses and with increased time out from radiation. 4,10 A more recent publication 11 found a dose threshold for endocrine dysfunction at 30 Gy in their skull base tumor case-control study, finding that thyroid-stimulating hormone (TSH) and adrenocorticotropic hormone deficiencies are rare in those receiving less than 50 Gy.…”

Section: Introductionmentioning

confidence: 99%

Assessing Quality of Life among Radiation-Induced Hypopituitary Patients

Ryder

Bellile

VanKoevering

et al. 2022

J Neurol Surg B Skull Base

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Introduction: Radiation-induced hypopituitarism (RIH) has long been recognized as one of the deleterious side effects of skull base radiation. This study aims to assess the quality of life (QoL) among patients with RIH compared to radiated patients who did not develop hypopituitarism using the validated Anterior Skull Base Questionnaire (ASBQ). Methods: This was a single institution retrospective cohort study. Included patients had a history of anterior skull base tumor, underwent at least one round of radiation to the skull base, and had filled out at least one ASBQ survey after their radiation treatment. Three statistical models were used to determine the effect of hypopituitarism and treatment on QoL scores. Results: 145 patients met inclusion criteria, and 330 ASBQ surveys were analyzed. 35 percent (51/145) had evidence of RIH at some point after their radiation treatment. Those with hypopituitarism had significantly lower overall ASBQ scores across all 3 models even after adjusting for potential confounders and intraperson correlation (average decrease of 0.24-0.45 on a 5-point Likert scale; p-values ranging from 0.0004 to 0.018). The increase in QoL with hormonal replacement was modulated by time out from radiation, with long-term survivors (5+ years out from radiation) gaining the most benefit from treatment (increase of 0.89 on a 5-point Likert scale, p 0.0412), especially in the vitality domain. Conclusion: This data demonstrate that hypopituitarism is an independent predictor of lower QOL. Early detection and appropriate treatment are essential to avoid the negative impact of hypopituitarism on QoL.

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Examination of the Dose-Effect Relationship of Radiation-Induced Hypopituitarism: Results of a Case-Control Study

Cited by 2 publications

References 15 publications

Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials

Dosage Modification of Traditional Chinese Medicine Prescriptions: An Analysis of Two Randomized Controlled Trials

Assessing Quality of Life among Radiation-Induced Hypopituitary Patients

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