A Prospective, Self-Controlled and Randomized Study about the Optimal Timing of Leucovorin Rescue after High Dose Methotrexate Management

Abstract Background and objectives: Methotrexate (MTX) is a folic acid reductase inhibitor widely used. Peripheral infusion of high dose MTX (HD-MTX) could prevent the central nervous system recurrence of leukemia and NHL. Due to the blood brain barrier, only 1-3% of MTX in the peripheral blood can enter the cerebrospinal fluid. Improving the peripheral MTX drug dosage helps to improve MTX concentration in the cerebrospinal fluid. However, high concentration of MTX has serious side effects to normal organs. Leucovorin (CF) rescue is given to reduce the toxic effect of methotrexate on normal cells. During high dose MTX therapy, monitoring of serum concentration of MTX and timely CF rescue therapy are mandatory so as to maximum the efficacy of MTX and minimize the toxicities. Due to the lack of randomized clinical trials with large sample, the safe dose and most appropriate time of leucovorin rescue treatment are of no consensus. In order to study the effect of different time of leucovorin rescue treatment on the serum concentration of MTX, we carried out this study. Patients and methods: We included patients who had pathological diagnosis of non-Hodgkin's lymphoma and indications to receive HD-MTX as single agent or component in combined regimen consecutively from October 2011 to June 2014 at our hospital. Patients were randomized to receive CF rescue at the sixth hour after MTX infusion in the first course and twelfth hour in the second course or the twelfth hour in the first course and sixth hour in the second course. A dosage of 3.5 g/m2 of MTX was provided. Adequate hydration, alkalization and monitoring of laboratory tests were administered. Intrathecal injection of MTX plus cytarabine and dexamethasone were given after MTX infusion. 100mg of CF was given at the first time, then 30mg of CF were given every 6 hours for a total of 7 times until the plasma concentration of MTX were lower than 1×10-7 mol/L. Blood samples were collected at 2, 12, 18, 24, 28, 72 hours after the beginning of MTX infusion. High performance liquid chromatography was used to test the plasma concentration of MTX. Results: There were 23 male patients and 12 female patients with a mean age of 41 years. Most of patients were diagnosed as diffuse large B cell lymphoma (65.7%). Eleven cases (31.4%) had central nervous system invasion at the time of HD-MTX treatment. Twenty-one patients (51%) had more than one extra-nodal lesion. Sixteen patients were randomly to be rescued at the sixth hour in the first course then the twelfth hour in the second course. Nineteen patients were randomly to be rescued at the twelfth hour in the first course then the sixth hour in the second course. The plasma concentration of MTX of patients rescued at the sixth hour at the time of 2, 12, 18, 24, 48 hours were 5.21±0.36×10-5 mol/L, 8.01±0.635×10-5 mol/L, 4.57±1.67×10-6 mol/L, 1.43±0.83×10-6 mol/L, 0.1±0.1×10-6 mol/L, respectively; The plasma concentration MTX of patients rescued at the twelfth hour at the time of 2, 12, 18, 24, 48 hours were 5.46±0.34×10-5 mol/L, 8.65±0.663×10-5 mol/L, 5.4±0.93×10-6 mol/L, 1.12±0.21×10-6 mol/L, 0.1±0.24×10-6 mol/L, respectively. There was no significant difference of MTX concentration level between patients treated with different CF rescue timing, P >0.05. Most of patients achieved maximal MTX concentration at the twelfth hour, and descended to be lower than the minimal effective concentration at the eighteenth hour. At the forty-eighth hour, majority of patients had MTX concentration being in a safe range. The rate of grade 3 to 4 adverse reactions including neutropenia, anemia, thrombocytopenia and grade 1 to 2 side effects including neutropenia, thrombocytopenia, mucositis, fatigue, and MTX discharge delay were higher when patients were rescued with CF at the twelfth hour, though P >0.05. Conclusion: Most of patients treated with high dose MTX reached the maximum MTX concentration at the twelfth hour after MTX infusion, and descended to be under the minimal effective concentration at the eighteenth hour, then to be in the safe range at the forty eighth hour. No significant difference of MTX concentration was found between patients rescued with CF at the sixth hour or the twelfth hour. However, adverse reactions were lower when patients were treated with CF rescue at the sixth hour. It seems a better choice to give patients CF rescue at the sixth hour after MTX infusion. Disclosures No relevant conflicts of interest to declare.

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Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

Journal of Intensive Care Medicine ◽

10.1177/08850666211038883 ◽

2021 ◽

pp. 088506662110388

Author(s):

Divya Birudaraju ◽

Sajad Hamal ◽

John A. Tayek

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Adrenocorticotropic Hormone ◽

Serum Cortisol ◽

High Dose ◽

Cortisol Response ◽

Acth Stimulation ◽

Double Blind ◽

Significant Difference ◽

To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

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Randomized Trial of Trimethoprim-Sulfamethoxazole versus Pyrimethamine-Sulfadiazine for Therapy of Toxoplasmic Encephalitis in Patients with AIDS

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.42.6.1346 ◽

1998 ◽

Vol 42 (6) ◽

pp. 1346-1349 ◽

Cited By ~ 91

Author(s):

Donato Torre ◽

Salvatore Casari ◽

Filippo Speranza ◽

Alessandra Donisi ◽

Giampietro Gregis ◽

...

Keyword(s):

Bacterial Infections ◽

Adverse Reactions ◽

Common Adverse Event ◽

Toxoplasmic Encephalitis ◽

Efficacy And Safety ◽

Acute Therapy ◽

Valuable Alternative ◽

Significant Difference ◽

To Receive ◽

Present Pilot Study

ABSTRACT The aim of the present pilot study was to compare the efficacy and safety of trimethoprim (TMP) and sulfamethoxazole (SMX) with those of the standard therapy pyrimethamine (P)-sulfadiazine (S) for the treatment of toxoplasmic encephalitis in patients with AIDS. This was a pilot, multicenter, randomized, and prospective study. Patients were randomly assigned to receive TMP (10 mg/kg of body weight/day) and SMX (50 mg/kg/day) or P (50 mg daily) and S (60 mg/kg/day) as acute therapy (for 4 weeks) and then as maintenance therapy for 3 months at half of the original dosage. Seventy-seven patients were enrolled and randomized to the study: 40 patients were treated with TMP-SMX and 37 were treated with P-S. There was no statistically significant difference in clinical efficacy during acute therapy. In contrast, patients randomized to TMP-SMX appeared more likely to achieve a complete radiologic response after acute therapy. Adverse reactions were significantly more frequent in patients treated with P-S, and skin rash was the most common adverse event noted in these patients. In conclusion, the results of the study suggest that TMP-SMX appears to be a valuable alternative to P-S, in particular in patients with opportunistic bacterial infections.

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Evaluation of The Effectiveness and Side Effects of Radiotherapy in Patients With Primary Nervous System Lymphoma. A Single Center Experience

Integrative Journal of Medical Sciences ◽

10.15342/ijms.7.252 ◽

2020 ◽

Vol 7 ◽

Author(s):

Timur Koca ◽

Aylin Fidan Korcum ◽

Yasemin Şengün ◽

Melek Gamze Aksu ◽

Mine Genç

Keyword(s):

Central Nervous System ◽

Overall Survival ◽

Nervous System ◽

Side Effects ◽

Disease Free Survival ◽

Central Nervous System Lymphoma ◽

Field Size ◽

High Dose ◽

Free Survival ◽

Significant Difference

Aim: In this study, we aimed to evaluate the overall and progression-free survival, the radiotherapy process and the early and late adverse effects in patients who underwent radiotherapy (RT) for primary nervous system lymphoma in our clinic.Method: Between January 2010 and September 2019, 16 patients who received radiotherapy due to primary central nervous system lymphoma in our clinic were examined according to their statistically significant differences in terms of survival and side effects.Results: The median disease-free survival of the patients was 6 months, and the median overall survival was 12.5 months. 18.75% of the patients could not receive chemotherapy but only radiotherapy. Radiotherapy doses were range from 2600 to 5000 cGy. When patients were evaluated in terms of radiotherapy dose, field size and chemotherapy, no statistically significant difference in overall survival was detected. Cognitive disorders were observed as the most common late side effects while the most common acute side effects in patients were headaches.Conclusion: In the treatment of primary central nervous system lymphoma, changes in radiotherapy portals and radiotherapy doses can be predicted in patients who received high-dose methotrexate chemotherapy or not. Furthermore, it has been considered that more comprehensive studies are needed to increase the success of treatment and provide standardization in treatment, especially in patients with elderly and comorbid diseases.

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Clopidogrel Pharmacokinetics in Malaysian Population Groups: The Impact of Inter-Ethnic Variability

Pharmaceuticals ◽

10.3390/ph11030074 ◽

2018 ◽

Vol 11 (3) ◽

pp. 74 ◽

Cited By ~ 2

Author(s):

Zaril Zakaria ◽

Alan Fong ◽

Raj Badhan

Keyword(s):

Plasma Concentration ◽

Plasma Concentrations ◽

High Dose ◽

Population Groups ◽

Adjunct Treatment ◽

Malaysian Population ◽

Significant Difference ◽

Target Plasma Concentration ◽

Ethnic Variability ◽

The Impact

Malaysia is a multi-ethnic society whereby the impact of pharmacogenetic differences between ethnic groups may contribute significantly to variability in clinical therapy. One of the leading causes of mortality in Malaysia is cardiovascular disease (CVD), which accounts for up to 26% of all hospital deaths annually. Clopidogrel is used as an adjunct treatment in the secondary prevention of cardiovascular events. CYP2C19 plays an integral part in the metabolism of clopidogrel to the active metabolite clopi-H4. However, CYP2C19 genetic polymorphism, prominent in Malaysians, could influence target clopi-H4 plasma concentrations for clinical efficacy. This study addresses how inter-ethnicity variability within the Malaysian population impacts the attainment of clopi-H4 target plasma concentration under different CYP2C19 polymorphisms through pharmacokinetic (PK) modelling. We illustrated a statistically significant difference (P < 0.001) in the clopi-H4 Cmax between the extensive metabolisers (EM) and poor metabolisers (PM) phenotypes with either Malay or Malaysian Chinese population groups. Furthermore, the number of PM individuals with peak clopi-H4 concentrations below the minimum therapeutic level was partially recovered using a high-dose strategy (600 mg loading dose followed by a 150 mg maintenance dose), which resulted in an approximate 50% increase in subjects attaining the minimum clopi-H4 plasma concentration for a therapeutic effect.

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Transplantation and Adoptive Cellular Therapy of Cancer: The Role of T-Cell Growth Factors

Cell Transplantation ◽

10.1177/096368979300200106 ◽

1993 ◽

Vol 2 (1) ◽

pp. 33-47 ◽

Cited By ~ 1

Author(s):

Michael T. Lotze

Keyword(s):

Growth Factors ◽

T Cell ◽

Cell Growth ◽

Response Rate ◽

High Dose ◽

Specific Lysis ◽

Modern Development ◽

Significant Difference ◽

T Cell Growth ◽

To Receive

The ability to transfer cultured lymphocytes required the availability and the understanding of the use of the T-cell growth factors IL-2, IL-4, IL-7, and IL-12. Application of these cytokines in vitro and in vivo has allowed the modern development of adoptive transfer of tumor reactive lymphocytes to the modern immunotherapy of patients with cancer. In a randomized prospective study of IL-2 administration compared with IL-2 and lymphokine-activated killer (LAK) cells, no increase in response rate was observed. In a total of 90 patients randomized to receive LAK and IL-2 and 91 patients randomized to receive IL-2 alone, there were a total of 24 responses in patients receiving cells and IL-2 and 16 responses in those receiving IL-2 alone (no significant difference). There was some suggestion that complete responses were observed more often in melanoma patients treated with LAK and IL-2. The most interesting aspect of this study is the prolonged duration of responses, lasting for many months or years. Unfortunately, given the large numbers of variables that were examined, it became very difficult to demonstrate a clear-cut association between clinical outcome (response) and any variable that was routinely measured. Significant antitumor responses have been observed greater than expected with IL-2 alone, with the administration of tumor-infiltrating lymphocytes to patients with melanoma. We currently use hollow fiber devices (Cellco, Germantown, MD) to expand cells up through the many doublings required to generate approximately 1-2 × 1011 cells over a period of 6 wk in culture. In a recent review of the results in patients with melanoma treated on such regimens in combination with high-dose IL-2, an approximately 20-50% response rate has been observed. The factors associated with response are still unclear. Although we initially felt that it was associated with specific lysis, subsequent studies from our group suggest that the relevant factor is specific cytokine (INF-γ, GM-CSF, TNF) production upon tumor stimulation. Additional studies will need to be done to clarify these issues.

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Pharmacogenomics and pharmacokinetics of efavirenz 400 or 600 mg in 184 treatment-naive HIV-infected patients in China

Pharmacogenomics ◽

10.2217/pgs-2019-0169 ◽

2020 ◽

Vol 21 (13) ◽

pp. 945-956

Author(s):

Rong Chen ◽

Jun Chen ◽

Jingna Xun ◽

Zhiliang Hu ◽

Qiong Huang ◽

...

Keyword(s):

Central Nervous System ◽

Nervous System ◽

Body Weight ◽

Plasma Levels ◽

Dose Group ◽

Adverse Reactions ◽

Standard Dose ◽

Treatment Naïve ◽

The Central Nervous System ◽

To Receive

Background: The pharmacogenomics and pharmacokinetics/pharmacodynamics of 400 mg efavirenz have rarely been reported. Materials & methods: A total of 184 treatment-naive HIV-infected patients were randomly assigned (1:1) to receive a lower dose (tenofovir disoproxil 200 mg, efavirenz 400 mg and lamivudine) or a standard dose regimen. Relationships between pharmacogenomics and efavirenz pharmacokinetics/pharmacodynamics were explored at 48 weeks. Results: There was no relationship between pharmacogenomics and adverse reactions of the central nervous system and antiretoviral efficacy. CYP2B6 516G>T, 785A>G, 18492C>T and ABCB1 3435C>T T/C were associated with higher efavirenz plasma levels in the standard but not the lower dose group. No relationship was found between pharmacogenomics and antiretoviral efficacy. Patients who were <60 kg had higher efavirenz concentration compared with those with weight ≥60 kg when using 600 mg efavirenz, this was not observed with 400 mg efavirenz. Conclusion: The effect of pharmacogenomics and body weight on the efavirenz concentration was significant in the 600 mg group but not in the 400 mg group.

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What Is The Optimal Dose Of Methotrexate In Primary Central Nervous System Lymphoma Treatment Regimens?

Blood ◽

10.1182/blood.v122.21.3040.3040 ◽

2013 ◽

Vol 122 (21) ◽

pp. 3040-3040

Author(s):

Samir Dalia ◽

Samantha L Price ◽

Peter Forsyth ◽

Celeste M. Bello ◽

Bijal D. Shah ◽

...

Keyword(s):

Central Nervous System ◽

Nervous System ◽

Total Dose ◽

Single Agent ◽

Central Nervous System Lymphoma ◽

Chemotherapeutic Agents ◽

High Dose ◽

Significant Difference ◽

Treatment Data ◽

Dose Reductions

Abstract Introduction Primary central nervous system lymphoma (PCNSL) is a rare disorder with a poor prognosis. The mainstay of treatment is single agent or combination high dose (≥3.5g/m2) methotrexate (HDMTX) based regimens. There is no consensus as to which dose of HDMTX improves outcomes in patients with PCNSL but doses of MTX greater than 3 g/m2 intravenously achieve therapeutic cerebrospinal fluid (CSF) concentrations. Purpose To determine if there is an optimal or total dose of HDMTX in PCNSL therapies that results in improved progression free (PFS) or overall survival (OS). Methods Patients at Moffitt Cancer Center with PCNSL were identified using our institutional database between January 1, 2000 and September 30, 2011. Patients with complete treatment data who were treated with HDMTX were included in this study. HDMTX was defined as MTX at a dose ≥ 3.5g/m2. Patient demographics, clinical, and treatment data were collected and analyzed. Treatment information collected included the starting dose of HDMTX, IV rituximab use, MTX toxicity and clearance, cycles of MTX, and total amount of MTX administered (g/m2). Data were analyzed using descriptive statistics and the Kaplan-Meier (KM) method was used to estimate median PFS and OS using the log rank test. P value of <0.05 was considered significant. All data was analyzed using SPSS statistical software version 21.0. Results A total of 51 patients were identified (Table 1). Median PFS was 13months (0-33) and median OS 43months (29-57). The addition of IV rituximab or other chemotherapy failed to improve PFS or OS. HDMTX dose reductions or the total dose of HDMTX administered did not significantly impact PFS or OS. Similarly, when comparing dosing of HDMTX there was no significant difference in 8g/m2 versus 3.5g/m2 (PFS p=0.56, OS p=0.68), or between patients receiving 8g/m2 versus <8g/m2 (PFS p=0.77, OS p=0.6) (Figure 1). Patients receiving 8g/m2 versus those receiving <8g/m2 of HDMTX had similar baseline characteristics except for more liver function abnormalities in the 8g/m2 group. Conclusions Differences in initial dosing of HDMTX or total dose of HDMTX therapy did not influence outcomes in our patients with PCNSL. Dose reductions in HDMTX, addition of other chemotherapeutic agents, or rituximab were not associated with improved PFS or OS. An intriguing plateau was observed in OS in the 8gm/m2 arm despite similar PFS, suggesting that the receipt of novel therapies in the relapsed setting may contribute to OS. Multicenter collaborative clinical trials are needed to further assess the optimal initial dose of HDMTX to administer in PCNSL. Disclosures: No relevant conflicts of interest to declare.

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The clinical effect of Chitosan nanoparticles against Helicobacter pylori

Materials Express ◽

10.1166/mex.2020.1726 ◽

2020 ◽

Vol 10 (7) ◽

pp. 1116-1121

Author(s):

Jing Wang ◽

Xinhong Wang ◽

Min Li ◽

Suxiang Fan

Keyword(s):

Triple Therapy ◽

Clinical Efficacy ◽

Adverse Reactions ◽

Chitosan Nanoparticles ◽

High Dose ◽

Significant Difference ◽

Oral Liquid ◽

Group A ◽

The Difference ◽

Group B

The objective of this study was to observe the clinical effect of Chitosan nanoparticles therapy on Helicobacter pylori (HP) infection. Three treatment groups (A, B, and control group C) were randomly assigned with 60 cases of HP each, making 180 cases. Group C received standard triple therapy (omeprazole + amoxicillin + clarithromycin), group A got a routine dose of Chitosan nanoparticles plus triple therapy, and group B got a high dose of Chitosan nanoparticles plus triple therapy. The course of treatment in each group was 7 days. The eradication rate, clinical efficacy and adverse reactions were observed. Up to 172 patients finished the experiment, with 59 patients in Group A, 57 in Group B and 56 in Group C. In a total analysis set (FAS), the eradication rates of HP in Group A, Group B and Group C were 80.00%, 80.70%, and 71.67%, respectively. There was no significant difference between the two groups (P > 0.05). In accordance with the PPS, the HP eradication rates of group A, B, and C were 81.36%, 80.70% and 76.79%, respectively, and there was no significant difference between the two groups (P > 0.05). The clinical efficacy of group A, B, and C were 91.67%, 91.23%, and 70.00%, respectively. The differences among the three groups were statistically significant (P < 0.05). In accordance with the PPS, the clinical efficacy of group A, B and C was 93.22%, 91.23%, and 75.00%, respectively. With a P-value of less than 0.05, the results indicated that the difference between the two groups was statistically significant. There were 21 adverse reactions in the experiment, including 3 in group A, 6 in group B, and 12 in group C. The difference was statistically significant (P < 0.05) between group A and B compared with group C, the difference was statistically significant (P < 0.05); the difference between group A and group B was statistically significant (P < 0.05). In conclusion the therapeutic effect of Chitosan nanoparticles and oral liquid, combined with triple therapy on HP infection is satisfactory, with less adverse reactions are. However, the findings suggest that it is not desirable to use a high dose Chitosan nanoparticles and oral liquid.

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Effect of Labor Epidural Analgesia with and without Fentanyl on Infant Breast-feeding

Anesthesiology ◽

10.1097/00000542-200512000-00016 ◽

2005 ◽

Vol 103 (6) ◽

pp. 1211-1217 ◽

Cited By ~ 98

Author(s):

Yaakov Beilin ◽

Carol A. Bodian ◽

Jane Weiser ◽

Sabera Hossain ◽

Ittamar Arnold ◽

...

Keyword(s):

Epidural Analgesia ◽

Breast Feeding ◽

Epidural Fentanyl ◽

High Dose ◽

Significant Difference ◽

Labor Epidural ◽

To Receive ◽

Breast Fed ◽

Fentanyl Group ◽

Intermediate Dose

Background The influence of labor epidural fentanyl on the neonate is controversial. The purpose of this study was to determine whether epidural fentanyl has an impact on breast-feeding. Methods Women who previously breast-fed a child and who requested labor epidural analgesia were randomly assigned in a double-blinded manner to one of three groups: (1) no fentanyl group, (2) intermediate-dose fentanyl group (intent to administer between 1 and 150 microg epidural fentanyl), or (3) high-dose epidural fentanyl group (intent to administer > 150 microg epidural fentanyl). On postpartum day 1, the mother and a lactation consultant separately assessed whether the infant was experiencing difficulty breast-feeding, and a pediatrician assessed infant neurobehavior. All women were contacted 6 weeks postpartum to determine whether they were still breast-feeding. Results Sixty women were randomly assigned to receive no fentanyl, 59 were randomly assigned to receive an intermediate dose, and 58 were randomly assigned to receive high-dose fentanyl. On postpartum day 1, women who were randomly assigned to receive high-dose fentanyl reported difficulty breast-feeding (n = 12, 21%) more often than women who were randomly assigned to receive an intermediate fentanyl dose (n = 6, 10%), or no fentanyl (n = 6, 10%), although this did not reach statistical significance (P = 0.09). There was also no significant difference among groups in breast-feeding difficulty based on the lactation consultant's evaluation (40% difficulty in each group; P = 1.0). Neurobehavior scores were lowest in the infants of women who were randomly assigned to receive more than 150 microg fentanyl (P = 0.03). At 6 weeks postpartum, more women who were randomly assigned to high-dose epidural fentanyl were not breast-feeding (n = 10, 17%) than women who were randomly assigned to receive either an intermediate fentanyl dose (n = 3, 5%) or no fentanyl (n = 1, 2%) (P = 0.005). Conclusions Among women who breast-fed previously, those who were randomly assigned to receive high-dose labor epidural fentanyl were more likely to have stopped breast-feeding 6 weeks postpartum than woman who were randomly assigned to receive less fentanyl or no fentanyl.

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Analysis of the Influence of High-Dose rhGH Therapy on Serum Vitamin D and IGF-1 Levels in School-Age Children with Idiopathic Short Stature

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/5776487 ◽

2021 ◽

Vol 2021 ◽

pp. 1-6

Author(s):

Juan Li ◽

Xuehui Zhang ◽

Shuyong Xie ◽

Shuangshuang Feng ◽

Min Niu

Keyword(s):

Vitamin D ◽

Dose Group ◽

Adverse Reactions ◽

Serum Vitamin ◽

School Age Children ◽

High Dose ◽

School Age ◽

Rhgh Therapy ◽

Serum Vitamin D ◽

Significant Difference

Objective. To discuss the influence of high-dose recombinant human growth hormone (rhGH) therapy on serum vitamin D and insulin-like growth factor-1 (IGF-1) levels in school-age children with idiopathic short stature (ISS). Method. A total of 103 school-age children with ISS were selected from June 2016 to June 2020 in our hospital. The enrolled cases were divided into the low-dose group (n = 59) and high-dose group (n = 44) according to the treatment dose of rhGH. After the treatment, the height (Ht), height standard deviation score (Ht SDS), growth velocity (GV), and other indicators were recorded. The serum 25-hydroxy vitamin D [25-(OH)D] and IGF-1 levels of the two groups were tested, and the occurrence of adverse reactions was recorded. Results. After treatment, the high-dose group outperformed the low-dose group in various growth effect indicators such as Ht, Ht SDS, and GV ( P < 0.05 ). After treatment, the serum 25-(OH)D of children with ISS in the two groups increased significantly, but there was no significant difference between the two groups ( P > 0.05 ). After treatment, the serum IGF-1 of children with ISS in the two groups increased significantly, but there was no significant difference between the two groups ( P > 0.05 ). For children with ISS, adverse reactions induced by rhGH therapy were very rare. There was no significant difference in the incidence of adverse reactions induced by different doses of rhGH in the treatment of ISS ( P > 0.05 ). Conclusion. rhGH has definite efficacy in the treatment of ISS children, for it can significantly increase the annual growth rate of ISS children in a dose-dependent manner. High-dose rhGH for ISS has a better therapeutic effect. At the same time, regardless of the dose level of rhGH, serum 25-(OH)D and IGF-1 levels in children with ISS were increased, with less adverse reactions and higher safety.

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