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CONFLICT OF INTEREST | The authors declare no conflict of interest. | PMC10098273 | ||
ACKNOWLEDGMENTS | We thank the staff from the pediatric department at Damascus University for facilitating the procedure during this study. This research has received no external funding. | PMC10098273 | ||
DATA AVAILABILITY STATEMENT | Data are available on request due to privacy from the corresponding author. | PMC10098273 | ||
REFERENCES | PMC10098273 | |||
Key Points | PMC10466168 | |||
Question | gestational diabetes | GESTATIONAL DIABETES | Does receiving group prenatal care vs individual prenatal care reduce the risk of gestational diabetes (GD)? | PMC10466168 |
Findings | In this large randomized clinical trial including 2348 participants, pregnant individuals receiving group prenatal care had a similar risk of developing GD as those receiving traditional individual prenatal care. | PMC10466168 | ||
Meaning | These findings suggest that individuals receiving both group prenatal care and traditional individual prenatal care had similar risk of developing GD, indicating that group prenatal care may be a possible treatment option for some individuals. | PMC10466168 | ||
Importance | gestational diabetes | GESTATIONAL DIABETES | The impact of group-based prenatal care (GPNC) model in the US on the risk of gestational diabetes (GD) and related adverse obstetric outcomes is unknown. | PMC10466168 |
Objective | To determine the effects of the GPNC model on risk of GD, its progression, and related adverse obstetric outcomes. | PMC10466168 | ||
Design, Setting, and Participants | This is a single-site, parallel-group, randomized clinical trial conducted between February 2016 and March 2020 at a large health care system in Greenville, South Carolina. Participants were individuals aged 14 to 45 years with pregnancies earlier than 21 weeks’ gestational age; follow-up continued to 8 weeks post part... | PMC10466168 | ||
Interventions | Eligible participants were randomized to receive either CenteringPregnancy, a widely used GPNC model, with 10 group-based sessions or traditional individual prenatal care (IPNC). | PMC10466168 | ||
Main Outcomes and Measures | GD-related adverse | SECONDARY, PREECLAMPSIA | The primary outcome was the incidence of GD diagnosed between 24 and 30 weeks of gestation. The secondary outcomes included progression to A2 GD (ie, GD treated with medications) and GD-related adverse obstetric outcomes (ie, preeclampsia, cesarean delivery, and large for gestational age). Log binomial models were perf... | PMC10466168 |
Results | preeclampsia | PREECLAMPSIA | Of all 2348 participants (mean [SD] age, 25.1 [5.4] years; 952 Black participants [40.5%]; 502 Hispanic participants [21.4%]; 863 White participants [36.8%]), 1176 participants were randomized to the GPNC group and 1174 were randomized to the IPNC group. Among all participants, 2144 (91.3%) completed a GD screening (10... | PMC10466168 |
Conclusions and Relevance | SECONDARY | In this secondary analysis of a randomized clinical trial among medically low-risk pregnant individuals, the risk of GD was similar between participants who received GPNC intervention and traditional IPNC, indicating that GPNC may be a feasible treatment option for some patients. | PMC10466168 | |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10466168 | ||
Introduction | Gestational diabetes | GESTATIONAL DIABETES, PREGNANCY COMPLICATIONS | Gestational diabetes (GD) is 1 of the most common pregnancy complications, affecting 4% to 8% of all pregnancies depending on diagnostic criteria and study populations.Lifestyle interventions (ie, diet and physical activity) have achieved a modest effect on improving rates of GD. | PMC10466168 |
Methods | PMC10466168 | |||
Study Design and Participants | SECONDARY | This study is a secondary analysis of the CRADLE study, | PMC10466168 | |
Centering and Racial Disparities Trial Diagram | Enrollment for the CRADLE study began on February 24, 2016, and ended on March 16, 2020, when our capacity for safe in-person GPNC sessions was limited by the COVID-19 pandemic. | PMC10466168 | ||
Randomization and Blinding | Eligible participants were randomly assigned in a 1:1 allocation, stratified by race and ethnicity, to receive either GPNC (intervention) or IPNC (control) as their prenatal care. Due to the nature of the intervention, participants and practitioners were not blinded to group assignments. However, the study analysts wer... | PMC10466168 | ||
Interventions | COMPLICATED PREGNANCIES | Participants in the IPNC group (control) received traditional prenatal care (an average 15 minutes for each visit) following the schedule of prenatal care visits recommended by the American College of Obstetricians and Gynecologists, which typically recommends a total of 13 visits for uncomplicated pregnancies. | PMC10466168 | |
Data Collection and Measures | Over the course of the study, 2 surveys were administered: survey 1 at baseline (<24 gestational weeks) and survey 2 between 30 and 36 gestational weeks. Both surveys were designed and administered using REDCap (Research Electronic Data Capture) software version 11.4.4 and delivered via tablet computers (iPad; Apple) d... | PMC10466168 | ||
Primary and Secondary Outcomes | proteinuria, preeclampsia | PREECLAMPSIA | Incidence of GD was the primary outcome for this study and was diagnosed according to the American College of Obstetricians and Gynecologists recommendation using 2-step screening, which was the standard practice at the clinical site.Secondary outcomes included progression from the White classificationWe evaluated adve... | PMC10466168 |
Statistical Analysis | SPONTANEOUS ABORTION, SECONDARY | The primary analyses compared the primary and secondary outcomes between GPNC and IPNC groups using the ITT approach. The ITT sample included all study participants according to their randomized assignment, regardless of missed visits, crossover between IPNC and GPNC, or transfer out of the practice. In the sensitivity... | PMC10466168 | |
Results | Among 2350 enrolled participants (1176 participants randomized to the GPNC group and 1174 randomized to the IPNC group), 2 twin pregnancies (1 in GPNC and 1 in IPNC) were identified after randomization and excluded, given the study eligibility criteria, resulting in a total of 2348 participants (mean [SD] age 25.1 [5.4... | PMC10466168 | ||
Baseline and Prognostic Characteristics | The study population was racially diverse, with 952 Black participants (40.5%), 502 Hispanic participants (21.4%), 863 White participants (36.8%), and 31 participants (1.3%) who identified as other race or multiracial. Baseline characteristics and prognostic factors were similar between the 2 groups ( | PMC10466168 | ||
Baseline Characteristics and Associated Factors for Gestational Diabetes in the Centering and Racial Disparities Study | SI conversion factor: To convert pounds to kilograms, multiply by 0.45.The analyses were conducted among the intention-to-treat sample.Other indicated Asian, Native Hawaiian, Other Pacific Islander, or unknown race.Prepregnancy body mass index was measured at first prenatal care visit and was calculated as weight in ki... | PMC10466168 | ||
Primary Outcome: GD Incidence | Overall, 157 (6.7%) participants developed GD, and there was no difference between incidence of GD in the GPNC group (83 participants [7.1%]) and IPNC group (74 participants [6.3%]) groups (adjusted RD, 0.7%; 95% CI, −1.2% to 2.7%) ( | PMC10466168 | ||
Comparing the Risk of Gestational Diabetes by Intervention Type in the Centering and Racial Disparities Study | REGRESSION | The analyses were conducted among the intention-to-treat sample.The regression model was adjusted for all baseline characteristics including smoking before pregnancy, race and ethnicity, maternal age, body mass index (calculated as weight in kilograms divided by height in meters squared) at enrollment, education, emplo... | PMC10466168 | |
Secondary Outcomes | Overall, 49.0% of participants (76 of 157 participants) with GD progressed to A2 GD. The incidence of A2 GD was 48.2% (39 of 83 participants) in the GPNC group and 50.0% (37 of 74 participants) in the IPNC group. The adjusted RD was −6.1% (95% CI, −21.3% to 9.1%) after controlling for all baseline characteristics ( | PMC10466168 | ||
Comparing the Risks of Progression to A2 GD and GD–Related Obstetric Outcomes by Intervention Type in the Centering and Racial Disparities Study | REGRESSION, GESTATIONAL DIABETES | Abbreviations: GD, gestational diabetes.The analyses were conducted among the intention-to-treat sample.The regression model was adjusted for all baseline characteristics including smoking before pregnancy, race and ethnicity, maternal age, body mass index (calculated as weight in kilograms divided by height in meters ... | PMC10466168 | |
Sensitivity Analyses | For sensitivity analyses, 825 participants in the GPNC group and 1099 in the IPNC group were left in the mITT sample (eFigure in We tracked 171 participants (85 in GPNC and 86 in IPNC) who were enrolled before March 17, 2020, whose study participation could have been influenced by the pandemic. Excluding these 171 part... | PMC10466168 | ||
Discussion | GD-related adverse | SECONDARY | In this secondary analysis of a large RCT, among 2348 pregnant participants from a single health care system, we found the risks of GD, progression to A2 GD, and GD-related adverse obstetric outcomes were similar between GPNC and IPNC groups. We did not find that the effect of GPNC on the risk of developing GD was diff... | PMC10466168 |
Limitations | SECONDARY | Our study had several limitations. First, the early termination of the trial due to the COVID-19 pandemic resulted in a smaller sample size than originally planned, limiting the power for our secondary analysis. According to our previously published observational study, | PMC10466168 | |
Conclusions | In this RCT among pregnant individuals, participants receiving GPNC had similar risk of developing GD, compared with participants receiving IPNC, suggesting that GPNC could be a feasible care option for some patients. Future studies should explore additional strategies to enhance participant engagement with GPNC. Moreo... | PMC10466168 | ||
1. Introduction | hypertension | HYPERTENSION | The use of garlic (A wealth of evidence exists to demonstrate that lowering blood pressure can substantially reduce premature morbidity and mortality [Several studies have shown that garlic can help lower blood pressure in individuals with hypertension [Aged black garlic (ABG) is a type of modified garlic that contains... | PMC10490347 |
2. Materials and Methods | PMC10490347 | |||
2.1. Experimental Design | hypertension | HYPERTENSION | The study was designed as a triple-blind, placebo-controlled, randomized parallel study to determine whether an optimized aged black garlic (ABG) extract could reduce systolic and diastolic blood pressure in subjects with Grade I hypertension. The study consisted of two periods. An initial period called the “Run-in pha... | PMC10490347 |
2.2. Intervention | DEL | The intervention consisted of a daily intake of one tablet after wake-up and before breakfast. Group L received an optimized ABG10+ -extract tablet manufactured by Pharmactive Biotech Products, S.L.U. (Madrid, Spain), according to a proprietary process. The extract was from garlic harvested in the area of Las Pedroñera... | PMC10490347 | |
2.3. Study Population | hypertension | DISEASE, MORBID OBESITY, HYPERTENSION | Volunteers were recruited in collaboration with the Atherothrombotic Disease Detection and Treatment Unit (UDETMA) of the Hospital Universitari Arnau de Vilanova (Lleida, Spain) from the database of patients with Grade I hypertension. The inclusion criteria included: men and women over 18 years of age with diagnosed hy... | PMC10490347 |
2.4. Sample Size Determination | The sample size was calculated based on the study published by Rothwell et al. [ | PMC10490347 | ||
2.5. Outcomes | PMC10490347 | |||
2.5.1. Blood Pressure | Office and home blood pressure were determined by the same oscillometric automatic sphygmomanometers (Medisana BU 512, Medisana GmbH, Neuss, Germany), with a maximum error tolerance for static pressure of ±3 mmHg. Volunteers were seated comfortably in a quiet environment for 5 min before blood pressure measurements. Of... | PMC10490347 | ||
2.5.2. Endothelial Function | REACTIVE HYPEREMIA | The EndoPAT™ parameters reactive hyperemia index (RHI) and augmentation index (AI | PMC10490347 | |
2.5.3. Nitric Oxide | Nitric oxide was determined by nitrate/nitrite concentration using a fluorometric assay kit (Abcam ab65327, Cambridge, UK) following manufacturer instructions. Serum samples were filtered with a 10 kDa Spin column (Abcam ab93349, Cambridge, UK) to deproteinize the samples before the analysis. The analysis consisted of ... | PMC10490347 | ||
2.5.4. Antioxidant Capacity | Antioxidant capacity was measured by the FRAP (ferric reducing antioxidant power) assay. Briefly, 900 μL of the FRAP reagent containing 2,4,6-tri(2-pyridyl)-s-triazine, FeCl | PMC10490347 | ||
2.5.5. Inflammatory Cytokines | The simultaneous assessment of serum concentrations of IL-2, IL-4, IL-5, IL-8, INF-γ, inducible protein 10 (IP-10), and soluble CD40 ligand (sCD40L) was performed using commercially available multiplex bead-based immunoassay kits (Milliplex MAP Human Cytokine/Chemokine Magnetic Bead Panel, HCYTOMAG-60K, Millipore, Bill... | PMC10490347 | ||
2.5.6. Angiotensin-Converting Enzyme (ACE) Activity | ACE activity was determined following the manufacturer’s instruction of Spinreact’s (41205, Sant Esteve de Bas, Spain) quantitative determination kit. Briefly, in this method, the direct substrate | PMC10490347 | ||
2.5.7. Statistical Analysis | SECONDARY, REGRESSIONS | Statistical analysis was performed as per protocol. Primary and secondary parameters were measured at baseline and after 12 weeks of intervention. Data are presented as mean ± standard deviation of the mean. Two-way ANOVA and multiple comparisons, used to analyze the treatment effect, were performed using Sidak’s test.... | PMC10490347 | |
3. Results | PMC10490347 | |||
3.1. Study Design | RECRUITMENT, GASTROESOPHAGEAL REFLUX | The recruitment phase included creating a database of potential volunteers according to the inclusion and exclusion criteria. Of the 303 patients in the database, 89 volunteers showed interest in participating in the study and entered the run-in phase. Eight volunteers did not complete the run-in phase due to placebo i... | PMC10490347 | |
3.2. Compliance and Reported Adverse Events | muscular cramps | ADVERSE EVENTS | Treatment compliance was determined from the number of pills taken divided by the total days of the treatment period. Some volunteers took extra treatment days due to volunteer availability adjustments in appointments. The mean treatment days in both groups were 87 ± 5 and 88 ± 5 for groups L and A, respectively. The m... | PMC10490347 |
3.3. Blood Pressure, Endothelial Function, and Related Variables | Changes in blood pressure were determined through two methods: the measurements in the office at baseline and 12 weeks and the daily measurement performed by the volunteers at home. The results of the office pressure measurements are shown in No changes in endothelial function parameters (RHI and AIRegarding the variab... | PMC10490347 | ||
3.4. Confounding Variables Analysis | No differences in response to the treatment were observed due to sex ( | PMC10490347 | ||
4. Discussion | inflammation, reduction in blood pressure, hypercholesterolemia | HYPERCHOLESTEROLEMIA, INFLAMMATION, CARDIOVASCULAR MORBIDITY, ADVERSE EFFECTS, HYPERTENSION | This study aimed to validate whether daily supplementation with an optimized black-garlic extract could help to control blood pressure in medicated people with Grade I hypertension. The results of this study suggest a drop in systolic and diastolic blood pressure of 1.8 and 1.5 mmHg, respectively, at values measured at... | PMC10490347 |
5. Conclusions | hypertension, reductions in blood pressure | HYPERTENSION | Based on the results obtained in this study, it can be concluded that daily supplementation with ABG extracts with low doses of SAC (0.25 mg/day) can induce significant reductions in blood pressure in individuals with Grade I hypertension and antihypertensive drug therapy. | PMC10490347 |
Author Contributions | CRediT author statement: J.C.E.S.: Conceptualization, Methodology, Validation, Formal analysis, Writing, Review and Editing. E.C.-B.: Investigation. A.G.-C.: Investigation. M.I.M.-V.: Funding acquisition, Resources, Review and Editing. D.G.-H.: Funding acquisition, Resources, Review and Editing. M.B.-L.: Investigation.... | PMC10490347 | ||
Institutional Review Board Statement | The study was conducted by the Declaration of Helsinki and approved by the Institutional Review Board (or Ethics Committee) of Hospital Universitari Arnau de Vilanova (CEIC-2435, 25 March 2021) for studies involving humans. | PMC10490347 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10490347 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10490347 | ||
Conflicts of Interest | A García-Carrasco, J.M. Valdivielso, and M. Portero-Otin do not declare any potential competing interests. Jose CE Serrano reports that Pharmactive Biotech Products S.L.U. provided financial support for study development. Maria Ines Moran Valero, Alberto E. Espinel, and Daniel Gonzalez Hedstrom report a relationship wi... | PMC10490347 | ||
Background | intraoperative blood loss, knee arthroplasty, blood loss, TKA | BLOOD LOSS, INTRAOPERATIVE BLOOD LOSS | The use of a tourniquet in combination with tranexamic acid (TXA) not only ensures clear vision, reduces intraoperative blood loss and shortens operative time but also improves cement-bone inter-digitation in total knee arthroplasty (TKA). However, there is no proof whether the blood flow blocking effect of tourniquet ... | PMC10655351 |
Methods | blood loss, petechiae | BLOOD LOSS, PETECHIAE, GROUP B, COMPLICATIONS | In this double-blind trial, 90 patients undergoing primary TKA were randomised into 2 groups: Group A, patients received intravenous TXA 10 min before tourniquet compression (20 mg/kg) and 3, 6 and 24 h later (10 mg/kg), and Group B, patients were treated the same as those in Group A but received intravenous TXA before... | PMC10655351 |
Results | No statistically significant difference was found between the 2 groups with regard to age, sex, weight, body mass index (BMI), Kellgren-Lawrence class, preoperative blood volume, preoperative laboratory values, operation and tourniquet times, transfusion rate, knee circumference, preoperative HSS, or VAS score ( | PMC10655351 | ||
Conclusion | swelling, blood loss, knee arthroplasty, petechiae, bruising | BLOOD LOSS, PETECHIAE, COMPLICATION | TXA was administered intravenously prior to tourniquet compression could effectively reduce blood loss in patients who had undergone total knee arthroplasty. However, there was no significant difference in knee swelling rate, subcutaneous bruising and petechiae incidence, knee function, complication rate or satisfactio... | PMC10655351 |
Keywords | PMC10655351 | |||
Introduction | bleeding, TKAs, pain, knee arthroplasty, TKA | OSTEOARTHRITIS OF THE KNEE, BLEEDING | Total knee arthroplasty (TKA) has become a routine procedure to reduce pain and improve the quality of life of patients with osteoarthritis of the knee, and the number of TKAs performed is increasing annually worldwide [Reducing perioperative bleeding and transfusion rates in patients undergoing TKA is a key measure to... | PMC10655351 |
Methods | PMC10655351 | |||
Patients and design | anaemia, varus-valgus, cardiovascular disease, end-stage osteoarthritis, lower limb arterial occlusion, flexion deformity, venous thrombosis | ANAEMIA, OSTEOARTHRITIS OF THE KNEE, CARDIOVASCULAR DISEASE, DISEASE, LIVER DISEASE, HAEMATOLOGICAL DISORDERS, VENOUS THROMBOSIS | This prospective, double-blind randomised study was approved by The Institutional Review Board of Panzhihua Central Hospital (no. pzhszxyyll-2022-10) and registered in the Chinese Clinical Trial Registry (ChiCRT-2100053885). Informed consent was obtained before participation in the study. Ninety patients with osteoarth... | PMC10655351 |
Treatment groups | GROUP B | In total, 90 patients were randomised to 1 of 2 groups. Group A received intravenous TXA 10 min before tourniquet compression (20 mg/kg) and 3, 6 and 24 h later (10 mg/kg); Group B was treated the same as Group A but received intravenous TXA before tourniquet release. The included patients were randomised into Groups A... | PMC10655351 | |
Surgical procedure | bleeding, postoperative pain | BLEEDING, CAVITY | All of the operations were performed by the same team of senior surgeons, all under general anaesthesia. We performed all operations through a midline skin incision and medial parapatellar approach. Intramedullary guides were used for all femoral preparations, and extramedullary guides were used for the tibial preparat... | PMC10655351 |
Postoperative management | All patients were managed using the same Postoperative protocols. One gram of TXA (5 ml, 0.5 g; Salvage Pharmaceutical CO.,LTD., Guizhou, China) was given intravenously at 3 and 6 h and on day 2 postoperatively; 1.5 g of Cefuroxime Sodium (1.5 g, Axetine; Medochemie Ltd., Limassol, Cyprus)was given as prophylaxis once ... | PMC10655351 | ||
Outcome measurements | bleeding | BLEEDING | Intraoperatively, the amount of bleeding, need for blood transfusion, duration of the operation and duration of tourniquet use were recorded, and the total blood volume was calculated according to the Nadler equation [ | PMC10655351 |
Statistical analysis | blood loss | BLOOD LOSS | The sample size was calculated on the basis of the difference in the primary outcome, namely, total blood loss. Based on pilot data from 24 patients who received unilateral primary TKA with TXA was given intravenously before tourniquet compression between December 2020 and September 2021, the mean total blood loss was ... | PMC10655351 |
Results | PMC10655351 | |||
Intraoperative and postoperative blood loss, haemoglobin and red blood cell count drop values | blood loss, HBL Hidden blood loss | BLOOD LOSS, INTRAOPERATIVE BLOOD LOSS, TOTAL BLOOD LOSS | There was no significant difference in IBL (52.7 ml vs. 63.4 ml,
Box plots of blood loss, Hb and RBC postoperatively between two groups. IBL Intraoperative blood loss, HBL Hidden blood loss, TBL Total blood loss, Hb Haemoglobin, RBC Red blood cell, ns No significant difference, *P < 0.05 | PMC10655351 |
Changes in haemoglobin, haematocrit and red blood cell count (RBC) | Preoperative haemoglobin, haematocrit and RBC were in the normal range in both groups (Table
Changes of hemoglobin, hematocrit and RBC in 2 groups | PMC10655351 | ||
Incidence of petechiae and knee circumference changes | petechiae | PETECHIAE, GROUP B | The incidence of petechiae, mean petechiae area and maximum petechiae area were not significantly different between the 2 groups, with the mean incidence of petechiae remaining at 23.5% and 25.0% and the mean petechiae area being approximately 1.0%, with the maximum petechiae area being 4.0% in Group A and 3.0% in Grou... | PMC10655351 |
Postoperative VAS scores, HSS scores and patient satisfaction | The preoperative VAS scores were 5.1 ± 1.4 and 4.9 ± 1.5 in Groups A and B, respectively, which started to drop postoperatively and gradually decreased to 1.3 ± 0.3 and 1.3 ± 0.6 at 3 months postoperatively. The HSS score decreased from 51.2 ± 7.3 and 51.0 ± 9.4 preoperatively to 48.0 ± 8.3 and 45.7 ± 9.0 on postoperat... | PMC10655351 | ||
Discussion | thrombosis, nonhealing, postoperative pain, blood loss, intraoperative and postoperative blood loss, pain, knee arthroplasty, thrombus, ’ postoperative hypoproteinaemia, cardiovascular or cerebrovascular accidents, coagulation abnormalities, postoperative knee swelling | THROMBOSIS, DEEP VEIN THROMBOSIS, BLOOD LOSS, WOUND INFECTION, ACUTE RENAL FAILURE, THROMBUS, ASYMPTOMATIC PULMONARY EMBOLISM, COMPLICATIONS | TXA administered intravenously prior to tourniquet compression could effectively reduce blood loss in patients who had undergone total knee arthroplasty. There was no statistical significance in the comparison of intraoperative and postoperative blood loss, postoperative haemoglobin, haematocrit or red blood cell count... | PMC10655351 |
Acknowledgements | This study adheres to CONSORT guidelines. We are thankful for the support of the nursing staffs from the Department of Orthopaedics, Panzhihua Central Hospital and the patients enrolled in this study. | PMC10655351 | ||
Author Contributions | Mingyou Wang and Yuping Lan were responsible for research, collect and analyse data, and wrote the main manuscript text; Qifeng Tao is responsible for research guidance, article review; Wang Hongping, Chen Chunyu and Mei zhu are responsible for research guidance, data collection and statistical analysis; All authors re... | PMC10655351 | ||
Funding | This research was funded by The Primary Health Development Research Center of Sichuan Province Program (SWFZ21-C-111), who is not involved in study design, data collection, analysis and interpretation or manuscript preparation. | PMC10655351 | ||
Data Availability | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10655351 | ||
Declarations | PMC10655351 | |||
Ethics approval and consent to participate | This study was approved by The Institutional Review Board of Panzhihua Central Hospital (no. pzhszxyyll-2022-27) and written informed consent to participate was obtained from all of the individual participants included in the study. All methods were carried out in accordance with relevant guidelines and regulations. | PMC10655351 | ||
Consent for publication | Not applicable. | PMC10655351 | ||
Competing interests | The authors declare no competing interests. | PMC10655351 | ||
Abbreviations | venous thrombosisPulmonary embolism | Intraoperative blood lossHidden blood lossTotal blood lossHemoglobinRed blood cellTotal knee arthroplastyTranexamic acidVisual analog scaleHospital for Special SurgeryLength of stayRange of motionDeep venous thrombosisPulmonary embolism | PMC10655351 | |
References | PMC10655351 | |||
1. Introduction | OMIM 264800, calcification of the skin, calcification, PXE | RARE DISEASE, DISEASES, PSEUDOXANTHOMA ELASTICUM | Both authors contributed as senior authors.Pseudoxanthoma elasticum (PXE) is characterized by low levels of inorganic pyrophosphate (PPi) and a high activity of tissue-nonspecific alkaline phosphatase (TNAP). Lansoprazole is a partial inhibitor of TNAP. The aim was to investigate whether lansoprazole increases plasma P... | PMC10003519 |
3. Discussion | calcification, PXE, gastrointestinal intolerance | DISEASE, OSTEOPOROTIC FRACTURE, PATHOGENESIS, MINERALIZATION | Our trial shows that administration of lansoprazole 30 mg increased PPi levels in patients with PXE compared with the placebo in a short period of 8 weeks. Because PPi is recognized as a molecule directly involved in the pathogenesis of calcification in these patients, lansoprazole might be considered for new clinical ... | PMC10003519 |
4. Materials and Methods | PXE symptoms, cardiovascular or cerebrovascular disease, diabetes | RENAL LITHIASIS, ADVERSE EVENTS, DISEASE, ADVERSE EVENT, DYSLIPIDEMIA, INTERMITTENT CLAUDICATION, BLOOD, HYPERTENSION, DIABETES | Capsules of lansoprazole 30 mg or a placebo were provided by the Pharmacy Service of Hospital Virgen de la Macarena, Sevilla, Spain. The random sequence was created using the software Random Integer Generator (Patients who consented to participate in the trial had 4 visits to the hospital, just before and after the two... | PMC10003519 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10003519 | ||
Author Contributions | M.G.F., J.L.C.L. and P.V. contributed to conception and study design; B.M.C., I.B.A., J.R.V., M.Á.R.C., R.B. and M.Á.S.C. contributed to data collection and data analysis. A.G.J. performed statistical analyses. V.M.B. prepared the drug and placebo capsules and blinded them. P.V. prepared the manuscript. All authors mai... | PMC10003519 | ||
Institutional Review Board Statement | This clinical trial was approved by the Ethics Committee of Málaga on 23 March 2017, as well for the Spanish Medicinal Products on 31 October 2018. The investigations were carried out following the rules of the Declaration of Helsinki of 1975 ( | PMC10003519 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10003519 | ||
Data Availability Statement | Data will be provided upon reasonable request. | PMC10003519 | ||
Conflicts of Interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest. | PMC10003519 |
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