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1.
Front Surg ; 11: 1396438, 2024.
Article in English | MEDLINE | ID: mdl-38948480

ABSTRACT

Introduction: Pelvic organs prolapse remains a significant health concern affecting millions of women worldwide. The use of native tissues to suspend the apex has acquired relevance in urogynecologic surgery. One of the most commonly used procedures performed without mesh is the technique described by Shull, consisting of suturing the vaginal apex to the uterosacral ligaments. The objective of the study is to evaluate the learning curve of laparoscopic Shull's repair for the correction of pelvic floor defects, including the surgery time and surgical outcomes. Materials and methods: This is a retrospective study conducted at the Policlinico G. Martino, University of Messina, Messina, Italy, and Policlinico Vanvitelli, Vanvitelli University, Naples, Italy. All patients affected by grade I-IV POP, consisting of apical prolapse with or without cystocele, and who underwent laparoscopic Shull's technique for prolapse correction were enrolled. The endpoints to estimate the learning curve for the procedure were the percentage of laparoscopic procedures completed, operative time, and the early complication rate. Results: A total of 31 laparoscopic Shull repairs were collected for the study. To evaluate the learning curve of the technique, we divided the 31 cases into three different groups: Procedures 0-10; 11-20; 21-31. The parameter for evaluating technique learning was the operative time. Group 21-31 demonstrated an operative time of 97 min (SD 20), compared with 121 min (SD 23) in group 0-10 and 120 min (SD 13) in group 11-20. A comparison of these means through ANOVA showed a p-value of 0.01 for the entire system, and 0.95 for the comparison between 0 and 10 and 11-20, 0.04 for 0-10 vs. 21-31, and 0.02 between 11 and 20 and 21-31. Conclusions: The rate of surgical improvement in terms of time became effective after an average of 20 procedures. However, the improvement seems to be effective case by case for surgeons skilled in basic endoscopy.

2.
Eur Rev Med Pharmacol Sci ; 28(9): 3375-3383, 2024 May.
Article in English | MEDLINE | ID: mdl-38766794

ABSTRACT

OBJECTIVE: Endometriosis means the presence of tissue similar to normal endometrium outside the uterus. Although surgical, hormonal, and analgesic treatment relieves symptoms and improves fertility, it is associated with side effects and a high recurrence rate. Alternative medicines like medicinal plants have been used for the treatment of chronic diseases. Given the global importance of endometriosis as a chronic disease affecting over 15% of all women in their fertile period, this systematic review aimed to give a comprehensive view of research on medicinal plants. MATERIALS AND METHODS: Comprehensive searches were performed on three databases, including PubMed/MEDLINE, Web of Science Core Collection (Indexes = SCI-EXPANDED, SSCI, A, and HCI Timespan), and Scopus, to identify papers published until June 2023. Keywords, such as "Endometriosis" and "Herbal Medicine", were used to search. A manual search of valid journals followed by a manual search of the references of the retrieved full-text articles was performed. All retrieved articles were imported into a database into Endnote X9. Articles that did not meet the inclusion criteria were excluded from the study, and the full texts of all the articles that met the inclusion criteria were assessed. Studies that evaluated the effects of herbal compounds on various aspects of endometriosis treatment were included in the review. RESULTS: In total, 11 studies were included in the present study. The evidence showed that in addition to safety, drugs available alongside treatments could play an effective role in improving the symptoms associated with endometriosis. In this study, the positive results of using Chinese treatments were reported in aspects such as fertility rate, pain, endometriosis recurrence rate, quality of life, sexual function, CA-125 level, and menopause symptoms. CONCLUSIONS: A wide range of preclinical and clinical studies evaluated the effectiveness and safety of medicinal plants in the treatment of endometriosis symptoms. Thus, alternative treatments for endometriosis with no or low side effects should be included in the holistic treatment of endometriosis upfront. However, there is still a need for well-designed trials to investigate standard interventions and specific and safe doses of herbal medicines.


Subject(s)
Endometriosis , Endometriosis/drug therapy , Humans , Female , Plants, Medicinal/chemistry , Phytotherapy , Plant Preparations/therapeutic use
3.
Eur Rev Med Pharmacol Sci ; 28(7): 2827-2836, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38639522

ABSTRACT

OBJECTIVE: The study aimed to evaluate the utility and safety of ancillary maneuvers during oocyte retrieval for patients with endometrioma that makes ovum pick-up hard due to poor ovarian surgical accessibility. PATIENTS AND METHODS: Cases of 251 women with ovarian endometriomas undergoing in vitro fertilization (IVF) in our infertility unit were retrospectively analyzed to evaluate the clinical IVF cycle outcomes after oocyte retrieval. Controls (n = 251) were age-matched women without endometriomas who underwent an uncomplicated oocyte retrieval. RESULTS: No statistically significant differences were observed between groups except for the number of oocytes retrieved, which was higher in the control group than in the group of women with endometrioma. On the contrary, there were no differences between the experimental groups in the fertilization rate and number of embryos, and neither were there in the pregnancy and live birth rate. Moreover, the surgical complications were infrequent and similar between the two analyzed groups. Accidental or voluntary endometrioma punctures were not accompanied by increases in the risk of a pelvic infection. CONCLUSIONS: In conclusion, patients with endometrioma can undergo high-performance oocyte recovery procedures thanks to safe accessory maneuvers during the ovum pick-up.


Subject(s)
Endometriosis , Infertility , Pregnancy , Humans , Female , Endometriosis/surgery , Endometriosis/complications , Retrospective Studies , Oocyte Retrieval , Fertilization in Vitro , Pregnancy Rate
4.
Eur Rev Med Pharmacol Sci ; 27(8): 3645-3663, 2023 04.
Article in English | MEDLINE | ID: mdl-37140315

ABSTRACT

Healthcare-associated infections are a serious threat in terms of morbidity and mortality for all patients receiving healthcare. The problem is aggravated by the increasingly widespread phenomenon of antibiotic resistance, with some microorganisms now resistant to all or almost all the currently available antibiotics. Nanomaterials are compounds used by many different industrial fields and they are currently studied for their intrinsic antimicrobial properties. To date, many researchers have considered using many different nanoparticles and nanomaterials to produce surfaces and medical devices with intrinsic antimicrobial features. Many compounds have shown very interesting and effective antimicrobial capacities and could be used, in the future, to manufacture new hospital surfaces and medical devices. However, many studies have to be carried out to evaluate the effective potential use of these compounds. The aim of this paper is to review the main literature regarding this topic, focusing on the main types of nanoparticles and nanomaterials studied for this purpose.


Subject(s)
Anti-Infective Agents , Cross Infection , Nanoparticles , Humans , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use
5.
Ultrasound Obstet Gynecol ; 60(5): 604-611, 2022 11.
Article in English | MEDLINE | ID: mdl-35656849

ABSTRACT

OBJECTIVES: To evaluate and compare the diagnostic test accuracy (DTA) of three-dimensional transvaginal ultrasound (3D-TVS) and magnetic resonance imaging (MRI) for deep myometrial infiltration (DMI) and cervical invasion for preoperative staging and surgery planning in patients with endometrial cancer (EC). METHODS: This systematic review and meta-analysis investigated the DTA of MRI and 3D-TVS for DMI and cervical invasion in patients with EC. A literature search was performed using MEDLINE, Scopus, EMBASE, ScienceDirect, The Cochrane library, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, EU Clinical Trials Register and World Health Organization International Clinical Trials Registry Platform to identify relevant studies published between January 2000 and December 2021. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. RESULTS: Five studies, including a total of 450 patients, were included in the systematic review. All five studies compared the DTA of 3D-TVS vs MRI for DMI, and three studies compared the DTA of 3D-TVS vs MRI for cervical invasion. Pooled sensitivity, positive likelihood ratio and negative likelihood ratio for detecting DMI using 3D-TVS were 77% (95% CI, 66-85%), 4.57 and 0.31, respectively. The respective values for detecting DMI on MRI were 80% (95% CI, 73-86%), 4.22 and 0.24. Bivariate metaregression indicated a similar DTA of 3D-TVS and MRI (P = 0.80) for the correct identification of DMI. Pooled ln diagnostic odds ratio for detecting cervical invasion was 3.11 (95% CI, 2.09-4.14) for 3D-TVS and 2.36 (95% CI, 0.90-3.83) for MRI. The risk of bias was low for most of the four domains assessed in QUADAS-2. CONCLUSION: 3D-TVS demonstrated good diagnostic accuracy in terms of sensitivity and specificity for the evaluation of DMI and cervical invasion, with results comparable with those of MRI. Thus, we confirmed the potential role of 3D-TVS in the preoperative staging and surgery planning in patients with EC. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.


Subject(s)
Endometrial Neoplasms , Myometrium , Pregnancy , Female , Humans , Neoplasm Invasiveness/pathology , Myometrium/diagnostic imaging , Endometrial Neoplasms/pathology , Ultrasonography/methods , Magnetic Resonance Imaging/methods , Sensitivity and Specificity , Neoplasm Staging
6.
Eur Rev Med Pharmacol Sci ; 26(7): 2610-2626, 2022 04.
Article in English | MEDLINE | ID: mdl-35442477

ABSTRACT

Pregnant women and their infants are at high risk to develop a severe COVID-19, with increased rates of hospitalisation to intensive care units, need for mechanical ventilation and mortality. Preterm birth, fetal vascular malperfusion, and premature rupture of membrane have been the most reported adverse pregnancy outcomes and these effects have been especially associated with the onset of the disease at early gestational age. The early expression of ACE2 and TMPRSS2 in human embryos has been proven, determining an increased susceptibility to SARS-CoV-2. Preterm infants born to women infected by SARS-CoV-2 have a higher risk of need for specialist neonatal care with prolonged hospitalization. Moreover, inflammation of developing embryos could cause long-term defects, regardless of vertical transmission of SARS-CoV-2. Due to Maternal Immune Activation (MIA), in utero inflammation is associated with neurodevelopmental, cognitive and psychiatric disorders in affected offspring. Despite risks that COVID-19 could induce in pregnancy, there are not many published data describing the safety and/or efficacy of COVID-19 vaccines in pregnant women, commonly not included in vaccine research. The evidence from the few pregnant women unintentionally enrolled in clinical trials and vaccinated suggests that COVID-19 vaccines, both based on mRNA and viral vectors, do not pose significant risks to the fetus or breastfeeding infants. Moreover, human studies using mRNA-based vaccines against Zika virus, influenza, and rabies have reported good safety and immunogenicity during pregnancy. In this review, we evaluate the role of COVID-19 in adverse pregnancy and neonatal outcomes and the need to vaccinate pregnant women.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Premature Birth , Zika Virus Infection , Zika Virus , COVID-19/prevention & control , COVID-19 Vaccines , Female , Humans , Infant, Newborn , Infant, Premature , Inflammation , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Pregnancy Outcome , RNA, Messenger , SARS-CoV-2 , Vaccination
7.
Eur Rev Med Pharmacol Sci ; 26(4): 1241-1247, 2022 Feb.
Article in English | MEDLINE | ID: mdl-35253180

ABSTRACT

Alpha-lipoic acid (ALA) plays a key role in many physiological processes, exerting anti-inflammatory, immunomodulatory, antioxidant, detoxifying, and insulin sensitizing activities. Since ALA improves insulin resistance (IR), it has been suggested that ALA could be beneficial it in the treatment of PCOS. The natural polyol myo-Inositol (myo-Ins) and its isomers (D-Chiro-Inositol, D-Chiro-Ins) has proven to improve PCOS features and clinical outcome, according to a compelling body of available studies. Few studies have proposed to strengthen the inositol effect by associating ALA. ALA does not seem to influence significantly reproductive hormones, while its beneficial effects are presumably restricted to the metabolic features of insulin resistant PCOS women. Therefore, ALA usefulness in improving inositol activity still awaits convincingly confirmation.  Experimental studies as well as proper randomized clinical trials, should be specifically tailored to assess this hypothesis. In absence of reliable evidence, ALA should not be recommended in the routinary clinical management of PCOS, even if associated to myo-Ins.


Subject(s)
Insulin Resistance , Polycystic Ovary Syndrome , Thioctic Acid , Female , Humans , Inositol/therapeutic use , Insulin/metabolism , Polycystic Ovary Syndrome/drug therapy , Polycystic Ovary Syndrome/metabolism , Thioctic Acid/therapeutic use
8.
Eur Rev Med Pharmacol Sci ; 26(24): 9107-9116, 2022 12.
Article in English | MEDLINE | ID: mdl-36591823

ABSTRACT

Menopausal transition entails a progressive decrease in hormone production by the ovaries that lead to important physical and psychological changes that could significantly affect quality of life. Hormone replacement therapy (HRT) administered from the onset of menopausal symptoms usually improves quality of life and life expectancy. Nevertheless, it is not risk-free. Ovarian tissue cryopreservation (OTC) has been investigated as a potential new strategy for delaying menopause and/or to avoid HRT. This review analyzes the critical points of HRT to assess whether OTC and subsequent reimplantation can affect postmenopausal management. We assessed available randomized clinical trials in PubMed, Cochrane Library, ISI web of science, and Scopus from August 2021 to November 2022, including studies and trials evaluating the efficacy of OTC in both cancer and menopausal patients, the efficacy of freezing techniques and the possible clinical scenarios that OTC can open, even from the standpoint of legal and ethical issues arising as such innovative techniques become mainstream. Lower duration of the graft and efficacy on estrogen secretions at a physiological and safer concentration of estrogen than conventional HRT based on hormonal supplements. OTC can reportedly trigger estrogen secretions at a lower and safer physiological concentration than conventional HRT. OTC and subsequent reimplantation remain a valid fertility-sparing approach in patients undergoing gonadotoxic treatments. Further studies are needed to better evaluate its safety and efficacy within postmenopausal therapy management and in order to lay out widely shared and evidence-based guidelines and best practices and perform such novel and innovative techniques in a legally and ethically safe fashion, in the best interest of patients and healthcare professionals.


Subject(s)
Estrogen Replacement Therapy , Postmenopause , Female , Humans , Estrogen Replacement Therapy/adverse effects , Quality of Life , Menopause , Estrogens , Cryopreservation
10.
BMC Pregnancy Childbirth ; 21(1): 356, 2021 May 04.
Article in English | MEDLINE | ID: mdl-33947354

ABSTRACT

BACKGROUND: The American College of Obstetricians and Gynecologists (ACOG) introduced a new standard of care in 2014, extending the duration of the second stage of labor in order to reduce caesarean delivery (CD) rates and its severe complications. The aim of the present study is to evaluate success rates of trial of labor after caesarean section (TOLAC), as well as maternal and neonatal outcomes after the establishment of the recent guidelines. METHODS: A retrospective study was performed at two large departments in Germany from January 2008 to January 2018. Patients undergoing TOLAC were divided into two groups. Group I (958 patients) was constituted before the establishment of the current guidelines, and Group II (588 patients) after the establishment of the guidelines. A subgroup analysis was performed to compare neonatal outcomes after successful TOLAC and operative vaginal delivery with those after failed TOLAC and secondary CD. RESULTS: The success rate of vaginal births after cesarean section (VBAC) fell from 66.4% in Group I to 55.8% in Group II (p < 0.001). The median duration of the second stage of labor was statistically significantly longer in Group II than in Group I (79.3 ± 61.9 vs. 69.3 ± 58.2 min) for patients without previous vaginal birth. The incidence of operative vaginal delivery decreased from Group I to Group II (9.6% vs. 6.8%). The incidence of third- and fourth-degree perineal lacerations, blood loss and emergency CD were similar in the two groups. Concerning the neonatal outcome, our groups did not differ significantly in regard of rates of umbilical artery cord pH < 7.1 (p = 0.108), the 5-min Apgar scores below 7 (p = 0.224) and intubation (p = 0.547). However, the transfer rates to the neonatal care unit were significantly higher in Group II than in Group I (p < 0.001). Neonatal outcomes did not differ significantly in the subgroup analysis. CONCLUSION: Extending the second stage of labor does not necessarily result in more vaginal births after TOLAC. Maternal and neonatal outcomes were similar in both groups. Further studies will be needed to evaluate the role of operative vaginal delivery and the duration of the second stage of labor in TOLAC.


Subject(s)
Labor Stage, Second , Trial of Labor , Vaginal Birth after Cesarean , Adult , Female , Humans , Infant, Newborn , Pregnancy , Pregnancy Outcome , Retrospective Studies
11.
Eur Rev Med Pharmacol Sci ; 25(8): 3316-3324, 2021 04.
Article in English | MEDLINE | ID: mdl-33928619

ABSTRACT

OBJECTIVE: This open-label non-randomized clinical study aimed at evaluating the effects of myo-inositol plus alpha-lactalbumin in two groups of PCOS women, treated in Mexico and Italy. Alpha-lactalbumin was used being effective in increasing myo-inositol intestinal absorption. This effect is very useful in greatly reducing the therapeutic failure of myo-inositol in some patients (inositol resistant subjects). PATIENTS AND METHODS: The study involved 34 normal weight or overweight patients (14 in Mexico and 20 in Italy), aged 18 to 40 years, with anovulation and infertility > 1 year and insulin resistance diagnosed by HOMA-Index. Patients were administered orally with 2 g myo-inositol, 50 mg alpha-lactalbumin, and 200 µg of folic acid twice a day for 6 months. Controls were the same patients at t0 (baseline). The primary outcome was HOMA-index decrease after 3 and 6 months of treatment. Other parameters monitored were BMI, progesterone, LH, FSH, total testosterone, free testosterone, androstenedione, total cholesterol, HDL, LDL, triglycerides. RESULTS: Recovery was general, and its relevance was higher when the starting point was further away from the normal range. The most important results were obtained with insulin, HOMA-index, LH, and androstenedione. No significant adverse effects were detected in both groups of patients. CONCLUSIONS: This clinical trial demonstrated for the first time that myo-inositol and alpha-lactalbumin improve important parameters in PCOS patients characterized by different metabolic profiles.


Subject(s)
Inositol/therapeutic use , Lactalbumin/therapeutic use , Polycystic Ovary Syndrome/drug therapy , Adolescent , Adult , Female , Humans , Italy , Mexico , Overweight/drug therapy , Young Adult
13.
Arch Gynecol Obstet ; 304(2): 511-519, 2021 08.
Article in English | MEDLINE | ID: mdl-33420814

ABSTRACT

INTRODUCTION: Despite the less frequent use of surgery in patients with vulvar cancer, the high rates of postoperative complications are still a matter of concern. The aim of the present study was to identify risk factors that influence postoperative complications rates in vulvar cancer and identify specific clinical parameters that may influence their incidence. MATERIALS: Patients who underwent curative-intent surgery for squamous cell carcinoma of the vulva from 2003 to 2018 were selected. All patient characteristics were analyzed as risk factors for the development of postoperative lymphocele, lymphedema, and wound dehiscence. The patients were followed up for 2 years postoperatively. RESULTS: The investigation comprised 121 patients, of whom 18.1% developed wound dehiscence, 17.7% a lymphocele, and 20.4% lymphedema. We found no significant evidence of an association between patient's characteristics and postoperative complications. The depth of tumor invasion and the appearance of lymph-node metastasis were significantly associated with postoperative complications. Free resection margins of 5 mm or more were associated with a reduced risk of postoperative complications compared to resection margins less than 5 mm. No complications were encountered after sentinel node biopsy (SNB). Complication rates were associated with inguinofemoral lymphadenectomy, but not with the extent of lymphadenectomy. The development of a lymphocele or wound dehiscence may be correlated with the development of long-term lymphedema. CONCLUSION: FIGO stage at diagnosis influences the risk of postoperative complications. The use of SNB minimized postoperative complications. Correlations between the free microscopic resection margin distance and the risk of postoperative wound dehiscence must be investigated further.


Subject(s)
Lymph Node Excision/adverse effects , Postoperative Complications/epidemiology , Vulvar Neoplasms/surgery , Adult , Aged , Aged, 80 and over , Factor Analysis, Statistical , Female , Humans , Lymphocele , Middle Aged , Neoplasm Staging , Postoperative Complications/etiology , Risk Factors , Vulvar Neoplasms/pathology
15.
J Phys Chem A ; 124(32): 6445-6457, 2020 Aug 13.
Article in English | MEDLINE | ID: mdl-32666800

ABSTRACT

In this paper, we report a quasi-classical trajectory study of the internal energy state specificity of dissociative O2 + N2 collision rates computed at high temperatures on an accurate potential energy surface (PES). This paper analyzes the outcomes of the trajectory calculations performed by explicitly considering the rotational state of the reactants and compares them with those of a previous study carried out by assuming a thermal rotational distribution. In particular, in order to quantify the deviation of the rotationally thermalized rates from the rotationally state-selected ones, we discuss here the properties of the corresponding state-specific and state-to-state cross sections with the support of both internuclear distance and bond-order reduced dimensionality representations of the isoenergetic contours of the PES. This allows us to single out a suitable bond-order-like process coordinate useful for modeling detailed dissociation cross sections and rate coefficients and relating them, as well, to some specific features of the PES. Furthermore, this is also shown to be useful for structuring data repositories of the molecular section of the European Open Science Cloud Project so as to obtain collaborative production, validation, reuse, and dissemination of chemical processes' knowledge and efficiency parameters.

16.
Eur Rev Med Pharmacol Sci ; 24(6): 3426-3432, 2020 03.
Article in English | MEDLINE | ID: mdl-32271462

ABSTRACT

The outbreak of Sars-CoV-2 (COVID-19) poses serious challenges to people's health worldwide. The management of the disease is mostly supportive, and respiratory failure from acute respiratory distress syndrome is the leading cause of death in a significant proportion of affected patients. Preliminary data point out that dramatic increase in IL-6 and subsequent cytokine release syndrome may account for the development of fatal interstitial pneumonia. Inhibition of IL-6 by blocking its specific receptor with monoclonal antibodies has been advocated as a promising attempt. Here we assess the potential utility of myo-Inositol, a polyol already in use for treating the newborn Respiratory Distress Syndrome, in downregulating the inflammatory response upon Sars-CoV-2 infection. Myo-Inositol proved to reduce IL-6 levels in a number of conditions and to mitigate the inflammatory cascade, while being devoid of any significant side effects. It is tempting to speculate that inositol could be beneficial in managing the most dreadful effects of Sars-CoV-2 infection.


Subject(s)
Betacoronavirus/drug effects , Coronavirus Infections/drug therapy , Cytokine Release Syndrome/etiology , Inositol/therapeutic use , Pneumonia, Viral/drug therapy , COVID-19 , Coronavirus Infections/complications , Coronavirus Infections/physiopathology , Down-Regulation , Humans , Interleukin-6/metabolism , Lung Neoplasms/metabolism , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/physiopathology , SARS-CoV-2 , COVID-19 Drug Treatment
18.
Oxid Med Cell Longev ; 2019: 1046504, 2019.
Article in English | MEDLINE | ID: mdl-30881586

ABSTRACT

The large amount of cauliflower industry waste represents an unexplored source of bioactive compounds. In this work, peptide hydrolysates from cauliflower leaves were characterized by combined bioanalytical approaches. Twelve peptide fractions were studied to evaluate unexplored biological activities by effect-based cellular bioassays. A potent inhibition of intracellular xanthine oxidase activity was observed in human vascular endothelial cells treated with one fraction, with an IC50 = 8.3 ± 0.6 µg/ml. A different fraction significantly induced the antioxidant enzyme superoxide dismutase 1 and decreased the tumor necrosis factor α-induced VCAM-1 expression, thus leading to a significant improvement in the viability of human vascular endothelial cells. Shotgun peptidomics and bioinformatics were used to retrieve the most probable bioactive peptide sequences. Our study shows that peptides from cauliflower waste should be recycled for producing valuable products useful for the prevention of endothelial dysfunction linked to atherogenesis progression.


Subject(s)
Brassica/chemistry , Peptides/therapeutic use , Xanthine Oxidase/chemistry , Endothelial Cells , Humans , Peptides/pharmacology
19.
Eur Rev Med Pharmacol Sci ; 22(11): 3602-3608, 2018 06.
Article in English | MEDLINE | ID: mdl-29917215

ABSTRACT

OBJECTIVE: This study aimed at evaluating the effects obtained by administering 30 mg of micronised dispersible ferric pyrophosphate plus 300 mg of alpha-lactalbumin (MDFP-AL) compared to 80 mg of ferrous gluconate (FG) in pregnant women affected by iron-deficiency anemia (IDA). PATIENTS AND METHODS: We considered eligible all second-trimester singleton pregnancies in women affected by IDA. We excluded any other disease, twin pregnancies, any other pharmacologic/nutraceutical treatments (besides folic acid) before/during pregnancy. We randomized patients in two groups: one underwent treatment with 1 tablet of MDFP-AL/day, the other one with 1 tablet of FG/day, for 30 days. We evaluated hemoglobin (Hb), ferritin, red blood cells (RBCs), serum iron, hematocrit (Hct), and side effects at baseline (T0), after 15 days (T1) and 30 days (T2). RESULTS: 50 women met the inclusion/exclusion criteria. We did not observe significant differences between the two groups for mean age, gestational age at the enrollment and parity. In MDFP-AL group, after 15 days (T1) Hb, ferritin, serum iron and Hct and were significantly improved respect to baseline (T0); after 30 days (T2), all the parameters, including RBCs, were significantly improved respect to baseline (T0). Similarly, in FG group the investigated parameters were improved both after 15 (T1) and 30 days (T2) respect to baseline (T0), although less in percentage terms respect to MDFP-AL group. The side effects rate was 24% in FG group, whereas MDFP-AL group did not show any significant side effect. CONCLUSIONS: Overall, MDFP-AL is more effective and safe than FG for the treatment of IDA in pregnant women.


Subject(s)
Anemia, Iron-Deficiency/drug therapy , Diphosphates/therapeutic use , Iron/therapeutic use , Lactalbumin/therapeutic use , Adult , Anemia, Iron-Deficiency/pathology , Diphosphates/chemistry , Double-Blind Method , Drug Compounding , Female , Ferrous Compounds/therapeutic use , Gestational Age , Humans , Iron/chemistry , Lactalbumin/chemistry , Pregnancy , Prospective Studies , Young Adult
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