Comparison of the Efficacy and Safety of Different Doses of Linaclotide for Patients with Chronic Constipation: A Meta-Analysis and Bayesian Analysis

Background. It is ambiguous whether a higher dose of linaclotide provides higher efficacy for chronic constipation (CC) patients. The meta-analysis aimed to assess the efficacy and safety of linaclotide doses ranging from 62.5 μg to 600 μg for CC patients. Methods. A comprehensive search was conducted, and STATA16 software was used for data analysis. Results. Seven studies with 4,107 patients were eligible. A significantly enhanced number of completely spontaneous bowel movement (CSBM) responders were found in the extremely low-dose group (OR: 2.94; 95% CI: 1.98–4.34; p < 0.001 ), the low-dose group (OR: 3.24; 95% CI: 2.44–4.31; p < 0.001 ), the medium-dose group (OR: 3.08; 95% CI: 1.46–6.50; p = 0.003 ), and high-dose group (OR: 4.79; 95% CI: 3.04–7.54; p < 0.001 ). Bayesian analysis showed the high-dose group obtained the maximum CSBM responder rate (OR: 4.94; 95% credible interval (CrI): 3.22–7.79; probability rank = 0.87) indirectly compared with extremely low-dose, low-dose, and medium-dose groups. However, no significant difference presented in the CSBM responder rate by pairwise comparisons of the different dose groups. Additionally, no more any adverse events occurred in the higher linaclotide dose group (RR: 0.91; 95% CrI: 0.60–1.38) indirectly compared with other dose groups. Conclusions. High dose of linaclotide could be more effective and safer for CC patients, which need more trials to confirm in the future.

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Recombinant Human Thyrotropin-Stimulated Radioiodine Therapy in Patients with Multinodular Goiters: A Meta-Analysis of Randomized Controlled Trials

Hormone and Metabolic Research ◽

10.1055/a-1240-5058 ◽

2020 ◽

Vol 52 (12) ◽

pp. 841-849

Author(s):

Chunmei Xu ◽

Ping Wang ◽

Huikai Miao ◽

Tianyue Xie ◽

Xiaojun Zhou ◽

...

Keyword(s):

Fixed Effects ◽

Dose Group ◽

Low Dose ◽

Radioiodine Therapy ◽

Meta Analysis ◽

High Dose Group ◽

High Dose ◽

Fixed Effects Model ◽

Recombinant Human Thyrotropin

AbstractA potential reduction of goiter volume (GV) of recombinant human thyrotropin (rhTSH) on multinodular goiters (MNG) was previously reported but controversial. Hence we conducted a meta-analysis to estimate the effect of rhTSH-stimulated radioiodine therapy in patients with MNG. PubMed, Cochrane, CNKI, VIP, and Wanfang databases were searched. Mean difference (MD) and odds ratios with 95% confidence intervals (95% CI) were derived by using an inverse variance random-effects model and fixed-effects model, respectively. Six studies (n=237) were involved in the analysis. For 12 months follow up, high dose (>0.1 mg) of rhTSH significantly reduced GV (MD=17.61; 95% CI=12.17 to 23.04; p<0.00001) compared with placebo. No effective pooled results of low dose of rhTSH (<0.1 mg) were applicable for only one study included. For 6 months follow up, the source of heterogeneity was determined by subgroup and sensitivity analysis. High dose group showed vast improvement in GV reduction (MD=16.62; 95% CI=1.34 to 31.90; p=0.03). The reduction of low dose group compared with placebo was inferior to high dose group. No available data were obtained to assess the influence of rhTSH after 36 months follow up for the only included study. Hypothyroidism incidence was higher for rhTSH group. No publication bias was seen. High dose of rhTSH treatment-stimulated radioactive 131I therapy after 6 months and 12 months follow up had a better effect in reducing GV, but with higher incidence of hypothyroidism. Owing to the limited methodological quality, more clinical researches are warranted in the future.

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Effect of Antithymocyte Globulin Dosage for Prophylactic Gvhd On Epstein-Barr Virus Reactivation and Diseases in Allogeneic Hematopoietic Stem Cell Transplantation

Blood ◽

10.1182/blood.v120.21.4486.4486 ◽

2012 ◽

Vol 120 (21) ◽

pp. 4486-4486

Author(s):

Guo-pan Yu ◽

Qifa Liu ◽

Jing SUN ◽

Li Xuan ◽

Meiqing Wu ◽

...

Keyword(s):

Dose Group ◽

Low Dose ◽

High Dose Group ◽

High Dose ◽

Hematopoietic Stem ◽

Barr Virus ◽

Ebv Reactivation ◽

Epstein Barr ◽

High Degree ◽

Medium Dose

Abstract Abstract 4486 Background: Antithymocyte globulin (ATG) is one of the main risk factors for Epstein-Barr virus (EBV) reactivation and disease in allogeneic hematopoietic stem cell transplantation (allo-HSCT), however, whether there is a correlation between ATG dose and EBV reactivation is unsure. Aim of this single-center prospective study is to explore the relationship between ATG dose and EBV reactivation in allo-HSCT. Methods: Ninety-nine patients with hematologic malignancies underwent allo-HSCT and administration of ATG for graft versus host disease (GVHD) prophylaxis were enrolled in this study in Nanfang hospital from February 2008 to February 2012. Sixty-one patients were unrelated donor transplants, thirty-eight were HLA-mismatched related donor transplants. GVHD prophylactic regimen was cyclosporine A+Methotrexate+ATG. According to donors' HLA matching, we chose three dosage groups of prophylactic ATG: low dose group with ATG dose of 5.0∼6.0mg/kg (n=28), medium dose group with ATG dose of 7.0∼8.0mg/kg (n=55), and high dose group with ATG doses of ≥10mg/kg (n=16). The levels EBV-DNA in plasma were regularly monitored by quantitative real-time polymerase chain reaction (RQ-PCR). Results: With a median follow-up of 21 (range, 1–50) months post allo-HSCT, the cumulative incidence of EBV viremia and EBV-associated diseases was 17.6% (5/28) and 17.6% (5/28) in low dose group, respectively, with 32.7% (18/55) and 29.1% (16/55) in medium dose group, respectively, with 50.0% (8/16) and 31.3% (5/16) in high dose group, respectively. There were statistical significances of the incidence (χ2□□9.555, P=0.008). Logistic regression models showed that ATG prophylaxis was one of the main risk factors for EBV infection (RR=16.728, P=0.000) while bivariate correlation analysis presented that the incidence of EBV reactivation was positively correlated with ATG prophylaxis dosage (rpearman = 0.452, P = 0.000). The cumulative incidence of high degree (II∼IV°) aGVHD was 35.7% (10/28) in low dose group, with 39.6% (21/53) in total and 50.0% (6/12) in relapsed leukemia with HLA-mismatched related transplantation in medium dose group, with 68.8% (11/16) in high dose group. There were not statistical significances of the incidence (χ2□□6.971, P=0.137). Conclusion: EBV reactivation might be positively correlated with ATG prophylaxis dosage. According to donors' HLA matching, reducing ATG prophylaxis dose appropriately could prevent EBV reactivation in allo-HSCT without increasing high degree aGVHD. Disclosures: No relevant conflicts of interest to declare.

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MO004THE SAFETY PROFILE OF REPEAT RITUXIMAB TREATMENT IN ANCA-ASSOCIATED VASCULITIS - A 10 YEAR SINGLE CENTRE STUDY

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa140.mo004 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

PEK GHE TAN ◽

Jennifer O'Brien ◽

Megan Griffith ◽

Marie Condon ◽

Tom Cairns ◽

...

Keyword(s):

Adverse Events ◽

Safety Profile ◽

Dose Group ◽

Low Dose ◽

High Dose Group ◽

High Dose ◽

Single Centre ◽

Anca Associated Vasculitis ◽

Remission Maintenance ◽

Medium Dose

Abstract Background and Aims Rituximab is a proven effective induction and remission-maintenance treatment in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Studies have identified hypogammaglobulinemia, infection, and late-onset neutropenia as potential adverse events. There is limited data on long-term outcomes following extended periods of B-cell depletion therapy with rituximab in AAV cohorts. We conducted a retrospective study to examine the safety profile of repeated rituximab treatment in AAV. Method All patients with AAV treated with rituximab between 1st January 2008 and 31st December 2018 were identified through local dispensary database. Patients were stratified into low (≤4g), medium (>4g to ≤8g) and high (>8g) dose groups according to the cumulative rituximab dose received until 1st October 2019. Baseline characteristics and events including death, opportunistic and severe infections (defined as infections required hospitalization and/or intravenous antibiotic administration), neutropenia (neutrophil count ≤1.5x109/L), hypogammaglobulinemia (IgG level≤5.0), infusion reactions and malignancy diagnosed post-rituximab treatment were examined and compared between the groups. Results 364 patients (49% male, 52 year old mean age) received rituximab for treatment of active disease or remission maintenance. 49%(n=175) had repeat rituximab treatments (267/513 treatment courses for relapsing disease and 247/513 for remission maintenance). There were 262 (72%), 70(19%) and 32(9%) patients in low-, medium- and high-dose groups respectively. The median cumulative rituximab dose for each group was 2g, 6g and 12g (p<0.001). Low-dose group patients were older (59 and 40 years, p<0.001) and more likely to have renal-limited disease compared to high-dose groups (19%vs4%; p<0.05). Conversely, there were more ear-nose-throat (ENT) /ocular limited (41% and 13%; p<0.05) and antiproteinase 3 (PR3)-ANCA positive disease (56% vs 38%, p<0.05) in high-dose compared to low-dose group. The overall median duration of follow up was 72 months (QR: 28-135months)(Table1). Outcomes (Table2): Infections: no difference in serious or opportunistic infection rate between groups (1.2 vs 0.1 vs 0.1infections/patient/year; p=0.18). 77% of opportunistic infections across all groups were related to herpesvirus (e.g. Cytomegalovirus/Herpes Zoster/Herpes Simplex) reactivation. Hypogammaglobulinemia: incidence was comparable between groups (9.7% vs 10% vs 9%, p=0.91). Overall median time to event was 5 months from first rituximab. Neutropenia: 101 patients had recorded neutropenia after rituximab (Low-dose: 32%; medium-dose 16% and High-dose: 22%, p<0.05). All were related to concurrent immunosuppressants (e.g. Azathioprine, cyclophosphamide or mycophenolate) or infection. Events resolved after withdrawal or reduction of concurrent immunosuppressant or treatment of underlying infection. Cancer: No difference in malignancy rate between groups (6% vs 14% vs 3%, p=0.22). 39 malignancies reported in 32 patients post rituximab treatment. The two commonest reported cancers were skin (36%) and breast cancer (21%) Deaths: 58 patients died during the study period. Mortality rate in the low and medium-dose groups were comparable (82% survival at 30 month after last rituximab). Conversely, there were no deaths in the high-dose group. Conclusion In this large, single-centre cohort of patients with AAV, we did not observe an increased incidence of adverse events with increasing cumulative rituximab exposure. This likely reflects physician bias in patient selection for repeat treatment and suggests that in selected patients, extended periods of rituximab treatment might be safe. The superior survival seen in high-dose group was likely related to higher proportion of ENT/ocular limited vasculitis.

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Efficacy and Safety of Different Maintenance Doses of Caffeine Citrate for Treatment of Apnea in Premature Infants: A Systematic Review and Meta-Analysis

BioMed Research International ◽

10.1155/2018/9061234 ◽

2018 ◽

Vol 2018 ◽

pp. 1-11 ◽

Cited By ~ 7

Author(s):

Jing Chen ◽

Lu Jin ◽

Xiao Chen

Keyword(s):

Premature Infants ◽

Dose Group ◽

Meta Analysis ◽

Biomedical Literature ◽

High Dose Group ◽

Cochrane Library ◽

Hospital Death ◽

High Dose ◽

Efficacy And Safety ◽

Caffeine Citrate

Background. Caffeine is widely used for the treatment of neonatal apnea, but there is no agreement on the optimum maintenance dose for preterm infants. Objective. The aims of this meta-analysis were to compare the efficacy and safety of high versus low maintenance doses of caffeine citrate for the treatment of apnea in premature infants. Methods. Literature searches were conducted using PubMed, Cochrane Library, OVID, Embase, Web of Science, Chinese Biomedical Literature, Weipu Journal, Wanfang, and CNKI databases up to September 2018. Only randomized controlled trials (RCTs) of caffeine citrate for apnea treatment in premature infants were included. Trials were divided into those testing high maintenance doses (10−20 mg/kg daily) and low maintenance doses (5−10 mg/kg daily) for comparison. Data collection and extraction, quality assessment, and data analyses were performed according to the Cochrane standards. Results. Among the 345 studies initially identified, thirteen RCTs involving 1515 patients were included. Compared to the low-dose group, the high-dose group exhibited greater effective treatment rate (RR: 1.37, 95%CI: 1.18 to 1.60, P<0.0001) and success rate for ventilator removal (RR: 1.74, 95%CI: 1.04 to 2.90, P=0.03), but higher incidence of tachycardia (RR: 2.02, 5%CI: 1.30 to 3.12, P=0.002). The high-dose group also demonstrated lower extubation failure rate (RR: 0.5, 95%CI: 0.35 to 0.71, P=0.0001), frequency of apnea (WMD: -1.55, 95%CI: -2.72 to -0.39, P=0.009), apnea duration (WMD: -4.85, 95%CI: -8.29 to -1.40, P=0.006), and incidence of bronchopulmonary dysplasia (RR: 0.79, 95%CI: 0.68 to 0.91, P=0.002). There were no significant group differences in other adverse events including in-hospital death (P>0.05). Conclusions. Higher maintenance doses of caffeine citrate appear more effective and safer than low maintenance doses for treatment of premature apnea, despite a higher incidence of tachycardia.

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Dose-Dependent Efficacy of Aripiprazole in Treating Patients With Schizophrenia or Schizoaffective Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.717715 ◽

2021 ◽

Vol 12 ◽

Author(s):

Li Qian ◽

Liao Xuemei ◽

Li Jitao ◽

Su Yun'Ai ◽

Si Tianmei

Keyword(s):

Side Effects ◽

Dose Group ◽

Low Dose ◽

Meta Analysis ◽

High Dose Group ◽

Controlled Trials ◽

High Dose ◽

Randomized Controlled ◽

Syndrome Scale ◽

Mean Differences

Purpose: To compare the efficacy and tolerability of different administration strategies of aripiprazole.Methods: We searched MEDLINE, EMBASE, the Cochrane Central, Web of Science, China National Knowledge Infrastructure(CNKI), and Wanfang Data Knowledge Service Platform(Wanfang) for randomized controlled trials (RCTs) of aripiprazole, using the terms: (aripiprazole) AND (schizophr* OR schizoaff*) AND (“syndrome scale” OR PANSS) AND (clini* OR trial). We retrieved study design, participant characteristics, comparison groups, and outcomes from each study.Results: In total, nine RCTs were selected for meta-analysis, which covered ~1,187 participants. We defined two treatment groups that represent different treatment strategies: (1) the high-dose group (the high-dose strategy) rapidly increased to doses higher than 15 mg/day in 2 weeks or began with doses higher than 15 mg/day, otherwise the group was defined as (2) the low-dose group (the low-dose strategy). If the initial or target doses of aripiprazole in a study were all higher than 15 mg/day, the high- and low-dose groups were created based on the relative level of the dose. The high-dose group showed significantly greater reductions in Positive and Negative Syndrome Scale (PANSS) total scores (standardized mean differences = −8.31, 95% confidence interval [CI] = −16.48, −0.13; P < 0.01; I2 = 96%) than the low-dose group. The high-dose group showed superior effects compared with the low-dose group in long-term studies (more than 8 weeks) (standardized mean differences = −13.81, 95% CI = −25.07, −2.55; P < 0.01; I2 = 96%). With exception of somnolence, we did not find significant differences in side effects or discontinuation due to adverse events. Sensitivity analyses produced similar results.Conclusion: The high-dose treatment strategy of aripiprazole for patients with schizophrenia or schizoaffective disorder may bring more benefits without obvious side effects.

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Newly Developed Recombinant Antithrombin Protects the Endothelial Glycocalyx in an Endotoxin-Induced Rat Model of Sepsis

International Journal of Molecular Sciences ◽

10.3390/ijms22010176 ◽

2020 ◽

Vol 22 (1) ◽

pp. 176

Author(s):

Toshiaki Iba ◽

Jerrold H. Levy ◽

Koichiro Aihara ◽

Katsuhiko Kadota ◽

Hiroshi Tanaka ◽

...

Keyword(s):

Dose Group ◽

Low Dose ◽

Leukocyte Adhesion ◽

Endothelial Glycocalyx ◽

High Dose Group ◽

Control Group ◽

High Dose ◽

Protective Effects ◽

Circulating Levels

(1) Background: The endothelial glycocalyx is a primary target during the early phase of sepsis. We previously reported a newly developed recombinant non-fucosylated antithrombin has protective effects in vitro. We further evaluated the effects of this recombinant antithrombin on the glycocalyx damage in an animal model of sepsis. (2) Methods: Following endotoxin injection, in Wistar rats, circulating levels of hyaluronan, syndecan-1 and other biomarkers were evaluated in low-dose or high-dose recombinant antithrombin-treated animals and a control group (n = 7 per group). Leukocyte adhesion and blood flow were evaluated with intravital microscopy. The glycocalyx was also examined using side-stream dark-field imaging. (3) Results: The activation of coagulation was inhibited by recombinant antithrombin, leukocyte adhesion was significantly decreased, and flow was better maintained in the high-dose group (both p < 0.05). Circulating levels of syndecan-1 (p < 0.01, high-dose group) and hyaluronan (p < 0.05, low-dose group; p < 0.01, high-dose group) were significantly reduced by recombinant antithrombin treatment. Increases in lactate and decreases in albumin levels were significantly attenuated in the high-dose group (p < 0.05, respectively). The glycocalyx thickness was reduced over time in control animals, but the derangement was attenuated and microvascular perfusion was better maintained in the high-dose group recombinant antithrombin group (p < 0.05). (4) Conclusions: Recombinant antithrombin maintained vascular integrity and the microcirculation by preserving the glycocalyx in this sepsis model, effects that were more prominent with high-dose therapy.

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Effect of Different Doses of Propofol and Nerve block Combined with General Anesthesia on The Intraoperative Anesthesia and Postoperative Awakening and Cognitive Function in Elderly Patients with Knee Osteoarthritis

Tobacco Regulatory Science ◽

10.18001/trs.7.4.1.23 ◽

2021 ◽

Vol 7 (4) ◽

pp. 697-705

Author(s):

Jianhui Ma ◽

Meimei Pang ◽

Xin Ding ◽

Shirong Fang ◽

Lichao Chu

Keyword(s):

Cognitive Function ◽

Elderly Patients ◽

General Anesthesia ◽

Nerve Block ◽

Dose Group ◽

Low Dose ◽

High Dose Group ◽

High Dose ◽

Knee Oa ◽

Different Doses

Objective. To explore the effect of different doses of propofol and nerve block combined with general anesthesia on the intraoperative anesthesia and postoperative awakening and cognitive function in elder patients with knee osteoarthritis (OA). Methods. According to the inclusion criteria for research object, we selected 98 elderly patients with knee OA who needed surgery and were admitted to our hospital from January 2019 to January 2021 for the study. Patients were divided into the low dose group (given 2 mg/kg propofol by pumping under constant speed during surgery) and the high dose group (given 4 mg/kg propofol by pumping during surgery) by the number table method to compare their indicators including the intraoperative anesthesia effect, with 49 cases in each group. Results. No between-group difference was shown in the anesthesia time and postoperative VAS scores, but the awakening time of the low dose group was significantly shorter than that of the high dose group (P<0.05); the differences in heart rate (HR) values at various time points between the two groups were not obvious, but the high dose group obtained significantly higher HR values at T4 than the low dose group; the mean arterial pressure (MAP) values of both groups were significantly reduced at Ti and then returned to the level before anesthesia (P>0.05); the bispectral index scores (BIS) of both groups experienced a marked drop at Ti and then recovered gradually, but failed to return to the level at T0 till the end, and a between-group difference in BIS indexes presented at Ti; the plasma corticosterone (CORT) concentration at Ti of both groups were significantly lowered and then returned to the level at T0, with no between-group difference; and compared with the low dose group, the high dose group achieved slightly lower mini-mental state examination (MMSE) scores at 24-72 h after surgery, with no significant difference between them (P>0.05). Conclusion. The therapy of different doses of propofol and nerve block combined with general anesthesia has no significant effect on the cognitive function in elderly knee OA patients after surgery. With the nerve block improving the analgesic effect, a low dose of propofol is good for the postoperative awakening of patients. Different doses of propofol inhibited the stress response to a different degree and produced good anesthesia outcomes in elderly patients, but comparatively speaking, a low-dose propofol ensures more smooth indexes and less effect on the intraoperative hemodynamics.

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Comparison of the in-vivo Effect of Two Tranexamic Acid Doses on Fibrinolysis Parameters in Adults Undergoing Valvular Cardiac Surgery with Cardiopulmonary Bypass - A Pilot Investigation

10.21203/rs.3.rs-65365/v1 ◽

2020 ◽

Author(s):

Zhen-feng ZHOU ◽

Wen Zhai ◽

Li-na YU ◽

Kai SUN ◽

Li-hong SUN ◽

...

Keyword(s):

Cardiac Surgery ◽

Placebo Group ◽

Cardiopulmonary Bypass ◽

Plasminogen Activator ◽

Dose Group ◽

Low Dose ◽

High Dose Group ◽

High Dose ◽

Pai 1

Abstract Background: The blood saving efficacy of TXA in cardiac surgery has been proved in several studies, but TXA dosing regimens were varied in those studies. Therefore, we performed this study to investigate if there is a dose dependent in-vivo effect of TXA on fibrinolysis parameters by measurement of fibrinolysis markers in adults undergoing cardiac surgery with CPB, which has not been systematically elucidated.Methods: A double-blind, randomized, controlled prospective trial was conducted from February 11, 2017 to May 05, 2017. Thirty patients undergoing cardiac valve surgery were identified and randomly divided into a placebo group, low-dose group and high-dose group by 1: 1: 1. Fibrinolysis parameters were measured by plasma levels of D-Dimers, plasminogen activator inhibitor-1 (PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI), plasmin-antiplasmin complex (PAP), tissue plasminogen activator (tPA) and thrombomodulin (TM). Those proteins were measured at five different sample times: preoperatively before the TXA injection (T1), 5 min after the TXA bolus (T2), 5 min after the initiation of CPB (T3), 5 min before the end of CPB (T4) and 5 min after the protamine administration (T5). A Thrombelastography (TEG) and standard coagulation test were also performed.Results: Compared with the control group, the level of the D-Dimers decreased in the low-dose and high-dose groups when the patients arrived at the ICU and on the first postoperative morning. Over time, the concentrations of PAI-1, TAFI, and TM, but not PAP and tPA, showed significant differences between the three groups (p <0.05). Compared with the placebo group, the plasma concentrations of PAI-1 and TAFI decreased significantly at the T3 and T4 (p <0.05); TAFI concentrations also decreased at the T5 in low-dose group (p <0.05). Compared with the low-dose group, the concentration of TM increased significantly at the T4 in high-dose group. No significant differences were observed in the levels of the coagulation proteins at any points between the groups.Conclusions: The vivo effect of low dose TXA is equivalent to high dose TXA on fibrinolysis parameters in adults undergoing valvular cardiac surgery with cardiopulmonary bypass, and we recommend a low dose TXA regimen for those patients.Clinical trial number and registry URL: ChiCTR-IPR-17010303; http://www.chictr.org.cn, Principal investigator: Zhen-feng ZHOU, Date of registration: January 1, 2017.

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Research on the Effects of the Extract of Polygala fallax Hemsl on Sex Hormones and ?-EP in Perimenopausal Rat Models

Journal of Clinical and Nursing Research ◽

10.26689/jcnr.v4i3.1235 ◽

2020 ◽

Vol 4 (3) ◽

Author(s):

Siyuan Yang ◽

Zhiyong Cao ◽

Jiabao Chen ◽

Gang Fang

Keyword(s):

Menstrual Cycle ◽

Sex Hormones ◽

Dose Group ◽

Low Dose ◽

Normal Group ◽

Dose Effect ◽

High Dose Group ◽

High Dose ◽

Model Group ◽

Rat Models

Objective: To study the effects of the ethnic medicine Polygala fallax Hemsl with Guangxi characteristics on the sex hormones and ?-EP in research objective perimenopausal rat models. Methods: 40 female SPF rats were randomly divided into 4 groups, including the normal, model, high-dose and low-dose groups. Rats of three groups except for the normal one were treated with perimenopausal modelling through the method of subcutaneous injection of compound 4-VCD for 15 consecutive days. Rats of the normal and model group were normally fed without any treatment. Rats of the high-dose and low-dose groups were administered by high- and low-dose intragastric administration of the extract of Polygala fallax Hemsl. According to the menstrual cycle of the vaginal smear of the rat, each menstrual cycle is a course of treatment and 6 consecutive courses of treatment would be given. The indexes of serum sex hormones (E2, FSH, LH) and ?-EP of rats in each group were observed after treatment. Results: After the treatment of 6 cycles, for the levels of ?-EP and E2, the model group was lowest (P<0.05), the normal group was highest (P<0.05); and the high-dose group was higher than the low-dose group; For the levels of FSH and LH, the normal group was lowest (P<0.05), the model group was highest (P<0.05), and the high-dose group was lower than the low-dose group. Conclusion: Guangxi characteristic national medicine Polygala fallax Hemsl can effectively improve the levels of serum sex hormones and ?-EP in perimenopausal rat models and relieve the related symptoms with a certain dose-effect relationship.

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