Methylprednisolone In Patients Research Articles

Efficacy of methylprednisolone in very early systemic sclerosis: results of the "Hit hard and early'' randomized controlled trial.

We hypothesized that glucocorticoids would induce remission in very early Systemic Sclerosis patients by inhibition of inflammation driving the disease. We examined the efficacy and safety of methylprednisolone in very early Systemic Sclerosis. In this trial adults with puffy fingers for less than three years, specific auto-antibodies and meeting the Very Early Diagnosis of Systemic Sclerosis criteria were randomly assigned (2:1) to methylprednisolone 1000 mg intravenously or placebo for 3 consecutive days 3 times with monthly intervals. The primary end point was nailfold capillary density at week 12. Capillary density at 52 weeks, number of megacapillaries, and patient-reported outcomes were secondary outcomes. In addition, we assessed disease progression and lung function decline over 52 weeks. We used linear regression analyses adjusted for baseline values and stratification variables to estimate differences between groups. Between February 2017 and February 2021, 87 patients were screened, of whom 30 (70% female, median (IQR) age 52·9 (40·8-60·8) years, median (IQR) disease duration 11.4 (4.6-18.6) months) were randomly assigned to methylprednisolone (n = 21) or placebo (n = 9). We found no difference in nailfold capillary density at 12 weeks: -0.5 (95% CI 1.1, 0.2) nor in any of the secondary outcomes. Eleven (37%) patients showed disease progression during 1 year follow up, 7 (23%) patients had a relevant pulmonary function decline. No serious adverse events were reported. No clinically relevant effect of short-term methylprednisolone in patients with very early Systemic Sclerosis was observed. A substantial proportion of patients showed disease progression.

Thyroid stimulating immunoglobulin concentration is associated with disease activity and predicts response to treatment with intravenous methylprednisolone in patients with Graves' orbitopathy.

Thyroid stimulating immunoglobulins (TSI) play a central role in the pathogenesis of Graves' orbitopathy (GO), while soluble interleukin-2 receptor (sIL-2R) is a marker for T-cell activity. We investigated TSI and sIL-2R levels in relation to thyroid function, disease activity and severity and response to treatment with intravenous methylprednisolone (IVMP) in patients with GO. TSI (bridge-based TSI binding assay), sIL-2R, TSH and fT4 levels were measured in biobank serum samples from 111 GO patients (37 male, 74 female; mean age 49.2 years old) and 25 healthy controls (5 male, 20 female; mean age 39.8 years old). Clinical characteristics and response to treatment were retrospectively retrieved from patient files. Higher sIL-2R levels were observed in GO patients compared to controls (p < 0.001). sIL-2R correlated with fT4 (r = 0.26), TSH (r = -0.40) and TSI (r = 0.21). TSI and sIL-2R concentrations were higher in patients with active compared to inactive GO (p < 0.001 and p < 0.05, respectively). Both TSI and sIL-2R correlated with total clinical activity score (CAS; r = 0.33 and r = 0.28, respectively) and with several individual CAS items. Cut-off levels for predicting active GO were 2.62 IU/L for TSI (AUC = 0.71, sensitivity 69%, specificity 69%) and 428 IU/mL for sIL-2R (AUC = 0.64, sensitivity 62%, specificity 62%). In multivariate testing higher TSI (p < 0.01), higher age (p < 0.001) and longer disease duration (p < 0.01) were associated with disease activity. TSI levels were higher in patients with a poor IVMP response (p = 0.048), while sIL-2R levels did not differ between responders and non-responders. TSI cut-off for predicting IVMP response was 19.4 IU/L (AUC = 0.69, sensitivity 50%, specificity 91%). In multivariate analysis TSI was the only independent predictor of response to IVMP (p < 0.05). High TSI levels are associated with active disease (cut-off 2.62 IU/L) and predict poor response to IVMP treatment (cut-off 19.4 IU/L) in GO. While sIL-2R correlates with disease activity, it is also related to thyroid function, making it less useful as an additional biomarker in GO.

Retracted: Study on the Efficacy and Safety of Ambroxol Combined with Methylprednisolone in Patients with Acute Lung Injury.

[This retracts the article DOI: 10.1155/2021/5771101.].

The Effect of Methylprednisolone on the Clinical and Laboratory Manifestations of a New Coronavirus Disease - 2019 Complicated by Severe Pneumonia

The article presents current data on the use of methylprednisolone in patients with COVID-19 (COronaVIrus Disease 2019) and severe pneumonia. The author presents his own observation of patients with COVID-19 complicated by severe pneumonia, where different modes of “pulse therapy” with methylprednisolone were used. It was shown that therapy with high doses of methylprednisolone had a positive effect on the course of COVID-19 complicated by severe pneumonia. On the background of therapy with methylprednisolone in the form of a pulse, the levels of interleukin-6, C-reactive protein in the blood and the erythrocyte sedimentation rate significantly decreased. During treatment with methylprednisolone, the blood pressure level remained stable, the thermometry and the degree of blood oxygen saturation normalized. During the observation of patients with COVID-19 complicated by severe pneumonia who received methylprednisolone in the form of “pulse therapy”, no undesirable effects were noted. Hyperglycemia was transient and did not require hypoglycemic therapy.

Glucocorticoid-induced adrenal insufficiency after therapy with intravenous methylprednisolone in patients with moderate-to-severe and active Graves' orbitopathy: assessment with a low-dose corticotropin test.

We aimed to assess adrenal function following treatment of moderate-to-severe and active Graves' orbitopathy (GO) with intravenous methylprednisolone (IVMP) in weekly pulses in a cumulative dose of 4.5 or 7.5g. We evaluated the impact of IVMP pulses on adrenal reserve using a low-dose (1μg) ACTH stimulation test (LDT) for the first time. In this prospective study we evaluated adrenal function in 21 patients with moderate-to-severe and active GO treated with 12 weekly IVMP pulses according to the European Group on Graves' Orbitopathy (EUGOGO) recommendations. We assessed serum cortisol, plasma adrenocorticotropic hormone (ACTH), and dehydroepiandrosterone sulfate (DHEA-S) levels before the 1st and 12th IVMP pulse. We performed dynamic testing using LDT before the 12th IVMP pulse in all patients. In those who failed LDT, adrenal function was reassessed with LDT and the overnight metyrapone test after 4-7weeks. Two patients failed to achieve serum cortisol levels ≥ 18.1μg/dL at 30 and 60min in LDT and were diagnosed with glucocorticoid-induced adrenal insufficiency (GC-induced AI). They were recommended to take hydrocortisone in situations of acute stress. Both patients were reassessed within 4-7weeks after treatment cessation and showed an adequate response in LDT and overnight metyrapone test. We observed a statistically significant decrease in DHEA-S levels (p = 0.004) before the 12th IVMP pulse compared to baseline in all patients. For the first time, our research shows that administering IVMP in 12 weekly pulses can result in GC-induced AI. We suggest that patients should undergo careful evaluation for GC-induced AI, including LDT, after therapy with IVMP according to EUGOGO guidelines. Screening for altered adrenal reserve could prevent life-threatening complications, particularly during acute stress situations.

MARVEL: A Randomized Double‐Blind, Placebo‐Controlled Trial in Patients Undergoing Endovascular Therapy: Study Rationale and Design

Background Steroids have pleiotropic neuroprotective actions including the regulation of inflammation and apoptosis which may influence the effects of ischemia on neurons, glial cells, and blood vessels. The effect of low‐dose methylprednisolone in patients with acute ischemic stroke in the endovascular therapy era remains unknown. This trial investigates the efficacy and safety of low‐dose methylprednisolone (2 mg/kg IV for 3 days) as adjunctive therapy for patients with acute ischemic stroke undergoing endovascular therapy within 24 hours from symptom onset. Methods The MARVEL (Methylprednisolone as Adjunctive Therapy for Acute Large Vessel Occlusion: A Randomized Double‐Blind, Placebo‐Controlled Trial in Patients Undergoing Endovascular Therapy) trial is an investigator‐initiated, prospective, randomized, double‐blind, placebo‐controlled multicenter clinical trial. Up to 1672 eligible patients with anterior circulation large‐vessel occlusion stroke presenting within 24 hours from symptom onset are planned to be consecutively randomized to receive methylprednisolone or placebo in a 1:1 ratio across 82 stroke centers in China. Results The primary outcome is the ordinal shift in the modified Rankin scale score at 90 days. Secondary outcomes include 90‐day functional independence (modified Rankin scale score, 0–2). The primary safety end points include mortality rate at 90 days and symptomatic intracerebral hemorrhage within 48 hours of endovascular therapy. Conclusion The MARVEL trial will provide evidence of the efficacy and safety of low‐dose methylprednisolone as adjunctive therapy for patients with anterior circulation large‐vessel occlusion stroke undergoing endovascular therapy.

Retracted: Clinical Efficacy of Gandakang Tablets plus Methylprednisolone in Patients with Systemic Lupus Erythematosus.

[This retracts the article DOI: 10.1155/2022/4797454.].

Incidence and Severity of COVID-19 Infection After Pulse Methylprednisolone in Patients with Multiple Sclerosis

Incidence and Severity of COVID-19 Infection After Pulse Methylprednisolone in Patients with Multiple Sclerosis

To Investigate the Efficacy of Long-Term Step-Reduction Methylprednisolone in the Treatment of Severe Persistent Thrombocytopenia after CAR-T Cell Therapy

We collected patients with thrombocytopenia after chimeric antigen receptor (CAR)T cell therapy for non-Hodgkin lymphoma in our center, and retrospectively analyzed the clinical characteristics of methylprednisolone for the treatment of thrombocytopenia after (CAR)T cell therapy .The primary objective was to evaluate the efficacy and safety of long-term step-reduced methylprednisolone in patients with severe persistent thrombocytopenia(Thrombocytopenia ≥ grade 3, duration≥2 weeks) after CAR-T cell therapy. This study retrospectively analyzed patients with non-Hodgkin lymphoma who received chimeric antigen receptor (CAR) T cell therapy in Tongji Hospital Affiliated to Tongji University from November 2018 to July 2023. 34 patients developed thrombocytopenia during treatment and follow-up,5 patients lost to follow-up;1 patient died of COVID-19 pneumonia;10 patients with thrombocytopenia after CAR-T cell therapy had poor response to TPO-RA, blood transfusion, and methylprednisolone, all of them progressed rapidly due to poor efficacy of CAR T cell therapy. The other 18 (CAR) T cell therapy patients with thrombocytopenia were all CR(Complete remission) assessed after 3 months (Table 1). Further analysis of the 18 patients with thrombocytopenia after (CAR) T cell therapy. The median follow-up period was 11.29 months (range,2.7 to 25.4 months), the lowest platelet count occurred 27.3 days (range, 4-106 days) after (CAR) T cell therapy. The incidence of grade 3-4 thrombocytopenia was 100%, and the incidence of grade 4 thrombocytopenia was 66.7%. The incidence of thrombocytopenia before (CAR) T cell therapy was 55.6%, all of them were grade 1-2 thrombocytopenia. Among them,11 patients with grade 3-4 thrombocytopenia with a duration＜2 weeks were effective of TPO-RA and platelet transfusion(Figure 1).7 patients with grade 3-4 thrombocytopenia with a duration≥2 weeks did not respond to treatment with TPO-RA or platelet transfusion, but long-term step-reduction methylprednisolone was effective (Figure 2). 7patients with thrombocytopenia who did not respond to TPO-RA or platelet transfusion,and were finally effective in methylprednisolone were further analyzed. The initial prednisone dose of methylprednisone was 1mg/kg/ day for 5-7 days, The dose was reduced step by step until platelets recovered to grade 1(Figure 3A).the median response time of the treatment was 16.6 days (range,6-30 days). Among them, 3 patients treated with methylprednisolone at a dose of 1mg/kg/ day for 5 day and then stop,after the discontinuation of methylprednisolone, relapse of thrombocytopenia occurred and the symptoms were relieved again after long-term step-reduction methylprednisolone treatment (Figure 3B). Apart from drug-controlled hyperglycemia and hypertension, we observed no other side effects of prednisone. Further, we found the median OS of the 7 patients who were treated with methylprednisolone was 28 months, and the median OS of the 11 patients who responded to TPO-RA was undefined (95% confidence interval 0.5296 to 25.06), with no significant difference in OS between the two groups (P=0.1224)(Figure 4) .The median PFS of the patients who were treated with methylprednisolone was 16 months, and the median PFS of the 11 patients who responded to TPO-RA was undefined (95% confidence interval 1.253 to 34.54), with a significant differences in PFS between the two groups (P=0.0063) (Figure 4). Studies have shown that long-term step-reduction methylprednisolone is effective in severe persistent thrombocytopenia (Thrombocytopenia ≥ grade 3, duration≥2 weeks) .There was no significant difference in OS between the the patients who did not respond to TPO-RA, platelet transfusion,and were finally treated with methylprednisolone and the patients who responded to TPO-RA, platelet transfusion, but PFS of the patients were treated with methylprednisolone was shorter, suggesting that severe and persistent thrombocytopenia may be related to disease progression.

Comparison of visual acuity recovery in 3-,5-, and 7-day schedules of intravenous methylprednisolone in patients with optic neuritis: a case-control study (P13-5.018)

Comparison of visual acuity recovery in 3-,5-, and 7-day schedules of intravenous methylprednisolone in patients with optic neuritis: a case-control study (P13-5.018)

Treatment With Erythropoietin for Patients With Optic Neuritis: Long-term Follow-up.

Erythropoietin (EPO) is a candidate neuroprotective drug. We assessed its long-term safety and efficacy as an adjunct to methylprednisolone in patients with optic neuritis and focused on conversions to multiple sclerosis (MS). The TONE trial randomized 108 patients with acute optic neuritis but without previously known MS to either 33,000 IU EPO or placebo in conjunction with 1,000 mg methylprednisolone daily for 3 days. After reaching the primary end point at 6 months, we conducted an open-label follow-up 2 years after randomization. The follow-up was attended by 83 of 103 initially analyzed patients (81%). There were no previously unreported adverse events. The adjusted treatment difference of peripapillary retinal nerve fiber layer atrophy in relation to the fellow eye at baseline was 1.27 µm (95% CI -6.45 to 8.98, p = 0.74). The adjusted treatment difference in low-contrast letter acuity was 2.87 on the 2.5% Sloan chart score (95% CI -7.92 to 13.65). Vision-related quality of life was similar in both treatment arms (National Eye Institute Visual Functioning Questionnaire median score [IQR]: 94.0 [88.0 to 96.9] in the EPO and 93.4 [89.5 to 97.4] in the placebo group). The rate of multiple sclerosis-free survival was 38% in the placebo and 53% in the EPO group (hazard ratio: 1.67, 95% CI 0.96 to 2.88, p = 0.068). In line with the results at 6 months, we found neither structural nor functional benefits in the visual system of patients with optic neuritis as a clinically isolated syndrome, 2 years after EPO administration. Although there were fewer early conversions to MS in the EPO group, the difference across the 2-year window was not statistically significant. This study provides Class II evidence that for patients with acute optic neuritis, EPO as an adjunct to methylprednisolone is well tolerated and does not improve long-term visual outcomes. The trial was preregistered before commencement at clinicaltrials.gov (NCT01962571).

Effect of 2 Different High-Dose Methylprednisolone Treatments on Clinical Outcomes in Severe COVID-19 Patients.

The present study aimed to evaluate and compare the use of 2 different high-dose methylprednisolone posology in treating severe coronavirus disease 2019 pneumonia regarding mortality and recovery time between themselves and against steroidal/ non-steroidal treatment. Severe coronavirus disease 2019 patients followed up between March 2020 and January 2021 were included. The steroid-free treatment protocol was applied before August 2020 (non-pulse group) and a treatment algorithm containing normal and high doses of methylprednisolone was applied after August 2020 (pulse group). Patients with clinical deterioration under the normal dose of methylprednisolone were administered 250 mg or 1000 mg of methylprednisolone for 3 days. We compared the pulse and non-pulse groups, in addition to pulse subgroups with each other, for clinical outcomes. A total of 138 patients were included, including 36 patients in the non-pulse group and 102 in the pulse group. In the pulse group, 70 patients received 1000 mg/day and 32 received 250 mg/day of high-dose methylprednisolone therapy. In the comparison of pulse and non-pulse patient groups, mortality rate was lower in the pulse group (P < .001), and the time to discharge without oxygen support was shorter. Although the patients in the 250 mg subgroup were older, there was no difference between the 250 mg and 1000 mg subgroups in terms of end of oxygen requirement, discharge with oxygen support, and mortality. In addition, the required time to reach the oxygen-free period in patients discharged without oxygen support was similar in the 2 subgroups, and the majority of patients in both subgroups reached the oxygen-free period on the 20th day after initiating methylprednisolone. Since there was no difference in clinical improvement between the use of 250 mg or 1000 mg methylprednisolone in patients with severe coronavirus disease 2019 infection, 1000 mg methylprednisolone was not required.

A radiomics model for predicting the response to methylprednisolone in brain necrosis after radiotherapy for nasopharyngeal carcinoma

BackgroundMethylprednisolone is recommended as the front-line therapy for radiation-induced brain necrosis (RN) after radiotherapy for nasopharyngeal carcinoma. However, some patients fail to benefit from methylprednisolone or even progress. This study aimed to develop and validate a radiomic model to predict the response to methylprednisolone in RN.MethodsSixty-six patients receiving methylprednisolone were enrolled. In total, 961 radiomic features were extracted from the pre-treatment magnetic resonance imagings of the brain. Least absolute shrinkage and selection operator regression was then applied to construct the radiomics signature. Combined with independent clinical predictors, a radiomics model was built with multivariate logistic regression analysis. Discrimination, calibration and clinical usefulness of the model were assessed. The model was internally validated using 10-fold cross-validation.ResultsThe radiomics signature consisted of 16 selected features and achieved favorable discrimination performance. The radiomics model incorporating the radiomics signature and the duration between radiotherapy and RN diagnosis, yielded an AUC of 0.966 and an optimism-corrected AUC of 0.967 via 10-fold cross-validation, which also revealed good discrimination. Calibration curves showed good agreement. Decision curve analysis confirmed the clinical utility of the model.ConclusionsThe presented radiomics model can be conveniently used to facilitate individualized prediction of the response to methylprednisolone in patients with RN.

High doses of methylprednisolone in patients with severe COVID-19 infection

High doses of methylprednisolone in patients with severe COVID-19 infection

Tennis elbow: a prospective comparative clinical study comparing the outcome of conservative of management local infiltrations of leucocyte enriched platelet-rich plasma and glucocorticoid

Background: Lateral epicondylitis is a painful condition of the elbow, characterised by pain and tenderness with resisted wrist extension. This study was carried out to evaluate the comparative efficacy of the local infiltration of leucocyte enriched platelet rich plasma (L-PRP) and methylprednisolone in patients with lateral epicondylitis.Methods: Sixty adult patients, between the ages 30 to 50 years, diagnosed with lateral epicondylitis of more than 12 weeks, were enrolled in the prospective randomised study. Their medical history and previous conservative treatment were recorded; the clinical evaluation of the tendinitis was made with the visual analogue scale (VAS), the disabilities of the arm, shoulder, and hand (DASH) outcome scores, the modified elbow performance index (MEPS), the functional assessment by patient-rated tennis elbow evaluation (PRTEE), together with the laboratory investigations. The patients were randomised using the computer-generated alphabets into two groups of 30: group A received PRP, and group B received corticosteroid.Results: Patients were seen at 4, 8 and 12 weeks to evaluate the post-injection status. VAS, DASH, and PRTEE scores were significantly reduced, and MEPS was significantly improved in group A compared to group B.Conclusions: PRP leads to superior healing with long-term therapeutic advantages compared to corticosteroids though it takes a little longer to have its effect.

The Comparison of Efficacy of Platelet Rich Plasma (PRP) with Methylprednisolone in Patients with Tennis Elbow

Objective: To study the efficacy of platelet-rich plasma with Methylprednisolone in patients with tennis elbow.&#x0D; Study Design: Prospective longitudinal study.&#x0D; Place and Duration of Study: Department of Orthopedics, Jinnah Postgraduate Medical Centre, Karachi, Feb 2019 to Sep 2020.&#x0D; Methodology: All the patients with chronic lateral epicondylitis with the onset of symptoms of greater than three months were grouped into two groups. Seventy-six patients in each group were treated. Group-A received an injection of 5ml Platelet-rich plasma. Group-B was administered 1 ml of Methylprednisolone (dosage; 4-30 mg). The severity of pain using the visual analogue scale was evaluated at baseline.&#x0D; Results: In the PRP group, significant changes in pain perception were observed. The mean baseline VAS score in the PRP group was 6.9 ± 1.7, which decreased to 3.4 ± 2.9, 1.7 ± 0.3, and 1.2 ± 1.4 at four weeks, 12 weeks, and 52 weeks follow-up visit, respectively. Similarly, in group-B (Methylprednisolone), there was a significant change from baseline to 52 weeks postprocedure (p&lt;0.001). It was found that the efficacy of Platelet free plasma was significantly higher than methylprednisolone (77.6% versus 48.7%, &lt;0.005).&#x0D; Conclusions: The study concluded that Plasma rich platelet therapy was significantly more effective in relieving the pain and improving the functional outcomes in patients with elbow epicondylitis than Methylprednisolone.

Evaluation of personalized methylprednisolone therapy in critically ill COVID-19 patients: an observational comparative study using real-life data.

Methylprednisolone is commonly used to attenuate the cytokine storm and prevent mortality in COVID-19 pneumonia. However, the optimal methylprednisolone dose and duration are unclear. Additional data are required on the effectiveness of methylprednisolone in reducing mortality in COVID-19. This real-life retrospective study aimed to analyze the data of a COVID-19 dedicated ICU and compare the mortality rates of standard care, low-dose, and pulse-dose methylprednisolone in patients requiring mechanical ventilatory support. Methylprednisolone's indication, dose, and duration were determined according to the severity of COVID-19 pneumonia based on the patient's demographic parameters, comorbidities, laboratory data, radiology, and arterial blood gas analysis results. 867 patients were grouped as: no methylprednisolone (standard care), low-dose (0.5-1 mg/kg/day) methylprednisolone or pulse-dose (250-1,000 mg/day) methylprednisolone. The overall mortality rate was 63.78%. Adjusting the dose of methylprednisolone according to the severity of the disease resulted in statistically similar mortality rates despite the increase in disease severity. Mortality was 62.71% in standard treatment, 65.76% in low-dose, and 62.10% in pulse-dose methylprednisolone groups (p = 0.633). Invasive mechanical ventilation at admission was associated with increased mortality (HR: 1.826 [95% CI: 1.542-2.161]; p < 0.001). Hematologic disorders and malignancies, arterial blood pH and HCO3, neutrophil count, and NLR at admission were also associated with mortality. Personalizing the dose and duration of methylprednisolone according to the patient's disease severity assessed with demographic, clinical, and laboratory results may benefit mortality in severe COVID-19 patients receiving ventilatory support in the ICU. Hematologic disorders and malignancies, arterial blood pH and HCO3, neutrophil count, and NLR at admission were associated with mortality in our patient cohort.

Methylprednisolone in the treatment of lymphangioleiomyomatosis

This case report proposes the use of pulsed methylprednisolone in a patient with lymphangioleiomyomatosis (LAM) who was invasively ventilated. A 38-year-old, East Indian gravida 4, para 1+2, patient with worsening respiratory function with spontaneous pneumothoraxes and hypoxemia was pulsed with methylprednisolone leading to rapid resolution of respiratory failure.The author proposes pulsed methylprednisolone in ventilated LAM patients, which gives another option to patients which resulted in alleviation of hypoxemia and maintaining foetal viability.

Effect of Oral Methylprednisolone on Decline in Kidney Function or Kidney Failure in Patients With IgA Nephropathy

The effect of glucocorticoids on major kidney outcomes and adverse events in IgA nephropathy has been uncertain. To evaluate the efficacy and adverse effects of methylprednisolone in patients with IgA nephropathy at high risk of kidney function decline. An international, multicenter, double-blind, randomized clinical trial that enrolled 503 participants with IgA nephropathy, proteinuria greater than or equal to 1 g per day, and estimated glomerular filtration rate (eGFR) of 20 to 120 mL/min/1.73 m2 after at least 3 months of optimized background care from 67 centers in Australia, Canada, China, India, and Malaysia between May 2012 and November 2019, with follow-up until June 2021. Participants were randomized in a 1:1 ratio to receive oral methylprednisolone (initially 0.6-0.8 mg/kg/d, maximum 48 mg/d, weaning by 8 mg/d/mo; n = 136) or placebo (n = 126). After 262 participants were randomized, an excess of serious infections was identified, leading to dose reduction (0.4 mg/kg/d, maximum 32 mg/d, weaning by 4 mg/d/mo) and addition of antibiotic prophylaxis for pneumocystis pneumonia for subsequent participants (121 in the oral methylprednisolone group and 120 in the placebo group). The primary end point was a composite of 40% decline in eGFR, kidney failure (dialysis, transplant), or death due to kidney disease. There were 11 secondary outcomes, including kidney failure. Among 503 randomized patients (mean age, 38 years; 198 [39%] women; mean eGFR, 61.5 mL/min/1.73 m2; mean proteinuria, 2.46 g/d), 493 (98%) completed the trial. Over a mean of 4.2 years of follow-up, the primary outcome occurred in 74 participants (28.8%) in the methylprednisolone group compared with 106 (43.1%) in the placebo group (hazard ratio [HR], 0.53 [95% CI, 0.39-0.72]; P < .001; absolute annual event rate difference, -4.8% per year [95% CI, -8.0% to -1.6%]). The effect on the primary outcome was seen across each dose compared with the relevant participants in the placebo group recruited to each regimen (P for heterogeneity = .11): full-dose HR, 0.58 (95% CI, 0.41-0.81); reduced-dose HR, 0.27 (95% CI, 0.11-0.65). Of the 11 prespecified secondary end points, 9 showed significant differences in favor of the intervention, including kidney failure (50 [19.5%] vs 67 [27.2%]; HR, 0.59 [95% CI, 0.40-0.87]; P = .008; annual event rate difference, -2.9% per year [95% CI, -5.4% to -0.3%]). Serious adverse events were more frequent with methylprednisolone vs placebo (28 [10.9%] vs 7 [2.8%] patients with serious adverse events), primarily with full-dose therapy compared with its matching placebo (22 [16.2%] vs 4 [3.2%]). Among patients with IgA nephropathy at high risk of progression, treatment with oral methylprednisolone for 6 to 9 months, compared with placebo, significantly reduced the risk of the composite outcome of kidney function decline, kidney failure, or death due to kidney disease. However, the incidence of serious adverse events was increased with oral methylprednisolone, mainly with high-dose therapy. ClinicalTrials.gov Identifier: NCT01560052.

Clinical Efficacy of Gandakang Tablets plus Methylprednisolone in Patients with Systemic Lupus Erythematosus.

Objective To evaluate the clinical efficacy of Gandakang tablets plus methylprednisolone in patients with systemic lupus erythematosus (SLE). Methods From February 2015 to February 2019, 60 eligible patients with SLE were recruited and assigned via the random number table method at a ratio of 1 : 1 to receive either methylprednisolone (control group) or Gandakang tablets plus methylprednisolone (observation group). The primary endpoint was clinical efficacy, and the secondary endpoints included Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, immunoglobulin (Ig), inflammatory factor levels, and adverse events. Results Gandakang tablets plus methylprednisolone were associated with a significantly higher treatment efficacy versus methylprednisolone alone (P < 0.05). Gandakang tablets plus methylprednisolone resulted in significantly lower SLEDAI scores and lower levels of IgG, IgM, IgA, tumor necrosis factor-α (TNF-α), interleukin-4 (IL-4), and interleukin-6 (IL-6) versus single medication of methylprednisolone (P < 0.05). The two groups showed a similar incidence of adverse events (P > 0.05). Patients given Gandakang tablets plus methylprednisolone had higher mental health, emotional role, physical role, social functioning, and bodily pain scores versus those receiving the monotherapy of methylprednisolone (P < 0.05). Conclusion Gandakang tablets plus methylprednisolone is effective in the treatment of SLE by enhancing the patients' immunity, mitigating the inflammatory response, eliminating negative emotions, and improving their quality of life.