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Gamma globulin combined with acyclovir for children with infectious mononucleosis and their effect on immune function
Li, Y., Chen, B.
American journal of translational research. 2023;15(6):4399-4407
Abstract
BACKGROUND Infectious mononucleosis (IM) is characterized by pharyngitis, cervical lymphadenopathy, fatigue and fever. IM is most commonly seen in primary Epstein-Barr virus (EBV) infection, with higher occurrence in children. OBJECTIVE To explore the value of gamma globulin combined with acyclovir for IM children and their impact on immune function. METHODS This prospective randomized controlled study recruited 111 children under 14 years old with IM from Anhui Provincial Children's Hospital during March 2019 and March 2022. Among them, 11 children dropped out, and 100 eligible children were randomized 1:1 into a control group and a study group. The control group received acyclovir, and the study group received additional gamma globulin. The baseline data, clinical efficacy, immune function, and adverse reactions were collected and compared. RESULTS The study group had a shorter antipyretic time, lymph node reduction time, pharyngitis improvement time, and hospital stay compared to the control group (P < 0.05). The study group yielded lower levels of total white blood cell count, alanine aminotransferase, and creatine kinase-MB than the control group (P < 0.05). After treatment, the levels of CD3+ and CD8+ were lower, and the levels of CD4+, CD4+/CD8+, IgA, and IgG were higher in the study group than those in the control group (all P < 0.05). The incidence of adverse reactions between the two groups was comparable (14.00% vs. 24.00%). The positive rates of EBV-specific antibody and nuclear antigen in the study group were lower than those in the control group (P < 0.05). CONCLUSION The combined treatment of gamma globulin and acyclovir is a promising alternative for patients with IM compared to acyclovir alone. This combined regimen shortens the duration of clinical manifestations in children, promotes the recovery of laboratory indices, improves clinical efficacy, and enhances immune function. Furthermore, its safety profile is acceptable, warranting its further promotion.
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Efficacy of Gamma Globulin Combined with Azithromycin Sequential Therapy in the Treatment of RMPP and Its Effect on Th1/Th2 Cytokine Levels
Qi, J., Jia, F., Tian, H., Yang, S.
Computational and Mathematical Methods in Medicine. 2022;2022:5162768
Abstract
OBJECTIVE To investigate the efficacy of gamma globulin combined with azithromycin sequential therapy in the treatment of children with refractory mycoplasma pneumonia and its effect on Th1/Th2 cytokine levels. METHOD From January 2021 to January 2022, 100 children diagnosed with refractory mycoplasma pneumonia were randomly divided into 2 groups (50 cases in each one), the control group was treated with azithromycin plus comprehensive basic treatment, and the treatment group was treated with combined treatment on the basis of the control group, gamma globulin therapy; the treatment effect and cytokine levels of the two groups were compared. RESULTS Th1, Th2, and Th1/Th2 before treatment were not significantly different between the two groups. Th1, Th2, and Th1/Th2 in the treatment group were significantly downregulated compared with those in the control group after treatment. The levels of IgG, IgA, and IgM in the treatment group were not significantly different from those in the control group before treatment but were significantly upregulated after treatment. IL-10, IL-6, and IL-2 levels were also significantly increased in the treatment group. The disappearance time of clinical symptoms such as fever, cough, and pulmonary rales in the treatment group was significantly shorter than that in the control group, and the cure rate in the treatment group was significantly better than that in the control group. CONCLUSION The clinical effect of gamma globulin combined with azithromycin sequential therapy in the treatment of children with refractory mycoplasma pneumonia is remarkable, which can reduce inflammatory factors, improve patients' immunity, and promote disease recovery.
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Adherence to community versus facility-based delivery of monthly malaria chemoprevention with dihydroartemisinin-piperaquine for the post-discharge management of severe anemia in Malawian children: A cluster randomized trial
Nkosi-Gondwe T, Robberstad B, Mukaka M, Idro R, Opoka RO, Banda S, Kühl MJ, O Ter Kuile F, Blomberg B, Phiri KS
PloS one. 2021;16(9):e0255769
Abstract
BACKGROUND The provision of post-discharge malaria chemoprevention (PMC) in children recently admitted with severe anemia reduces the risk of death and re-admissions in malaria endemic countries. The main objective of this trial was to identify the most effective method of delivering dihydroartemesinin-piperaquine to children recovering from severe anemia. METHODS This was a 5-arm, cluster-randomized trial among under-5 children hospitalized with severe anemia at Zomba Central Hospital in Southern Malawi. Children were randomized to receive three day treatment doses of dihydroartemesinin-piperaquine monthly either; 1) in the community without a short text reminder; 2) in the community with a short message reminder; 3) in the community with a community health worker reminder; 4) at the facility without a short text reminder; or 5) at the facility with a short message reminder. The primary outcome measure was adherence to all treatment doses of dihydroartemesinin-piperaquine and this was assessed by pill-counts done by field workers during home visits. Poisson regression was utilized for analysis. RESULTS Between March 2016 and October 2018, 1460 clusters were randomized. A total of 667 children were screened and 375 from 329 clusters were eligible and enrolled from the hospital. Adherence was higher in all three community-based compared to the two facility-based delivery (156/221 [70·6%] vs. 78/150 [52·0%], IRR = 1·24,95%CI 1·06-1·44, p = 0·006). This was observed in both the SMS group (IRR = 1·41,1·21-1·64, p<0·001) and in the non-SMS group (IRR = 1·37,1·18-1·61, p<0·001). Although adherence was higher among SMS recipients (98/148 66·2%] vs. non-SMS 82/144 (56·9%), there was no statistical evidence that SMS reminders resulted in greater adherence ([IRR = 1·03,0·88-1·21, p = 0·68). When compared to the facility-based non-SMS arm (control arm), community-based delivery utilizing CHWs resulted in higher adherence [39/76 (51·3%) vs. 54/79 (68·4%), IRR = 1·32, 1·14-1·54, p<0·001]. INTERPRETATION Community-based delivery of dihydroartemesinin-piperaquine for post-discharge malaria chemoprevention in children recovering from severe anemia resulted in higher adherence compared to facility-based methods. TRIAL REGISTRATION NCT02721420; ClinicalTrials.gov.
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The Effectiveness of Different Doses of Intravenous Immunoglobulin on Severe Hand, Foot and Mouth Disease: A Meta-Analysis
Jiao W, Tan SR, Huang YF, Mu L, Yang Y, Wang Y, Wu XE
Medical principles and practice : international journal of the Kuwait University, Health Science Centre. 2019
Abstract
OBJECTIVE To conduct a meta-analysis of evidence from randomized controlled trails (RCTs) of different doses of Intravenous Immunoglobulin (IVIG) in children with severe hand, foot and mouth disease (HFMD) to provide the scientific basis for clinical practice. METHODS A search of PubMed-Medline, CNKI, Wanfang, and VIP database (until 30 June 2017) was performed and Software RevMan5.3 was used to evaluate the effect of different doses of IVIG on HFMD in RCTs, We used random effects models (or fixed effects models) and generic inverse variance methods to process quantitative data, followed by a leave-one-out method for sensitivity analysis. RESULTS From a total of 420 entries identified via searches, 8 RCTs involving 1450 patients were included in the final analysis. The results of the meta-analysis showed that compared with conventional therapy alone, conventional therapy combined with IVIG had shorter fever clearance time, shorter rash regression time and shorter clinical cure time. Subgroup analyses showed that the high-dose group (1g/kg per day) had shorter fever clearance time (p < 0.05), shorter rash regression (p < 0.05), shorter remission time of neurological symptoms (p < 0.05), but longer clinical cure time (p > 0.05). CONCLUSION The high-dose group has a better prognosis, however, the advantages and disadvantages should be carefully considered when deciding the doses in the treatment of severe HFMD.
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Intravenous immunoglobulin for the treatment of childhood encephalitis
Iro MA, Martin NG, Absoud M, Pollard AJ
The Cochrane Database of Systematic Reviews. 2017;((10)):CD011367.
Abstract
BACKGROUND Encephalitis is a syndrome of neurological dysfunction due to inflammation of the brain parenchyma, caused by an infection or an exaggerated host immune response, or both. Attenuation of brain inflammation through modulation of the immune response could improve patient outcomes. Biological agents such as immunoglobulin that have both anti-inflammatory and immunomodulatory properties may therefore be useful as adjunctive therapies for people with encephalitis. OBJECTIVES To assess the efficacy and safety of intravenous immunoglobulin (IVIG) as add-on treatment for children with encephalitis. SEARCH METHODS The Cochrane Multiple Sclerosis and Rare Diseases of the CNS group's Information Specialist searched the following databases up to 30 September 2016: CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, and the WHO ICTRP Search Portal. In addition, two review authors searched Science Citation Index Expanded (SCI-EXPANDED) & Conference Proceedings Citation Index - Science (CPCI-S) (Web of Science Core Collection, Thomson Reuters) (1945 to January 2016), Global Health Library (Virtual Health Library), and Database of Abstracts of Reviews of Effects (DARE). SELECTION CRITERIA Randomised controlled trials (RCTs) comparing IVIG in addition to standard care versus standard care alone or placebo. DATA COLLECTION AND ANALYSIS Two review authors independently selected articles for inclusion, extracted relevant data, and assessed quality of trials. We resolved disagreements by discussion among the review authors. Where possible, we contacted authors of included studies for additional information. We presented results as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI). MAIN RESULTS The search identified three RCTs with 138 participants. All three trials included only children with viral encephalitis, one of these included only children with Japanese encephalitis, a specific form of viral encephalitis. Only the trial of Japanese encephalitis (22 children) contributed to the primary outcome of this review and follow-up in that study was for three to six months after hospital discharge. There was no follow-up of participants in the other two studies. We identified one ongoing trial.For the primary outcomes, the results showed no significant difference between IVIG and placebo when used in the treatment of children with Japanese encephalitis: significant disability (RR 0.75, 95% CI 0.22 to 2.60; P = 0.65) and serious adverse events (RR 1.00, 95% CI 0.07 to 14.05; P = 1.00).For the secondary outcomes, the study of Japanese encephalitis showed no significant difference between IVIG and placebo when assessing significant disability at hospital discharge (RR 1.00, 95% CI 0.60 to 1.67). There was no significant difference (P = 0.53) in Glasgow Coma Score at discharge between IVIG (median score 14; range 3 to 15) and placebo (median 14 score; range 7 to 15) in the Japanese encephalitis study. The median length of hospital stay in the Japanese encephalitis study was similar for IVIG-treated (median 13 days; range 9 to 21) and placebo-treated (median 12 days; range 6 to 18) children (P = 0.59).Pooled analysis of the results of the other two studies resulted in a significantly lower mean length of hospital stay (MD -4.54 days, 95% CI -7.47 to -1.61; P = 0.002), time to resolution of fever (MD -0.97 days, 95% CI -1.25 to -0.69; P < 0.00001), time to stop spasms (MD -1.49 days, 95% CI -1.97 to -1.01; P < 0.00001), time to regain consciousness (MD -1.10 days, 95% CI -1.48 to -0.72; P < 0.00001), and time to resolution of neuropathic symptoms (MD -3.20 days, 95% CI -3.34 to -3.06; P < 0.00001) in favour of IVIG when compared with standard care.None of the included studies reported other outcomes of interest in this review including need for invasive ventilation, duration of invasive ventilation, cognitive impairment, poor adaptive functioning, quality of life, number of seizures, and new diagnosis of epilepsy.The quality of evidence was very low for all outcomes of this review. AUTHORS' CONC
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Delaying Iron Therapy until 28 Days after Antimalarial Treatment Is Associated with Greater Iron Incorporation and Equivalent Hematologic Recovery after 56 Days in Children: A Randomized Controlled Trial
Cusick SE, Opoka RO, Abrams SA, John CC, Georgieff MK, Mupere E
The Journal of Nutrition. 2016;146((9):):1769-74
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Abstract
BACKGROUND Iron therapy begun concurrently with antimalarial treatment may not be well absorbed because of malaria-induced inflammation. Delaying the start of iron therapy may permit better iron absorption and distribution. OBJECTIVE We compared erythrocyte iron incorporation in children who started iron supplementation concurrently with antimalarial treatment or 28 d later. We hypothesized that delayed iron supplementation would be associated with greater incorporation and better hematologic recovery. METHODS We enrolled 100 children aged 6-59 mo with malaria and hemoglobin concentrations of 50.0-99.9 g/L who presented to Mulago Hospital, Kampala, into a randomized trial of iron therapy. All children were administered antimalarial treatment. Children with zinc protoporphyrin (ZPP) ≥80 mumol/mol heme were randomly assigned to start iron supplementation concurrently with the antimalarial treatment [immediate iron (I) group] or 28 d later [delayed iron (D) group]. All children were administered iron-stable isotope 57Fe on day 0 and 58Fe on day 28. We compared the percentage of iron incorporation at the start of supplementation (I group at day 0 compared with D group at day 28, aim 1) and hematologic recovery at day 56 (aim 2). RESULTS The percentage of iron incorporation (mean +/- SE) was greater at day 28 in the D group (16.5% +/- 1.7%) than at day 0 in the I group (7.9% +/- 0.5%; P < 0.001). On day 56, concentrations of hemoglobin and ZPP and plasma ferritin, soluble transferrin receptor (sTfR), hepcidin, and C-reactive protein did not differ between the groups. On day 28, the hemoglobin (mean +/- SD) and plasma iron markers (geometric mean; 95% CI) reflected poorer iron status in the D group than in the I group at this intervening time as follows: hemoglobin (105 +/- 15.9 compared with 112 +/- 12.4 g/L; P = 0.04), ferritin (39.3 mug/L; 23.5, 65.7 mug/L compared with 79.9 mug/L; 58.3, 110 mug/L; P = 0.02), sTfR (8.9 mg/L; 7.4, 10.7 mg/L compared with 6.7 mg/L; 6.1, 7.5 mg/L; P = 0.01), and hepcidin (13.3 ng/mL; 8.3, 21.2 ng/mL compared with 38.8 ng/mL; 28.3, 53.3 ng/mL; P < 0.001). CONCLUSIONS Delaying the start of iron improves incorporation but leads to equivalent hematologic recovery at day 56 in Ugandan children with malaria and anemia. These results do not demonstrate a clear, short-term benefit of delaying iron. This trial was registered at clinicaltrials.gov as NCT01754701.
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A preliminary randomized double blind placebo-controlled trial of intravenous immunoglobulin for Japanese encephalitis in Nepal
Rayamajhi A, Nightingale S, Bhatta NK, Singh R, Ledger E, Bista KP, Lewthwaite P, Mahaseth C, Turtle L, Robinson JS, et al
PLoS ONE [Electronic Resource]. 2015;10((4):):e0122608.
Abstract
BACKGROUND Japanese encephalitis (JE) virus (JEV) is a mosquito-borne flavivirus found across Asia that is closely related to West Nile virus. There is no known antiviral treatment for any flavivirus. Results from in vitro studies and animal models suggest intravenous immunoglobulin (IVIG) containing virus-specific neutralizing antibody may be effective in improving outcome in viral encephalitis. IVIG's anti-inflammatory properties may also be beneficial. METHODOLOGY/PRINCIPAL FINDINGS We performed a pilot feasibility randomized double-blind placebo-controlled trial of IVIG containing anti-JEV neutralizing antibody (ImmunoRel, 400mg/kg/day for 5 days) in children with suspected JE at two sites in Nepal; we also examined the effect on serum neutralizing antibody titre and cytokine profiles. 22 children were recruited, 13 of whom had confirmed JE; 11 received IVIG and 11 placebo, with no protocol violations. One child (IVIG group) died during treatment and two (placebo) subsequently following hospital discharge. Overall, there was no difference in outcome between treatment groups at discharge or follow up. Passive transfer of anti-JEV antibody was seen in JEV negative children. JEV positive children treated with IVIG had JEV-specific neutralizing antibody titres approximately 16 times higher than those treated with placebo (p=0.2), which was more than could be explained by passive transfer alone. IL-4 and IL-6 were higher in the IVIG group. CONCLUSIONS/SIGNIFICANCE A trial of IVIG for JE in Nepal is feasible. IVIG may augment the development of neutralizing antibodies in JEV positive patients. IVIG appears an appealing option for JE treatment that warrants further study. TRIAL REGISTRATION ClinicalTrials.gov NCT01856205.
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The effect of blood storage age on treatment of lactic acidosis by transfusion in children with severe malarial anaemia: a pilot, randomized, controlled trial
Dhabangi A, Mworozi E, Lubega IR, Cserti-Gazdewich CM, Maganda A, Dzik WH
Malaria Journal. 2013;12:55
Abstract
BACKGROUND Severe malarial anaemia requiring blood transfusion is a life-threatening condition affecting millions of children in sub-Saharan Africa. Up to 40% of children with severe malarial anaemia have associated lactic acidosis. Lactic acidosis in these children is strongly associated with fatal outcomes and is corrected by blood transfusion. However, it is not known whether the storage age of blood for transfusion affects resolution of lactic acidosis. The objective of this pilot study was to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anaemia and demonstrate feasibility of conducting a large trial. METHODS Children aged six to 59 months admitted to Acute Care Unit of Mulago Hospital (Kampala, Uganda) with severe malarial anaemia (haemoglobin<=5g/dL) and lactic acidosis (blood lactate >=5mmol/L), were randomly assigned to receive either blood of short storage age (one to 10 days) or long storage age (21-35days) by gravity infusion. Seventy-four patients were enrolled and randomized to two equal-sized study arms. Physiological measurements, including blood lactate, oxygen saturation, haemoglobin, and vital signs, were taken at baseline, during and after transfusion. The primary outcome variable was the proportion of children whose lactic acidosis resolved by four hours after transfusion. RESULTS Thirty-four of 37 (92%) of the children in the short storage treatment arm compared to 30/37 (81%) in the long storage arm achieved a blood lactate <5mmol/L by four hours post transfusion (p value=0.308). The mean time to lactic acidosis resolution was 2.65hours (95% CI; 2.25-3.05) in the short storage arm, compared to 3.35hours (95% CI; 2.60-4.10) in the long storage arm (p value=0.264). CONCLUSION Pilot data suggest that among children with severe malarial anaemia and lactic acidosis transfused with packed red blood cells, the storage age of blood does not affect resolution of lactic acidosis. The results support a larger and well-powered study which is under way. TRIAL REGISTRATION clinicaltrials.gov NCT01580111.
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Oral immunoglobulin for the prevention of rotavirus infection in low birth weight infants
Pammi M, Haque KN
Cochrane Database of Systematic Reviews. 2011;11:CD003740
Abstract
BACKGROUND Rotavirus is a common neonatal nosocomial viral infection and epidemics with the newer P(6)G9 strains have been reported. Local mucosal immunity in the intestine to rotavirus is important in the resolution of infection and protection against subsequent infections. Oral administration of anti-rotaviral immunoglobulin preparations might be a useful strategy in preventing rotaviral infections, especially in low birth weight babies. OBJECTIVES To determine the effectiveness and safety of oral immunoglobulin preparations for the prevention of rotavirus infection in hospitalized low birthweight infants (birthweight < 2500 g) SEARCH METHODS The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE, EMBASE, CINAHL, biological Abstracts (BIOSIS), Science Citation Index for articles citing Barnes 1982 and the proceedings of the Pediatric Academic Societies from 1991 onwards were searched in July 2011. Ongoing trials were also searched at clinicaltrials.gov and controlled-trials.com SELECTION CRITERIA The criteria used to select studies for inclusion were: 1) design: randomized or quasi-randomized controlled trials; 2) participants: hospitalized low birthweight infants; 3) intervention: oral immunoglobulin preparations for prevention of rotavirus infection compared to placebo OR no intervention; 4) at least one of the following outcomes were reported: all cause mortality during hospital stay, mortality due to rotavirus infection during hospital stay, rotavirus infection , duration of diarrhea, need for rehydration, duration of viral excretion, duration of infection control measures, length of hospital stay in days, recurrent diarrhea or chronic diarrhea. DATA COLLECTION AND ANALYSIS The two review authors independently abstracted data from the included trials. MAIN RESULTS One published study (Barnes 1982) was eligible for inclusion in this review. Barnes 1982 found no significant difference in the rates of rotavirus infection after oral gammaglobulin versus placebo in hospitalized low birthweight babies [RR 1.27 (95% CI 0.65 to 2.37)]. In the subset of infants who became infected with rotavirus after receiving gammaglobulin or placebo for prevention of rotavirus infection, there was no significant difference in the duration of rotavirus excretion between the group who had gammaglobulin (mean 2 days, range 1 to 4 days) and the group who had placebo (mean 3 days, range 1 to 6 days). Barnes 1982 reported no adverse effects after administration of oral immunoglobulin preparations. AUTHORS' CONCLUSIONS Current evidence does not support the use of oral immunoglobulin preparations to prevent rotavirus infection in low birthweight infants. Researchers are encouraged to conduct well-designed neonatal trials using the newer preparations of anti-rotaviral immunoglobulins (colostrum, egg yolk immunoglobulins) and include cost effectiveness evaluations.
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Oral immunoglobulin for the treatment of rotavirus diarrhea in low birth weight infants
Pammi M, Haque KN
Cochrane Database of Systematic Reviews. 2011;((10):):CD003742.
Abstract
BACKGROUND Rotavirus infection is the most common neonatal nosocomial viral infection. It is a major health problem worldwide. Epidemics with the newer P(6)G9 strains have been reported in neonatal units globally. These strains can cause severe symptoms in most infected infants. Infection control measures become necessary and the utilization of hospital resources increase. Local mucosal immunity in the intestine to rotavirus is important in the resolution of infection and protection against subsequent infections. Boosting local immunity by oral administration of anti-rotaviral immunoglobulin preparations might be a useful strategy in treating rotaviral infections, especially in low birth weight babies. OBJECTIVES To determine the effectiveness and safety of oral immunoglobulin preparations for the treatment of rotavirus diarrhea in hospitalized low birth weight infants (birth weight less than 2500 g) SEARCH STRATEGY Electronic databases including The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2004), MEDLINE, EMBASE and CINAHL, Biological Abstracts (BIOSIS) were searched by the strategy outlined in the protocol. Science Citation Index search for all articles that referenced Barnes 1982 were searched. The proceedings of the Pediatric Academic Societies published online at 'Abstracts Online' were searched. Ongoing registered trials at www.clinicaltrials.gov and www.controlled-trials.com were searched. Authors prominent in the field were contacted for any unpublished articles and more information on published articles was sought. Reference lists of identified clinical trials and personal files were also reviewed. The above search was updated in July 2011. SELECTION CRITERIA The criteria used to select studies for inclusion were: 1) Design: randomized or quasi-randomized controlled trials 2) Hospitalized low birth weight infants with rotavirus diarrhea 3) Intervention: Oral immunoglobulin preparations compared to placebo or no intervention 4) At least one of the following outcomes were reported: All cause mortality during hospital stay, mortality due to rotavirus infection during hospital stay, duration of diarrhea, need for rehydration, duration of viral excretion, duration of infection control measures, length of hospital stay in days, recurrent diarrhea or chronic diarrhea. DATA COLLECTION AND ANALYSIS The two reviewers were to independently abstract data from eligible trials. No data were available for analysis. MAIN RESULTS No eligible randomized controlled trials were found. AUTHORS' CONCLUSIONS No randomized controlled trials that assessed the effectiveness or safety of oral immunoglobulin preparations for the treatment of rotavirus diarrhea in hospitalized low birth weight infants were found. Clinical trials that address the issue of oral immunoglobulin treatment of rotavirus infection are needed.