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Journal of Orthopaedic Surgery and... Oct 2021The analgesic efficacy of magnesium sulphate added to bupivacaine for arthroscopy remains controversial. We conduct a systematic review and meta-analysis to explore the... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The analgesic efficacy of magnesium sulphate added to bupivacaine for arthroscopy remains controversial. We conduct a systematic review and meta-analysis to explore the efficacy of magnesium sulphate in combination with bupivacaine for arthroscopy.
METHODS
We searched PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through July 2020 for randomized controlled trials (RCTs) assessing the effect of magnesium sulphate plus bupivacaine versus bupivacaine for arthroscopy. This meta-analysis is performed using the random-effect model.
RESULTS
Six RCTs were included in the meta-analysis. Overall, compared with bupivacaine for arthroscopy, combination analgesia using magnesium plus bupivacaine was associated with significantly prolonged duration of analgesia (SMD=0.93; 95% CI=0.27 to 1.60; P=0.006) and first time to analgesic requirement (SMD=196.57; 95% CI=13.90 to 379.24; P=0.03), reduced pain scores (SMD=-1.71; 95% CI=-2.96 to -0.46; P=0.007) and analgesic consumption (SMD=-1.04; 95% CI=-1.49 to -0.60; P<0.00001), but showed no remarkable influence on nausea or vomiting (OR=1.54; 95% CI=0.60 to 3.97; P=0.37).
CONCLUSIONS
Magnesium sulphate added to bupivacaine may significantly improve the analgesic efficacy for arthroscopy.
Topics: Analgesics; Arthroscopy; Bupivacaine; Humans; Magnesium; Magnesium Sulfate; Pain, Postoperative; Randomized Controlled Trials as Topic
PubMed: 34629096
DOI: 10.1186/s13018-021-02609-w -
Frontiers in Pharmacology 2019Several interventions are available for the management of hypoxic ischemic encephalopathy (HIE), but no studies have compared their relative efficacy in a single...
Several interventions are available for the management of hypoxic ischemic encephalopathy (HIE), but no studies have compared their relative efficacy in a single analysis. This study aims to compare and determine the effectiveness of available interventions for HIE using direct and indirect data. Large randomized trials were identified from PubMed, EMBASE, CINAHL Plus, AMED, and Cochrane Library of Clinical Trials database from inception until June 30, 2018. Two independent reviewers extracted study data and performed quality assessment. Direct and network meta-analysis of randomized controlled trials was performed to obtained pooled results comparing the effectiveness of different therapies used in HIE on mortality, neurodevelopmental delay at 18 months, as well as adverse events. Their probability of having the highest efficacy and safety was estimated and ranked. The certainty of evidence for the primary outcomes of mortality and mortality or neurodevelopmental delay at 18 months was evaluated using GRADE criteria. Fifteen studies comparing five interventions were included in the network meta-analysis. Whole body cooling [Odds ratio: 0.62 (95% credible interval: 0.46-0.83); 8 trials, high certainty of evidence] was the most effective treatment in reducing the risk of mortality, followed by selective head cooling (0.73; 0.48-1.11; 2 trials, moderate certainty of evidence) and use of magnesium sulfate (0.79; 0.20-3.06; 2 trials, low certainty of evidence). Whole body hypothermia (0.48; 0.33-0.71; 5 trials), selective head hypothermia (0.54; 0.32-0.89; 2 trials), and erythropoietin (0.36; 0.19-0.66; 2 trials) were more effective for reducing the risk of mortality and neurodevelopmental delay at 18 months (moderate to high certainty). Among neonates treated for HIE, the use of erythropoietin (0.36; 0.18-0.74, 2 trials) and whole body hypothermia (0.61; 0.45-0.83; 7 trials) were associated with lower rates of cerebral palsy. Similarly, there were lower rates of seizures among neonates treated with erythropoietin (0.35; 0.13-0.94; 1 trial) and whole body hypothermia (0.64; 0.46-0.87, 7 trials). The findings support current guidelines using therapeutic hypothermia in neonates with HIE. However, more trials are needed to determine the role of adjuvant therapy to hypothermia in reducing the risk of mortality and/or neurodevelopmental delay.
PubMed: 31708771
DOI: 10.3389/fphar.2019.01221 -
The Cochrane Database of Systematic... Jul 2019At the end of 2016, 145 countries reported to the World Health Organization (WHO) over 173,000 new cases of leprosy worldwide. In the past 20 years, over 16 million... (Review)
Review
BACKGROUND
At the end of 2016, 145 countries reported to the World Health Organization (WHO) over 173,000 new cases of leprosy worldwide. In the past 20 years, over 16 million people have been treated for leprosy globally. The condition's main complications are injuries and ulceration caused by sensory loss from nerve damage. In this review we explored interventions to prevent or treat secondary damage to the skin in people affected by leprosy (Hansen's disease). This is an update of a Cochrane Review published in 2008.
OBJECTIVES
To assess the effects of education, information, self-care programmes, dressings, skin care, footwear and other measures for preventing and healing secondary damage to the skin in persons affected by leprosy.
SEARCH METHODS
We updated our searches of the following databases up to July 2018: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, AMED, LILACS, and CINAHL. We also searched five trial registers, three grey literature databases, and the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).
SELECTION CRITERIA
RCTs or quasi-RCTs or randomised cross-over trials involving anyone with leprosy and potential damage to peripheral nerves who was treated with any intervention designed to prevent damage, heal existing ulcers, and prevent development of new ulcers. Eligible comparisons were usual care, no interventions, or other interventions (e.g. other types of dressings or footwear).
DATA COLLECTION AND ANALYSIS
We adhered to standard methodological procedures expected by Cochrane. Primary outcomes were prevention of ulcer(s), healing of existing ulcer(s) and adverse events. We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
We included 14 trials (854 participants). Eleven studies reported on gender (men: 472, women: 157). Participant age varied from 18 to 74 years. Most participants had a single, mainly non-infected, wound on one foot, which had been there for less than a year. Only seven studies reported whole study duration (there was no follow-up post-treatment), which was on average six months (range: 1 to 12 months). The studies were conducted in Brazil, Ethiopia, Egypt, Indonesia, Mexico, South Korea, and India. Many 'Risk of bias' assessments were rated as unclear risk due to limited information. Six studies had high risk of bias in at least one domain, including selection and attrition bias.Thirteen studies evaluated different interventions for treating existing ulcers, one of them also evaluated prevention of new ulcers. One study aimed to prevent skin changes, such as cracking and fissures. Investigated interventions included: laser therapy, light-emitting diode (LED), zinc tape, intralesional pentoxifylline, pulsed magnetic fields, wax therapy, ketanserin, human amniotic membrane gel, phenytoin, plaster shoes, and footwear.We are uncertain about the following key results, as the certainty of evidence is very low. All time points were measured from baseline.Three studies compared zinc tape versus other interventions and reported results in favour of zinc tape. One study compared zinc tape versus magnesium sulphate: at one month the number of healed ulcers and reduction in mean ulcer area was higher with zinc tape (risk ratio (RR) 2.00, 95% confidence interval (CI) 0.43 to 9.21, and mean difference (MD) -14.30 mm², 95% CI -26.51 to -2.09, respectively, 28 participants). Another study compared zinc tape and povidone iodine and found that even though there was a greater reduction in ulcer area after six weeks of treatment with zinc tape, there was no clear difference due to the wide 95% CI (MD 128.00 mm², 95% CI -110.01 to 366.01; 38 participants). The third study (90 participants) compared adhesive zinc tape with gauze soaked in Eusol, and found the healing time for deep ulcers was less compared to zinc tape: 17 days (95% CI 12 to 20) versus 30 days (95% CI 21 to 63). Adverse events were only collected in the study comparing zinc tape with gauze soaked in Eusol: there were no signs of skin sensitisation in either group at two months.Two studies compared topical phenytoin versus saline dressing and reported results in favour of phenytoin. One study reported a greater mean percentage reduction of ulcer area after four weeks with phenytoin 2% (MD 39.30%, 95% CI 25.82 to 52.78; 23 participants), and the other study reported a greater mean percentage reduction of ulcer volume (16.60%) after four weeks with phenytoin (95% CI 8.46 to 24.74; 100 participants). No adverse events were observed with either treatment during the four-month treatment period (2 studies, 123 participants). Prevention of ulcers was not evaluated in these nor the zinc studies, as the interventions were not for preventative use.Two studies compared protective footwear (with or without self-care) with either 1) polyvinyl chloride (PVC) boots, or 2) pulsed magnetic fields plus self-care and protective footwear. In the study comparing canvas shoes versus PVC boots, none of the 72 participants with scars at the start of the study developed new ulcers over one-year follow-up. Healing of ulcers was assessed in 38 participants from this study, but we are unclear if there is a difference between groups. In the study comparing pulsed magnetic fields (in addition to self-care and protective footwear) to only self-care and footwear in 33 participants, we are uncertain if the mean volume of ulcers at four to five weeks' follow-up was different between groups; this study did not evaluate the prevention of ulcers. Information for adverse events was only reported in the study comparing canvas shoes with PVC boots; the authors stated that the PVC boots could become hot in strong sunlight and possibly burn the feet.
AUTHORS' CONCLUSIONS
Based on the available evidence, we could not draw firm conclusions about the effects of the included interventions. The main evidence limitations were high or unclear risk of bias, including selection, performance, detection, and attrition bias; imprecision due to few participants in the studies; and indirectness from poor outcome measurement and inapplicable interventions. Future research should clearly report important outcomes, such as adverse events, and assess widely available interventions, which should include treatments aimed at prevention. These trials should ensure allocation concealment, blinding, and an adequate sample size.
PubMed: 31425632
DOI: 10.1002/14651858.CD012235.pub2 -
The Cochrane Database of Systematic... Dec 2020Acute bronchiolitis is a significant burden on children, their families and healthcare facilities. It mostly affects children younger than two years of age. Treatment... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Acute bronchiolitis is a significant burden on children, their families and healthcare facilities. It mostly affects children younger than two years of age. Treatment involves adequate hydration, humidified oxygen supplementation, and nebulisation of medications, such as salbutamol, epinephrine, and hypertonic saline. The effectiveness of magnesium sulphate for acute bronchiolitis is unclear.
OBJECTIVES
To assess the effects of magnesium sulphate in acute bronchiolitis in children up to two years of age.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, LILACS, CINAHL, and two trials registries to 30 April 2020. We contacted trial authors to identify additional studies. We searched conference proceedings and reference lists of retrieved articles. Unpublished and published studies were eligible for inclusion.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-RCTs, comparing magnesium sulphate, alone or with another treatment, with placebo or another treatment, in children up to two years old with acute bronchiolitis. Primary outcomes were time to recovery, mortality, and adverse events. Secondary outcomes were duration of hospital stay, clinical severity score at 0 to 24 hours and 25 to 48 hours after treatment, pulmonary function test, hospital readmission within 30 days, duration of mechanical ventilation, and duration of intensive care unit stay.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We used GRADE methods to assess the certainty of the evidence.
MAIN RESULTS
We included four RCTs (564 children). One study received funding from a hospital and one from a university; two studies did not report funding sources. Comparator interventions differed among all four trials. Studies were conducted in Qatar, Turkey, Iran, and India. We assessed two studies to be at an overall low risk of bias, and two to be at unclear risk of bias, overall. The certainty of the evidence for all outcomes and comparisons was very low except for one: hospital re-admission rate within 30 days of discharge for magnesium sulphate versus placebo. None of the studies measured time to recovery, duration of mechanical ventilation, duration of intensive care unit stay, or pulmonary function. There were no events of mortality or adverse effects for magnesium sulphate compared with placebo (1 RCT, 160 children). The effects of magnesium sulphate on clinical severity are uncertain (at 0 to 24 hours: mean difference (MD) on the Wang score 0.13, 95% confidence interval (CI) -0.28 to 0.54; and at 25 to 48 hours: MD on the Wang score -0.42, 95% CI -0.84 to -0.00). Magnesium sulphate may increase hospital re-admission rate within 30 days of discharge (risk ratio (RR) 3.16, 95% CI 1.20 to 8.27; 158 children; low-certainty evidence). None of our primary outcomes were measured for magnesium sulphate compared with hypertonic saline (1 RCT, 220 children). Effects were uncertain on the duration of hospital stay in days (MD 0.00, 95% CI -0.28 to 0.28), and on clinical severity on the Respiratory Distress Assessment Instrument (RDAI) score at 25 to 48 hours (MD 0.10, 95% CI -0.39 to 0.59). There were no events of mortality or adverse effects for magnesium sulphate, with or without salbutamol, compared with salbutamol (1 RCT, 57 children). Effects on the duration of hospital stay were uncertain (magnesium sulphate: 24 hours (95% CI 25.8 to 47.4), magnesium sulphate + salbutamol: 20 hours (95% CI 15.3 to 39.0), and salbutamol: 24 hours (95% CI 23.4 to 76.9)). None of our primary outcomes were measured for magnesium sulphate + epinephrine compared with no treatment or normal saline + epinephrine (1 RCT,120 children). Effects were uncertain for the duration of hospital stay in hours (MD -0.40, 95% CI -3.94 to 3.14), and for RDAI scores (0 to 24 hours: MD -0.20, 95% CI -1.06 to 0.66; and 25 to 48 hours: MD -0.90, 95% CI -1.75 to -0.05).
AUTHORS' CONCLUSIONS
There is insufficient evidence to establish the efficacy and safety of magnesium sulphate for treating children up to two years of age with acute bronchiolitis. No evidence was available for time to recovery, duration of mechanical ventilation and intensive care unit stay, or pulmonary function. There was no information about adverse events for some comparisons. Well-designed RCTs to assess the effects of magnesium sulphate for children with acute bronchiolitis are needed. Important outcomes, such as time to recovery and adverse events should be measured.
Topics: Acute Disease; Albuterol; Bias; Bronchiolitis; Bronchodilator Agents; Drug Therapy, Combination; Epinephrine; Humans; Infant; Infant, Newborn; Length of Stay; Magnesium Sulfate; Patient Readmission; Placebos; Randomized Controlled Trials as Topic; Saline Solution; Severity of Illness Index
PubMed: 33316083
DOI: 10.1002/14651858.CD012965.pub2 -
The Cochrane Database of Systematic... Aug 2017Cerebral palsy is an umbrella term encompassing disorders of movement and posture, attributed to non-progressive disturbances occurring in the developing fetal or infant... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cerebral palsy is an umbrella term encompassing disorders of movement and posture, attributed to non-progressive disturbances occurring in the developing fetal or infant brain. As there are diverse risk factors and causes, no one strategy will prevent all cerebral palsy. Therefore, there is a need to systematically consider all potentially relevant interventions for their contribution to prevention.
OBJECTIVES
To summarise the evidence from Cochrane reviews regarding the effects of antenatal and intrapartum interventions for preventing cerebral palsy.
METHODS
We searched the Cochrane Database of Systematic Reviews on 7 August 2016, for reviews of antenatal or intrapartum interventions reporting on cerebral palsy. Two authors assessed reviews for inclusion, extracted data, assessed review quality, using AMSTAR and ROBIS, and quality of the evidence, using the GRADE approach. We organised reviews by topic, and summarised findings in text and tables. We categorised interventions as effective (high-quality evidence of effectiveness); possibly effective (moderate-quality evidence of effectiveness); ineffective (high-quality evidence of harm or of lack of effectiveness); probably ineffective (moderate-quality evidence of harm or of lack of effectiveness); and no conclusions possible (low- to very low-quality evidence).
MAIN RESULTS
We included 15 Cochrane reviews. A further 62 reviews pre-specified the outcome cerebral palsy in their methods, but none of the included randomised controlled trials (RCTs) reported this outcome. The included reviews were high quality and at low risk of bias. They included 279 RCTs; data for cerebral palsy were available from 27 (10%) RCTs, involving 32,490 children. They considered interventions for: treating mild to moderate hypertension (two) and pre-eclampsia (two); diagnosing and preventing fetal compromise in labour (one); preventing preterm birth (four); preterm fetal maturation or neuroprotection (five); and managing preterm fetal compromise (one). Quality of evidence ranged from very low to high. Effective interventions: high-quality evidence of effectiveness There was a reduction in cerebral palsy in children born to women at risk of preterm birth who received magnesium sulphate for neuroprotection of the fetus compared with placebo (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.54 to 0.87; five RCTs; 6145 children). Probably ineffective interventions: moderate-quality evidence of harm There was an increase in cerebral palsy in children born to mothers in preterm labour with intact membranes who received any prophylactic antibiotics versus no antibiotics (RR 1.82, 95% CI 0.99 to 3.34; one RCT; 3173 children). There was an increase in cerebral palsy in children, who as preterm babies with suspected fetal compromise, were born immediately compared with those for whom birth was deferred (RR 5.88, 95% CI 1.33 to 26.02; one RCT; 507 children). Probably ineffective interventions: moderate-quality evidence of lack of effectiveness There was no clear difference in the presence of cerebral palsy in children born to women at risk of preterm birth who received repeat doses of corticosteroids compared with a single course (RR 1.03, 95% CI 0.71 to 1.50; four RCTs; 3800 children). No conclusions possible: low- to very low-quality evidence Low-quality evidence found there was a possible reduction in cerebral palsy for children born to women at risk of preterm birth who received antenatal corticosteroids for accelerating fetal lung maturation compared with placebo (RR 0.60, 95% CI 0.34 to 1.03; five RCTs; 904 children). There was no clear difference in the presence of cerebral palsy with interventionist care for severe pre-eclampsia versus expectant care (RR 6.01, 95% CI 0.75 to 48.14; one RCT; 262 children); magnesium sulphate for pre-eclampsia versus placebo (RR 0.34, 95% CI 0.09 to 1.26; one RCT; 2895 children); continuous cardiotocography for fetal assessment during labour versus intermittent auscultation (average RR 1.75, 95% CI 0.84 to 3.63; two RCTs; 13,252 children); prenatal progesterone for prevention of preterm birth versus placebo (RR 0.14, 95% CI 0.01 to 3.48; one RCT; 274 children); and betamimetics for inhibiting preterm labour versus placebo (RR 0.19, 95% CI 0.02 to 1.63; one RCT; 246 children).Very low-quality found no clear difference for the presence of cerebral palsy with any antihypertensive drug (oral beta-blockers) for treatment of mild to moderate hypertension versus placebo (RR 0.33, 95% CI 0.01 to 8.01; one RCT; 110 children); magnesium sulphate for prevention of preterm birth versus other tocolytic agents (RR 0.13, 95% CI 0.01 to 2.51; one RCT; 106 children); and vitamin K and phenobarbital prior to preterm birth for prevention of neonatal periventricular haemorrhage versus placebo (RR 0.77, 95% CI 0.33 to 1.76; one RCT; 299 children).
AUTHORS' CONCLUSIONS
This overview summarises evidence from Cochrane reviews on the effects of antenatal and intrapartum interventions on cerebral palsy, and can be used by researchers, funding bodies, policy makers, clinicians and consumers to aid decision-making and evidence translation. We recommend that readers consult the included Cochrane reviews to formally assess other benefits or harms of included interventions, including impacts on risk factors for cerebral palsy (such as the reduction in intraventricular haemorrhage for preterm babies following exposure to antenatal corticosteroids).Magnesium sulphate for women at risk of preterm birth for fetal neuroprotection can prevent cerebral palsy. Prophylactic antibiotics for women in preterm labour with intact membranes, and immediate rather than deferred birth of preterm babies with suspected fetal compromise, may increase the risk of cerebral palsy. Repeat doses compared with a single course of antenatal corticosteroids for women at risk of preterm birth do not clearly impact the risk of cerebral palsy.Cerebral palsy is rarely diagnosed at birth, has diverse risk factors and causes, and is diagnosed in approximately one in 500 children. To date, only a small proportion of Cochrane reviews assessing antenatal and intrapartum interventions have been able to report on this outcome. There is an urgent need for long-term follow-up of RCTs of interventions addressing risk factors for cerebral palsy, and consideration of the use of relatively new interim assessments (including the General Movements Assessment). Such RCTs must be rigorous in their design, and aim for consistency in cerebral palsy outcome measurement and reporting to facilitate pooling of data, to focus research efforts on prevention.
Topics: Antibiotic Prophylaxis; Cerebral Palsy; Female; Fetal Distress; Humans; Hypertension; Infant, Premature; Magnesium Sulfate; Neuroprotective Agents; Parturition; Pre-Eclampsia; Pregnancy; Pregnancy Complications, Cardiovascular; Premature Birth; Prenatal Care; Randomized Controlled Trials as Topic; Review Literature as Topic
PubMed: 28786098
DOI: 10.1002/14651858.CD012077.pub2 -
Medicine Dec 2018The aim of this systematic review is to investigate the effects of perioperative intravenous administration of MgSO4 on postoperative pain, analgesic consumption and...
INTRODUCTION
The aim of this systematic review is to investigate the effects of perioperative intravenous administration of MgSO4 on postoperative pain, analgesic consumption and adverse effects in patients undergoing orthopedic surgery.
METHODS
Two investigators independently searched for articles on randomized controlled trials (RCTs) from 1998 to 2016 in Pubmed, Web of science and Google scholar. We evaluated clinical outcomes, comparing postoperative pain scores, cumulative analgesic consumption, time to first analgesia, and adverse effects between orthopedic surgery patients with and without the administration of MgSO4.
RESULTS
After screening 2350 articles, 11 RCTs (with a total sample size of 535 subjects) were included in this systematic review. Perioperative intravenous administered MgSO4 could reduce postoperative pain intensity compared with control in 6 trials (55%), but without significant difference in 5 trials (45%). With MgSO4 treatments, postoperative analgesic consumption was significantly reduced in 8 trials (73%), and without significant difference in 2 trials (18%). Two trials evaluated the time to first request of analgesic after surgery and showed prolong of 2.3 hours and 93 minutes respectively. MgSO4 group had less postoperative nausea (relative risk [RR] = 0.32, 95% confidence interval [CI] = 0.12-0.82, number needed to harm [NNH] = 8.8), vomiting (RR = 0.38, 95% CI = 0.15-0.92, NNH = 9.7), and shivering (RR = 0.31, 95% CI = 0.11-0.88, NNH = 5.2).
CONCLUSION
Perioperative intravenous administration of MgSO4 in orthopedic surgery could reduce postoperative analgesic consumption and adverse effects such as vomiting, nausea, and shivering. These trials do not provide convincing evidence of beneficial effects on postoperative pain intensity and the time to first analgesic request. More trials should be conducted for the roles of MgSO4 in pain management for orthopedic surgery. However, intravenous MgSO4 administration should be considered as a strategy to relieve postoperative pain in orthopedic surgery patients.
Topics: Administration, Intravenous; Analgesia; Humans; Magnesium Sulfate; Orthopedic Procedures; Pain Measurement; Pain, Postoperative; Postoperative Care; Randomized Controlled Trials as Topic
PubMed: 30558026
DOI: 10.1097/MD.0000000000013583 -
PLOS Global Public Health 2024The quality of medicines for the prevention and management of hypertensive disorders of pregnancy globally is a critical challenge in the reduction of maternal mortality...
The quality of medicines for the prevention and management of hypertensive disorders of pregnancy globally is a critical challenge in the reduction of maternal mortality rate. We aimed to conduct a systematic review of available studies on the quality of the eight medicines recommended globally for the prevention and management of hypertensive disorders of pregnancy. We searched five electronic databases- Ovid MEDLINE, EMBASE, CINAHL, ProQuest and Cochrane Library, and also grey literature, without year or language limitations. Any study assessing the quality parameters (Active Pharmaceutical Ingredients, pH, sterility, solubility, impurities) of medicines by using any valid laboratory methods was eligible. Two reviewers independently screened the studies, extracted data and applied Medicine Quality Assessment Reporting Guidelines tool for quality assessment. Results were narratively reported and stratified by the drug types. Of 5669 citations screened, 33 studies from 27 countries were included. Five studies reported on the quality of magnesium sulphate-two (Nigeria and USA) found substandard medicine due to failing API specification and contaminants, respectively. Another study from Nigeria and a multi-country study (10 lower-middle- and low-income countries) found poor-quality due to failing the pH criteria. Seven of eight studies evaluating aspirin found quality issues, including degraded medicines in five studies (Brazil, USA, Yugoslavia and Pakistan). Five studies of calcium supplements found quality issues, particularly heavy metal contamination. Of 15 antihypertensives quality studies, 12 found substandard medicines and one study identified counterfeit medicines. This systematic review identified pervasive issues of poor-quality medicines across all recommended medicines used to prevent or treat hypertensive disorders of pregnancy, raising concerns regarding their safety and effectiveness.
PubMed: 38412179
DOI: 10.1371/journal.pgph.0002962 -
CNS Drugs Aug 2020Refractory status epilepticus (RSE) represents a serious medical condition requiring early and targeted therapy. Given the increasing number of elderly or multimorbid... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Refractory status epilepticus (RSE) represents a serious medical condition requiring early and targeted therapy. Given the increasing number of elderly or multimorbid patients with a limitation of life-sustaining therapy (LOT) or within a palliative care setting (PCS), guidelines-oriented therapy escalation options for RSE have to be omitted frequently.
OBJECTIVES
This systematic review sought to summarize the evidence for fourth-line antiseizure drugs (ASDs) and other minimally or non-invasive therapeutic options beyond guideline recommendations in patients with RSE to elaborate on possible treatment options for patients undergoing LOT or in a PCS.
METHODS
A systematic review of the literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, focusing on fourth-line ASDs or other minimally or non-invasive therapeutic options was performed in February and June 2020 using the MEDLINE, EMBASE and Cochrane databases. The search terminology was constructed using the name of the specific ASD or therapy option and the term 'status epilepticus' with the use of Boolean operators, e.g. "(brivaracetam) AND (status epilepticus)". The respective Medical Subject Headings (MeSH) and Emtree terms were used, if available.
RESULTS
There is currently no level 1, grade A evidence for the use of ASDs in RSE. The best evidence was found for the use of lacosamide and topiramate (level 3, grade C), followed by brivaracetam, perampanel (each level 4, grade D) and stiripentol, oxcarbazepine and zonisamide (each level 5, grade D). Regarding non-medicinal options, there is little evidence for the use of the ketogenic diet (level 4, grade D) and magnesium sulfate (level 5, grade D) in RSE. The broad use of immunomodulatory or immunosuppressive treatment options in the absence of a presumed autoimmune etiology cannot be recommended; however, if an autoimmune etiology is assumed, steroid pulse, intravenous immunoglobulins and plasma exchange/plasmapheresis should be considered (level 4, grade D). Even if several studies suggested that the use of neurosteroids (level 5, grade D) is beneficial in RSE, the current data situation indicates that there is formal evidence against it.
CONCLUSIONS
RSE in patients undergoing LOT or in a PCS represents a challenge for modern clinicians and epileptologists. The evidence for the use of ASDs in RSE beyond that in current guidelines is low, but several effective and well-tolerated options are available that should be considered in this patient population. More so than in any other population, advance care planning, advance directives, and medical ethical aspects have to be considered carefully before and during therapy.
Topics: Anticonvulsants; Autoimmunity; Humans; Immunoglobulins, Intravenous; Palliative Care; Status Epilepticus
PubMed: 32705422
DOI: 10.1007/s40263-020-00747-z -
Journal of Cardiothoracic Surgery Jun 2024Systematic evaluation of the safety of del Nido cardioplegia compared to cold blood cardioplegia in adult cardiac surgery. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Systematic evaluation of the safety of del Nido cardioplegia compared to cold blood cardioplegia in adult cardiac surgery.
METHODS
We systematically searched PubMed, EMbase, The Cochrane Library and ClinicalTrials.gov for randomized clinical trials (published by 14 January 2024) comparing del Nido cardioplegia to cold blood cardioplegia in adult. Our main endpoints were myocardial injury markers and clinical outcomes. We assessed pooled data by use of a random-effects model or a fixed-effects model.
RESULTS
A total of 10 studies were identified, incorporating 889 patients who received del Nido cardioplegia and 907 patients who received cold blood cardioplegia. The meta-analysis results showed that compared with the cold blood cardioplegia, the del Nido cardioplegia had less volume of cardioplegia, higher rate of spontaneous rhythm recovery after cross clamp release, lower levels of postoperative cardiac troponin T and creatinine kinase-myocardial band, all of which were statistically significant. However, there was no statistically significant difference in postoperative troponin I and postoperative left ventricular ejection fraction. The clinical outcomes including mechanical ventilation time, intensive care unit stay time, hospital stay time, postoperative stroke, postoperative new-onset atrial fibrillation, postoperative heart failure requiring intra-aortic balloon pump mechanical circulation support, and in-hospital mortality of both are comparable.
CONCLUSION
Existing evidence suggests that del Nido cardioplegia reduced volume of cardioplegia administration and attempts of defibrillation. The superior postoperative results in CTnT and CK-MB may provide a direction for further research on improvement of the composition of cardioplegia.
Topics: Humans; Heart Arrest, Induced; Randomized Controlled Trials as Topic; Cardiac Surgical Procedures; Cardioplegic Solutions; Adult; Potassium Chloride; Mannitol; Lidocaine; Solutions; Electrolytes; Magnesium Sulfate; Sodium Bicarbonate
PubMed: 38909234
DOI: 10.1186/s13019-024-02846-0 -
PloS One 2020There are concerns about the quality of medicines available in low- and middle-income countries (LMIC) to manage hemorrhage, pre-eclampsia/eclampsia and sepsis. We aimed...
BACKGROUND
There are concerns about the quality of medicines available in low- and middle-income countries (LMIC) to manage hemorrhage, pre-eclampsia/eclampsia and sepsis. We aimed to identify, critically appraise, and synthesize the findings of studies on the quality of these three types of medicines available in LMIC.
METHODS
This systematic review searched Medline, EMBASE and LILACS (from inception to 25 May 2020) for studies on the quality of selected medicines available in LMIC that provided at least the amount of active pharmaceutical ingredient. We contacted study authors for additional information. We excluded simulation studies. We used the MEDQUARG tool to assess study quality. The main outcome was the prevalence of failed samples.
FINDINGS
We identified 9699 unique citations and included 34 studies (3159 samples from 40 countries) in the review. Most studies (65%) had low quality (scores <6/12). Overall, 48.9% of 1890 uterotonic samples (19 studies) failed quality tests; failures rates were 75% for ergometrine and nearly 40% each for oxytocin and misoprostol. The overall prevalence of failed injectable antibiotics (1090 samples, 18 studies) was 13.4%, ranging from 2.9% for injectable metronidazole (34 samples, 3 studies) to 16.0% for cefazolin (449 samples, 2 studies). The prevalence of low quality magnesium sulphate (179 samples, 2 studies) was 3.4%. We did not find any studies on the quality of carbetocin, tranexamic acid, or clindamycin.
CONCLUSIONS
There is a widespread problem with the quality of medicines used to manage life-threatening maternal conditions in LMIC. This can be a contributing factor to high maternal mortality rates in these regions.
Topics: Developing Countries; Female; Humans; Pregnancy; Pregnancy Complications; Quality of Health Care
PubMed: 32649710
DOI: 10.1371/journal.pone.0236060