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European Journal of Drug Metabolism and... Oct 2020Omeprazole is a proton pump inhibitor (PPI) that is used in acid suppression therapy in infants. In this study we aimed to develop a pediatric omeprazole suppository,...
BACKGROUND AND OBJECTIVE
Omeprazole is a proton pump inhibitor (PPI) that is used in acid suppression therapy in infants. In this study we aimed to develop a pediatric omeprazole suppository, with good physical and chemical stability, suitable for pharmaceutical batch production.
METHODS
The composition of the suppository consisted of omeprazole, witepsol H15 and arginine (L) base. To achieve evenly distributed omeprazole suspension suppositories, the temperature, stirring rate, and arginine (L) base amount were varied. A previously validated quantitative high-performance liquid chromatography-ultraviolet method was modified and a long-term stability study was performed for one year.
RESULTS
Evenly distributed omeprazole suspension suppositories were obtained by adding 100 mg arginine (L) base and pouring at a temperature of 34.7 °C and a stirring speed of 200 rpm. The long-term stability study showed no signs of discoloration and a stable omeprazole content between 90 and 110% over 1 year if stored in the dark at room temperature.
CONCLUSION
We developed a pediatric omeprazole suppository. This formulation may provide a good alternative to manipulated commercial or extemporaneously compounded omeprazole oral formulations for infants. Clinical studies are needed to establish efficacy and safety in this young population.
Topics: Arginine; Chemistry, Pharmaceutical; Chromatography, High Pressure Liquid; Drug Compounding; Drug Stability; Excipients; Humans; Infant; Omeprazole; Proton Pump Inhibitors; Suppositories; Temperature; Triglycerides
PubMed: 32594306
DOI: 10.1007/s13318-020-00629-1 -
Revista Brasileira de Ginecologia E... Jan 2019The gestational complication most associated with perinatal mortality and morbidity is spontaneous preterm birth with gestational age < 37 weeks. Therefore, it is... (Comparative Study)
Comparative Study Review
OBJECTIVE
The gestational complication most associated with perinatal mortality and morbidity is spontaneous preterm birth with gestational age < 37 weeks. Therefore, it is necessary to identify its risk factors and attempt its prevention. The benefits of the pessary in prematurity are under investigation. Our objective was to analyze the use of the pessary in the prevention of preterm births in published studies, and to compare its efficacy with other methods.
METHODS
Randomized clinical trials published between 2010 and 2018 were selected from electronic databases. Studies on multiple gestations were excluded.
RESULTS
Two studies were in favor of the pessary as a preventive method, one study was contrary to the method and another two showed no statistically significant difference. The meta-analysis showed no statistical difference with the use of a cervical pessary in the reduction of births < 37 (odds ratio [OR]: 0.63; confidence interval [95% CI]: 0.38-1.06) and < 34 weeks (OR: 0.74; 95% CI: 0.35-1.57) CONCLUSION: The pooled data available to date seems to show a lack of efficacy of the cervical pessary in the prevention of preterm birth, although the heterogeneity of the studies made comparisons more difficult.
Topics: Female; Humans; Pessaries; Pregnancy; Premature Birth; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30716786
DOI: 10.1055/s-0038-1676511 -
BioMed Research International 2016Astragalus polysaccharide (APS) (used for intestinal protection) was added to formulate the Tongshu suppository to improve the pharmacokinetics of Aceclofenac, which...
Astragalus polysaccharide (APS) (used for intestinal protection) was added to formulate the Tongshu suppository to improve the pharmacokinetics of Aceclofenac, which were assessed in New Zealand rabbits using an orthogonal experimental design. The single-agent Aceclofenac was taken as the control formulation. The concentration-time and drug release curves were drawn, and T max (min), C max (μg·mL(-1)), AUC0→∞ , and MRT were compared using a pharmacokinetic systems program. The formulated Tongshu suppository had moderate hardness, a smooth surface with uniform color, and theoretical drug-loading rate of 8%. Its release rate was in accordance with the drug preparation requirements. The concentration-time curves and drug release curves revealed that the maximum concentrations (C max) were 4.18 ± 1.03 μg·mL(-1) and 3.34 ± 0.41 μg·mL(-1) for the Tongshu and Aceclofenac suppositories, respectively, showing statistically insignificant difference, while the peak times were 34.87 ± 4.69 min and 34.76 ± 6.34 min, respectively, also showing statistically insignificant difference. Compared with the Aceclofenac suppository, the relative bioavailability of the Tongshu suppository was 104.4%, and the difference between them was statistically insignificant. In this experiment, the Tongshu suppository was prepared using the hot-melt method. In vivo pharmacokinetic studies confirmed it had higher bioavailability than the Aceclofenac suppository.
Topics: Animals; Area Under Curve; Biological Availability; Chemistry, Pharmaceutical; Color; Diclofenac; Drug Liberation; Hardness; Rabbits; Rats; Suppositories; Technology, Pharmaceutical
PubMed: 27610366
DOI: 10.1155/2016/1691579 -
The Cochrane Database of Systematic... Dec 2014Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management, particularly when a woman does not want surgery or when she is considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment.
OBJECTIVES
To determine whether mechanical devices are useful in the management of adult female urinary incontinence.
SEARCH METHODS
For this second update we searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 21 August 2014), EMBASE (January 1947 to 2014 Week 34), CINAHL (January 1982 to 25 August 2014), and the reference lists of relevant articles.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined by symptom, sign or urodynamic diagnosis.
DATA COLLECTION AND ANALYSIS
The reviewers assessed the identified studies for eligibility and risk of bias and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 5.3).
MAIN RESULTS
One new trial was identified and included in this update bringing the total to eight trials involving 787 women. Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Four trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. One trial compared three groups: a mechanical device alone, behavioural therapy (pelvic floor muscle training) alone and behavioural therapy combined with a mechanical device. While at three months there were more withdrawals from the device-only group, at 12 months differences between the groups were not sustained on any measure.
AUTHORS' CONCLUSIONS
The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment.
Topics: Adult; Aged; Exercise Therapy; Female; Humans; Middle Aged; Muscle Contraction; Pelvic Floor; Pessaries; Prostheses and Implants; Randomized Controlled Trials as Topic; Tampons, Surgical; Urinary Incontinence; Urinary Sphincter, Artificial
PubMed: 25517397
DOI: 10.1002/14651858.CD001756.pub6 -
Acta Medica Iranica Nov 2016This study investigated efficacy and side effects of Morphine suppository for pain management after the first elective caesarean delivery in comparison to Diclofenac... (Randomized Controlled Trial)
Randomized Controlled Trial
This study investigated efficacy and side effects of Morphine suppository for pain management after the first elective caesarean delivery in comparison to Diclofenac suppository. One hundred women aged 18-40 with term pregnancies undergoing elective caesarean section for the first time participated in this prospective project. Exclusion criteria included drug sensitivity, fetal malformations or defects, and complications during the cesarean operation. After same spinal anesthesia and same surgical techniques and in the recovery room patients consecutively received 100 mg diclofenac suppository or 10 mg morphine suppository. The pain severity was rated by "Numerical Rating Scale." There was not the difference between two groups in terms of basal information. Pain score was significantly different between two groups in the first 12 hours (5.66 ±1.36 in morphine group and 3.63±0.96 in diclofenac group) but not in the second 12 hour period. Considering pain scores every two hours in first 12 hours and every 4 hours in second 12 hours, morphine group had higher scores in comparison to diclofenac group. Also, the morphine group required pethidine injection sooner than the other group. The time giving first pethidine injection was 3.28±2.16 hours after operation in morphine group and 5.24±4.07 hours after operation (P<0.05). This study demonstrated that diclofenac suppository in comparison to morphine suppository decreased subjective pain scores in the first twenty-four hours after elective caesarean section which reached statistical significance in the first twelve hours. Although in diclofenac group, pethidine injection was prescribed significantly later.
Topics: Administration, Intravaginal; Adult; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Cesarean Section; Diclofenac; Female; Humans; Morphine; Pain Management; Pain Measurement; Pain, Postoperative; Pregnancy; Prospective Studies; Suppositories; Treatment Outcome
PubMed: 28033693
DOI: No ID Found -
Disease Markers 2022To investigate the efficacy of the Panax notoginseng Ejiao suppository in patients with ulcerative proctitis and its effect on inflammatory response and immune function. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To investigate the efficacy of the Panax notoginseng Ejiao suppository in patients with ulcerative proctitis and its effect on inflammatory response and immune function.
METHODS
This study recruited 100 patients with ulcerative proctitis who were hospitalized to our hospital's anorectal outpatient department between May 2015 and October 2020. They were randomly separated into either a control or a study group, with 50 cases in each. The control group received the mesalazine suppository, whereas the study group received the Panax notoginseng Ejiao suppository. Outcome measures included clinical effectiveness, inflammatory response, and immunological state of patients.
RESULTS
The total efficiency in the study group was significantly higher than that in the control group ( = 0.019). The Mayo score and Baron endoscopic score between the two groups were significantly decreased after treatment, with lower results in the study group ( < 0.05). The inflammatory variables were dramatically reduced following therapy, with the study group doing worse. Following treatment, the number of Th 17 cells declined dramatically in both groups, while the proportion of Treg cells increased significantly, with greater alterations of Th17 cells and Treg cells observed in the study group than those in the control group ( < 0.05). The Panax notoginseng Ejiao suppository resulted in significantly shorter time lapses before symptom alleviation and a lower incidence of recurrence at 6 months after treatment versus mesalazine suppository ( < 0.05).
CONCLUSION
In patients with ulcerative proctitis, the Panax notoginseng Ejiao suppository significantly improves clinical efficacy, reduces the incidence of recurrence, mitigates inflammatory response, and improves immune function.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Gelatin; Humans; Immunity; Inflammation; Mesalamine; Panax notoginseng; Suppositories; Treatment Outcome
PubMed: 36188425
DOI: 10.1155/2022/1479964 -
International Urogynecology Journal Nov 2023Recurrent urinary tract infections (rUTIs) are a burden to patients and the health care economy. Vaginal probiotics and supplements have gained significant attention in...
INTRODUCTION AND HYPOTHESIS
Recurrent urinary tract infections (rUTIs) are a burden to patients and the health care economy. Vaginal probiotics and supplements have gained significant attention in mainstream media and lay press as a non-antibiotic alternative. We performed a systematic review to determine whether vaginal probiotics are an effective means of prophylaxis for rUTI.
METHODS
A PubMed/MEDLINE article search was performed from inception to August 2022 for prospective, in vivo use of vaginal suppositories for the prevention of rUTIs. Search terms included: vaginal probiotic suppository (34 results), vaginal probiotic randomized (184 results), vaginal probiotic prevention (441 results), vaginal probiotic UTI (21 results), and vaginal probiotic urinary tract infection (91 results). A total of 771 article titles and abstracts were screened.
RESULTS
A total of 8 articles fit the inclusion criteria and were reviewed and summarized. Four were randomized controlled trials, with 3 of the studies having a placebo arm. Three were prospective cohort studies, and 1 was a single arm, open label trial. Five of the 7 articles that specifically evaluated for rUTI reduction with vaginal suppositories did find a decreased incidence with probiotic use; however, only 2 had statistically significant results. Both of these were studies of Lactobacillus crispatus and were not randomized. Three studies demonstrated the efficacy and safety of Lactobacillus as a vaginal suppository.
CONCLUSION
Current data support the use of vaginal suppositories containing Lactobacillus as a safe, non-antibiotic measure, but actual reduction of rUTI in susceptible women remains inconclusive. The appropriate dosing and duration of therapy remain unknown.
Topics: Humans; Female; Suppositories; Prospective Studies; Lactobacillus; Vagina; Urinary Tract Infections
PubMed: 37392226
DOI: 10.1007/s00192-023-05568-4 -
The Cochrane Database of Systematic... Aug 2018Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP is common, limited supportive data can be found in the literature regarding the preoperative and postoperative interventions related to these procedures. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse. A broad spectrum of perioperative interventions are available, and although the benefits of interventions such as prophylactic antibiotics before abdominal surgery are well established, others are unique to women undergoing POP surgeries and as such need to be investigated separately.
OBJECTIVES
The aim of this review is to compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for pelvic organ prolapse.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In Process, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings (searched 30 November 2017), and reference lists of relevant articles. We also contacted researchers in the field.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic pelvic organ prolapse that compared a perioperative intervention related to pelvic organ prolapse surgery versus no treatment or another intervention.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. Our primary outcomes were objective failure at any site and subjective postoperative prolapse symptoms. We also measured adverse effects, focusing on intraoperative blood loss and blood transfusion, intraoperative ureteral injury, and postoperative urinary tract infection.
MAIN RESULTS
We included 15 RCTs that compared eight different interventions versus no treatment for 1992 women in five countries. Most interventions were assessed by only one RCT with evidence quality ranging from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates.Pelvic floor muscle training (PFMT) compared with no treatment (three RCTs) - peri-operative intervention The simplest of the PFMT programmes required women to attend six perioperative consultations in the three months surrounding prolapse surgery. Trial results provided no clear evidence of a difference between groups in objective failure at any site at 12 to 24 months (odds ratio (OR) 0.93, 95% confidence interval (CI) 0.56 to 1.54; two RCTs, 327 women; moderate-quality evidence). With respect to awareness of prolapse, findings were inconsistent. One RCT found no evidence of a difference between groups at 24 months (OR 1.07, 95% CI 0.61 to 1.87; one RCT, 305 women; low-quality evidence), and a second small RCT reported symptom reduction from the Pelvic Organ Prolapse Symptom Questionnaire completed by the intervention group at 12 months (mean difference (MD) -3.90, 95% CI -6.11 to -1.69; one RCT, 27 women; low-quality evidence). Researchers found no clear differences between groups at 24-month follow-up in rates of repeat surgery (or pessary) for prolapse (OR 1.92, 95% CI 0.74 to 5.02; one RCT, 316 women; low-quality evidence).Other interventionsSingle RCTs evaluated the following interventions: preoperative guided imagery (N = 44); injection of vasoconstrictor agent at commencement of vaginal prolapse surgery (N = 76); ureteral stent placement during uterosacral ligament suspension (N = 91); vaginal pack (N = 116); prophylactic antibiotics for women requiring postoperative urinary catheterisation (N = 159); and postoperative vaginal dilators (N = 60).Two RCTs evaluated bowel preparation (N = 298), and four RCTs assessed the method and timing of postoperative catheterisation (N = 514) - all in different comparisons.None of these studies reported our primary review outcomes. One study reported intraoperative blood loss and suggested that vaginal injection of vasoconstrictors at commencement of surgery may reduce blood loss by a mean of about 30 mL. Another study reported intraoperative ureteral injury and found no clear evidence that ureteral stent placement reduces ureteral injury. Three RCTs reported postoperative urinary tract infection and found no conclusive evidence that rates of urinary tract infection were influenced by use of a vaginal pack, prophylactic antibiotics, or vaginal dilators. Other studies did not report these outcomes.
AUTHORS' CONCLUSIONS
There was a paucity of data about perioperative interventions in pelvic organ prolapse surgery. A structured programme of pelvic floor muscle training before and after prolapse surgery did not consistently demonstrate any benefit for the intervention; however, this finding is based on the results of two small studies. With regard to other interventions (preoperative bowel preparation and injection of vasoconstrictor agent, ureteral stent placement during uterosacral ligament suspension, postoperative vaginal pack insertion, use of vaginal dilators, prophylactic antibiotics for postoperative catheter care), we found no evidence regarding rates of recurrent prolapse and no clear evidence that these interventions were associated with clinically meaningful reductions in adverse effects, such as intraoperative or postoperative blood transfusion, intraoperative ureteral injury, or postoperative urinary tract infection.
Topics: Antibiotic Prophylaxis; Exercise; Female; Humans; Imagery, Psychotherapy; Pelvic Floor; Pelvic Organ Prolapse; Perioperative Care; Pessaries; Randomized Controlled Trials as Topic; Recurrence; Reoperation; Stents; Vasoconstrictor Agents
PubMed: 30121957
DOI: 10.1002/14651858.CD013105 -
Revue Medicale de Liege Mar 2016
Topics: Aged; Female; Foreign Bodies; Humans; Pelvic Organ Prolapse; Pessaries; Time Factors
PubMed: 27311240
DOI: No ID Found -
The Cochrane Database of Systematic... Apr 2022There are a limited number of treatment options for people with corticosteroid-refractory ulcerative colitis. Animal models of inflammatory bowel disease and... (Review)
Review
BACKGROUND
There are a limited number of treatment options for people with corticosteroid-refractory ulcerative colitis. Animal models of inflammatory bowel disease and uncontrolled studies in humans suggest that tacrolimus may be an effective treatment for ulcerative colitis.
OBJECTIVES
To evaluate the efficacy and safety of tacrolimus for induction of remission in people with corticosteroid-refractory ulcerative colitis.
SEARCH METHODS
We searched the Cochrane Gut group specialised register, CENTRAL, MEDLINE (PubMed), Embase, Clinicaltrials.gov and WHO ICTRP from inception to October 2021 to identify relevant randomised controlled trials (RCT).
SELECTION CRITERIA
Two review authors independently selected potentially relevant studies to determine eligibility based on the prespecified criteria.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and analysed them using Review Manager Web. The primary outcomes were induction of remission and clinical improvement, as defined by the studies and expressed as a percentage of the participants randomised (intention-to-treat analysis).
MAIN RESULTS
This review included five RCTs with 347 participants who had active ulcerative colitis or ulcerative proctitis. The duration of intervention varied between two weeks and eight weeks. Tacrolimus versus placebo Tacrolimus (oral and rectal) may be superior in achieving clinical remission compared to placebo (oral and rectal) (14/87 participants with tacrolimus versus 1/61 participants with placebo; risk ratio (RR) 3.76, 95% confidence interval (CI) 1.03 to 13.73; 3 studies). These results are of low certainty due to imprecision and risk of bias. Tacrolimus (oral and rectal) may be superior for clinical improvement compared to placebo (oral and rectal) (45/87 participants with tacrolimus versus 7/61 participants with placebo; RR 4.47, 95% CI 2.15 to 9.29; 3 studies). These results are of low certainty due to imprecision and risk of bias. The evidence is very uncertain about the effects of tacrolimus (oral and rectal) on serious adverse events compared to placebo (oral and rectal) (2/87 participants with tacrolimus versus 0/61 participants with placebo; RR 2.44, 95% CI 0.12 to 48.77; 3 studies). These results are of very low certainty due to high imprecision and risk of bias. Tacrolimus versus ciclosporin One study compared oral tacrolimus to intravenous ciclosporin, with an intervention lasting two weeks and 113 randomised participants. The evidence is very uncertain about the effect of tacrolimus on achievement of clinical remission compared to ciclosporin (15/33 participants with tacrolimus versus 24/80 participants with ciclosporin; RR 1.52, 95% CI 0.92 to 2.50). The results are of very low certainty due to risk of bias and high imprecision. The evidence is very uncertain about the effect of tacrolimus on clinical improvement compared to intravenous ciclosporin (23/33 participants with tacrolimus versus 62/80 participants with ciclosporin; RR 0.90, 95% CI 0.70 to 1.16). The results are of very low certainty due to risk of bias and imprecision. Tacrolimus versus beclometasone One study compared tacrolimus suppositories with beclometasone suppositories in an intervention lasting four weeks with 88 randomised participants. There may be little to no difference in achievement of clinical remission (16/44 participants with tacrolimus versus 15/44 participants with beclometasone; RR 1.07, 95% CI 0.60 to 1.88). The results are of low certainty due to high imprecision. There may be little to no difference in clinical improvement when comparing tacrolimus suppositories to beclometasone suppositories (22/44 participants with tacrolimus versus 22/44 with beclometasone; RR 1.00, 95% CI 0.66 to 1.52). The results are of low certainty due to high imprecision. There may be little to no difference in serious adverse events when comparing tacrolimus suppositories to beclometasone suppositories (1/44 participants with tacrolimus versus 0/44 with beclometasone; RR 3.00, 95% CI 0.13 to 71.70). These results are of low certainty due to high imprecision. There may be little to no difference in total adverse events when comparing tacrolimus suppositories to beclometasone suppositories (21/44 participants with tacrolimus versus 14/44 participants with beclometasone; RR 1.50, 95% CI 0.88 to 2.55). These results are of low certainty due to high imprecision. No secondary outcomes were reported for people requiring rescue medication or to undergo surgery.
AUTHORS' CONCLUSIONS
There is low-certainty evidence that tacrolimus may be superior to placebo for achievement of clinical remission and clinical improvement in corticosteroid-refractory colitis or corticosteroid-refractory proctitis. The evidence is very uncertain about the effect of tacrolimus compared to ciclosporin for achievement of clinical remission or clinical improvement. There may be no difference between tacrolimus and beclometasone for inducing clinical remission or clinical improvement. The cohorts studied to date were small, with missing data sets, offered short follow-up and the clinical endpoints used were not in line with those suggested by regulatory bodies. Therefore, no clinical practice conclusions can be made. This review highlights the need for further research that targets the relevant clinical questions, uses appropriate trial methodology and reports key findings in a systematic manner that facilitates future integration of findings with current evidence to better inform clinicians and patients. Future studies need to be adequately powered and of pertinent duration so as to capture the efficacy and effectiveness of tacrolimus in the medium to long term. Well-structured efficacy studies need to be followed up by long-term phase 4 extensions to provide key outputs and inform in a real-world setting.
Topics: Adrenal Cortex Hormones; Beclomethasone; Colitis, Ulcerative; Cyclosporine; Humans; Proctitis; Remission Induction; Suppositories; Tacrolimus
PubMed: 35388476
DOI: 10.1002/14651858.CD007216.pub2