Misoprostol

米索前列醇
  • 文章类型: Case Reports
    近年来,特发性消化性溃疡(IPU)的频率增加。然而,IPU的临床病理特征尚未完全阐明,复发和难治性病例的治疗方法尚未确定。
    一名四十多岁的男子主诉上腹部不适。食管胃十二指肠镜检查显示胃角较小曲率的胃溃疡。根除幽门螺杆菌后,胃溃疡复发,尽管施用钾竞争性酸阻滞剂(PCAB),并对IPU进行了诊断。24小时胃内pH监测显示胃酸抑制不足。在患者的治疗中加入米索前列醇。随后,溃疡愈合,未观察到复发。
    对于耐火IPU,通过24小时胃pH监测评估病理生理功能可能导致选择合适的治疗方法.如果质子泵抑制剂和PCAB不能改善IPU,可考虑与米索前列醇联合治疗.
    UNASSIGNED: In recent years, the frequency of idiopathic peptic ulcers (IPUs) has increased. However, the clinicopathological characteristics of IPU have not been fully elucidated and treatment methods for recurrent and refractory cases have not yet been established.
    UNASSIGNED: A man in his forties complained of epigastric discomfort. Esophagogastroduodenoscopy revealed a gastric ulcer in the lesser curvature of the gastric angle. After Helicobacter pylori was eradicated, the gastric ulcer recurred despite the administration of a potassium competitive acid blocker (PCAB), and a diagnosis of IPU was made. Twenty-four-hour intragastric pH monitoring revealed insufficient gastric acid suppression. Misoprostol was added to the patient\'s treatment. Subsequently, the ulcer healed and recurrence was not observed.
    UNASSIGNED: For refractory IPU, the evaluation of pathophysiological function through 24-h gastric pH monitoring may lead to the selection of an appropriate treatment. If a proton pump inhibitor and PCAB do not improve the IPU, combination treatment with misoprostol may be considered as an option.
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  • 文章类型: Journal Article
    流产,妊娠12周之前的早期妊娠常见并发症,通常是医学管理。我们旨在评估妊娠早期流产妇女的医疗管理成功率和并发症发生率。我们的目标是计算治疗后三周内子宫完全排空率,感染率,大量失血,重新入场,或手术疏散。
    这是一项回顾性横断面研究,包括2019年1月至2019年12月在迪拜Latifa医院妇科诊断为妊娠不到13周流产的妇女。这些患者给予阴道米索前列醇,400-800mcg每6-8小时,直到怀孕。
    该研究包括294名女性。成功率为60.5%(178/294)。20名妇女出现严重失血(6.8%),四名妇女出现感染(1.4%),76要求再入院(25.9%),12名妇女接受了输血(4.1%),74名妇女需要手术后送(25.2%)。无效,无疤痕的子宫,治疗前腹痛伴阴道出血的存在与药物治疗的成功显著相关(p<0.05)。
    所研究的医疗方案的成功率位于文献中引用的下限。成功率的差异可以归因于其他研究中对成功的不同定义。无效,无瘢痕子宫和腹痛伴阴道出血与较高的成功率相关.
    UNASSIGNED: Miscarriage, a common complication of early pregnancy before 12 completed weeks of gestation, is typically managed medically. We aimed to estimate the success and complication rate of medical management in women with first-trimester missed miscarriages. Our objective was to calculate the rate of complete uterine evacuation within three weeks of treatment, rate of infection, significant blood loss, re-admission, or surgical evacuation.
    UNASSIGNED: It was a retrospective cross-sectional study that included women diagnosed with miscarriage at less than 13 weeks\' gestation in Latifa Hospital\'s Gynecology Department from January 2019 to December 2019 in Dubai. These patients were given vaginal misoprostol, 400-800 mcg every 6-8 hours until expulsion of pregnancy.
    UNASSIGNED: There were 294 women included in the study. The success rate was 60.5% (178/294). Twenty women developed significant blood loss (6.8%), four women developed infection (1.4%), 76 required readmission (25.9%), 12 women received blood transfusion (4.1%), and 74 women required a surgical evacuation (25.2%). Nulliparity, unscarred uterus, and the presence of abdominal pain with vaginal bleeding before treatment were significantly associated with the successful medical treatment (p<0.05).
    UNASSIGNED: The success rate of the medical regimen studied lies on the lower end of what is quoted in the literature. The difference in the success rate could be attributed to the different definitions of success in other studies. Nulliparity, unscarred uterus and presence of abdominal pain with vaginal bleeding were associated with higher success.
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  • 文章类型: Journal Article
    该研究旨在对新开发的药物进行全面的体外和体内评估,正在申请专利,粉末到水凝胶,成膜聚合物复合基质,具有组织保护和微生物组支持特性,并将其与泊洛沙姆407的特性进行比较。这项研究使用了体外试验的组合,包括组织活力和细胞迁移,和雄性糖尿病小鼠体内伤口愈合评估。还分析了伤口部位的微生物组动力学。体外测定证明,聚合物复合物碱基是非细胞毒性的,并且其相对于泊洛沙姆407增强细胞迁移。在体内,聚合物复合基质表现出优异的伤口愈合能力,特别是与米索前列醇和苯妥英合用,如减少的伤口面积和炎症评分所证明的。微生物组分析显示,与聚合物复合物碱处理的伤口相关的细菌种群发生了有利的变化。聚合物复合基质在伤口护理中显示出临床意义,可能提供更好的治疗,安全和微生物组支持。其在药物递送中的转化特性和功效使其成为高级伤口护理应用的有希望的候选者,特别是在慢性伤口管理中。
    The study aimed to perform a comprehensive in vitro and in vivo evaluation of a newly developed, patent-pending, powder-to-hydrogel, film-forming polymer complex base, which possesses tissue-protective and microbiome-supportive properties, and to compare its characteristics with poloxamer 407. The study used a combination of in vitro assays, including tissue viability and cell migration, and in vivo wound healing evaluations in male diabetic mice. Microbiome dynamics at wound sites were also analyzed. The in vitro assays demonstrated that the polymer complex base was non-cytotoxic and that it enhanced cell migration over poloxamer 407. In vivo, the polymer complex base demonstrated superior wound healing capabilities, particularly in combination with misoprostol and phenytoin, as evidenced by the reduced wound area and inflammation scores. Microbiome analysis revealed favorable shifts in bacterial populations associated with the polymer complex base-treated wounds. The polymer complex base demonstrates clinical significance in wound care, potentially offering improved healing, safety and microbiome support. Its transformative properties and efficacy in drug delivery make it a promising candidate for advanced wound care applications, particularly in chronic wound management.
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  • 文章类型: Journal Article
    目的:本研究的目的是评估在低风险孕妇人群中使用阴道米索前列醇引产的成功率和预测因素。
    方法:对196名孕妇进行了前瞻性队列研究。罗布森分类的第2组和第4组接受阴道米索前列醇引产(每6小时25μg片剂,多达4片,最长24小时)。引产的成功被认为是阴道分娩的成功。二元逻辑回归用于确定阴道米索前列醇成功引产的最佳预测因素。
    结果:在分析的所有孕妇中,140例(71.4%)成功,56例(28.6%)不成功。成功引产的孕妇怀孕次数较多(1.69vs.1.36,p=0.023),较高的交货数量(0.57与0.19,p<0.001),更高的Bishop分数(2.0vs.1.38,p=0.002),和更低的米索前列醇25μg片剂(2.18vs.2.57,p=0.031)。以前没有分娩[x2(1)=3.14,比值比(OR):0.24,95%置信区间(CI):0.10-0.57,R2Nagelkerke:0.91,p=0.001]和以前一次分娩的存在[x2(1)=6.0,OR:3.40,95%CI:1.13-10.16,R2Nagelkerke:0.043,p=0.029]是阴道前列腺醇成功引产的
    结论:在低风险人群中观察到使用阴道米索前列醇的引产成功率很高,主要发生在经胎和胎龄>41周。以前没有分娩降低了引产的成功率,而之前的一次分娩增加了引产的成功率。
    OBJECTIVE: The aim of this study was to evaluate the success rate and predictors of labor induction using vaginal misoprostol in a low-risk pregnant women population.
    METHODS: A prospective cohort study was carried out with 196 pregnant women. Groups 2 and 4 of the Robson Classification admitted for induction of labor with vaginal misoprostol (25 μg tablets every 6 h, up to 4 tablets, for a maximum of 24 h). The success of labor induction was considered the achievement of vaginal delivery. Binary logistic regression was used to determine the best predictors of successful induction of labor with vaginal misoprostol.
    RESULTS: Of all the pregnant women analyzed, 140 (71.4%) were successful and 56 (28.6%) were unsuccessful. Pregnant women who achieved successful induction had a higher number of pregnancies (1.69 vs. 1.36, p=0.023), a higher number of deliveries (0.57 vs. 0.19, p<0.001), a higher Bishop score (2.0 vs. 1.38, p=0.002), and lower misoprostol 25 μg tablets (2.18 vs. 2.57, p=0.031). No previous deliveries [x2(1)=3.14, odds ratio (OR): 0.24, 95% confidence interval (CI): 0.10-0.57, R2 Nagelkerke: 0.91, p=0.001] and the presence of one previous delivery [x2(1)=6.0, OR: 3.40, 95% CI: 1.13-10.16, R2 Nagelkerke: 0.043, p=0.029] were significant predictors of successful induction of labor with vaginal misoprostol.
    CONCLUSIONS: A high rate of labor induction success using vaginal misoprostol in a low-risk population was observed, mainly in multiparous and with gestational age>41 weeks. No previous delivery decreased the success of labor induction, while one previous delivery increased the success of labor induction.
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  • 文章类型: Journal Article
    为了比较宫颈成熟时间与使用阴道米索前列醇加Hyoscine-N-丁基溴,单独使用米索前列醇阴道。
    一项双盲随机对照试验,泛非临床试验注册(PACTR)批准号为PACTR202112821475292。
    联邦医疗中心,Asaba,尼日利亚。
    共纳入126名符合产前宫颈成熟的患者。
    A组的参与者有25微克阴道米索前列醇和1毫升肌内安慰剂,B组中的患者有25µg阴道米索前列醇和20mg肌内Hyoscine(1ml)。当需要时使用催产素输注,劳动按照部门协议进行监督。
    宫颈成熟时间。
    hyoscine组的平均宫颈成熟时间(8.48±4.36小时)明显短于安慰剂组(11.40±7.33小时);p值0.02,95%CI0.80-5.05。A组(7.38±5.28小时)平均诱导-分娩间期与B组(7.75±5.04小时)比较,差异无统计学意义,值为0.54。交付方式具有可比性。然而,B组女性(53,84.1%)的阴道分娩率高于A组女性(50,79.4%);p值0.49.甲组13名妇女(20.6%)剖腹产,B组中有10名妇女(15.9%)进行了剖腹产(p值0.49,RR0.94,CI0.80-1.11)。两组间不良母婴结局无统计学意义。
    当用作阴道米索前列醇的辅助药物时,肌内hyoscine可有效减少宫颈成熟时间,没有明显的不良母婴结局。
    没有声明。
    UNASSIGNED: To compare cervical ripening time with the use of vaginal Misoprostol plus Hyoscine-N-Butylbromide, with vaginal Misoprostol alone.
    UNASSIGNED: A double-blind randomized controlled trial with Pan-African Clinical Trials Registry (PACTR) approval number PACTR202112821475292.
    UNASSIGNED: Federal Medical Centre, Asaba, Nigeria.
    UNASSIGNED: A total of 126 eligible antenatal patients for cervical ripening were enrolled.
    UNASSIGNED: Participants in Group A had 25µg of vaginal misoprostol with 1ml of intramuscular placebo, and those in Group B had 25µg of vaginal misoprostol with 20mg of Intramuscular Hyoscine (1 ml). Oxytocin infusion was used when indicated, and the labour was supervised as per departmental protocol.
    UNASSIGNED: Cervical ripening time.
    UNASSIGNED: The mean cervical ripening time was statistically significantly shorter in the hyoscine group (8.48±4.36 hours) than in the placebo group (11.40±7.33 hours); p-value 0.02, 95% CI 0.80-5.05. There was no statistically significant difference in the mean induction-delivery interval in Group A (7.38±5.28 hours) compared to Group B (7.75±5.04 hours), with a value of 0.54. The mode of delivery was comparable. However, women in Group B (53, 84.1%) achieved more vaginal deliveries than women in Group A (50, 79.4%); p-value 0.49. Thirteen women in Group A (20.6%) had a caesarean section, while ten women (15.9%) in Group B had a caesarean section (p-value 0.49, RR 0.94, CI 0.80-1.11). Adverse maternal and neonatal outcomes were not statistically significant between the two groups.
    UNASSIGNED: Intramuscular hyoscine was effective in reducing cervical ripening time when used as an adjunct to vaginal Misoprostol, with no significant adverse maternal or neonatal outcome.
    UNASSIGNED: None declared.
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  • 文章类型: Journal Article
    背景:然而,米索前列醇通常用于终止妊娠,但它也会引起副作用。单硝酸异山梨酯(ISMN)可以通过增加前列腺素E2的产生和血管舒张来帮助子宫颈成熟。考虑到这一领域的研究结果是矛盾的,本研究的目的是评估阴道ISMN联合米索前列醇与单用米索前列醇在早期和中期流产治疗中的疗效和安全性.
    方法:搜索过程是通过PubMed界面对MEDLINE进行的,Scopus,Web-of-Science,科学直接,Cochrane中央控制试验登记册(CENTRAL),谷歌学者,ClinicalTrials.gov,和世界卫生组织国际临床试验注册平台,直到2023年11月10日。我们对偏倚的评估基于随机试验的偏倚风险工具(RoB2)的版本2,我们的证据质量水平由GRADE确定。使用ReviewManager(RevMan)5.1版对所有数据进行Meta分析。
    结果:七项随机临床试验纳入系统评价,三项纳入荟萃分析,混合质量。荟萃分析结果显示,在妊娠中期流产中,将ISMN与阴道米索前列醇结合使用可显著缩短引产间期,具体到4.21h(95%CI:-7.45至-0.97,P=0.01)。在米索前列醇中添加阴道ISMN,与单独的阴道米索前列醇相比,完成堕胎的几率增加了3.76倍。(95%CI:1.08~13.15,P=0.04)。
    结论:这项研究的结果可以提供有价值的见解,旨在加强对专业环境中非手术药物流产方法的咨询和支持。此外,它提高了临床治疗的有效性,减少了流产管理方案中不必要的手术干预的发生。
    BACKGROUND: However, misoprostol is often used to terminate a pregnancy, but it can also cause side effects. Isosorbide mononitrate (ISMN) can help the cervix mature by increasing the production of prostaglandin E2 and vasodilation. Considering that the results of studies in this field are contradictory, it is the purpose of this study to evaluate the efficacy and safety of vaginal ISMN plus misoprostol compared to misoprostol alone in the management of first- and second-trimester abortions.
    METHODS: The search process was conducted for MEDLINE through the PubMed interface, Scopus, Web-of-Science, Science Direct, the Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform until November 10, 2023. Our assessment of bias was based on version 2 of the risk-of-bias tool (RoB2) for randomized trials and our level of evidence quality was determined by GRADE. Meta-analysis of all data was carried out using Review Manager (RevMan) version 5.1.
    RESULTS: Seven randomized clinical trials were included in the systematic review and three in the meta-analysis, with mixed quality. The results of the meta-analysis revealed that in the second-trimester abortion, the inclusion of ISMN in conjunction with vaginal misoprostol results in a noteworthy reduction in the induction abortion interval, specifically by 4.21 h (95% CI: -7.45 to -0.97, P = 0.01). The addition of vaginal ISMN to misoprostol, compared to vaginal misoprostol alone, increased the odds of a completed abortion by 3.76 times. (95% CI: 1.08 to 13.15, P = 0.04).
    CONCLUSIONS: The findings of this study can offer valuable insights aimed at enhancing counseling and support for non-surgical methods of medication abortion within professional settings. Moreover, it improves the effectiveness of clinical treatment and reduces the occurrence of unnecessary surgical interventions in the abortion management protocol.
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  • 文章类型: Case Reports
    产后出血(PPH)仍然是孕产妇死亡的主要原因,主要归因于子宫收缩。世界卫生组织(WHO)和国际妇产科联合会(FIGO)都认可米索前列醇不仅用于预防而且用于治疗PPH。然而,米索前列醇的给药通常与短暂性发热有关,归因于在某些动物研究中观察到的下丘脑设定点的变化。米索前列醇诱导的高热可偶尔表现为颤抖的前驱症状,特别是当通过舌下途径给药时,与阴道和直肠途径相比,它实现了更高且更快的最大血浆浓度。减少发烧的一般管理策略包括脱衣服和毯子,施加凉爽的压缩,口服对乙酰氨基酚,并确保充分的水化。虽然一些病例报告了米索前列醇引起的惊厥,高热导致惊厥和随后的横纹肌溶解是一种罕见且可能致命的副作用。在这种情况下,我们强调米索前列醇用于治疗PPH,但导致横纹肌溶解的情况.我们的目标是强调米索前列醇的副作用以及考虑将米索前列醇与解热管理初始组合以最大程度地减少与高热相关的副作用的风险并防止其他严重并发症的重要性。
    Postpartum hemorrhage (PPH) remains the leading cause of maternal mortality, primarily attributed to uterine atony. Both the World Health Organization (WHO) and the International Federation of Gynecology and Obstetrics (FIGO) endorse the use of misoprostol not only for the prevention but also for the treatment of PPH. However, the administration of misoprostol is commonly associated with transient pyrexia, attributed to a shift in the hypothalamic set point observed in certain animal studies. Misoprostol-induced hyperpyrexia can occasionally manifest with a prodrome of shivering, particularly when administered via the sublingual route, which achieves a higher and faster maximum plasma concentration compared to vaginal and rectal routes. General management strategies to reduce fever involve removing clothing and blankets, applying cool compresses, administering oral acetaminophen, and ensuring adequate hydration. While some cases have reported misoprostol-induced convulsions, hyperpyrexia leading to convulsions and subsequent rhabdomyolysis is a rare and potentially lethal side effect. In this case presentation, we emphasize a scenario where misoprostol was employed for the treatment of PPH but led to rhabdomyolysis. Our goal is to highlight the side effects of misoprostol and the significance of considering the initial combination of misoprostol with anti-pyretic management to minimize the risk of hyperthermia-related side effects and prevent additional severe complications.
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  • 文章类型: Journal Article
    背景:非酒精性脂肪性肝炎(NASH)的管理是一个未满足的临床需求。米索前列醇,前列腺素E1是天然存在的前列腺素E1的结构类似物,据报道可以减少促炎细胞因子的产生,并且可能在治疗NASH中具有潜在作用。我们旨在评估米索前列醇治疗NASH患者的疗效和安全性。
    方法:在此阶段2,双盲,随机化,安慰剂对照试验,NASH患者以1∶1的比例随机分组,接受200µg米索前列醇或安慰剂,每日3次,共2个月.主要终点是肝功能测试(LFTs)的改善,白细胞介素-6(IL-6)和内毒素水平。次要终点是胰岛素抵抗的改善,血脂异常,肝纤维化和肝脂肪变性。
    结果:共有50名患者接受了随机分组,其中44人(88%)为男性。年龄范围为25-64岁(平均值±SE(SEM)38.1±1.4)。19例(38%)患者合并2型糖尿病。32例(64%)患者超重或肥胖。在2个月的治疗结束时,总白细胞计数(TLC)减少(p=0.005),丙氨酸氨基转移酶(ALT)(p<0.001),谷草转氨酶(AST)(p=0.002)和受控衰减参数(CAP)(p=0.003)在米索前列醇组中观察到,而安慰剂随后ALT下降(p<0.001),AST(p=0.018),γ-谷氨酰转移酶(GGT)(p=0.003),CAP(p=0.010)和甘油三酯(p=0.048)。胰岛素抵抗没有减少,两组的肝纤维化(弹性成像)和血脂异常。然而,与安慰剂组相比,米索前列醇导致CAP显著降低(p=0.039)。此外,在米索前列醇组中,治疗前和治疗后IL-6和内毒素水平保持稳定,而在安慰剂组,IL-6水平升高(p=0.049).米索前列醇组有6例(12%)患者出现至少1例不良事件,安慰剂组中有5例(10%)。米索前列醇组最常见的不良事件是腹泻。各组均未发生危及生命事件或治疗相关死亡。
    结论:米索前列醇和安慰剂组的生化特征均有改善,无统计学意义。然而,脂肪变性有了更多的改善,正如CAP所描绘的,米索前列醇组和安慰剂组IL-6水平恶化。
    背景:NCT05804305。
    BACKGROUND: The management of non-alcoholic steatohepatitis (NASH) is an unmet clinical need. Misoprostol, a structural analogue of naturally occurring prostaglandin E1, has been reported to decrease proinflammatory cytokine production and may have a potential role in treating NASH. We aimed to evaluate the efficacy and safety of misoprostol in treating patients with NASH.
    METHODS: In this phase 2, double-blind, randomised, placebo-controlled trial, patients with NASH were randomly assigned in a 1:1 ratio to receive 200 µg of misoprostol or placebo thrice daily for 2 months. The primary endpoint was an improvement in liver function tests (LFTs), interleukin-6 (IL-6) and endotoxin levels. The secondary endpoint was improvement in insulin resistance, dyslipidaemia, hepatic fibrosis and hepatic steatosis.
    RESULTS: A total of 50 patients underwent randomisation, of whom 44 (88%) were males. The age range was 25-64 years (mean±SE of mean (SEM) 38.1±1.4). 19 (38%) patients had concomitant type 2 diabetes mellitus. 32 (64%) patients were either overweight or obese. At the end of 2 months\' treatment, a reduction in total leucocyte count (TLC) (p=0.005), alanine aminotransferase (ALT) (p<0.001), aspartate aminotransferase (AST) (p=0.002) and controlled attenuation parameter (CAP) (p=0.003) was observed in the misoprostol group, whereas placebo ensued a decline in ALT (p<0.001), AST (p=0.018), gamma-glutamyl transferase (GGT) (p=0.003), CAP (p=0.010) and triglycerides (p=0.048). There was no diminution in insulin resistance, hepatic fibrosis (elastography) and dyslipidaemia in both groups. However, misoprostol resulted in a significant reduction in CAP as compared with the placebo group (p=0.039). Moreover, in the misoprostol group, pretreatment and post-treatment IL-6 and endotoxin levels remained stable, while in the placebo group, an increase in the IL-6 levels was noted (p=0.049). Six (12%) patients had at least one adverse event in the misoprostol group, as did five (10%) in the placebo group. The most common adverse event in the misoprostol group was diarrhoea. No life-threatening events or treatment-related deaths occurred in each group.
    CONCLUSIONS: Improvement in the biochemical profile was seen in both misoprostol and placebo groups without any statistically significant difference. However, there was more improvement in steatosis, as depicted by CAP, in the misoprostol group and worsening of IL-6 levels in the placebo group.
    BACKGROUND: NCT05804305.
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  • 文章类型: Journal Article
    背景:在印度,使用米非司酮和米索前列醇的药物流产可在妊娠63天。这占该国所有堕胎的67.5%。我们进行了评估,以确定药物流产药物的可用性,特别是组合包,在印度。
    方法:我们在国家一级应用了世界卫生组织景观评估协议。评估协议包括对现有可用性框架的五步调整,包括在线数据收集,案头审查,国家一级的关键线人访谈,和分析,以确定障碍和机会,以提高医疗流产的可用性。评估于2021年8月至3月间进行。
    结果:药物流产药物被列入国家基本药物清单,并在印度有处方。评估确定了由35家制造商开发的42种组合包装产品。药物流产药物的质量由国家当局监管;但是随着健康移交给各州,有显著的州际差异。这在整个融资过程中都可以看到,采购,制造,和药物流产药物分发前质量保证的监测机制。有必要加强供应链系统,确保训练有素的提供者的一致可用性,并提高社区对使用药物流产药物进行早期流产的认识,在评估时。
    结论:存在提高药物流产药物的可用性和质量的机会。例如,统一执行监管标准,在制造过程中更加重视质量保证,以及各州采购和供应链系统的标准化。需要对提供者进行药物流产的定期在职培训。最后,需要在证据传播和社区参与方面进行创新,以了解最近修订的堕胎法。
    药物流产在印度很流行,并受益于自由的法律背景。重要的是要了解该国优质流产药物的可用性。使用世界卫生组织国家评估协议和药物流产药物的可用性框架,我们从供应到需求检查了这些药物的可用性。我们利用这些信息来确定增加质量保证的药物流产的机会。我们发现,药物流产的背景因各州而异。加强采购和供应链管理,应在国家一级更加重视质量保证和制造业监管。还需要培训,以增加提供者对最新国家准则和法律的了解,以确保尊重和以人为本的服务。最后,应该让公众了解药物流产是一种安全有效的选择,尤其是早期流产。
    BACKGROUND: Medical abortion with mifepristone and misoprostol can be provided up to 63 days\' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India.
    METHODS: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021.
    RESULTS: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment.
    CONCLUSIONS: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed.
    Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions.
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  • 文章类型: Journal Article
    背景:尽管它们对降低孕产妇死亡率很重要,关于获得米非司酮的信息,米索前列醇,东地中海地区的避孕药物有限。
    方法:一种标准化评估工具,用于测量获得米非司酮的情况,米索前列醇,世卫组织基本药物清单(EML)中的避孕药物在东地中海区域的八个国家(阿富汗,伊拉克,黎巴嫩,利比亚,摩洛哥,巴勒斯坦,巴基斯坦,和索马里)在2020-2021年之间。评估的重点是五项获取措施:1)将药物纳入国家计划生育指南;2)将药物纳入综合堕胎护理指南;3)将药物纳入国家基本药物清单;4)药物注册;5)米非司酮的采购和预测,米索前列醇,和避孕药。对这八项国家评估的结果进行了描述性分析。
    结果:只有黎巴嫩和巴基斯坦在其国家计划生育指南中纳入了WHO-EML的所有12种避孕药具。只有阿富汗和黎巴嫩在堕胎后护理指南中包括米非司酮和米非司酮-米索前列醇组合,但这些药物不包括在他们的国家EMLs。利比亚和索马里缺乏药品注册的国家监管机构。大多数避孕药包括在黎巴嫩的国家EMLs中,摩洛哥和巴基斯坦已注册。米索前列醇被列入EML,并在六个国家注册(阿富汗,伊拉克,黎巴嫩,摩洛哥,巴勒斯坦,和巴基斯坦)。然而,只有三个国家采购了米索前列醇(伊拉克,摩洛哥,和索马里)。
    结论:这些发现可以指导旨在提高米非司酮可用性的努力,米索前列醇,以及东地中海地区的避孕药物。机会包括扩大国家EML,包括米非司酮的更多选择,米索前列醇,并加强注册和采购制度,以确保这些药物的可获得性是国家法律和文化上可接受的。
    确保获得米非司酮,米索前列醇,避孕药物对改善妇女健康至关重要,更具体地说,降低产妇死亡率,改善东地中海区域妇女的性健康和生殖健康。这项研究的目的是分析国家评估的结果,以获取有关执行相关政策和程序的信息。这些是确保获得米非司酮的政策,米索前列醇,和研究中包括的八个东地中海区域国家在公共部门的避孕药物(阿富汗,伊拉克,利比亚,黎巴嫩,摩洛哥,巴勒斯坦,巴基斯坦,和索马里)。评估在2020年至2021年之间完成。我们发现,大多数国家并没有在其国家计划生育指南中纳入世卫组织基本药物清单(EML)中的所有12种避孕药具。没有任何国家制定了国家堕胎护理指南,也没有将米非司酮(单独或与米索前列醇联合使用)纳入国家EML。利比亚和索马里缺乏药品注册的国家监管机构。大多数避孕药包括在黎巴嫩的国家EMLs中,摩洛哥和巴基斯坦已注册。米索前列醇被列入EML-并在六个国家注册(阿富汗,伊拉克,黎巴嫩,摩洛哥,巴勒斯坦,和巴基斯坦)然而,只有三个国家采购了米索前列醇(伊拉克,摩洛哥,和索马里)。我们的发现为米非司酮的使用提供了系统级障碍的证据,米索前列醇,和避孕药(例如,缺乏关于EML的指导方针或纳入,缺乏注册和采购),可以支持加强制药部门的政策和宣传努力,以更好地确保米非司酮的供应,米索前列醇,根据国家法律和现行文化,在国家一级向育龄妇女提供避孕药具。
    BACKGROUND: Despite their importance in reducing maternal mortality, information on access to Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region is limited.
    METHODS: A standardized assessment tool measuring access to Mifepristone, Misoprostol, and contraceptive medicines included in the WHO essential medicines list (EML) was implemented in eight countries in the Eastern Mediterranean Region (Afghanistan, Iraq, Lebanon, Libya, Morocco, Palestine, Pakistan, and Somalia) between 2020-2021. The assessment focused on five access measures: 1) the inclusion of medicines in national family planning guidelines; 2) inclusion of medicines in comprehensive abortion care guidelines; 3) inclusion of medicines on national essential medicines lists; 4) medicines registration; and 5) procurement and forecasting of Mifepristone, Misoprostol, and contraceptive medicines. A descriptive analysis of findings from these eight national assessments was conducted.
    RESULTS: Only Lebanon and Pakistan included all 12 contraceptives that are enlisted in the WHO-EML within their national family planning guidelines. Only Afghanistan and Lebanon included mifepristone and mifepristone-misoprostol combination in post-abortion care guidelines, but these medicines were not included in their national EMLs. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs-and registered-in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan). However, only three countries procured misoprostol (Iraq, Morocco, and Somalia).
    CONCLUSIONS: These findings can guide efforts aimed at improving the availability of Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region. Opportunities include expanding national EMLs to include more options for Mifepristone, Misoprostol, and contraceptive medicines and strengthening the registration and procurement systems to ensure these medicines\' availability were permitted under national law and where culturally acceptable.
    Ensuring access to Mifepristone, Misoprostol, and contraceptive medicines is critical to improving women’s health, and more specifically reducing maternal mortality and improving women’s sexual and reproductive health in the Eastern Mediterranean Region.The aim of this study was to analyse findings from national assessments to capture information on the implementation of relevant policies and procedures. Those were the policies that ensure access to Mifepristone, Misoprostol, and contraceptive medicines in the public sector for the eight Eastern Mediterranean Region countries included in the study (Afghanistan, Iraq, Libya, Lebanon, Morocco, Palestine, Pakistan, and Somalia). The assessments were completed between 2020 and 2021.We found that most countries did not include all twelve contraceptives enlisted in the WHO essential medicines list (EML) in their national family planning guidelines. No country had developed a national abortion care guidelines nor included mifepristone (alone or in combination with misoprostol) on national EML. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs—and registered—in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan) yet, only three countries procured misoprostol (Iraq, Morocco, and Somalia).Our findings provide evidence on system-level barriers to availability of Mifepristone, Misoprostol, and contraceptive medicines (e.g., lack of guidelines or inclusion on EML, lack of registration and procurement) that can support policy and advocacy efforts to strengthen the pharmaceutical sector to better ensure availability of Mifepristone, Misoprostol, and contraceptive medicines to women in reproductive age at the country-level in accordance with the national law and prevailing culture.
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