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Change Control from Initiation to Implementation in the Pharmaceutical Industry: A Comprehensive Review 制药行业从启动到实施的变革控制:全面回顾
Pub Date : 2024-07-26 DOI: 10.26452/ijrps.v15i3.4681
Soaib Ahmed, Souvik Kundu, Rahul Patra, Jaydip Ray
Change control plays a role in cGMP, just as all aspects of quality management should continually strive for enhancement. It works with a prior mechanism that empowers designated personnel across fields to assess, as well as having permission to authorize proposing or doing modifications that would impact the status that was prevalidated for the process system, including facilities, systems, and equipment. Change management involves overseeing changes in staff, protocols, operations, and product standards. These changes can occur in areas such as manufacturing, quality control, quality assurance, engineering, research and development (R&D), and marketing. Depending on their significance, changes may be categorized as critical, major, or minor; they may also be classified as emergency, planned, or unplanned based on their nature. Effective change management encompasses the coordination of personnel resources along with protocols to ensure consistency in operations and product excellence. It is a component of GMP compliance, as regulatory bodies mandate companies to demonstrate proficiency in managing changes. The process entails initiating a change request, followed by evaluating its impact on the product before devising an action plan for implementation, ultimately culminating with the Change Control Board (CCB) making decisions regarding the proposed changes.
变更控制在 cGMP 中发挥着作用,正如质量管理的各个方面都应不断努力改进一样。它采用事先机制,授权各领域的指定人员进行评估,并允许他们授权提出或进行修改,以影响工艺系统(包括设施、系统和设备)的既定状态。变更管理包括监督员工、协议、操作和产品标准的变更。这些变化可能发生在制造、质量控制、质量保证、工程、研发和营销等领域。根据其重要性,变革可分为关键、主要或次要变革;根据其性质,变革还可分为紧急、计划内或计划外变革。有效的变更管理包括协调人力资源和协议,以确保运营的一致性和产品的卓越性。它是 GMP 合规性的一个组成部分,因为监管机构要求企业展示管理变更的能力。这一过程包括启动变更请求,然后评估其对产品的影响,最后制定实施行动计划,最终由变更控制委员会(CCB)就拟议的变更做出决定。
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引用次数: 0
Comparative Study of Sublingual Misoprostol and Dinoprostone Gel in Labour Induction and Its Implication on Maternal and Neonatal Outcome 舌下含服米索前列醇和地诺前列酮凝胶引产的比较研究及其对产妇和新生儿结局的影响
Pub Date : 2024-07-24 DOI: 10.26452/ijrps.v15i2.4680
Subashree Ilangovan, Selvi A
Effective and safe induction of labour is crucial in modern obstetric practice. This study aims to compare the efficacy and safety of sublingual misoprostol versus dinoprostone gel in inducing labour. A prospective, randomized controlled trial was conducted at a tertiary care hospital. A total of 828 pregnant women requiring labour induction were randomly assigned to receive either sublingual misoprostol (n=414) or dinoprostone gel (n=414). The primary outcome was the success rate of labour induction, defined as vaginal delivery within 24 hours. Secondary outcomes included the time interval from induction to delivery, incidence of hyperstimulation syndrome, mode of delivery, and maternal and neonatal outcomes. Data were analyzed using SPSS, with statistical significance set at p
有效而安全的引产在现代产科实践中至关重要。本研究旨在比较舌下含服米索前列醇和地诺前列酮凝胶引产的有效性和安全性。一项前瞻性随机对照试验在一家三级医院进行。共有828名需要引产的孕妇被随机分配接受舌下含服米索前列醇(414人)或地诺前列酮凝胶(414人)。主要结果是引产成功率,即在24小时内经阴道分娩。次要结果包括从引产到分娩的时间间隔、过度刺激综合征的发生率、分娩方式以及产妇和新生儿的预后。数据采用 SPSS 进行分析,统计显著性设定为 p
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引用次数: 0
GC-MS Analysis of Bioactive Phytochemicals in Kalanchoe lanceolata for Antimicrobial and Antidiabetic Activities GC-MS 分析 Kalanchoe lanceolata 中具有生物活性的植物化学物质的抗菌和抗糖尿病活性
Pub Date : 2024-07-17 DOI: 10.26452/ijrps.v15i3.4678
Sravanthi Suram, Lali Lingfa, Baloji Gugulothu, Srinivas Ankanagari
The herb Kalanchoe lanceolata, which is widely used in traditional medicine, has showed promise in treating a range of ailments. Despite its widespread usage in traditional medicine, the phytochemical contents of K. lanceolata are not well studied, particularly in terms of its potential involvement in diabetes management. In this study, the objective was to identify the phytochemical constituents of K. lanceolata and determine how they can help with diabetes management. The whole plant methanolic, ethyl acetate, and petroleum ether extracts were analysed with GC-MS to identify bioactive components. In this study, 63 compounds were identified, 27 of which possess bioactive properties. Acorenone B, columbin, phytol, astaxanthin, β-sitosterol, 2,4-di-tert-butylphenol, and caryophyllene oxide are significant compounds found to be present in K. lanceolata. In silico molecular docking studies predicted the antidiabetic and antibacterial properties of phytochemical compounds. These compounds show potential as antibacterial, antifungal and antidiabetic agents. This study stresses the significance of K. lanceolata bioactive components and sheds light on the therapeutic potential in diabetes control.
在传统医学中被广泛使用的草药 Kalanchoe lanceolata 在治疗一系列疾病方面表现出了良好的前景。尽管 K. lanceolata 在传统医学中被广泛使用,但对其植物化学成分的研究并不深入,尤其是在其参与糖尿病治疗的潜力方面。本研究的目的是鉴定 K. lanceolata 的植物化学成分,并确定它们如何有助于糖尿病的治疗。研究人员使用气相色谱-质谱仪分析了全植物甲醇、乙酸乙酯和石油醚提取物,以确定生物活性成分。这项研究共鉴定出 63 种化合物,其中 27 种具有生物活性。在 K. lanceolata 中发现的重要化合物有 Acorenone B、columbin、phytol、虾青素、β-谷甾醇、2,4-二叔丁基苯酚和氧化叶黄素。硅学分子对接研究预测了植物化学化合物的抗糖尿病和抗菌特性。这些化合物具有抗菌、抗真菌和抗糖尿病的潜力。这项研究强调了 K. lanceolata 生物活性成分的重要性,并揭示了其在控制糖尿病方面的治疗潜力。
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引用次数: 0
Nutraceutical Muffins: Development and Sensory Evaluation 营养松饼:开发和感官评估
Pub Date : 2024-07-17 DOI: 10.26452/ijrps.v15i3.4679
Bhatt Mehul K, Goswami Dhruvi, Rajgor Hiral, Patel Devanshi, Vora Jahanavee, Talaviya Priti, Shah Nehal
Health professionals and consumers are increasingly urging food corporations to produce healthier options, leading to a rise in the popularity of gluten-free flours like millet, sweet potatoes, and mung bean flour. Nutraceutical muffins offer a novel approach by combining the enjoyment of a tasty snack with the health benefits of bioactive compounds. These muffins are formulated with ingredients such as mung bean flour, spinach powder, guava powder, jaggery, and ghee to provide dietary fiber, vitamins, minerals, and antioxidants. Gluten-free and suitable for diabetics, they also address health concerns such as energy enhancement, vitamin deficiency, constipation, and bone health. In conclusion, nutraceutical muffins present an exciting way to merge health and flavor, making functional ingredients easily accessible in daily diets. However, further research is needed to optimize their formulation and validate their health benefits.
保健专家和消费者越来越多地敦促食品公司生产更健康的食品,这导致小米、红薯和绿豆粉等无麸质面粉越来越受欢迎。营养松饼将美味零食的享受与生物活性化合物的健康益处相结合,提供了一种新颖的方法。这些松饼的配料包括绿豆粉、菠菜粉、番石榴粉、琼脂和酥油,可提供膳食纤维、维生素、矿物质和抗氧化剂。它们不含麸质,适合糖尿病患者食用,还能解决能量增强、维生素缺乏、便秘和骨骼健康等健康问题。总之,保健食品松饼提供了一种令人兴奋的方式,将健康与美味融为一体,使日常饮食中很容易获得功能性成分。不过,还需要进一步研究,以优化其配方并验证其对健康的益处。
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引用次数: 0
Cention-N: A Review Cention-N:回顾
Pub Date : 2024-05-20 DOI: 10.26452/ijrps.v15i2.4676
Ashima Varshney, Sonal Gupta, Kumari Akancha, Neha Lal
An ideal material used for restoration should be adhesive, tooth coloured, resistant to wear, nontoxic and biocompatible with the tissue. Various direct filling materials are available in dentistry such as amalgam, glass ionomer cement (GIC) and esthetic composite material, each of them having its advantages and disadvantages hence proper selection of restorative materials will help for its clinical success. Cention-N is a new alkasite, bulk filling, basic tooth-coloured, radiopaque material introduced by Ivoclar Vivadent in 2016. It is a self-curing filling material with optimum light curing. It consists of an isofiller which reduces the polymerization shrinkage and utilizes an alkaline filler which is capable of releasing acid-neutralizing ions. It presents with good mechanical properties and long-term stability due to the cross-linking of methacrylates in the final restoration hence it can be used in load-bearing areas. Cention-N can be efficiently used in pediatric patients as it is moisture resistant and releases fluoride which helps in remineralizing teeth thus preventing secondary caries. The use of caution is restricted in the anterior tooth as it is available only in one shade.
理想的修复材料应具有粘接性、牙色、耐磨损、无毒以及与组织的生物相容性。牙科中有多种直接充填材料,如汞合金、玻璃离子粘固剂(GIC)和美容复合材料,它们各有优缺点,因此正确选择修复材料有助于临床成功。Cention-N是Ivoclar Vivadent公司于2016年推出的一种新型烷基石、体充填、基牙色、不透光材料。它是一种具有最佳光固化效果的自固化填充材料。它由可减少聚合收缩的异构填料和可释放酸中和离子的碱性填料组成。由于甲基丙烯酸酯在最终修复体中的交联作用,它具有良好的机械性能和长期稳定性,因此可用于承重区域。Cention-N 可以有效地用于儿童患者,因为它具有防潮性,并能释放氟化物,有助于牙齿再矿化,从而防止继发性龋齿。由于只有一种色调,因此在前牙的使用受到限制。
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引用次数: 12
Hypotensive Anaesthesia in Functional Endoscopic Sinus Surgeries: A Systematic Review 功能性内窥镜鼻窦手术中的降压麻醉:系统回顾
Pub Date : 2024-02-29 DOI: 10.26452/ijrps.v15i1.4664
Govindarajan A, Swetha Ns, Govind Shaji, P. S
This systematic review comprehensively analyzes the literature on hypotensive anesthesia in Functional Endoscopic Sinus Surgeries (FESS), crucial for treating sinonasal disorders. The anesthesia technique choice significantly influences FESS outcomes. Hypotensive anesthesia, involving controlled blood pressure reduction during surgery, garners attention for potential benefits. A database search identified relevant studies examining its efficacy, safety, and impact on intraoperative visibility, surgical time, blood loss, and postoperative outcomes. Various drugs, including inhalational agents, hypocapnia, hypercapnia, local adrenaline, fentanyl, remifentanil, esmolol, dexmedetomidine, and nitroglycerine, have been employed to minimize bleeding and enhance operative conditions. Sevoflurane is a common inhalation agent. Dexmedetomidine, with lower bolus doses, proves advantageous for visibility and achieving a MAP of 60 mm Hg swiftly. Opioids have a lower hypotensive potential, nitroglycerine lacks analgesic effects, and beta-blockers provide favorable conditions. Dexmedetomidine's prolonged analgesia correlates with improved postoperative outcomes. Limited studies explore combined drugs' efficacy or side effects. Cognitive dysfunction is a concern, with hypotension approved up to a MAP of 60 mm Hg. The technique's application extends to children, but careful patient selection is crucial, considering contraindications and comorbidities.
这篇系统性综述全面分析了功能性内窥镜鼻窦手术(FESS)中的低血压麻醉文献,FESS 是治疗鼻窦疾病的关键。麻醉技术的选择在很大程度上影响着 FESS 的效果。低血压麻醉是指在手术过程中控制血压的降低,因其潜在的益处而备受关注。通过数据库搜索发现了相关研究,这些研究探讨了低血压麻醉的有效性、安全性以及对术中可见度、手术时间、失血量和术后效果的影响。各种药物,包括吸入剂、低碳酸血症、高碳酸血症、局部肾上腺素、芬太尼、瑞芬太尼、艾司洛尔、右美托咪定和硝酸甘油,都被用来减少出血和改善手术条件。七氟醚是一种常用的吸入剂。右美托咪定的栓剂剂量较低,在能见度和迅速达到 MAP 60 mm Hg 方面具有优势。阿片类药物的降压潜能较低,硝酸甘油缺乏镇痛作用,而β-受体阻滞剂则提供了有利条件。右美托咪定可延长镇痛时间,从而改善术后效果。有关联合用药的疗效或副作用的研究有限。认知功能障碍是一个令人担忧的问题,血压最高可达 60 mm Hg。该技术适用于儿童,但考虑到禁忌症和合并症,谨慎选择患者至关重要。
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引用次数: 0
Comparative study of rubber band ligation versus surgical excision in the treatment of second-degree haemorrhoids 橡皮筋结扎与手术切除治疗二度痔疮的比较研究
Pub Date : 2024-02-12 DOI: 10.26452/ijrps.v15i1.4663
Kishore D, Debarath Das, Lakshmana R, Pravin Dhas, S. N, Malarmannan M
Our study focused on comparing the efficacy of Rubber Band Ligation (banding), a day-care and cost-effective procedure, with conventional haemorrhoidectomy in the treatment of haemorrhoids. The study included 120 patients diagnosed through proctoscopic examination, with 60 assigned to each group. Patients were randomly selected through simple alternation for banding or haemorrhoidectomy after receiving procedural explanations and providing consent. Banding, utilizing Barron's band applicator and Hemoband suction device under local anaesthesia, demonstrated notable advantages. Comparison parameters included bleeding, pain, prolapse, and overall relief during follow-ups. Banding showed significantly lower bleeding persistence at 4 weeks compared to haemorrhoidectomy (p < 0.001). Prolapse rates were comparable between the two groups (10%). Complete relief was observed in 1.66% of patients in both groups at the first follow-up (p = 0.929). Banding resulted in moderate pain levels compared to haemorrhoidectomy. Hospital stay duration favoured banding, with 71.66% discharged in 1-3 days, while haemorrhoidectomy had longer stays (3-6 days: 26.66%, >6 days: 1.66%). In conclusion, Rubber Band Ligation emerged as a more effective and preferable method for second-degree haemorrhoids, providing better outcomes, reduced bleeding, and shorter hospital stays compared to conventional haemorrhoidectomy.
我们的研究重点是比较橡胶带结扎术(一种日间护理且经济有效的手术)与传统痔疮切除术在治疗痔疮方面的疗效。该研究包括 120 名通过直肠镜检查确诊的患者,每组 60 人。患者在接受程序说明并同意后,通过简单交替的方式被随机选中,接受绷带术或痔切除术。在局部麻醉的情况下,利用巴伦痔疮带套扎器和痔疮带抽吸器进行痔疮带套扎,显示出显著的优势。比较参数包括出血、疼痛、脱垂和随访期间的总体缓解情况。与痔切除术相比,痔环扎术在 4 周后的出血持续率明显较低(P < 0.001)。两组的脱垂率相当(10%)。首次随访时,两组中均有 1.66% 的患者症状完全缓解(p = 0.929)。与痔切除术相比,绑扎术的疼痛程度适中。住院时间方面,71.66%的患者在1-3天内出院,而痔切除术的住院时间较长(3-6天:26.66%,6天以上:1.66%)。总之,与传统的痔疮切除术相比,橡皮筋结扎术是治疗二度痔疮更有效、更可取的方法,能提供更好的疗效、减少出血并缩短住院时间。
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引用次数: 0
Comparative study of tissue culture and sensitivity versus swab culture and sensitivity of microorganisms in the healing of diabetic foot ulcers 糖尿病足溃疡愈合中微生物的组织培养和敏感性与拭子培养和敏感性的比较研究
Pub Date : 2024-02-12 DOI: 10.26452/ijrps.v15i1.4660
Debarath Das, Kishore D, Lakshmana R, Pravin Dhas, S. N, Malarmannan M
This prospective observational study, conducted at the Department of General Surgery, SRM Medical College and Hospital, aimed to assess the effectiveness of tissue culture and sensitivity compared to swab culture and sensitivity in the healing of diabetic foot ulcers through antibiotic sensitivity of microorganisms. Between May 2016 and August 2017, 160 subjects with diabetic foot ulcers were randomly assigned treatment based on either swab or tissue culture findings. Patients were followed at 15-day intervals for up to 60 days. Results showed positive swab cultures in 76.88% and positive tissue cultures in 92.50% of the study population. The most prevalent organism in swab cultures was Proteus (14.38%), while Pseudomonas (16.88%) dominated in tissue cultures. The cumulative proportion of subjects developing granulation tissue was faster in the tissue culture group, reaching 57.50% at 15 to 30 days and 99% at 31 to 45 days. The swab culture group exhibited proportions of 48.80%, 75%, and 93.80% at the same intervals. In conclusion, diabetic foot ulcer treatment based on tissue culture showed slightly faster healing rates compared to swab culture. However, both groups achieved good ulcer healing within the 60-day follow-up period. These findings emphasize the importance of choosing an appropriate culture method for effective management of diabetic foot ulcers.
这项前瞻性观察研究在 SRM 医学院附属医院普外科进行,旨在通过微生物的抗生素敏感性评估组织培养和药敏与拭子培养和药敏相比在糖尿病足溃疡愈合方面的效果。2016年5月至2017年8月期间,160名糖尿病足溃疡患者根据拭子或组织培养结果被随机分配治疗。每隔15天对患者进行一次随访,最长达60天。结果显示,76.88%的研究对象拭子培养呈阳性,92.50%的研究对象组织培养呈阳性。拭子培养中最常见的微生物是变形杆菌(14.38%),而组织培养中则以假单胞菌(16.88%)为主。组织培养组中出现肉芽组织的受试者累积比例较快,在 15 至 30 天时达到 57.50%,在 31 至 45 天时达到 99%。拭子培养组在相同时间间隔内的比例分别为 48.80%、75% 和 93.80%。总之,与拭子培养法相比,组织培养法治疗糖尿病足溃疡的愈合速度稍快。不过,两组患者都在 60 天的随访期内实现了良好的溃疡愈合。这些发现强调了选择合适的培养方法对有效治疗糖尿病足溃疡的重要性。
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引用次数: 0
Physicochemical and heavy metal analysis of Yavani-Sadav Churan – An Ayurvedic formulation Yavani-Sadav Churan(一种阿育吠陀配方)的理化和重金属分析
Pub Date : 2024-02-12 DOI: 10.26452/ijrps.v15i1.4661
Suman Lata, Sonia Dhiman, Mamta Rana
Ayurveda is the most ancient documented healing heritage of the world that describes health management through natural products. Bhaishjya Kalpana, a branch of Ayurveda, describes details of pharmaceutical preparations of different dosage forms. Chooran kalpana is one of the solid dosage forms considered the secondary Kalpana of Kalka kalpana. In a common language, it is known as powder medicine and is used extensively in Ayurvedic treatment. For promoting Ayurveda, traditional health management introduced the term Drug standardization in the manufacturing of Ayurvedic medicine to ensure good quality medicines for the satisfaction of customers in the international market. Drug standardization is the core issue not only for Bhaishjya Kalpana but also for the entire Ayurveda health care. In the present study, Yavani–Sadav Churan was prepared and the physicochemical and Heavy metal analysis of churan is the main aim of the study. In this study, different parameters for assessment of purity, quality, and safety of Yavanisadava chooran will be carried out like organoleptic characteristics, loss on drying, total ash, acid insoluble ash, water-soluble extractives, and Alcohol soluble extractives. pH, Bulk density, Tap density, Particle size, TLC and Heavy metal analysis by AAS method etc., which contribute to a great extent for standardization.
阿育吠陀是世界上最古老的有文献记载的治疗遗产,它描述了通过天然产品进行健康管理的方法。Bhaishjya Kalpana 是阿育吠陀的一个分支,详细描述了不同剂型的药物制剂。Chooran kalpana 是固体制剂之一,被认为是 Kalka kalpana 的次级 Kalpana。通俗地说,它被称为粉末药物,在阿育吠陀疗法中被广泛使用。为了推广阿育吠陀,传统健康管理部门在阿育吠陀药物生产中引入了药物标准化这一术语,以确保药品质量优良,满足国际市场客户的需求。药品标准化不仅是 Bhaishjya Kalpana 的核心问题,也是整个阿育吠陀保健的核心问题。本研究制备了 Yavani-Sadav Churan,研究的主要目的是对 Churan 进行理化和重金属分析。在这项研究中,将对雅瓦尼-萨达瓦楚兰的纯度、质量和安全性进行不同参数的评估,如感官特征、干燥损失、总灰分、酸性不溶性灰分、水溶性萃取物、醇溶性萃取物、pH 值、堆积密度、塔普密度、粒度、TLC 和 AAS 法重金属分析等,这些参数在很大程度上有助于实现标准化。
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引用次数: 0
Comparative study of rubber band ligation versus surgical excision in the treatment of second-degree haemorrhoids 橡皮筋结扎与手术切除治疗二度痔疮的比较研究
Pub Date : 2024-02-12 DOI: 10.26452/ijrps.v15i1.4663
Kishore D, Debarath Das, Lakshmana R, Pravin Dhas, S. N, Malarmannan M
Our study focused on comparing the efficacy of Rubber Band Ligation (banding), a day-care and cost-effective procedure, with conventional haemorrhoidectomy in the treatment of haemorrhoids. The study included 120 patients diagnosed through proctoscopic examination, with 60 assigned to each group. Patients were randomly selected through simple alternation for banding or haemorrhoidectomy after receiving procedural explanations and providing consent. Banding, utilizing Barron's band applicator and Hemoband suction device under local anaesthesia, demonstrated notable advantages. Comparison parameters included bleeding, pain, prolapse, and overall relief during follow-ups. Banding showed significantly lower bleeding persistence at 4 weeks compared to haemorrhoidectomy (p < 0.001). Prolapse rates were comparable between the two groups (10%). Complete relief was observed in 1.66% of patients in both groups at the first follow-up (p = 0.929). Banding resulted in moderate pain levels compared to haemorrhoidectomy. Hospital stay duration favoured banding, with 71.66% discharged in 1-3 days, while haemorrhoidectomy had longer stays (3-6 days: 26.66%, >6 days: 1.66%). In conclusion, Rubber Band Ligation emerged as a more effective and preferable method for second-degree haemorrhoids, providing better outcomes, reduced bleeding, and shorter hospital stays compared to conventional haemorrhoidectomy.
我们的研究重点是比较橡胶带结扎术(一种日间护理且经济有效的手术)与传统痔疮切除术在治疗痔疮方面的疗效。该研究包括 120 名通过直肠镜检查确诊的患者,每组 60 人。患者在接受程序说明并同意后,通过简单交替的方式被随机选中,接受绷带术或痔切除术。在局部麻醉的情况下,利用巴伦痔疮带套扎器和痔疮带抽吸器进行痔疮带套扎,显示出显著的优势。比较参数包括出血、疼痛、脱垂和随访期间的总体缓解情况。与痔切除术相比,痔环扎术在 4 周后的出血持续率明显较低(P < 0.001)。两组的脱垂率相当(10%)。首次随访时,两组中均有 1.66% 的患者症状完全缓解(p = 0.929)。与痔切除术相比,绑扎术的疼痛程度适中。住院时间方面,71.66%的患者在1-3天内出院,而痔切除术的住院时间较长(3-6天:26.66%,6天以上:1.66%)。总之,与传统的痔疮切除术相比,橡皮筋结扎术是治疗二度痔疮更有效、更可取的方法,能提供更好的疗效、减少出血并缩短住院时间。
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引用次数: 0
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International Journal of Research in Pharmaceutical Sciences
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