clinical effect

临床效果
  • 文章类型: Journal Article
    目的:IgA肾病(IgAN)是全球最常见的原发性肾小球疾病。妊娠IgAN患者更容易出现不良妊娠结局(APO)。然而,APO的危险因素及其对妊娠IgAN患者长期肾脏结局的影响尚不清楚.
    方法:我们进行了一项涵盖2003-2019年的回顾性观察性研究,包括44例有妊娠史的女性IgAN患者,以调查APO的危险因素及其对IgAN临床结局的影响。在有和没有APO的妊娠IgAN妇女中评估了肾功能结果和蛋白尿缓解。
    结果:在这项回顾性和观察性研究中,我们发现APO患者的血清肌酐和IgM水平较高,和较低的血红蛋白水平,而其他临床特征,病理特征和治疗方案无显著差异。我们发现贫血和血清IgM水平升高是APO的独立危险因素。无APO的IgAN孕妇的蛋白尿缓解比例高于有APO的孕妇,但肾功能结果没有差异。
    结论:妊娠IgAN患者风险较高,包括较低的血红蛋白水平和较高的IgM水平值得加强监测,在妊娠合并APO的IgAN患者中,应进行积极的治疗以减少蛋白尿。
    OBJECTIVE: IgA nephropathy (IgAN) is the most common primary glomerular disease worldwide. Pregnant IgAN patients are more susceptible to adverse pregnancy outcomes (APO). However, the risk factor for APO and its effects on the long-term renal outcome of pregnant IgAN patients remained unclear.
    METHODS: We performed a retrospective observational study covering 2003-2019 that included 44 female IgAN patients with pregnancy history to investigate the risk factor for APO and its impact on clinical outcome in IgAN. Renal function outcome and proteinuria remission were evaluated in pregnant IgAN women with and without APO.
    RESULTS: In this retrospective and observational study, we found that patients with APO exhibited higher levels of serum creatinine and IgM, and lower haemoglobin levels while other clinical characteristics, pathological characteristics and therapy protocol had no significant difference. We found that anaemia and a higher level of serum IgM were independent risk factors for APO. IgAN pregnant women without APO experienced a higher proportion of proteinuria remission than those with APO, but there is no difference in the renal function outcome.
    CONCLUSIONS: Pregnant IgAN patients with higher risks, including lower haemoglobin levels and higher IgM levels deserve intensive monitoring, and aggressive therapy to reduce proteinuria should be carried out in pregnant IgAN patients with APO.
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  • 文章类型: Journal Article
    目的:评估上颌后牙区域导航辅助立即植入(IIP)的植入物准确性和临床效果的准确性。
    方法:本研究纳入了2021年1月至2022年12月在上颌后区接受IIP植入的60例患者,分为动态导航和徒手植入组。所有临床指标,包括初始稳定性,植入物偏差(入口点偏差,终点偏差,深度偏差和角度偏差),边缘骨吸收和植入成功率,有系统地记录。
    结果:所有植入物均成功放置,平均扭矩为(24.38±1.84)N。cm.平均入口点偏差,导航组的顶点偏差和角度偏差均明显小于徒手组(P<0.05)。导航组的边缘骨吸收明显少于徒手组(P<0.05)。所有牙种植体均被认为手术成功,平均随访时间为(27.8±8.4)个月。
    结论:上颌骨后区应用动态导航辅助即刻种植体植入可取得良好的种植精度和满意的临床效果。
    OBJECTIVE: To evaluate the accuracy of the implant accuracy and clinical effect of navigation-assisted immediate implant placement (IIP) in the posterior maxillary tooth region.
    METHODS: This study included 60 patients with 96 implants undergoing IIP in the posterior maxillary region from January 2021 to December 2022, stratified into dynamic navigation and freehand implant groups. All clinical indicators, including initial stability, implant deviation (entry point deviation, end point deviation, depth deviation and angle deviation), marginal bone resorption and implant success rate, were systematically recorded.
    RESULTS: All implants were successfully placed with an average torque of (24.38 ± 1.84)N.cm. The mean entry point deviation, apex point deviation and angular deviation in the navigation group were significantly smaller than that of the freehand group (P < 0.05). Marginal bone resorption was significantly less in the navigated group than in the freehand group (P < 0.05). All dental implants were considered an operational success and the mean follow-up time was (27.8 ± 8.4) months.
    CONCLUSIONS: The application of dynamic navigation-assisted immediate implant placement in the maxillary posterior region can achieve good implant accuracy and satisfactory clinical results.
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  • 文章类型: Journal Article
    A型主动脉夹层的初始手术有局限性,在巨大假性动脉瘤形成和远端血管供血减少的情况下,可能需要再次手术。在这项研究中,我们收集在我院接受心脏大血管手术患者的病例资料,分析A型主动脉夹层再手术治疗方案的有效性,并总结我们的治疗经验.
    在2018年6月至2022年12月之间,62例A型主动脉夹层(TAAD)患者在先前的手术治疗后接受了再次手术。其中,49例(男45例)行主动脉腔内修复术(EVAR),平均年龄(49.69±10.21)岁(30~75岁),13例患者(11例男性)接受了胸腹主动脉置换术(TAAR),平均年龄为(41.00±11.18)岁(23-66岁)。在这项研究中,我们对62例患者的记录资料进行回顾性分析.此外,我们总结并分析了他们的CT血管造影(CTA)结果和围手术期并发症。
    在EVAR组中,47例患者(95.92%)成功植入重叠支架,围手术期死亡2例。术后并发症包括脑梗死(4.08%),急性肾功能不全(30.61%),肺功能不全和需要呼吸机(6.12%),伤口愈合不良(2.04%),术后再次手术(16.33%),下肢缺血(2.04%)。在TAAR组中,12例(92.31%)成功实施血运重建,1例死亡。术后并发症包括脑梗死(7.69%),急性肾损伤(46.15%),肺功能不全和需要呼吸机(15.38%),伤口愈合不良(30.77%)和术后再次手术(15.38%)。
    根据研究结果,与TAAR相比,EVAR侵入性较小,更快的恢复,并为一些高风险和高年龄合并基础疾病的患者提供了更好的选择。然而,由于血管病变,EVAR后血运重建率高于TAAR.与许多国家和地区采用升主动脉置换术+半主动脉弓置换术治疗急性A型主动脉夹层相比,在中国,使用升主动脉置换术+主动脉弓置换术+象鼻支架的创伤更大,但有利于再次手术。对于年轻患者来说,治疗应结合血管病变和长期生活质量进行个体化选择。
    UNASSIGNED: The initial operation for type A aortic dissection has limitations, and there may be a need for reoperation in cases such as giant pseudoaneurysm formation and reduced blood supply to the distal vessels. In this study, we collected case data of patients who underwent cardiac major vascular surgery at our hospital to analyze the effectiveness of reoperation treatment options for type A aortic dissection and to summarize our treatment experience.
    UNASSIGNED: Between June 2018 and December 2022, 62 patients with type A aortic dissection (TAAD) underwent reoperation after previous surgical treatment. Of these, 49 patients (45 males) underwent endovascular aortic repair (EVAR) with a mean age of (49.69 ± 10.21) years (30-75 years), and 13 patients (11 males) underwent thoracoabdominal aortic replacement (TAAR) with a mean age of (41.00 ± 11.18) years (23-66 years). In this study, we retrospectively analyzed the recorded data of 62 patients. In addition, we summarized and analyzed their Computed Tomographic Angiography (CTA) results and perioperative complications.
    UNASSIGNED: In the EVAR group, 47 patients (95.92%) were successfully implanted with overlapping stents, and 2 patients died in the perioperative period. Postoperative complications included cerebral infarction (4.08%), acute renal insufficiency (30.61%), pulmonary insufficiency and need for ventilator (6.12%), poor wound healing (2.04%), postoperative reoperation (16.33%), and lower limb ischemia (2.04%). In the TAAR group, 12 patients (92.31%) were successfully revascularized and 1 patient died in the perioperative period. Postoperative complications included cerebral infarction (7.69%), acute kidney injury (46.15%), pulmonary insufficiency and need for ventilator (15.38%), poor wound healing (30.77%) and postoperative reoperation (15.38%).
    UNASSIGNED: According to the results of the study, compared with TAAR, EVAR was less invasive, faster recovery, and offered a better choice for some high-risk and high-age patients with comorbid underlying diseases. However, the rate of revascularization was higher after EVAR than TAAR due to vascular lesions. Compared with the use of ascending aortic replacement + hemi-aortic arch replacement for acute type A aortic dissection in many countries and regions, the use of ascending aortic replacement + aortic arch replacement + elephant trunk stent is more traumatic in China, but facilitates reoperation. For young patients, the choice of treatment should be individualized combining vascular lesions and long-term quality of life.
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  • 文章类型: Journal Article
    评价优质护理干预对老年白内障患者生活质量的影响和临床效果。
    这是一项临床比较研究。选取天津医科大学眼科医院手术治疗的120例老年白内障患者,随机分为对照组和实验组,从2021年1月15日至2022年1月15日,每组60例。对照组患者在围手术期给予常规护理,实验组在围手术期给予优质护理干预。焦虑(SAS)评分的差异,抑郁(SDS)评分,眼内压(IOP)恢复,比较分析两组患者手术并发症发生率及治疗前后满意度。
    两组在身体功能方面没有观察到统计学上的显着差异,心理功能,干预前社会功能和物质生活状况评分(P>0.05)。干预之后,与对照组相比,实验组上述指标明显改善,差异有统计学意义(P=0.00)。此外,实验组SAS和SDS较对照组明显降低,差异有统计学意义(P=0.00)。
    优质护理干预提高了老年白内障患者治疗的各种益处,如有效降低眼内压,改善患者的生活质量,降低术后并发症的发生率,提高患者满意度。
    UNASSIGNED: To evaluate the impact and clinical effect of high-quality nursing intervention on the quality of life of elderly cataract patients and its clinical effect.
    UNASSIGNED: This is a clinical comparative study. One hundred and twenty elderly cataract patients admitted to Tianjin Medical University Eye Hospital for surgical treatment were recruited and randomly divided into two groups: the control and experimental group, with 60 cases in each group from January 15, 2021 to January 15, 2022. Patients in the control group were given conventional nursing care in the perioperative period, while those in the experimental group were given high-quality nursing intervention in the perioperative period. The differences in anxiety (SAS) scores, depression (SDS) scores, intraocular pressure (IOP) recovery, the incidence of surgical complications and satisfaction before and after treatment between the two groups were compared and analyzed.
    UNASSIGNED: No statistically significant difference was observed between the two groups in physical functioning, psychological functioning, social functioning and material life status scores before intervention(P>0.05). After the intervention, the above indicators improved significantly in the experimental group compared to the control group, with statistically significant differences (P=0.00). Moreover, SAS and SDS decreased significantly in the experimental group compared to the control group, with statistically significant differences(P=0.00).
    UNASSIGNED: High-quality nursing intervention improves various benefits in the treatment of elderly cataract patients, such as effectively reducing intraocular pressure, ameliorating patients\' quality of life, lowering the incidence of postoperative complications, and improving patient satisfaction.
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  • 文章类型: Journal Article
    背景:四肢转移性骨病变可引起严重疼痛和病理性骨折,显著影响患者的生活质量。及时干预和有效治疗长骨转移瘤可以积极影响患者的预后。包括生存率和后续治疗选择。
    目的:本研究的目的是比较两种手术重建技术的疗效和相关并发症,并提出一种更有效的长骨转移肢体重建方法。
    方法:对2017年1月至2022年6月在我科接受四肢长骨转移手术治疗的28例临床资料完整的患者进行了回顾性研究。根据手术方法将患者分为两组。在第1组中,对受影响的骨骼进行刮擦并填充水泥,然后用钢板或髓内钉固定。在第2组中,完全去除受影响的骨段,并用定制的椎间假体代替。各种因素,包括一般患者信息,手术细节,手术效果,和常见的并发症,进行了比较和分析。
    结果:两组患者的一般资料无显著差异,包括年龄,性别,手术部位,和原发性肿瘤类型。第1组手术时间分别为115.37min和第2组手术时间分别为108.90min(p>0.05)。然而,术中失血量组间差异显著,第1组769ml,第2组521ml(p<0.05)。术后MSTS评分1组为91%,2组为92%(p>0.05)。术后并发症包括内固定失败2例,肿瘤复发3例,发生率为33%。而第2组有2例内固定失败的发生率为15%。
    结论:这项研究的结果表明,两种手术技术均可有效治疗四肢长骨转移瘤。然而,第2组患者的定制椎间假体技术显示并发症发生率较低,术中失血量较少.因此,对于长骨转移瘤,可能是一种更有效的肢体重建方法。需要更大样本量的进一步研究来证实这些发现。
    BACKGROUND: Metastatic bone lesions in the extremities can cause severe pain and pathological fractures, significantly affecting patients\' quality of life. Timely intervention and effective management of long bone metastases can positively influence patient outcomes, including survival rates and subsequent treatment options.
    OBJECTIVE: The objective of this study is to compare the efficacy and associated complications of two surgical reconstruction techniques and propose a more effective limb reconstruction approach for long bone metastases.
    METHODS: A retrospective study was conducted on 28 patients with complete clinical data who underwent a surgical procedure for long bone metastases of the extremities in our department between January 2017 and June 2022. The patients were divided into two groups based on their surgical methods. In group 1, the affected bones were curetted and filled with cement, then secured with plates or intramedullary nails. In group 2, the affected bone segments were completely removed and replaced with custom intercalary prostheses. Various factors, including general patient information, surgical details, surgical effectiveness, and common complications, were compared and analyzed.
    RESULTS: There were no significant differences in general patient information between the two groups, including age, gender, surgical site, and primary tumor type. The operative times were 115.37 min for group 1 and 108.90 min for group 2, respectively (p > 0.05). However, intraoperative blood loss differed significantly between the groups, with 769 ml in group 1 and 521 ml in group 2 (p < 0.05). The postoperative MSTS scores were 91% for group 1 and 92% for group 2 (p > 0.05). Postoperative complications included two cases of internal fixation failure and three cases of tumor recurrence in group 1, resulting in a 33% incidence rate, while group 2 experienced a 15% incidence rate with two cases of internal fixation failure.
    CONCLUSIONS: The results of this study suggest that both surgical techniques are effective for the treatment of long bone metastases of the extremities. However, the custom intercalary prostheses technique in group 2 showed a lower incidence of complications and less intraoperative blood loss. Therefore, it may be a more effective limb reconstruction approach for long bone metastases. Further studies with larger sample sizes are needed to confirm these findings.
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  • 文章类型: Journal Article
    目的:寻找更有效、更安全的神经根型颈椎病(CSR)治疗方法,导致微创颈椎后路椎间孔切开术(MI-PCF)的快速发展和日益普及。本研究旨在比较两种用于MI-PCF手术的重要方法:通道辅助颈椎键孔技术联合超声骨凿(CKH-UBO)和后路经皮内镜下颈椎椎间孔切开术(PPECF)。
    方法:分析了接受单水平CKH-UBO(n=35)或PPECF(n=40)治疗的患者的数据。临床结果,包括颈部和手臂疼痛的视觉模拟量表(VAS)评分,颈部残疾指数(NDI)修改了Macnab标准,在术前评估,还有三天,三个月,术后一年。
    结果:预后良好的患者百分比分别为97.14%和92.5%,分别。CKH-UBO组的平均手术时间明显短于PPECF组(p<0.001),而PPECF组的平均切口长度明显小于CKH-UBO组。两组在失血方面无显著差异,住院,和三天的临床结果,三个月,术后12个月。
    结论:CKH-UBO治疗CSR可达到与PPECF相同的手术效果。然而,CKH-UBO节省了更多的时间,但需要患者进行更大的切口。
    OBJECTIVE: The search for more effective and safe treatment methods for cervical spondylotic radiculopathy (CSR) has led to the rapid development and increasing popularity of minimally invasive posterior cervical foraminotomy (MI-PCF). This study aims to compare two important approaches for MI-PCF surgery: the channel-assisted cervical key hole technology combined with ultrasonic bone osteotome (CKH-UBO) and posterior percutaneous endoscopic cervical foraminotomy (PPECF).
    METHODS: Data from patients treated with single-level CKH-UBO (n = 35) or PPECF (n = 40) were analyzed. Clinical outcomes, including visual analogue scale (VAS) scores for neck and arm pain, Neck Disability Index (NDI), and modified Macnab criteria, were assessed preoperatively, as well as at three days, three months, and one year postoperatively.
    RESULTS: The percentages of patients with excellent and good outcomes were 97.14% and 92.5%, respectively. The average surgical time in the CKH-UBO group was significantly shorter than in the PPECF group (p < 0.001), while the average incision length in the PPECF group was significantly smaller than in the CKH-UBO group. There were no significant differences between the two groups in terms of blood loss, hospital stay, and clinical outcomes at three days, three months, and 12 months postoperatively.
    CONCLUSIONS: CKH-UBO can achieve the same surgical outcomes as PPECF for the treatment of CSR. However, CKH-UBO saves more time but requires patients to undergo larger incisions.
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  • 文章类型: Journal Article
    肌肉减少症和骨质疏松症椎体压缩性骨折(OVCF)是随着年龄增长而增加的常见疾病。本研究旨在探讨肌少症对经皮椎体后凸成形术(PKP)术后OVCF患者的影响。
    纳入宁波市第六医院2021年1月至2022年3月接受单水平PKP治疗的101例患者。符合我们纳入标准的45例OVCF伴肌肉减少症患者被纳入肌肉减少症-PKP组(SPKP组),正常PKP组(NPKP组)56例。所有临床和放射学数据均从病历中收集。基线特征,与操作相关的参数(操作时间,步行时间,住院,手术段),临床结果(视觉模拟评分[VAS],Oswestry残疾指数[ODI],日本骨科协会对木材的评分[JOA]),放射学结果(椎体前高度率和局部后凸角度),Macnab得分,并对并发症进行评估和比较。
    年龄没有显著差异,性别,手术节段术前VAS评分,ODI,或JOA两组间比较(P>0.05)。SPKP组的体重指数(BMI)明显较低,骨矿物质密度(BMD),平滑肌指数(SMI)优于NPKP组(P<0.05)。SPKP组住院时间和下床时间明显长于NPKP组(3.7±0.8vs3.4±0.5和2.0±0.8vs1.6±0.5,P<0.05)。在SPKP组中,NPKP组随访6个月和12个月时的临床结局明显优于SPKP组(P<0.05),随访6个月后,NPKP组椎体前缘高度率明显优于SPKP组(P<0.05)。此外,SPKP组并发症例数明显增多(P<0.05)。
    肌肉减少症可以降低经皮椎体后凸成形术的临床效果,此外。需要相关研究来验证肌少症对OVCF患者的影响。
    UNASSIGNED: Sarcopenia and osteoporosis vertebral compression fractures (OVCF) are common diseases that increase with age. This study aimed to investigate the effects of sarcopenia on OVCF patients after percutaneous kyphoplasty (PKP).
    UNASSIGNED: Data of 101 patients who were treated with single-level PKP between January 2021 and March 2022 at Ningbo No.6 Hospital were enrolled. Forty-five OVCF patients with sarcopenia who met our inclusion criteria were included in the Sarcopenia-PKP group (SPKP group), and 56 patients in the Normal-PKP group (NPKP group). All clinical and radiological data were collected from medical records. Baseline characteristics, operation-related parameters (operation time, time to ambulation, hospital stay, surgery segment), clinical outcomes (visual analog score [VAS], Oswestry Disability Index [ODI], Japanese Orthopaedic Association Scores [JOA] of lumber), radiological outcomes (vertebral anterior height rate and local kyphosis angle), Macnab score, and complications were evaluated and compared.
    UNASSIGNED: There were no significant differences in age, sex, surgical segment preoperative VAS score, ODI, or JOA between the two groups (P > 0.05). The SPKP group had a significantly lower body mass index (BMI), bone mineral density (BMD), and smooth muscle index (SMI) than the NPKP group (P < 0.05). Significantly longer hospital stays and time to ambulation in SPKP group than NPKP group (3.7±0.8 vs 3.4±0.5 and 2.0±0.8 vs 1.6±0.5, P < 0.05). In SPKP group, significantly better clinical outcomes at 6- and 12-months follow-up were observed in NPKP group than SPKP group (P < 0.05), and NPKP group showed significantly better in vertebral anterior height rates than SPKP group after 6-month follow-up (P < 0.05). Moreover, there were significantly more cases of complications in the SPKP group (P < 0.05).
    UNASSIGNED: Sarcopenia could reduce the clinical effect of percutaneous kyphoplasty, and furthermore. Related studies are needed to verify the effect of sarcopenia on OVCF patients.
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  • 文章类型: Journal Article
    背景:羟考酮/对乙酰氨基酚在中国多次被报道滥用。为了解决这个问题,中国国家当局联合出台政策,要求从2019年9月1日起将羟考酮/对乙酰氨基酚作为精神药物进行管理.本文旨在评估该政策在医疗机构中的实施效果。方法:我们使用中断时间序列分析来检查处方片剂平均数的即时水平和斜率变化,羟考酮/对乙酰氨基酚处方比例超过30粒,根据2018年1月1日至2021年6月30日(42个月)西安市5家三级医院的处方数据,每个处方的供应天数和供应天数超过10天的比例。我们把处方分成两组,一个是长期吸毒者,另一个是短期吸毒者。结果:总的来说,12,491种处方被纳入最终研究,为短期和长期吸毒者提供8,941和3,550张处方,分别。各部门开出的处方比例存在显著差异,在短期和长期吸毒者的政策实施前后之间观察到(p<0.001)。对于短期吸毒者,政策实施仅与超过30片的处方比例立即下降相关(-4.09%,p<0.001)。对于长期吸毒者,在政策之后,处方的平均片剂数量和处方的平均比例超过30片经历了22.96片的水平下降(p<0.001)和41.13%的水平下降(p<0.001),分别;平均供应天数显着下降(每个处方6.88天)和斜率增加(每月0.19天),供应天数超过10天的平均比例显着下降(每个处方-10.51%)和斜率增加(每月0.27%)。结论:对羟考酮/对乙酰氨基酚实施更严格的管理,实现了降低短期吸毒者滥用风险的目标。对于那些长期吸毒者来说,由于干预后超过10天的处方仍处于较高水平,因此需要加强政策。需要针对不同药物需求的患者的政策。可以实施许多其他策略,包括制定具体的指导方针/原则和开展培训计划。
    Background: Oxycodone/acetaminophen has been reported for misuse for many times in China. To cope with that, Chinese national authorities jointly issued a policy, requiring that oxycodone/acetaminophen should be managed as a psychotropic medicine starting 1 September 2019. This paper aimed to evaluate the effect of this policy in medical institutions. Methods: We used interrupted time-series analysis to examine the immediate level and slope changes in the mean number of tablets prescribed, proportion of oxycodone/acetaminophen prescription exceeding 30 pills, days supplied per prescription and the proportion of days supplied exceeding 10 days with prescription data from 5 tertiary hospitals in Xi\'an city between 1 January 2018 and 30 June 2021 (42 months). We divided the prescriptions into two groups, one for long-term drug users, and the other for short-term drug users. Results: In total, 12,491 prescriptions were included in the final study, with 8,941 and 3,550 prescriptions for the short-term and long-term drug users, respectively. Significant differences in the proportion of prescriptions issued by various departments, were observed between pre- and post-implementation of the policy for both short-term and long-term drug users (p < 0.001). For short-term drug users, the policy implementation was only associated with an immediate level decrease in proportion of prescriptions exceeding 30 tablets (-4.09%, p < 0.001). For long-term drug users, after the policy, the mean number of tablets prescribed and the mean proportion of prescriptions exceeding 30 tablets experienced a level decrease of 22.96 tablets (p < 0.001) and a level decrease of 41.13% (p < 0.001), respectively; the mean number of days supplied showed a significant level decrease (6.88 days per prescription) and slope increase (0.19 days per month), and the mean proportion of days supplied exceeding 10 days showed a significant level decrease (-10.51% per prescription) and a slope increase (0.27% per month). Conclusion: Implementation of stricter management for oxycodone/acetaminophen achieved its goal of reducing the risk of misuse in short-term drug users. For those long-term drug users, policy needed to be strengthened as the prescription exceeding 10 days was still at a high level after the intervention. Policies targeting patients with different drug demands are needed. Many other strategies can be implemented, including establishing specific guidelines/principles and conducting training programs.
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  • 文章类型: Journal Article
    随着国家药品集中采购政策在我国的逐步实行,对中标仿制药的有效性和安全性的担忧再次增加,但缺乏相关研究。这个现实世界,我们进行了前后研究,以探讨在两种通用奥氮平(其中一种是中标产品)之间转换的临床效果.比较转换前后血清奥氮平浓度。共纳入30例患者,结果显示对数变换,中标的通用奥氮平的剂量调整浓度明显低于另一种通用奥氮平,而转换前后的临床总体印象疾病严重程度或改善等级没有显着差异。这项研究表明,精神药物的通用版本可能与另一种通用药物不具有治疗等效性或生物等效性。在每个切换中功效或耐受性的变化是可能的。在仿制药之间切换期间,治疗药物监测可能是一个有价值的工具。有必要对目标人群中的其他通用精神药物进行更大的前瞻性临床研究。
    With the National Centralized Drug Procurement policy gradually applied nationally in China, concerns about the effectiveness and safety of bid-winning generic drugs are growing again, but relevant studies are lacking. This real-world, before-and-after study was conducted to explore the clinical effects of switching between two versions of generic olanzapine (one of them was bid-winning product). Pre-and post-switching serum olanzapine concentrations were compared. A total of 30 patients were included and results showed the log-transformed, dose-adjusted concentration of bid-winning generic olanzapine was significantly lower than that of another generic olanzapine, while no significant differences were shown on Clinical Global Impressions Severity of Illness or Improvement ratings before and after switching. This study suggest that a generic version of a psychotropic medication may not be of therapeutic equivalence or bioequivalence with another generic one. Changes in efficacy or tolerability are possible in every switch. Therapeutic drug monitoring could be a valuable tool during switches between generic drugs. Larger prospective clinical studies for other generic psychotropic medications in target populations are warranted.
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  • 文章类型: Journal Article
    背景:对于单节段腰椎间盘退变性疾病(DDD)的治疗,斜外侧椎间融合术(OLIF)具有临床优势。是否需要结合内固定进行治疗一直是争论的主题。
    目的:比较单行斜外侧椎间融合术(S-OLIF)与OLIF联合椎体外侧螺钉固定(F-OLIF)治疗单节段腰椎DDD的早期临床效果。
    方法:对2018年8月至2021年5月应用OLIF技术治疗单节段腰椎DDD的34例患者资料进行回顾性分析。患者分为S-OLIF组(n=18)和F-OLIF组(n=16)。术中失血,手术时间,并记录住院时间。评估手术前后疼痛视觉模拟评分(VAS)和Oswestry残疾指数(ODI)。光盘高度(DH),孔高度(FH),融合节段脊柱前凸(FSL),腰椎前凸(LL),网箱沉降,术前、术后通过CT检查进行融合测量。
    结果:S-OLIF组比F-OLIF组手术时间短,术中出血量少,差异有统计学意义(p<0.05),但住院时间差异无统计学意义。两组患者术后VAS评分和ODI均显著低于术前,但两组术后差异无统计学意义。术后FH差异无统计学意义,DH,两组的FSL和LL。两组均随访12个月。在两组中,在最后一次随访中实现了融合。
    结论:根据短期随访结果,S-OLIF和F-OLIF治疗单节段腰椎DDD均能获得可靠、稳定的融合,临床效果良好。
    BACKGROUND: For the treatment of single-level lumbar degenerative disc disease (DDD), oblique lateral interbody fusion (OLIF) has clinical advantages. Whether internal fixation needs to be combined for treatment has been the subject of debate.
    OBJECTIVE: To compare the early clinical effects of standalone oblique lateral interbody fusion (S-OLIF) versus OLIF combined with lateral screw fixation of the vertebral body (F-OLIF) on single-level lumbar DDD.
    METHODS: A retrospective analysis was performed on the data of 34 patients for whom the OLIF technique was applied to treat single-level lumbar DDD from August 2018 to May 2021. Patients were divided into the S-OLIF (n= 18) and F-OLIF groups (n= 16). Intraoperative blood loss, operative time, and length of hospital stay were recorded. The pain visual analogue scale (VAS) and Oswestry disability index (ODI) before and after the operation were evaluated. The disc height (DH), foraminal height (FH), fused segment lordosis (FSL), lumbar lordosis (LL), cage subsidence, and fusion by CT examination were measured before and after the operation.
    RESULTS: The S-OLIF group experienced a shorter operative time and less intraoperative blood loss than the F-OLIF group, and the differences were statistically significant (p< 0.05), but the difference in the length of hospital stay was not statistically significant. The postoperative VAS score and ODI of the two groups were significantly lower than those before the operation, but the postoperative differences between the two groups were not statistically significant. Differences were not statistically significant in postoperative FH, DH, FSL and LL of the two groups. Both groups were followed up for no less than 12 months. In the two groups, fusion was achieved at the last follow-up visit.
    CONCLUSIONS: According to short-term follow-up results, both S-OLIF and F-OLIF can achieve reliable and stable fusion and good clinical effect in the treatment of single-level lumbar DDD.
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