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Gender Disparities in the Clinical Trials and Real-World Utilization of Systemic Therapy in the Management of Urothelial Carcinoma 尿路上皮癌系统治疗的临床试验和实际应用中的性别差异
Pub Date : 2023-11-01 DOI: 10.1097/ju9.0000000000000052
Hiroko Miyagi, Shahab Bozorgmehri, Nikhil V. Batra, Jonathan A. Chatzkel, Brian Hemendra Ramnaraign, Kathryn Hitchcock, Robert A. Zlotecki, Wayne Brisbane, Paul L. Crispen, Padraic O'Malley
Objectives: The objectives of this study was (1) to examine the representation of women in clinical trials for systemic therapy in muscle-invasive (MIBC) or metastatic bladder cancer (BC) and (2) to determine the association between sex and systemic therapy in the treatment of MIBC or metastatic BC. Methods: A review of bladder cancer systemic therapy clinical trials cited by the National Comprehensive Cancer Network guidelines was performed. Proportions of women were compared with the corresponding proportions in the US population with bladder cancer between 1975 and 2018, based on the Surveillance, Epidemiology, and End Results database. We also used the National Cancer Database (NCDB) to identify 55,951 patients with American Joint Committee on Cancer clinical stage II, III, and IV bladder cancer between 2004 and 2015. We determined the predictors of systemic therapy for bladder cancer treatment using a multivariable logistic regression model. Results: 26.9% of the US bladder cancer population were women; however, only 17.7% of participants in US clinical trials and 19.9% of participants in all clinical trials were female, indicating an absolute difference of 9.2% (95% confidence interval [CI]: 6.2%-12.1%; P < .001) and 7.0% (95% CI: 6.1%-7.9%; P < .001), respectively. Multivariable analysis of the NCDB showed that women had decreased odds of receiving systemic therapy compared with male patients with MIBC or metastatic BC (odds ratio: 0.93, 95% CI: 0.89-0.96; P < .001). Conclusion: Women are underrepresented in MIBC and/or metastatic BC systemic therapy clinical trials. In addition, women are less likely than men to receive systemic therapy for the treatment of MIBC or metastatic BC. Further research is needed to investigate the reasons for gender disparities in treatment of MIBC or metastatic BC as well as the participation in clinical trials.
目的:本研究的目的是:(1)检查女性在肌肉侵袭性(MIBC)或转移性膀胱癌(BC)全身治疗临床试验中的代表性;(2)确定性别与全身治疗在MIBC或转移性膀胱癌治疗中的关系。方法:回顾国家综合癌症网络指南引用的膀胱癌全身治疗临床试验。根据监测、流行病学和最终结果数据库,将1975年至2018年期间美国膀胱癌患者中女性的比例与相应比例进行了比较。我们还使用国家癌症数据库(NCDB)来确定2004年至2015年间美国癌症联合委员会临床II、III和IV期膀胱癌的55,951例患者。我们使用多变量logistic回归模型确定膀胱癌全身治疗的预测因素。结果:26.9%的美国膀胱癌患者为女性;然而,在美国临床试验中只有17.7%的参与者是女性,在所有临床试验中只有19.9%的参与者是女性,绝对差异为9.2%(95%置信区间[CI]: 6.2%-12.1%;P & lt;.001)和7.0% (95% CI: 6.1%-7.9%;P & lt;措施),分别。NCDB的多变量分析显示,与患有MIBC或转移性BC的男性患者相比,女性接受全身治疗的几率降低(优势比:0.93,95% CI: 0.89-0.96;P & lt;措施)。结论:女性在MIBC和/或转移性BC全身治疗临床试验中的代表性不足。此外,女性比男性更不可能接受全身治疗来治疗MIBC或转移性BC。需要进一步的研究来调查在治疗MIBC或转移性BC以及参与临床试验中性别差异的原因。
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引用次数: 1
Large Intra-abdominal Testicular Neoplasm Involving the Bladder and Ureter in an Adult Male with Bilateral Cryptorchidism 成年男性双侧隐睾肿物累及膀胱及输尿管
Pub Date : 2023-11-01 DOI: 10.1097/ju9.0000000000000074
Pedro Rodrigues Beal, Tiago Aparecido Silva, Vitor Bonadia Buonfiglio, Luciana Saboya Brito Dal Col, Renato Meirelles Mariano Da Costa Junior, Luiz Henrique Correa Portari FIlho, Marcus Vinicius Sadi
Abstract Cryptorchidism remains as one of the most significant risk factors for the development of testicular cancer (TC). The occurrence of TC in undescended testes can represent challenges to both diagnosis and management because the clinical presentation can delay a definitive diagnosis, and surgical management of intra-abdominal masses can be difficult. We present a case of an adult male with bilateral cryptorchidism diagnosed with a large intra-abdominal TC which was subjected to surgical resection.
隐睾仍然是睾丸癌(TC)发展的最重要的危险因素之一。隐睾TC的发生对诊断和治疗都是一个挑战,因为临床表现可能会延迟明确的诊断,并且腹内肿块的手术治疗可能很困难。我们提出一个病例的成年男性与双侧隐睾诊断为大腹腔TC,并进行手术切除。
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引用次数: 0
Editorial Comment in Response to: Postoperative Oral Care Pathways are Not Required at the Time of Buccal Mucosa Harvest 编辑评论以作回应:采集颊黏膜时不需要术后口腔护理路径
Pub Date : 2023-11-01 DOI: 10.1097/ju9.0000000000000076
Susan M. MacDonald
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引用次数: 0
Pelvic Floor Dysfunction: A Common Cause of Chronic Orchialgia 盆底功能障碍:慢性睾丸痛的常见原因
Pub Date : 2023-11-01 DOI: 10.1097/ju9.0000000000000070
Amy Zheng, Austin K. Bramwell, Jennifer A. Kane, Jonathan T. Pham, Susan M. MacDonald
Purpose: We determined the prevalence of pelvic floor dysfunction (PFD) as an etiology for chronic orchialgia in a single tertiary care practice and characterized the presenting symptoms of chronic orchialgia patients with PFD. Materials and Methods: An IRB-approved retrospective review was performed for patients diagnosed with chronic orchialgia from 2016 to 2021 using CPT codes N50.82 (scrotal pain), N50.819 (testicle pain), and G89.29 (chronic pain in testicle). Patients with acute orchialgia (<3 months) were excluded. PFD was diagnosed on a 360-degree digital rectal examination when increased tone or pain to palpation of the levator ani muscle group was noted. Suspected etiology of the orchialgia and accompanying urinary, bowel, or sexual symptoms were recorded. Unpaired t -tests were used to determine significant associations while accounting for differences in sample size. Results: Of 136 patients with chronic orchialgia, the most common etiologies were classified as idiopathic (37.7%); prior surgery (32.1%); varicocele, hydrocele, or spermatocele (28.3%); PFD (17.6%); and postinfection (11.3%). Chronic orchialgia patients with PFD (n = 24) were significantly more likely to present with accompanying urinary ( P < .01), bowel ( P < .01), and sexual dysfunction ( P = .04) symptoms. Orchialgia patients with PFD were more likely to report symptoms of functional obstruction, particularly urinary hesitancy ( P < .01), constipation ( P < .01), and painful ejaculation ( P < .01), compared with patients without PFD. Conclusions: PFD was determined to be the etiology in 1 in 6 patients with chronic orchialgia. All patients presenting with chronic orchialgia and obstructive symptoms warrant a 360-degree rectal examination as part of their initial evaluation. IRB Protocol Number: 10677.
目的:我们在单一三级医疗实践中确定盆底功能障碍(PFD)作为慢性睾丸痛病因的患病率,并描述慢性睾丸痛合并PFD患者的表现症状。材料和方法:对2016年至2021年诊断为慢性睾丸痛的患者进行回顾性研究,CPT代码为N50.82(阴囊疼痛)、N50.819(睾丸疼痛)和G89.29(睾丸慢性疼痛)。排除急性睾丸痛(3个月)患者。当发现提肛肌群张力增加或触诊疼痛时,通过360度直肠指检诊断为PFD。对疑似病因的睾丸痛及伴随的泌尿、肠道或性症状进行记录。在考虑样本量差异的同时,使用非配对t检验来确定显著关联。结果:136例慢性睾丸痛患者中,最常见的病因为特发性(37.7%);既往手术(32.1%);精索静脉曲张、精索积液或精索膨出(28.3%);PFD (17.6%);感染后(11.3%)。慢性睾丸痛合并PFD患者(n = 24)更有可能出现伴尿(P <0.01),肠(P <.01),性功能障碍(P = .04)症状。伴有PFD的睾丸痛患者更有可能报告功能性梗阻症状,特别是尿犹豫(P <P <.01)、射精疼痛(P <.01),与无PFD患者相比。结论:慢性睾丸痛6例中有1例病因为PFD。所有出现慢性睾丸痛和梗阻性症状的患者都需要进行360度直肠检查,作为其初步评估的一部分。IRB协议号:10677。
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引用次数: 2
Functional Follow-Up After Cystectomy and Urinary Diversion: A Narrative Review 膀胱切除术和尿路转流术后的功能随访:叙述性综述
Pub Date : 2023-11-01 DOI: 10.1097/ju9.0000000000000071
Ernest Kaufmann, Peter C. Black, James W. F. Catto, H. Djaladat, S. Ghodoussipour, Jill M. Hamilton-Reeves, Bente Thoft Jensen, W. Kassouf, S. V. Lauridsen, S. P. Lerner, Carlos Llorente, Katherine Loftus, Ilaria Lucca, Alberto Martini, Mark A. Preston, S. P. Psutka, J. Sfakianos, Jay Shah, M. S. Wettstein, Stephen B. Williams, S. Daneshmand, C. Fankhauser
Follow-up after urinary diversion aims to detect functional complications to prevent harm and improve quality of life. We conducted a literature search and reviewed guidelines and institutional follow-up protocols. We included 14 studies providing data of 3282 patients. Functional complications can be seen in up to 90% of all patients within 15 years after urinary diversion and mainly include impairment of urinary or sexual function as well as renal/metabolic disturbances, but only limited evidence supporting any functional follow-up recommendation was identified. Current guideline recommendation should be rephrased to ensure routine implementation of functional follow-up investigation. Future research is required to assess whether, which, and how follow-up protocols after cystectomy affect functional results to inform optimal surveillance procedures after treatment. In this review of recommended follow-up protocols after cystectomy, we observed different recommendations and discuss future research areas.
尿路转流术后的随访旨在发现功能性并发症,以预防伤害并提高生活质量。 我们进行了文献检索,并查阅了指南和机构随访协议。 我们纳入了 14 项研究,提供了 3282 例患者的数据。在尿路改道术后 15 年内,高达 90% 的患者会出现功能性并发症,主要包括泌尿或性功能受损以及肾脏/代谢紊乱,但仅有有限的证据支持任何功能性随访建议。目前的指南建议应重新措辞,以确保常规实施功能性随访调查。 未来的研究需要评估膀胱切除术后的随访方案是否、哪些以及如何影响功能结果,从而为治疗后的最佳监测程序提供依据。 在这篇关于膀胱切除术后推荐随访方案的综述中,我们观察到了不同的建议,并讨论了未来的研究领域。
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引用次数: 0
Editorial Comment: Pelvic Floor Dysfunction: A Common Cause of Chronic Orchialgia 编辑评论:盆底功能障碍:慢性睾丸炎的常见病因
Pub Date : 2023-11-01 DOI: 10.1097/ju9.0000000000000078
Leo Puhalla, Scott D. Lundy
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引用次数: 0
JU Open Plus: Beyond Borders JU Open Plus:超越国界
Pub Date : 2023-11-01 DOI: 10.1097/ju9.0000000000000094
John W. Davis
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引用次数: 0
The Minimal Utility of Analyzing Ureteropelvic Junction Tissue at the Time of Pyeloplasty 肾盂成形术时分析输尿管肾盂连接处组织的最小效用
Pub Date : 2023-10-01 DOI: 10.1097/ju9.0000000000000059
Jasper C. Bash, Solange Bassale, Sudhir Isharwal
Introduction: Ureteropelvic junction obstruction is a common cause of upper tract obstruction that often necessitates surgical intervention because of its severe implications. A high proportion of these surgeries include pathologic analysis of this tissue with unclear clinical value. We examined our institution's practices concerning sending the ureteropelvic junction (UPJ) specimens for pathology analysis, its clinical value, and the associated costs for both pediatric and adult cases. Methods: We performed retrospective chart review using Current Procedural Terminology codes for pyeloplasty over 8 years. Clinical variables were extracted from operative reports, path reports, and postoperative clinic notes. Pathology results were classified dichotomously as “benign” or “malignant” and subsequently assigned to 1 of 4 categories—inflammation, fibrosis, muscular hyperplasia, or no atypical findings. Results: Two hundred sixty-nine pyeloplasty surgeries were included, 68% of which were in children. Pathologic analysis was requested in most of the cases (91%), and this was slightly more common in adults (94%) than in pediatric patients (90%). All available pathology reports found benign findings in the UPJ specimen, mostly commonly categorized as “normal.” No cases of malignancy were noted. At the list price for pathologic analysis, $103,027 was spent over 8 years without the discovery of clinically significant pathology findings. Conclusions: There was a lack of clinically meaningful results from pathologic analysis of UPJ specimens excised during pyeloplasty. A UPJ specimen should not be routinely sent for pathologic analysis rather selectively if there is clinical concern for nonbenign etiology of UPJ obstruction.
导读:肾盂输尿管连接处梗阻是上尿路梗阻的常见原因,由于其严重的影响,通常需要手术干预。这些手术中有很大一部分包括该组织的病理分析,临床价值不明确。我们检查了我院关于送输尿管肾盂连接处(UPJ)标本进行病理分析的做法,其临床价值,以及儿童和成人病例的相关费用。方法:我们使用现行程序术语代码进行回顾性图表回顾超过8年的肾盂成形术。从手术报告、路径报告和术后临床记录中提取临床变量。病理结果分为“良性”或“恶性”,随后分为炎症、纤维化、肌肉增生或无非典型表现4类中的1类。结果:本文包括269例肾盂成形术,其中68%为儿童。大多数病例(91%)要求进行病理分析,成人(94%)比儿科患者(90%)稍多见。所有可用的病理报告均发现UPJ标本呈良性,通常归类为“正常”。未发现恶性肿瘤。以病理分析的标价计算,在没有发现临床显著病理结果的情况下,花费了103,027美元。结论:肾盂成形术中切除的UPJ标本的病理分析缺乏临床意义。如果临床上存在UPJ阻塞的非良性病因,则不应常规送UPJ标本进行病理分析。
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引用次数: 2
JU Open Plus: Section Meetings—Science, Practice Improvement, and Networking JU Open Plus:分组会议-科学,实践改进和网络
Pub Date : 2023-10-01 DOI: 10.1097/ju9.0000000000000075
John W. Davis
SEPTEMBER 2023 ISSUE REVIEW We start our September issue review with the research communication from Takahara et al from Japan.1 The article reviews the needs for minimally invasive surgeons to offer partial nephrectomy, when indicated, and to achieve a trifecta of warm ischemia time <25 minutes, negative surgical margins, and no complications. They report on an early experience with a 3D workstation product called Atrena. I am sure you have to see it in person to appreciate its contribution. From the article's figure, the surgeon can have this program on a tablet nearby and rotate, zoom, and make some structures translucent. Images can then be pushed into the daVinci console with TilePro. They present an early experience of 15 cases, with 14 achieving the “trifecta.” Intraoperative navigation will certainly be a hot topic for the foreseeable future to augment the improvements realized thus far in surgical vision and ergonomics. JU Open Plus will have several articles types to publish research including reviews, hypothesis-generating study, clinical trials, and videos as manuscripts. We have 2 interesting case reports. Cohen et al2 report on a rare case of metastatic clear cell renal cell carcinoma within Birt-Hogg-Dube syndrome. The interests in the case are the genetic mutations identified that were common to bilateral renal lesions and a brain metastasis. The discussion emphasizes germline testing for multifocal or bilateral renal cell carcinoma and the possibility of clear cell histology with Birt-Hogg-Dube syndrome. Faber et al3 report on primary renal neuroendocrine tumor causing Zollinger-Ellison syndrome. Primary renal neuroendocrine tumors are very rare and generally treated surgically. The gastrin-secreting tumors will have gastrointestinal symptoms as described. With early detection, this lesion was amenable for partial nephrectomy. If you are in board review mode, see their figure 2 with an octreotide scan–positive lesion due to somatostatin receptor avidity. For original articles, Rasheed et al4 studied the emerging field of telemedicine: What are the barriers to successful connections? For our system, I see patients mostly struggling with how to turn on their camera or microphone. In this study, a volunteer medical student group was working with groups including geriatric and pediatric patients. They break it down into 4 themes: completing registration, familiarity and access to video conference software, proxy access for pediatric patients, and various technical questions. They present an algorithm and discussion on pathways to success. As a sign of the times, my institution is not only expanding telemedicine visits and access but also starting to credential the staff in multiple states to expand our reach. Norman et al5 pose a long-standing question in prostate cancer diagnostics—What to do with results that are not cancer but are not “not” cancer either. The tracked patients had high-grade prostatic intraepithelial neoplasm, atyp
然而,我不是第一个在1940年到1941年服役的约翰·戴维斯——和我的名字没有关系!AUA部分服务于许多关键目的。科学和实践建设的内容是重要的所有执业和学术泌尿科医生。许多泌尿外科住院医师在分会会议上展示他们的第一次研究。网络是非常有益的-无论是在泌尿科医生和许多配偶/重要的其他人每年来参加。在这一期,我将重点介绍我们最近在德克萨斯州奥斯汀举行的第102次会议上的一些人/地方/事物的图片,这次会议是在Chad LaGrange主席(内布拉斯加州)和Fernando Kim(科罗拉多州,也是我们的JU Open Plus副主编)的领导下举行的。对于特写人物来说,在这样的会议上有很多照片可供选择。图1和图2来自董事会/历任总裁晚宴。图3突出了流行的全体会议辩论形式和具有挑战性的案例讨论。图4-6突出了值得注意的会议活动,如墨西哥泌尿外科协会早餐、早晨瑜伽和嘉宾演讲。对于地点,图7突出显示了奥斯汀的一些景点,如市中心的天际线和德克萨斯大学奥斯汀分校。图8突出显示了一些添加到会议体验中的有趣的“事物”。图1所示。:人。2023年美国大学协会中南部赛区以董事会/前任主席晚宴拉开帷幕。该活动的特色是前任总统的“有趣”主题演讲。今年,来自墨西哥的Arturo Mendoza-Valdes(2004-2005年总裁)为我们介绍了龙舌兰酒的历史、生产和品尝。图2。:人。出席2023年奥斯汀会议的历届主席:从左至右:约翰·戴维斯(2022年)、迈克·库克森(2021年)、蒂姆·兰福德(2018年)、托马斯·格里布林(2019年)、德玛拉·卡普兰(2015年)、詹姆斯·温德尔肯(2002年)、阿图罗·门多萨-瓦尔德斯(2005年)、布莱恩·弗林(2017年)、艾伦·莫雷(2013年)、詹姆斯·卡明斯(2020年)。图3。:人。功能性泌尿外科阻滞:Oluwarotimi Nettey(休斯顿)讨论了如何修复放射性瘘。图4。:人。墨西哥泌尿外科学会总是带来一大群教员、住院医师和摘要。他们有自己的早餐会议,如图所示。他们的特邀全体会议发言人是Grisel Hernandez博士(坐在左边)。图5。:人。晨间瑜伽,俯瞰奥斯汀市中心。健康一直是SCS项目的焦点。图6。:人。游客!所有小组会议的一个亮点是向小组专家学习。约翰·马尔霍尔(纽约)。杰夫·卡恩斯(明尼苏达州)。6c: Inderbir Gill(加州)。6d:查德·拉格朗日总统与特邀发言人卢·卡武西(纽约)。图7。:地方。德克萨斯州的奥斯汀是一个举办小组会议的好地方——一个以户外活动、烧烤、德克萨斯州国会大厦和德克萨斯大学奥斯汀分校为特色的新兴城市。图7a:奥斯汀的天际线和伯德小姐湖。图7b:利特菲尔德喷泉——位于通往德克萨斯大学奥斯汀塔的南广场上的第一次世界大战纪念碑。在庆祝的日子里,这座塔被点燃成橘黄色——既有学术庆祝,也有体育庆祝。图8。:东西。图8a:龙舌兰酒品尝。图8b: Dr. Damara Kaplan赢得了一个SCS品牌的Yeti Tumbler。图8c:主题夜间娱乐活动包括犰狳比赛。
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引用次数: 0
Carcinogenic Effects of Nitrosodimethylamine Contamination in Ranitidine: Defining the Relationship With Renal Malignancies 雷尼替丁中亚硝基二甲胺污染的致癌作用:确定与肾脏恶性肿瘤的关系
Pub Date : 2023-10-01 DOI: 10.1097/ju9.0000000000000062
Richard E. Link
Patients with renal cell carcinoma (RCC) often feel struck by lightning. Unsatisfied by relatively modest associations of RCC with advancing age, male sex, tobacco exposure, and Western diets rich in red meat,1,2 patients reach for causative connections to occupational exposures and drugs. Exposure to trichloroethylene and chronic analgesic use has perhaps the most compelling association with RCC.3 However, many other drugs have been implicated in contributing to RCC without convincing proof. Urologists must be prepared to field these questions from their patients when they arise. The cautionary tale of the rise and fall of ranitidine, once the highest-selling drug on the planet, is fascinating and of particular interest to patients with RCC and their physicians. The downfall of ranitidine derived from the detection of a known carcinogen in the medication, nitrosodimethylamine (NDMA), linked to RCC and other tumors in animals. The authors describe the preclinical evidence for NDMA contamination in ranitidine, its connection to carcinogenesis in animals, and the challenges inherent in asking the critical clinical question: “Did ranitidine ingestion contribute to RCC tumorigenesis in humans?” The available population cohort data exploring this association are clouded by short follow-up, inhomogeneous data collection, the lack of screening imaging to detect subclinical tumors, and a range of other confounders. Moreover, NDMA levels were not actually measured in any of these studies. The story highlights the inherent difficulty in connecting an extremely pervasive drug exposure to a specific type of cancer unless the associated risk is exceptionally high. For practicing urologists, the take home message of this well-written review is that no clear association between ranitidine exposure and the development of RCC currently exists.4 However, the authors appropriately recommend that we view this conclusion, based entirely on observational studies with significant weaknesses, with caution when counseling our patients.
肾细胞癌(RCC)患者常有被雷击的感觉。不满意的是,RCC与年龄增长、男性、吸烟暴露和富含红肉的西方饮食之间存在相对有限的关联,1,2名患者将病因与职业暴露和药物联系起来。暴露于三氯乙烯和长期使用止痛药可能与RCC有最令人信服的联系。然而,许多其他药物也与RCC有关,但没有令人信服的证据。当病人提出这些问题时,泌尿科医生必须准备好回答。雷尼替丁曾经是这个星球上销量最高的药物,它的起起落落的警示故事令人着迷,对肾癌患者和他们的医生特别感兴趣。雷尼替丁的失败源于在药物中检测到一种已知的致癌物质,亚硝基二甲胺(NDMA),与RCC和其他动物肿瘤有关。作者描述了雷尼替丁中NDMA污染的临床前证据,它与动物致癌性的联系,以及提出关键临床问题所固有的挑战:“雷尼替丁摄入是否有助于人类RCC肿瘤的发生?”由于随访时间短、数据收集不均匀、缺乏检测亚临床肿瘤的筛查成像以及一系列其他混杂因素,探索这种关联的现有人群队列数据受到影响。此外,这些研究都没有实际测量NDMA水平。这个故事强调了将极其普遍的药物暴露与特定类型的癌症联系起来的固有困难,除非相关风险非常高。对于执业泌尿科医生来说,这篇写得很好的综述所传达的信息是,雷尼替丁暴露与肾癌发展之间目前还不存在明确的联系然而,作者恰当地建议我们在咨询患者时要谨慎看待这一结论,这一结论完全基于有明显弱点的观察性研究。
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引用次数: 1
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JU open plus
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