Impact of an enhanced recovery after surgery protocol on short-term outcomes in elderly patients undergoing pancreaticoduodenectomy

BackgroundTo determine whether the short-term benefits associated with an enhanced recovery after surgery programme (ERAS) following pancreaticoduodenectomy (PD) vary with age.Methods830 consecutive patients who underwent PD between January 2009 and March 2019 were divided according to age: elderly (≥75 years) vs. non-elderly patients (<75 years). Within each age group, cohort characteristics and outcomes were compared between patients treated pre- and post-ERAS (ERAS was systematically introduced in December 2012). Univariable and multivariable analysis were then performed, to assess whether ERAS was independently associated with length of hospital stay (LOS).ResultsOf the entire cohort, 577 of 830 patients (69.5%) were managed according to an ERAS protocol, and 170 patients (20.5%) were aged ≥75 years old. Patients treated post-ERAS were significantly more comorbid than those pre-ERAS, with a mean Charlson Comorbidity Index of 4.6 vs. 4.1 (p < 0.001) and 6.0 vs. 5.7 (p = 0.039) for the non-elderly and elderly subgroups, respectively. There were significantly fewer medical complications in non-elderly patients treated post-ERAS compared to pre-ERAS (12.4% vs. 22.4%; p = 0.002), but not in elderly patients (23.6% vs. 14.0%; p = 0.203). On multivariable analysis, ERAS was independently associated with reduced LOS in both elderly (14.8% reduction, 95% CI: 0.7–27.0%, p = 0.041) and non-elderly patients (15.6% reduction, 95% CI: 9.2–21.6%, p < 0.001), with the effect size being similar in each group.ConclusionERAS protocols can be safely applied to patients undergoing pancreaticoduodenectomy irrespective of age. Implementation of an ERAS protocol was associated with a significant reduction in postoperative LOS in both elderly and non-elderly patients, despite higher comorbidity in the post-ERAS period.     

Proxalutamide in metastatic castration-resistant prostate cancer: Primary analysis of a multicenter,randomized, open-label,phase 2 trial

We aim to assess the safety and efficacy of proxalutamide, a novel androgen receptor antagonist, for men with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter, randomized, open-label, phase 2 trial. In our study, the enrolled mCRPC patients were randomized to 100, 200 and 300 mg dose groups at 1:1:1. The primary efficacy endpoint was prostate-specific antigen (PSA) response rate. The secondary endpoints included objective response rate (ORR), disease control rate (DCR) and time to PSA and radiographic progression. Safety and pharmacokinetics were also assessed. Finally, there were 108 patients from 17 centers being enrolled. By week 16, there were 13 (35.1%), 12 (36.4%) and 15 (42.9%) patients with confirmed 50% or greater PSA decline in 100 mg (n = 37), 200 mg (n = 33) and 300 mg (n = 35) groups, respectively. Among the 19 patients with target lesions at study entry, three (15.8%) had a partial response and 12 (63.2%) had stable disease. The ORRs of 20.0%, 22.2%, 0% and DCRs of 80.0%, 88.9%, 60.0% were, respectively, achieved in 100, 200 and 300 mg groups. By the maximum follow-up time of 24 weeks, there were 42.6% and 10.2% of cases experiencing PSA progression and radiographic progression, respectively. Overall, adverse events (AEs) were experienced by 94.4% of patients, most of which were mild or moderate. There were 28 patients experiencing ≥grade 3 AEs. The most common AEs were fatigue (17.6%), anemia (14.8%), elevated AST (14.8%) and ALT (13.0%), decreased appetite (13.0%). These findings preliminarily showed the promising antitumor activity of proxalutamide in patients with mCRPC with a manageable safety profile. The proxalutamide dose of 200 mg daily is recommended for future phase 3 trial (Clinical trial registration no. CTR20170177).     

Global burden of thermal burns, 1990–2017: Unbalanced distributions and temporal trends assessed from the Global Burden of Disease Study 2017

BackgroundMany studies demonstrate that being burned has both physical and psychological sequelae that affect quality of life. Further, these effects may be more prevalent in some regions and populations. We sought to access the unbalanced distributions and temporal trends concerning the health burden of thermal burns.MethodsData were collected from the Global Burden of Disease Study 2017, and the disability-adjusted life year (DALY)¹ was used as a measure of health burden. Linear regression was used to evaluate the relationship between the age-standardized DALY rate and socio-demographic index.² Joinpoint regression analysis and comparison line charts were all applied to assess the temporal trends of burns.ResultsThe age-standardized DALY rate of global thermal burns decreased by 43.7%, from 197 (95% CI: 152–228) per 100,000 in 1990 to 111 (95% CI: 93–129) per 100,000 in 2017. The burden was borne mainly by children 1–4 years of age and people over 80 years. Socio-demographic index was negatively correlated with the age-standardized DALY rate. In low-middle and low socio-demographic index regions, the decreasing trends were slower than other regions with an average annual percentage change of ?2.1% (95% CI: ?2.2 to ?2.0) and ?2.1% (95% CI: ?2.1 to ?2.0), respectively. Among six geographical regions, Africa presented the highest age-standardized DALY rates of 352 (95% CI: 275–410) per 100,000 in 1990 and 208 (95% CI: 175–236) per 100,000 in 2017, and also the slowest average decreasing trend, with an average annual percentage change of ?1.9% (95% CI: ?2 to ?1.8).ConclusionsThe global burden of thermal burns shows a downward trend from 1990 to 2017, and regions with lower socio-demographic index and Africa show greater burdens and smaller downward trends.     

Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine

Clinical trial outcome reporting differs between studies integrating traditional Chinese medicine (TCM) and Western medicine, so that some clinical trials are not eligible for inclusion in a systematic review. The excluded studies are therefore less widely disseminated, and even valid studies are less likely to yield impact. This problem may be addressed by developing core outcome sets (COSs) for integrative medicine in specific healthcare areas. The first stage of development is to define the scope of the COS for integrative medicine, the second stage is to establish the need for such a COS, and the third stage is to develop a protocol and register the COS. The final stage involves three steps: (i) development of a comprehensive list of outcomes (including efficacy outcomes and safety outcomes and TCM syndromes) using systematic review, qualitative or cross-sectional research, and reviews of package inserts and medical records; (ii) merging and grouping of outcomes within domains; (iii) conducting two rounds of Delphi survey and consensus meetings with a range of stakeholders. The final COS will include a general COS and core TCM syndrome- set. Development of COSs for clinical trials of integrative medicine may help to standardize outcome reporting and reduce publication bias in the future.     

血流重建术对成人烟雾病患者抑郁焦虑状态的影响

目的 探讨血流重建术对成人烟雾病患者抑郁、焦虑状态和脑灌注的影响,并分析抑郁、焦虑状态改变与脑灌注变化的相关性.方法 连续纳入2015年1月至2016年6月我院收治的成人烟雾病患者64例,其中手术治疗42例(联合血流重建组16例、间接血流重建组26例),保守治疗22例(保守治疗组).在入院时、治疗6个月(±1个月)和治疗12个月(±1个月)时,分别采用患者健康问卷抑郁自评量表(PHQ-9)和广泛性焦虑障碍量表(GAD-7)评估抑郁、焦虑状态,入院和6个月(±1个月)时采用头颅计算机断层扫描灌注成像(CTP)评估脑灌注.采用方差分析和最小显著差异法比较各组患者焦虑、抑郁症状改善情况和脑灌注变化,采用Pearson相关性分析探究情绪改善程度和脑灌注变化改善程度的相关性.结果 3组患者性别、年龄、受教育年限、入院时美国国立卫生研究院中风量表(NIHSS)评分、脑白质病变Fazekas评分和卒中史差异均无统计学意义(P均>0.05).联合血流重建组和间接血流重建组术后6个月PHQ-9评分和GAD-7评分均较入院时降低(P均<0.05),术后12个月PHQ-9和GAD-7评分较术后6个月相比差异均无统计学意义(P均>0.05).联合血流重建组和间接血流重建组术后6个月时PHQ-9和GAD-7评分的改善程度差异均无统计学意义(P>0.05).保守治疗组患者术后6、12个月PHQ-9和GAD-7评分与入院时相比差异均无统计学意义(P均>0.05).术后6个月联合血流重建组和间接血流重建组脑灌注达峰时间(TTP)均较入院时下降(P=0.04、0.04),脑血流量(CBF)均较入院时提高(P=0.02、0.04).术后6个月时手术治疗患者PHQ-9评分的改善程度与TTP的改善程度呈正相关(r=0.62,P<0.01).结论 血流重建术可改善成人烟雾病患者的抑郁、焦虑情绪,且间接血流重建术和联合血流重建术效果相当.手术可能通过改善烟雾病患者的脑灌注来改善患者的抑郁、焦虑状态.     

脑性瘫痪患者肢体解痉、矫形与功能重建的手术治疗研究进展

目的 总结脑性瘫痪（脑瘫）患者在肢体解痉、矫形与功能重建等手术治疗方面的研究进展。方法 在中国知网、万方数据、PubMed等中、英文数据库,检索2000年1月—2021年6月发表的关于脑瘫诊断和治疗的相关文献,剔除内容不符、质量较低、证据等级不高、重复研究的文献,最终纳入47篇文献,从肢体解痉、矫形和功能重建3个方面对脑瘫的手术治疗进行总结、分析。结果 关于脑瘫的手术治疗,目前可供选择的术式有很多。（1）解痉手术：包括选择性脊神经后根切断术（SPR）和选择性周围神经切断术（SPN）。SPR手术可广泛降低肢体肌张力,更适合肢体强直型痉挛;而SPN降低肌群中单块肌肉张力的效果确切、创伤小,适用于局灶性痉挛。（2）矫形手术：通过肌腱转位、延长或紧缩调整肌张力、松解痉挛、缓解或矫正畸形,手术方式包括跟腱延长术、腘绳肌松解、胫后肌延长、胫前肌移位、内收肌切断术等。临床上矫形手术常作为解痉手术的重要补充,脑瘫患者往往需先接受SPR/SPN解除痉挛,再进行矫形手术。（3）肢体功能重建手术：包括神经段移植嵌入嫁接术、带血管的神经移位嫁接术及神经束间侧侧缝合术等改良周围神经移位术,可重建患者部分运动功能和感觉功能。结论 脑瘫的手术治疗非常重要,个体化制定分期手术方案,联合应用肢体解痉、矫形和改良神经移位术,对于缓解中枢神经系统损伤后的肢体痉挛、矫正畸形及重建肢体部分功能有积极的作用。