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Comparison of 3 Paclitaxel-Based Chemoradiotherapy Regimens for Patients With Locally Advanced Esophageal Squamous Cell Cancer: A Randomized Clinical Trial.
Ai, D, Ye, J, Wei, S, Li, Y, Luo, H, Cao, J, Zhu, Z, Zhao, W, Lin, Q, Yang, H, et al
JAMA network open. 2022;(2):e220120
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Abstract
IMPORTANCE Multiple paclitaxel-based regimens are widely used in chemoradiation therapy against esophageal cancer, including regimens combining paclitaxel with fluorouracil, cisplatin, and carboplatin. However, which among these 3 regimens provides the best prognosis with minimum adverse events is still unknown. OBJECTIVE To compare the efficacy and adverse events of fluorouracil, cisplatin, and carboplatin in definitive chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC). DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial of patients with ESCC was conducted in 11 treatment centers in China. Eligible patients were aged 18 to 75 years and had histologically confirmed ESCC stages IIa to IVa with no prior treatment, Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ functions. The study was conducted between July 2015 and February 2018, and the cutoff date for data analysis was August 31, 2020. INTERVENTIONS Patients with locally advanced ESCC were randomly assigned (1:1:1) to groups combining paclitaxel treatment with fluorouracil, cisplatin, or carboplatin. Patients in the cisplatin group were treated with 2 cycles of concurrent chemoradiotherapy followed by 2 cycles of consolidation chemotherapy with monthly paclitaxel plus cisplatin. For the fluorouracil group, patients were administered 6 cycles of weekly paclitaxel plus fluorouracil in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus fluorouracil in consolidation chemotherapy. Patients in the carboplatin group were treated with 6 cycles of weekly paclitaxel plus carboplatin in concurrent chemoradiotherapy followed by 2 cycles of monthly paclitaxel plus carboplatin in consolidation chemotherapy. All patients received radiotherapy of 61.2 Gy delivered in 34 fractions. MAIN OUTCOMES AND MEASURES The primary end point was overall survival (OS). The secondary end points were progression-free survival and adverse events. RESULTS Overall, 321 patients (median [IQR] age, 64 years [59-69 years]; 248 [77.3%] men) with ESCC from 11 centers were randomized into fluorouracil, cisplatin, or carboplatin groups between July 2015 and February 2018. Over a median (IQR) follow-up time of surviving patients of 46.0 months (36.6-53.0 months), the 3-year OS rates were 57.2% in the fluorouracil group, 60.1% in the cisplatin group, and 56.5% in the carboplatin group, respectively (fluorouracil vs cisplatin: HR, 1.06; 95% CI, 0.71-1.60; P = .77; fluorouracil vs carboplatin: HR, 0.94; 95% CI, 0.63-1.40; P = .77). The cisplatin group had significantly higher incidences of acute grade 3 or 4 neutropenia (69 events [60.8%] vs 19 [17.8%] for fluorouracil and 37 [34.6%] carboplatin; P < .001), thrombocytopenia (14 events [13.1%] vs 4 [3.7%] for fluorouracil and 5 [4.7%] for carboplatin; P = .01), anemia (50 events above grade 2 [46.7%] vs 25 [23.4%] for fluorouracil and 37 [34.6%] for carboplatin; P = .35), fatigue (11 events [10.3%] vs 2 [1.9%] for fluorouracil and 1 [0.9%] carboplatin; P = .007), and vomiting (17 events above grade 2 [15.9%] vs 3 [2.8%] for fluorouracil and 5 [4.7%] for carboplatin; P < .001) than the other 2 groups. CONCLUSIONS AND RELEVANCE In this randomized clinical trial, paclitaxel plus fluorouracil did not show OS superiority over paclitaxel plus cisplatin or paclitaxel plus carboplatin regimens in definitive chemoradiation in patients with locally advanced ESCC. Higher rates of hematologic and gastrointestinal toxic effects were reported in the cisplatin group compared with those in the fluorouracil or carboplatin groups. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02459457.
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Comparison of IVF and IVM outcomes in the same patient treated with a modified IVM protocol along with an oocytes-maturing system containing melatonin: A pilot study.
Li, X, Mu, Y, Elshewy, N, Ding, D, Zou, H, Chen, B, Chen, C, Wei, Z, Cao, Y, Zhou, P, et al
Life sciences. 2021;:118706
Abstract
AIM: To compare embryonic developmental competence and clinical outcomes of oocytes matured in vivo (IVF oocytes) and those matured in vitro (IVM oocytes) from the same IVM/IVF cycles, and to analyze the clinical efficiency of a melatonin-supplemented in vitro maturation system combined with a modified IVM/IVF protocol. MAIN METHODS We randomly recruited 22 patients undergoing IVM/IVF treatment protocol in our medical centre. The fertilization, cleavage and blastocyst formation rates, as well as clinical pregnancy, implantation and live birth/ongoing pregnancy rates were analysed and compared between IVF and IVM oocytes. We evaluated mitochondrial function indicators by fluorescence staining and confocal microscopy, including mitochondrial membrane potential, reactive oxygen species and calcium (Ca2+) levels in 15 IVF and 15 IVM oocytes. KEY FINDINGS There were no significant differences in fertilization or blastocyst formation rates between the IVF and IVM groups, whereas the cleavage rate was significantly higher in the IVF versus IVM group (100% vs 93.4 ± 10.9%, p = 0.03). There were no significant differences in the clinical pregnancy, implantation or live birth/ongoing pregnancy rates between the two groups. The cumulative clinical pregnancy and ongoing pregnancy/live birth rate per pick-up oocyte in the IVM/IVF treatment cycles were 68.2% (15/22) and 54.5% (12/22), respectively. The reactive oxygen species and Ca2+ levels were significantly increased, and mitochondrial membrane potential was significantly decreased, in IVM compared with IVF oocytes. SIGNIFICANCE The modified IVM/IVF protocol can be effectively applied to the treatment of some indicated patients and achieve ideal clinical outcomes, even though the developmental potential of IVM oocytes may not be as high as IVF oocytes.
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Comparison of First-Line Treatments for Patients With Extensive-Stage Small Cell Lung Cancer: A Systematic Review and Network Meta-analysis.
Zhou, T, Zhang, Z, Luo, F, Zhao, Y, Hou, X, Liu, T, Wang, K, Zhao, H, Huang, Y, Zhang, L
JAMA network open. 2020;(10):e2015748
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Abstract
IMPORTANCE Combinations of chemotherapy with immunotherapy or bevacizumab in first-line treatments of extensive-stage small cell lung cancer (ES-SCLC) have been evaluated in various clinical trials. However, it remains unclear what the optimal combination regimen is. OBJECTIVE To clarify which first-line combination regimen is associated with the best tumor response among patients with ES-SCLC. DATA SOURCES Electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science) were systematically searched to extract eligible literature from database inception to December 2019. STUDY SELECTION Head-to-head randomized clinical trials on first-line treatments for patients with ES-SCLC were included with outcomes and toxic effects reported, including objective response rate (ORR, involving complete response and partial response), disease control rate (DCR, involving complete response, partial response, and stable disease), progression-free survival (PFS), overall survival (OS), and treatment related adverse events (TRAEs) of grades 3 to 5. Of 199 eligible articles, 14 were included. DATA EXTRACTION AND SYNTHESIS Data were independently extracted and collected by 2 reviewers based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline. Data were pooled using a random-effects model. MAIN OUTCOMES AND MEASURES Main outcomes were OS, PFS, DCR, ORR, and TRAEs of grades 3 to 5. RESULTS A total of 3 phase 2 and 11 phase 3 randomized clinical trials involving 4838 patients were included. Programmed cell death ligand 1 (PD-L1) inhibitor (durvalumab and atezolizumab) plus etoposide-based chemotherapy, compared with etoposide-based chemotherapy alone, showed the most favorable OS (hazard ratio, 1.40; 95% CI, 1.09-1.80) and the best DCR (odds ratio [OR], 0.42; 95% CI, 0.21-0.81). Bevacizumab plus etoposide-based chemotherapy provided the best PFS compared with etoposide-based chemotherapy alone (hazard ratio, 1.54; 95% CI, 1.09-2.27), although this was not translated into OS benefit. The addition of PD-L1 inhibitors to etoposide-platinum chemotherapy caused no more toxic effects in general (compared with etoposide-based chemotherapy alone: OR, 1.14; 95% CI, 0.36-2.31), while bevacizumab plus etoposide-platinum regimen induced the most TRAEs grades 3 to 5 among all first-line treatments (eg, compared with irinotecan-platinum regimen: OR, 4.24; 95% CI, 1.26-14.57). Based on the surface under the cumulative ranking curve value, PD-L1 inhibitor plus etoposide-platinum had the highest probability of being ranked first for OS (0.87) and DCR (0.97). CONCLUSIONS AND RELEVANCE The findings of this systematic review and network meta-analysis suggest that the combination of a PD-L1 inhibitor (durvalumab and atezolizumab) and etoposide-based chemotherapy may be an optimal first-line treatment option for patients with ES-SCLC patients.
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An Observational Study of Sex Differences in Takayasu Arteritis in China: Implications for Worldwide Regional Differences.
Zhang, Z, Wang, W, Zhou, M, Lu, PYJ, Li, Y, Chen, Y
Annals of vascular surgery. 2020;:309-317
Abstract
BACKGROUND This study analyzes the demographics of patients affected by Takayasu arteritis (TA). The study further explores the correlation and other contributory factors to the regional differences between the ratios of females to males (sex ratio). METHODS This was a retrospective study using 1,011 clinical cases diagnosed with TA (as per 1990 American College of Rheumatology criteria) between 1982 and 2015 collected from the Peking Union Medical College Hospital (PUMCH) database. Literature review of TA studies published from 1992 to 2016 via the PubMed search was also conducted with exclusion of the studies less than 50 cases. General characteristics, sex ratios and regional differences worldwide, sex ratio variation in different age group, relationship between sex ratio and gross domestic product (GDP) per capita, and main lesion involved in different sexual group were statistically analyzed. RESULTS The average age of these 1,011 patients was 32.5 ± 15.1 years, with 763 women comprising 75.5% of the cohort, giving a female-to-male ratio (F:M ratio) of 3.1:1. The F:M ratio of TA patients at PUMCH was equal to that of a previous study from China, but significantly lower than that in Japan, Italy, Turkey, Mexico, Korea (all P < 0.05), but higher than that in India (P < 0.05), and Thailand (although not statistically significant at P = 0.08). The sex ratio of TA patients between PUMCH and Japanese databases significantly differed at all age groups (P < 0.05), with the exception of the youngest (≤9 years; P = 0.57) and oldest (≥70 years; P = 0.32) patients. A significant correlation between the TA FM ratio and GDP per capita was observed, with a correlation coefficient of ρ = 0.730 (P = 0.04). A sex difference in lesion distribution was also observed: women had significantly more aortic arch involvement (P = 0.02), whereas lower limb artery involvement was more frequent in men (P < 0.001). CONCLUSIONS The sex ratio of patients with TA in China significantly differed from that in many other countries. Genetics, dietary habits, and environmental conditions may affect the incidences of TA in female versus male patients. Aortic arch branch vessels are involved more frequently in women; renal artery and iliac artery involvements are more common in men.
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Evaluation of matcha tea quality index using portable NIR spectroscopy coupled with chemometric algorithms.
Wang, J, Zareef, M, He, P, Sun, H, Chen, Q, Li, H, Ouyang, Q, Guo, Z, Zhang, Z, Xu, D
Journal of the science of food and agriculture. 2019;(11):5019-5027
Abstract
BACKGROUND The study reports a portable near infrared (NIR) spectroscopy system coupled with chemometric algorithms for prediction of tea polyphenols and amino acids in order to index matcha tea quality. RESULTS Spectral data were preprocessed by standard normal variate (SNV), mean center (MC) and first-order derivative (1st D) tests. The data were then subjected to full spectral partial least squares (PLS) and four variable selection algorithms, such as random frog partial least square (RF-PLS), synergy interval partial least square (Si-PLS), genetic algorithm-partial least square (GA-PLS) and competitive adaptive reweighted sampling partial least square (CARS-PLS). RF-PLS was established and identified as the optimum model based on the values of the correlation coefficients of prediction (RP ), root mean square error of prediction (RMSEP) and residual predictive deviation (RPD), which were 0.8625, 0.82% and 2.13, and 0.9662, 0.14% and 3.83, respectively, for tea polyphenols and amino acids. The content range of tea polyphenols and amino acids in matcha tea samples was 8.51-14.58% and 2.10-3.75%, respectively. The quality of matcha tea was successfully classified with an accuracy rate of 83.33% as qualified, unqualified and excellent grade. CONCLUSION The proposed method can be used as a rapid, accurate and non-destructive platform to classify various matcha tea samples based on the ratio of tea polyphenols to amino acids. © 2019 Society of Chemical Industry.
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Clinical and radiological results comparison of allograft and polyetheretherketone cage for one to two-level anterior cervical discectomy and fusion: A CONSORT-compliant article.
Yang, S, Yu, Y, Liu, X, Zhang, Z, Hou, T, Xu, J, Wu, W, Luo, F
Medicine. 2019;(45):e17935
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BACKGROUND Recently, many kinds of cages for cervical fusion have been developed to avoid the related complications caused by tricortical iliac crest graft. The existing literature has reported the excellent clinical efficacy and superior fusion rate. However, various types of cages have their own disadvantages. Which bone graft material is the best choice for cage with the fewest complications? At present, there is still no conclusion. METHODS By reviewing patients with 1 to 2-level cervical degenerative disease in our hospital with a novel cage made of allograft or polyetheretherketone (PEEK), we evaluated the efficacy and reliability of the new cage in anterior cervical discectomy and fusion (ACDF). From 2015 to 2016, a prospective review of 58 and 49 consecutive cases with spondylotic radiculopathy or myelopathy undergoing ACDF using allograft (group A) and PEEK (group B) cage were performed. The follow-up ranged from 12 to 40 months. Intraoperative index, clinical outcome and complications were recorded. Radiographs evaluated segmental and overall cervical lordosis, the height of the intervertebral space, interbody height ratio (IHR), cage positioning, and fusion state. RESULTS A total of 134 cages were implanted. Compared to preoperatively, the visual analog scale (VAS) and neck disability index (NDI) were reduced postoperatively without any change during the subsequent follow-up in both groups. There was no migration or extrusion of the cages at the latest follow-up. There were 2 and 4 patients suffering dysphagia respectively. In both groups, the intervertebral height, IHR, segmental and overall cervical lordosis were significantly greater than pre-operation (P < .05) and were maintained at the last follow-up, but were not statistically significant (P > .05). The allograft group achieved a fusion rate of 100% (58/58) according to CT scans at 3 months post-operation, while PEEK group was 91.8% (45/49), which reached 95.9% (47/49) at 6 months and 100% at 12 months. In addition, the fusion state was maintained in all patients at the last follow-up. CONCLUSION Our data showed that the new allograft cage is superior to the PEEK cage in providing a high fusion rate and fewer complications after 1-level and 2-level ACDF procedures. It may represent an excellent alternative to other cages.
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Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial.
Zhao, D, Chen, Z, Hu, S, Lin, J, Shao, Z, Wang, G, Xiao, W, Zheng, Y, Zhang, Z, Shi, Y, et al
Clinical drug investigation. 2019;(4):369-377
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BACKGROUND AND OBJECTIVE Loxoprofen (LOX) is a nonsteroidal anti-inflammatory drug (NSAID). Although oral administration of LOX has been widely prescribed, clinical guidelines for osteoarthritis generally recommend topical rather than oral NSAIDs in specific patients. However, there is limited information on the effects of loxoprofen sodium oral (LOX-O) versus loxoprofen sodium hydrogel transdermal patch (LOX-T) in myalgia patients. Hence, this non-inferiority study was designed to compare the efficacy and safety of LOX-O versus LOX-T in Chinese patients with myalgia. METHODS In this double-blind, double-dummy, parallel-group, randomized controlled trial, 182 Chinese patients were enrolled and randomized equally to either LOX-T or LOX-O treatment for 2 weeks. Patients in the LOX-T group applied one sheet of the active LOX-T once a day on the affected site and took one placebo tablet three times a day immediately after meals, whereas patients in the LOX-O group applied one sheet of the placebo patch once a day and took one active LOX-O three times a day. Primary endpoint was the proportion of patients with 50% overall improvement or higher at the final visit. The cutoff value of a non-inferiority difference was set as - 10%. RESULTS In the full analysis set, the primary endpoint of final efficacy rate was 81.3% (n = 91) in the LOX-T group and 72.2% (n = 88) in the LOX-O group. The difference between the two groups was 9.1% [95% confidence interval (CI) - 3.1 to 21.3%], which showed that LOX-T was non-inferior compared with LOX-O. No serious adverse events occurred in either group. CONCLUSIONS This trial showed the non-inferiority of LOX-T compared with LOX-O in efficacy and safety in Chinese patients with myalgia. Also, the characteristic features of topical LOX-T, such as better compliance and lower risk-benefit ratio, make it more favorable for clinical practice. TRIAL REGISTRATION The study was registered in the isrctn.com registry (ISRCTN trial ID: ISRCTN16227145).
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Respiratory electrophysiologic studies in chronic obstructive pulmonary disease.
Wang, Y, Liu, N, Zhang, Z
Medicine. 2019;(1):e13993
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Respiratory failure is common during acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). Phrenic nerve conduction (PNC), transcranial magnetic stimulation (TMS), and cervical magnetic stimulation (CMS) are of great value in identifying the feature and site of AE-COPD.PNC, TMS, and CMS were performed in 20 AE-COPD patients with respiratory failure, and re-examined after weaning. Latencies and amplitudes of the diaphragmatic compound muscle action potential (dCMAP), motor evoked potential of the diaphragm (dMEP) evoked by TMS and CMS, and central motor conduction time (CMCT) were measured. Blood gas analysis and serum electrolyte levels were also evaluated. The results were compared with those from 20 healthy subjects.AE-COPD patients showed prolonged CMCT and latencies of dCMAP and dMEP, decreased amplitudes of dCMAP and dMEP evoked by CMS, while CMCT and the latency of dMEP evoked by TMS were shortened after weaning. Significant correlation was identified between arterial blood gas analysis, serum electrolyte levels, disease duration, the duration of mechanical ventilation and the electrophysiological findings in AE-COPD patients prior to weaning.The central and peripheral respiratory pathway is involved in AE-COPD. Central respiratory pathway function is improved after weaning in AE-COPD patients with respiratory failure.
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Switching Lamivudine with Adefovir Dipivoxil Combination Therapy to Entecavir Monotherapy Provides Better Viral Suppression and Kidney Safety.
Lian, JS, Zhang, XL, Lu, YF, Chen, JY, Zhang, YM, Jia, HY, Zhang, Z, Yang, YD
International journal of medical sciences. 2019;(1):17-22
Abstract
Introduction: Most chronic hepatitis B (CHB) patients in China are primitively treated with a combination of lamivudine (LAM) and adefovir dipivoxil (ADV). Although antiviral resistance can be avoided with this combination therapy, using it can have harmful side effects related to ADV, specifically kidney and bone injury. This study was designed to compare viral suppression and kidney safety when switching LAM and ADV combination therapy de novo to entecavir (ETV) monotherapy in patients with CHB and compensated hepatic cirrhosis. Materials and methods: In total, 360 CHB and compensated liver cirrhosis patients who received treatment of LAM and ADV combination therapy for more than 1 year were included in this study. One hundred and eighty patients continued combination therapy to serve as a control group and the other 180 patients were switched to ETV monotherapy to serve as the experimental group. The total course of therapy was 3 years. Laboratory studies were done every 3 months to measure liver and kidney function. Studies included glomerular filtration rate (eGFR), HBV-DNA, urine β2-microglobulin (β2-M) and retinol binding protein (RBP). Results: In the experimental group, an HBV-DNA level below 20 IU/ml was found in 77.65%, 85.88%, and 94.77% in years 1, 2, and 3, respectively. In the control group, HBV-DNA levels were below 20 IU/ml in 69.66%, 75.42%, and 85.80% in years 1, 2, and 3, respectively. Low HBV-DNA levels in the experimental group were significantly less common than in the control group on the second and third year; P values were 0.009 and 0.006 for years 2 and 3, respectively. The cumulative genetic mutation rate was 3.49% in the experimental group and 8.88% in the control group (P=0.044). Decreases in eGFR more than 30% from baseline were found in 0%, 0.56%, and 1.74% of patients in the experimental group and 4.49%, 9.14% and 14.79% in patients in the control group in the first, second, and third year, respectively. Serum creatinine more than 50 μmol/L above baseline was found in 0%, 0% and 1.74% of patients in the experimental group and 1.12%, 4.00% and 5.32% of patients in the control group in years 1, 2, and 3, respectively. The urine β2-M and RBP levels were abnormal more often in the experimental group than in the control group. Conclusion: Switching to ETV monotherapy can decrease HBV-DNA levels, reduce the genetic mutation rate, and prevent renal damage caused by LAM and ADV combination therapy in patients with CHB and compensated liver cirrhosis. Patients receiving LAM and ADV combination therapy de novo should be switched to ETV monotherapy immediately.
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Comparison of postoperative lymphocytes and interleukins between laparoscopy-assisted and open radical gastrectomy for early gastric cancer.
Xia, X, Zhang, Z, Xu, J, Zhao, G, Yu, F
The Journal of international medical research. 2019;(1):303-310
Abstract
OBJECTIVE This study aimed to study the effects of laparoscopic-assisted radical gastrectomy (LAG) and open radical gastrectomy (OG) on immune function and inflammatory factors in patients with early gastric cancer. METHODS Seventy-five patients with pT1N0M0 gastric cancer in Ren Ji Hospital from August 2017 to January 2018 were studied. Lymphocytes subsets and interleukins were compared preoperatively and on the third postoperative day (POD3) and seventh postoperative day (POD7). RESULTS There were no significant differences in age, sex, body mass index, duration of the operation, estimated blood loss, total gastrectomy rate, postoperative first fluid diet, and the levels of preoperative lymphocytes subsets and interleukins between the two groups. The number of CD4+ T cells and the CD4+/CD8+ ratio in the LAG group were significantly higher than those in the OG group on POD3. However, the number of CD8+ T cells, and interleukin-6 and interleukin-8 levels in the LAG group were significantly lower than those in the OG group on POD3. CONCLUSIONS Laparoscopy can effectively reduce the levels of inflammatory factors and has less effect on the immune system than OG.