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1.
[Meta-analysis of laparoscopic versus open surgery for palliative resection of the primary tumor in stage IV colorectal cancer].
Tan, SJ, Jiang, Y, Xi, QL, Meng, QY, Zhuang, QL, Han, YS, Wu, GH
Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery. 2020;(6):589-596
Abstract
Objective: To systematically evaluate the safety and efficacy of laparoscopic versus open surgery for palliative resection of the primary tumor in stage IV colorectal cancer. Methods: The databases of CNKI, Wanfang, VIP, PubMed, EMBASE and Cochrane Library were searched to retrieve randomized controlled trials (RCT) or clinical controlled trials (CCT) comparing laparoscopic surgery with open surgery for palliative resection of the primary tumor in stage IV colorectal cancer published from January 1991 to May 2019. Chinese search terms included "colorectum/colon/rectum" , "cancer/malignant tumor" , "laparoscopy" , "metastasis" , " IV" ; English search terms included "laparoscop*" , "colo*" , "rect*" , "cancer/tumor/carcinoma/neoplasm" , " IV" , "metasta*" . Inclusion criteria: (1) RCT or CCT, with or without allocation concealment or blinding; (2) patients with stage IV colorectal cancer that was diagnosed preoperatively and would receive resection of the primary tumor; (3) the primary tumor that was palliatively resected by laparoscopic or open procedure. Exclusion criteria: (1) no valid data available in the literature; (2) single study sample size ≤20; (3) subjects with colorectal benign disease; (4) metastatic resection or lymph node dissection was performed intraoperatively in an attempt to perform radical surgery; (5) duplicate publication of the literature. Two researchers independently evaluated the quality of the included studies. In case of disagreement, the evaluation was performed by discussion or a third researcher was invited to participate. The data were extracted from the included studies, and the Cochrane Collaboration RevMan 5.1.0 version software was used for this meta-analysis. Results: Four CCTs with a total of 864 patients were included in this study, including 216 patients in the laparoscopic group and 648 patients in the open group. Compared with the open group, except for longer operation time (WMD=37.60, 95% CI: 26.11 to 49.08, P<0.05), laparoscopic group had less intraoperative blood loss (WMD=-74.89, 95% CI: -144.78 to -5.00, P<0.05), earlier first flatus and food intake after surgery (WMD=-1.00, 95% CI: -1.12 to -0.87, P<0.05; WMD=-1.61, 95%CI: -2.16 to -1.06, P<0.05), shorter hospital stay (WMD=-2.01, 95% CI: -2.21 to -1.80, P<0.05) and lower morbidity of postoperative complication (OR=0.52, 95% CI: 0.35 to 0.77, P<0.05). However, no significant differences were found in time to start postoperative chemotherapy, postoperative chemotherapy rate, and mortality (P > all 0.05). Conclusion: Laparoscopic surgery for palliative resection of the primary tumor is safe and feasible to enhance recovery after surgery by promoting postoperative bowel function recovery, shortening hospital stay and reducing postoperative complication in stage IV colorectal cancer.
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2.
Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial.
Zhu, J, Bao, Y, Du, L, Huang, H, Lv, Q, Jiang, Y, Dai, Y, Chen, Z, Shi, J, Shi, Y, et al
Trials. 2020;(1):516
Abstract
BACKGROUND Less invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. However, the mechanism underlying its beneficial effect and variations in the technique of administration may prevent its widespread use. This trial aims to evaluate the effects of two methods of surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation, in preterm infants with respiratory distress syndrome (RDS). METHODS The LISA Or Low Peak Pressure trial is to be conducted in 14 tertiary neonatal intensive care units in China. A total of 600 preterm infants born with gestational age between 250/7 and 316/7 weeks and with a primary diagnosis of RDS will be involved in the study. Infants will be randomized to the LISA or LPPSA group when surfactant therapy is indicated. Primary outcomes include mortality, severity of bronchopulmonary dysplasia at 36 weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72 h of life. Secondary outcomes include the days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration. The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined. DISCUSSION Data from recent systematic review and meta-analysis have suggested a possible improvement in outcomes of preterm infants with RDS by the LISA technique. However, robust evidence is lacking. Why LISA plays a potential role in reducing respiratory morbidity, mainly BPD in preterm infants, remains unclear. The possible explanations are the active and uninterrupted delivery of continuous positive airway pressure during the LISA procedure and the avoidance of complications caused by intubation and relatively high pressure/volume ventilation following surfactant administration. We hypothesized that LISA's effectiveness lies mainly in avoiding relatively high-pressure positive ventilation immediately following surfactant administration. Thus, this multicenter randomized controlled trial will focus on issues of endotracheal intubation and the pressure/volume used during conventional surfactant administration. The effectiveness, safety and comorbidities of preterm infants following LISA or LPPSA will be evaluated. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR1900020970. Registered on 23 January 2019.
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3.
Sarcopenia associates with increased risk of hepatocellular carcinoma among male patients with cirrhosis.
Feng, Z, Zhao, H, Jiang, Y, He, Z, Sun, X, Rong, P, Wang, W
Clinical nutrition (Edinburgh, Scotland). 2020;(10):3132-3139
Abstract
BACKGROUND & AIMS Sarcopenia is associated with a higher rate of complications and is an independent predictor of poor outcomes in cirrhosis. The aim of this study was to investigate the association between sarcopenia and the risk of hepatocellular carcinoma (HCC) among patients with cirrhosis. METHODS Four hundred and ninety-two patients with cirrhosis and no evidence of HCC from 2008 to 2017 were enrolled, who had baseline abdominal computed tomography (CT) analyzed for identification of sarcopenia according to the previously established sex-specific cutoffs. The main endpoint of follow-up was the occurrence of HCC. RESULTS The majority of patients were male (365/492, 74.2%), and sarcopenia were present in 238 (48.4%) patients at baseline. During a median follow-up of 3.6 years, 54 (11.0%) patients developed HCC. The cumulative incidence of HCC was significantly higher in male patients with sarcopenia than those without sarcopenia (P = 0.001), but not in female patients (P = 0.26). Multivariate Cox regression analysis showed that sarcopenia (hazard ratio [HR], 2.27; 95% confidence interval [CI], 1.09-4.74) was a significant independent factor for HCC development in male patients with cirrhosis, which was consistently identified through competing-risk analysis (subdistribution HR, 2.20; 95% CI, 1.02-4.72). After propensity score matching, male cirrhotic patients with sarcopenia still had a higher risk of HCC than those without sarcopenia (P = 0.02). CONCLUSION Sarcopenia is associated with an increased risk of developing HCC among male patients with cirrhosis. Therefore, nutritional assessment and necessary interventions in specific cirrhotic patients need to be valued.
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4.
Comparative effectiveness and safety of traditional Chinese medicine supporting Qi and enriching blood for cancer related anemia in patients not receiving chemoradiotherapy: a meta-analysis and systematic review.
Dang, Z, Liu, X, Wang, X, Li, M, Jiang, Y, Wang, X, Yang, Z
Drug design, development and therapy. 2019;:221-230
Abstract
A systematic review and meta-analysis of previous randomized controlled trials of traditional Chinese medicine (TCM) supporting Qi and enriching blood in the treatment of cancer related anemia (CRA) in patients not receiving chemoradiotherapy were conducted. A total of 13 randomized controlled trials were included. Compared with the control group, better improvement was found for the level of hemoglobin (mean difference=4.57, 95% CI [1.38, 7.76], P=0.005) and overall therapeutic effect (risk ratio [RR]=1.31, 95% CI [1.18, 1.46], P<0.000) in the TCM groups. The incidence of related adverse events was not increased in the TCM groups (RR=0.54, 95% CI [0.29, 0.99], P=0.05). However, due to the relatively low quality and the small sample sizes of the included studies, the results should be interpreted with a degree of caution. Nevertheless, TCM with the role of supporting Qi and enriching blood may be a safe and effective treatment for CRA in patients not receiving chemoradiotherapy and might be considered as an alternative treatment to conventional western medicine including iron supplements and erythropoietin.
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5.
Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial.
Wang, Y, Li, Z, Zhao, X, Wang, C, Wang, X, Wang, D, Liang, L, Liu, L, Wang, C, Li, H, et al
JAMA. 2018;(3):245-254
Abstract
IMPORTANCE In China and other parts of the world, hospital personnel adherence to evidence-based stroke care is limited. OBJECTIVE To determine whether a multifaceted quality improvement intervention can improve hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke (AIS) in China. DESIGN, SETTING, AND PARTICIPANTS A multicenter, cluster-randomized clinical trial among 40 public hospitals in China that enrolled 4800 patients hospitalized with AIS from August 10, 2014, through June 20, 2015, with 12-month follow-up through July 30, 2016. INTERVENTIONS Twenty hospitals received a multifaceted quality improvement intervention (intervention group; 2400 patients), including a clinical pathway, care protocols, quality coordinator oversight, and performance measure monitoring and feedback. Twenty hospitals participated in the stroke registry with usual care (control group; 2400 patients). MAIN OUTCOMES AND MEASURES The primary outcome was hospital personnel adherence to 9 AIS performance measures, with co-primary outcomes of a composite of percentage of performance measures adhered to, and as all-or-none. Secondary outcomes included in-hospital mortality and long-term outcomes (a new vascular event, disability [modified Rankin Scale score, 3-5], and all-cause mortality) at 3, 6, and 12 months. RESULTS Among 4800 patients with AIS enrolled from 40 hospitals and randomized (mean age, 65 years; women, 1757 [36.6%]), 3980 patients (82.9%) completed the 12-month follow-up of the trial. Patients in intervention group were more likely to receive performance measures than those in the control groups (composite measure, 88.2% vs 84.8%, respectively; absolute difference, 3.54% [95% CI, 0.68% to 6.40%], P = .02). The all-or-none measure did not significantly differ between the intervention and control groups (53.8% vs 47.8%, respectively; absolute difference, 6.69% [95% CI, -0.41% to 13.79%], P = .06). New clinical vascular events were significantly reduced in the intervention group compared with the control group at 3 months (3.9% vs 5.3%, respectively; difference, -2.03% [95% CI, -3.51% to -0.55%]; P = .007), 6 months (6.3% vs 7.8%, respectively; difference, -2.18% [95% CI, -4.0% to -0.35%]; P = .02) and 12 months (9.1% vs 11.8%, respectively; difference, -3.13% [95% CI, -5.28% to -0.97%]; P = .005). CONCLUSIONS AND RELEVANCE Among 40 hospitals in China, a multifaceted quality improvement intervention compared with usual care resulted in a statistically significant but small improvement in hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke when assessed as a composite measure, but not as an all-or-none measure. Further research is needed to understand the generalizability of these findings. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02212912.
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6.
Assessment of Vascularity in Hepatic Alveolar Echinococcosis: Comparison of Quantified Dual-Energy CT with Histopathologic Parameters.
Jiang, Y, Li, J, Wang, J, Xiao, H, Li, T, Liu, H, Liu, W
PloS one. 2016;(2):e0149440
Abstract
PURPOSE To investigate whether dual-energy computer tomography(DECT) could determine the angiographic vascularity of alveolar echinococcosis lesions by comparing the quantitative iodine concentration (IC) with the microvascular density (MVD). MATERIAL AND METHODS Twenty-five patients (16 men, 9 women; mean age, 40.9 ± 13.8 years) with confirmed hepatic alveolar echinococcosis (HAE) underwent DECT of the abdomen, consisting of arterial phase (AP), portal venous phase (PVP), and delayed phase (DP) scanning, in dual-source mode (100 kV/140 kV). Image data were processed with a DECT software algorithm that was designed for the evaluation of iodine distribution in the different layers (marginal zone, solid and cystic) of the lesions. The CT patterns of HAE lesions were classified into three types: solid type, pseudocystic type and 'geographic map' (mixed) type. The IC measurements in different layers and different types of lesions were statistically compared. MVD was examined using CD34 immunohistochemical staining of the resected HAE tissue and scored based on the percentage of positively stained cells and their intensity. Pearson's correlation analysis was used to evaluate the potential correlation between DECT parameters and MVD. RESULTS A total of 27 HAE lesions were evaluated, of which 9 were solid type, 3 were pseudocystic type and 15 were mixed type. The mean lesion size was 100.7 ± 47.3 mm. There was a significant difference in the IC measurements between different layers of HAE lesions during each scan phase (p < 0.001). The IC in the marginal zone was significantly higher than in the solid and cystic components in AP (2.15 mg/mL vs. 0.17 or 0.01 mg/mL), PVP (3.08 mg/mL vs. 0.1 or 0.02 mg/mL), and DP (2.93 mg/mL vs. 0.04 or 0.02 mg/mL). No significant difference was found among the different CT patterns of HAE lesions. Positive expression of CD34 in the marginal zones surrounding HAE lesions was found in 92.5% (25/27) of lesions, of which 18.5% (5/27) were strongly positive, 62.7% (17/27) were moderately positive, and 11.1% (3/27) were weakly positive. In contrast, 7.4% (2/27) of the lesions were negative for CD34. There was a positive correlation between IC measurements and MVD in the marginal zone of HAE lesions (r = 0.73, p < 0.05). CONCLUSIONS The DECT quantitative iodine concentration was significantly correlated with MVD in the marginal zones surrounding HAE lesions. Dual-energy CT using a quantitative analytic methodology can be used to evaluate the vascularity of AE.
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7.
[Comparison of clinical effects of bromfenac sodium ophthalmic solution 0.1% versus glucocorticoids for post-LASEK usage].
Chen, S, Jiang, Y, Yu, C, Li, Y
[Zhonghua yan ke za zhi] Chinese journal of ophthalmology. 2015;(1):45-50
Abstract
OBJECTIVE To evaluate the safety, effectiveness and compliance of Bronuck (bromfenac sodium ophthalmic solution 0.1%) following LASEK in comparison with glucocorticoids. METHODS In this prospective trial, 60 patients (120 eyes) undergoing LASEK were randomized into the bromfenac sodium group (60 eyes) and control group (60 eyes). Patients in both groups initially received dexamethasone 0.1% four times a day after LASEK for 7 days, and then the patients in the bromfenac sodium group were given Bronuck twice a day for the next 11 weeks, while the patients from the control group were given fluorometholone 0.1% with gradually decreased doses during the same period. Results of the routine examinations done before and 3, 10, 30, 90 and 180 days after LASEK were recorded, including uncorrected visual acuity, best corrected visual acuity, intraocular pressure (IOP), corneal topography, ocular symptoms and signs, which were used for comparison between the two groups. All data of right eyes were analyzed for their independence, normality and homogeneity of variance. Independent samples t-test or non-parametric Mann-Whitney test was performed accordingly. RESULTS There was no statistically significant difference in IOP and corneal topography (K1, K2, SAI, SRI and CY) between the two groups postoperatively. The IOP was (16.33 ± 6.21) mmHg(1 mmHg = 0.133 kPa), (15.67 ± 2.82) mmHg, (15.35 ± 2.22) mmHg and (13.10 ± 3.41) mmHg in the bromfenac sodium group, and (16.87 ± 3.68) mmHg, (14.05 ± 2.23) mmHg, (14.39 ± 2.22) mmHg and (13.18 ± 2.49) mmHg in the control group at 10, 30, 90 and 180 days, respectively. The bromfenac sodium group showed significantly better uncorrected visual acuity (5.16 ± 0.08) than the control group (5.02 ± 0.09) on day 30 (t = 2.32, P < 0.05). In the bromfenac sodium group, four eyes had visual fatigue, and four eyes had dry eye symptoms on day 180. Epithelial flaps were all well positioned with satisfying healing process. Each group had one case (two eyes) of haze on day 30, and the bromfenac sodium group had another case (2 eyes) of new-onset haze on day 60. But all the cases of haze were graded 0.5 according to the Fantes Standard, too mild to compromise their visual acuities, and were resolved after frequent topical medication for 1 month. Four patients from the control group were prescribed antiglaucoma medications due to elevated IOP. The refractive status remained stable for patients from both groups. CONCLUSIONS Administration of Bronuck can reduce the amount of or partially substitute for corticosteroids. Mild haze early after LASEK may disappear after intensive treatment.
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8.
Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial.
Lv, QW, Zhang, W, Shi, Q, Zheng, WJ, Li, X, Chen, H, Wu, QJ, Jiang, WL, Li, HB, Gong, L, et al
Annals of the rheumatic diseases. 2015;(6):1078-86
Abstract
OBJECTIVES To compare the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) with methotrexate (MTX) in the treatment of active rheumatoid arthritis (RA). METHODS Design: a multicentre, open-label, randomised controlled trial. All patients were assessed by trained investigators who were unaware of the therapeutic regimen. INTERVENTION 207 patients with active RA were randomly allocated (1:1:1) to treatment with MTX 12.5 mg once a week, or TwHF 20 mg three times a day, or the two in combination. At week 12, if reduction of the 28-joint count Disease Activity Score (DAS28) was <30% in the monotherapy groups, the patient was switched to MTX+TwHF. The primary efficacy point was the proportion of patients achieving an American College of Rheumatology (ACR) 50 response at week 24. RESULTS 174/207 (84.1%) patients completed 24 weeks of the trial. In an intention-to-treat analysis, the proportion of patients reaching the ACR50 response criteria was 46.4% (32/69), 55.1% (38/69) and 76.8% (53/69), respectively, in the MTX, TwHF and MTX+TwHF groups (TwHF vs MTX monotherapy, p=0.014; MTX+TwHF vs MTX monotherapy, p<0.001). Similar statistically significant patterns at week 24 were found for ACR20, ACR70, clinical Disease Activity Index good responses, EULAR good response, remission rate and low disease activity rate. Significant improvement in the Health Assessment Questionnaire and 36-item Short-Form Health Survey questionnaire scores from baseline to week 24 was seen in each treatment arm (p<0.05), though no significant difference was found among the treatment arms (p>0.05). The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis. Seven, three and five women in the TwHF, MTX and combination groups, respectively, developed irregular menstruation (TwHF vs MTX monotherapy, p=0.216). CONCLUSIONS TwHF monotherapy was not inferior to, and MTX+TwHF was better than, MTX monotherapy in controlling disease activity in patients with active RA. TRIAL REGISTRATION NUMBER NCT01613079.
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9.
Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial.
Jiang, Y, Zhang, ZL, Zhang, ZL, Zhu, HM, Wu, YY, Cheng, Q, Wu, FL, Xing, XP, Liu, JL, Yu, W, et al
Clinical interventions in aging. 2014;:121-7
Abstract
OBJECTIVE To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women. METHOD This multicenter, randomized, double-blinded, double-dummy, noninferiority, positive drug-controlled clinical trial was conducted in five Chinese sites. Eligible Chinese women with postmenopausal osteoporosis (N=236) were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 μg/day, respectively, for 1 year. Additionally, all patients received calcium 500 mg/day. Posttreatment bone mineral density (BMD), new fracture onsets, and serum osteocalcin (OC) and undercarboxylated OC (ucOC) levels were compared with the baseline value in patients of both groups. RESULTS A total of 213 patients (90.3%) completed the study. After 1 year of treatment, BMD among patients in Group M significantly increased from baseline by 1.2% and 2.7% at the lumbar spine and trochanter, respectively (P<0.001); and the percentage increase of BMD in Group A was 2.2% and 1.8%, respectively (P<0.001). No difference was observed between groups. There were no changes in femoral neck BMD in both groups. Two patients (1.9%, 2/108) in Group M and four patients (3.8%, 4/105) in Group A had new fracture onsets (P>0.05). In Group M, OC and ucOC decreased from baseline by 38.7% and 82.3%, respectively (P<0.001). In Group A, OC and ucOC decreased by 25.8% and 34.8%, respectively (P<0.001). Decreases in serum OC and ucOC were more obvious in Group M than in Group A (P<0.001). The safety profile of menatetrenone was similar to alfacalcidol. CONCLUSION Menatetrenone is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women.
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10.
Comparative effects of TV watching, recreational computer use, and sedentary video game play on spontaneous energy intake in male children. A randomised crossover trial.
Marsh, S, Ni Mhurchu, C, Jiang, Y, Maddison, R
Appetite. 2014;:13-8
Abstract
To compare the effects of three screen-based sedentary behaviours on acute energy intake (EI) in children. Normal-weight males aged 9-13 years participated in a randomised crossover trial conducted in a laboratory setting between November 2012 and February 2013 in Auckland, New Zealand. EI during an ad libitum meal was compared for three 1-hour conditions: (1) television (TV) watching, (2) sedentary video game (VG) play, and (3) recreational computer use. The primary endpoint was total EI from food and drink. Mixed regression models were used to evaluate the treatment conditions adjusting for age, BMI, and appetite at baseline. A total of 20 participants were randomised and all completed the three conditions. Total EI from food and drink in the TV, computer, and VG conditions was estimated at 820 (SE 73.15), 685 (SE 73.33), and 696 (SE 73.16) kcal, respectively, with EI being significantly greater in the TV versus computer condition (+135; P = 0.04), a trend towards greater intake in the TV versus VG condition (+124; P = 0.06), but not significantly different between the computer and VG conditions (-10; P = 0.87). TV watching was associated with greater EI compared with computer use, and a trend towards greater EI compared with VG play.