Objective To investigate efficacy and toxicity of XELOX or FOLFOX4 regimen as neoadjuvant concurrent chemoradiotherapy for stage Ⅱ/Ⅲ middle and low rectal cancer. Methods From June 2011 to March 2014, 120 patients with stage Ⅱ/Ⅲ middle and low rectal cancer who underwent the surgical treatment were enrolled in The Fifth People’s Hospital of Qinghai Province, then were randomly divided into radiotherapy+FOLFOX4 regimen group and radiotherapy+XELOX regimen group. The radiotherapy and chemotherapy were performed simultaneously before the radical resection of rectal cancer. Three-dimensional conformal radiotherapy: 1.8–2.0 Gy/times, 5 times/week, a total of 25 times, the total dose was 45.0–50.0 Gy. At the same time, 2 cycles of chemotherapy were performed according to the FOLFOX4 program (oxaliplatin+leucovorin+5-fluorouracil) or XELOX regimen (capecitabine tablet+oxaliplatin). The radical surgery was performed on 4 to 8 weeks after the preoperative chemoradiotherapy, then 8 to 12 cycles of FOLFOX4 chemotherapy and 4 to 6 cycles of XELOX chemotherapy were completed in the radiotherapy+FOLFOX4 regimen group and the radiotherapy+XELOX regimen group respectively on 1 month after the radical surgery. The curative effect and the occurrence of acute toxicity were observed. Results ① There were no significant differences in thegeneral data such as the gender, age, cT stage, cN stage, TNM stage, histological type, differentiation degree, etc. between the two groups(P>0.05). ② The reduced staging rates of cT and cN in the radiotherapy+XELOX regimen group was 63.3% (38/60) and 86.7% (52/60), respectively, which was significantly higher than that in the radiotherapy+FOLFOX4 regimen group〔38.3% (23/60) and 53.3% (32/60), respectively〕 , the differences were statistically significant (P<0.05). ③ The complete response rate and the effective rate (complete response rate+partial response rate) in the radiotherapy+XELOX regimen group were significantly higher than those in the radiotherapy+FOLFOX4 regimen group (P<0.05). ④ The overall 3-year survival rate in the radiotherapy+XELOX regimen group was significantly higher than that in the radiotherapy+FOLFOX4 regimen group (P<0.05). There were no significant differences in the 3-year disease-free survival rate, distant metastasis rate, and local recurrence rate between the two groups (P>0.05). ⑤ All the patients suffered from 3 to 4 degrees toxicities, however, the incidence rates of the overall toxicity and the diarrhea toxicity in the radiotherapy+XELOX regimen group were significantly lower than those in the radiotherapy+FOLFOX4 regimen group (P<0.05). Conclusion Preliminary results of limited cases in this study show that XELOX regimen is more effective and less acute toxicity than FOLFOX4 regimen for preoperative concurrent chemoradiotherapy for patients with stage Ⅱ/Ⅲ middle and low rectal cancer.
Objective To assess the improvement of different resistance training regimens on blood lipid metabolism and insulin resistance in patients with type 2 diabetes mellitus (T2DM). Methods PubMed, ProQuest, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang, and VIP databases were searched to collect randomized controlled trials of resistance training intervention to improve blood lipids and insulin resistance in patients with T2DM. The search time range was from the establishment of the databases to May 2023. Two reviewers assessed the risk of bias of the included studies using the Physiotherapy Evidence Database scale, and performed a network meta-analysis of the extracted data using Stata 16.0 software. Results In the end, 24 articles were included, and a total of 983 participants were enrolled. The result of network meta-analysis showed that high-frequency and moderate-intensity resistance exercise significantly improved the levels of insulin resistance [standardized mean difference=−1.71, 95% confidence interval (CI) (−2.75, −0.67)], triglycerides [weighted mean difference (WMD)=−0.27 mmol/L, 95%CI (−0.51, −0.04) mmol/L], and total cholesterol [WMD=−0.16 mmol/L, 95%CI (−0.20, −0.12) mmol/L], but had no significant effect on improving the level of high-density lipoprotein [WMD=0.05 mmol/L, 95%CI (−0.02, 0.11) mmol/L] or low-density lipoprotein [WMD=−0.20 mmol/L, 95%CI (−0.42, 0.03) mmol/L]. The results of cumulative probability ranking showed that high-frequency and moderate-intensity resistance exercise was the best in improving insulin resistance, triglycerides, high-density lipoprotein and low-density lipoprotein levels. Conclusion Based on current evidence, high-frequency and moderate-intensity resistance exercise may be the best resistance exercise regimen to improve insulin resistance and lipid metabolism in patients with T2DM.
ObjectiveTo evaluate the prognostic significance of serum levels of vascular endothelial growth factor (VEGF) and insulin-like growth factors-Ⅰ (IGF-Ⅰ) in advanced gastric cancer patients who were treated with oxaliplatin/5-fluorouracil (FOLFOX). MethodsNinety-six advanced gastric cancer patients who were treated with FOLFOX in our hospital between March 2007 to August 2010 were enrolled in this study. All of the patients were treated with oxaliplatin (85 mg/m2) as a 2-hour infusion on day 1, and leucovorin (20 mg/m2, about 10 min) on day 1 and day 2, followed by a 5-fluorouracil bolus (400 mg/m2) and 22 hours of continuous infusion of 600 mg/m2. Treatment was repeated in 2-week intervals, and patients received 4 chemotherapy cycle in total. The levels of serum VEGF and IGF-Ⅰ were measured using enzyme-linked immunoassays. The relationship between serum levels of VEGF/IGF-Ⅰ and the clinicopathological characteristics of patients, the relationship between serum levels of VEGF/IGF-Ⅰ and prognosis of patients, were analyzed. ResultsThe serum levels of VEGF and IGF-Ⅰ were (464.4±57.4) pg/mL and (33.5±7.3) ng/mL, respectively. The serum level of VEGF was related with surgical history, Lauren's classification, TNM staging before treatment, and pathological type (P < 0.05), and serum level of IGF-Ⅰ was related with TNM staging before treatment and number of transferred organs (P < 0.05). The serum levels of VEGF and IGF-Ⅰ in stable disease (SD) +progressive disease (PD) patiens were higher than those of complete response (CR) +partial response (PR) patients (P < 0.05). The results of Cox proportional hazard regression model showed that, effect of chemotherapy (HR=1.764, P=0.006), number of transferred organs (HR=1.662, P=0.015), serum level of VEGF (HR=1.834, P=0.012) and IGF-Ⅰ (HR=1.855, P=0.008), were all significantly related with time to progression (TTP); serum level of VEGF (HR=2.205, P=0.002) and IGF-Ⅰ (HR=1.931, P=0.004) were all significantly related with overall survival (OS). ConclusionLevels of serum VEGF and IGF-Ⅰ are independent prognostic factors in patients with advanced gastric cancer who were treated with FOLFOX chemotherapy.
Random allocation to intervention groups remains the best method of ensuring that the groups being compared are similar at the onset of study and of avoiding removing selection bias between groups of patients. The success of randomization depends on two interrelated processes. First, an unpredictable allocation sequence must be generated based on a random procedure. Second, strict implementation of that sequence must be secured through an assignment mechanism called allocation concealment to prevent those involved in a trial from knowing upcoming assignments. Inadequate allocation concealment can lead to clinicians scheduling patient’s assignment and compromising the unpredictable allocation sequence.
ObjectiveTo evaluate the efficacy and toxicity of TEC and CEF regimen in preoperative chemotherapy for patients with breast cancer. MethodsA total of one hundred breast cancer patients undergoing preoperative chemotherapy were divided into TEC group (n=50) and CEF group (n=50) by the pairgroup method and received surgical therapy after three courses of chemotherapy. The efficacy and toxicity of preoperative chemotherapy of patients in two groups were analyzed. ResultsFour patients with stage ⅢB breast cancer quit from CEF group after two courses of treatment because of the worse satisfaction. Clinical complete remission (cCR) was 7 cases, clinic partial remission (cPR) was 34 cases, stable disease (SD) was 9 cases, therefore, the remission rate (RR) was 82.0% (41/50), and reduction rate of tumor was 64.0% (32/50) in TEC group. cCR was 2 cases, cPR was 32 cases, SD was 12 cases, thus the RR was 680% (34/50), and reduction rate of tumor was 40.0% (20/50) in CEF group. The clinical efficacy and reduction rate of tumor of patients in TEC group were significantly superior than those in CEF group (Plt;0.05). The negative conversion ratio of lymph nodes were 54.1% (20/37) and 57.1% (20/35) in TEC group and CEF group, which was not statistically different (Plt;0.05). The occurrence of hair loss and leukopenia of patients in TEC group were significantly higher than those in CEF group (Plt;0.05), while the differences in thrombocytopenia, low concentration of hemoglobin, nausea, vomiting, diarrhea, cardiac toxicity, and neurotoxicity were not significant (Pgt;0.05). ConclusionTEC regimen is better than CEF regimen in the efficacy and safety of neo-adjuant therapy for patients with breast cancer, and well tolerated.
Objective ① To document the way in which allocation concealment is described and coded for studies included in Cochrane Reviews.②To feed back any gaps or miscodings to individual review groups.③ To suggest changes and expansions to advice on how to code and describe allocation concealment methods.Methods The coding and description of methods of allocation concealment for studies included in all 1 596 reviews on issue 1, 2003 of The Cochrane Library are being extracted.So far results are available for 10.8% (173/1 596) of reviews containing 1 844 studies, from 10 Collaborative Review Groups (CRGs).Discrepancies, and inconsistencies with the Cochrane Reviewers’ Handbook, are being documented and analysed.Results The current coding of the adequacy of allocation concealment in studies included in Cochrane reviews is not likely to be very accurate.This is due to failure to describe methods of allocation concealment (38.6% of the sample of 1 844 studies) as well as miscoding (at least an additional 9.2%).The most common method for studies coded A was some variation of envelope use (133/675-19.7% of all A codes). The most common "method" for studies coded B was method unclear or not described in the report of the study (426/665, 64% of all B codes).Conclusions Since adequate allocation concealment is so important in protecting against bias in randomised controlled trials, it needs to be accurately coded and described.We need to improve how this is done for studies included in Cochrane Reviews.Since over half the studies coded as D were likely to have been where reviewers omitted to enter a code, the default should be changed from D to "code not supplied".Structural changes to RevMan are suggested-ideally the addition of a separate new study quality assessment table with fixed headings as well as the facility to enter free text.Suggestions for improving coding in particular reviews will be fed back to CRGs in the next stages of this project.Suggestions for additions to the Cochrane Reviewers’ Handbook are also made.
ObjectiveTo investigate effects of vitamin K2 in combination with 5-fluorouracil (5-FU) on proliferation, migration, and invasiveness of hepatocellular carcinoma cells in vitro. MethodsHuman hepatocellular carcinoma PLC/RAF/5 cells were cultured in vitro and exposed to vitamin K2 (10 μmol/L) and 5-FU (10 μg/mL) alone or in combination for 24 h. The cell proliferation, migration, and invasiveness were measured by CCK-8 assay, wound-scratch assay, and Matrigel invasion chamber assay, respectively. ResultsThe abilities of proliferation, migration, and invasion of PLC/RAF/5 cells were significantly decreased after either alone vitamin K2 or 5-FU treatment (all P<0.05) as compared with the control cells, and above effects were further enhanced by the vitamin K2 in combination with 5-FU treatment as compared with either alone drug treatment (all P<0.05). ConclusionCombination use of vitamin K2 and 5-FU might be an effective method for inhibiting growth, migration, and invasiveness of hepatocellular carcinoma cells.
Objective To investigate the relationships between circulating tumor cells (CTCs), circulating tumor endothelial cells (CTECs) and treatment methods in patients with nasopharyngeal carcinoma (NPC) at different stages of treatment. Methods The data of NPC patients at different treatment periods in West China Hospital of Sichuan University from March 2016 to November 2019 were retrospectively collected. The patients received CTCs test and part of those patients received CTECs test, by subtraction enrichment-immunostaining-fluorescence in situ hybridization. The relationships of CTCs and CTECs with radiotherapy and chemotherapy, and the correlations between CTCs and CTECs in NPC patients were analyzed. Results A total of 191 patients were included. Among them, there were 66 cases before initial treatment, 38 cases after induction chemotherapy, and 87 cases after concurrent chemoradiotherapy. A total of 127 patients received CTECs test, including 41 cases before initial treatment, 29 cases after induction chemotherapy, and 57 cases after concurrent chemoradiotherapy. The positive rates of CTCs were 89.4%, 81.6% and 69.0% respectively in the three stages of treatment, and the difference was statistically significant only between the pre-treatment group and the post-concurrent chemoradiotherapy group (P=0.003). The number of CTCs in the post-concurrent chemoradiotherapy group was lower than that in the pre-treatment group and the post-induction chemotherapy group (P<0.001, P=0.002). The number of triploid CTCs in the post-concurrent chemoradiotherapy group was significantly different from that in the pre-treatment group and the post-induction chemotherapy group (P=0.009, P=0.013). The number of tetraploid CTCs in the post-concurrent chemoradiotherapy group was significantly different from that in the post-induction chemotherapy group (P=0.007). The number of polyploidy (pentaploid or > 5 copies of chromosome 8) CTCs in the post-concurrent chemoradiotherapy group was significantly different from that in the pre-treatment group (P<0.001). The positive rates of CTECs were 70.7%, 82.8% and 64.9% respectively in the three stages of treatment, and the difference was not statistically significant (P>0.05). The number of CTECs in the post-concurrent chemoradiotherapy group was only lower than that in the post-induction chemotherapy group (P=0.009). There was no significant difference in the number of triploid or tetraploid CTECs among the three groups (P=0.265, P=0.088). The number of polyploid CTECs was statistically different only between the post-concurrent chemoradiotherapy group and the post-induction chemotherapy group (P=0.007). Spearman correlation analysis showed that there was a significant positive correlation between CTCs and CTECs (rs=0.437, P<0.001). Conclusions Concurrent chemoradiotherapy plays a decisive role in reducing the number of CTCs in the blood of NPC patients, while induction chemotherapy does not appear to directly cause changes in the number of CTCs. In NPC patients, different types of CTCs have different responses to different treatments. There is a significant positive correlation between CTECs level and CTCs level in NPC.