Objective To compare the clinical effect between neo-adjuvant chemotherapy combined with operation and simple operation under multi-disciplinary team in rectal cancer. Methods A survey of 72 patients with rectal cancer from Nov. 2007 to Mar. 2008 were studied. Patients were divided into two groups using a simple random method: 33 cases in combined therapy group were treated with single period neo-adjuvant chemotherapy as well as operation and 39 cases in control group received operation only. To compare the differences of perioperative period indexes between two groups. Results During the differences of indexes of age, gender, differentiation degree, clinicopathologic stage as well as the distance to dentate line of tumor, there was no statistical significance between combined therapy group and control group (Pgt;0.05). And at the same time, the operative type, operative time and bleeding quantity in operation had no statistically significant difference between two groups (Pgt;0.05). As for the postoperative rehabilitation indexes, the time of vent to normal in combined therapy group was earlier than that in control group, but the intake time was later than that in control group （Plt;0.05）. Falling range from preoperative CEA to postoperative CEA was larger in combined therapy group than that in control group （Plt;0.05）; and the falling range from preoperative WBC to postoperative WBC had no significant difference between two groups （Pgt;0.05）. Conclusion The clinical effect of combined therapy is obviously superior to simple operation, suggesting that neo-adjuvant chemotherapy combined with operation is feasible and safe.
摘要:目的: 随机对照研究、评估生物反馈训练治疗慢性功能性便秘的疗效。 方法 : 60例慢性功能性便秘患者,随机分为治疗组30例和对照组30例。治疗组接受1个疗程(5周)生物反馈训练治疗(10次为一个疗程、一次30～45分钟、每周2次)。对照组患者接受聚乙二醇4000 10g BID 口服,疗程5周。治疗前后作便秘症状评分、结肠通过试验检测、直肠肛门压力检测。 结果 : 生物反馈训练和聚乙二醇4000均可使多数慢性功能性便秘患者的大便次数、大便性状及伴随症状恢复正常或缓解,总有效率分别为667%和80%(P ＞005)。生物反馈训练和聚乙二醇4000口服治疗后,结肠通过试验72小时标志物排出率分别为75%及73%,均较治疗前明显增加。生物反馈训练治疗后力排时肛门压明显下降。 结论 : 生物反馈训练对出口梗阻型、慢传输型便秘均有效,是一种有效的、新兴的治疗慢性功能性便秘的方法,可作为功能性便秘的一线治疗方法。Abstract: Objective: To assess the clinic effect of biofeedback therapy for functional constipation. Methods : Sixty cases of chronic functional constipation were randomly divided into treatment group (30 cases) and control group (30 cases). Cases in the treatment group were exposed to biofeedback for a fiveweeklong treatment course—individual treatment lasted for 3045 minutes and twice per week. Patients in the control group received PEG 4000 10g BID for five weeks. Data from constipation symptom score, colonic transit test, and anorectal manometry were done and compared before and after two kinds of treatments. Results : Biofeedback training and PEG 4000 could restore the stoolfrequency, stool characteristics and accompanying symptoms to normal or mitigation of the majority of patients with chronic functional constipation, with the total effective rates being 667% and 80% (P gt;005), respectively. After biofeedback training and PGE 4000 treatment, the discharge rate of 72hour markers of colonic transit test significantly increased to 75% and 73%, respectively. Additionally, anorectal pressure decreased dramatically after biofeedback training. Conclusion : Biofeedback training would play a positive role in outlet obstruction and slow transit constipation. Thus, it could be an effective firstline treatment of chronic functional constipation.
ObjectiveTo investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. MethodsA study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference (P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. Results ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups (P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant (P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant (P>0.05). There was no significant difference in the operation time between groups (P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups (P<0.05); there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant (P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups (P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups (P>0.05), while there was a significant difference in IL-6 between groups (P<0.05). Conclusion Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
ObjectiveTo evaluate the effects of leukocyte filtration (LF) on blood components and cytokines of residual pump blood after cardiopulmonary bypass (CPB). MethodsForty patients who underwent selective cardiac surgery with CPB in Fu wai Hospital from December 2012 to February 2013 were included in this study. There were 34 male and 6 female patients with their age of 16-72 years. All the patients were randomly divided into an experimental group and a control group. In the experimental group, patients received residual pump blood transfusion which had been processed with LF and stored in sterile blood collection bags. In the control group, patients received residual pump blood transfusion which was stored in sterile blood collection bags without LF process after CPB. Blood samples were taken before CPB (T1) at the end of CPB (T2) and 4 hours (T3) after CPB to examine blood components and concentrations of IL-6, IL-10 and TNF-α. ResultsWhite blood cell count and neutrophil count of the experimental group were significantly lower than those of the control group at T2 and T3 (P<0.05). There was no statistical difference in red blood cell count, hemoglobin,hematocrit or free hemoglobin at respective time points between the 2 groups (P>0.05). There was no statistical difference in plasma IL-6,IL-10 or TNF-α concentrations at different time points within either group (P>0.05) or at respective time points between the 2 groups (P>0.05). ConclusionLF can reduce white blood cell count and neutrophil count of residual pump blood,but does not significantly change other blood components and plasma concentrations of IL-6,IL-10 or TNF-α after CPB.
ObjectiveTo compare the knee flexion degree after high-flexion versus standard total knee arthroplasty (TKA). MethodRelevant randomized controlled trials on comparison of knee flexion degree after high-flexion versus standard TKA were identified from Cochrane Library, PubMed, Embase, China National Knowledge Infrastructure from the establishment of these databases until October 2015. A systematic review was performed to compare knee flexion degree, knee function score and complications between the two types of prostheses. Analyses were conducted using RevMan version 5.2.0 software. ResultsTwenty-one studies were included in this Meta-analysis. The results showed that the knee flexion degree was higher in high-flexion group than that in the standard group[WMD=2.71°, 95%CI (0.96, 4.46)°, P=0.002]; while the difference was not significant leaving out six low-quality literatures[WMD=0.72°, 95%CI (-0.15, 1.60)°, P=0.10]. There was no significant difference in knee function score between the two groups[WMD=-0.54, 95%CI (-1.34, 0.25), P=0.18]. There was no significant difference in complications between the two groups[OR=0.99, 95%CI (0.53, 1.84), P=0.98]. ConclusionsThe important finding from the current study is that there is no evidence to support that the use of high-flexion prostheses is superior to the standard prostheses during total knee arthroplasty.
ObjectiveTo explore the short-term effectiveness of domestic robot-assisted total knee arthroplasty (RATKA) conducted by a prospective randomized controlled trial.MethodsPatients who were scheduled for primary unilateral TKA between October 2020 and December 2020 were eligible in this randomized controlled trial. According to the random number table method, they were allocated to the traditional TKA group and the RATKA group [application of the Yuanhua robotic-assisted TKA (YUANHUA-TKA) system during operation]. A total of 63 patients met the selection criteria were enrolled in the study, of which 3 cases voluntarily withdrew from the trial. And finally 60 cases were enrolled for analysis; of which 28 cases were in the RATKA group and 32 cases were in the traditional TKA group. There was no significant difference in gender, age, body mass index, American Society of Anesthesiologists (ASA) classification, duration of osteoarthritis, surgical side, and preoperative knee visual analogue scale (VAS) resting and motion scores, joint range of motion (ROM), Knee Society Score (KSS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain, stiffness, and function scores, hip-knee-ankle angle (HKA) deviation (P>0.05). The operation time and intraoperative blood loss of the two groups were recorded. Knee joint VAS resting and motion scores, ROM, KSS scores, and WOMAC pain, stiffness, and function scores were used to evaluate the knee joint function and pain. Gait analysis (flexion and extension angle) was conducted at 3 months after operation. The full length X-ray films of lower limbs and anteroposterior and lateral X-ray films of knee joint were taken. The HKA deviation, lateral tibia component (LTC), frontal femoral component (FFC), frontal tibia component (FTC), and lateral femoral component (LFC) measured on the X-ray films were used to evaluat the lower limb alignment and prosthesis position.ResultsThe operations of the two groups completed successfully; the incisions healed by first intention after operation, and no complications related to the operation occurred. The operation time of the RATKA group was significantly longer than that of the traditional TKA group (t=12.253, P=0.001), and there was no significant difference in intraoperative blood loss between the two groups (t=3.382, P=0.071). All patients were followed up 3 months. At 3 months after operation, the knee joint VAS resting and motion scores, ROM, KSS scores, and WOMAC pain, stiffness, and function scores improved significantly when compared with preoperatively in the two groups (P<0.05); there was no significant difference of pre- and post-operative indicators between the two groups (P>0.05). The gait analysis showed that the flexion and extension angle in the RATKA group was significantly bigger than that in the traditional TKA group (t=9.469, P=0.003). X-ray films reexamination at 3 months after operation showed that the prostheses in the two groups were in good positions, and there was no adverse events such as prosthesis loosening or sinking. There were significant differences in the HKA deviation between pre- and post-operation in the two groups (P<0.05), but the difference of pre- and post-operative HKA deviation between the two groups was not significant (t=1.254, P=0.267). There was no significant difference in FFC, FTC, and LFC between the two groups (P>0.05); the LTC was significantly smaller in the RATKA group than in the traditional TKA group (t=17.819, P=0.000), which was closer to the ideal value.ConclusionYUANHUA-TKA system can improve the accuracy of osteotomy and the prosthesis placement as well as the lower limb alignment. Its short-term effectiveness can be promised, but long-term effectiveness needs to be further studied.
Objectives To systematically review the efficacy and safety of non-systemic lymph dissection (NSMLD) vs. systemic lymph dissection (SMLD) for early stage non-small cell lung cancer (NSCLC). Methods PubMed, EMbase, Web of Science and The Cochrane Library databases were searched online to collect randomized controlled trials (RCTs) and non-randomized controlled studies (NRCTs) of NSMLD vs. SMLD for NSCLC patients from inception to October, 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 16 studies (4 RCTs and 12 NRCTs) involving 4 718 patients were included. The results of meta-analysis showed that: Compared with the SMLD group, the NSMLD group had higher mortality (HR=1.23, 95%CI 1.11 to 1.37, P<0.000 1). There were no significant differences in disease-free survival, local recurrence rate, distant metastasis rate, and safety between two groups. In addition, the NSMLD group had shorter operation time, and lower drainage and blood loss. Subgroup analysis was performed according to operation methods. The results showed that: NSMLD group by lymph node sampling (LN-S) had higher mortality than SMLD group (HR=1.43, 95%CI 1.17 to 1.75,P=0.004), NSMLD group by lobe-specific lymph node dissection (L-SLD) did not have higher mortality. Conclusions Current evidence shows that: compared with SMLD, NSMLD by L-SLD do not have higher mortality in early stage NSCLC patients, while NSMLD by LN-S have higher mortality. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
ObjectiveTo investigate the effectiveness of preemptive analgesia with imrecoxib on analgesia after anterior cruciate ligament (ACL) reconstruction. MethodsA total of 160 patients with ACL injuries who met the selection criteria and were admitted between November 2020 and August 2021 were selected and divided into 4 groups according to the random number table method (n=40). Group A began to take imrecoxib 3 days before operation (100 mg/time, 2 times/day); group B began to take imrecoxib 1 day before operation (100 mg/time, 2 times/day); group C took 200 mg of imrecoxib 2 hours before operation (5 mL of water); and group D did not take any analgesic drugs before operation. There was no significant difference in gender, age, body mass index, constituent ratio of meniscal injuries with preoperative MRI grade 3, constituent ratio of cartilage injury Outerbridge grade 3, and visual analogue scale (VAS) score at the time of injury and at rest among 4 groups (P>0.05). The operation time, hospitalization stay, constituent ratio of perioperative American Society of Anesthesiologists (ASA) grade 1, postoperative opioid dosage, and complications were recorded. The VAS scores were used to evaluate the degree of knee joint pain, including resting VAS scores before operation and at 6, 24, 48 hours, and 1, 3, 6, and 12 months after operation, and walking, knee flexion, and night VAS scores at 1, 3, 6, and 12 months after operation. The knee injury and osteoarthritis score (KOOS) was used to evaluate postoperative quality of life and knee-related symptoms of patients, mainly including pain, symptoms, daily activities, sports and entertainment functions, knee-related quality of life (QOL); and the Lysholm score was used to evaluate knee joint function. ResultsAll patients were followed up 1 year. There was no significant difference in operation time, hospitalization time, or constituent ratio of perioperative ASA grade 1 among 4 groups (P>0.05); the dosage of opioids in groups A-C was significantly less than that in group D (P<0.05). Except for 1 case of postoperative fever in group B, no complications such as joint infection, deep vein thrombosis of the lower extremities, or knee joint instability occurred in each group. The resting VAS scores of groups A-C at 6 and 24 hours after operation were lower than those of group D, and the score of group A at 6 hours after operation was lower than those of group C, and the differences were significant (P<0.05). At 1 month after operation, the knee flexion VAS scores of groups A-C were lower than those of group D, the walking VAS scores of groups A and B were lower than those of groups C and D, the differences were significant (P<0.05). At 1 month after operation, the KOOS pain scores in groups A-C were higher than those in group D, there was significant difference between groups A, B and group D (P<0.05); the KOOS QOL scores in groups A-C were higher than that in group D, all showing significant differences (P<0.05), but there was no significant difference between groups A-C (P>0.05). There was no significant difference in VAS scores and KOOS scores between the groups at other time points (P>0.05). And there was no significant difference in Lysholm scores between the groups at 1, 3, 6, and 12 months after operation (P>0.05). ConclusionCompared with the traditional analgesic scheme, applying the concept of preemptive analgesia with imrecoxib to manage the perioperative pain of ACL reconstruction can effectively reduce the early postoperative pain, reduce the dosage of opioids, and promote the early recovery of limb function.