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.
Objective To investigate the effect of different degrees of wound eversion on scar formation at the donor site of anterolateral thigh flaps by a prospective clinical randomized controlled study. MethodsAccording to the degree of wound eversion, the clinical trial was designed with groups of non-eversion (group A), eversion of 0.5 cm (group B), and eversion of 1.0 cm (group C). Patients who underwent anterolateral femoral flap transplantation between September 2021 and March 2023 were collected as study subjects, and a total of 36 patients were included according to the selection criteria. After resected the anterolateral thigh flaps during operation, the wound at donor site of each patient was divided into two equal incisions, and the random number table method was used to group them (n=24) and perform corresponding treatments. Thirty of these patients completed follow-up and were included in the final study (group A n=18, group B n=23, and group C n=29). There were 26 males and 4 females with a median age of 53 years (range, 35-62 years). The body mass index was 17.88-29.18 kg/m2 (mean, 23.09 kg/m2). There was no significant difference in the age and body mass index between groups (P>0.05). The incision healing and scar quality of three groups were compared, as well as the Patient and Observer Scar Assessment Scale (POSAS) score [including the observer component of the POSAS (OSAS) and the patient component of the POSAS (PSAS)], Vancouver Scar Scale (VSS) score, scar width, and patient satisfaction score [visual analogue scale (VAS) score]. Results In group C, 1 case had poor healing of the incision after operation, which healed after debridement and dressing change; 1 case had incision necrosis at 3 months after operation, which healed by second intention after active dressing change and suturing again. The other incisions in all groups healed by first intention. At 6 months after operation, the PSAS, OSAS, and patient satisfaction scores were the lowest in group B, followed by group A, and the highest in group C. The differences between the groups were significant (P<0.05). There was no significant difference between the groups in the VSS scores and scar widths (P>0.05). ConclusionModerate everted closure may reduce the formation of hypertrophic scars at the incision site of the anterior lateral thigh flap to a certain extent.
ObjectiveTo discuss the clinical effects of intercostals nerve freezing technique for analgesia on post-operative chest. MethodsWe included 80 patients with thoracotomy in Zhongshan Hospital in Xiamen University between June 2013 and June 2014. The patients were divided into a trial group (30 males and 10 females at average age of 59.90± 10.62 years) and a control groups (28 males and 12 females at average age of 59.85± 10.52 years) by random digital table. The patients in the trial group were treated with frozen the intercostals nerve roots located in the incision and next intercostals before closing the chest by cryotherapy therapy apparatus (K520 type, Beijing Kulan Company). The patients in the control group were treated with self-control intravenous analgesia pump post-operation. We compared the postoperative incision pain and cough, sputum reflection score, and pulmonary complications between the two groups. ResultsThe pain degree in the trial group was significantly weaker than that in the control group on the first day, the second day and the seventh day after operation (t=-6.45, -4.95, -3.14, P < 0.05). Cough, sputum reflection score were significantly higher than those in the control group (P < 0.01). Pulmonary complications were significantly lower (t=3.023, P < 0.05). There were 4 patients with pneumonia and no pulmonary atelectasis in the trial group. While there were 8 patients with pneumonia in the control group and 1 patient with pulmonary atelectasis. ConclusionIntercostals nerve freezing technique can drastically reduce postoperative pain in the patients with open thoracic operation, effectively promote patient cough and expectoration, and reduce pulmonary complications rate.
Objective To explore the feasibility and safety of non-gastrointestinal decompression after esophagectomy and the necessity of gastric tube or the time to remove gastric tube. Methods Thirty patients with esophageal cancer who underwent surgical treatment in the Department of Thoracic and Cardiovascular Surgery, Nanjing Drum Tower Hospital, were included in the trial from June to October 2017. The patients were randomly and equally assigned to a trial group (non-gastrointestinal decompression) or a control group (gastrointestinal decompression). There was no significant difference in age (P=1.000), sex (P=1.000), tumor location (P=0.732), pathological type (P=1.000), pathological stage (P=0.507), and operation time (P=0.674) between the two groups. The clinical effect between the two groups were compared. Results There was no statistical difference in incidences of anastomotic leakage (P=1.000), anastomotic bleeding (P=1.000), gastroesophageal reflux (P=1.000) between the two groups. And there was no statistical difference in time of the first flatus (P=0.629) and the first bowel movement (P=0.599) after operation between the two groups. Conclusion Without gastrointestinal decompression after Ivor Lewis esophagectomy does not increase the incidences of anastomotic leakage, anastomotic bleeding and gastroesophageal reflux, and has no significant effect on the recovery of gastrointestinal function. Without gastrointestinal decompression after Ivor Lewis esophagectomy is safe and feasible. Removing gastric tube on the second day after operation is reasonable and feasible.
ObjectiveTo investigate the socioeconomic benefits of enhanced recovery after surgery (ERAS) in perioperative period of selective laparoscopic cholecystectomy (LC) by prospective, randomized, controlled clinical study.MethodsA total of 90 patients were recruited in the Hetian Regional People’s Hospital from November 1, 2019 to December 25, 2019. PASS 11 software was used to calculate the sample size. They were grouped into an ERAS group and a tradition group by 1∶1 by random digital table. The patients in the ERAS and the tradition groups were treated with ERAS conception and traditional method respectively during the perioperative period. The postoperative hospitalization time, the first feeding time, the first getting out of bed time, and the first anal exhaust time after operation; the total hospitalization costs, intraoperative infusion, and postoperative total infusion; the intraoperative anesthesia intubation method, trocar layout, and operation time; the pain points of 6 h,12 h and 24 h after operation; the nausea and vomiting after operation; complications and re-hospitalization rate within 30 d after operation were compared between two groups.ResultsA total of 86 patients finally were included in the study, including 44 cases in the ERAS group and 42 cases in the tradition group. The basic data such as the gender, age, body mass index, etiology, blood routine, liver and kidney functions, etc. between the two groups were not statistically significant (P>0.05). Between the two groups, there were no significant differences in the intraoperative anesthesia intubation method, trocar layout, and operation time (P>0.05). Compared with the tradition group, the hospitalization time, the first feeding time, the first getting out of bed time, and the first anal exhaust time after operation were shorter (P<0.05); the total hospitalization costs, intraoperative infusion, and postoperative total infusion were less (P<0.05); the pain points of 6 h,12 h and 24 h after operation were lower (P<0.05); and the times of nausea and vomiting after operation were less (P<0.05) in the ERAS group. There were no complications such as the intraperitoneal bleeding, biliary leakage, and infection after operation, and no re-hospitalized patients within 30 d in both groups.ConclusionApplication of ERAS conception in selective LC perioperative period in Hetian Regional People’s Hospital of Xinjiang Uygur Autonomous Region cannot only shorten postoperative hospitalization time, reduce costs of hospitalization, help to overcome poverty, but also reduce occurrence of complications such as pain, nausea and vomiting, etc.
ObjectiveTo probe into the clinical value of supine cervical vertebra traction with neck flexion in treating cervical spondylotic radiculopathy. MethodsFrom August 2011 to December 2013, 71 patients were divided randomly into a treatment group of 36 cases and a control group of 35 cases. They were treated respectively with supine cervical vertebra traction with neck flexion, and cervical vertebra traction on a sitting position. Both groups had acupuncture, moxibustion, massage and medium frequency electrotherapy. The period of observation was 15 days. We evaluated the results by surveying physiological curvature of the cervical spine on lateral radiograph, and visual analogue scale (VAS), neck disability index (NDI), criteria of diagnosis and therapeutic effect of syndromes in traditional Chinese medicine syndrome and clinical assessment scale for cervical spondylosis (CASCS) were also used. ResultsPhysiological curvature of cervical spine was much improved in both groups after treatment (P<0.05). The distance of cervical vertebra arc between vertebral anterior edge sequences in treatment group before treating was (4.07±3.63) mm and it was (9.03±4.31) mm after treatment. For the control group, those two numbers were respectively (4.13±3.02) and (8.87±3.97) mm. There was no significant difference in the distance of cervical vertebra arc and its increase between vertebral anterior edge between the two groups after treatment. There was significant difference in the efficiency rate between the two groups (P<0.05) (treatment group 100.00%, control group 97.14%). When cured rate and cured-markedly effective rate were added, the treatment group (80.56%) was much better than the control group (51.43%) (P<0.01). As to VAS score, NDI and CASCS scores, both groups got much better after treatment (P<0.01). For VAS, the treatment group decreased from 8.43±0.75 before treatment to 1.40±0.61 after treatment, while the control group from 8.35±0.78 before treatment to 2.55±0.59 after treatment. For NDI, the treatment group decreased from 54.13±7.44 before treatment to 10.78±4.55 after treatment, while the control group from 55.85±8.72 to 12.66±5.48. For CASCS, the treatment group rose from 34.88±5.39 before treatment to 74.65±6.73 after treatment, while the control group from 34.77±4.89 to 69.03±6.21. After treatment, VAS score of the treatment group was much lower than the control group (P<0.01). There was no difference between the two groups on NDI (P>0.05). CASCS score of the treatment group was significantly higher than the control group after the treatment (P<0.01). There was no significant difference in the increase of CASCS score between the two groups after treatment (P>0.05). ConclusionVertebra traction combined with acupuncture, moxibustion, massage and medium frequency electrotherapy is therapeutic for cervical spondylotic radiculopathy and traction at a supine and flexing position is better.
ObjectiveTo compare the clinical and radiographic results between primary total knee arthroplasty (TKA) via mini-subvastus or conventional approach through a prospective randomized controlled study.MethodsNinety-four patients (104 knees) undergoing primary TKA between January 2011 and April 2012 were evaluated and randomly divided into 2 groups. Forty-six patients (52 knees) underwent TKA via conventional approach (conventional approach group), and 48 patients (52 knees) underwent TKA via mini-subvastus approach (mini-subvastus approach group). In these patients, 45 cases (51 knees) in conventional approach group and 45 cases (49 knees) in mini-subvastus approach group were followed up and recruited in the final analysis. There was no significant difference in age, gender, body mass index, sides, osteoarthritis grading, American Knee Society Score (KSS), Hospital for Special Surgery (HSS) score, visual analogue scale (VAS), range of motion (ROM) of knee between 2 groups (P>0.05). The clinical indexes were recorded and analyzed, including the operation time, length of incision, total blood loss, blood transfusion after operation, hospital stay time, the time of performing straight leg raise, incision condition, VAS score, ROM of knee, HSS score, and KSS score, hip-knee-ankle angle (HKA), femoral anatomic axis and the femoral prosthesis joint angle (femoral angle), tibia anatomic axis and tibial prosthesis joint angle (tibial angle), femoral prosthesis flexion angle (FPFA), and posterior slope angle (PSA) of the tibial plateau.ResultsAll patients were followed up. The average follow-up time was 66.4 months (range, 60.0-72.5 months) in conventional approach group and 65.6 months (range, 60.0-71.2 months) in mini-subvastus approach group. Compared with the conventional approach group, the incision of mini-subvastus approach group shortened, the operation time prolonged, and the time when patients started straight leg raise exercises was earlier; showing significant differences between 2 groups (P<0.05). There was no significant difference in hospital stay time, total blood loss, and numbers of blood transfusion between 2 groups (P>0.05). The complication rate was 8.2% (4/49) in mini-subvastus approach group and 0 in conventional approach group, showing no significant difference between 2 groups (P=0.054). At 1 and 3 days, the VAS and the ROM of knee in mini-subvastus approach group were significantly better than those in conventional approach group (P<0.05); but there was no significant difference in above indexes between 2 groups at 14 day (P>0.05). There was no significant difference in HSS and KSS scores between 2 groups at the 1, 3, 6, 12 months and 3, 5 years (P>0.05). X-ray film showed no aseptic loosening in all cases. There was no significant difference in the measured values and incidence of abnormal patient of HKA, femoral angle, tibial angle, FPFA, and PSA at last follow-up between 2 groups (P>0.05).ConclusionTKA via mini-subvastus approach is helpful to the early function recovery of knee, but the long-term effectiveness is consistent with TKA via conventional approach. As the limited exposure, TKA via mini-subvastus spproach may has high risk of operative complications.
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.
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.