Abstract： Surgical repair of functional tricuspid regurgitation (FTR) is often carried out concomitantly with other leftsided heart valve procedures. Though diseases of both left heart valve and tricuspid were treated during the surgery, postoperative residual or recurrent tricuspid regurgitation has been clearly associated with progressive heart failure and worsened longterm survival. To date, surgical interventions mainly address FTR at three anatomic levels: commissure, annulus and leaflets. However, a certain mid and longterm failure rate after operation still exists. High surgical mortality rates have been reported in patients with recurrent tricuspid regurgitation requiring complex reoperations. With a better understanding of tricuspid anatomical complex and valvuloplasty, significant improvements have been made in FTR surgical indications and techniques. This review article will focus on the development of surgical indications in tricuspid valve repair, while the repair techniques and their impact on longterm clinical outcome will also be compared.
In order to better incorporate patient input in clinical trials, the US Food and Drug Administration has included "patient-focused drug development" in the selection and development of clinical outcome assessments, and formulated a series of guidelines. Based on the third guiding principle, "Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments", this article summarizes the clinical outcome assessments from five aspects: concept, development process, scoring mechanism, interference factors and sensitivity, and introduces four different types of clinical outcome assessments, providing new ideas for "patient-focused drug development" efficacy evaluation in clinical trials.
With the transformation of modern medical models, patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes have become internationally recognized clinical outcome assessment indicators, and scales have also become important evaluation tools, among which translation and cross-cultural adaptation are one of the important sources of scales. However, at present, there are fewer guidelines for scale translation in China. At present, domestic scale translation has not yet been unified and standardized in clinical reporting. Most translation reports provide readers with incomplete information, which affects the development of scale translation, and the methodology related to the translation of clinical outcome assessment scales still focuses on patient-reported outcome scales, which creates a gap in terms of the recommendations for the rest of the types of translations, a gap which leads to inconsistencies in the translation methodology and process. In this paper, we will develop specific translation methods and processes for each of the four current types of clinical outcome assessments by combining scale translation guidelines to support a standardized approach to translation, cross-cultural adaptation, and linguistic validation for use in standardizing the process of recommending translations of patient-reported outcome scales, clinical-reported outcome scales, observer-reported outcome scales, and behavioral outcome scales.
ObjectiveTo evaluate the clinical therapeutic effect of support plates on Schatzker type Ⅳ tibial plateau fractures.MethodsPatients with Schatzker type Ⅳ tibial plateau fractures underwent support plates treatment between April 2013 and September 2014 by using the medial incision or posterior medial incision, if necessary, with other auxiliary incisions, with limited contact compression plate, 1/3 tubular plate or " T” plate to support the fracture. ResultsA total of 14 patients including 6 males and 8 females with an average age of (35.2±9.8) years (ranged from 20 to 52 years) were enrolled in this study and followed up for 12–25 months with an average of (16.3±4.0) months. The knee joints were flexed 80–130° with an average of (97.9±13.1)° one month after the surgery and 90–140° with an average of (119.3±12.1)° three months after the surgery. One year postoperatively, the mean Hospital of Special Surgery knee score ranged from 78 to 96 with an average of 88.4±4.9. Last follow-up assessment of knee function according to Rasmussen scoring system showed excellent in 8 cases, good in 4 cases, and fair in 2 cases; the excellent and good rate was 85.7%. No postoperative complications such as infection, nonunion, vascular nerve injury, or internal fixation failure occurred. ConclusionThe support plates for the treatment of Schatzker type Ⅳ tibial plateau fractures can maintain good reduction, prevent the secondary collapse of the tibial plateau, ensure that knee joint has good alignment, less complications with vascular or nerve injuries, and finally get a satisfied function recovery.
ObjectiveTo investigate surgical indications and techniques of video-assisted thoracoscopic surgery (VATS) for mediastinal lymph node tuberculosis. MethodsClinical data of 27 patients who underwent VATS for mediastinal lymph node tuberculosis between January 2010 and March 2013 in Wuhan Medical Treatment Center were retrospectively analyzed. There were 16 male and 11 female patients with their age of 18-67 (30.23±10.72) years. ResultsThere was no in-hospital death. Postoperative complications included recurrent laryngeal nerve injury in 1 patient, delayed wound healing in 1 patient and pneumothorax in 1 patient. Postoperatively, all the patients received intensified anti-tubercular treatment, and were engaged in normal physical activities during follow-up of 6 months. ConclusionVATS is safe and reliable for the treatment of mediastinal lymph node tuberculosis, and anti-tubercular treatment is needed before and after the operation.
Objective To observe the clinical outcomes of Hangman fracture treated by anterior cervical discectomy and fusion. Methods A total of 41 patients with Hangman fracture were retrospectively analyzed, who underwent anterior cervical discectomy and fusion from May 2010 to May 2016. Intervertebral bone graft fusion was observed through postoperative radiographic images, and improvement of symptoms was evaluated by Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Modified Japanese Orthopaedic Association Scale (m-JOA). Surgical complications were evaluated as well. Results No severe complications occurred after surgery, but 5 patients had a transient dysphagia, which relieved spontaneously. Thirty-five patients had a fusion of intervertebral bone graft 3 months after surgery, and the remaining 6 patients did at the last follow-up. The VAS score was improved from 4.5±1.6 pre-operatively to 2.4±1.7 immediately post-operatively (P>0.05), and was further improved to 0.7±0.9 at the last follow-up (P<0.05). The NDI score was improved from 29.3±10.9 pre-operatively to 13.2±5.4 immediately post-operatively (P<0.05), and was further improved to 4.6±3.1 at the last follow-up (P<0.05). The m-JOA score was improved from 8.4±2.3 pre-operatively to 11.6±3.5 immediately post-operatively (P<0.05), and was further improved to 14.3±2.0 at the last follow-up (P<0.05). Conclusion Anterior cervical discectomy and fusion can be used in Hangman fracture, which is safe and reliable.
The patient, as the person who experiences the disease first-hand, has the most direct and accurate experience of the pain of the disease and the most accurate need for health products. Although there is a vast array of technological means to combat disease and maintain health, the human burden of disease has not been reduced and the health needs of patients have not been fully met. Therefore, "patient-focused drug development" is imperative. Gathering comprehensive information from patients through multiple channels and incorporating this information into the entire drug development process can help ensure that patients’ experiences, perspectives, needs and priorities are taken into account and valued. This article will introduce the concept, development process and the specific problems it faces in patient-focused drug development.
ObjectiveTo evaluate the impact of using alanyl-glutamine dipeptide on clinical outcome for gastric cancer patients with nutritional risk after total gastrectomy. MethodsThis study was carried out in the period from March to August 2015. The nutritional risk was screened by continuous sampling method in the new hospitalized patients with gastric cancer who would undergo total gastrectomy. The patients were grouped randomly. Alanyl-glutamine was given to the experimental group patients. The clinical data of the two groups were analyzed, such as the laboratory parame-ters of nutritional status and hepatorenal function, complications of surgery, the nutrition-related hospitalization day, etc. ResultsThe preoperative data were consistent in the two groups of the included 40 cases. The results showed, in the third and seventh days after surgery, the level of plasma albumin was higher in the experimental group than in the control group〔(33.9±5.6) g/L vs. (30.8±4.0) g/L and (36.6±3.9) g/L vs. (33.9±4.2) g/L, respectively). Also, the CD4+/CD8+ cells immune index was significantly improved in the experimental group after surgery (1.7±0.7 vs. 1.2±0.3, P < 0.05). The recovery time of intestinal function〔(65.7±5.3) h vs. (71.6±7.2)h, P < 0.01)〕and nutrition-related hospitalization day〔(10.1±1.8) d vs. (11.7±1.9)d, P < 0.01)〕in alanyl-glutamine dipeptide group were shorted than that in the control group. No serious adverse drug reactions were found in the patients during the treatment period. ConclusionApplication alanyl-glutamine to the patients with nutritional risk after total gastrectomy could partly improve clinical outcome indicators.
ObjectiveTo investigate the prevalence of the nutritional risks, the relationship between application of nutritional support and the clinical outcome of patients with gastrointestinal major surgery in the Frist People's Hospital of Shuangliu. MethodsGastrointestinal major surgery patients in Department of General Surgery in the Frist People's Hospital of Shuangliu from March 2010 to March 2014 were consecutively enrolled. Patients who provided informed consent were screened by NRS 2002, tracking nutrition support status and analysis the relationship between nutrition support and clinical outcome. In this study, the clinical outcome index included postoperative complications and hospitalization time. ResultsThere were totally 130 cases enrolled, 112 cases completed assessment by NRS 2002. The prevalence of nutritional risk was 75.9%(85/112), there were totally 57 patients(50.9%) received nutrition support, and all for parenteral nutrition. The prevalence of postoperative complication was 46.4%(52/112). The prevalence of postoperative complication in patients who had nutritional risk and received nutritional support was 41.7%(15/36), whereas, in patients who had nutritional risk but not received nutritional support was 73.5%(36/49), there was statistically significant difference between the 2 groups(P=0.002). In patients who not had nutritional risk, the postoperative complication rate was only 3.7%(1/27). ConclusionsBecause of noninvasive and easy to operate, NRS 2002 are adpted to hospitalized patients with gastrointestinal major surgery. Because of the specific of disease metabolism, the higher nutritional risk occurres in patients with gastrointestinal major surgery, appropriate nutritional support for this kinds of patients can reduce the incidence of postoperative complication, and improve the prognosis.
Objective To evaluate clinical outcomes of complete video-assisted thoracoscopic surgery （VATS） lobectomy for patients with peripheral lung cancer.?Methods?We retrospectively analyzed clinical data of 90 consecutive patients with peripheral lung cancer who underwent complete VATS lobectomy from July 2009 to December 2011 in Provincial Hospital Affiliated to Anhui Medical University. There were 55 male patients and 35 female patients with their age of 33-79 （62.5 ±11.5） years. Lymph node dissection group and number, operation time, intraoperative blood loss, length of postoperative chest drainage, length of postoperative hospitalization, postoperative morbidity and pain score were analyzed.?Results?There was no hospital death in this group. Operation time was 135.0±32.5 min, intraoperative blood loss was 230.0±80.4 ml, length of postoperative chest drainage was 4.8±2.1 days, and pain score on the third postoperative day was 5.3±1.2. A total of 520 groups and 1 568 lymph nodes were dissected during the operation, with 5.8 groups and 17.4 lymph nodes dissected in each patient. There were 71 groups with lymph node metastasis, a positive rate of 13.7% （71/520）. Postoperatively, 2 patients had hoarseness and 3 patients had chylothorax, who were all cured after proper treatment. Ninety patients were followed up for 1-24 months. During follow-up, 4 patients died of tumor metastasis, and other patients were all alive with good quality of life.?Conclusion?Complete VATS lobectomy is a minimally invasive technique for patients with peripheral lung cancer with better postoperative recovery and reduced pain level. The safety and degree of radical resection of complete VATS lobectomy is similar to those of routine thoracotomy lobectomy. Complete VATS lobectomy can be recommended as a surgical treatment for patients with peripheral lung cancer.