High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
An intervention with clinical application must be effective and safe, therefore, when evaluating interventions, the benefit-harm ratio should be considered, and only those interventions with more benefits than harms have application value. To evaluate the benefits and harms of an intervention evidence of both benefits and harms should be reported in clinical trials. To promote better reporting of harms in randomized controlled trials, the CONSORT group had added an entry on harms in the 2001 version of the CONSORT statement, and then in 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated, the reporting of harms is still inadequate. The CONSORT group has updated《Better reporting of harms in randomized trial: an extension of the CCONSORT statement.》, published《CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials》. This article presents and explains the Harms 2022, with the aim of helping researchers better understand and use the statement, with a view to improving the reporting quality of harms in clinical trials.
ObjectiveTo explore the feasibility and safety of clinical application of bipolar coagulation forceps in open thyroid operations and summarize the operation skill. MethodsThe clinical data of 347 cases performed thyroid operations with bipolar coagulation forceps and Harmonic scalpel respectively from October 2010 to October 2014 in our hospital were analyzed retrospectively. ResultsNo statistical differences was found on the operative time, intraoperative bleeding, postoperative drainage, and postoperative hospitalization of the two groups (P > 0.05). The complications of transient palsy of recurrent laryngeal nerve and transient functional insufficiency of parathyroid were more in Harmonic scalpel group than in bipolar coagulation forceps group with statistical difference (P < 0.05). But there was no difference of the complications of airway obstruction, permanent injuries of recurrent laryngeal nerve, parathyroid and superior laryngeal nerve in the two groups (P > 0.05). ConclusionsThyroid operations with bipolar coagulation forceps are safe and feasible. Coagulation tightly along the thyroid capsule followed by incision with explicit subtle dissection is the key point of the decrease of complications.
ObjectiveTo evaluate the feasibility of clipless laparoscopic cholecystectomy (LC) to patients with calculous cholecystitis in acute inflammation stage. Methods The clinical data of 169 patients with calculous cholecystitis in acute inflammation stage who underwent clipless LC from December 2008 to July 2010 were analyzed. ResultsAll patients were successfully operated by LC except one case who suffered from gallbladder perforation and a conversion to open surgery was performed. The operation time ranged from 25-70 min (mean 38 min). The blood loss ranged from 10-200 ml (mean 22 ml). Peritoneal drainage was done in 38 patients, and the drainage time ranged from 1-6 d (mean 1.8 d). The time to out-of-bed activity was at 2 h after operation and the hospitalization time was 3-7 d (mean 3.5 d). There was no complication such as bile duct injury, hemorrhage, billiary leakage, and intra-abdominal infection. ConclusionWith improvement of operator’s experiences and skills, the clipless LC becomes feasible and safe for patients with calculous cholecystitis in acute inflammation stage.
Building a harmonious socialist society reflects the inherent requirement of building a prosperous, democratic, civilized and harmonious modern socialist country. Strengthening medical and health services, and improving the level of people's health is one of the most important measures in constructing a socialist harmonious society of the CPC Central committee. Hospital is an important part of medical and health services. Hospital trade union is the bridge and link between the party and workers. Therefore, hospital trade union should give full play to its function and role, actively participate and promote the construction of harmonious hospital. The current hospital trade unions need positioned and explored under the present situation.
It is essential to improve the practice of community healthcare service for the resolution of the problem of inadequate and overly expensive medical services, to promote the harmonization of doctor-patient relationship. From the aspects of the introduction of community healthcare service and the necessity of its standard management, the civil legal relation of community healthcare and its major problems, as well as the rights and duties of community doctors, the authors discussed the importance and necessity of scientific management, right protection by law as well as sound and orderly development of community healthcare service.
ObjectiveTo investigate the cause and treatment for chyle fistula after neck radical dissection using harmonic scalpel. MethodsFrom January 2005 to April 2009, 105 patients with thyroid carcinoma underwent thyroidectomy by harmonic scalpel (harmonic scalpel group) and 110 patients with thyroid carcinoma by conventional procedures (conventional group). Postoperative chyle fistula in all the cases was studied retrospectively. ResultsThe incidence of chyle fistula was 5.71% (6 of 105 patients) in the harmonic scalpel group and 0.91% (1 of 110 patients) in the conventional group. The difference was significant between two groups (Plt;0.05). ConclusionsHarmonic scalpel increases the risk of chyle fistula in neck radical dissection. The conventional procedures with exposing and preserving or ligating the thoracic duct can reduce the risk significantly.
ObjectiveTo compare the advantages and drawbacks of harmonic scalpel (HS) versus conventional electro-scalpel (ES) in the surgery for carcinoma of uterine cervix. MethodsA total of 126 patients with stage Ⅰ uterine cervix carcinoma who underwent surgery between January 2011 and November 2015 were randomly and averagely divided into HS group and ES group with 63 patients in each. The operation time, intra-operative bleeding volume, the number of lymph nodes detected and operation cost were compared between the two groups of patients. ResultsAll the patients underwent surgery successfully. There were significant differences between the HS and ES groups in terms of operation time[(202.06±11.67) minutes vs.(223.48±18.01) minutes, P<0.001], intra-operative bleeding[(373.97±27.95) mL vs.(458.16±33.18) mL, P<0.001], operation cost[(4 171.43±276.46) yuan vs.(3 101.54±258.59) yuan, P<0.001]. There was no significant difference between the two groups in terms of the number of lymph nodes detected (10.38±2.43 vs.9.76±2.61, P=0.172). ConclusionThe use of harmonic scalpel can reduce operation time and intra-operative bleeding volume effectively, but it cannot increase the number of lymph nodes detected. Moreover, it significantly increases the operation cost and economic burden for the patients.
ObjectivesTo systematically review the safety of harmonic scalpel and conventional resection in superficial parotidectomy.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) or cohort studies of harmonic scalpel and conventional resection in superficial parotidectomy from the inception of the database to December, 2018. Two reviewers independently screened literatures, extracted data and assessed risk of bias of the included studies. Then meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 10 studies involving 671 post-cesarean section patients (361 patients in harmonic scalpel group and 310 patients in conventional resection group) were included. The results of meta-analysis showed that: compared with conventional resection, harmonic scalpel had shorter operative time (MD=−23.82, 95%CI −31.20 to −16.44, P<0.000 01), less postoperative drain output (MD=−26.25, 95%CI −38.95 to −13.55, P<0.000 1), less intraoperative blood loss (MD=−23.78, 95%CI −28.64 to −18.91, P<0.000 01), shorter duration of hospital stay (MD=−1.19, 95%CI −2.14 to −0.23, P=0.02), and lower temporary facial nerve palsy rate (OR=0.27, 95%CI 0.14 to 0.50, P<0.000 1). However, there was no significant difference in the incidence of parotid gland leakage between two groups (OR=0.42, 95%CI 0.16 to 1.06, P=0.07).ConclusionsThe current evidence demonstrates that, compared to conventional resection, harmonic scalpel resection is safer. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To assess the outcome of harmonic scalpel (HS) in esophageal cancer surgery and to provide evidence for the role of HS in the enhanced recovery after surgery (ERAS) and short-term prognosis after esophageal cancer surgery. Methods We collected the clinical data of 81 esophageal cancer patients receiving surgery by HS between January 1 and December 31, 2016 and successfully followed up in our department. There were 67 males and 14 females with an average age of 64.07±7.52 years. Sweet approach was adopted in 16 patients, Ivor-Lewis approach in 23 and McKeown approach in 40. Intrathoracic anastomosis was completed in 41 patients and cervical anastomosis in 40. The length of total hospital stay and postoperative hospital stay, operation time, intraoperative blood loss, duration and volume of thoracic drainage and perioperative complications were recorded and compared in patients with different surgical approaches and anastomosis sites. Results For these 81 patients, the operation time was 276.7±70.4 min, and the intraoperative blood loss was 115.9±69.7 ml. The postoperative duration of thoracic drainage, postoperative complication rate and the drainage volume were 12.3±5.3 d, 35.80% and 1 411.9±1 199.5 ml, respectively. During the follow-up, 15 patients died and the cumulative survival rate was 81.48%. There was no obvious HS-related complication. The operation time of Sweet approach was shorter than that of Ivor-Lewis or McKeown approach (P=0.012) and the dissected lymph nodes were less in Sweet approach (P=0.035). There was no significant difference in perioperative indexes and postoperative short-term prognosis between intrathoracic anastomosis and cervical anastomosis. Conclusion HS is widely used in the surgery for esophageal cancer with safety and effectiveness, which is worthy of clinical application.