ObjectiveTo investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.MethodsUsing hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.ResultsThe total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.ConclusionsThe number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data (IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials.
Objective To apply the method of evidence-based medicine to identify the best therapy option for an emergency patient with upper gastrointestinal hemorrhage. Methods According to time and logical sequence of clinical events, a complete decision tree was built after the following steps to find the best treatment: clear decision-making, drawing decision tree graphics, listing the outcome probability, giving appropriate values to the final outcome, calculating and determining the best strategies. Results The performance of endoscopic therapy for the patient with upper gastrointestinal hemorrhage within the first six hours had little effect on the prognosis. Interventional therapy after the failure of endoscopic therapy had less mortality than direct surgical exploration. Conclusion Making clinical decision analyses via drawing the decision tree can help doctors clarify their ideas, get comprehensive views of clinical problems, and ultimately choose the best treatment strategy for patients.
ObjectiveTo explore the clinical effect of keeping the pancreatic capsule in radical gastrectomy for early stage of gastric cancer.
MethodsTwo hundreds and seven patients with early stage of gastric cancer who were treated in our hospital from Jan 2011 to December 2011 were enrolled prospectively, and were divided into experimental group (n=95) and control group (n=112). Patients in experimental group kept the pancreatic capsule in radical gastrec-tomy, but patients in control group didn't keep the pancreatic capsule. Comparison of the clinical effect between the 2 groups was performed.
ResultsThe blood loss[(134.1±5.3) mL vs. (150.3±3.7) mL] and operation time[(76.4±5.7) min vs. (87.5±9.1) min]of experimental group were all lower or shorter than those of control group (P<0.05), but there were no significant difference between the 2 groups in incidence of total complication[7.37% (7/95) vs. 10.71% (12/112)], stomal leak[3.16% (3/95) vs. 4.46% (5/112)], and anastomotic stenosis[4.21% (4/95) vs. 6.25% (7/112)], P>0.05. All of the 207 patients were followed-up for 1-36 months, with the median time of 17.5 months. During the follow-up period, in experimental group, there were 30 patients suffered from recurrence, 23 patients suffered from metastasis, and 44 patients died, and the 1-and 3-year survival rates was 84.21% (80/95) and 53.68% (51/95) respectively, 1- and 3-year disease free survival rates was 80.00% (76/95) and 48.42% (46/95) respectively; in control group, there were 37 patients suffered from recurrence, 23 patients suffered from metastasis, and 49 patients died, and the 1-and 3-year survival rates was 85.71% (96/112) and 56.25% (63/112) respectively, 1-and 3-year disease free survival rates was 81.25% (91/112) and 49.11% (55/112) respectively. There were no significant difference in the 1-and 3-year survival rate, 1-and 3-year disease free survival rate (P>0.05). In addition, there were no significant difference in the survival and disease free survival situation (P>0.05).
ConclusionsSurvival and disease free survival situation of keeping the pancreatic capsule in radical gastrectomy is similar with traditionally radical gastrectomy, but surgery of keeping the pancreatic capsule in radical gastrectomy has the advantages of less bleeding and shorter operation time, which is worthy of further study.
ObjectiveTo observe the clinical features and treatment outcomes of patients with intraocular foreign bodies with endophthalmitis, and analyze the prognostic factors affecting the anatomic and visual outcomes of patients. MethodsA retrospective clinical study. A total of 1 704 patients (1 704 eyes) with intraocular foreign body at Eye Hospital, Wenzhou Medical University from January 2015 to June 2024 were included in this study. Endophthalmitis was diagnosed in 263 eyes (15.4%, 263/1 704). Patients who lost follow-up in our hospital after surgery were excluded, 155 patients with 155 eyes were finally included in the study. Uncorrected visual acuity (UCVA) examination was performed before operation. Best corrected visual acuity (BCVA) examination was performed both after the first stage debridement and during follow-up. The visual acuity test is performed using a standard logarithmic visual acuity chart, which is statistically converted to logarithm of the minimum angle of resolution (logMAR) visual acuity. Demographic characteristics (gender, age), trauma characteristics (time of injury, occupation characteristics, nature of foreign body), anatomical injury (wound zoning, nature of infection, etc.), clinical treatment (interval between operation and injury, rate of second operation, etc.) and outcome (vision outcome, complications, anatomic outcome, etc.) were recorded. Prophylactic intravitreous injection of 10 mg/ml of cefazolin sodium 0.1 ml (including 1 mg of cefazolin sodium) was given on the basis of perioperative systemic administration of cefazolin sodium from 2022. Anatomical outcomes included anatomical reduction, silicone oil-dependent, and ophthalmectomy. The visual outcomes of the patients were categorized into three groups based on the best-corrected visual acuity at the final follow-up: visual acuity worse than 0.05, visual acuity between 0.05 and 0.3, and visual acuity better than 0.3. Generalized linear mixed model (GLMM) was used to analyze the correlation between the timing of treatment, nature of foreign body, nature of infection, number of operations, location of injury and the anatomic and visual outcomes of patients. ResultsOf 155 patients, 149 were males and 6 were females, mean age was (45.7±12.9) years, patients with monocular injury. Magnetic, non-magnetic, unidentified metal and vegetable, mineral, animal and unidentified foreign bodies were 102 (65.8%, 102/155), 2 (1.3%, 2/155), 28 (18.1%, 28/155), 1 (0.6%, 1/155), 12 (7.7%, 12/155), 7 (4.5%, 7/155), 3 (1.9%, 3/155) cases, respectively. The time between injury and removal of foreign body was (98.1±359.5) h. The foreign bodies were removed in 136 eyes (87.2%, 136/155) in the primary surgery, 67 cases combined with debridement and suture, 68 cases combined with pars plana vitrectomy (PPV), and 1 case suffered ophthalmectomy. The slide and culture results revealed that the eyes positive for bacteria and those positive for a mixed infection of bacteria and fungi were 80 (51.2%, 80/155) and 2 (1.3%, 2/155) eyes, respectively; 73 eyes (46.8%, 73/155) were negative. Among the 80 eyes positive for bacteria, staphylococcus epidermidis and bacillus cereus were found in 26 (32.5%, 26/80) and 23 (28.8%, 23/80) eyes, respectively. Drug sensitivity testing indicated that vancomycin, gentamicin and amikacin had low drug resistance (1.79%, 6.67%, 0.0%, respectively). The mean preoperative logMAR UCVA was 1.67±0.79. In the outcome of visual function, 78, 26 and 51 patients with visual acuity ＜0.05, 0.05-0.3, ＞0.3, respectively. At the last follow-up, there were 56 cases (36.1%, 56/155) of silicone oil dependence, 93 cases (60%, 93/155) of anatomic reduction, and 6 cases (3.9%, 6/155) suffered ophthalmectomy, the mean intraocular pressure was (13.6±6.1) mm Hg (1 mm Hg= 0.133 kPa). Preoperative visual acuity was strongly correlated with visual outcomes (F=6.896, P=0.001). Preoperative visual acuity (F=5.310, P=0.023) and surgical method (F=20.448, P＜0.001) were closely related to the anatomical outcome, while age, treatment time, foreign body nature, wound zoning, infection nature, and foreign body removal time had no statistical correlation with the anatomic and functional outcome (P＞0.05). During 2015 to 2024, the incidence of intraocular foreign body-related endophthalmitis was 12.5%-22.7%, which showed a fluctuating upward trend. The incidence of endophthalmitis increased during 2022 to 2024 compared with the period from 2019 to 2021, but no statistically difference was found (χ2=3.856, P=0.05). ConclusionsThe incidence of intraocular foreign body related endophthalmitis was 15.4%. Staphylococcus epidermidis and Bacillus cereus are the first and second pathogenic bacteria. The incidence of endophthalmitis is not significantly reduced with intravitreal injection of cefazolin sodium. Preoperative UCVA and surgical method were closely related to the anatomic outcome of patients.
ObjectivesTo evaluate the reporting status of conflict of interest and economic evidence in Chinese clinical practice guidelines published in 2017 and to provide implications for the guideline development in China.MethodsCNKI, WanFang Data and Google Scholar were electronically searched to collect clinical practice guidelines published in 2017 from January 1st to December 31st, 2017. Two authors independently screened literature, extracted information of interest, such as conflict of interest disclosure and economic evidences, then, the analysis was performed by using the Microsoft Excel 20013 software.ResultsA total of 53 guidelines were included; in which, 14 (26.42%) disclosed conflict of interest, 10 (18.87%) stated sources of funding, and 6 (11.32%) mentioned economics evidence.ConclusionIn China, inadequate attention is addressed to the conflict of interest disclosure and economics evidence during the development of clinical practice guidelines. We propose the inclusion of conflict of interest and economics evidence disclosure in clinical practice guidelines, which will improve their objectivity, independence, and transparency.
To explain how to treat common gastric diseases like chronic gastritis, peptic ulcer, functional dyspepsia and gastric oesophageal reflux disease (GORD) based on evidence-based medicine. Through this paper, we try to help readers find and use clinical evidence to solve clinical problems.
Objective To provide the anatomic bases for clinical application of the second dorsal metacarpal artery(SDMA) island flap with double pivot points. Methods The origin,branches and distribution of the recurrent cutaneous branch of the SDMA were observed in 30 adult fresh cadaver specimens, which were illustrated with special dye.Eighteen cases of skin defets of the thumb were repaired with the SDMA island flap. The defect locations were the dorsal part in 11 cases and palmar part in 7 cases, including 3 cases of defect in association with long pollical extensor defect and 2 cases of defect in association with dorsal skin defect of proximal finger. The flap area ranged from 2 cm×3 cmto 3 cm×5 cm. Results The appearance of therecurrent cutaneous branch of the SDMA was observed in all cases(100%), which originated 0.5±0.2 cm distant from the distal intersectiones between the SDMA and the index extensor and disappeared 1.2±0.5 cm distant from the proximal metacarpophalangeal joint. The branches of 1.7±0.7 were seen with a longitudinal fan-like distributionforward proximal part on the deep surface of the dorsal superficial vein. The exradius and the length of the recurrent cutaneous branch of the SDMA were 0.3±0.1 mm and 6.5±0.8 mm, respectively. The transplanted flaps survived in all cases and 16 cases were followed up for 8-14 months. The colour and appearance of the skin were satisfactory. The two-point discriminations were 0.9 mm in 3 cases by bridging digital nerve and 1.1 mm in 9 cases by anastomosing dorsal digital nerve; while the two-point discrimination was 13-15 mm in 4 cases without anastomosing nerve. Conclusion The origin,branches and distribution of the recurrent cutaneous branch of the SDMA is constant, which provide a potentially longer pedicle and increase the possibility to rotate the flap and also avoid the donor skin defect of rotation of the flap.
ObjectiveTo analyze the clinical characteristics and epidemiological characteristics of patients with coronavirus disease 2019 treated early in Jiangxi province.MethodsFour-night patients with coronavirus disease 2019 treated in this hospital from January 21st to 27th, 2020 were included in this study. The epidemiological and clinical data of patients after admission were collected, and laboratory tests such as blood routine, urine routine, stool routine, liver and kidney function, electrolytes, myocardial enzymes, erythrocyte sedimentation (ESR), C-reactive protein (CRP), calcitonin, coagulation, T cell subset and Chest CT were reviewed. The clinical results of common and severe/critically ill patients were compared.ResultsOf the 49 patients, 40 were common and 9 were severe/critical. Fourty-six patients had a clear history of contact with Wuhan or other areas of Hubei. The sex ratio was 2.06∶1, and the average age was 42.9 years. The symptoms were mainly fever (78.7%), cough (38.8%), and fatigue (18.4%). 28.6% (14 cases) of patients had hypertension and diabetes. Serum lymphocyte count and calcium concentration of the patients were decreased, but lactate dehydrogenase, ESR, CRP and serum amyloid A were increased in these patients. T lymphocyte subsets (CD3+, CD4+, CD8+) decreased significantly in these patients. Forty-seven patients (95.9%) had single or scattered patchy ground glass density shadows on the chest CT. Compared with common patients, the patients with severe/critical patients were older (P=0.023), hospitalized later (P=0.002), and had higher comorbidities (P=0.017). ESR (P=0.001）, CRP (P=0.010) and the serum amyloid A (P=0.040) increased significantly, while CD3+ (P<0.001), CD4+ (P=0.012), CD8+ (P=0.006) decreased significantly in severe/critical patients.ConclusionsThe patients with coronavirus disease 2019 in Jiangxi province are commonly imported from Wuhan. Severe/critical patients are older, hospitalized later, and have more medical complications and more severe systemic inflammatory reactions than common patients.
