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.
ObjectiveTo investigate the clinical characteristics and prognosis of cerebral hemorrhage in young and elderly patients, to provide evidences for individual clinical diagnosis and treatment, and lay a foundation for building a predictive model of prognosis in cerebral hemorrhage.MethodsPatients with spontaneous cerebral hemorrhage in the Third People’s Hospital of Chengdu were recruited prospectively and continuously from January 2014 to January 2019. They were divided into the youth group (≤50 years old) and the elderly group (>50 years old), and their risk factors, disease characteristics, etiology, and prognosis were analyzed.ResultsA total of 757 patients were recruited. There were 160 cases (21.1%) in the youth group, including 120 males and 40 females, aged from 17 to 50 years, with an average age of (42.06±7.62) years old; 597 cases (78.9%) in the elderly group, including 361 males and 236 females, aged from 51 to 96 years, with an average age of (69.34±10.56) years old. The incidences of hypertension (74.2% vs. 51.2%), diabetes (15.1% vs. 4.4%), coronary heart disease (12.1% vs. 1.3%), and the level of blood glucose at admission [7.1 (5.8, 8.4) vs. 6.3 (5.3, 8.1) mmol/L] in the elderly group were higher than those in the youth group (P<0.05), respectively. However, the proportions of males (60.5% vs. 75.0%), smoking (24.5% vs. 36.9%), and the diastolic blood pressure at admission [(92.37±18.50) vs. (100.95±25.25) mm Hg (1 mm Hg=0.133 kPa)] in the elderly group were lower than those in the youth group (P<0.05), respectively. There was no significant difference between the two groups in systolic blood pressure at admission, Glasgow Coma Score, National Institutes of Health Stroke Scale score, initial hematoma volume, hematoma enlargement, brain hernia, location of hemorrhage, midline shift, hydrocephalus, combined subarachnoid hemorrhage, or intraventricular extension (P>0.05). Hypertension was the most common etiology in the two groups. There was a significant difference in the etiology of cerebral hemorrhage between the two groups (P<0.05), the difference was mainly reflected in cerebral amyloid angiopathy, cavernous hemangioma, and arteriovenous malformation. The fatality rate during hospitalization (9.4% vs. 20.9%), 3 months after discharge (10.3% vs. 26.3%), and at 1 year follow-up (19.0% vs. 37.6%) in the youth group was lower than that in the elderly group (P<0.05), respectively. The disability rate 3 months after discharge and at 1 year follow-up in the youth group was lower than that in the elderly group (32.1% vs. 44.2%, 16.9% vs. 34.4%; P<0.05), respectively.ConclusionsThe education of healthy lifestyles should be strengthened to reduce the adverse effects of smoking in young patients. Young patients should choose antihypertensives that can control diastolic blood pressure better. There are more structural abnormalities in young patients, so routine vascular examination is reasonable. It is necessary to focus on whether the original underlying diseases are stable in elderly patients. Cerebral amyloid angiopathy is an important cause of cerebral hemorrhage in elderly patients, and is a risk factor of recurrence. Anticoagulation or antiplatelet therapy should be cautious.
ObjectiveTo explore the clinical and video EEG features of patients with post-stroke epilepsy (PSE).MethodsThe clinical data of 68 patients with epilepsy after cerebral infarction and 33 patients with epilepsy after cerebral hemorrhage were analyzed retrospectively from January 2015 to June 2018 in the Affilated Hospital of Jining Medical University. There were 5 cases of early-onset epilepsy, and the rest were late-onset epilepsy. There were 68 cases of cerebral infarction (1 case showed post-infarction hemorrhagic transformation), 33 cases of cerebral hemorrhage; 51 females, 50 males (f∶m = 1.02∶1); the onset age was 45 ~ 101 years, with an average of (68.10 ± 10.26) years.ResultsThe time from seizure to stroke in 101 cases was (28.92 ± 35.61) months, 60 cases (59.40%) ≤ 1 year, 26 cases (25.74%) 1 ~ 5 years, and 15 cases (14.85%) 5 ~ 10 years. Post-stroke epilepsy had no relation to gender (P>0.05). The age of onset is mostly in 60 to 75 years old (62.38%). Seizure often happen within 1 year after stroke (59.4%). The type of attack is focal seizure (77.23%). Cortical infarction (77.94%), cerebral artery stenosis (83.82%), hypertension, diabetes, and atrial fibrillation are risk factors for epilepsy after infarction. The abnormal rate of EEG for PSE is 90.1%, which was manifested as slow wave in the lesion side, epileptic wave in the lesion side or contralateral side.ConclusionsThe location, duration, age and severity of cerebral artery stenosis in patients with PSE are closely related to the occurrence of seizure. VEEG plays an important role in the diagnosis, treatment and prognosis of epilepsy.
Objective To analyze the significance of operation date in clinical path designing of cleft lip-palate. Methods The case records of cleft lip-palate patients from 8 hospitals in Gansu province were collected from 2005 to 2008. By means of comprehensive analysis of case records and frequencies of hospitalization duration, analyzed the influence of operation date selection on hospitalization duration in clinical path designing. Result In Gansu province, the average hospitalization duration of cleft lip-palate was 11 days, and the operation was usually done at the sixth day. The main preparations for operation were kinds of examinations. Within five days after operation, most treatments were postoperative care, diet and antibiotic therapy. Conclusion The strategy of operation date selection is much important to ascertain the real hospitalization duration in clinical path designing.
Objective To investigate the clinical typing and their relevant surgical treatment principle and method of pressure sore. Methods From January 1983 to April 2006, 122 patients with 179 pressure sores were treated. There were 93 males and29 females, aging 1568 years. The pressure sores were located at sacrococcygeus (54 lesions), petrochanteric region (37 lesions), ischial tuberosity (30 lesions), heel (17 lesions), olecranon (15 lesions), scapula (9 lesions), lateral malleolar (7 lesions), caput fibulace (4 lesions), pretibial (3 lesions), and lumbar region (3 lesims)respectivly. The disease course was from 2 months to 11 years. The areas of pressure sores were from 1.5 cm× 1.0 cm to 20.0 cm×18.0 cm. According to the wound characteristics, the pressure sores were divided into three types：sinus type（12/179）, ulcer type （74/179） and mixed type（93/179）.Aimed at different types of pressure sore, skin grafting, skin flap and myocutaneous flap were employed to repair wound. The areas of flaps were from 5.0 cm×3.5 cm to 26.0 cm×14.5 cm. The areas of skin grafting were from 7 cm×5 cm to 23 cm×12 cm. Results All wounds of sinus type healed by firstintention except one; and all flaps survived. All wounds of uler type healed byfirst intention; and the flaps survived completely except two which had a partial necrosis. All flaps which harvested to repair 93 pressure sores of mixed typewere survived. But one or two sinus occurred in 8 cases. Two healed by operation, and the others healed by dressing exchange. The wounds healed by first intention. The donor sites healed by first intention. The routine followup in 73 patients after 6 months showed that the recurrence appeared in 4 mixed type. The recurrence rate was 55% and the other patients had good outcome. Conclusion Clinical typing of pressure sore is helpful to select the suitable operation method and improve the rate of success.
ObjectiveTo compare drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, completion and results publication.MethodsWe randomly selected 190 clinical trials that were registered in ClinicalTrials.gov from 2009 to 2014, and followed up to December 31st, 2019. Comparisons were made for the type of sponsor, phase, design, and completion status by the sponsor’s country.ResultsAmong all included clinical trials, trials from the United States, Europe, Japan and China accounted for 50.5%, 34.2%, 9.0% and 6.3%, respectively. Among these trials, 71.1% had been completed and 69.5% disclosed results had been published publicly prior to the end of follow-up, and differences between countries were statistically significant (P<0.05). Two-thirds of the trials in China were phase Ⅲ/Ⅳ trials; in contrast, most of the clinical trials in the United States and Europe were phase Ⅰ/Ⅱ trials. The proportion of using double-blind, randomized controlled trial design was the highest in the United States (46.9%) and the lowest in China (8.3%). Chinese sponsors were mostly hospitals/universities (58.3%), while in other countries drug trials were mostly sponsored by the industry and in Japan the proportion was as high as 94.0%.ConclusionsThe number of drug trials registered in ClinicalTrials.gov from China is small and these trials are less likely to be completed and have results published/disclosed. Pharmaceutical companies in China should pay more attention to the public registration of their clinical trials, particularly those in early phases, and improve trial design and management.
ObjectiveTo explore the clinical effect and safety of laparoscopic cytoreductive surgery combined with gestrinone in the treatment of adenomyosis. MethodsWe retrospectively analyzed the clinical data of 82 patients with adenomyosis who accepted treatment in our hospital from January 2008 to April 2011. According to different treatment method, the patients were divided into three groups. Twenty-seven patients in the treatment group underwent laparoscopic cytoreductive surgery combined with postoperative treatment with gestrinone. For the 25 patients in the surgery group, only laparoscopic cytoreductive surgery was performed, and 30 other patients who only received oral gestrinone were designated as the medicine group. Dysmenorrhea, menstrual volume, uterine size, serum carcinoembryonic antigen 125 (CA125), anemia, and drug side effects were respectively recorded before and after surgery. ResultsThe dysmenorrhea degree reduced significantly in all the three groups. There was no significant difference in the degree of dysmenorrhea, menstrual volume, and uterine volume between the treatment group and the surgery group (P>0.05); the dysmenorrhea degree was significantly different between the treatment group and the medicine group (P<0.05); the differences in hemoglobin levels and the serum CA125 level between the treatment group and the surgery group 12 months later were significant (P=0.019, P=0.049). ConclusionThe laparoscopic cytoreductive surgery combined with gestrinone in treating adenomyosis can improve recent curative effect and provide more effective symptom control compared with surgery alone.
Objective To evaluate the effect of vitamin A (Vit A) supplementation on the morbidity and mortality in children with infectious diseases. Methods We searched Cochrane Library (Issue 1, 2004), MEDLINE (1966-2004.3) and The PedsCCM Evidence-Based Journal Club (1992-2002). Relevant systematic reviews and randomized controlled trials (RCTs) of Vit A supplementation on morbidity and mortality in children with infectious diseases were obtained. Results We collected 107 studies and identified 13 systematic reviews or RCTs. The evidence showed that the effect of Vit A supplementation on morbidity and mortality was affected by the nutritional status of the children. Vit A supplementation given to Vit A deficient children could reduce the morbidity of diarrhea and mortality of measles. However, Vit A supplementation would increase the morbidity of diarrhoea and respiratory infections in children with sufficient nutrition. Conclusions The nutritional status of children correlates with morbidity and mortality of some infectious diseases, and the nutritional status and serum Vit A level should be evaluated before Vit A supplementation applied.
ObjectiveTo evaluate the quality of guidelines for the management of delirium in adult patients in the last ten years, so as to provide references for updating, selection, implementation guidelines and delirium management optimization.MethodsWe searched guidelines from databases including PubMed, EMbase, WanFang Data and CNKI, and websites of guidelines from January 1st 2010 to September 1st 2019. Guidelines were comprehensively screened, evaluated based on AGREE Ⅱ and data was independently extracted by two researchers.ResultsGuidelines of NICE, RNAO and SIGN had higher scores, while CSCCM’s and IPS’s gained lower. Among domains of AGREE Ⅱ, Domain I (scope and purpose) and IV (clarity of presentation) scored the highest, with a minimum of Domain Ⅱ (stakeholder involvement) and V (applicability). Delirium management focused on screening, prediction, prevention and treatment both pharmacologically and non-pharmacologically, and information support.ConclusionsFuture development of delirium guidelines should follow the methodology of guideline development, update or adjustment, and dedicate to every domain, especially domain of application. Medical staffs can establish our own domestic guidelines based on high quality guidelines, to promote knowledge translation and delirium management.
ObjectiveTo investigate the influence of misplaced subclavian vein (SCV) catheter into the ipsilateral internal jugular vein (IJV) on transpulmonary thermodilution (TPTD) measurements and explore the possible mechanisms preliminarily.MethodsIn this prospective study, 408 patients in whom an SCV catheterization was indicated for TPTD monitoring were enrolled. A first set of TPTD measurements was collected at baseline in all patients (group 1, SCV catheters were correctly placed; group 2, SCV catheters were misplaced into the ipsilateral IJV). The parameters included mean transit time (MTt), downslope time (DSt), cardiac index (CI), global end-diastolic volume index (GEDVI) and extra-vascular lung water index (EVLWI). A second set of TPTD measurements was performed only in those with catheter misplacement immediately after the misplaced SCV catheters being corrected (Group 3). The differences in MTt, DSt, GEDVI and EVLWI between group 2 and 3 were recorded as ΔMTt, ΔDSt, ΔGEDVI and ΔEVLWI, respectively.ResultsGEDVI and EVLWI were significantly higher (all P<0.001) in group 2 than those in group 1, while CI was not significantly different (P>0.05) between these two groups. Multivariate logistic regression identified PaO2/FiO2 [adjusted odds ratio (OR) 1.492/10 mm Hg; 95% confidence interval (CI), 1.180 - 1.884; P<0.001], GEDVI (OR=1.307/10 mL/m2, 95% CI 1.131 - 1.511; P<0.001) and EVLWI (OR=3.05; 95%CI 1.593 - 5.840; P<0.001) as the 3 independent factors associated with the misplacement of SCV catheter into the ipsilateral IJV. In group 2, GEDVI [(1041±122)mL/m2 vs. (790±102)mL/m2, P<0.001], EVLWI [(20.3±4.0)mL/kg vs. (10.3±2.3)mL/kg, P<0.001], CI [(3.6±1.2)L·min–1·m–2 vs. (2.9±1.0)L·min–1·m–2, P<0.001], MTt [(38.2±13.3)s vs. (30.8±9.4)s, P<0.001] and DSt [(18.9±7.2)s vs. (13.2±4.9)s, P<0.001)] were significantly higher than those in Group 3. Multiple regression analysis demonstrated that ΔEVLWI (R2=0.86, P<0.001) was negatively correlated with ΔMTt (coefficient±SE, –0.52±0.12; P<0.001) and positively correlated with ΔDSt (coefficient±SE, 1.45±0.17; P<0.001).ConclusionsDuring TPTD measurements, indicator injection through an SCV catheter misplaced into the ipsilateral IJV results in an overestimation of CI, GEDVI and EVLWI. The increase in DSt might be a key factor in explaining the overestimation of EVLWI in patients with misplaced SCV catheters. Given that the accurate measurements of GEDVI and EVLWI are of utmost importance for guiding resuscitation and decision-making regarding fluids administration, immediate repositioning is required if a misplacement is suspected and confirmed by the chest X-ray.