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.
Objective To share the experience of the diagnosis and treatment of children with hand-foot-mouth disease. Methods We retrospectively analyzed 31 children with hand-foot-mouth disease in our hospital from April 2007 to June 2007 in terms of epidemiology, clinical features, treatment and prognosis. Results The average age of the children was 2.8 years, and 20 out of the 31 cases were from nurseries and kindergartens. Eighteen had clear contact history. Typical signs and symptoms, including oral ulcerative herpes and blister-like rash in extremities, were found in all cases. All the children were cured after timely diagnosis and early treatment with ribavirin, without any severe complications. Conclusion Timely treatment based on early diagnosis and considerate care are important for children with hand-foot-mouth disease. Nurseries, kindergartens and primary schools should attach great importance to relevant prophylaxis and isolation. These are essential for reducing the occurrence and prevalence of this disease.
Objective To evaluate the characteristics, classification, treatment methods, and cl inical outcomes of the spoke heel injuries in children. Methods From June 2001 to June 2008, 289 children with bicycle or motorcycle spoke heel injuries were treated, including 179 males and 110 females aged 2-12 years old (average 3.9 years old). There were 179 cases of skin contusion and laceration (type I), 83 cases of skin and soft tissue defect with Achilles tendon exposure (type II), and 27 cases of wide skin and soft tissue defect with the Achilles tendon defect and rupture (type III). The defect size of the skin or the soft tissues ranged from 3 cm × 2 cm to 11 cm × 7 cm in type II and type III injury. The time between injury and hospital admission was 1-53 days (average 14.5 days). Child patients with type I injury were managed with dressing or suturing after debridement. For the child patients with type II injury, the wound was repaired with the regional fascia flap in 53 cases, the reverse sural neurocutaneous vascular flap in 19 cases, the reverse saphenous neurocutaneous vascular flap in 9 cases, and the lateral supramalleolar flap in 2 cases. For the child patients with type III injury, 6 cases underwent primary repair of the Achilles tendon followed by the transposition of the reverse sural neurocutaneous vascular flap, 3 cases received primary repair of the wound with the reverse sural neurocutaneous vascular flap and secondary reconstruction of the Achilles tendon with the upturned fascia strip or the ipsilateral il iotibial tract transplant, and 18 cases underwent primary repair of the wound and the Achilles tendon with the sl iding bi-pedicled gastrocnemius musculocutaneous flap. The flap size ranged from 4 cm × 2 cm to 30 cm × 12 cm. All the donor sites were closed bypartial suture and spl it-thickness skins graft. The lower l imbs were immobil ized with plaster spl ints after operation. Results All the flaps survived except for 1 case of type II suffering from distal flap venous crisis 3 days after operation and 6 cases of type III suffering from distal flap necrosis 3-5 days after operation. All those flaps survived after symptomatic treatment. All the skin grafts at the donor site survived uneventfully. All the wounds healed by first intention. All child patients were followed up for 15-820 days (average 42 days). Child patients with type I and type II injury had a full recovery of ankle functions. While 25 cases of type III injury had ankle dorsal extension degree loss (10-30°) and unilateral plantar flexion strength decrease 3 months after operationwithout influence on walking, and 2 cases recovered well. Conclusion Spoke heel injury in children has special mec hanisms of injury, and the choice of proper treatment method should be based on the types of injury.
ObjectivesTo systematically review the efficacy of absorbable barbed suture versus traditional absorbable suture in total knee arthroplasty (TKA).MethodsPubMed, EMbase, The Cochrane Library, CBM, WanFang Data, CNKI and VIP databases were electronically searched to collect clinical trials of absorbable barbed suture versus traditional absorbable suture in TKA from inception to November, 2017. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 randomized controlled trials (RCTs) and 5 cohort studies were included, involving 2 008 patients. Meta-analysis showed that the joint capsule suture time of the absorbable barbed suture group [MD=–4.31, 95% CI (–4.72, –3.90), P<0.000 01], the incidence of acupuncture injury during suture [OR=0.14, 95% CI (0.03, 0.61),P=0.009], and incision complication rate [OR=0.56, 95% CI (0.36, 0.88), P=0.01] were significantly lower than the traditional absorbable suture group, but the incidence of suture fracture [OR=23.03, 95% CI (3.08, 172.09),P=0.002] was higher, yet the difference was statistically significant. There were no significant differences in the incidence of superficial infection, deep infection, aseptic redness, incision dehiscence and KSS score at 3 months after operation (P>0.05).ConclusionsAvailable evidence suggests that the use of absorbable barbed sutures to close the TKA surgical incision shortens the time to suture the joint capsule, reduces the incidence of acupuncture injury as well as the overall incidence of incision complications without increasing superficial infection, deep infection, and sterility. The incidence of redness and incision splitting has no significant effects on joint function at 3 months after surgery, however the incidence of suture fracture is higher. Due to limited quality and quantity of the included studies, the above conclusions are required to be verified by more high-quality studies.
Evidence-based medicine (EBM) practice requires high-quality evidence. With the rigorous and systematic processes including legislation, literature search, literature screening, literature quality assessment, data collection, data analysis, results interpretation and original evaluation updating, the systematic review/meta-analysis is recognized as the clinical evidence with highest intensive argument for reasons of ensuring the authenticity and reliability of the findings and conclusions. Before it is applied to the specific clinical practice, a clinical doctor has to evaluate whether its results are applicable to patients or not, whether it contains all possible important results or not, whether the diagnosis and treatment benefiting from its interventions are clinically significant to patients or not, and additionally, has to take the treatment expense and patient’s value orientation into consideration. EBM clinical practice occurs for demands, and updates consciously for its authenticity, patient’s individuation and disease complexity. It has a broad development space for no other reason than its defect and imperfection.
Objective To compare the balance of simple randomization, stratified blocked randomization and minimization. Methods Monte Carlo technique was employed to simulate the treatment allocation of simple randomization, stratified blocked randomization and minimization respectively, then the balance of treatment allocation in each group and the balance for every prognostic factor were compared. Results The simulation demonstrated that minimization provides the best performance to ensure balance in the number of patients between groups and prognostic factors. Balance in prognostic factors achieved with stratified blocked randomization was similar to that achieved with simple randomization. Conclusion Minimization offers the best balance in the number of patients and prognostic factors between groups.
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.