Objective To evaluate the results of operative treatment of acetabular fractures and to investigate its influence factors. Methods The cl inical data were analyzed retrospectively from 82 patients with acetabular fractures treated between September 2004 and June 2009. Of 82 patients, 65 were male and 17 were female, aged 26-72 years (mean, 38 years).Fractures were caused by traffic accident in 62 cases, by crush in 13 cases, and by fall ing from height in 7 cases. The time from injury to admission was 30 minutes to 12 days (median, 7.6 hours) in 70 cases, 12 cases were transferred because poor result after 34-67 days of conservative treatment. According to Judet classification, there were 24 cases of posterior wall fracture, 3 cases of posterior column fracture, 1 case of anterior wall fracture, 2 cases of anterior column fracture, 6 cases of transverse fracture, 16 cases of transverse and posterior wall fracture, 4 cases of posterior column and posterior wall fracture, 5 cases of T-type fracture, 3 cases of anterior and posterior hemitransverse fracture, and 18 cases of complete both-column fracture; 24 cases combined with dislocation of the hip. During operation, Kocher-Langenbeck approach was used in 49 cases, anterior il ioinguinal approach in 19 cases, and the combination of anterior and posterior approaches in 14 cases. Reconstructive plate (74 cases) and hollow lag screw (8 cases) internal fixation were used. The function of the hip was evaluated according to the modified Merled’Aubigne- Postel hip score system postoperatively. According to fracture type, age, lower extremity fracture before operation, qual ity of reduction, timing of surgery, hi p dislocation and time of reduction, operative approach, deep vein thrombosis (DVT), and heterotopic ossification (HO), the patients were divided into the groups and the results were compared. Results Accordancewith the Matta X-ray evaluation criteria, anatomic reduction was achieved in 21 cases, good reduction in 37 cases, fair reduction in 16 cases, and poor reduction in 8 cases, and the excellent and good rate was 71%. All the cases were followed up 12-52 months mean, 34 months). Iatrogenic sciatic nerve injury occurred in 8 cases, infection in 3 cases, HO in 16 cases, DVT in 3 cases, hip posttraumatic arthritis in 12 cases, and avascular necrosis of the femoral head in 9 cases. X-ray examination showed that 80 cases achieved fracture union at 10-24 weeks after operation (mean, 14 weeks) and 2 cases had fracture delayed union at 10 months and 12 months after operation. According to the modified Merled’Aubigne-Postel hip score system, the function of the hip was rated as excellent in 26 cases, good in 32, fair in 20, and poor in 4 at 6 months after operation; the excellent and good rate was 71%. The affecting factors of cl inical results of acetabular fractures were fracture type, age, lower extremity fracture before operation, qual ity of reduction, timing of surgery, hip dislocation and time of reduction (P lt; 0.05). However the operative approach, DVT, and HO were not affecting factor of the acetabular fractures (P gt; 0.05). Conclusion Operative treatment of acetabular fractures has a satisfying therapeutic effect. Fracture type, age, lower extremity fracture before operation, qual ity of reduction, timing of surgery, hip dislocation, and time of reduction are risk factors affecting postoperative results.
Evidence-based evidence translated into health care services requires three conversion processes, preclinical research-clinical research-implementation research, which might take a very long time. In order to speed up the process of research results translated into daily medical practice and health policy, an effectiveness-implementation hybrid design combining the effectiveness research of clinical and implementation research was emerging. This paper introduced the concept, classification and application of effectiveness-implementation hybrid design, to provide references for researchers in this area.
Objective To evaluate the effectiveness of GnRH antagonist on vitro fertilization-embryo transfer (IVF-ET). Methods We searched CBMdisc (1979 to 2010), Wanfang (1994 to 2010), CNKI (1994 to 2010), VIP (1989 to 2010), PubMed (1997 to 2010), PML (1997 to 2010), FMJS (2000-2010), and 9 related journals to identify randomized controlled trials (RCTs) on the comparison between GnRH antagonist (GnRHA) and GnRH agonist (GnRHa). The quality of included trials was critically appraised. RevMan 4.2.7 software was used for statistical analysis. Results Six published RCTs involving 1 208 participants were included. Compared with the GnRHa group, stimulation duration in the GnRHA group was lower (WMD= –1.07, 95%CI –1.38 to –0.76), dose of gonadotrophins (Gns) in the GnRHA group was slightly lower (WMD= –0.49, 95%CI –1.63 to 0.66), endometrial thickness at the time of HCG administration was no significant difference in the two groups (WMD= –0.09, 95%CI –0.42 to 0.24), number of oocytes retrieved in the GnRHA group was lower (WMD= –1.80, 95%CI –2.48 to –1.12), OHSS rate in the GnRHA group was slightly lower (Peto OR= 0.77, 95%CI 0.35 to 1.72), pregnancy rate in the GnRHA group was slightly lower (Peto OR= 0.83, 95%CI 0.65 to 1.05), miscarraige rate as no significant difference in the two groups (Peto OR= 1.49, 95%CI 0.79 to 2.82). Conclusions Compared with GnRHa, GnRHA requires shorter stimulation duration and less Gn, less affected the pregnancy rate, and reduces the incidence of OHSS. The use of GnRHA in clinical practice is relatively flexible with good acceptability. GnRHA for the superovulation IVF-ET offers an alternative treatment. The above conclusion still needs more well-designed, multi-center, and large-scale RCTs to confirm and update.
Regulatory science of medical devices serves the scientific research and regulatory activities for supervision of medical devices. Principles of science and transparency and conduction of evidence-based study, which is advocated in Evidence-based science(EBS), also apply to regulatory science of medical devices, including using evidence-based scientific tools and methods to demonstrate the safety and effectiveness, as well as quality, efficacy and cost-effectiveness of total life cycle of medical products, target customers, and scope. EBS provides both new methods and tools for regulatory science for medical devices, and provides a new basis for further scientific regulatory decisions.
Objective To study the efficacy and adverse events of adjunctive perampanel in children with refractory epilepsy. Methods A prospective study was carried out in 45 children with refractory epilepsy, who were treated in our hospital from January 2020 to February 2021 using perampanel as an add-on treatment, with a criteria for enrollment and the starting dose of perampanel. Follow-up would be taken at once a month. Afte 3 months would check blood routine, liver function, kidney function and humoral immunity. The EEG was reviewed after 6 months. The initial dose of perampanel was 0.04 mg/(kg·d) (the maximum didn't exceed 2 mg/d), increasing by 0.04 mg/(kg·d) every two weeks, and the maximum maintenance dose didn't exceed 6 mg/d. The efficacy and adverse reactions of perampanel were evaluated by comparing the seizure frequency and EEG results before and after a 6-month add-on therapy.ResultsAmong the 45 children,complete seizure control was achieved in 7 cases after the therapy, and the seizure attacks were reduced in 26 cases, showing a total response rate of 73.3%. After the treatment, the epileptiform discharge of 28 children was reduced, and the effective rate was 62.22%. During the observation period, all the blood routine, liver function, kidney function,and humoral immunity of the children were normal.10 cases of adverse reactions occurred after the additional treatment of perampanel, and the adverse reaction rate was 22.22%. Conclusions Perampanel has good efficacy and safety in the add-on treatment of refractory epilepsy.
Objective To provide the objective basis for the evaluation of the operative results of vascularized greater trochanter bone flap in treating osteonecrosis of the femoral head (ONFH) by three-dimensional gait analysis. Methods Between March 2006 and March 2007, 35 patients with ONFH were treated with vascularized greater trochanter bone flap, and gait analysis was made by using three-dimensional gait analysis system before operation and at 1, 2 years afteroperation. There were 23 males and 12 females, aged 21-52 years (mean, 35.2 years), including 8 cases of steroid-induced, 7 cases of traumatic, 6 cases of alcohol ic, and 14 cases of idiopathic ONFH. The left side was involved in 15 cases, and right side in 20 cases. According to Association Research Circulation Osseous (ARCO) classification, all patients were diagnosed as having femoral-head necrosis at stage III. Preoperative Harris hip functional score (HHS) was 56.2 ± 5.6. The disease duration was 1.5-18.6 years (mean, 5.2 years). Results All incisions healed at stage I without early postoperative compl ications of deep vein thrombosis and infections of incision. Thirty-five patients were followed up 2-3 years with an average of 2.5 years. At 2 years after operation, the HHS score was 85.8 ± 4.1, showing significant difference when compared with the preoperative score (t=23.200, P=0.000). Before operation, patients showed a hip muscles gait, short gait, reduce pain gait, and the pathological gaits significantly improved at 1 year after operation. At 1 year and 2 years after operation, step frequency, pace, step length and hip flexion, hip extension, knee flexion, ankle flexion were significantly improved (P lt; 0.01). Acceleration-time curves showed that negative wave and spinous wave at acceleration-stance phase of front feet and hind feet in affected l imb were obviously reduced at 1 year and 2 years after operation. Postoperative petronas wave appeared at swing phase; the preoperative situation was three normal phase waves. Conclusion These results suggest that three-dimensional gait analysis before and after vascularized greater trochanter for ONFH can evaluate precisely hip vitodynamics variation.
Objective To systematically evaluate the effectiveness and safety of minimally invasive video-assisted thyroidectomy (MIVAT) and conventional open thyroidectomy (COT) in treatment of thyroid carcinoma without lymph node metastasis. Methods Databases including PubMed, EMbase, The Cochrane Library (Issue 3, 2015), WanFang, CBM, VIP and CNKI were searched to collect the randomized controlled trails (RCTs) and non-RCTs about MIVAT and COT in treatment of thyroid carcinoma without lymph node metastasis. The retrieval time was from inception to October 2015. The studies were screened according to the inclusion and exclusion criterias, and the data was extracted and the quality of studies was evaluated by 2 reviewers independently. Then the Meta-analysis was conducted by using RevMan 5.2 software. Results A total of 13 non-RCTs involving 3 083 cases were included. The results of Meta-analysis showed that: compared with COT group, operative time of MIVAT group was longer (MD=31.36, 95% CI: 27.68-35.03, P<0.05), hospital stay (MD=-0.16, 95% CI: -0.28--0.04, P=0.01) and length of scar (MD=-1.51, 95% CI: -1.63--1.39, P<0.05) of MIVAT group were shorter, but there was no significant difference in the incidences of transient hypocalcemia (OR=1.29, 95% CI: 0.93-1.78, P=0.13), transient laryngeal nerve palsy (OR=1.42, 95% CI: 0.93-2.17, P=0.11), hemotoma (OR=1.21, 95% CI: 0.64-2.29, P=0.56), recurrence (OR=0.61, 95% CI: 0.28-1.33, P=0.22), number of retrieved central lymph nodes (MD=-0.10, 95% CI: -0.98-0.78, P=0.82), and the size of tumors (MD=-0.02, 95% CI: -0.06-0.02, P=0.39) between the 2 groups. Conclusion MIVAT is safe and feasible in treatment of thyroid carcinoma without lymph node metastasis when its indications are strictly controlled.
Objective To evaluate the effectiveness of mifepristone concomitant with misoprostol for medical abortion. Methods We searched the related original studies worldwide, and controlled prospective studies and systematic reviews based on randomized controlled trials （RCTs）. Nine electronic databases were searched. Ten journals and reference lists of eligible studies were handsearched. Two reviewers independently screened the studies for eligibility, evaluated the quality, and extracted the data from eligible studies, with confirmation by cross checking. Any disputes were decided by a third person. Meta-analysis was conducted using statistical software RevMan 4.2. After heterogeneity test was done （α=0.05 ） , data without heterogeneity were pooled using a fixed effect model, and those with heterogeneity could be solved by sensitivity＂ analysis, subgroup analysis or random effect model. Results We found eight original trials （n = 3 348 ） that compared medical abortion with surgical abortion, nine trials （n =6 116） that investigating the effect of gestational ages on medical abortion, five trials （n = 1 934） on the use of mifepristone and two trials （n =2381 ） on intervals of administration of mifepristone and misoprostol were located. Quality of foreign studies was better than that of Chinese studies. Therate of complete abortion was higher in surgical abortion group than that in medical abortion group with odds ratio （OR） 0. 18 and 95% confidence interval （CI） 0. 11 to 0.27. The rate of incomplete abortion and abortion failure was higher in medical abortion group with OR 3.32, and 95% CI 1.79 to 6.17, OR 7.36, 95% CI 4. 17 to 12.98, respectively. The rate of complete abortion in the group with gestational age over 49 days was lower than that with gestational age under 49 days with OR 0.51 and 95% CI 0.43 to 0.61. The rate of incomplete abortion and abortion failure was higher in the group with gestational age over 49 days with OR 1.66, 95% CI 1.32 to 2.09 and OR 3.37, 95% CI 2.30 to 4. 94.There were no significant differences observed in the rates of complete abortion, incomplete abortion, abortion failed, time of expelling pregnant sac and time of menses recovery between the single and multi-dosage of mifepristone. Except for the rate of complete abortion, which was higher in 〈48h group, there was a comparable effectiveness for different intervals of mifepristone and ntisoprostol. Conclusions This review showes that it is important to improve the quality of Chinese original studies. Although the effectiveness is better in the surgical abortion group, the rate of complete abortion of medical abortion achieved is 91.6% （1 648/1 800）. This is acceptable for clinicians and women who do not want to be pregnance. The rate of complete abortion is lower in the gestation over 49 days, which had a statistically difference, but little clinical significance. It is necessary to consider increasing the gestational age of medical abortion, especially for those women who have contradictions of surgical abortion or are afraid of operation. Effectiveness of single dosage of mifeprostone is similar to that ofmulti-dosage, but single dosage might be more convenient. This review suggests that shortening the interval ofmifepristone and misoprostol administration should be considered and the best and shortest interval time need to be identified with better evidence.
ObjectiveTo evaluate the safety and efficacy of local sodium citrate anticoagulation for routine hemodialysis in high-risk patients with hemorrhage.MethodsA total of 150 patients who were admitted to West China Hospital from October 2018 to March 2019 for routine hemodialysis treatment with high-risk bleeding were selected as study objects. The patients were divided into without heparin anticoagulation group (group A) and with 4% sodium citrate anticoagulation group (group B) by random number table method, with 75 cases in each group. Biochemical indicators, serum calcium ion concentration, local anticoagulation safety index of citrate and dialysis adequacy index, blood coagulation in dialyzer and tube during dialysis wre observed in the two groups.ResultsThe coagulation events in group B were significantly lower than those in group A (Z=–4.889, P<0.001), and the urea clearance index in group B was higher than that in group A [(1.26±0.12) vs. (0.73±0.13) L/(min·1.73 m2); t=22.418, P<0.05]. There was a significant difference in the changes of urea nitrogen [(3.53±1.05) vs.(3.12±1.11) mmol/L; t=2.323, P=0.021] 24 hours after dialysis; other indicators showed no statistically significant difference (P>0.05). After the filter, serum calcium ion concentrations in group B at different time points were lower than those in group A [2 hours: (0.52±0.07) vs. (0.64±0.08) mmol/L; 4 hours: (0.56±0.09) vs.(0.63±0.09) mmol/L; t=5.198, 0.525, P<0.001], and the coagulation time was higher in group B than that in group A [2 hours: (172.56±14.78) vs. (151.45±19.81) s; 4 hours: (168.45±16.48) vs. (152.88±16.54) s; t=7.396, 5.775, P<0.001]. None of the patients had dialysis-related adverse events.ConclusionFour percent sodium citrate is effective and safe in anticoagulation therapy for hemodialysis patients, and it can reduce the risk of coagulation in dialyzer and ensure the adequacy of maintenance hemodialysis.
ObjectiveTo evaluate clinical curative effect of sphincter preservation method of improved minimally invasive surgery to primary cure for horseshoe-shaped perianal abscess. MethodsOne hundred and twenty hospitalized patients diagnosed as horseshoe-shaped perianal abscess were analyzed by prospective, random, single-blind, parallel-group design method, and were randomly divided into two groups, one group of sphincter preservation method of improved minimally invasive surgery (observation group), another group of traditional method of hanging line drainage and multiple incisions of radian shape (control group). The cure rate, long-term recurrence, postoperative pain score within 9 d, hospitalization time, incision healing time, scar area after healing, postoperative anal function score and perioperative and long-term complications were compared in these two groups. ResultsAll the operations were successfully completed in these two groups. There were 56 cases of primary healing in the observation group and 55 cases of primary healing in the control group. Compared with the control group, the postoperative pain score on day 2-4 or on day 7-9 was lower (P < 0.05), the incision healing time was shorter (P < 0.05), and the postoperative anal function score was lower (P < 0.05) in the observation group. There was no incision infection and hemorrhoea in these two groups. The hospitalization time, scar area after healing, incidence rate of urinary retention, hepatic and renal dysfunction, and the total white blood cells > 10.0×109/L had no significant differences between these two groups (P > 0.05). There was no long-term recurrence, anal stenosis, and anal incontinence during following-up of 6 months in these two groups. ConclusionPreliminary research results show that sphincter preservation method of improved minimally invasive surgery to primary cure for horseshoe-shaped perianal abscess has a reliable clinical curative effect, fast healing, and less postoperative complications.