Objective To study the efficacy and safety of combined anti-tuberculosis regimen containing bedaquiline in the treatment of multidrug-resistant tuberculosis (MDR-TB). Methods A total of 69 MDR-TB patients treated by joint regimen combined bedaquiline with other anti-tuberculosis drugs between March 2018 and August 2019 in Public Health Clinical Center of Chengdu were taken as the trial group, and 60 MDR-TB patients received treatment without bedaquiline between June 2016 and December 2017 in the same hospital were taken as the control group. The efficacy and safety of the two groups were compared. Results The 69 patients in the trial group included 44 males and 25 females, aged from 21 to 63 years, with an average of (34.6±11.0) years; 58 patients (84.1%) completed the 24-week treatment with bedaquiline, while 11 patients did not complete the treatment, including 3 deaths (4.3%), 1 loss of follow-up (1.4%), 1 withdrawal from the study (1.4%), and 6 discontinuation due to adverse events (8.7%). Among the 54 patients with positive results of tuberculosis on baseline sputum culture, 49 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 90.7%), and the median negative conversion time was 13.0 weeks. The 60 patients in the control group included 45 males and 15 females, aged from 16 to 66 years, with an average of (35.5±13.2) years. Among the 53 patients with positive results of tuberculosis on baseline sputum culture, 30 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 56.6%), and the median negative conversion time was 12.0 weeks. The negative conversion rate of sputum bacteria in the trial group was significantly higher than that in the control group (χ2=16.133, P<0.001). The most common adverse reactions in the trial group were liver function abnormalities (42 cases, 60.9%), prolonged QTc interval (37 cases, 53.6%), electrolyte disturbances (20 cases, 29.0%), and blood system damage (20 cases, 29.0%). In the 37 patients who experienced prolonged QTc interval, there were 8 patients with QTc intervals≥500 ms and 29 patients with QTc intervals ≥450 ms and <500 ms, with a median occurrence time of 16.0 weeks, among whom 25 patients experienced prolonged QTc interval in 4-48 weeks after the withdrawal of bedaquiline. Conclusion The negative conversion rate of tuberculosis sputum culture of patients with MDR-TB treated by bedaquiline combined with other anti- tuberculosis drugs is high, but electrocardiogram should be closely monitored during and after the treatment in order to guard against the potential cardiac toxic effects of bedaquiline.
ObjectivesThe primary objectives of this rapid health technology assessment (RHTA) were to assess the safety and effectiveness of Da Vinci surgical system compared with traditional e surgeries, so as to provide the currently-available best evidence for health decision makers and clinical workers. MethodsA comprehensive search of electronic databases (EMbase, PubMed, The Cochrane Library, Web of Science, CNKI, VIP, CBM and WanFang Data) and relevant professional HTA websites were conducted from inceptionto October 9, 2012. Two reviews independently screen literature according to the inclusion and exclusion criteria, extracted data, and assess the quality of included studies. The data based on secondary studies were reported, and a final recommendation and its level was made based on assessment outcome. ResultsA total of 21 studies were included, encompassing 7 HTAs and 14 systematic reviews/metaanalyses. The included studies involved radical prostatectomy, hysterectomy, nephrectomy, coronary artery bypass graft, and gastric fundoplication. Though the included HTAs and systematic reviews/meta-analyses focus on different diseases, the outcomes showed significant differences existed between Da Vinci surgical system and other routine surgery in clinical effectiveness and safety of different diseases. Compared with routine surgery, Da Vinci surgical system shortened hospital stay; decreased operation conversion rates, blood loss and blood transfusion rates during surgery; but it increased operative time. Besides, compared with traditional laparoscopic surgery, Da Vinci surgical system shortened operation time and hospital stay, and decreased operation conversion rates, blood loss and blood transfusion rates during surgery. ConclusionCurrent evidence shows that the clinical effectiveness and safety outcomes of Da Vinci surgical system differ in diseases. Currently, most included HTAs and systematic reviews/meta-analyses are based on observational studies, relevant prospective randomized controlled trials lack, and the evidence is graded as low quality, health decision makers are suggested to apply this evidence with caution on the basis of comprehensive consideration.
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.
ObjectivesTo explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.MethodsPubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.ResultsA total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.ConclusionsOPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.
Objective To assess the efficacy of lamivudine in patients with HBeAg positive chronic hepatitis B.Methods MEDLINE, SCI, Current Content Connect, The Cochrane Library, and Chinese Biomedical Database were searched from the beginning to September 2005, and the references of eligible studies were manually screened. R.andomized controlled trials comparing lamivudine with non-antiviral interventions （ placebo, no treatment and standard care ） in patients with chronic hepatitis B were eligible for inclusion. Two investigators independently assessed the quality and extracted the data. Heterogeneity was examined by Chi-square test. Fixed and random effect meta-analysis were used to pool the data. Subgroup analyses were used in treatment course. Results Eleven R.CTs were included （ n = 1 237 ）. All reported the effect of lamivudine （100 mg/d） , and one of them included lamivudine （25 mg/d）. The treatment duration of 52 weeks and less than 26 weeks were reported in eight and three RCTs, respectively. Six RCTs adequately applied randomization, while other five RCTs were not reported in detail. Four RCTs adequately enforced allocation concealment, five RCTs enforced blinding bitterly. The others were not reported in detail. It was found by meta-analysis that, compared with the control, lamivudine （100 mg/d, 52 W） could significantly clear HBeAg [42.6% vs. 13% , RR 3.20, 95% CI （2.33, 4. 38）] and clearHBVDNA [71.78% vs. 20, 36%, RR3.42, 95%CI （2.80,4.19）], normalize ALT [65% vs. 34.9%, RR1.91, 95%CI （1.64,2.21）], achieve HBeAgseroconversion [16.1% vs. 7.29% , RR2.12, 95%CI （1.24,3.80） ] and histology response [57. 9% vs. 26.2%, RR 2. 17, 95% CI （ 1.67,2.81 ） ] ; Lanfivudine （100 mg/ d, 12 W） could effectively clear HBV DNA [ 50.7% vs 3.92% , RR 8.68, 95% CI （1.72,43.74 ） ] , but was not effective in loss of HBeAg, HBeAg seroconversion and normalization of ALT, Lamivudine （25 mg/d） could effectively clear HBV DNA [97.7% vs. 22.2% , RR 4.41, 95% CI （2.86,6.79） ] and improve histology response [59.3% vs. 30% , RR1.98, 95% CI （1.31,2.99 ） ], but was not effective in HBeAg seroconversion. Conclusions Lamivudine （100 mg/ d） is effective in clearing HBV DNA and HBeAg, normalizing ALT and achieving HBeAg seroconversion.
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.
ObjectiveTo compare the effectiveness of haemocoagulase agkistrodon and tranexamic acid and sodium chloride in the prevention and treatment of perioperative bleeding in a real world setting. MethodsA research database was constructed based on the records of inpatient visits using haemocoagulase agkistrodon and tranexamic acid and sodium chloride according to the SuValue? database from January 1, 2016 to December 31, 2020. The patients were divided into two groups according to the different interventions. After matching with a 1∶1 propensity score, the effectiveness of two groups was compared. ResultsA total of 858 patients were included in each of the two groups, and there was no statistically significant difference in baseline characteristics between the two groups (P>0.05). Research results showed that patients using haemocoagulase agkistrodon had significantly reduced length of hospital stay, decrease in hematocrit, average estimated surgical bleeding, and decrease in hemoglobin (P<0.01). ConclusionHaemocoagulase agkistrodon has better effectiveness than tranexamic acid and sodium chloride for reducing perioperative blood loss based on current real world evidence.
Objective To evaluate the effectiveness of TCu380AIUD comparing with other common IUDs. Methods CBMDISC (1979 to 2005), Wanfang (1994 to 2005), CNKI (1974 to 2005), CMCC (1979 to 2005), CMAC (1994 to 2005), EMbase (1974 to 2004), MEDLINE (1974 to 2005), WHO/RHL (2004 to 2005), The Cochrane Library (Issue 4, 2004), SCI (1985 to 2005), POPLINE (1966 to 2003) and 9 relevant journals were searched for randomized controlled trials (RCTs) comparing TCu380AIUD with other common IUDs. The quality of included trials was critically appraised. RevMan4.2.7 software was used for statistical analysis. Results Fifteen published studies involving 20 417 participants were included. The results of meta-analyses were expressed with OR (cumulative expulsion rate, cumulative pregnancy rate, cumulative rate of removing for medical reasons) and 95% CI. Compared with TCu380A, TCu220C resulted in lower cumulative expulsion rate at 0.5 and 1 year of follow-up [OR 0.36 (0.18 to 0.70); 0.44 (0.31 to 0.62), respectively], higher cumulative pregnancy rate at ten years of follow-up [1.22 (1.04 to 1.43)], lower cumulative rate of removing for medical reasons at 0.5 year of follow-up [0.59 (0.36 to 0.97)]; MLCu375 resulted in higher cumulative expulsion rate at 1 year of follow-up [2.17 (1.29 to 3.67)], higher cumulative pregnancy rate at 1 and 2 years of follow-up [1.72 (1.18 to 2.50); 1.28 (1.02 to 1.60)]; UCD300 resulted in lower cumulative expulsion rate at five years of follow-up [0.38 (0.27 to 0.56)]; Medicated Gamma 380IUD resulted in lower cumulative rate of removing for medical reasons at 1 year of follow-up [0.31 (0.14 to 0.70)]. Conclusions Compared with TCu380A which is considered as a standard of IUDs, the performance of TCu220C is inferior in contraception, but TCu220C is also a good IUD in performance; The overall clinical performance of MLCu375IUD was as good as that of TCu380A; UCD300 is of the characteristic of lower cumulative expulsion rate; Medicated Gamma 380IUD can decrease side effects effectively. However, larger multi-center randomized comparative trials with longer follow-up periods are needed to confirm the conclusion
Objective To investigate the cl inical directive significance of three-dimensional reconstruction of CT in treating mandibular angle hypertrophy. Methods Between March 2009 and January 2011, 18 patients with mandibular angle hypertrophy were treated using the three-dimensional reconstruction technology of CT. All patients were female, aged20-36 years with an average of 25 years. Eighteen patients included: 14 single mandibular angle hypertrophy, 3 mandibular angle hypertrophy with masseter hypertrophy, and 1 mandibular angle hypertrophy with bilateral asymmetry; 6 cases of ptosis of mandibular angle, 9 cases of prominent mandibular angle, and 3 cases of introversive mandibular angle. According to the types of mandibular angle hypertrophy, the surgical methods could be correctly chosen. The procedure was planned and simulated; the osteotomy l ine was marked and the osteotomy was measured on the workstations of three-dimensional reconstruction. Results No fracture of mandible occurred in the operation. Facial nerve temporary attack occurred in 1 case and recovered at 3 months after operation. All patients were followed up 6-12 months (mean, 7.6 months). After 6 months of operation, the effectiveness was satisfactory in 15 cases, basically satisfactory in 2 cases, and unsatisfactory in 1 case (bilateral asymmetry). Conclusion Based on three-dimensional reconstruction technology of CT, surgical design performed on the model will promote the accuracy of operation. Basically symmetrical appearances can be achieved with satisfactory results.
To compare the effectiveness between open reduction combined with internal fixation and artificial radial head replacement in treating Mason type-III comminuted fracture of radial head, to provide the evidence for available treatment methods. Methods Between January 2004 and June 2008, 65 cases of Mason type-III comminuted fractures were treated with open reduction, AO mini plate and screw system or a combination of Kirschner treatment (internal fixation group, n=35) and with artificial radial head replacement (replacement group, n=30). In internal fixation group, there were 21 males and 14 females with an age range of 21 to 35 years (mean, 30.7 years); the causes of injury were traffic accidentin 12 cases, fall ing from height in 8 cases, and a fall in 15 cases; the locations were left side in 23 cases and right side in 12 cases; and the time between injury and surgery was 1-7 days (mean, 3 days). In replacement group, there were 19 males and 11 females with an age range of 23 to 67 years (mean, 32.5 years); the causes of injury were traffic accident in 7 cases, fall ing from height in 8 cases, and a fall in 15 cases; the locations were left side in 17 cases and right side in 13 cases; and the time between injury and surgery was 1-6 days (mean, 1.5 days). There was no significant difference in gender, age, disease cause, disease duration, or other general information between 2 groups (P gt; 0.05), so that 2 series of patients had comparabil ity. Results Incisions healed primarily in 2 groups. All patients were followed up 1 to 4 years with an average of 2.5 years. There were significant differences in elbow flexion angle, extension angle, and forearm rotation angle between 2 groups (P lt; 0.05), but no significant difference in elbow pronation or supination weakness (P gt; 0.05). In internal fixation group, primary union occurred in 29 cases, delayed union in 2 cases, nonunion with ectopic ossification in 2 cases, and internal fixation failure in 2 cases. In replacement group, elbow flexion angle lost beyond 30o in 1 case after 1 year, elbow stiffness occurred in 1 case because prosthesis was too long. According to Broberg and Morrey elbow scores system, the scores were 69.51 ± 10.23 in internal fixation group and 81.55 ± 12.06 in replacement group, showing significant difference (P lt; 0.05). The results were excellent in 15 cases, good in 5 cases, fair in 11 cases, and poor in 4 cases with an excellent and good rate of 57.1% in internal fixation group; the results were excellent in17 cases, good in 5 cases, fair in 6 cases, and poor in 2 cases with an excellent and good rate of 73.3%. Conclusion Artificial radial head replacement can achieve better joint function compared with open reduction combined with internal fixation in treating Mason type-III comminuted fractures of radial head.