Objective To assess the effect of Dengzhanhua Injection for angina pectoris. Methods We performed an electronic search for MEDLINE (1966 to 2004), EMBASE (1974 to 2004), The Cochrane Library (Issue 4, 2004), CBM and CNKI (1980 to 2004). We included randomized controlled trials that met the inclusion and exclusion criteria and evaluated the quality of those trials and performed the meta-analysis by RevMan 4.2.7. Results Eight trials were included involving 634 patients. However, they were of poor quality. The results of meta-analysis indicated that there were statistical difference on symptoms and electrocardiogram (ECG) improvements between Dengzhanhua and control group (Breviscarpine≥30 mg) with RR 1.26, 95%CI 1.11 to 1.44 and RR 1.30, 95%CI 1.14 to 1.49, respectively. However, Dengzhanhua Injection (Breviscarpinelt;30 mg) vs. basic therapy showed no statistical difference in either symptom improvement (RR 1.03, 95%CI was 0.90 to 1.18) or ECG improvement (RR 1.01, 95%CI 0.86 to 1.20). In addition, Dengzhanhua decreased the myocardial infarction attacks in one year following up (OR 0.06, 95%CI 0.01 to 0.29). Conclusions Little evidence shows that Dengzhanhua is superior to simple basic therapy in the symptoms and ECG improvements as an auxiliary drug. However, this systematic review can not draw a conclusion about the effectiveness of Dengzhanhua Injection compared to simple basic therapy in the treatment of angina pectoris due to the poor quantity of included trials.
Objective To evaluate an improving operative procedure and the cl inical results of arthroscopically assisted treatment for acute patellar dislocation. Methods Between April 2006 and March 2009, 22 patients (25 knees) with primary acute complete dislocation of the patella underwent an improving arthroscopic operation, release of lateral retinaculum and suture of medial capsule and retinaculum structure. There were 5 males and 17 females with an average age of 23.6 years (range, 14-34 years). Three patients had bilateral procedure. Eleven left knees and 14 right knees were involved. The disease duration was 1-10 days with an average of 5.9 days. All patients had lateral dislocation; of them, 14 patients showed reduction without treatment, and 8 patients showed dislocation at admission and were given close manipulative reduction. The results were positive for apprehension test in all patients with the l imitation of passive motion and for Ballottable Patella Sign in 15 cases. Lysholm score, visual analogue scale (VAS) score, and Insall scale were adopted to evaluate the effect. Results All incisions healed by first intention. All the patients were followed up 12-36 months (17 months on average). During the first 3 months after operation, sunken skin in the puncture point medial to the patella was observed in 12 knees; 10 knees suffered pain of the soft tissue lateral to the patella; 15 knees felt tense in the soft tissue medial to the patella, however, all these problems disappeared or recovered gradually after rehabil itation and conservative treatment. No recurrence of dislocation was observed during the follow-up. Lysholm score was significantly improved from preoperative 67.3 ± 5.7 to postoperative 96.6 ± 4.5 (t=3.241, P=0.003) and VAS score from 6.5 ± 0.5 to 1.8 ± 0.4 (t=2.154, P=0.040). According to Insall scale, the results were excellent in 18 knees, good in 5 knees, and fair in 2 knees at 1 year after operation with an excellent and good rate of 92%. Conclusion The improving procedure of arthroscopically assisted treatment for acute patellar dislocation is a minimally invasive operation and has a number of benefits. Its short-term cl inical outcome was satisfactory.
Effectiveness-implementation hybrid designs can test the effectiveness of interventions and the outcomes of implementation strategies concurrently and accelerate the transformation of research results into routine practice. This paper introduced three types of effectiveness-implementation hybrid designs and corresponding reporting guidelines, including standards for reporting implementation studies, cluster randomized design and CONSORT 2010, stepped-wedge cluster randomized design and extended version CONSORT 2018, qualitative research and COREQ reporting guideline, and provide references for domestic researchers to produce research reports on effectiveness-implementation hybrid design.
Objective To evaluate the operative procedure and the cl inical effectiveness of open reduction and internal fixation in the treatment of posterior malleolus fractures. Methods Between June 2005 and December 2008, 46 patients with posterior malleolus fractures were treated with open reduction and internal fixation and followed up. There were 29 males and 17 females with an average age of 47.7 years (range, 19-76 years). Fractures were caused by sprain in 17 cases, by fallingin 15 cases, by traffic accident in 12 cases, and by other reasons in 2 cases. The locations were left ankle in 25 cases and right ankle in 21 cases. There were 6 simple posterior malleolus fractures, 13 lateral and posterior malleolus fractures, and 22 trimalleolar fractures, and 5 lateral and posterior malleolus fractures accompanying by injury of deltoid l igament of ankle. According to Lauge- Hansen classification system, 13 cases and 9 cases were rated as supination-external rotation type III and type IV respectively, and 18 cases as pronation-external rotation type IV. According to Naoki’s classification of posterior malleolus fractures, there were 29 cases of posterolateral-obl ique type, 11 cases of medial-extension type, and 6 cases of small-shell type. Seven patients underwent emergency operation and 39 patients underwent selective operation. Results Two patients developed superficial infection, which was cured after dressing change, and the other incisions healed by first intention. Forty-six patients were followed up 37 months on average (range, 18-63 months). All fractures healed after 3 to 6 months (mean, 4.3 months). One patient developed lateral suralcutaneous nerve injury, and 9 patients had mild weight-bearing pain or discomfort. The results of American Orthopaedic Foot and Ankle Society (AOFAS) ankle and hindfoot score were excellent in 17 cases, good in 21 cases, and fair in 8 cases with an excellent and good rate of 83%. The mean visual analogue scale (VAS) score was 1.9 (range, 0-5). Conclusion The anatomic reduction and internal fixation can achieve the satisfactory results in the treatment of posterior malleolus fractures. The best treatment and fixation methods should be chosen based on different types of posterior malleolus fractures.
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
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 explore the effectiveness and safety of ziprasidone in the treatment of female patients with schizophrenia. Methods A before-after study design with prospective consecutive data collection was adopted. From June 2006 to May 2007, 30 female patients with schizophrenia discharged from the Second Veterans Hospital of Shanxi Province were included. Ziprasidone 60-120 mg/d was orally administered for 6 weeks. Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) were measured before the treatment and at the end of Week 2, 4 and 6 after the treatment, respectively.Results At Week 6, the significant improvement rate and the total improvement rate were 86.67% and 93.33%, respectively; the incidence of side effects was 86.67%. Conclusion Ziprasidone is safe and effective in the treatment of schizophrenia. Since it will not increase body weight or the level of prolactin, it can be especially applied to female schizophrenic patients.
Objective To systematically review the psychological resilience intervention in China, so as to evaluate its effectiveness. Methods Studies published as of October 2012 were searched in CBM, VIP, CNKI and WanFang Data. The randomized controlled trials (RCTs) and controlled before-and-after trials (CBAs) about psychological resilience intervention were included. Two reviewers independently performed screening, quality assessment and data extraction, and then reached a consensus after cross-check and discussion. Qualitative synthesis was adopted instead of meta-analysis for the existed significant deviations in outcomes of included studies. Results A total of 8 studies including 3 RCTs and 5 CBAs were included for the analysis. All the studies referred to the objects of students, including 6 for college students, 1 for secondary school students and 1 for left behind students in rural junior school. All 8 studies evaluated the effectiveness of group psychological guidance, 1 of which also compared the outcomes of psychological lectures. All the included trials suggested that group psychological guidance and psychological lectures might significantly improve the psychological resilience of subjects. Conclusion Current studies on psychological resilience intervention are limited, the measure has been taken seems relatively single, which mainly focuses on students and lacks of high-quality research design. It suggests take more diverse psychological resilience interventions for different population, and evaluate both short-term and long-term effectiveness by performing large sample, strictly designed and high-quality trials.
ObjectiveTo investigate the correlation between the effectiveness and the changes of spine-pelvic sagittal parameters for patients with spondylolisthesis before and after operation. MethodsA retrospective analysis was made on the clinical data of 32 patients with single segmental degenerative lumbar spondylolisthesis at L4 who accorded with the inclusion criteria between June 2011 and January 2014 (trial group). There were 13 males and 19 females, aged 51-67 years (mean, 59 years). According to Meyerding degree, there were 21 cases of degree I, 10 cases of degree Ⅱ, and 1 case of degree Ⅲ. All patients were treated with transforaminal lumbar interbody fusion (TLIF) surgery. Thirty-five healthy adults at the age of 46-67 years (mean, 57 years) were enrolled as normal controls (control group). The standing position lumbar lateral X-ray films (T12-S1, bilateral femoral head) were taken at pre- and post-operation to measure the pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), lumbar lordosis (LL), disc height (DH), and slip percentage (SP); the visual analogue scale (VAS) and Oswestry disability index (ODI) were recorded. Pearson correlation analysis was used to analyze the correlation between the preoperative various spine-pelvic sagittal parameters and the VAS score and the ODI. After operation, Pearson correlation analysis was used to evaluate the correlation between the changes of these parameters and the improve rates of VAS score and ODI. ResultsAll patients of trial group were followed up 15-22 months (mean, 18 months). At last follow-up, the VAS score, ODI, PT, SS, LL, SP, and DH were significantly improved when compared with preoperative values (P<0.05), except for PI (t=-1.445, P=0.158). There was no significant difference in PT, SS, LL, and DH between trial and control groups at last follow-up (P>0.05); PI was slightly bigger than that of control group (t=8.531, P=0.043). Pearson correlation analysis showed that there was a correlation between spine-pelvic sagittal parameters of PI, PT, SS, and LL (P<0.05); preoperative parameters (except for LL and DH) had correlation with ODI and VAS scores (P<0.05). Postoperative parameters (except for PI) had correlation with the improve rates of ODI and VAS scores (P<0.05), especially for the changes of PT and the improvements of ODI and VAS scores. ConclusionThere is a correlation between the changes of spine-pelvic sagittal parameters at pre- and post-operation and effectiveness in patients with lumbar spondylolisthesis. The correlation between the changes of PT and the improvement rates of ODI and VAS scores is more marked. The good effectiveness is closely related with the improved PT.
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.