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.
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 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.
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.
To compare the effectiveness of dressing by a combination of traditional Chinese medicine (TCM)-Western medicine (WM) after TCM bath and by the silver sulfadiazine cream (SD-Ag) in treating residual deep burn wound. Methods A total of 128 cases of residual deep burn wound between July 2003 and December 2009 were randomly divided into the TCM-WM treatment group (70 cases) and the WM control group (58 cases). In the treatment group, there were 45 males and 25 females with an average age of 38.6 years (range, 18-60 years), including 34 cases of flame burns, 28 cases of molten steel burns, and 8 cases of chemical burns with an average burn area of 57.6% total body surface area (TBSA) and an average residual wound of 7.4% TBSA. In the control group, there were 50 males and 8 females with an average of 37.9 years (range, 20-59 years), including 26 cases of flame burns, 12 cases of hot water burns, 16 cases of molten steel burns, and 4 cases of chemical burns with an average burn area of 56.5% TBSA and an average residual wound of 6.9%TBSA. There was no significant difference in general data between 2 groups (P gt; 0.05), so the cl inical data of 2 groups had comparabil ity. In the treatment group, the patients had a bath with TCM, and then the wounds were treated with dressing change of combined TCM-WM. In the control group, the wounds were treated with SD-Ag after cleaning the wounds with chlorhexidine solution. The pain, wound heal ing time, and the rate of scar formation were observed in 2 groups after treatment. Results According to wound pain classification after medication, the results were excellent in 23 cases, good in 30 cases, fair in 17 cases in the treatment group; were excellent in 17 cases, good in 20 cases, fair in 13 cases, poor in 5 cases, and fairly poor in 3 cases in the control group. The wound heal ing time of the treatment group (13.45 ± 4.74) days was significantly shorter than that of the control group [(23.87 ± 14.45) days, P lt; 0.05)]. After 2 weeks of treatment, scar occurred in 15 patients (21.4%) of the treatment group and 35 patients (60.3%) of the control group, showing significant difference (P lt; 0.05). Conclusion Based on TCM bath, a combination of TCM-WM for the residual burn wounds is obviously superior to SD-Ag. It has the advantages of rapid heal ing, l ight pain, no obvious scar, and short hospital ization time.
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 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 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.
ObjectiveIn order to evaluate the efficacy, safety and tolerability of adjunctive perampanel in children with refractory epilepsy. MethodsThis study collected medical records of 34 children with refractory epilepsy, who were admitted to Children’s Hospital of Soochow University from January 2020 to January 2021. By comparing the baseline status with the status at 4, 8, 12, 24, 36, and 48 weeks of follow-up, the efficacy and adverse reactions of perampanel were evaluated. ResultsThe mean age of the patients treated with perampanel was 8.1±4.1 years. The male-to-female ratio was 1: 1. After the addition of perampanel, the average responder rate at the 4th, 8th, 12th, 24th, 36th, 48th weeks were 37.5%, 46.7%, 50.0%, 47.4%, 53.8%, 42.9%. The adverse events were reported by 32.4%, and the retention rate was 88.2%. ConclusionsPerampanel has good efficacy, safety and tolerability in the treatment of refractory epilepsy. Moreover, personalized treatment and better baseline seizure control may increase the effectiveness and retention rate of perampanel.
Objective To evaluate the effectiveness of Medicated γ-IUD compared with other IUDs for contraception. Methods CBMdisc （1986 -2005）, VIP （1989 -2005） , CNKI （1994-2005） , The Cochrane Library （Issue 4, 2005 ） and 10 related journals were searched for randomized controlled trials （R.CTs） and quasi-randomized controlled trials （quasi-RCTs） on the comparison between γ-IUD and other IUDs. The quality of included trials was critically appraised. RevMan 4.2.8 software was used for statistical analysis. Results Ten published studies with 8 381 participants were included. The results of meta-analysis were expressed with Peto OR （ cumulative pregnancy rate, cumulative expulsion rate, cumulative rate of removing for medical reasons） or OIL （ cumulative continuation rate ） and 95% CI. Compared with MSSR-165, Medicated γ-25,200 resulted in lower pregnancy rate at 1, 2, 3 years of follow-up [ with the OR （95% CI） 0. 31 （0.15,0.64） , 0. 31 （0. 17,0.54） , 0. 31 （0.19,0. 51） , respectively], lower cumulative expulsion rate in5 year follow-up [0.26 （0.17,0.40）, 0.28 （0.20,0.41）, 0.30 （0.21,0.42）, 0.29 （0.19,0.44）, 0.32 （0.21, 0. 48 ）, respectively], lower cumulative rate of removing for medical reasons.after 4 year follow-up [0.57 （0.36,0. 92 ） ], and higher rate of cunmlative continuation in 5 years of follow-up 13.35 （ 2.29,4.89 ） , 2.76 （ 2.06,3, 69 ） , 2.41 （1.89,3.08）, 2.22 （1.69,2.91）, 1.99 （1.55,2.55）, respectively]. Compared with TCu220, Medicated γ-25,200 resulted in lower cumulative pregnancy rate after follow-up 2, 3 years [ 0.46 （0.25 ,0.87 ） ; 0.48 （0.27,0. 85 ） ], lower cumulative expulsion rate after 1 year follow-up [ 0. 58 （0.35,0.97） ] , lower cumulative rate of being removed for medical reasons in5 year follow-up [0.37 （0.23,0.59）, 0.38 （0.26,0.56）, 0.45 （0.32,0.64）, 0.47 （0.30,0.73）, 0.58 （0.39,0.87）, respectively ] and higher rate of cumulative continuation in 5 years of follow-up [ 2. 15 （ 1.61,2.87 ）, 2.02 （ 1.56,2.63）, 1.72 （ 1.34,2.20）, 1.44 （ 1.08,1.91 ）, 1, 39 （ 1.07,1.80）, respectively]. Compared with Uterus-Cu, Medicated γ-25,200 resulted in higher rate of cumulative continuation after follow-up 1 year [ 0.51 （0.34, 0.77） ]. Compared with MLCu375, Medicated γ-25,200 resulted in lower cumulative rate of being removed for medical reasons and higher rate of cumulative continuation after follow-up for 3 years [ 0. 22 （0.09,0.52） , 2.84 （ 1.64,4. 94 ）]. Compared with TCu380A, Medicated γ-25, 200 resulted in lower cumulative rate of being removed for medical reasons and higher rate of cumulative continuation in follow-up for 2 years [ 0.36 （ 0.18,0.73 ）, 0.29 （ 0. 12,0.70 ） ; 3.06 （ 1.72,5.44）, 3.61 （1.75,7.47） ]. Conclusions Available evidence shows that Medicated γ-IUD has better or equal effectiveness when compared with other IUDs. However, more RCTs with high quality and longer follow up period are needed to confirm the conclusion.
