Objective?To assess the efficacy and safety of Hirudoid for microcirculation disorder. Methods?We searched The Cochrane Library (Issue 4, 2009), PubMed, EMbase, CNKI, CBM, and VIP databases up to December 2009. Randomized controlled trials (RCTs) or quasi-RCTs concerning Hirudoid for microcirculation disorder were included. The methodological quality of the included studies was assessed according to the Cochrane Reviewer’s Handbook 5.0.1, and meta-analyses were conducted using RevMan software 5.0. Results?Twenty-five RCTs were included, of which only one was graded as high quality and others were of low quality. The results of meta-analyses showed: Hirudoid could be effective in preventing the occurrence of phlebitis (OR=0.18, 95%CI 0.13 to 0.25). Hirudoid for treating phlebitis was also significantly better than magnesium sulfate or placebo (OR=7.18, 95%CI 4.59 to 11.22) and the time to symptom relief of Hirudoid was significantly shorter than placebo (MD= –?29, 95%CI –?37.30 to –?20.70). Hirudoid for internal fistula in hemodialysis patients was better than the simple hot compress (OR=8.89, 95%CI 4.25 to 18.58), and also better than the magnesium sulfate plus hot compress (OR=7.62, 95%CI 2.84 to 20.44). Hirudoid could also prevent the formation of hematoma and eliminate hematoma quickly. Hirudoid for tissue injury caused by irritating fluid extravasation was significantly better than magnesium sulfate (OR=4.25, 95%CI 2.06 to 8.78). Conclusion?Hirudoid can significantly improve the microcirculation disorder, especially to the phlebitis. Due to the low quality of the included studies, further, more high quality trials are required.
Objective To evaluate the efficacy and safety of angiotensin-converting enzyme inhibitor (ACEI) on the left ventricular texture parameters, blood kinetics parameters, degree of cardiac function and rate of side effects of patients with heart failure when compared to angiotensin receptor blocker (ARB). Methods We searched MEDLINE (1966 to 2004), EMBASE (1989 to 2000), The Cochrane Library (Issue 1, 2004), IPA (1970 to 2004), and Chinese Biomedicine Database (1980 to 2003). The quality of included studies such as randomization, blinding, allocation concealment and loss of follow up was evaluated and meta-analysis was performd by RevMan 4.2 software. Results Eighteen randomized controlled trials (RCTs) were included. The meta-analysis of efficacy didn’t show statistical significance when comparing the pooled effect size of left ventricular end-diastolic diameter (LVEDD), cardiac output (CO), heart rate (HR), degree of cardiac function. The pooled RR rate of side effects was 2.17, 95%CI 1.53 to 3.07, P＜0.000 01. Conclusions No evidence shows significant difference of ACEI group from ARB group in the improvement of cardiac function and left ventricle remodeling. The rate of side effects of ACEI is statistically higher than that of ARB.
Objective To assess the effectiveness and safety of fructose 1,6-diphosphate （FDP） in the treatment of hypoxic ischemic encephalopathy （HIE）patients. Methods Biomedical databases, including MEDLINE （1977 -2004 ）, EMBASE（1989- 2004） ,Cochrane Injuries Group trials register, Cochrane Controlled Trials Register, CBMdisk and CNKI （1994- 2005 ）were searched. Chnical trials were collecte＆Quality assessments of chnical trials were carried out. Randomized controlled trials （RCTs） with mortality and the incidence of cerebral palsy, epilepsy and mental defect were selected for meta-analysis. Results Nine RCTs were included, and all were done in China. None of the 9 RCTs described the method of randomization or allocation concealment. None of the 9 RCTs mentioned wether blindness was use＆ In Jadad score, 5 trials were scored by 2 and 4 trials were 1. Seven trials were included in the meta-analysis of death, which showed that the obsolute risk （OR） [95% confidence interval （CI）] of death following FDP administration was 0. 50 （95% CI 0. 21 to 1.16）. Five RCTs reported the results of follow-up. When intention to treat （ITT） analysis was adopted, the OR of FDP on cerebral palsy was 0. 36 （95% CI 0. 19 to 0. 89）, on epilepsy was 0.74 （95% CI 0. 29 to 1.88）, and on dementia was 0. 21 （95% CI 0. 06 to 0.70）. We didn＇t conduct sensitivity analysis because no RCTs were of high quality. We didn＇t identify clinical trials compared with adverse reactions between the two groups. Conclusions The quality of RCTs on FDP for HIE is poor. Because there were no RCTs of high quality available, we can＇t draw a conlusion. Well-designed RCTs with economic evaluation are urgently needed to evaluate the value of FDP in the treatment of HIE.
Objective To assess the response rate, improvement in neurological function and safety of cinepazide maleate injection for patients with cerebral infarction. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the Cochrane Central Register of Controlled Trials (Issue 1, 2010), PubMed (1948 to March 2010), EMbase (1966 to March 2010) and Chinese Bio-Medicine Database (1978 to March 2010). We also hand searched relevant literatures and obtained unpublished trials from pharmaceutical companies. The Cochrane Collaboration’s software RevMan5.0 was used for meta-analysis. Results Fifteen randomized controlled trials involving 1 456 patients were included. The results of meta-analyses indicated that: 1) Neurological deficits: We identified 11 trials involved 978 patients. Cinepazide maleate injection group compared with the control groups (placebo, Xuesaitong, Dansen and Nimodipine) could significantly improve the neurological deficits. The difference was statistically significant with WMD= – 4.64, 95%CI – 6.43 to – 2.85, WMD= – 2.39, 95%CI – 4.37 to – 0.42, WMD= – 3.67, 95%CI – 5.26 to – 2.07 and WMD= – 6.14, 95%CI – 8.39 to – 3.89, respectively. 2) Response rate: A total of 14 trials involved 1 349 patients were identified. Compared with control groups (placebo, Xuesaitong, Dansen and Nimodipine), cinepazide maleate injection group were more efficient, the difference was statistically significant with RR=1.33, 95%CI 1.16 to 1.54; RR=1.24, 95%CI 1.04 to 1.50; RR=1.33, 95%CI 1.23 to 1.43 and RR=1.29, 95%CI 1.12 to 1.49, respectively. 3) Adverse events: No serious adverse events were observed. But the difference of adverse events reports of headache and skin itching in cinepazide maleate injection group was statistically significant compared with the control groups. Conclusion Current evidence shows that cinepazide maleate injection can reduce neurological deficits in patients with acute cerebral infarction, improve the clinical treatment efficacy without serious adverse events. Due to limited quality of included studies, high-quality, large sample randomized controlled trials are required.
Objective To introduce the evidence-based evaluation on off-label uses at home and abroad, so as to investigate a systematic method of evidence-based evaluation on off-label uses. Methods In combination with the domestic and international research literature, a systematic method of evidence-based evaluation on off-label uses was discussed from the following three aspects: sources of evidence, levels of evidence, and recommendation strength. Results Sources of evidence included Clinical Pharmacology, DRUGDEX? System, NCCN Drugs amp; Biologics Compendium and handsearched literature. Levels of evidence and recommendation strength could refer to the 2009 grade system of Oxford Centre for Evidence-Based Medicine, and the strength of recommendations and scientific support of DRUGDEX? System. Conclusion A systematic method of evidence-based evaluation on off-label uses is initially established.
ObjectiveChinese practice guideline for therapeutic drug monitoring of vancomycin is the first therapeutic drug monitoring guideline in the framework of GRADE in China. The guideline panels met a recommendation consensus in December 21th, 2014 and finalized 14 recommendations. The aim of the current study was to assess the property of recommendations and revise them.
MethodsWe commissioned an external review of recommendations by questionnaire. Physicians, clinical pharmacists and nurses above or equal to intermediate certificate were investigated for appreciations, clarity and feasibility of 14 recommendations as well as other suggestions about guideline. The guideline panels discussed the results and revised recommendations based on the result of external review.
ResultsA total of 40 physicians, clinical pharmacist and nurses from 11 departments of 4 hospitals participated in the external review. The overall appreciation degree of recommendations was 70%, the overall clarity degree of recommendations was 88%, and the overall feasibility degree of recommendations was 70%. Among them, appreciation degree of 4 recommendations and feasibility degree of 5 recommendations were fewer than 50%. 165 subjective suggestions were received. After review of the results, the guideline panels reserved 6 recommendations while revised 8 (Deleted 4, combined 2 and improved 2).
ConclusionOur external review is an exploration and attempt in the region of development of Chinese evidence-based practice guideline. More interest-related individuals are involved in the development of guideline. Clarity and feasibility of recommendations are ensured.
ObjectiveTo systematically review the quality of guidelines concerning management of helicobacter pylori (H. pylori) infection, so as to improve the guidelines of low quality and promote the clinical practice of high quality guidelines.
MethodDatabases including PubMed, CNKI, Guidelines International Network (GIN), National Guideline Clearinghouse (NGC), National Institute for Health and Clinical Excellence (NICE), Scottish Intercollegiate Guidelines Network (SIGN), American Society of Health-System Pharmacists (ASHP) and Google search engine were searched from January 2005 to April 2015 to collect guidelines concerning H. pylori management about recent ten years. The methodological quality of included guidelines was evaluated according to the AGREE Ⅱ instrument, and the difference in indications and recommended first-line therapy of H. pylori eradication among different guidelines were compared.
ResultsA total of 13 guidelines were included. According to the AGREE Ⅱ instrument, the highest scores were for clarity and presentation 92.6% (78%-100%) and the lowest were for editorial independence 35.7% (0%-92%). The mean scores for rest domains were: scope and purpose 70.2% (39%-100%), stakeholder involvement 41.4% (22%-75%), rigor of development 41.7% (11%-82%), applicability 58.1% (35%-85%).
ConclusionThe quality of guidelines for management of H. pylori infection is not high. Great efforts are needed to provide reliable and high quality guidelines, especially for the domains of stakeholder involvement, rigor of development, and editorial independence.
Objective To assess the effectiveness and safety of an aerosol inhalation of ambroxol in accessory treatment of pneumonia. Methods Biomedical databases, including MEDLINE, EMbase, The Cochrane Central Register of Controlled Trials (CENTRAL), CBM-disk and CNKI were searched. Randomized controlled trials (RCTs) and quasi-RCTs that compare aerosol inhalation of ambroxol with placebo or other aerosol inhalation regimens were collected. A critical quality assessment and Meta-analysis were performed for included studies. Results Thirteen RCTs were included and all of them were carried out in China. None of the trials described the method of randomization, allocation concealment, blind, and follow-up. With Juni scales, 13 trials scored C degree. Compared with the control group, aerosol inhalation of ambroxol improved total improvement rate and symptoms, and shortened hospital stay. Although statistical difference was not found in some comparisons, all trials showed beneficial tendency. We didn’t find any RCTs describing the safety of ambroxol aerosol inhalation. Conclusion Because of the low quality of RCTs on ambroxol aerosol inhalation for pneumonia, no reliable conclusion can be drawn from our Meta-analysis. Well-designed RCTs and economic evaluation are urgently needed to evaluate the value and safety of aerosol inhalation of ambroxol in treating pneumonia.
Objective To assess the efficacy and safety of fructose-1,6 diphosphate (FDP) in the treatment of cerebral infarction. Methods We searched MEDLINE, EMbase, Cochrane CENTRAL Register of Controlled Trials, CBM and CNKI in 2006. Randomized controlled trials(RCTs) or quasi-randomized controlled trials involving FDP for cerebral infarction were collected. We assessed the quality of the studies and conducted meta-analyse with The Cochrane Collaboration’s RevMan 4.2. Results Ten RCTs were included, 9 of which were of low quality and only one was graded as high quality. None of the trials reported the number of patients who had died or were dependent at the end of long term follow-up. After 7 to 30 days of treatment, improvement of neurological deficiency was associated with FDP compared with placebo or control [OR 2.45, 95%CI (1.91,3.15)]. There was no statistical difference in the death rate between the FDP and control groups at the end of the treatment [RD –0.01, 95%CI (–0.03,0.01)]. One study found that FDP had a similar safety profile [OR 1.24, 95%CI (0.32,4.75)] to the control group. None of the trials compared the costs in the treatment groups. Conclusions The quality of the published clinical trials on FDP in the treatment of cerebral infarction is poor. FDP may improve short-term neurological deficits, but seems unlikely to decrease mortality. Moreover, we found no evidence to support the long-term efficacy of FDP on mortality, dependency and neurological deficit. Large-scale and high quality clinical trials with sufficient follow-ups are needed to evaluate the role of FDP in the treatment of cerebral infarction.
Objective To evaluate the effectiveness and safety of aromatase inhibitors in ovulation induction for women with unexplained infertility. Methods The databases such as CNKI (1994 to June 2011), WanFang Data (1982 to June 2011), PubMed (1966 to June 2011) and The Cochrane Library (Issue 6, 2011) were searched to collect randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs) for the comparison between aromatase inhibitors (AIs) and clomiphene citrate (CC). The quality of the retrieved trials was critically appraised and meta-analyses were conducted using RevMan 5.0.1 software. Results Nine studies were included; all of them were published in English. The results of meta-analyses showed there were no significant differences between AIs and CC in the pregnancy rate (RR=1.02, 95%CI 0.71 to 1.47), miscarriage rate (RR=1.00 95%CI 0.61 to 1.63), multiple pregnancy rate (RD= –0.02, 95%CI –0.07 to 0.03), and incidence rate of adverse events (RD=0.00, 95%CI –0.01 to 0.01); there were still no significant differences between the AIs+gonadotropin (Gn) group and the CC+Gn group in the pregnancy rate (RR=0.98, 95%CI 0.68 to 1.42), miscarriage rate (RR=1.23, 95%CI 0.70 to 2.15), multiple pregnancy rate (RD=0.00, 95%CI –0.10 to 0.10), and incidence rate of adverse events (RD=0.00, 95%CI –0.10 to 0.01). Conclusion Whether aromatase inhibitors can replace clomiphene citrate in ovulation induction for women with unexplained infertility is still an issue that has to be identified by performing well-designed large scale RCTs with longer follow-up duration.
