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 Through assessing the quality of systematic reviews/meta-analyses conducted by hospital pharmacists in China, to learn relevant situations and to promote the development and application of evidence-based pharmacy in hospital. Methods The following databases such as CBM, CNKI, Wanfang Database, VIP, CMCI, The Cochrane Library, EMbase and PubMed were searched from the establishment date to April 15th, 2011, to collect all published systematic reviews/meta-analyses conducted by hospital pharmacists in China. Two reviewers independently extracted the published information according to the inclusive and exclusive criteria, and assessed the methodology and reporting quality of the included literatures with OQAQ and PRISMA. Disagreements were discussed or resolved by the third reviewer. Data analysis was conducted by using SPSS17.0 software. Results Two hundred and sixteen Chinese literatures (including 40 on traditional Chinese medicine), and 15 English literatures were identified. The number of literatures has increased rapidly since 2008. Beijing and Sichuan were the top 2 districts in the number of literatures. All of the included literatures were published in 62 magazines sponsored by 87 hospitals, such as China Pharmacy, and Chinese Journey of Evidence-Based Medicine. The total downloads of Chinese literatures were 14346, and the total citations of all literatures were 154. The methodology and reporting quality of the randomized controlled trials (RCTs) involved in 220 systematic reviews/meta-analyses literatures were assessed, which showed the highest and lowest scores of methodological quality were 6 and 3, respectively, and the average score was 4.27±0.55. The highest and lowest scores of reporting quality were 22.5 and 9, respectively, and the average score was 16.49±2.98. Conclusion Although the evidence-based pharmacy in hospital begins late in China, it develops rapidly, and offers lots of evidence to policy decision, guidelines and rational drug use. However, there is still room for improvement of the methodology and reporting quality in future reviews.
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.
Objective To evaluate the efficacy, safety and economics of digestive enzyme for dyspepsia. Methods Electronic databases such as PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), CBM, VIP and CNKI were searched from establishment dates of databases to June 2010 to identify the randomized controlled trials (RCTs) of digestive enzyme for dyspepsia. Then studies were identified according to predefined inclusion and exclusion criteria, and their quality was evaluated. The meta-analysis was performed using RevMan 5.0 software. Results Eight studies involving 1 092 patients were included, 3 of which were Grade B while the rest were Grade C. The results of the meta-analysis showed that the total efficacy rate of oryz-aspergillus enzyme and pancreatin tablet, compound digestive enzymes capsule, and compound azintamide enteric-coated tablet for dyspepsia were better than either placebo or blank intervention, with the results as (OR=49.70, 95%CI 17.16 to 143.96), (OR=7.71, 95%CI 3.88 to 15.33) and (OR=16.27, 95%CI 6.85 to 38.66), respectively. The efficacy for treating loss of appetite, abdominal distension, abdominal pain, diarrhea and belching was superior to either placebo or blank intervention. Oryz-aspergillus enzyme and pancreatin tablet was inferior to compound digestive enzyme capsule in treating dyspepsia following cholecystectomy. No significant difference was observed in treating dyspepsia following chronic pancreatitis between compound azintamide enteric-coated tablet and compound digestive enzymes capsule. Drug-related adverse reactions as well as economic evaluation were not reported in included studies. Conclusion Digestive enzyme is effective for dyspepsia caused by various diseases. The OR of digestive enzyme versus the placebo/blank-control group shows that oryz-aspergillus enzyme and pancreatin tablet is better than other digestive enzyme drugs.
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.
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 evaluate the effectiveness of Xingnaojing (XNJ) injection in the treatment of acute alcohol intoxication. Methods The Cochrane library (Issue 4, 2008), MEDLINE (1989 to 2008), WANFANG database (1991 to 2008), CBM (1991 to 2008), and CNKI (1991 to 2008) were searched. The quality of included studies was assessed according to the criteria recommended Cochrane Collaboration.Meta-analyses were performed using RevMan 4.2.2 software. Results Twenty seven trials, all published in China were included. The quality of these studies was low. Meta-analyses showed that normal treatment plus XNJ could significantly shorten action time [WMD= – 90.62 min, 95%CI (– 121.12, – 60.11)] and effective time [WMD= – 124.97 min, 95%CI (– 183.54, – 66.40)]. Normal treatment plus XNJ was similar with normal treatment plus naloxone in action time. No significant differences were observed in effective time between naloxone and XNJ. Conclusions It shows that XNJ injection plus western medical therapy is superior to western medical therapy. The curative efficacy of XNJ and Naloxone was similar.
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.