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 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.
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.
ObjectiveTo investigate the reporting and methodological quality of systematic reviews/ meta-analyses conducted by hospital pharmacists in China, so as to improve the quality of systematic reviews/ meta-analyses in this field. MethodsThe literatures were retrieved from CNKI, WanFang Data, VIP, CBM, CMCI, PubMed, EMbase, The Cochrane Library from the establishment date to March 17th, 2016. According to the inclusive and exclusive criteria, authors independently screened and extracted the published information. Reporting and methodological quality of included reviews were evaluated by PRIMSA statements and AMSTAR checklists. Data analysis was conducted by using Excel 2013 software and SPSS 20.0 software. ResultsOne thousand and eighteen systematic reviews/ meta-analyses were included, including 871 Chinese literatures and 147 English literatures. The average score of PRIMSA was 18.41±2.84, and the average score of AMSTAR was 7.38±1.28. The main problems of PRIMSA were structured summary, objectives, protocol and registration, additional analyses and funding. The main problems of AMSTAR were priori design, status of publication and list of studies (included and excluded). Univariate analysis showed that some factors could improve the quality of methodology and reporting, including studies in English (P<0.000 1), published after checklists' (P<0.000 1), hospital in higher-level (P<0.000 1), illuminating the funding or interest conflict (P<0.000 1). Pearson analysis indicated that linear correlation were detected between PRISMA scores and AMSTAR scores (P<0.000 1), as well as citations and AMSTAR scores (P=0.045). ConclusionEvidenced-based pharmacy in hospital has developed rapidly, the quality of methodology and reporting have increaseed year by year, but further improvement should be considered in different aspects. The methods to evaluate the clinical application of these systematic reviews/ meta-analyses should be developed in the future.