ObjectiveTo systematically review the correlation between the birth number and the risk of breast cancer of Chinese female. MethodsWe electronically searched databases including the CNKI, WanFang Data and VIP databases from inception to September 1st 2015, to collect case-control studies about the correlation between the number of births and the risk of breast cancer among Chinese female. Two reviewers independently screened literature, extracted data, and evaluated the risk of bias of included studies. Then meta-analysis was performed by using Stata software. ResultsA total of 14 case-control studies involving 3 428 patients and 3 906 controls were included. The results of meta-analysis showed that:the females who had term birth had significant lower incidence of breast cancer than those without childbirth history (OR=0.429, 95%CI 0.322 to 0.571). Subgroup analysis based on the number of term birth showed that:Compared with the female without childbirth history, those who had term birth of one time (OR=0.464, 95%CI 0.321 to 0.670), two times (OR=0.394, 95%CI 0.269 to 0.576) and≥3 times (OR=0.340, 95%CI 0.232 to 0.499) had significant lower incidence of breast cancer. ConclusionTerm birth is a protective factor for breast cancer of Chinese female, and more times of term birth will decrease the risk of breast cancer.
Objective To appraise the current situation of randomized controlled trials (RCTs) on information of common-used digestive-related medicines afforded by medicine-salesmen. Methods RCTs on digestive-related medicines were assessed according to clinical epidemiologic standard. Results 60 medicines containing 252 therapeutic articles were searched and 75 RCTs were identified and assessed. Conclusion The qualities and quantities of RCTs of information on digestive-related medicines were of large difference, the RCTs afforded by the joint pharmaceutical enterprises are much better than those of foreign ones and domestic ones.
Background Acute pancreatitis is one of the most severe acute abdominal conditions. Recently with the understanding of pathophysiology and pathogenesis of acute pancreatitis, cytokines, especially platelet-activating factor (PAF), have been shown to play an important role. Lexipafant is a potent inhibitor of PAF. It has shown exiting results in the animal experiments, so randomized controlled studies are needed to assess the impact of lexipafant for acute pancreatitis. Objectives To determine whether lexipafant can alter the course, prevent or treat organ failure and reduce mortality in acute pancreatitis. Search strategy Electronic databases were searched and reference lists from included studies were also handsearched. Published abstracts from conference proceedings and ten kinds of Chinese medical journals were handsearched for additional citations. Personal contaction with colleagues and experts in the field of pancreatitis was performed to identify potentially relevant trials. Selection criteria Randomized, controlled trials, In which participants went in hospital within 72 hours of belliache episode, comparing lexipafant to placebo or other interventions on organ failure rate or mortality of acute pancreatitis. Data collection and analysis Data related to the clinical outcomes were extracted by two reviewers independently, if there was any divarication, they would have a discussion. Main Results Three studies meet the inclusion criteria up to 2001. Compared with control group, lexipafant had the tendency of reducing the early deaths (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.23 to1.38, P=0.2), accelerating the recovery of organ failure (OR 0.40, 95%CI 0.12 to 1.32, P=0.13) and reducing the occurrence of new organ failure OR 0.34, but these results had no statistical significance. A large-scale multicentre randomized controlled trial including 1 500 patients has been completed in America, but the result has not been published. Reviewers’ Conclusions Current evidence couldn’t draw the final conclusion. So the large-scale of randomized controlled trials is required.
ObjectivesTo systematically review the efficacy and safety of butylphthalide soft capsule with routine treatment for Alzheimer’s disease (AD).MethodsDatabases including CNKI, WanFang Data, VIP, CBM, PubMed, EMbase, and The Cochrane Library were electronically searched from September 2002 to July 2018 to collect randomized controlled trials of butylphthalide soft capsule with routine treatment for Alzheimer’s disease. The trial was screened based on inclusion and exclusion criteria, and the methodological quality of the included trial was assessed. Meta-analysis was then performed by Revman 5.3 software.ResultsA total of 8 studies involving 576 patients were included. The butylphthalide soft capsule group included 283 patients and the control group included 293 patients. The result of meta-analysis showed that butylphthalide soft capsule with routine treatment (Donepezil hydrochloride or Memantine or EGb761) significantly improved the score of mini-mental state examination (MMSE) (MD=3.19, 95% CI 2.69 to 3.69, P<0.001) and clinical efficacy (RR=1.36, 95%CI 1.21 to 1.53, P<0.001). There was no significant difference in number of adverse events between the butylphthalide group and the control group (RR=1.13, 95%CI 0.77 to 1.67, P=0.52).ConclusionsBased on the routine treatment, combining with butylphthalide soft capsule can further facilitate cognitive function of AD and improve clinical efficacy. At the same time, no increase in adverse reactions has been found. However, due to the low quality of the included studies, more high quality randomized controlled trials are required to verify the results.
Objective To review the development and quality control of modern tissue banks. Methods The rules, regulations and the management literatures about tissue banks were extensivelyand comprehensively reviewed. Results Tissue banks havea significant progress and are developing to concentration, industrialization and standardization gradually. Quality control is being paid more attention in modern tissue banks. Conclusion Modern tissue banks will have a good future and the quality control must be intensified.
Objective To assess the effectiveness and safety of Jiuweirougan granule in the treatment of chronic hepatitis with hepatic fibrosis. Methods A double-blind, double dummy and randomized controlled method was adopted. Forty-six patients were selected by using the inclusion and exclusion criteria and were randomizedly allocated to the treatment group (n=23, Jiuweirougan 10 g, twice a day) and the control group (n=23, treated with Biejiaruangan 4 pills, three times a day). The duration of treatment for both groups lasted for 6 months. Results Two patients in the treatment group dropped out halfway through the study, while one patient in the control group was withdrawal for irregular treatment. Analysis according to intention-to-treat (ITT) and per-protocol (PP) was conducted. In the treatment group, the effective rates of TCM (Traditional Chinese Medicine) on the syndrome were 82.61% (19/23) (ITT) and 90.48% (19/21) (PP), while in the control group, there were 86.96% (20/23) (ITT) and 86.36% (19/20) (PP). There was no significant difference between the two groups (P＞0.05). The improvement rate of serum parameters in the treatment group such as hyaluronic acid (HA), type Ⅲ procollagen (PCⅢ), type Ⅳ collagewn (CⅣ) and laminin (LN) were 28.57% (6/21), 23.81% (5/21), 28.57% (6/21) and 4.76% (1/21), respectively, while in control group, the rates were 36.37% (8/22),13.64% (3/22), 36.37% (8/22) and 9.09% (2/22), respectively. No significant difference was seen between the two groups (P＞0.05). ITT and PP analysis revealed similar results. No obvious adverse effects were noted. Conclusion Jiuweirougan granule may improve chronic hepatitis with fibrosis, and its effect is equal to that of Biejiaruangan. No obvious toxic-adverse effects were seen.
Objective To evaluate the efficacy and safety of testosterone supplementary treatment for the middle-aged and the senile with insulin resistance (IR). Methods Such databases as PubMed (Jan. 1966 to July 2010), EMbase (Jan. 1984 to July 2010), The Cochrane Library (Issue 3, 2010), CBM (1978 to July 2010), CNKI (Jan. 1994 to July 2010), WanFang Data (1994 to July 2010) and VIP Data (1989 to July 2010) were searched. Randomized controlled trials (RCTs) about testosterone treatment for IR were included. Two reviewers independently extracted the data and evaluated the quality of the included studies. Meta-analyses were performed for the results of homogeneous studies by using RevMan 5.0 software, and other results not suitable for meta-analysis were described with qualitative analyses. Results Nine RCTs involving 573 patients were included. Of them, 308 cases were in the testosterone group and 265 in the placebo group. The baseline data of studies was comparable. The results of meta-analyses showed that, a) Efficacy: testosterone was superior to placebo in decreasing insulin resistance index (HOMA-IR) (WMD= –?0.56, 95%CI –?0.75 to –?0.37) and fasting insulin (FINS) (WMD= –2.4, 95%CI –3.25 to –1.56); and b) Safety: no significant difference was found in prostate specific antigen (PSA) (WMD= –?0.02, 95%CI –?0.22 to 0.18). Conclusion The testosterone supplementary treatment for insulin resistance is superior to the placebo, and there is no significant difference in PSA compared to the placebo. More multicenter double-blind RCTs in large-scale are required to verify this conclusion because of lack of high quality literature with large sample size.
ObjectiveTo evaluate the current status and trend of methodological quality of multi-center randomized controlled trials (RCTs) of stroke treatments in Chinese Mainland.MethodsMulti-center RCTs of stroke treatments conducted in Chinese Mainland published in Chinese or English language from January 2000 to December 2019 were retrieved from seven databases including PubMed, Cochrane Central Registry of Controlled Trials, Embase, China Biology Medicine, China National Knowledge Infrastructure, Chinese Science and Technique Journals Database, and Wanfang Database. The basic information was collected. Methodological items were referred to the Cochrane Collaboration’s tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measure.ResultsA total of 90 multi-center RCTs were included, of which 39 were published from 2000 to 2009, and 51 were published from 2010 to 2019. The total number of trials published from 2010 to 2019 was 1.31 times of that published from 2000 to 2009. The research subjects were ischemic stroke patients in 58.9% (53/90) of the RCTs, intracerebral hemorrhage patients in 14.4% (13/90) of the RCTs, and ischemic stroke patients as well as hemorrhagic stroke patients in 26.7% (24/90) of the RCTs. There were 55.6% (50/90) drug trials, and 44.4% (40/90) non-drug trials. There were statistically significant differences in the loss of visit report (P=0.005), primary and secondary outcome indicators report (P=0.027), and adverse reaction report (P=0.007) between the two periods; there was no statistically significant difference in reported adequate randomized methods (P=0.341), allocation concealment (P=0.611), blindness (P=0.551), used intentionality analysis (P=0.573), or follow-up time (P=0.061) between the two periods.ConclusionIn the past 20 years in Chinese Mainland, the quality of stroke treatment RCTs improves slowly, and more attention should be paid to develop the RCTs of true randomization, blinding, and better patient outcome measures.
ObjectiveTo systematically review the risk factors in elderly patients with primary hypertension with morning blood pressure surge in China, so asto provide references for clinical treatment and prevention of complications. MethodsSuch databases as PubMed, EMbase, The Cochrane Library (Issue 11, 2013), CNKI, VIP and WanFang Data were electronically searched for the case-control studies about morning blood pressure surge (MBPS) among elderly patients with primary hypertension in China from January 2006 to June 2014 were collected. Literature was screened according to inclusion and exclusion criteria, data were extracted and the methodological quality of the included studies was assessed, and then meta-analysis was conducted using RevMan 5.2 software. ResultsA total of 16 studies involving 2 007 cases were finally included, of which 956 cases were detected with MBPS. The results of meta-analysis showed that significant differences were found in glucose levels (MD=0.42, 95%CI 0.04 to 0.81, P=0.03), urinary microalbumin levels (MD=23.85, 95%CI 6.64 to 41.07, P=0.007), incidences of cerebrovascular events (OR=1.96, 95%CI 1.25 to 3.08, P=0.004), carotid atherosclerosis (OR=5.13, 95%CI 1.70 to 15.45, P=0.004) and left ventricular hypertrophy (OR=2.49, 95%CI 1.70 to 3.64, P < 0.000 01), left ventricular mass (MD=12.89, 95%CI 3.94 to 21.84, P=0.005), and carotid artery intima-media thickness (MD=0.08, 95%CI 0.02 to 0.14, P=0.009); while no significant difference was found in gender (OR=1.12, 95%CI 0.84 to 1.49, P=0.44), total cholesterol levels (MD=0.01, 95%CI-0.11 to 0.12, P=0.92), and creatinine levels (MD=1.77, 95%CI-1.16 to 4.70, P=0.24) between patients with or without MBPS. ConclusionCurrent evidence shows that glucose levels, early kidney damage, emergent cerebrovascular events and the reconstruction of the artery and the left ventricle are risk factors of abnormal MBPS in China. However, the above conclusion needs to be verified by further conducting high quality prospective studies.
ObjectiveTo systematically review the efficacy and safety of irinotecan as neoadjuvant chemotherapy (INAC) plus radical surgery (RS) for cervical cancer. MethodsWe searched databases including PubMed, EMbase, The Cochrane Library (Issue 10, 2014), CBM, CNKI, VIP and WanFang Data to collect clinical studies on INAC plus RS versus RS alone or other neoadjuvant chemotherapy drugs plus RS in the treatment of cervical cancer. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. ResultsA total of 6 studies (4 RCTs and 2 CCTs) involving 596 patients were included. The results of meta-analysis showed that, compared with the RS alone group, the INAC group was superior in reducing operation time (MD=-16.17, 95%CI -21.88 to -10.46, P<0.000 01), intraoperative blood loss (MD=-39.56, 95%CI -51.96 to -27.17, P<0.000 01), increasing 3-years OS (OR=0.29, 95%CI 0.15 to 0.57, P<0.000 3), reducing incidence of positive parametrical involvement (OR=0.27, 95%CI 0.12 to 0.60, P=0.001) and incidence of lymphovascular space invasion (OR=0.24, 95%CI 0.09 to 0.61, P=0.003). However, there were no significant differences in the incidence of lymph node metastasis (OR=0.55, 95%CI 0.29 to 1.03, P=0.06) and positive surgical margin (OR=0.33, 95%CI 0.03 to 3.86, P=0.38) between the two groups. Compared with the paclitaxel plus RS group, there were no significant differences for the INAC group in the effective rate (OR=1.58, 95%CI 0.20 to 12.32, P=0.66) and the incidence of more than grade Ⅲ adverse events (OR=2.27, 95%CI 0.62 to 8.27, P=0.21). ConclusionINAC is effective and tolerable in the treatment of cervical cancer. Due to the limitation of quantity and quality of the included studies, more high quality studies are needed to verify the above conclusion.