Objective To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss (SSHL). Search strategy Electronic databases: MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search: Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1 155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque,were probably better than some vasodilators (dextran, papaverine, 654-2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers’ conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can’t draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.
Objective To systematically evaluate the efficacy and safety of palonosetron hydrochloride injection for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately or highly emetogenic chemotherapy. Methods Searched PubMed, Embase, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biological Medical Database, Wanfang Database and VIP Chinese Science and Technology Journal Database to find domestic and abroad published literatures of palonosetron used to control CINV associated with moderately or highly emetogenic chemotherapy. Two reviewers independently selected literatures, extracted data and assessed quality of the included studies by the Cochrane handbook 5.1. Meta-analysis was performed using RevMan 5.3 software. Results Twenty trials involving 4 919 patients were included. The results of meta-analysis showed statistically significant differences between palonosetron and first-generation 5-hydroxytryptamine3 receptor antagonists (5-HT3RAS) in prevention of acute〔RR=1.09, 95%CI (1.40, 1.14),P=0.000 4〕, delayed 〔RR=1.26, 95%CI (1.15, 1.37),P＜0.000 01〕, and overall phase of CINV 〔RR=1.19, 95%CI (1.10, 1.30),P＜0.000 1〕. Subgroup analyses indicated that there were no statistical significances between palonosetron and granisetron (P=0.09) or ondansetron (P=0.08) in prevention of acute CINV, as well as between palonosetron and first-generation 5-HT3RAS in prophylaxis of moderately CINV (P=0.18), while there was statistical significance in favor of palonosetron in prophylaxis of delayed and overall phase of CINV. Compared with first-generation 5-HT3RAS, there were different in prophylaxis of highly chemotherapy-induced acute〔RR=1.10, 95%CI (1.02, 1.18),P=0.01〕, delayed〔RR=1.20, 95%CI (1.06, 1.36),P=0.005〕, and overall phase〔RR=1.18, 95%CI (1.04,1.33),P=0.008〕of CINV. In terms of safety, such as headache, constipation, diarrhea and dizziness, there were no statistical differences between two groups. Conclusions Palonosetron hydrochloride injection showed efficacy in prophylaxis of moderately or highly CINV, and didn't increase adverse events. Palonosetron hydrochloride injection is more better than first-generation 5-HT3RAS, especially in prevention of highly CINV, and can significantly improve the control rate of acute, delayed, and overall phase of CINV.
Randomized controlled trials (RCTs) are the gold standard for the design of clinical trials. Because of some practical difficulties, more and more researchers think that the appropriate use of non-randomized controlled trials may make up for the weakness of RCT and will achieve the same research purpose. Therefore, non-RCTs are also very important. Taking studies on multiple sclerosis for example, this article briefly introduces the significance of non-randomized contolled trials.
Objective To evaluate the efficacy and safety of tranexamic acid in arthroscopic anterior cruciate ligament reconstruction by meta-analysis. Methods The databases searched included Embase, PubMed, Cochrane Library, Wanfang, China National Knowledge Infrastructure and Chongqing VIP. The search time range was from the establishment of the databases to September 2022. All randomized controlled trials using tranexamic acid in arthroscopic anterior cruciate ligament reconstruction were collected. The outcome indicators were postoperative blood loss, postoperative joint cavity puncture rate, postoperative hematoma rate, postoperative Visual Analogue Scale score, and postoperative knee joint range of motion. RevMan 5.3 analysis software was selected for meta-analysis. Results A total of 6 articles were included, including 660 patients. Meta-analysis showed that the postoperative blood loss in the tranexamic acid group was lower than that in the control group [weighted mean difference (WMD)=?24.32 mL, 95% confidence interval (CI) (?33.73 mL, ?14.91 mL), P<0.000 01]. The postoperative Visual Analogue Scale score in the tranexamic acid group was lower than that in the control group [WMD=?0.69, 95%CI (?1.21, ?0.18), P=0.009]. The postoperative knee joint range of motion in the tranexamic acid group was higher than that in the control group [WMD=2.88°, 95%CI (0.55°, 5.21°), P=0.02]. The postoperative joint cavity puncture rate in the tranexamic acid group was lower than that in the control group [risk ratio (RR)=0.25, 95%CI (0.12, 0.53), P=0.0003]. The postoperative hematoma rate in the tranexamic acid group was lower than that in the control group [RR=0.40, 95%CI (0.21, 0.78), P=0.007]. Conclusion The patients who used tranexamic acid in in arthroscopic anterior cruciate ligament reconstruction have less postoperative bleeding, lower knee joint puncture rate and hematoma formation rate, which are conducive to pain relief and functional rehabilitation.
ObjectivesTo systematically evaluate the efficacy and safety of 1 470 nm laser vaporization vs. transurethral resection of prostate (TURP) for benign prostatic hyperplasia (BPH).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) about the efficacy and safety of 1 470 nm laser vaporization vs. TURP for BPH from inception to October 22nd, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 6 RCTs and 4 non-RCTs were included. The results of meta-analysis showed that: 1 470 nm laser vaporization was superior to TURP in reducing intraoperative bleeding (MD=?103.87, 95%CI ?148.08 to ?59.65, P<0.000 01), hospital stay (MD=?3.82, 95%CI ?4.35 to ?3.28, P<0.000 01), postoperative indwelling catheter time (MD=?2.24, 95%CI ?3.45 to ?1.02, P=0.000 3), postoperative hemoglobin (MD=?1.63, 95%CI ?3.14 to ?0.12, P=0.03) and rate of secondary hemorrhage (OR=0.13, 95%CI 0.03 to 0.48, P=0.002). There were no significant differences in operative time, bladder irrigation time, transient urinary incontinence and urethral stricture, IPSS Score and Qmax at 3 months after operation between the two groups (P>0.05).ConclusionCurrent evidence shows that 1 470 nm laser vaporization is superior to TURP in reducing intraoperative bleeding and secondary hemorrhage. It may be more suitable for prostate surgery in anticoagulant or coagulative dysfunction patients. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
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 conduct a meta-analysis of the evidence on the efficacy and safety of hyperbaric oxygen therapy for vascular cognitive impairment. Methods China National Knowledge Infrastructure, Chongqing VIP, Wanfang, SinoMed, PubMed, Embase, CINHAL, Cochrance Library were searched for all literatures on randomized controlled trials of hyperbaric oxygen therapy for vascular cognitive impairment from the establishment of databases to May 2022. Literature screening was performed by Endnote X9 software, and meta-analysis was performed by RevMan 5.4.1 software. Results A total of 36 papers were included, with 3093 patients, including 1549 cases in the observation group (hyperbaric oxygen combined with drug treatment) and 1544 cases in the control group (drug treatment alone). Compared with the control group, the effective rate of the observation group [relative risk=1.23, 95% confidence interval (CI) (1.15, 1.30), P<0.00001], the scores of Mini Mental Status Examination [mean difference (MD)=3.19, 95%CI (2.66, 3.73), P<0.00001], and the scores of Montreal Cognitive Assessment [MD=2.98, 95%CI (2.07, 3.89), P<0.00001] were better than those of the control group. There was no significant difference in adverse reactions between the observation group and the control group (P>0.05). For the scores of Activities of Daily Living, subgroup analysis showed high heterogeneity among studies, so pooled analysis was not performed. Conclusion Compared with drug therapy alone, hyperbaric oxygen combined with drug therapy can improve the cognitive function of patients with vascular cognitive impairment to a certain extent without increasing adverse reactions.
Objective To evaluate the effectiveness and safety of different injection sites for collagenase chemonucleolysis for lumbar intervertebral disc protrusion (LIDP). Methods We searched for randomized controlled trials (RCTs) and quasi-RCTs in the following electronic databases: Pubmed (1966 to May 2006), EMBASE(1966 to May 2006), The Cochrane library (Issue 2, 2006), CRD(Center for Reviews and Dissemination),York University, CBM (1978 to May 2006 ), CNKI(1994-2006)and VIP(1989-2006). Quality assessment and data extraction were conducted by two reviewers independently. Disagreement was resolved through discussion. Results Eight studies involving a total of 1035 participants met the inclusion criteria. Meta-analysis was not carried out because of apparent heterogeneity. Four studies made comparisons among intradisc, extradisc, and combined intra- and extra-disc injection. One study (62 participants) showed that intradisc injection was superior to extradisc injection (RR 3.71, 95% CI 1.19 to 11.58, Plt;0.05). Another study (240 participants) showed that intradisc injection was superior to combined intra- and extra-disc injection after 3 months and 6 months of follow-up (RR 0.88, 95% CI 0.80 to 0.98, Plt;0.05). The other two studies showed no significant difference among intradisc, extradisc, and combined intra- and extra-disc injection. Four studies (436 participants in total) showed that amongst three extradisc injections, both anterior epidural space injection and lateral epidural space injection were superior to posterior epidural space injection (Plt;0.05). Although one study indicated that anterior epidural space injection was superior to lateral epidural space injection (RR 1.24, 95% CI 1.03 to 1.51, Plt;0.05), no statistical significance was found between anterior epidural space injection and lateral epidural space injection in two other studies (Pgt;0.05). Conclusions There is insufficient evidence to identify which injection site for collagenase is the most effective for lumbar intervertebral disc protrusion. The included studies showed that both anterior and lateral epidural space injection were superior to posterior epidural space injection. However, these studies are too small and poor quality, and have different diagnostic criteria, follow-up time points, outcome measures and efficacy parameters. Thus, more high quality and large-scale RCTs are needed.
Objective To investigate the current situation of randomized controlled trials or clinical controlled trial (RCT/CCT) on chronic hepatitis B and whether to offer reliable evidence for clinical practice in China. Methods RCT/CCT identified from six Chinese clinical journals were searched manually and assessed according to international standard of evidence-based medicine. Results 308 issues containing 212 therapeutic articles and 88 RCT/CCT on chronic hepatitis B were identified and analyzed. Conclusion the quantity and quality of RCT/CCT of chronic hepatitis B did not meet the need of clinical practice.
ObjectiveTo analyze the safety and efficacy of vacuum-assisted venous drainage (VAVD) in cardiac surgery under cardiopulmonary bypass (CPB).MethodsA total of 180 patients from 3 centers between November 17, 2017 and October 1, 2018 were enrolled and randomly assigned to a VAVD group and a gravity drainage (GD) group by 1∶1 ratio. During the open-heart surgery under CPB, the VAVD group completely relied on VAVD, and the GD group used conventional GD. The primary endpoint was arterial flow before CPB, 15 min after aortic cross-clamping and rewarming to 36 °C of nasopharyngeal temperature. The secondary endpoints included hematocrit, hemoglobin concentration, blood product transfusion, etc. The safety endpoint was free hemoglobin concentration, etc.ResultsThe full analysis set contained 175 patients, 87 in the VAVD group and 88 in the GD group. Patients in the VAVD group were aged 52.8±12.0 years, and males accounted for 55.2%; patients in the GD group were aged 51.4±12.1 years, and males accounted for 59.1%. The demographic characteristics between the two groups were not statistically different. Compared to the GD group, the VAVD group could provide comparable arterial flow in CPB [average of 3 time points, 2.37±0.22 L/(min·m2) vs. 2.41±0.25 L/(min·m2), P=0.271], while not elevating free hemoglobin concentration.ConclusionVAVD can provide enough venous drainage, while not elevating free hemoglobin concentration or damaging blood.
