Sodium Tanshinone Ⅱ A Sulfonate for Coronary Heart Disease: A Systematic Review of Randomized Controlled Trials

Objective: To assess whether an adjunctive therapy of Sodium Tanshinone ⅡA Sulfonate Injection(STS) is effective and safe in improving clinical outcomes in patients with coronary heart disease(CHD). Methods: A literature search was conducted through PubMed, the Cochrane Library, Knowledge Infrastructure Databases(CNKI), Chinese Biomedical Literature Database(SinoMed), Chinese Science and Technology Periodical Database(VIP) and Wanfang Database up to August 2017. Randomized controlled trials(RCTs) comparing STS with placebo or no additional treatments on the basis of standard conventional medicine therapies were included. The outcomes were all-cause mortality, major acute cardiovascular events(MACEs), cardiac function and inflammatory factors. The risk of bias assessment according to the Cochrane Handbook was used to evaluate the methodological quality of the included trials. Revman 5.3 software was used for data analyses. Results: A total of 22 RCTs involving 1,873 participants were included. All of the trials used STS as adjunctive treatment to standard conventional medicine therapy. Due to the poor quality of methodologies of most trials, only limited evidence showed that a combination of STS with percutaneous coronary intervention(PCI) or thrombolytic therapy(TT) might be more effective on reduction of all cause death rate than TT alone [risk ratio(RR) 0.25, 95% confidence interval(CI) 0.07 to 0.87] or PCI alone(RR 0.42, 95% CI 0.04 to 4.36). The results of 6 trials comparing STS plus TT with TT alone showed that the addition of STS significantly reduced the incidence of cardiac shock(RR 0.35, 95% CI 0.14 to 0.86), heart failure(RR 0.41, 95% CI 0.20 to 0.83) and arrhythmia(RR 0.21, 95% CI 0.12 to 0.46). STS combined with TT also showed a superior effect on cardiac function and inflammatory factor. No severe adverse event was reported related to STS. Conclusions: As an adjunctive therapy, STS combined with standard conventional medicine seems to be more effective on all-cause mortality or MACEs than conventional medicine treatment alone with less side effects. However, we cannot make a firm conclusion due to low quality of inclusion trials. Well-designed trials with high methodological quality are needed to validate the effect of STS for CHD patients.     

Songling Xuemaikang Capsule(松龄血脉康胶嚢)for Primary Hypertension: A Systematic Review of Randomized Controlled Trials

Objective:To evaluate the effectiveness and safety of Songling Xuemaikang Capsule(松龄血脉康胶囊,SXC) for the treatment of primary hypertension.Methods:An extensive search including Cochrane Library,PubMed,Cochrane Central Register of Controlled Trials(CENTRAL),Chinese Biomedical Literature Database(CBM),Chinese National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP),KoreaMed,Japanese database,and online clinical trial registry websites was performed up to February 2013.Randomized controlled trials(RCTs) regarding SXC for the treatment of primary hypertension were searched without no language restrictions.The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0,and RevMan 5.0 provided by the Cochrane Collaboration.Result:A total of 17 RCTs involving1,778 patients were included.Meta-analysis showed that there was no significant difference between SXC and antihypertensive agents on systolic blood pressure[mean difference(MD):-0.10[-4.83,4.63];P=0.97]and diastolic blood pressure(MD:1.00[-1.16,3.16];P=0.36),but SXC combined with antihypertensive drugs was more effective in lowering systolic blood pressure(MD:-6.17[-7.86,-4.49];P0.00001) and diastolic blood pressure(MD:-7.24[-8.62,-5.85];P0.00001) compared with the antihypertensive drugs alone.Conclusions:SXC used alone or combined with antihypertensive drugs appear to be an effective treatment for lowering elevated blood pressure and improving symptoms in patients with primary hypertension.However,the conclusion cannot be drawn definitely due to the poor quality of the included studies.There is still an urgent need for well-designed,long-term studies to address the benefits of SXC for treating primary hypertension.     

Wendan Decoction(温胆汤) for Treatment of Schizophrenia: A Systematic Review of Randomized Controlled Trials

Objective: To assess the beneficial and adverse effects of Wendan Decoction(温胆汤, WDD) for the treatment of schizophrenia. Methods: Five electronic databases were searched until May 2014, including the Chinese National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the Chinese Scientist Journal Database, Pub Med, and the Cochrane Central Register of Controlled Trials in the Cochrane Library. The randomized controlled trials(RCTs) testing WDD against placebo, antipsychotic drugs, or WDD combined with antipsychotic drugs against antipsychotic drugs alone were included. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results: Thirteen RCTs(involving 1,174 patients) were included and the methodological quality was evaluated as generally low. The pooled results showed that WDD combined with antipsychotic drugs were more effective in clinical comprehensive effect, Positive and Negative Syndrome Scale(PANSS) scores and Brief Psychiatric Rating Scale scores compared with antipsychotic drugs alone. However, WDD had less effectiveness compared with antipsychotics in clinical comprehensive effect; and WDD was not different from antipsychotic drugs for PANSS scores. The side effects were significantly reduced in the intervention group compared with the control group. Conclusions: WDD appears to be effective on improving symptoms in patients with schizophrenia. However, due to poor methodological quality in the majority of the included trials, the potential benefit from WDD needs to be confirmed in rigorous trials and the design and reporting of trials should follow the international standards.     

Sodium Tanshinone ⅡA Sulfonate Ameliorates Microcirculatory Disturbance of Small Intestine by Attenuating the Production of Reactive Oxygen Species in Rats with Sepsis

Objective: To examine whether sodium tanshinone ⅡA sulfonate(STS), the main effective component of Salvia miltiorrhiza is effective in relieving the microcirculatory disturbance of small intestine by suppressing the production of reactive oxygen species(ROS) in rats with sepsis. Methods: A rat model of sepsis was induced by cecal ligation and puncture(CLP). Rats(n=40) were randomly divided into 4 groups: sham-operated group(sham, n=10), sepsis group(CLP, n=10), STS treatment group(STS, n=10) and ROS scavenger dimethylthiourea(DMTU, n=10) group. Animals in the STS group were injected with STS(1 mg/kg) for 10 min through the right external jugular vein after the CLP operation, and animals in the CLP group were given the same volume of normal saline after the CLP operation. Animals in the DMTU group were intraperitoneally injected with 5 m L/kg of 20% DMTU 1 h before CLP. The histopathologic changes in the intestinal tissues and changes of mesenteric microcirculation were observed. The levels of ROS in intestinal tissues from each group were qualitatively evaluated using a fluorescent microscope. The expressions of apoptosis signal-regulating kinase(ASK1), phosphorylated ASK1(phospho-ASK1), p38 mitogen-activated protein kinases(p38 MAPK), phosphorylated p38 MAPK(phospho-p38 MAPK) and tissue factor(TF) were determined by Western blotting. Results: It was shown that there were obvious microcirculatory disturbance(P0.05) and tissue injuries in intestinal tissues after CLP operation. The levels of ROS production, phospho-ASK1, phospho-p38 MAPK and TF were increased. Both STS and DMTU suppressed ROS, phospho-ASK1, phospho-p38 MAPK and TF production, and ameliorated the microcirculatory disturbance and tissues injury(P0.01). Conclusion: STS can ameliorate the microcirculatory disturbance of the small intestine by attenuating the production of ROS in rats with sepsis.     

Efficacy of Getong Tongluo Capsule(葛酮通络胶嚢)for Convalescent-Phase of Ischemic Stroke and Primary Hypertension:A Multicenter,Randomized,Double-Blind,Controlled Trial

Objective:To evaluate whether the efficacy of Getong Tongluo Capsule(葛酮通络胶囊,GTC,consisted of total flavone of Radix Puerariae)on improving patients'quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba(EGB)for patients with convalescent-phase ischemic stroke and primary hypertension.Methods:This randomized,positive-drug-and placebo-controlled,double-blind trial was conducted from September 2015 to October 2017.Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions,twice a day for 12 weeks:(1)GTC 250 mg plus EGB-matching placebo 40 mg(237 cases,GTC group),(2)EGB 40 mg plus GTC-matching placebo 250 mg(120 cases,EGB group)or(3)GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg(120 cases,placebo group).Moreover,all patients were orally administered aspirin enteric-coated tablets 100 mg,once a day fo r 12 weeks.The primary outcome was the Barthel Index(Bl).The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale(NIHSS)scores.The incidence and severity of adverse events(AEs)were calculated and assessed.Results:The Bl relative independence rates,the clinical recovery rates of NIHSS,and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment(P<0.05),and no statistical significance was found between the GTC and EGB groups(P>0.05).The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12,18 and 24 weeks after treatment(P<0.01).There were no statistically significant differences in the incidences of AEs,adverse drug reactions,or serious AEs among the 3 groups(P>0.05).Conclusion:GTC exhibited significant efficacy in improving patients'quality of life as well as neurological function and controlling hypertension.     

Ginkgo Leaf Extract and Dipyridamole Injection as Adjuvant Treatment for Angina Pectoris: A Meta-Analysis of 41 Randomized Controlled Trials

Objective: To provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection(GD) as one adjuvant therapy for treating angina pectoris(AP) and to evaluate the relevant randomized controlled trials(RCTs) with meta-analysis. Methods: RCTs concerning AP treated by GD were searched in China Biology Medicine Disc(SinoMed), PubMed, the China National Knowledge Infrastructure Database(CNKI), the Chinese Scientific Journals Database(VIP), Wanfang Database, Embase, and the Cochrane Library, from inception to February, 2017. The Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. The Review Manager 5.3 software was utilized to conduct the meta-analysis. Results: A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine(WM) against AP was associated with a higher total effective rate [risk ratio(RR)=1.25, 95% confidence interval(CI): 1.21–1.29, P0.01], total effective rate of electrocardiogram(RR=1.29, 95% CI: 1.21–1.36, P0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference(MD)=–0.56, 95% CI: –0,81 to –0.30, P0.01], fibrinogen [MD=–1.02, 95% CI: –1.50 to –0.54, P0.01], whole blood low shear viscosity [MD=–2.27, 95% CI: –3.04 to –1.49, P0.01], and whole blood high shear viscosity(MD=–0.90, 95% CI: 1.37 to –0.44, P0.01). Conclusions: Comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.     

Danshen Injection as Adjuvant Treatment for Unstable Angina Pectoris: A Systematic Review and Meta-analysis

Objective: To systematically evaluate the clinical effectiveness and safety of Danshen Injection(丹参注射液, DS) as one adjuvant treatment for conventional therapy with Western medicine(WM) for unstable angina pectoris(UAP). Methods: Using literature databases, a thorough and systematic retrieval of randomized controlled trials(RCTs) comparing DS plus WM with WM was conducted from inception to April 2015. The extracted data from included studies was analyzed by Review Manager 5.2 software. The Cochrane risk of bias tool was used to assess the quality of included studies, and Begg's and Egger's tests conducted by Stata 12.0 were used to evaluate the potential presence of publication bias. Results: A total of 17 RCTs, which involving 1,433 participants, were identified and reviewed. The meta-analysis indicated that the combined use of DS and WM was significantly superior to WM alone for UAP in terms of the total effectiveness rate of angina pectoris [risk ratio(RR) =1.23, 95% confidence interval(CI): 1.17, 1.29, P0.01] and the total effectiveness rate of electrocardiogram(ECG) [RR=1.18, 95%CI: 1.06, 1.30, P=0.001]. Additionally, DS could also further reduce the content of fibrinogen, adjust blood lipid level, correct T wave inversion, and so on. Fifteen adverse drug reactions were reported in two studies, Four of which appeared in the experimental group. Conclusion: Based on the systematic review, the combined use of DS and WM was more effective than WM alone, it can be further widely used in clinic, however, there was no exact conclusion for its safety.     

A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population

Objective: To evaluate the efficacy and safety of salvianolate in elderly patients with unstable angina pectoris (UAP). Methods: A prospective double-blind randomized placebo-controlled multicenter trial in elderly patients with UAP from 13 third-grade class-A hospitals in China was performed. A total of 318 patients were randomly allocated in a 1:1 ratio to an experimental group (160 patients) and a control group (158 patients). The experimental group was treated with salvianolate for 14 days on the basis of conventional medicine, and the control group was given a placebo for 14 days with the same criteria. Follow-up was lasted 28 days in both groups. The primary endpoint was biweekly frequency of angina pectoris attacks. The secondary endpoints included biweekly dosage of nitroglycerin, the Seattle Angina Questionnaire, angina pectoris severity and duration, myocardial injury markers, high-sensitivity C-reactive protein (hs-CRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), as well as major adverse cardiovascular events (MACEs). Safety was assessed according to adverse events and serious adverse events. Results: Baseline characteristics were similar between treatment groups. Compared with those in the control group, the frequency of biweekly angina attacks (2.92 vs. 4.08, P=0.025), the biweekly dosage of nitroglycerin, as well as the severity and duration of angina attacks (P<0.01) were reduced by salvianolate. The Seattle Angina Questionnaire score was also significantly improved in the experimental group than in the control group (P<0.05). No significant differences were observed between the two groups with respect to the incidence of MACEs. Salvianolate was well tolerated. Conclusions: Salvianolate appear to have efficacy and well tolerated for elderly patients with UAP. [ClinicalTrials.gov identifier: NCT03037047]     

丹参酮ⅡA磺酸钠治疗不稳定型心绞痛的临床应用研究

目的观察丹参酮ⅡA磺酸钠注射液治疗不稳定型心绞痛(UAP)的疗效以及对不稳定型心绞痛血清炎症因子水平的影响。方法将2007年12月～2009年10月间在我院心内科住院治疗的64例UAP患者随机分为治疗组(32例)和对照组(32例),两组均常规给予硝酸酯类、β受体阻滞剂、阿司匹林等药物治疗。治疗组加用丹参酮ⅡA磺酸钠注射液,疗程为14d,观察治疗前后临床症状、EGG及血液流变学等参数变化,比较两组治疗的临床疗效;测定各组患者入院时和治疗后hs-CRP、IL-6的水平。结果加用丹参酮ⅡA磺酸钠注射液干预2周后,治疗组临床症状、EGG及血液流变学参数的改善均优于对照组,两组间比较差异有统计学意义(P0.05);两组血清hs-CRP、IL-6水平及两组治疗后血清hs-CRP、IL-6水平比较差异均有统计学意义(P0.05)。结论在常规治疗基础上加用丹参酮ⅡA磺酸钠可显著降低不稳定型心绞痛患者血清中多种炎症因子水平,并明显改善不稳定型心绞痛患者的临床症状。     

舒血宁注射液治疗不稳定型心绞痛疗效分析

目的:观察舒血宁注射液治疗冠心病心绞痛的疗效和安全性。方法:将68例符合纳入标准的临床观察病例随机分为试验组和对照组,两组患者均常规口服消心痛片、阿司匹林肠溶片。治疗组患者在此基础上加用舒血宁注射液治疗,观察每组治疗前后的安全性指标(一般体检项目,血、尿、便常规化验,肝肾功能)与疗效性指标(心绞痛症状、心电图变化)的变化。结果:治疗组症状改善94.4%,心电图改善72.2%;对照组症状改善78.1%,心电图改善53.1%,治疗组疗效优于对照组(P<0.05)。结论:舒血宁注射液用于冠心病心绞痛的治疗,疗效肯定,临床使用安全。     

葛根素注射液治疗不稳定型心绞痛疗效观察

目的:评价葛根素对不稳定型心绞痛的临床疗效。方法:85例不稳定型心绞痛患者随机分为2组,均常规口服消心痛,同时治疗组葛根素注射液400mg/d,对照组极化液500mL/d。结果:2周后心绞痛缓解,总有效率对照组为70%,治疗组为88.9%,差别不显著(P>0.05);心电图疗效比较,治疗组心肌缺血改善的总有效率71.1%,对照组40%,差别显著(P<0.05);血液流变学比较,治疗组全血粘度、血浆粘度及血小板聚集率均有明显改善(P<0.05),而对照组无此作用。结论:葛根素能有效地改善不稳定型心绞痛患者的症状,抗心肌缺血,降低血液粘度。     

参附注射液治疗不稳定性心绞痛的临床疗效观察

目的：研究参附注射液对冠心病心绞痛的影响.方法：将60例冠心病心绞痛患者随机分为治疗组与对照组,对照组应用肠溶阿斯匹林片、硝酸脂类、β受体阻滞剂、钙拮抗剂口服药及5％ GS 250 ml＋硝酸甘油5 mg静滴,1次/d,治疗组在此基础上加用参附注射液60 ml＋5％ GS250ml静滴1次/d,均14d为1个疗程.结果：治疗组临床症状、疗效及心电图疗效均明显优于对照组,有显著性差异（P＜0.05）.结论：参附注射液可明显减少冠心病心绞痛的发作频率,增加冠状动脉的血流量,降低心肌耗氧量,使心肌缺血缺氧得到明显改善.     

丹参酮ⅡA磺酸钠注射液治疗急性心肌梗死的临床研究

目的 观察丹参酮ⅡA磺酸钠(STS)注射液治疗急性心肌梗死(AMI)的疗效.方法 96例AMI患者随机分为观察组46例和对照组50例,对照组用常规治疗方法,观察组在此基础上加用STS注射液.结果 治疗2周后观察左室功能好转,梗死后心绞痛发生率下降,与对照组比较有较显著性差异,两组心律失常、住院病死率无显著性差异.结论 STS注射液治疗AMI可改善左室功能及心肌缺血,临床应用安全有效.     

不稳定性心绞痛治疗进展

急性冠状动脉综合征包括不稳定心绞痛、非Q波心肌梗塞和Q波心肌梗死,为一连续性病理生理过程的不同阶段和不同血液动力学改变。临床表现取决于冠状动脉受损的严重程度,血栓形成的类型和范围,缺血时间和范围,心肌坏死量。缺血范围和程度与病变血管支数,血管狭窄程度,侧支循环是否建立及影响供氧因素有关。这里主要讨论急性缺血综合征,即不稳定性心绞痛及     

Acupuncture Treatment for Post-Stroke Dysphagia: An Update Meta-Analysis of Randomized Controlled Trials

Objective

To explore the effectiveness and safety of acupuncture in patients with post-stroke dysphagia by an update meta-analysis.

Methods

Potentially eligible RCTs aimed to evaluate the effects of acupuncture vs. non-acupuncture treatments, such as rehabilitation training or routine medication on the swallowing difficulty after stroke were searched from PubMed, Cochrane Library, China National Knowledge Infrastructure, and other database from the earliest record to June 2016. Patient demographics, regimens for acupuncture, type of controls, methods of randomization, and measurements of the clinical symptoms of dysphagia were retrieved. The relative risk (RR) and 95% confidence interval (CI) of effective rate of dysphagia was calculated after intervention performed following admission. Subgroup analyses and a metaregression analysis were performed to describe the heterogeneity.

Results

Twenty-nine RCTs comprising 2,190 patients were included. The included studies had a medium quality grade based on the Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) checklist. Acupuncture therapy provided a higher effective rate compared with nonacupuncture treatments [RR=1.33, 95% confidence interval (CI), 1.25 to 1.43]. Subgroup and meta-regression analyses suggested that acupuncture intensity and measurement method were main sources of heterogeneity and resulted in a significant difference for pooled effect size. No severe adverse events were documented in these RCTs.

Conclusions

Our meta-analysis provides a new evidence supporting the efficacy and safety of acupuncture in treatment to post-stroke dysphagia in short-term compared with rehabilitation or medication. More high-quality and large-scale research studies are needed.