Cardioprotective effect of saffron total glycoside tablets in patients with breast cancer receiving anthracycline-based chemotherapy: study protocol for a multicentre, randomised, parallel, double-blind, placebo-controlled clinical trial.

BACKGROUND: Breast cancer is the most common cancer worldwide. Anthracyclines, alone or in combination with other chemotherapeutic agents, are the most effective chemotherapy agents against breast cancer. However, the dose-dependent cardiotoxicity of anthracyclines is a serious drawback in clinical treatment. Considerable efforts have been made to establish suggestions to avoid anthracycline-induced cardiotoxicity. Crocin extracted from saffron has potential cardioprotective effects against anthracycline-induced cardiotoxicity. The aim of this study was to estimate the cardioprotective effects and safety of saffron total glycoside tablets relative to placebo in patients with breast cancer undergoing anthracycline-based chemotherapy. METHODS: This is a multicentre, randomised, double-blind, placebo-controlled clinical trial. A sample of 200 participants (100 per group) with breast cancer will be randomly assigned to receive either saffron total glycoside tablet or placebo (four tablets each time, three times each day) for 6 months. Each participant will be interviewed three times: baseline (visit 1), after 3 months (visit 2), and after 6 months (visit 3). The primary outcome is to confirm if administration of saffron total glycoside tablets reduces the rate of cardiotoxicity relative to that with placebo. Secondary outcomes include new arrhythmic events, and cardiac troponin I and N-terminal pro-B-type natriuretic peptide levels. The quantity, quality, and severity of the adverse events will be carefully documented. DISCUSSION: We look forward to obtaining high-quality evidence that can be used to formulate clinical practice guidelines. Thus, the findings of this study are expected to help fill the current gap in cardiotoxicity prevention drugs. TRIAL REGISTRATION: This trial was published in the Chinese Clinical Trial Registry (No. ChiCTR2000041134, registered on 19th December 2020).

Effect of Chinese Medicine on No or Slow Reflow after Percutaneous Coronary Intervention in Myocardial Infarction Patients: A Systematic Review and Meta-Analysis.

OBJECTIVE: To systematic review the effect of Chinese medicine (CM) on no or slow reflow after percutaneous coronary intervention (PCI) in myocardial infarction (MI) patients. METHODS: The PubMed, EMBASE databases, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, China National Knowledge Infrastructure (CNKI), Chinese BioMedical Literature Database (CBM), Wanfang Knowledge Service Platform (Wanfang Database) and Chinese Scientific Journal Database (VIP) were searched up to December 2017. Randomized controlled trials (RCTs) which evaluated the effect of CM therapies on no or slow reflow after PCI in MI patients were included. The primary outcome was the effect of reperfusion. Secondary outcomes were left ventricular ejection fraction, incidence of major adverse cardiovascular events and adverse effect. RESULTS: Ten RCTs covering 814 patients were included. Two studies revealed that the incidence of no or slow reflow was less in Shenmai Injection () group than in the control group measured by thrombolysis in myocardial infarction (TIMI) ⩽ 2 (risk ratio=0.55, 95% confidence interval 0.38 to 0.81, P=0.003, I2=37%). Two studies indicated that Salvianolate Injection showed no additional benefit on no or slow reflow measured by corrected TIMI frame count compared with the conventional treatment (mean difference -4.24, 95% confidence interval -13.03 to 4.54, P=0.34, I2=86%). In addition, Tongxinluo Capsules (), Danhong Injection () and Xuesaitong Injection () may have the potential to reduce no or slow reflow measured during or after PCI in individual studies. CONCLUSIONS: Current evidence from RCTs are not sufficient to evaluate the effect of CM adjuvant therapies on no or slow reflow after PCI for MI patients. The included studies are limited by small sample size and unclear baseline conditions. Further rigorously designed researches and verification studies with sufficient number of patients are warranted.

[Advance in studies on effect of traditional Chinese (Tibetan) medicines in prevention and treatment of acute altitude sickness].

Acute altitude reaction is a stress response of organism to special altitude environmental factors such as hypoxia, low pressure, cold, dry and strong ultraviolet. As it is the most incident disease in high altitude areas, its prevention remains a problem to be solved. In China, the traditional Chinese (Tibetan) medicines have been recognized as an effective means of preventing and treating acute altitude sicknesses. Some single-recipe or compound traditional Chinese (Tibetan) medicines have been proved to be effective for acute altitude sicknesses. In this article, we will describe traditional Chinese (Tibetan) medicines of different types with efficacy in prevention and treatment of altitude sicknesses.

[A randomized double-blinded controlled trial of Xuefu Zhuyu Capsule on short-term quality of life in unstable anginal patients with blood-stasis syndrome after percutaneous coronary intervention].

BACKGROUND: With the wide application of percutaneous coronary intervention (PCI) in patients with coronary heart disease (CHD), it is a popularly concerned problem within clinical doctors to promote the patients' early recovery and improve their health related quality of life (HR-QoL). OBJECTIVE: To evaluate the efficacy and safety of Xuefu Zhuyu (XFZY) Capsule, a compound traditional Chinese herbal medicine for activating blood circulation, in improving HR-QoL in unstable angina (UA) patients with blood-stasis syndrome after PCI, and to make a comparison with Shengmai (SM) Capsule. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: The study was performed at Rescue Center of Emergency, Beijing Anzhen Hospital, China Capital University of Medical Science from March 2008 to February 2009. Using a randomized, double-blinded, double-dummy and placebo controlled study design, ninety patients diagnosed as UA and concomitant blood stasis syndrome after successful PCI therapy were enrolled and randomized into three groups: XFZY group, SM group and placebo group, and the patients were administered with the corresponding medications for 4 weeks. MAIN OUTCOME MEASURES: The Short-Form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QoL in each group before and after the treatment. RESULTS: A total of 90 patients were recruited and 4 cases of them withdrew from the study during the treatment period indicating a 4.4% of dropping rate. After the treatment, several domains of scores in SF-36 and SAQ were significantly increased in three groups (P<0.05, P<0.01). The efficacy of XFZY Capsule in improving body pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), angina stability (AS), angina frequency (AF), as well as treatment satisfaction (TS) was better than that of placebo (P<0.05, P<0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, TS were improved as compared with those in the SM group (P<0.05). No obvious adverse reaction was found during and after the treatment with the exception of one case in XFZY group reporting of discomfort in the stomach. CONCLUSION: Compared with SM Capsule, a short-term treatment of XFZY Capsule exhibits better efficacy in improving HR-QoL in UA patients with blood-stasis syndrome after PCI. However, its long-term efficacy and safety needs further investigation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT00817024.

[Effects of Qingkailing effective components on nuclear factor-kappa B in an ischemia-reperfusion injury model of rat brain microvascular endothelial cells in vitro].

OBJECTIVE: To establish an ischemia-reperfusion injury model of rat cerebral microvascular endothelial cells (MVECs) in vitro, and to explore the relationship between nuclear factor-kappa B (NF-kappaB) and the protective effects of Qingkailing effective components (hyocholic acid, taurocholic acid, baicalin, jasminoidin, Pinctada martensii) on MVECs. METHODS: Brain MVECs of male rats were digested with trypsin and subcultured, then the content of MVECs was adjusted to 1x10 (5)/mL and the MVECs were divided into normal control group, untreated group, hyocholic acid group, taurocholic acid group, baicalin group, jasminoidin group, Pinctada martensii group and nimodipine group, with six holes in each group. Except for the normal control group, the MVECs in the other groups were exposed in oxygen and glucose deprivation (OGD) circumstance in vitro to simulate ischemia-reperfusion injury. Immunocytochemical staining and image analysis system were used to observe the expression of NF-kappaB protein. RESULTS: Under a light microscope, the nuclei of MVECs in the normal control group were blank. Staining intensity of NF-kappaB protein in the nucleus in the untreated group was much deeper than that in the endochylema, with NF-kappaB shifted to nucleus after activation; a small quantity of NF-kappaB protein were expressed in the border of nucleus next to endochylema in groups of Qingkailing effective components, and the NF-kappaB protein expression was weaker than that in the untreated group. With the image analysis, we found that transmittance of nucleus and endochylema in the untreated group was significantly lower than that in the normal control group (P<0.01). Transmittance of nucleus and endochylema in the treated groups was higher than that in the untreated group (P<0.05, P<0.01). CONCLUSION: Qingkailing effective components have significant effect in inhibiting NF-kappaB protein transferring from endochylema to nucleus in vitro.

[Correlation between syndrome factor combination and cardiac function as well as blood-lipid in coronary heart disease].

OBJECTIVE: To discuss the distribution laws of traditional Chinese medicine (TCM) syndrome factor and their combination in coronary heart disease (CHD), and to study the correlation between the TCM syndrome factor combination and cardiac function as well as blood-lipid. METHODS: The parameters of the cardiac function of 300 patients with a final diagnosis of CHD by coronary angiography were measured by echocardiography, and the levels of blood lipids in the CHD patients were detected. An analysis of the correlation was done between the TCM syndrome factor combination and cardiac function as well as blood-lipid in CHD. RESULTS: The TCM syndrome factor combinations of CHD were blood stasis due to qi deficiency, qi and yin deficiency, intermingled phlegm and blood stasis, and yang deficiency and blood stasis. The ejection fraction of CHD patients with yang deficiency and blood stasis was markedly decreased. The levels of triglyceride and low-density lipoprotein cholesterol in CHD patients with intermingled phlegm and blood stasis were markedly increased, and the level of triglyceride in CHD patients with qi and yin deficiency was markedly increased too. CONCLUSION: The treatment of CHD should aim directly at the symptoms and causes. It is also proved that some compound traditional Chinese herbal medicines for supplementing qi and activating blood circulation, nourishing yin and resolving phlegm, and activating yang should be used in treatment of CHD. In cases of CHD with low cardiac function, particular emphasis should be laid on activating yang and blood circulation, while in cases of CHD with blood-lipid disturbance, particular emphasis should be laid on resolving phlegm and activating blood circulation, replenishing qi and nourishing yin.

[Characteristics of coronary arteriography and traditional Chinese medicine syndrome of 1,069 patients with coronary artery disease].

OBJECTIVE: To study the characteristics of coronary arteriography and traditional Chinese medicine syndrome of 1,069 patients with coronary artery disease (CAD). METHODS: One thousand and sixty-nine patients with CAD were investigated by epidemiological method. The patients were divided into young patients (n=82, aged 45 years or younger) and middle-aged and old patients (n=987, older than 45 years). The characteristics of the two groups were analyzed, including clinical data, coronary arteriography and traditional Chinese medicine syndrome. RESULTS: Compared with middle-aged and old patients, proportion of male, triglyceride, total cholesterol, smoking patients, acute myocardial infarction and family history of CAD in young patients were significantly higher (P<0.05). Patients accompanying with hypertension and diabetes in middle-aged and old patients were more than those in young patients (P<0.05). Occurrence rates of morbidity of left circumflex coronary artery, left main coronary artery and multi-branch were higher in middle-aged and old patients (P<0.05), however, the occurrence rates of morbidity of single and double-branch were higher in young patients (P<0.05). The occurrence rates of syndromes of qi stagnation and phlegm turbidity in young patients were higher than those in middle-aged and old patients (P<0.05). But the proportions of cold coagulation, yin deficiency, yang deficiency and kidney deficiency in middle-aged and old patients were obviously higher (P<0.05). CONCLUSION: The traditional Chinese medicine syndrome and pathological changes of CAD in young patients are different from those in old patients.