Combination of Xuesaitong and Aspirin Based on the Antiplatelet Effect and Gastrointestinal Injury: Study Protocol for a Randomized Controlled Noninferiority Trial.

BACKGROUND: Aspirin is the first-line medication for prevention and treatment of coronary heart disease (CHD). However, long-term use of aspirin resulting in gastrointestinal mucosal injury and bleeding limits the regularity of medication. Xuesaitong is a marketed Chinese medicine contained main active component in Panax notoginseng saponins (PNS), which can significantly inhibit platelet aggregation in patients with CHD. Our previous studies have already showed that PNS could reduce the gastrointestinal mucosal injury caused by aspirin in preclinical study. However, there is a need for further clinical studies to evaluate synergy and attenuation effect of the combination. METHODS: This trial is a prospectively planned, open-labeled, parallel-grouped, single-centered clinical trial. A total of eligible 480 participants will be randomly allocated into three groups: aspirin group, Xuesaitong group, and drug combination group at a ratio of 1 : 1 : 1. The primary outcome is the change of platelet aggregation rate and calprotectin activity. Secondary outcomes include PAC-1, P-selectin, P2Y12, I-FABP activity, and fecal occult blood. Discussion. The results of the study are expected to provide evidence of high methodological and reporting quality on the synergy function of Xuesaitong and aspirin upon the antiplatelet and anti-gastrointestinal injury effect for CHD. It also provides an experimental basis for clinical rational drug combination therapy. Trial Registration. This trial was registered in the Chinese Clinical Trail Registry, ChiCTR2000036311, on 22 August 2020, http://www.chictr.org.cn/edit.aspx?pid=58798&htm=4.

Yi-qi-yang-yin-tang increases the sensitivity of KG1a leukemia stem cells to daunorubicin by promoting cell cycle progression and regulating the expression of PTEN, TOPOII and mTOR.

The present study aimed to investigate the effects of serum containing a combination of yi-qi-yang-yin-tang (YQYYT) and daunorubicin (DNR) on multidrug resistance in KG1a leukemia stem cells (LSCs). The effects of YQYYT and DNR on proliferation, cell cycle progression and the expression of phosphatase and tensin homolog (PTEN), topoisomerase II (Topo II) and mechanistic target of rapamycin (mTOR) in KG1a cells were investigated in vitro using cell counting kit-8 assay, flow cytometry, reverse transcription-quantitative polymerase chain reaction and western blotting, respectively. It was revealed that YQYYT-containing serum did not affect proliferation of KG1a cells compared with the blank group. Furthermore, there were no significant differences on the inhibition of proliferation among different groups at various concentrations of YQYYT. Treatment with YQYYT-containing serum (volume, 20 and 40 µl) and DNR was able to significantly inhibit the proliferation of KG1a cells compared with the blank group. The inhibition rate in the treatment group with YQYYT-containing serum (40 µl) and DNR for 48 h (72.5%) was higher compared with treatment for 24 h (60.4%, P<0.01). Treatment with YQYYT-containing serum was able to promote G0 phase of KG1a cells into cell cycle in a dose- and time-dependent manner, and significantly upregulated the mRNA expression of PTEN and Topo II, but did not affect mTOR expression compared with the blank group. Treatment with serum containing YQYYT alone did not directly affect the proliferation of KG1a cells, but when the cells were treated with a combination of YQYYT-containing serum and DNR, the proliferation of KG1a cells was significantly inhibited in a dose- and time-dependent manner. Furthermore, treatment with YQYYT-containing serum was able to promote cell cycle progression of KG1a cells in the G0 phase and upregulate the expression of the negative regulatory genes PTEN and Topo II. These results indicated the potential of YQYYT to reverse multidrug resistance in LSCs.

[Standardization of names in prescriptions of traditional Chinese medicines].

Chinese medicine prescriptions are a type of medical documents written by doctors after they understand the patients' conditions for syndrome differentiation. Chinese medicine prescriptions are also the basis for pharmacy personnel to dispense medicines and guide patients to use drugs. It has the legal, technical and economic significances. Chinese medicine prescriptions contain such information of names, quantity and usage. Whether the names of drugs in Chinese medicine prescriptions are standardized or not is directly related to the safety and efficacy of the drugs. At present, nonstandard clinical prescriptions are frequently seen. With "Chinese medicine prescription", "names of drug in Chinese medicine prescription" and "standards of Chinese medicine prescription" as key words, the author searched CNKI, Wanfang and other databases, and consulted nearly 100 literatures, so as to summarize current names of drugs in traditional Chinese medicine prescription, analyze the reasons, and give suggestions, in the expectation of standardizing the names of drugs used in traditional Chinese medicine prescriptions.

Qualitative analysis on a proposal for key specific medical treatment for aplastic anemia.

OBJECTIVE: By reviewing the medical treatments for aplastic anemia (AA, Suilao Disease), which is the important research interest of Collaborative Group, Key Department of Blood Disease, State Administration of Chinese medicine, the consensus on the diseases have been reached among the different units of the collaborative group. METHODS: Using qualitative analysis, we determined the characteristics, location and pathogenesis of Suilao disease. We discovered the ways of traditional Chinese medical treatment in curing Suilao disease. RESULTS: Acute AA (acute suilao) and chronic AA (chronic suilao) diseases require different treatment. Acute AA requires 3 phrases of treatments, which are "cold", "warm" and "hot". However, chronic AA requires a dialectic treatment, which involves reinforcement of the Shen (Kidney). Suitable Chinese medical treatments for curing Suilao disease were discussed and reached a consensus. CONCLUSION: It is concluded that a summarized therapy approved by many experts could be widely used.

Compound Zhebei granules combined with chemotherapy for the treatment of refractory acute leukemia: a randomized clinical trial.

OBJECTIVE: To observe the effect of compound Zhebei granules (CZBG) with chemotherapy in the treatment of refractory acute leukemia. METHODS: In this multicenter, double-blind, placebo-controlled clinical trial, we used a central (online) randomization system to assign 235 patients to two treatment groups. A total of 118 patients received chemotherapy combined with CZBG (4 g, twice daily) and 117 patients received chemotherapy plus placebo. The clinical efficacy was evaluated at the end of one chemotherapeutic cycle. RESULTS: In the full analysis set, in which deaths due to disease progression were regarded as inefficacy, the rates of complete remission (CR) and partial remission (CR + PR) were 32.35% and 50.00% , respectively, for the chemotherapy combined with CZBG group, and 23.08% and 35.58%, respectively, for the chemotherapy plus placebo group. There was a statistically significant difference between the two groups according to a χ2 test (P < 0.05). In the per protocol analysis set (PPS), the CR (33.67%), CR+PR (52.04%) response rates for the chemotherapy plus CZBG group were significantly different from the response rates of the control group (CR: 24.24% and CR+PR: 37.37%), respectively (P < 0.05). CONCLUSION: CZBG plus chemotherapy can improve the clinical remission rate of refractory acute leukemia after one just one therapeutic cycle.

[Research of reversal effect of PESV to multi-drug resistance of leukemia stem cell].

Using the BALB/c mouse multidrug resistance model of leukemia, the effect of peptide extract from scorpion venom (PESV) to the upstream signal factors of P-gp of MDR leukemia stem cells on the mouse tumor block was observed, and the mechanism of PESV to reverse the MDR of LSC was studied. At the same time, the expression of P-gp, MDR1 mRNA and PI3-K, NF-κB were respectively detected through flow cytometry, RT-PCR, Western blot and Elisa, and the mouse liver, spleen were examined via histopathological methods. The results of the experiment were as follows: mice of the control group didn't show any obvious changes, while mice of the other six groups all showed arched back, emaciation, liver swell, and inflammation was found in all liver tissue. The expression level of P-gp and PI3K on the LSC membrane of mouse tumor block was down-regulated; the expression of MDR1 mRNA in the cytoplasm was obviously down in the PESV low dose group, and which was inordinately up in the middle dose group and the high dose group. The expression level of NF-κB in the leukemia stem cell nucleus remarkably decreased. PESV had a outstanding role of down-regulating PI3K, NF-κb, MDR1 which were all upstream factors of P-gp, and to a certain degree enhanced the sensitivity of LSC to ADM. Therefore, this experiment explained one of the mighty mechanism of PESV to reverse MDR of LSC, and provided a foundation to further study of combinational anti-cancer effects of PESV.

[Brief introduction of research methods of commodity specification and grade of Chinese medicinal materials].

The commodity specification and grade of Chinese medicinal materials is a measure of the quality of traditional Chinese medicines (TCMs), which directly impacts on the safety and effectiveness of clinical medicines. It is an urgent problem to establish a set of standards which can both interpret the scientific connotation of the commodity specification and grade of Chinese medicinal materials and play a significant role on clinical medicines as well as markets. This paper reviews the research methods of the commodity specification and grade of Chinese medicinal materials such as sensory evaluation, chemical assessment, biological evaluation, and cited the applications of various methods for the classification of TCMs. It provides technical support for establishing standards of the commodity specification and grade of Chinese medicinal materials, and also constructs scientific basis for clinical rational drug use.