Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying Qi and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.

Clinical effect of enriching qi, activating blood circulation, clearing away dampness and heat combined with western medicine in the treatment of idiopathic membranous nephropathy: A meta-analysis

Objective:To systemically review the efficacy and safety about the method of enriching qi,activating blood circulation,clearing away dampness and heat combined with western medicine in the therapy of patients with idiopathy membranous nephropathy(IMN).Methods:We collected the randomized controlled trials(RCTs)of enriching qi,activating blood circulation,clearing away dampness and heat for the treatment of IMN from Pub Med,The Cochrane Library,Medline,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),Wanfang Data and Wiper Databases.Bias of risk of retrieval literature was evaluated according to Cochrane Collaboration standard,and Review Manager 5.3 software was used for statistical analysis.Results:Fourteen trials(836 participants)were included in the meta-analysis.This kind of traditional Chinese method combined with western medicine in the treatment of IMN exerted statistical differences in reducing 24-hour urinary protein[WMD=-0.97,95%CI(-1.30,-0.65),Z=5.86(P<0.00001)]and elevating serum albumin[WMD=3.83,95%CI(2.10,5.57),Z=4.33,P<0.0001],lowering serum cholesterol[WMD=-0.82,95%CI(-1.08,-0.56),Z=6.18,P<0.00001],triglycerides[WMD=-0.39,95%CI(-0.67,-0.11),Z=2.77,P=0.006]and reducing the risk of adverse events[OR=0.29,95%CI[0.16,0.50],Z=4.35,P<0.0001]in the patients with IMN as compared with controls.However,there was no statistically significant difference between the method and controls when combining all trials in serum creatinine[WMD=-5.52,95%CI(-18.06,7.03),Z=0.86,P=0.39],when combining all trials in urea nitrogen[WMD=-0.90,95%CI(-2.22,0.41),Z=1.35,P=0.18].Conclusion:The method of enriching qi,activating blood circulation,clearing away dampness and heat combined with western medicine exerts certain advantages and better safety in treating patients with IMN.However,for the inferiority of the included studies,the conclusion still needs high-quality and large-sample prospective randomized controlled trials to verify.

Effects of Heat Clearing and Stasis Resolving Method on PTS,Inflammatory Factors and T-lymphocyte Subsets in Peripheral Blood of URM Patients with Suppressed Internal Heat

[Objectives]To explore the effects of heat clearing and stasis resolving method on prethrombotic state,inflammatory factors and T-lymphocyte subsets in peripheral blood of unexplained recurrent miscarriage(URM)patients with suppressed internal heat.[Methods]Thirty cases of URM patients with suppressed internal heat and 30 normal women were collected,and characteristics of changes in peripheral serum D-dimer(D-D),fibrin degradation product(FDP),fibrinogen(FIB),IL-6,IL-10 and TNF-α,CD,CD,CD,CD,CDlevels were detected.URM patients were treated with traditional Chinese medicine for clearing heat and resolving blood stasis for 3 menstrual cycles,and the changes of indicators before and after treatment were observed.[Results]Compared with normal women,the peripheral serum levels of D-D,IL-6,TNF-αand CDin URM patients with suppressed internal heat were increased(P<0.05),while the IL-10 lymphocyte level was significantly decreased(P<0.05);compared with that before treatment,the contents of D-D,IL-6,TNF-αand CDdecreased after 3 menstrual cycles(P<0.05),while the contents of IL-10 and CDT lymphocytes increased significantly(P<0.05).[Conclusions]The heat clearing heat and stasis resolving method can effectively improve the prethrombotic state of URM,and the action mechanism may be related to the regulation of immune and peripheral blood inflammatory factors.

Doctor Song Fuyin's Experience in Treating Hashimoto's Thyroiditis Based on Qi,Blood Essence and Spirit Syndrome Differentiation Stage Classification

The paper systematically summarizes the experience of Director Song Fuyin in treating Hashimoto's thyroiditis which is a typical emotional disease that causes obvious changes in organ morphology and endocrine and body fluid metabolism.It belongs to the category of psychosomatic diseases,and is the embodiment of a series of pathogenesis processes of qi disease,blood disease,essence disease and deformation in TCM theory.The whole course of the disease is dominated by the dialectical relationship of mutual influence,mutual control,mutual root and mutual use among the deity disease,qi disease,blood disease,essence and spiritual disease.Therefore,the treatment emphasizes the dialectical relationship based on qi,blood,essence and spirit.At the beginning,the treatment focuses on regulating qi and clearing heat and eliminating phlegm;at the middle stage,the treatment focuses on replenishing essence and promoting yang and eliminating wind and calming the deity;at the late stage,the treatment focuses on replenishing qi and eliminating phlegm and promoting collages.Flexible use of calming the spirits,regulating qi,dispersing essence,eliminating phlegm,promoting blood and other methods of stage classification treatment,can be targeted,improve the cure rate of the disease.This article aims to clarify the experience of Director Song Fuyin in treating Hashimoto's thyroiditis based on syndrome differentiation of qi,blood essence and spirit.

Randomized Double-blinded and Controlled Clinical Trial on Treatment of HIV/AIDS by Zhongyan-4 (中研-4号)

Objective： To assess the efficacy and safety of Zhongyan-4 （中研-4号, ZY-4, a Chinese herbal preparation worked out according to the therapeutic principle of supplementing qi, nourishing Yin, clearing heat and detoxication） in treating HIV/AIDS patients in the early or middle stage. Methods： Adopted was randomized double-blinded and placebo-parallel-controlled method, with 72 HIV/AIDS patients randomly divided into the ZY-4 group （36 patients） treated with ZY-4 and the control group （36 patients） treated with placebo. The treatment course was six months. The index of OD4^＋, OD8^＋ counts, body weight, clinical symptom scoring were estimated at 4 time points （0, 1, 3 and 6 month in the course）, and also the viral load before and after treatment. The whole course of observation was completed in 63 patients, 30 in the ZY-4 group and 33 in the control group. Results： OD4^＋ count in the ZY-4 group got elevated by 7.70 4±150.96/mm^3 on average, while that in the control group lowered by 27.33 4±85.28 /mm^3 . Fifteen out of the 30 patients in the ZY-4 group had their OD4^＋ count increased, which was evidently much higher than that in the control group （8/33, P〈0. 05）, suggesting that the efficacy of ZY-4 is superior to that of placebo in elevating OD4^＋ count. Moreover, ZY-4 showed actions in elevating OD45RA^＋ and OD8^＋ count, reducing HIV virus load, improving clinical symptom/sign and increasing body weight of patients. No obvious adverse reaction was found in the clinical trial. Conclusion： ZY-4 has an immunity-protective and/or rebuilding function in HIV/AIDS patients in the early and middle stage, and also shows effects in lowering viral load, increasing body weight and improving symptoms and signs to a certain degree.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on Treating Ulcerative Colitis by the Integration Method of Heat-Clearing, Damp-Excreting, Spleen-Strengthening, and Stasis-Removing of Traditional Chinese Medicine with Western Medicine

Objective:The objective of this study was to systematically evaluate the clinical efficacy of the integration method of heat-clearing, dampness-excreting,spleen-strengthening, and stasis-removing from traditional Chinese medicine (TCM) combined with Western medicine for the treatment of ulcerative colitis(UC).Materials and Methods:The databases China National Knowledge Infrastructure,China Biology Medicinedisc(CBMdisc),WANFANG, VIP, and PubMed were searched for randomized controlled trials investigating the integration of the TCM methods of clearing heat,draining dampness, invigorating the spleen, and removing stasis, combined with Western medicine to treat UC from January 2009 to March 2019. Two reviewers independently conducted literature searches, screenings, data extractions, and literature bias evaluations. A meta-analysis was conducted using RevMan 5.3 and Stata 13.0 software. Results:In total, 15 studies involving 1289 patients were included. The results of the meta-analysis showed that the total effective rate of treatment in the experimental groups was higher than that of the control groups (relative risk [RR]=1.27, 95%confidence interval [CI]:1.21, 1.35, Z=8.74, P <0.00001). In the subgroup analysis, the total effective rate of oral TCM combined with Western medicine was higher than that of the control groups (RR=1.24, 95%CI:1.15, 1.33, Z=5.88, P <0.00001). The total effective rate of oral TCM with enemas combined with Western medicine was higher than that of the control group (RR=1.30, 95%CI:1.12, 1.50, Z=3.52, P=0.0004).The comparison between Western medicine alone and oral TCM combined with enteroscopy and Western medicine showed that the effective rate of enteroscopy (RR=1.18, 95%CI:1.05, 1.33, Z=2.86, P=0.004) and the symptom scores before and after treatment all improved more in the combined treatment groups than in those of the Western medicine group alone, with statistically significant differences (RR=-4.23, 95%CI:-4.93,-3.53, Z=11.84, P <0.00001). Conclusion:The integration of the TCM methods of heat clearing, dampness excreting, spleen strengthening, and stasis removing combined with Western medicine can significantly improve the cure rate of UC, and is an effective method to treat UC.

Synthesis and characterization of high ionic conductivity ScSZ core/shell nanocomposites

High performance solid electrolytes have been widely used in many devices, such as intermediate temperature（650–850 oC） solid oxide fuel cells, oxygen sensors, super capacitors, etc. In order to solve the problem of phase stability and high grain boundary resistance during the working process, the novel core/shell structure ScSZ nanocomposites were successfully prepared by fractional-precipated method. Non core/shell composites were also prepared by co-precipitation at the same Sc/Zr ratio for comparison. high-resolution transmission electron microscopy（HRTEM）, X-ray photoelectron spectroscopy（XPS）, Raman characterization were performed to identify the microstructure and phase configuration of the obtained composites. According to HRTEM, clear rich scandia shell layer of 2–4 nm existed at the edge of each core/shell particle. The HRTEM figures of non core/shell composites were homogeneous without the shell structure. XPS element analysis for core/shell composite indicated that scandium ratio increased and zirconium ratio decreased when heat treatment temperature fell. When the heating temperature fell down to 450 oC, scandium ratio reached nearly 35 mol.%. EIS and DC measurement were taken for both kinds of electrolytes to study the electrochemical properties. The ionic conductivity were 178.2 and 154.4 mS/cm at 850 oC for core/shell and non core/shell electrolytes, respectively. The mechanism of conductivity improvement was also studied. It was predicted that the core/shell interface could improve ionic conductivity by modifying the space-charge regions. This result outlines a novel and potential direction for high-end electrolytes to enhance ionic conductivity.