基于复方丹参滴丸美国FDAⅢ期临床试验探讨中医临床疗效评价指标的选取

通过总结疗效评价指标的优缺点及适用范围,基于复方丹参滴丸的指标选择经验,从疾病特点、中医药特色和替代指标运用等方面探讨中医临床疗效评价指标的选取。

现代数学方法与中医临床疗效评价终点指标选择思路

终点指标已成为目前临床干预评价指标的最佳选择。从终点指标的选择现状、选择依据出发,分析现代数学方法在中医临床疗效评价中的应用情况,指出引入主成分分析或因子分析,结合频数统计,构建综合得分数学模型,适用于中医临床疗效评价终点指标选择,为终点指标的筛选与优化提供新的方法学思路。

风化煤改变黄河三角洲盐渍化土壤溶液组分的过程

黄河三角洲盐渍土改良具有重要的经济和社会意义。风化煤(0%、1%、3%、5%)添加到不同含盐量(1.0 mg·g^(-1)、7.5 mg·g^(-1)、35.3 mg·g^(-1))的滨海盐渍化土壤后,可降低土壤浸提液的钠吸附比(Sodium adsorption ratio,SAR)及Cl^-/SO_4^(2-)比,有助于减轻盐渍危害。7.5 mg·g^(-1)含盐量土壤在5%添加下SAR由7.81降为6.61,Cl^-/SO_4^(2-)由10.20降为8.25。风化煤中丰富的羧基等表面官能团及Ca^(2+),可通过三个作用过程改变盐渍化土壤溶液的离子组成,涉及:(1)风化煤固相Ca^(2+)与溶液Na^+离子的交换,从而降低土壤溶液中Na^+的浓度和危害;(2)溶液中Ca^(2+)与土壤交换性Na^+的置换,有助于土壤团聚体的形成和Na^+的淋洗;(3)溶液中的Na^+与风化煤中的溶解性有机质形成络合物,使Na^+的活度和植物有效性降低,间接起到减害作用。此外,钠吸附比和氯硫比可用于在实验室初步判断风化煤等物料用于盐渍土改良的潜力和效果。

农林废弃物田间曝氧水-火联动制炭设备及技术研究

生物炭具备固碳减排、提升地力、修复污染土壤等功效,但其推广应用面临着成本过高的难题。为降低其生产(设备与场地的运维费用)和使用成本(原料与炭品的运输费用),该文研发田间制炭技术,将生物质就地转化为生物炭。通过水-火联动技术,可在田间曝氧环境下制备得到生物炭。研究表明,原材料特性决定着成炭的操作工艺;其中,竹柳采用单向引燃、槽面喷水控温、通孔喷雾成炭的方式进行,棉秆采用单向引燃与控温、喷水横切炭体、喷雾成炭的方式进行,芦苇采用多位点引燃、槽面和通孔同时控温、逐层分区喷雾成炭的方式进行。采用该技术制备的生物炭表现出了较好的均质性,成炭率在30%左右;同时保存了较多的营养元素,如碳质量分数介于43.49%~60.30%、氮质量分数介于0.52%~0.86%;具有丰富的表面官能团,如羧基含量介于0.98~1.09mol/kg、酚羟基含量介于0.53~0.59mol/kg;具有较大的比表面积,介于16.0~262.2 m^2/g。竹柳、棉秆和芦苇在成炭过程中产生的烟气经尾气处理系统处理后(PM 2.5(56、66、68μg/m^3)、PM 10(100、114、128μg/m^3))均达到排放标准。该文提供的田间制炭技术操作简单、成本低且效率高。实践表明,农民在自家田里可制炭达1 t/(d·人),成本仅需162.5元/t。该文研究结果可为生物炭的推广应用提供参考。

复方丹参滴丸治疗心肌梗死患者终点事件发生情况的队列研究

目的：观察复方丹参滴丸治疗心肌梗死患者终点事件的发生情况。方法：采用回顾性队列研究设计,使用复方丹参滴丸≥28 d者入暴露组,〈28 d者入非暴露组,纳入山东省8家三级甲等中医院急性心肌梗死患者,随访其出院后复方丹参滴丸的使用情况及终点事件的发生情况,采用多因素Logistic回归分析法分析复方丹参滴丸与终点事件的相关性。结果：研究共纳入1 452例心肌梗死患者,完成随访1 210例,失访242例;暴露组207例,非暴露组1 003例;终点事件前三位依次为心血管再入院334例、心源性死亡170例、再梗死95例;与非暴露组相比,暴露组心源性死亡、再梗死的发生率较低（P〈0.05）;回归分析显示中暴露和强暴露是心源性死亡的保护因素,抗栓药物治疗是再入院和血运重建的保护因素,血管紧张素转化酶抑制剂（ACEI）/血管紧张素受体阻滞药（ARB）药物治疗是再入院、急性心力衰竭的保护因素,年龄是心源性死亡、急性心力衰竭、严重心律失常、他因死亡的危险因素,合并2型糖尿病是心源性死亡、急性心力衰竭、他因死亡的危险因素。结论：复方丹参滴丸能降低心肌梗死患者随访期间心源性死亡、再梗死的风险,使用复方丹参滴丸6个月以上的心肌梗死患者获益更大。

废SCR脱硝催化剂再生与金属回收及载体回用技术

为实现我国燃煤锅炉烟气中氮氧化物(NO_(x))的超低排放,选择性催化还原(SCR)技术被大量推广应用。SCR技术的关键在于脱硝催化剂的性能,脱硝催化剂在使用过程中由于物理结构损坏和化学中毒导致催化剂失活。随着SCR技术推广而产生的废脱硝催化剂量大幅度增加,面临着带来环境污染风险和资源浪费问题。基于废脱硝催化剂主要成分锐钛型TiO_(2)、钨、钒与新催化剂一致,循环回用至新催化剂制备是必然的发展趋势。废脱硝催化剂的回收利用主要分直接再生回用、有价金属回收和载体回用三类。直接再生回用针对的是结构完好的废脱硝催化剂,可采用空气吹扫、清水冲洗、化学药剂清洗、活性植入、高温焙烧等工艺处理。我国废脱硝催化剂的结构破损率超过50%,大部分无法直接再生回用,可采取酸碱主导工艺、熔融技术从破损的废脱硝催化剂中回收V、W、Ti等有价金属。因此,需要加快研究可行的载体回用技术,创建基于脱硝催化剂载体孔结构劣化指数的载体重构技术判定标准,揭示载体深度净化和重构机理,形成经济合理的废弃环保催化剂无害化、资源化成套技术。以资源绿色循环利用为目标,根据废SCR脱硝催化剂的品质设计适宜的技术路线和生产工艺。未来可通过对废SCR脱硝催化剂再生全生命周期运行管理和催化剂产品在长期运行中的特征表现及运行深入探究,完善工艺、加强回收利用效率和降低生产能耗,解决再生载体催化剂可靠性的难题。

腐殖质纳米颗粒对镉污染土壤的修复

外源腐殖质可改变土壤镉(Cd)的含量和状态。以风化煤为原料制备的不溶性胡敏酸为吸附剂,对比研究了其对冶炼厂周边污染土壤及人工模拟污染土壤中Cd的钝化效果。再以泥炭为原料,制备富里酸钾为主的水溶性腐殖酸钾为淋洗剂,用于活化、去除上述2种土壤中的Cd。结果表明,胡敏酸在砂质的人工模拟污染土壤中钝化效果更好,2%的剂量可使土壤中Ca Cl2提取态Cd的浓度(0.103 mg·L^(-1))降低19.7%。腐殖酸钾去除土壤Cd的效率随淋洗剂浓度增加而提高,在10 g·L^(-1)的浓度时,单次淋洗可去除高达38.1%的Cd。傅里叶变换红外光谱分析表明,腐殖质与Cd反应后形成了羧酸盐。因此,腐殖质纳米颗粒既可以钝化土壤中的Cd,也可以活化土壤中的Cd,从而达到修复Cd污染土壤的目的。其关键在于根据钝化或活化的目标,选择溶解度适当的腐殖质材料。

Tonifying Qi and activating blood circulation in terms of Traditional Chinese Medicine: their effects in patients with myocardial infarction

OBJECTIVE: To investigate the effects of tonifying Qi and activating blood circulation(SQABC), a method in Traditional Chinese Medicine(TCM), on end-point events in patients with myocardial infarction(MI) in this retrospective cohort study.METHODS: Clinical data were obtained from the medical records of patients with acute MI(AMI),both during hospitalization and follow-up, and included general demographic information(age, gender, and contact information), TCM regimens used,and end-point events.RESULTS: A total of 1596 patients with AMI were enrolled to this study, but data of only 1210 casesare accessible till follow-up. We classified the patients based on the exposure levels of SQABC.When comparing the results between all exposure and non-exposure groups, significant differences were identified, both during hospitalization and follow-ups. During hospitalization, cardiac death(4.40% vs 21.55%, P < 0.05) and cardiac shock(3.04% vs 11.62%, P < 0.05) were significantly lower in the exposure group than the non-exposure group. Similarly, during the follow-up, cardiac death(12.04% vs 20.49%, P < 0.05), acute heart failure(7.27% vs 11.81%, P < 0.05), composite endpoint of reinfarction and stroke(9.11% vs 15.28%,P < 0.05), and rehospitalization due to angina(25.49% vs 34.38%, P < 0.05) were significantly lower in the exposure group than the non-exposure group.CONCLUSION: Our findings suggest that SQABC can significantly benefits the subjects in the management of high-risk AMI in them.

Efficacy of Traditional Chinese Medicine in patients with acute myocardial infarction suffering from diabetes mellitus

OBJECTIVE: To investigate the "real world" effectiveness of Traditional Chinese Medicine(TCM) in patients with acute myocardial infarction suffering from diabetes mellitus(AMI+DM patients).METHODS: This was a retrospective cohort study.During hospitalization, the "exposure group" was defined as patients who had a TCM injection for ≥ 7 d.During follow-up, the definition of the exposure group was application of a Chinese patent medicine or decoction of Chinese medicine for ≥ 28 d.General information(age, sex, contact details), TCM use and endpoint events of AMI+DM patients during hospitalization and follow-up were collected.The correlation between TCM and the end-point events of AMI + DM patients was analyzed using a multiple logistic regression method.RESULTS: A total of 479 AMI + DM patients were enrolled and 345 cases were followed up. During hospitalization, TCM, age, hypertension and use of an angiotensin-converting enzyme inhibitor(ACEI)or angiotensin receptor blocker(ARB) were associated with cardiac death. During follow-up, TCM was associated with cardiac death. TCM was a relevant factor for a composite endpoint of re-infarction and stroke. TCM, anti-thrombotic therapy and lipid-lowering therapy were related to acute heart failure. TCM, anti-thrombotic therapy, anti-MI therapy and ACEI/ARB use exhibited a strong correlation with re-hospitalization due to cardiovascular disease.CONCLUSION: TCM reduced the prevalence of cardiac death during hospitalization, and cardiac death, a composite endpoint of re-infarction and stroke, acute heart failure and re-hospitalization due to cardiovascular disease during follow-up.