Comparative Evaluation of Antitumor Chinese Patent Medicine Injections Based on Evidence-Based Medicine and Markov Model

Objective: The objective of this study was to explore the safety, efficacy, economy, and other aspects of frequently-used antitumor Chinese patent medicine injections through a comprehensive evaluation of evidence-based medical research to provide scientific information and decision-making basis for drug selection, rational drug use, public awareness of safe drug use, and medical insurance. Materials and Methods: The names of five frequently used antitumor Chinese patent medicine injections were used as search terms, including the compound Sophora flavescens injection, Kangai injection, Aidi injection, Kanglaite injection, and Brucea javanica oil emulsion injection. Relevant evidence-based medical research was extracted from the databases. A descriptive evaluation was conducted, and the Markov model was used for the cost-benefit analysis. Finally, the above injections are ranked by comprehensive scores using the multi-criteria decision analysis and Delphi method. Results: The five injections had their own advantages in enhancing the effectiveness of anti-tumor treatments, improving the quality of life for cancer patients, and reducing the incidence of adverse reactions. From the perspective of economy and other attributes, compound S. flavescens was superior to B. javanica oil, Aidi, Kangai, and Kanglaite. After a comprehensive evaluation of the above five injections, the compound S. flavescens injection received the highest score. Conclusions: Compound S. flavescens, Kangai, Aidi, B. javanica oil, and Kanglaite have their own advantages in effectiveness and no significant difference in safety. Compound S. flavescens injection has the highest comprehensive score. Clinical attention should be paid to monitoring the initial stage of medication and special groups.

Study on Effect of Chinese Herbal Medicine for Enhancing Therapeutic Efficacy on Refractory Drug Resistant Leukemia

The so-called multidrug resistance （MDR） of leukemic cells means the cross resistance of leukemic cells against multiple anti-tumor agents with different constitution and acting mechanism, which takes place simultaneous after resistance to a single contacted drug has been produced. Tumor cells with MDR would now show a low sensitivity to anti-tumor agents, making chemotherapy ineffective or of little effect. Moreover, MDR is one of the pathogenetic factors for inducing refractory leukemia.

Application of immune checkpoint targets in the anti-tumor novel drugs and traditional Chinese medicine development

Immune checkpoints are the crucial regulators of immune system and play essential roles in maintaining self-tolerance,preventing autoimmune responses,and minimizing tissue damage by regulating the duration and intensity of the immune response.Furthermore,immune checkpoints are usually overexpressed in cancer cells or noninvasive cells in tumor tissues and are capable of suppressing the antitumor response.Based on substantial physiological analyses as well as preclinical and clinical studies,checkpoint molecules have been evaluated as potential therapeutic targets for the treatment of multiple types of cancers.In the last few years,extensive evidence has supported the immunoregulatory effects of traditional Chinese medicines(TCMs).The main advantage of TCMs and natural medicine is that they usually contain multiple active components,which can act on multiple targets at the same time,resulting in additive or synergistic effects.The strong immune regulation function of traditional Chinese medicine on immune checkpoints has also been of great interest.For example,Astragalus membranaceus polysaccharides can induce anti-PD-1 antibody responses in animals,and these antibodies can overcome the exhaustion of immune cells under tumor immune evasion.Furthermore,many other TCM molecules could also be novel and effective drug candidates for the treatment of cancers.Therefore,it is essential to assess the application of immune checkpoints in the development of new drugs and TCMs.In this review,we focus on research progress in the field of immune checkpoints based on three topics:(1)immune checkpoint targets and pathways,(2)development of novel immune checkpoint-based drugs,and(3)application of immune checkpoints in the development of TCMs.

Prognostic analysis of transarterial chemoembolization combined with a traditional Chinese herbal medicine formula for treatment of unresectable hepatocellular carcinoma

Background Transarterial chemoembolization （TACE） is the most widely used primary treatment for unresectable hepatocellular carcinoma （HCC） due to its survival benefit, though its clinical effect is still far from satisfactory. Jiedufang （JDF） granule preparation is a commonly used Chinese herbal medicine formula for HCC. The aim of this study was to evaluate the effect of combined therapy with TACE and JDF granule preparation in treatment of unresectable HCC on survival. Methods A retrospective study of TACE was performed in 165 patients with unresectable HCC who were admitted between January 2002 and December 2007 in Changhai Hospital, Shanghai, China. Of the 165 patients, 80 patients （study group） received combined therapy consisting of TACE and a long-term maintenance treatment with oral JDF granule preparation, and the remaining 85 patients （control group） received TACE alone. The survival rates of both groups were calculated by the Kaplan-Meier method. Factors possibly affecting survival were assessed by multivariate analysis in the Cox proportional hazard model, such as maximum tumor size, number of lesions, portal vein invasion, and etc. Results The median overall survival was 9.2 months （95% CI： 6.94-11.46） in the study group versus 5.87 months （95% CI： 4.21-7.52） in the control group. In the study group,survival rates of the 1-, 2- and 3-year follow-up were 41.2%, 18.4%, and 9.6%, respectively. Significant independent prognostic factors identified by the Cox regression analysis were as follows： serum hepatitis B surface antigen （HBsAg） （P=0.014）, maximum tumor size （P=0.027）, number of lesions （P 〈0.001）, portal vein invasion （P 〈0.001）, and the therapy model （P=-0.006）. Conclusion Combination therapy of TACE and JDF granule preparation may significantly prolong survival of patients with unresectable HCC.

药物罐联合中药热熨对急性腰扭伤患者的治疗效果研究

目的探究药物罐联合中药热熨对急性腰扭伤患者的治疗效果。方法纳入2022年5月至2023年5月南通市中医院收治的130例急性腰扭伤患者,以随机数字表法分为对照组(n=65,常规药物配合物理治疗)、观察组(n=65,药物罐联合中药热熨疗法),收集患者临床疗效、疼痛评分、腰椎功能评分、疼痛发作频率与时间。结果观察组临床疗效(96.92%,63/65)明显高于对照组(84.62%,55/65),差异有统计学意义(χ^(2)=5.876,P=0.015)。治疗后,观察组疼痛数字评分法(NRS),改良日本骨科学会(M-JOA)低于对照组(P<0.05)。治疗后,观察组疼痛发作频率低于对照组,发作时间短于对照组(P<0.05)。结论与常规药物配合物理治疗措施相比,以中医为代表的中药热熨+药物罐疗法能够充分发挥中药疗效,缓解患者腰部疼痛,降低疼痛发作频率,改善患者腰椎功能与生活质量。

A comprehensive analysis of the Bencao(herbal)small RNA Atlas reveals novel RNA therapeutics for treating human diseases

Cross-kingdom herbal mi RNA was first reported in 2012.Using a modified herbal extraction protocol,we obtained 73,677,287sequences by RNA-seq from 245 traditional Chinese Medicine(TCM),of which 20,758,257 were unique sequences.We constructed a Bencao(herbal)small RNA(s RNA)Atlas(http://bencao.bmicc.cn),annotated the sequences by sequence-based clustering,and created a nomenclature system for Bencao s RNAs.The profiles of 21,757 mi RNAs in the Atlas were highly consistent with those of plant mi RNAs in mi RBase.Using software tools,our results demonstrated that all human genes might be regulated by s RNAs from the Bencao s RNA Atlas,part of the predicted human target genes were experimentally validated,suggesting that Bencao s RNAs might be one of the main bioactive components of herbal medicines.We established roadmaps for oligonucleotide drugs development and optimization of TCM prescriptions.Moreover,the decoctosome,a lipo-nano particle consisting of 0.5%–2.5%of the decoction,demonstrated potent medical effects.We propose a Bencao(herbal)Index,including small-molecule compounds(SM),protein peptides(P),nucleic acid(N),non-nucleic and non-proteinogenic large-molecule compounds(LM)and elements from Mendeleev's periodic table(E),to quantitatively measure the medical effects of botanic medicine.The Bencao s RNA Atlas is a resource for developing gene-targeting oligonucleotide drugs and optimizing botanical medicine,and may provide potential remedies for the theory and practice of one medicine.

中医药治疗肝纤维化的优势与特色

肝纤维化是各种慢性肝病的共同病理过程,与肝脏疾病进展相关,是影响肝脏疾病转归和肝细胞癌风险的关键因素。早期过程可逆,若不及时干预治疗,程度逐渐加重终将发展为肝硬化,甚至肝细胞癌,危及人们健康。因此,积极防治肝纤维化具有重要的意义,而肝纤维化的发病机制复杂,西医治疗单一、局限,尚缺乏疗效确切且公认的抗纤维化药物,治疗存在巨大的医疗需求。随着国内外学者的努力研究,中医药治疗成为了逆转肝纤维化和抗纤维化进展的热点和重要突破点,且发现了多靶点、多途径的优势,本文将从辩证、治法、药物配伍及与现代分子机制结合等方面详细阐述中医药治疗肝纤维化的特色和优势。

中药熏洗治疗抗肿瘤靶向药物所致手足综合征临床疗效研究

目的 探究抗肿瘤靶向药物所致手足综合征患者以中药熏洗治疗的效果。方法 选取2021年3月—2023年6月江门市人民医院抗肿瘤靶向药物治疗导致手足综合征患者80例为研究对象,以随机数表法分为两组,各40例。对照组以西药方案治疗,观察组以中药加味三柏散熏洗治疗。比较两组治疗效果。结果 观察组总有效率(95.00%)较对照组高,差异有统计学意义(χ^(2)=4.114,P<0.05)。治疗后,观察组中医症状积分均较对照组低,差异有统计学意义(P<0.05)。治疗后,观察组生活质量评分均较对照组高,差异有统计学意义(P<0.05)。结论 抗肿瘤靶向药物所致手足综合征治疗中,中药熏洗治疗有效性、安全性高,还利于患者生活质量的提高。

中药联合肝动脉化疗栓塞术治疗原发性肝癌系统评价的再评价

目的:评价中药联合经肝动脉化疗栓塞术治疗原发性肝癌系统评价的方法学偏倚及其结论的可靠性。方法:计算机检索Cochrane图书馆、Pub Med、Guideline、中国生物医学文献数据库、中国期刊全文数据库与万方数据库,收集高质量中药联合经肝动脉化疗栓塞术治疗原发性肝癌的系统评价文献进行再评价。结果:共纳入12篇(项)系统评价。结果显示,中药联合肝动脉化疗栓塞治疗原发性肝癌可提高瘤体客观疗效、延长患者生存时间、提高生存质量,减少术后不良反应发生,且无严重中药相关不良反应报道。结论:中药联合经肝动脉化疗栓塞术治疗原发性肝癌的临床疗效显著优于单纯行经肝动脉化疗栓塞术,且安全性较好。

补肾活血泄浊汤治疗大鼠局灶性节段性肾小球硬化的研究

目的 :观察中药补肾活血泄浊汤对大鼠局灶性节段性肾小球硬化的治疗作用及作用机制。方法 :采用单侧肾切除术 ,两次尾静脉注射阿霉素法复制局灶性节段性肾小球硬化模型 ,分为补肾活血泄浊汤治疗组、模型组和正常组。实验的前 6周每周测大鼠 2 4h尿蛋白 ,后 6周隔周测大鼠 2 4h尿蛋白 ,第 6 0d、10 0d时测定血清白蛋白、胆固醇、肌酐、尿素氮含量 ,并进行光镜、电镜、原位杂交、免疫组化等观察。结果 :治疗组各项指标与模型组相比均有显著性差异 ,形态学观察也显示治疗组损害轻于模型组。结论 :补肾活血泄浊汤能够明显保护病鼠肾功能 ,明显减轻病鼠细胞外基质沉积 。

中西医结合疗法治疗初治继发性肺结核病的临床疗效及安全性评价

目的评价中西医结合疗法治疗初治继发性肺结核的临床疗效及安全性。方法临床选择1404例符合西医初治继发性肺结核和中医肺痨(肺阴亏虚、气阴两虚、阴虚火旺证候)诊断标准的患者,进行随机、对照、单盲、多中心临床试验。试验组口服西药+中药,对照组单纯口服西药,疗程6个月。观察2组不良反应发生率和临床症状改善情况,评价其临床疗效及安全性。结果试验组可减少治疗中因药物引起的肝损伤及其他不良反应,不良反应发生率组间比较差异有统计学意义(P<0.001)。肺阴虚证治疗2、4、6个月后,阴虚火旺证治疗6个月后,气阴两虚证治疗4、6个月后症状总积分组间比较差异有统计学意义(P<0.001)。中医证候疗效组间比较差异有统计学意义(P<0.001)。安全性评价分层分析组间比较差异有统计学意义(P<0.001)。结论采用中西医结合方法治疗初治继发性肺结核可减少单纯西药治疗引起的不良反应,减轻临床症状,提高临床疗效和安全性。

鸡白痢沙门氏菌耐药性中药抑制剂的临床治疗效果

采用胸肌注射法对7日龄蛋雏鸡人工感染耐药菌株发病,分7组进行药物治疗试验,分别为抑制剂高剂量组、抑制剂中剂量组、抑制剂低剂量组、西药对照组(环丙沙星)、中药对照组(中药复方制剂)、阳性对照组(感染不给药)和阴性对照组(不感染不给药),饮水给药,连用7d,停药观察14d。结果表明,耐药抑制剂对感染鸡的死亡率降低到10%,治愈率达到70%,有效率达到90%,相对增重率达到101.18%。该耐药抑制剂对鸡耐药沙门氏菌感染具有良好的治疗作用。

不同治法中药复方对H_(22)肝癌小鼠瘤质量和体质量及免疫功能的影响

目的:比较不同治法的中药复方对H22肝癌小鼠瘤质量、体质量及免疫功能等的影响。方法:选择移植性肝癌H22小鼠为模型,观察不同治法的中药复方常规水煎剂的抑瘤作用,并通过检测各组小鼠T淋巴细胞增殖功能、自然杀伤细胞(natural killer,NK)杀伤功能、T淋巴细胞表型变化及γ干扰素(interferon-γ,IFN-γ)和白细胞介素-4(interleukin-4,IL-4)含量来比较免疫功能状况。结果:以毒攻毒组小鼠瘤质量显著小于其他各组小鼠,抑瘤率达65.8%(P<0.01);其他4组抑瘤率在10.1%～17.1%之间。以毒攻毒组小鼠体质量明显下降,出现脱毛现象;扶正培本组小鼠毛发生长良好,活泼好动。以毒攻毒组小鼠T淋巴细胞转化刺激指数(stimulation index,SI)增加显著(SI=4.34,P<0.01),说明以毒攻毒组小鼠T细胞具有较强的增殖能力;其余各组小鼠SI均低于3,表明这些组的小鼠T细胞无明显增殖作用。清热解毒、活血化瘀和以毒攻毒组小鼠NK细胞百分数显著增高,分别为生理盐水组的5.05、4.07和5.17倍(P<0.01);扶正培本和化痰散结组小鼠NK细胞杀伤活性未见显著升高。IFN-γ检测结果显示,以毒攻毒组小鼠T细胞分泌IFN-γ能力显著升高(P<0.05);IL-4检测结果显示,除扶正培本组外,清热解毒、活血化瘀、化痰散结和以毒攻毒组小鼠T细胞分泌IL-4的能力也均显著升高(P<0.01)。结论:以毒攻毒法能有效抑制肿瘤细胞的生长,明显增强小鼠细胞和体液免疫功能;扶正培本法则有良好的强壮作用。

治疗痛风药物研究进展

随着人们生活水平的提高,痛风的发病率不断上升并出现低龄化,寻找高效低毒的抗痛风药物成为当务之急。目前,对于痛风的常规治疗仍以西药为主,这些药物以不同的作用机制达到缓解或治疗痛风的目的,但临床发现它们都具有一定的毒副作用。近年来,越来越多的研究者着手于抗痛风天然药物的开发,其疗效与毒副作用尚待进一步的临床验证。本文对目前临床上常用的抗痛风药物及正在研发中的抗痛风药物进行了综述,总结痛风病不同分期的药物治疗特点,阐述各期药物治疗潜在危害和处理方法,归纳抗高尿酸血症或痛风的中药研究,为开发新型抗痛风药物提供有效途径,并对抗痛风新药的研发进行了展望。

对长期服用含西药的中成药的癫痫患者血药浓度监测

目的分析本院癫痫患者因长期服用外院自制中成药导致中枢性神经系统反应的病例。方法用荧光偏振免疫法,测定患者丙戊酸、卡马西平、苯巴比妥、苯妥英钠的血药浓度。结果丙戊酸、卡马西平、苯巴比妥、苯妥英钠血药浓度分别为38.09,0.34,0.18,0.65μg·mL-1。每单一成分均低于最低有效血药浓度;但4种药合并使用,可产生大协同作用。结论尽可能减少合并用药品种,广泛开展治疗药物监测。

复方槐角口服液的抗炎、镇痛和止血作用

复方槐角口服液是在借鉴传统中成药槐角丸组方基础上研究开发的一种治疗痔疮的纯天然中药制剂。现经药理学研究证实，该口服液（５，１０ｇ·ｋｇ－１，ｉｇ）对由二甲苯诱发的小鼠耳部水肿和由蛋清诱发的大鼠足爪肿胀均呈现抑制作用，能有效地控制急性炎症过程，并且对棉球引起的大鼠肉芽肿组织增生也有一定抑制作用。在小鼠热板和扭体法实验模型上呈现镇痛作用。尚可缩短出血、凝血时间，止血效果明显。本研究结果提示该口服液仍能保持槐角丸重要药效学特性。

中药透皮吸收促进剂的研究进展

经皮给药系统(transdermal drug delivery system,TDDS)由于具有超越一般给药方式的独特优点,其研究已经成为第3代药物制剂开发研究的中心内容之一。然而在经皮给药的临床应用中,人们发现,药物的经皮吸收存在着各种障碍,使得药物很难达到预期的有效的治疗效果。近年来,透皮吸收促进剂(penetration enhancers,PE)的应用为经皮给药系统的研究与应用带来了契机,而天然的中药PE以其具有起效快、效果好、副作用小等优点,正日益引起人们的重视,显示出广阔的发展前景。

开展中药个体化用药与治疗药物监测的现状及探讨

目的:对中药个体化用药及治疗药物监测进行初步探讨,为相关研究的开展提供一定的参考依据。方法:对中药临床用药及安全性现状进行分析,并充分借鉴中医药理论及现代系统生物学研究成果,开展中药个体化用药与治疗药物监测研究。将因证选方-因证选药-因证选炮制品三者有机结合,完成个体化用药;同时,以易失阴亡阳的虚证、重证、危证、急证以及毒性较大、作用剧烈的方药为主要对象,采用中医临床证法、血药浓度法、生命体征及生化指标法、基因蛋白组学指标法、代谢组学/血液小分子物质变化指标法,开展治疗药物监测。结果与结论:中药个体化用药与治疗药物监测研究符合中医药理论及现代研究成果,但需要进一步、深入开展大量研究工作。

益生菌对大肠癌辅助化疗期免疫功能的影响

目的观察益生菌对大肠癌辅助化疗期脾虚证患者的肠道菌群及免疫功能的影响。方法将60例大肠癌辅助化疗期脾虚证患者随机分为益生菌组、中药组和对照组。3组在常规化疗基础上分别予中药加益生菌、中药、未行中药及益生菌治疗,治疗4周。观察治疗前后T细胞亚群、大便SIgA及肠道菌群变化。结果治疗后益生菌组较中药组、对照组CD3+、CD4+、CD4+/CD8+比例上升、大便SIgA水平升高(P<0.05),且双歧杆菌/大肠杆菌比例增加(P<0.05)。结论益生菌加中药治疗较单用中药治疗可增强细胞免疫功能,有效改善大肠癌辅助化疗期脾虚证患者肠道菌群失调。

服用“纯中药”制剂的癫痫患者抗癫痫药血药浓度监测

目的:了解某些抗癫痫"纯中药"制剂中是否含有抗癫痫西药成分,为临床合理用药提供依据。方法:对服用"纯中药"制剂的30例癫痫患者,用荧光偏振免疫法(FPIA)筛检其是否含有丙戊酸(VPA)、卡马西平(CBZ)、苯巴比妥(PB)、苯妥英钠(DPA)等4种常用抗癫痫西药。结果:30例患者中,检测出上述1～4种常用抗癫痫西药的28例,占93.3%。其中VPA 16例,平均浓度(12.02±14.97)μg·ml^(-1);CBZ 20例,平均浓度(2.43±2.54)μg·ml^(-1);PB 23例,平均浓度(14.57±16.63)μg·ml^(-1);DPA 22例,平均浓度(7.31±13.43)μg·ml^(-1)。结论:在所谓的抗癫痫"纯中药"制剂中暗加西药较普遍,严重侵犯了患者知情权,妨碍了抗癫痫的正规治疗,有损患者健康。