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      • 化湿通痹方治疗湿热蕴脾型勃起功能障碍的多中心、随机、对照、非劣效性试验

        ZOU He-de, ZHANG Pei-hai, CHEN Wen-kang, HU Bao-feng, WANG Jian-wei, ZENG Hong-sen, DU Guan-chao, GAO Qing-he, MA Zi-yang, MA Yong-jie, ZHANG Ya-peng, CAO Rui, ZHANG He-kun, LIN Wei, XU Hao-ran, ZHAO Jia-you
        2026, 32(2): 111-119. DOI: 10.1007/s11655-025-4142-0
        Abstract：目的:评价中药复方化湿通痹方(Huashi Tongbi Formula, HTF)治疗湿热蕴脾型勃起功能障碍(erectile dysfunction, ED)的疗效和安全性, 并基于肠道菌群分析探讨其可能的作用机制.方法:采用多中心、随机、平行阳性对照、非劣效性试验方法, 纳入162例湿热蕴脾型ED患者, 使用随机数字表法按2:1比例随机分为治疗组(108例)和对照组(54例). 治疗组给予HTF颗粒(每次1袋, 每日2次). 对照组给予枸橼酸西登那片(50mg, 按需口服). 两组均治疗8周, 随访8周. 主要指标为治疗8周后的有效率, 采用意向治疗(intention-to-treat, ITT)和符合方案(per-protocol, PP)方法进行分析, 次要指标包括国际勃起功能指数-5(International Index of Erectile Function-5, IIEF-5)评分、勃起质量评分(Erectile Quality Score, EQS)、和中医证候 (Chinese medicine syndrome, CMS) 评分, 在8周的治疗期内每2周进行ITT分析, 在8周随访期内每4周进行ITT分析. 16S rDNA测序用于分析HTF对肠道微生物群的影响. 记录两组患者的不良事件(adverse events, AEs)和安全性指标变化情况.结果:共有162例患者纳入ITT分析, 其中23例患者在试验期间退出(治疗组12例, 对照组11例), 139例患者纳入PP分析. ITT和PP分析显示, 治疗8周后, 治疗组和对照组有效率的差异和95%置信区间(confidence intervals, CIs)分别为-3.7%(-17.9%, 10.5%) 和-4.5%(-18.2%, 9.2%). 治疗2周时, 治疗组IIEF-5和EQS评分较低, CMS评分较高(P<0.05); 治疗4周时, 治疗组IIEF-5较低 (P<0.05), 两组EQS和CMS评分相当(P>0.05); 治疗6周时, 两组所有评分 (IIEF-5、EQS、CMS)组间相当(P>0.05); 治疗8周时, 两组IIEF-5和EQS评分相当, 治疗组CMS评分较低(P<0.05). 在第4周和第8周随访中, 治疗组IIEF-5和EQS评分较高, CMS评分较低(P<0.05). 与基线相比, 治疗后两组显示所有评分均改善(P<0.05). 两组安全性指标差异无统计学意义(P>0.05). HTF治疗后, 毛螺菌科和布劳特氏菌属相对丰度增加, 对组间微生物群落的差异贡献最大. 治疗组短乳杆菌和乳植杆菌丰度增加, 嗜胆菌属、糖单胞菌、髌骨菌和其他细菌丰度减少(线性判别分析>2). 治疗组氨基酸相关酶、外泌体、线粒体生物发生等肠道微生物群的9种预测功能降低, 蛋白激酶功能增加(P<0.05).结论:HTF治疗湿热蕴脾型ED的疗效不劣于西地那非片, 具有缓解整体症状和停药后疗效稳定持久的优势, 其机制可能由调节肠道菌群介导. (注册号: ChiCTR2300067825)  
        Keywords：化湿通痹方;中药;勃起功能障碍;肠道菌群;非劣效性;随机对照试验   
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        Updated：2026-02-14
      • CHEN Yuan-hong, XU Wei-xin, YU Wen-jun, WANG Chun-fang, GUO Chun, LUO Yan-hong
        2026, 32(2): 120-127. DOI: 10.1007/s11655-025-4132-2
        Abstract：Objectives:To explore the effect of Pollen Pini (PP) on SMMC-7721 hepatoma cells.Methods:The anti-proliferative effects of PP on SMMC-7721 cells were evaluated using cell counting kit-8 assay following 48 h treatment with concentrations ranging from 1.25 to 37.50 μg/μL. Flow cytometry analysis at the half maximal inhibitory concentration (IC50) revealed significant apoptosis induction and cell cycle alterations. For in vivo evaluation, SMMC-7721 xenograft-bearing nude mice were administered either vehicle (0.9% NaCl) or PP(500 mg/kg) via intraperitoneal injection every other day for 3 weeks. Subsequent tumor analysis included mass spectrometry-based proteomics and examination of phosphoinositide-3 kinase (PI3K)/protein kinase B (Akt)/Myc pathway proteins by immunohistochemistry and Western blot. Combination therapy with 25 μmol/L PI3K inhibitor and PP (IC50) showed optimal efficacy, with Western blot revealing maximal protein modulation at 24 h.Results:PP had an anti-tumor effect on SMMC-7721 cells in vitro, with the IC50 concentration of 18.94 mg/mL. PP could promote the death of SMMC-7721 cells (P<0.01) and regulate the cell cycle more in G0/G1 phase cells (P<0.01). After the treatment effect of PP, the protein content of SMMC-7721 cells changed and the contents of cancer-promoting proteins PI3K, Akt and Myc decreased (P<0.01). PI3K inhibitor could reduce the proliferation of SMMC-7721 cells, and PI3K inhibitor combined with PP significantly reduced the expression of PI3K in SMMC-7721 cells(P<0.01).Conclusion:PP has an anti-tumor effect on SMMC-7721 cells through the PI3K-Akt signaling pathway.  
        Keywords：Pollen Pini;Chinese medicine;SMMC-7721;anti-tumor effect;phosphoinositide-3 kinase;protein kinase B   
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        Updated：2026-02-14

      • 莪术烯通过抑制MEK/ERK信号通路诱导结直肠癌细胞凋亡

        PENG Jian, LU Ju, LI Guo-hua, MA Meng-meng, MOU Yi-ping, ZHU Qi-cong
        2026, 32(2): 128-137. DOI: 10.1007/s11655-025-4123-3
        Abstract：目的:探究莪术烯在体内外结直肠癌模型中的抗肿瘤活性.方法:采用 0、20、40、60 μg/mL 不同浓度的莪术烯处理人结直肠癌细胞株HT29与HCT8, 作用时长24 h. 通过CCk-8剂盒检测细胞活力, 克隆形成实验检测细胞增殖能力, 流式细胞术检测细胞凋亡率; 利用JC-1荧光探针试剂盒检测线粒体膜电位变化, 采用Fluo-3AM 与Mag-fluo-3AM 荧光染色法检测细胞内钙离子水平. 同时, 选用3-甲基腺嘌呤 (3-MA) 、氯喹 (CQ) 、坏死凋亡抑制剂-1 (Nec-1) 等多种细胞死亡抑制剂验证莪术烯诱导的细胞死亡机制. 借助分子对接技术, 分析莪术烯与丝裂原活化细胞外信号调节激酶 (MEK) 蛋白的结合能力; 采用蛋白质印迹法 (Western blot) 检测磷酸化 MEK (p-MEK) 、磷酸化细胞外信号调节激酶 (p-ERK) 、B细胞淋巴瘤-2 (Bcl-2) 、Bcl-2 相关X蛋白 (Bax) 、多聚腺苷二磷酸核糖聚合酶 (PARP) 及剪切型多聚腺苷二磷酸核糖聚合酶 (Cleaved PARP) 等关键蛋白的表达水平. 最后, 将存活的HT29细胞皮下接种至雄性BALB/c 裸鼠右侧背侧腹部, 开展体内药效评估.结果:莪术烯可呈时间与剂量依赖性抑制HT29和HCT8细胞增殖并诱导其凋亡 (均P<0.05) . 进一步验证发现, 凋亡抑制剂Z-VAD-FMK可逆转莪术烯诱导的细胞死亡 (P<0.05) , 而 3-MA、CQ、Nec-1则无此作用. 与对照组相比, 60 μg/mL 浓度的莪术烯可通过影响细胞内钙离子分布、活性氧水平, 上调剪切型PARP的表达 (均P<0.01) ; 同时降低线粒体膜电位, 并下调p-MEK、p-ERK、Bcl-2 及PARP的表达 (均P<0.05) , 且莪术烯与MEK蛋白的分子结合能为-7.1 kcal/mol. 实验结果证实, 莪术烯可抑制 MEK/ERK 信号通路的活化, 而预先使用 MEK 激活剂C16-PAF可显著缓解莪术烯诱导的细胞死亡 (均 P<0.05) . 体内实验结果显示, 莪术烯可显著抑制裸鼠皮下移植瘤的生长.结论:莪术烯通过抑制MEK/ERK信号通路诱导结直肠癌细胞凋亡, 有望成为治疗结直肠癌患者的潜在化疗药物.  
        Keywords：莪术烯;结直肠癌;MEK/ERK;细胞外调节蛋白激酶;细胞凋亡;中药   
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        Updated：2026-02-14
      • Noor Azleen Mohamad, Amirah Abdul Rahman, Siti Hamimah Sheikh Abdul Kadir, Safaa M. Naes, Musalmah Mazlan, Suzana Makpol
        2026, 32(2): 138-146. DOI: 10.1007/s11655-025-4133-1
        Abstract：Objective:To elucidate the effect of hydroxychavicol (HC) in combination with 5-fluorouracil(5-FU) on purine metabolism and apoptosis in colorectal cancer cell lines HT-29 and DLD-1.Methods:The viability of HT-29 and DLD-1 cells when treated with HC, (0–1,000 μmol/L) 5-FU (0–100 μmol/L) alone, and HC+5-FU for 24 and 48 h was determined. Hypoxanthine (HPX) and xanthine oxidoreductase (XOR) were evaluated, as well as reactive oxygen species (ROS) levels and mitochondrial membrane potential (MMP). The expression levels of genes including nucleoside transporters equilibrative nucleotide transport 1 and 2 (ENT1 and ENT2), the pro-apoptotic gene Caspase-3 (CASP3), and the anti-apoptotic gene BCL2 were analysed by quantitative polymerase chain reaction.Results:Both HPX and XOR levels in cells treated with HC+5-FU were significantly decreased(P<0.05) after 24 and 48 h compared to control cells. ROS levels in HT-29 and DLD-1 treated with HC+5-FU for 24 and 48 h were 26.2% and 21.4%, and 9.1% and 20.5%, respectively, significantly lower than control cells. MMP assays indicated mitochondrial depolarisation. In HT-29 cells, ENT1 and BCL2 were downregulated at 24 h, and CASP3 was upregulated at 48 h. In DLD-1 cells, ENT1 and ENT2 were downregulated, while CASP3 showed a transient decrease at 24 h.Conclusions:The combination of HC + 5-FU demonstrated synergistic effects in HT-29 and DLD-1 cells, disrupting oxidative balance and purine metabolism, as reflected in reduced hypoxanthine levels, XOR activity, and ROS production. This treatment also induced mitochondrial membrane depolarisation and altered apoptosis-related gene expression, supporting its role in apoptosis induction.  
        Keywords：apoptosis;colorectal cancer;hydroxychavicol;purine metabolism;5-fluorouracil   
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        Updated：2026-02-14

      • 人参二醇组皂苷对放射性心脏损伤小鼠的保护作用及其机制

        LAN Jin-jian, GAI Jin-yu, SONG Wen-jing, LIU Ying, ZHAO Yan-na, WANG Bo-lin, LYU Ke-ren, GAO Rui-lan, YU Xiao-ling
        2026, 32(2): 147-156. DOI: 10.1007/s11655-025-4144-y
        Abstract：方法:采用X射线照射 BALB/c小鼠建立RIHD模型, 并通过随机数字表法将其随机分为3组 (每组n=10) ;正常对照组和 RIHD 模型组给予生理盐水, PDS-C 组给予 PDS-C (80 mg/Kg) 治疗12周. 通过超声成像观察心脏功能, 检测血清心肌酶, 并对心脏组织进行病理检查. 转录组分析正常小鼠和放射性心肌病 (RIHD) 小鼠差异转录基因. 通过免疫组织化学、免疫组织荧光和蛋白质印迹法分别检测了炎症因子和纤维化蛋白的表达水平. 用 PDS-C (20、40、80 mg/L) 干预辐照H9c2 大鼠心肌细胞, 检测炎症因子和纤维化蛋白. 同时用佛波酯(PMA)作为核因子κB (NF-κB) 激活剂和 BAY11-7082 作为抑制剂验证 PDS-C 对 NF-κB 转录因子的影响.结果:正常小鼠与放射性心脏损伤 (RIHD) 小鼠之间存在差异表达的基因主要与NF-κB转录因子有关, 差异基因同时与心脏炎症有关. PDS-C 显著提高了 RIHD 小鼠的心脏射血分数和左心室缩短分数 (P<0.05) , 同时改善RIHD 小鼠天冬氨酸氨基转移酶、肌酸激酶、肌酸激酶同工酶和乳酸脱氢酶的水平 (P<0.05) . 心脏组织病理显示RIHD 小鼠存在明显水肿、严重坏死和核固缩; 然而PDS-C 明显减轻了心脏损伤的程度. 此外, PDS-C 降低了白细胞介素IL-1、IL-6、Smad2、CTGF和 NF-κB 的水平 (P<0.05) . 细胞学实验表明, PDS-C 降低了辐射 H9c2 细胞中的活性氧水平 (P<0.05) , 上述炎症因子和纤维化相关蛋白的表达与小鼠模型的结果一致.结论:PDS-C 通过抑制 NF-κB 信号通路减轻炎症和纤维化而保护辐照小鼠心脏作用.  
        Keywords：人参二醇组皂苷;中药;放射性心脏损伤;纤维化;NF-κB信号通路   
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        Updated：2026-02-14

        Evidence-Based Integrative Medicine

      • ZHANG Chu-chu, ZHANG Jun-yue, LIU Ying, WANG Xiao-xi, GAO De-qiang, CHEN Ze-hui, LIU Yi, LIN Hong-sheng, LI Hai-yan, ZHENG Jia-bin
        2026, 32(2): 157-164. DOI: 10.1007/s11655-025-4150-0
        Abstract：Background:Lung cancer remains one of the most malignant cancers worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of all cases. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are recommended as first-line treatments for advanced EGFR-mutated NSCLC. Classical Chinese herb formulas have shown potential clinical benefits in NSCLC management. However, few studies have systematically compared the efficacy and safety of EGFR-TKIs monotherapy versus EGFR-TKIs combined with classical Chinese herb formulas.Objective:To evaluate the efficacy and safety of EGFR-TKIs monotherapy versus EGFR-TKIs combined with classical Chinese herb formulas in the treatment of NSCLC.Methods:A systematic search was conducted to identify randomized controlled trials (RCTs) in which patients with NSCLC were randomly assigned to receive either EGFR-TKIs monotherapy or EGFR-TKIs combined with classical Chinese herbal formulas. The combined regimens include EGFR-TKIs plus Chinese herbal compounds (CHCT), EGFR-TKIs plus Chinese traditional medicine injections (CTMIT), and EGFR-TKIs plus Chinese patent medicines (CPMT). Electronic databases search included PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang Data, VIP Database, the International Clinical Trial Registry Platform, and the Chinese Clinical Trial Registry, from inception updated to February 26, 2025. Given that all outcomes were binary, odds ratios (ORs) along with 95% confidence intervals (CIs) were computed. Pairwise comparisons and Bayesian network meta-analyses were used for the same outcome assessment, including progressive disease (PD), disease control rate (DCR), objective response rate (ORR), rash, diarrhea, and drug-induced liver injury (DILI) with the former reporting ORs and 95% CIs while the latter ORs and 95% credible intervals (CrIs).Resuts:A total of 155 RCTs involving 12,441 patients with NSCLC were included. For efficacy outcomes, EGFR-TKIs monotherapy was associated with a higher risk of PD compared with CHCT (OR: 2.43, 95% CrI: 2.11–2.76), CTMIT (OR: 2.98, 95% CrI: 2.47–3.58), and CPMT(OR: 1.94, 95% CrI: 1.44–2.64) combination therapies, while CPMT was associated with a lower risk of PD than CTMIT (OR: 0.65, 95% CrI: 0.46–0.94). In terms of ORR, CHCT (OR: 0.53, 95% CrI: 0.47–0.59), CTMIT (OR: 0.43, 95% CrI: 0.36–0.50), and CPMT(OR: 0.52, 95% CrI: 0.40–0.68) combination therapies all demonstrated significantly higher ORR than EGFR-TKIs monotherapy, with CTMIT also showing a higher ORR compared with CHCT (OR: 0.81, 95% CrI:0.67–0.99). For DCR, combination therapy with CHCT(OR: 0.39, 95% CrI: 0.34–0.46), CTMIT (OR: 0.33,95% CrI: 0.26–0.42), and CPMT (OR: 0.57, 95% CrI: 0.41–0.77) combination therapies were superior to EGFR-TKIs monotherapy, and both CHCT (OR: 1.44, 95% CrI:1.01–2.05) and CTMIT (OR: 1.70, 95% CrI: 1.16–2.50) showed better DCR than CPMT. For safety outcomes, EGFR-TKIs monotherapy was associated with a higher incidence of rash compared with CHCT (OR: 1.82, 95% CrI:1.46–2.30) and CTMIT (OR: 1.55, 95% CrI: 1.01–2.41) combination therapies, a higher incidence of diarrhea compared with CHCT (OR: 2.52, 95% CrI: 1.99–3.21) and CPMT (OR: 2.56, 95% CrI: 1.43–4.58), and a higher incidence of DILI compared with CHCT (OR: 2.02, 95% CrI: 1.33–3.13).Conclusions:This study provides evidence to support the potential value of combining Chinese herbal formulas with EGFR-TKIs in the treatment of NSCLC, aligning with current clinical guidelines. The findings indicate that EGFR-TKIs combined with Chinese herbal formulas (CHCT, CTMIT, CPMT) are associated with higher ORR and DCR, and a lower risk of PD, compared with EGFR-TKIs monotherapy. Additionally, CHCT may reduce the incidence of rash in EGFR-TKIs treated patients. Further well-designed RCTs are warranted to compare the efficacy and safety of different combined therapeutic strategies in NSCLC patients. (Registration No. CRD42024521654)  
        Keywords：Chinese herbal drug;epidermal growth factor receptor tyrosine kinase inhibitor;integrative medicine;network meta-analysis;non-small cell lung cancer   
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        Updated：2026-02-14
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