Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. The diagnosis of male infertility has a negative effect on men's physical and psychological status, poses a threat to their social relationships, lowers self-esteem, and disrupts family harmony. At present, the treatment of ASZ and OA are all mostly empirical, including antioxidants, endocrine therapy, and anti-infection. However, there are still limitations due to inefficiencies. Linggui Yangyuan paste (LGYY), a traditional Chinese compound herbal past, had been used to treat ASZ and OA for several years at the Xiyuan Hospital of China Academy of Chinese Medical Sciences. The investigators designed this program to study the efficacy and safety of LGYY for the treatment of patients with male infertility (AZS and OA).

开始日期2023-06-01

申办/合作机构

中国中医科学院西苑医院

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100 项与五子衍宗口服液相关的临床结果

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100 项与五子衍宗口服液相关的转化医学

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100 项与五子衍宗口服液相关的专利（医药）

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项与五子衍宗口服液相关的文献（医药）

2024-12-31·JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Decoction of Yougui Wan combined with Wuzi Yanzong Wan ameliorates thin endometrium in a mouse model

Article

作者: Xiang, Jun ; Zhou, Xiaohong ; Su, Aifang

BACKGROUND:

This study aimed to determine the effect and mechanism of the Decoction of Yougui Wan combined with Wuzi Yanzong Wan (DYWWYW), a traditional Chinese herbal formula, in a mouse model with thin endometrium induced by 95% ethanol.

METHODS:

Thin endometrium mice were treated with progynova (0.002 mg) as well as a low and high dose of DYWWYW (0.05 and 0.5 mL DYWWYW, respectively, diluted in 2 mL normal saline). Western blotting and qRT-PCR analyses were performed to determine the protein and mRNA expression levels, respectively, of integrin αγβ3 and leukaemia inhibitor factor (LIF) in uterus tissues. Serum oestradiol and progesterone concentrations were determined via ELISA. The remaining thin endometrium mice were mated with male mice, and the number of embryos implanted in the different groups was calculated.

RESULTS:

A high dose of DYWWYW effectively ameliorated the injury of endometrium caused by 95% ethanol. The levels of oestradiol, progesterone, αγβ3 and LIF in thin endometrium mice treated with a high dose of DYWWYW were also significantly elevated. Additionally, a high dose of DYWWYW remarkably increased the number of embryo implantations in mice with thin endometrium.

CONCLUSION:

DYWWYW has improvement effects on thin endometrium by elevating the levels of endogenous oestradiol, progesterone, αγβ3, and LIF in a mouse model.

2024-01-01·Journal of ethnopharmacology

Wuzi Yanzong administration alleviates Sertoli cell injury by recovering AKT/mTOR-mediated autophagy and the mTORC1–mTROC2 balance in aging-induced testicular dysfunction

Article

作者: Zhao, Haixia ; Chang, Yanyu ; Yuan, Ding ; Deng, He ; Wu, Jie ; Zhang, Changcheng ; He, Yumin ; Zhou, Benwen

ETHNOPHARMACOLOGICAL RELEVANCE:

Wuzi Yanzong Prescription (WZ), a classic traditional Chinese medicine formula, has the properties of kidney nourishing and essence strengthening, and it is widely used to treat male infertility with a long history. Sertoli cells are injured with aging, resulting in testicular dysfunction, and WZ effectively rejuvenates the age-related decline of testicular function. However, whether the therapeutic effects of WZ on aging-related testicular dysfunction are dependent on the restoration of Sertoli cell function remains unclear.

AIM OF THE STUDY:

In a mouse model of natural aging, we explored the protective effects of WZ and its potential mechanisms.

MATERIALS AND METHODS:

Fifteen-month-old C57BL/6 mice were randomized to receive either standard diet or WZ (2 and 8 g/kg) for 3 months. Meanwhile, 10 1-month-old mice were considered the adult control group and received standard diet for 3 months. The testis and epididymis were rapidly collected, and the sperm quality, testicular histology, Sertoli cell numbers, tight junction (TJ) ultrastructure, and blood-testis barrier-associated protein expression and localization were assessed.

RESULTS:

WZ significantly increased sperm concentration and sperm viability, improved the degenerative histomorphology and elevated the seminiferous epithelium height. Furthermore, WZ increased the number of Sertoli cells, restored the ultrastructure of the Sertoli cell TJ, and upregulated the expression of TJ-associated proteins (zonula occludens-1 and Claudin11), ectoplasm specialized-associated proteins (N-Cadherin, E-Cadherin and β-Catenin), and gap junction-associated protein (connexin 43), but did not affect the expression of Occludin and cytoskeletal protein (Vimentin). In addition, WZ did not change the localization of zonula occludens-1 and β-Catenin in aged testis. Moreover, WZ increased the expression of autophagy-associated proteins (light chain 3 beta and autophagy related 5) and decreased the expression of p62, phosphorylated mammalian target of rapamycin, and phosphorylated AKT in Sertoli cells. Finally, we found that WZ attenuated mTOR complex 1 (mTORC1) activity and upregulated mTORC2 activity, as evidenced by inhibition of the expression of the regulatory-associated protein of mTOR, phosphorylated p70 S6K, and phosphorylated ribosomal protein s6 and enhancement of the expression of Rictor in the Sertoli cells of aging mice.

CONCLUSIONS:

WZ improves the injury of Sertoli cells by restoring AKT/mTOR-mediated autophagy and the mTORC1-mTROC2 balance in Sertoli cells during aging. Our findings provide a new mechanism of WZ in the treatment of aging-induced testicular dysfunction.

2023-10-01·Metabolic brain disease

Wuzi Yanzong Pill relieves MPTP-induced motor dysfunction and neuron loss by inhibiting NLRP3 inflammasome-mediated neuroinflammation.

Article

作者: Yang, Li-Xia ; Zhang, Bo ; Pan, Tao ; Ma, Cun-Gen ; Xiao, Qi ; Xiao, Bao-Guo ; Chai, Zhi ; Fan, Hui-Jie ; Xu, Lei ; Jin, Xiao-Ming ; Qin, Shao-Chen

Parkinson disease (PD) is an age-related neurodegenerative disease, which is associated with the loss of dopaminergic neurons (DA neurons) in the substantia nigra pars compacta (SNpc), and neuroinflammation may lead to the occurrence of PD. Wuzi Yanzong Pill (WYP) has demonstrated neuroprotective and anti-inflammatory properties, but its molecular mechanism of action is still unclear. In this study, we used 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-induced PD mice and LPS-mediated BV2 microglia to explore WYP intervention, anti-inflammatory effect and molecular mechanism in vivo and in vitro. The results showed that oral administration of WYP in MPTP-induced PD mice for 2 weeks ameliorated abnormal motor dysfunction, attenuated the loss of TH + neurons in SNpc, protected dopaminergic neurons, and inhibited the activation of microglia in MPTP-induced PD mice and LPS-stimulated BV2 cell. Meanwhile, WYP intervention inhibited the expression of IL-6, TNF-α, Pro-IL-1β, IL-1β, Pro-IL-18, IL-18 and enhanced the expression of IL-10 in the SNpc of PD mice. Simultaneously, WYP intervention inhibited the expression of NLRP3 inflammasome, accompanied by the decrease of the TLR4/MyD88/NF-κB pathway. However, the exact target and interaction of WYP on NLRP3 inflammasome and TLR4/MyD88/NF-κB pathway still needs to be further investigated.

项与五子衍宗口服液相关的新闻（医药）

2022-08-16

·药明康德

重磅综述：过去一年肺癌治疗领域重要突破有哪些？这四种药物推动检测、诊疗发展！

▎药明康德内容团队编辑肺癌是全球最常见也是最凶险的癌症类型之一。肺癌治疗领域的开拓进展不断为肺癌患者带来新的治疗选择，改善结局。随着对肺癌分子生物学特征的进一步了解，针对多种特定突变的在研精准疗法正在开花结果；已经在晚期肺癌临床实践中成为标准治疗的靶向疗法和免疫疗法，也正在向早期肺癌拓展和探索。近日，癌症领域知名期刊 Cancer 发表重磅综述文章，来自美国西北大学范伯格医学院（Northwestern University Feinberg School of Medicine）的Jyoti D. Patel和Nisha A. Mohindra教授分享了他们眼中肺癌治疗领域过去一年中的重要突破。综述强调，肺癌靶向以及免疫治疗的不断突破凸显了分子检测以及PD-L1检测的重要性。目前不同肺癌临床诊疗指南均建议晚期NSCLC患者在诊断时需检测多种生物标志物，包括 EGFR、ALK、ROS1、BRAF、KRAS、NTRK、MET、RET 以及 HER2 基因的表达状态。与此同时，考虑到早期肺癌辅助治疗最新研究成果，对于这部分患者 EGFR 突变状态以及PD-L1表达状态的检测也已经显得十分必要。截图来源： Cancer 向前线挺近：免疫疗法乘风破浪 2021年10月，美国FDA批准阿替利珠单抗用于PD-L1表达≥1%、经手术切除、以铂类为基础化疗之后Ⅱ-ⅢA期NSCLC患者的辅助治疗。这项批准主要基于IMpower-010试验的结果。 IMpower010试验是一项随机、多国、3期试验，旨在手术完全切除和接受以铂类为基础辅助化疗的患者中，评估阿替利珠单抗与最佳支持治疗（BSC）相比的疗效和安全性。研究中，共计1005例患者以1：1的比例随机接受为期1年的阿替利珠单抗（n=507）或BSC（n=498）治疗。所有患者在阿替利珠单抗治疗前均接受了以铂类为基础的辅助化疗。中位随访32个月的结果表明，阿替利珠单抗辅助治疗显著改善了II–IIIA期患者（肿瘤表达PD-L1≥1%）的无病生存期（DFS）（HR=0.66；95%CI：0.50-0.88；p=0.0039），3年DFS率达到60%（BSC组为48%）。研究在总体II–IIIA期患者中观察到DFS获益（HR=0.79；95%CI：0.64-0.96；p=0.020），而在肿瘤表达PD-L1≥50%的患者中获益幅度最为显著（HR=0.43；95%CI：0.27–0.68）。尽管本试验的总生存期结果尚未成熟，但不可否认的是，在肺癌的辅助治疗中，我们又拥有了新的有效武器！图片来源：123RF 除辅助治疗外，免疫治疗在肺癌新辅助治疗中的应用潜力也同样备受关注。综述指出 CheckMate-816试验“首次”在NSCLC患者3期临床试验中得出结论：纳武利尤单抗联合化疗新辅助治疗与单纯化疗相比，显著改善了患者的病理学完全缓解率（24.0% vs. 2.2%；p<0.0001）。值得一提的是，在CheckMate-816试验中，患者在随机分组后接受3个周期的纳武利尤单抗联合含铂双药化疗，或3个周期的化疗治疗，然后接受手术。接受纳武利尤单抗联合化疗以及单纯化疗的两组患者，分别有83%和75%接受了确定性切除，这提示增加新辅助免疫治疗并不影响手术切除范围或时机。当前这项试验以及其他类似试验的后续进展将有助于我们进一步明确免疫联合新辅助治疗对肺癌患者生存期的影响。未来我们仍有必要探索新辅助治疗后患者病理学完全缓解与否对生存期的影响，以及免疫治疗与手术有机结合的最佳方案。创新药物突破：这些靶点不再“无药可用” 尽管近几年来NSCLC患者的靶向治疗取得了瞩目的进展，但是仍有部分分子亚型的NSCLC患者尚缺乏有效的靶向药物。我们可以惊喜地看到，在所有“难以成药”的靶点中，针对 KRAS 突变、 EGFR 20号外显子插入突变、 HER2 突变的创新药物治疗在过去一年中纷纷迎来了重要突破。图片来源：123RF KRAS 突变肺腺癌患者约有25%~30%存在 KRAS 基因致癌激活突变。但是该类突变难以靶向（KRAS蛋白为近乎球形结构，无明显结合位点），且既往药物治疗临床研究进展有限。 2021年5月，创新药物sotorasib获批用于 KRAS G12C 突变（ KRAS 突变中最常见变异，约占肺腺癌13%）肺癌患者的治疗。 Sotorasib是一种小分子KRAS G12C抑制剂，可以与 KRAS G12C 突变半胱氨酸残基不可逆共价结合并占据开关II区域，使其稳定在非活性状态。 CODEBREAK试验是一项单臂、2期试验，旨在评估既往接受标准治疗的 KRAS G12C 突变NSCLC患者，后线接受sotorasib治疗的疗效。在接受sotorasib治疗的124例可评估患者中，37%达到客观缓解、81%疾病得到控制。患者中位无进展生存期（PFS）为6.8个月；中位缓解持续时间（DOR）为11.1个月；中位总生存期为12.5个月。总体而言，sotorasib治疗为绝大多数患者带来持久临床获益，且在一些难治亚型中表现出可观疗效。值得关注的是，除sotorasib外，他新型药物，如adagrasib也在 KRAS G12C 突变NSCLC患者中表现出可观疗效，未来有望成为此类患者治疗的新选择。 EGFR 20号外显子插入突变除 KRAS 突变外， EGFR 20号外显子插入突变的NSCLC患者（约占肺腺癌2%）此前同样缺乏有效的靶向治疗药物。 2021年末，两款靶向EGFR 20号外显子插入突变的药物获得FDA批准，即amivantamab（靶向EGFR和MET的双特异性抗体）和mobocertinib（高选择性EGFR 20号外显子插入突变口服酪氨酸激酶抑制剂）。 Amivantamab： Amivantamab可与EGFR和MET胞外域特异性结合。CHRYSALIS研究（首次人体、1期、剂量递增和剂量扩展研究）的结果显示：在81例可评估的患者中，amivantamab治疗总缓解率达40%；中位DOR为11.1个月。 Mobocertinib： Mobocertinib为强效、不可逆EGFR 20号外显子插入突变靶向抑制剂。研究101（The Study 101一项多队列、非随机、标签开放试验）的结果显示：在114例局部晚期或转移性EGFR 20号外显子插入突变的NSCLC患者中，mobocertinib治疗总缓解率达28%；中位DOR为17.5个月；中位PFS为7.3个月；中位OS为24.0个月。 HER2 基因突变 HER2 基因突变亚型在NSCLC腺癌患者中所占比例约为3%，这类患者目前同样缺乏有效靶向疗法。T-DXd（Trastuzumab deruxtecan，Enhertu）为靶向HER2的抗体药物偶联物。DESTINY-Lung01是一项单臂、2期试验，在91例既往接受过其他药物治疗的转移性、HER2突变NSCLC患者中评估了T-DXd的疗效。中位随访13.1个月的结果显示，研究中55%的接受T-DXd治疗的患者达到总体缓解；92%疾病得到控制。患者中位PFS为8.2个月；中位OS为17.8个月。研究结果提示， T-DXd是转移性、HER2突变NSCLC患者的有效靶向治疗选择。值得一提的是，近日美国FDA宣布加速批准T-DXd扩展适应症，用于治疗携带激活性HER2突变的无法切除或转移性NSCLC患者（此前接受过一种系统性治疗），这是FDA批准治疗HER2突变NSCLC的首款药物。这一加速批准是基于随机双盲的剂量优化临床试验DESTINY-Lung02的积极结果。在包含52名患者的主要疗效分析队列中，T-DXd达到58%的确认客观缓解率，中位缓解持续时间为8.7个月。相关阅读 2022中华医学会肺癌诊疗指南出炉！韩宝惠教授解读更新要点（附全文）吴一龙教授团队重磅：首次定义肺癌术后潜在治愈人群！作者解读：这一指标有重要预测价值！非小细胞肺癌EGFR-TKI耐药后治疗，2022WCLC专场带来6大进展 2022WCLC：非小细胞肺癌进展后，帕博利珠单抗“再治疗”仍可行参考资料 [1] Mohindra, N. A., & Patel, J. D. Top advances in lung cancer, 2021. Cancer. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com