[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical study on the efficacy and safety of Shuanghuang Shengbai oral liquid in the treatment of grade I and II neutropenia (deficiency of both essence and qi) caused by chemotherapy in patients with primary non-small cell lung adenocarcinoma

初步评价双黄升白口服液治疗晚期原发性非小细胞肺癌因化疗所致Ⅰ、Ⅱ度中性粒细胞减少（精气两亏证）的有效性、安全性，为Ⅲ期临床研究提供依据

[Translation]

To preliminarily evaluate the effectiveness and safety of Shuanghuang Shengbai oral liquid in the treatment of grade I and II neutropenia (deficiency of both essence and qi) caused by chemotherapy in advanced primary non-small cell lung cancer, and to provide a basis for phase III clinical research

Start Date14 Apr 2020

Sponsor / Collaborator

Changshu Lei Yun Shang Pharmaceutical Co. Ltd.

[+1]

100 Clinical Results associated with Shuanghuang Shengbai Oral Liquid

100 Translational Medicine associated with Shuanghuang Shengbai Oral Liquid

100 Patents (Medical) associated with Shuanghuang Shengbai Oral Liquid

Literatures (Medical) associated with Shuanghuang Shengbai Oral Liquid

05 Sep 2017·Oncotarget

Shuanghuang Shengbai granule cures myelosuppression and suppresses lung cancer progression: mechanism and therapeutic targets from the aspect of microRNAs

Article

Author: Xu, Zhenye ; Wang, Lifang ; Wang, Shuang

BACKGROUNDShuanghuang Shengbai granule is effective in curing cyclophosphamide-induced myelosuppression without promoting lung cancer development. This study aims to investigate its mechanism and therapeutic targets.METHODSNude mice with lung cancer were treated with physiological saline (control), cyclophosphamide, or cyclophosphamide + Shuanghuang Shengbai. MicroRNA microarray was used to investigate the differentially expressed microRNAs in lung cancer stem cells or bone marrow hematopoietic stem cells between the three groups. MicroRNA expressions were confirmed using quantitative real time-polymerase chain reaction.RESULTSCyclophosphamide suppressed tumor growth and decreased the ratio of SP⁺ lung cancer stem cells (P<0.05). Shuanghuang Shengbai further decreased the ratios of SP⁺ and CD24⁺IGF1R⁺ lung cancer stem cells (P<0.05). Shuanghuang Shengbai completely reversed the cyclophosphamide-induced decreases in white blood cells, proliferation index of bone marrow cells, and the ratio of CD34⁺SCA1⁺ bone marrow hematopoietic stem cells (P<0.05). We found 45 and 343 altered microRNAs for SP⁺ lung cancer stem cells and CD34⁺SCA1⁺ bone marrow hematopoietic stem cells, respectively. Moreover, miR-32*, miR-466i-5p, and mmu-miR-669c in SP⁺ lung cancer stem cells were confirmed, as well as mmu-miR-106b*, mmu-miR-144, mmu-miR-669k*, mmu-miR-142-3p, mmu-miR-210, and mmu-miR-223 in CD34⁺SCA1⁺ bone marrow hematopoietic stem cells.CONCLUSIONShuanghuang Shengbai might promote the proliferation of CD34⁺SCA1⁺ bone marrow hematopoietic stem cells via up-regulating mmu-miR-106b*, mmu-miR-144, and mmu-miR-669k*, as well as down-regulating mmu-miR-142-3p, mmu-miR-210, and mmu-miR-223. Shuanghuang Shengbai might further inhibit the proliferation of SP⁺ lung cancer stem cells via enhancing the expressions of miR-32*, miR-466i-5p, and mmu-miR-669c. These might be the mechanism and therapeutic targets of Shuanghuang Shengbai granule.

01 Feb 2017·Chinese Journal of Integrative MedicineQ3 · MEDICINE

Clinical observation of Shuanghuang Shengbai Granule (双黄升白颗粒) on prevention and treatment of myelosuppression caused by chemotherapy in cancer patients

Q3 · MEDICINE

Article

Author: Xu, Zhen-Ye ; Deng, Hai-Bin ; Hou, An-Ji ; Yu, Lei ; Xiang, Yi ; Wang, Li-Fang ; Yan, Gui-Ying ; Wu, Ji ; Zhang, Ming ; Zhao, Xiao-Zhen ; Wang, Zhong-Qi

OBJECTIVETo study the efficacy and safety of Shuanghuang Shengbai Granule (, SSG), a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy.METHODSA total of 330 patients were randomly assigned to the treatment group (220 cases, analysed 209 cases) and the control group (110 cases, analysed 102 cases) with a 2:1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation.RESULTSAt the 7th day of chemotherapy, the white blood cells (WBCs) level in the treatment group was significantly higher than that in the control group (P<0.05). After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade I, while 8.1% and 5.7% of patients emerged grade III and grade IV myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group (P<0.05). The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group (84.2% vs. 72.5%, P<0.05). The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3⁺ and CD4⁺ cells were significantly increased in the treatment group after treatment (P<0.05). The discrepancy of CD3⁺ and CD4⁺ cell activity before and after treatment in both groups were significantly different (P<0.05). No obvious adverse event occurred in both groups.CONCLUSIONSSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.

01 Feb 2017·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Effect of Shuanghuang Shengbai Granule on Wnt Signal Transduction Pathway in Tumor-bearing Mice with Chemotherapy Induced Myelosuppression].

Article

Author: Wang, Li-Fang ; Su, Wan ; Sl, Hai-Long ; Xu, Zhen-Ye ; Deng, Hai-Bin ; Wang, Zhong-Qi

Objective To observe the regulation of Shuanghuang Shengbai Granule (SHSBG) on regulating Wnt signaling pathway in tumor-bearing mice with chemotherapy induced myelosuppression. Methods Chemotherapy induced myelosuppression model was established in Lewis lung tumor bearing mice by intraperitoneal injection of cyclophosphamide (CTX). And then they were intervened by SHSBG. Routine white blood cell (WBC) count, red blood cell (RBC) count, platelet count, and tumor mass were calculated. Ratios of bone marrow hematopoietic stem cell (Sca, CD34 double positive cells) were detec- ted by flow cytometry. mRNA expression of main genes in Wnt signaling pathway (Wnt, β-catenin, Frizzted, DSH, GSK3) were detected using real time fluorescent quantitative PCR. Results The number of WBC and ratio of hematopoietic stem cells in the treatment group were higher than those in the model group (P<0. 05). Expressions of Wnt, β-catenin, Frizzted, DSH, and GSK3 mRNA in the bone marrow were higher in the treatment group than in the model group (P <0. 05). Expressions of Wnt, β-catenin, Frizzted, and DSH mRNA expression in tumors were lower in the treatment group than in the model group (P <0. 05). There was no statistical difference in counts of RBC and platelet, tumor mass, or GSK3 mR- NA expression among all groups (P >0. 05). Conclusions The mechanism for SHSBG treating myelo-suppression was related to regulating Wnt signaling pathway. Besides, it had dual regulation effect on Wnt signaling pathway, up-regulating expressions of main genes in Wnt signaling pathway while inhibiting ex- pressions of partial genes in tumors.

100 Deals associated with Shuanghuang Shengbai Oral Liquid

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Indication	Highest Phase	Country/Location	Organization	Date
Neutropenia	Phase 2	CN	Longhua Hospital Shanghai University of TCM	14 Apr 2020
Neutropenia	Phase 2	CN	Changshu Lei Yun Shang Pharmaceutical Co. Ltd.	14 Apr 2020

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