CN115192594A - New application of rosiglitazone and anti-tumor drug composition containing rosiglitazone - Google Patents
New application of rosiglitazone and anti-tumor drug composition containing rosiglitazone Download PDFInfo
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Abstract
The invention discloses a new application of rosiglitazone and an antitumor drug combination containing rosiglitazone, wherein the rosiglitazone is used as a synergist for improving the antitumor effect of polyethylene glycol modified doxorubicin lipidosome; the anti-tumor medicine composition containing the rosiglitazone consists of rosiglitazone and polyethylene glycol modified doxorubicin lipidosome, wherein the weight percentage of rosiglitazone: the mass ratio of the polyethylene glycol modified doxorubicin liposome is 1. The invention can improve the clinical curative effect of PLD, benefit the improvement of the treatment of tumor patients, and provide a new idea for the development of a tumor targeted nano drug delivery system; the application of the rosiglitazone is expanded.
Description
The patent application of the invention is the application number accepted by the national intellectual property office of the people's republic of China: 201711073022.0, application date: 11/2017, 03, applicant: zhejiang tumor hospital, the name of the invention is: a new application of rosiglitazone and a divisional application of an anti-tumor drug combination containing rosiglitazone.
Technical Field
The invention relates to the technical field of antitumor drugs, and in particular relates to a new application of rosiglitazone and an antitumor drug combination containing rosiglitazone.
Background
Malignant tumor is a disease seriously threatening human health and life, and chemotherapy is one of the most important treatment means for malignant tumor, but the curative effect bottleneck still exists in the current chemotherapy. The tumor targeting drug delivery system is a breakthrough for searching high-efficiency and low-toxicity antitumor drugs due to good selectivity of the tumor targeting drug delivery system to tumor target tissues [1]. However, recent studies have shown that liposomal chemotherapy does not improve efficacy over traditional chemotherapy [2]. Polyethylene glycol modified doxorubicin liposome (PLD) is the first long-circulating liposome approved by FDA, and it can significantly reduce toxicity compared to conventional doxorubicin, but its therapeutic effect is not better than that of doxorubicin, and its approved indication range is far less broad than that of conventional doxorubicin [3,4]. In recent years, more and more research has focused on the possible special microenvironment of tumors as one of the important reasons for the poor efficacy of chemotherapy [5,6].
The tumor microenvironment is capable of secreting large amounts of growth factors and cytokines such as fibroblasts, inflammatory cells, vascular endothelial cells, etc., the constituents of which include collagen, laminin and proteoglycan complexes [7]. Among them, cancer Associated Fibroblast (CAF) is a main tumor stromal cell, which plays an important role in the development and development of tumors and is a potential target for tumor therapy [8,9]. CAF cells also have strong capacity for synthesizing stroma, and can directly synthesize type I, type III and type IV collagens, resulting in excessive deposition of stroma components, and causing the tumor stroma to show a phenomenon of connective organization [10]. The connective organization phenomenon is not favorable for the chemotherapy drug to permeate from blood vessels to tumor cells, and may be one of the important reasons for the poor curative effect of the targeting preparation of the macromolecular liposome [11]. Therefore, how to promote the permeation of PLD from the blood vessels to the stroma is the key to improve its therapeutic effect.
Rosiglitazone (RSG) is a thiazolidinedione type antidiabetic agent that is effective in controlling blood glucose by increasing insulin sensitivity. Rosiglitazone is a highly selective and potent agonist of the peroxisome proliferator-activated receptor gamma (PPAR-gamma). Human PPAR receptors are present in the major target tissues of insulin, such as liver, adipose and muscle tissues. Rosiglitazone activates PPAR-gamma nuclear receptors and regulates the transcription of insulin-responsive genes involved in glucose production, transport and utilization.
Disclosure of Invention
The invention aims to provide a new application of rosiglitazone.
The invention also provides an antitumor drug composition containing rosiglitazone, which can improve the clinical curative effect of PLD, benefit the treatment of tumor patients and provide a new idea for the development of a tumor-targeted nano drug delivery system; the application of the rosiglitazone is expanded.
The technical scheme adopted by the invention for solving the technical problems is as follows:
the new use of rosiglitazone as synergist for raising the antitumor effect of polyglycol modified doxorubicin liposome.
The rosiglitazone can obviously improve the intratumoral concentration of the polyethylene glycol modified doxorubicin liposome.
An antitumor drug combination containing rosiglitazone, which consists of rosiglitazone and polyethylene glycol modified doxorubicin liposome, wherein the weight ratio of rosiglitazone: the mass ratio of the polyethylene glycol modified doxorubicin liposome is 1.
Preferably, the using method comprises the following steps: and in the treatment period of the polyethylene glycol modified doxorubicin liposome and 1-2 weeks before the treatment period, orally taking rosiglitazone every day, wherein the dosage of the orally taking rosiglitazone every day is 25% -100% of the effective treatment amount of the polyethylene glycol modified doxorubicin liposome.
The effective treatment amount of the polyethylene glycol modified doxorubicin liposome is 30-40 mg/time and once every 2-3 weeks.
The invention has the beneficial effects that: 1. the clinical curative effect of PLD can be improved, the therapeutic benefit of tumor patients can be improved, and a new idea is provided for the development of a tumor targeted nano drug delivery system; 2. the application of the rosiglitazone is expanded.
Drawings
FIG. 1 shows the distribution and quantification of intra-tumor PLD: (A) in vivo fluorescence imaging of tumor tissue: the tumor doxorubicin fluorescence pretreated by high-dose RSG (HD-RSG) is obviously enhanced compared with that of a single-use group (PLD); (B) Doxorubicin content in tumor tissue: high dose RSG combination (orange solid diamond), low dose RSG combination (orange open diamond), PLD single use (black square).
FIG. 2 is the effect of rosiglitazone and PLD on tumor volume in a colon cancer graft tumor model in nude mice.
FIG. 3 is the effect of rosiglitazone and PLD on tumor mass in a model of colon cancer transplantable tumor in nude mice.
Detailed Description
The technical solution of the present invention will be further specifically described below by way of specific examples.
In the present invention, the raw materials and equipment used are commercially available or commonly used in the art, unless otherwise specified. The methods in the following examples are conventional in the art unless otherwise specified.
Example 1:
an antitumor drug combination containing rosiglitazone, which consists of rosiglitazone and polyethylene glycol modified doxorubicin liposome, wherein the weight ratio of rosiglitazone: the mass ratio of the polyethylene glycol modified doxorubicin liposome is 1.
Example 2:
an antitumor drug combination containing rosiglitazone, which consists of rosiglitazone and polyethylene glycol modified doxorubicin liposome, wherein the weight ratio of rosiglitazone: the mass ratio of the polyethylene glycol modified doxorubicin liposome is 1.
Example 3:
an antitumor drug combination containing rosiglitazone, which consists of rosiglitazone and polyethylene glycol modified doxorubicin liposome, wherein the weight ratio of rosiglitazone: the mass ratio of the polyethylene glycol modified doxorubicin liposome is 1.
The application method of the rosiglitazone-containing antitumor drug combination comprises the following steps:
the patient is orally taken with rosiglitazone every day in the treatment period of the polyethylene glycol modified doxorubicin liposome and 1-2 weeks before the treatment period, the daily oral rosiglitazone dosage is 25% -100% of the effective treatment amount of the polyethylene glycol modified doxorubicin liposome, the effective treatment amount of the polyethylene glycol modified doxorubicin liposome is 30-40 mg/time, and the administration is carried out once in 2-3 weeks during the treatment period. For example, the effective treatment amount of the polyethylene glycol modified doxorubicin liposome is 40 mg/time, and the daily oral rosiglitazone dosage is 10-40 mg/day.
Test part:
1. and (3) culturing the colon cancer cell strain: SW620 cell line was cultured in DMEM F12 (1 2 Culturing under the condition, and constructing an in vivo transplantation tumor model.
2. Construction of a colon cancer model: female BALB/c nude mice (body weight, 16-22 g) were inoculated subcutaneously with 1X 107 colon cancer SW620 cell lines in the right axilla. When the tumor volume grows to about 150mm 3 Stripping tumor tissue, and cutting into pieces of 1-2mm 3 Particle size inoculation and new nude mice underarm, so passaging. Taking the 3 rd generation nude mice with tumor, and waiting for the tumor body to grow to 100mm 3 And then used for the study.
Grouping and intervening: dividing the tumor-bearing nude mice into 5 groups according to the tumor volume, and intervening as follows: control group (tail vein injection of physiological saline), PLD single-treatment group (tail vein injection of PLD,4mg/kg, respectively, on days 8, 11, 14 and 17 after the grouping), RSG single-use group (gastric lavage of RSG once per day on days 1-17 from the start of the study, 4 mg/kg), low-dose RSG combination group (gastric lavage of RSG once per day on days 1-17 from the start of the study; PLD,1mg/kg, simultaneously on days 8, 11, 14 and 17), high-dose RSG combination group (gastric lavage of RSG once per day on days 1-17 from the start of the study; PLD,4mg/kg, simultaneously on days 8, 11, 14 and 17). Tumor volume was measured 2 times per week during the study, and the day after the end of dosing, nude mice were sacrificed and weighed after tumor detachment.
3. The combination of rosiglitazone (AA) can significantly improve the intratumoral concentration of PLD
The combination of rosiglitazone (1 mg/kg and 4 mg/kg) can obviously improve the concentration of the doxorubicin in the tumor, and obviously improve the fluorescence intensity of the doxorubicin in the tumor: especially under the action of high dose RSG, the concentration of the intratumoral doxorubicin is increased from 6.86 +/-0.23 mu g/g of the PLD single-use group to 10.27 +/-1.49 mu g/g, which is increased by 49.7% (p = 0.0013); the low dose group was elevated to 8.88 ± 1.79 μ g/g, also with a significant trend of increase compared to the single use group (p = 0.0067) (see fig. 1).
4. The combination of rosiglitazone can obviously improve the in-vivo anti-tumor effect of PLD
4.1 general status of nude mice
The general condition of the nude mice is good in the observation period, and the activity of part of the mice is weakened, the mice are favored to be clustered and the food intake is reduced along with the increase of tumor bodies in the later period of observation. No mice died. The weight of the mice is not changed greatly and slightly before and after administration, the weight of the mice is reduced by 5 percent on average in 18 days, the weight of the nude mice in other groups is not changed obviously, and the table 1 shows that the combination of RSG does not increase the toxicity of treatment.
Table 1 change in body weight of drug to nude mice during rosiglitazone treatment (relative body weight,%)
4.2 Effect of rosiglitazone on PLD tumor inhibition
The inhibition rate of PLD single drug (4 mg/kg) against colon cancer transplants was 48.5%, whereas rosiglitazone (4 mg/kg) alone had little inhibition effect against colon cancer transplants (tumor inhibition rate 5.07%, p =0.794 compared to solvent group). However, when the rosiglitazone and the PLD are used together, the tumor inhibition effect is enhanced, and the inhibition rates on the tumor weight are respectively 60.46% (1 mg/kg of the rosiglitazone used together) and 66.67% (4 mg/kg of the rosiglitazone used together); the results of one-way ANOVA analysis showed that the antitumor effect of PLD was potentiated with the combination of rosiglitazone (p = 0.000). The comparison between groups was performed using the t-test, and the results showed that the tumor weights of rosiglitazone (4 mg/kg) and the PLD combination group were significantly lower than that of the PLD single group (p = 0.031). (see Table 2,3,4, FIG. 2,3 for details).
TABLE 2 tumor-inhibiting effect of rosiglitazone and PLD on nude mouse colon cancer transplantation tumor model
| Group (mg/kg) | Average tumor weight (g) | Tumor inhibition Rate (%) |
| Control group | 2.91±0.84 | - |
| PLD(4) | 1.50±0.36 | 48.53 |
| RSG(4) | 2.76±1.15 | 5.07 |
| RSG(1)+PLD(4) | 1.15±0.21 | 60.46 |
| RSG(4)+PLD(4) | 0.97±0.27 | 66.67 |
TABLE 3 Effect of the combination of rosiglitazone on PLD tumor inhibition (differences between groups, t-test, p-value)
TABLE 4 Total effect of rosiglitazone intervention on PLD tumor inhibition (one-way ANOVA test)
Reference:
1.van Elk，M.，et al.，Nanomedicines for advanced cancer treatments：Transitioning towards responsive systems.Int J Pharm，2016.515(1-2)：p.132-164.
2.Petersen，G.H.，et al.，Meta-analysis of clinical and preclinicalstudies comparing the anticancer efficacy of liposomal versus conventionalnon-liposomal doxorubicin.J Control Release，2016.232：p.255-64.
3.Gabizon,A.,H.Shmeeda,and T.Grenader,Pharmacological basis ofpegylated liposomal doxorubicin:impact on cancer therapy.Eur J Pharm Sci,2012.45(4):p.388-98.
4.Gabizon,A.A.,Y.Patil,and N.M.La-Beck,New insights and evolving roleof pegylated liposomal doxorubicin in cancer therapy.Drug Resist Updat,2016.29:p.90-106.
5.Hanahan,D.,Rethinking the war on cancer.Lancet,2014.383(9916):p.558-63.
6.Straussman,R.,et al.,Tumour micro-environment elicits innateresistance to RAF inhibitors through HGF secretion.Nature,2012.487(7408):p.500-4.
7.Ishii,G.,A.Ochiai,and S.Neri,Phenotypic and functionalheterogeneity of cancer-associated fibroblast within the tumormicroenvironment.Adv Drug Deliv Rev,2016.99(Pt B):p.186-96.
8.Micke,P.and A.Ostman,Tumour-stroma interaction:cancer-associatedfibroblasts as novel targets in anti-cancer therapyLung Cancer,2004.45Suppl2:p.S163-75.
9.Togo,S.,et al.,Carcinoma-associated fibroblasts are a promisingtherapeutic target.Cancers(Basel),2013.5(1):p.149-69.
10.Liu,M.,J.Xu,and H.Deng,Tangled fibroblasts in tumor-stromainteractions.Int J Cancer,2011.129(8):p.1795-805.
11.Olive,K.P.,et al.,Inhibition of Hedgehog signaling enhancesdelivery of chemotherapy in a mouse model of pancreatic cancer.Science,2009.324(5933):p.1457-61。
the above-described embodiment is a preferred embodiment of the present invention, and is not intended to limit the present invention in any way, and other variations and modifications may be made without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (2)
1. The anti-colon cancer drug combination containing rosiglitazone is applied to the preparation of drugs for treating colon cancer, and consists of rosiglitazone and polyethylene glycol modified doxorubicin liposome, wherein the weight ratio of rosiglitazone: the mass ratio of the polyethylene glycol modified doxorubicin liposome is 1 to 1.
2. The use according to claim 1, characterized in that it is used by: orally taking rosiglitazone every day in the treatment period of the polyethylene glycol modified doxorubicin liposome and 1-2 weeks before the treatment period, wherein the dosage of the orally taken rosiglitazone every day is 25% -100% of the effective treatment amount of the polyethylene glycol modified doxorubicin liposome; the effective treatment amount of the polyethylene glycol modified doxorubicin liposome is 30-40 mg/time and once every 2-3 weeks.
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| 方罗等: "聚乙二醇修饰的多柔比星脂质体在我国肿瘤患者体内的药动学研究", 《中国药学杂志》, vol. 47, no. 3, pages 223 - 228 * |
| 李金鹏等: "结肠癌阿霉素不敏感与上皮细胞间质细胞样转化的关系", 《世界华人消化杂志》, vol. 22, no. 20, pages 2900 - 2904 * |
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