Megestrol acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and early-stage endometrial adenocarcinoma: a prospective study

Objective To evaluate the efficacy of medroxyprogesterone acetate(MA)plus metformin as the primary fertility-sparing treatment for atypical endometrial hyperplasia(AEH)and early-stage grade 1 endometrial adenocarcinoma(G1 EAC)and the recurrence rate after treatment.Methods Sixty patients(aged 20-42 years)with AEH and/or grade 1 EAC limited to the endometrium were enrolled prospectively and randomized into two groups(n=30)to receive oral MA treatment at the daily dose of 160 mg(control)or MA plus oral metformin(850 mg,twice a day)for at least 6 months.The treatment could extend to 12 months until a complete response(CR)was achieved,and follow-up hysteroscopy and curettage were performed every 3 months.For all the patients who achieved CR,endometrial expressions of IGFBP-rP1,p-Akt and p-AMPK were detected immunohistochemically.Results A total of 58 patients completed the treatment.After 9 months of treatment,23(76.7%)patients in the combined treatment group and 20(71.4%)in the control group achieved CR;two patients in the control group achieved CR after converting to the combined treatment.The recurrence rate did not differ significantly between the control group and combined treatment group(30.0%vs 22.7%,P>0.05).Ten(35.7%)patients in the control group experienced significant weight gain of 5.7±6.1 kg,while none of the patients receiving the combined treatment exhibited significant body weight changes.Compared with the control group,the patients receiving the combined treatment showed enhanced endometrial expressions of IGFBP-rP1 and p-AMPK with lowered p-Akt expression.Conclusion Metformin combined with MA may provide an effective option for fertility-sparing treatment of AEH and grade 1 stage IA EAC,and the clinical benefits of metformin for controlling MA-induced weight gain and promoting endometrial expressions of IGFBP-rP1 and p-AMPK while inhibiting p-Akt expression warrants further study.

LC-MS/MS Method for Determination of Megestrol in Human Plasma and Its Application in Bioequivalence Study

A rapid and highly selective liquid chromatography-tandem mass spectrometric （LC-MS/MS） method for the determination of megestrol in human plasma was described using medry- sone as internal standard （IS）. Blood samples were collected from 20 healthy volunteers after oral ad- ministration of 160 mg megestrol acetate dispersible tablets. The analytes were extracted by liq- uid-liquid extraction procedure and separated on a hanbon lichrospher column with the mobile phase of methanol and water containing 0.1% formic acid and 20 mmol/L ammonium acetate （5：1, v/v）. Positive ion electrospray ionization with multiple reaction-monitoring mode （MRM） was employed by monitor- ing the transitions m/z 385.5-325.4 and m/z 387.5-327.4 for megestrol and medrysone, respectively. Under the isocratic separation conditions, the chromatographic rim time was approximately 2.54 min for megestrol and 2.59 min for medrysone. The calibration curve range was from 0.5 to 200.0 ng/mL. The inter-batch and intra-batch precision and accuracy were less than 5.2% relative standard deviation （RSD） and 6.4% relative error （RE）. The proposed method was successfully applied in the bioequivalence study of megestrol acetate dispersible tablets.

Serum levels of megestrol acetate，reproductive hormones and morphological changes in women using megestrol acetate silicone r

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Study on the Clinical Efficacy of Megestrol Acetate Dispersible Tablets in Adjuvant Treatment of Acute Leukemia

Objective:To analyze the clinical efficacy of megestrol acetate dispersible tablets in the adjuvant treatment of acute leukemia.Methods:80 patients with acute leukemia admitted from December 2021 to December 2022 were randomly divided into two groups.The control group underwent chemotherapy,and the observation group took megestrol acetate dispersible tablets and underwent chemotherapy.The effect of the treatments were evaluated by analyzing the albumin(Alb)and prealbumin(Palb)indicators,and the adverse reactions were observed.Results:There was no significant difference in Alb and Palb indexes between the two groups before treatment(P>0.05).After treatment,Alb and Palb indexes in the observation group were greater than those in the control group(P<0.05).The incidence of adverse reactions in the control group was 20.00%,which was significantly higher than the observation group(5.00%),with P<0.05.Conclusion:The combination of megestrol acetate dispersible tablets and chemotherapy is more effective in treating patients with acute leukemia,and the Alb and Palb indexes can be optimized.Besides,there are fewer adverse reactions,which means that the treatment is relatively safe.

Abdominal acupuncture combined with megestrol acetate for advanced cancer-related anorexia:A randomized controlled trial

Objective:To observe the clinical effect difference between abdominal acupuncture combined with megestrol acetate and megestrol acetate for advanced cancer-related anorexia.Methods:A total of 60 patients with advanced cancer-related anorexia were randomly divided into an abdominal acupuncture combined with oral megestrol acetate treatment group(group A)and oral megestrol acetate treatment group(group B),with 30 cases in each group.Both groups were given nutritional assessment,nutritional supplementation,improvement of constipation,correction of electrolyte disturbance and other general treatments.In addition,group B was given another 160 mg megestrol acetate dispersible tablet once a day.Group A was treated with abdominal acupuncture on the basis of group B treatment,5 times a week,and both the groups were treated for 2 weeks.The appetite visual analog scale(VAS),Karnofsky(KPS)score,and body weight of the two groups were observed before and after treatment,and the clinical efficacy was evaluated.Results:After treatment,the appetite VAS in the both groups were lower than those before treatment,the Karnofsky(KPS)scores were higher than those before treatment,and the differences were statistically significant(both P<0.05).The differences of appetite VAS and KPS score before and after treatment in group A were higher than those of group B,and the differences were statistically significant(both P<0.05).After treatment,the body weights of the two groups were higher than those before treatment,and the difference of group A before and after treatment was higher than that of group B,but the difference was not statistically significant(P>0.05).The effective rate of group A was 76.7%and that of group B was 50%,the difference was statistically significant(P<0.05).Conclusion:Abdominal acupuncture combined with oral megestrol acetate and oral megestrol acetate both can effectively improve the appetite and functional status of patients with advanced cancer-related anorexia.Abdominal acupuncture can improve the curative effect,which is better than that of western medication alone,providing a new idea for the treatment of advanced cancer-related anorexia in the future.

Research on Treatment of Female ldiopathic Precocious Puberty withCombined Traditional Chinese Medicine and Megestrol Acetate

Objective: To find effective therapeutic approach for treating true idiopathic precocious puberty suitable to our national condition and different from gonadotrophin releasing hormone analogue. Methods: One hundred and six girls with idiopathic precocious puberty were divided into 3 groups. The 51 girls in the TCMWM group were treated with Chinese herbal medicine combined with megestrol acetate (MA), 35 girls in the MA group treated with megestrol acetate alone, and 20 girls were taken as control group and given no treatment at all. Luteinizing hormone releasing hormone (LHRH) stimulating test were performed before and after treatment, and the size of the uterus and ovary, linear growth rate, X-ray bone age measurement and final height prediction were also observed simultaneously. Results: After treated with TCM-WM for 2.7 years in average,the luteinizing hormone (LH) peak value of LHRH stimulating test was reduced from 48. 5 ± 5. 2 IU/L to 12.2 ± 1. 3 IU/L, size of uterus and ovary decreased, secondary sexual characteristics regressed, the bone age difference/chronological age difference value (ΔBA/ΔCA) reduced from 1. 35 ± 0. 09 to 0. 65 ± 0. 05 and predictive final height increased from 153. 3 ± 0. 5 cm to 158. 5 ± 0. 6 cm. Conclusion: TCM-WM therapy could not only modulate the function of hypothalamic-pituitary-ovarian axis and the development of internal genitalia, but also could decelerate skeletal growth, delay skeletal maturation, and thereby prevent premature epiphyseal fusion and increase the final height of patients.

Clinical Study on Treatment of Advanced Non-small Cell Lung Cancer by Arsenious Acid Combined with Tα-1 Thymus Peptide and Megestrol Acetate

Objective: To observe the therape utic effect of arsenious acid combined with Tα-1 thymus peptide and megestro l acetate on advanced non-small cell lung cancer.Methods: Nintey-two patients were divided randomly into the tr eated group( n =45) and the control group( n =47). The treated group were tr eated with arsenious acid combined with Tα-1 thymus peptide and megestrol ac etate, and the control group were treated with chemotherapy in the NP protocol .Results: (1) Therapeutic effect :In the 36 patients of the treated group, 2 were evaluated as CR, 8 as PR, 9 as MR, 8 as SD and 9 as PD, the CR+PR rate being 27.7% (10/36), while in the 40 patients of the control group, the co rresponding numbers were 3, 10, 11, 9, 7 and 32.5% (13/40). Comparison between t he CR+PR rate between the two groups showed insignificant difference ( P >0.05 ). (2)Clinical benefit rate: The positive rate of Karnofsky scores in the treate d group and the control group was 44.4% and 20.0% respectively; and the positive rate of body weight in the two groups was 33.3% and 12.5% respectively, the dif ference between the two groups was significant ( all P <0.05). (3)Changes of T- cell subsets and NK cell activity: CD4 and CD4/CD8 ratio after treatment i n the treated group increased significantly ( P <0.05), while in the control group, CD3, CD4, CD4/CD8 ratio and NK cell activity all lowered significantly ( P <0.01). Comparison between the two groups after treatment showed significa nt difference in CD4, CD4/CD8 ratio and NK cell activity, with those in the trea ted group all higher than those in the control group ( P <0.01). (4)Adeverse -reaction: No serious adverse reaction was found in both two groups. (5)Media n survival period:The treated group was 30 weeks and that in the control group w as 28.5 weeks, and the difference between the two groups was insignificant ( P >0.05).Conclusion: Arsenious acid combined with Tα-1 thymus peptide and megestrol acetate was a relatively effective scheme with low toxicity in tre ating advanced NSCLC.

甲地孕酮对肺癌合并肌肉减少症患者相关细胞因子影响的探讨

目的:检测肺癌合并肌肉减少症患者口服甲地孕酮后骨骼肌质量的增加情况及对IL-1β、IL-6、IFN-γ、TNF-α细胞因子的水平影响,分析细胞因子表达与肌肉减少症的关系,为此类患者的全程管理、疗效预测及提早筛查提供新思路。方法:分析2023年6月至2024年6月邵阳市中心医院就诊的60例肺癌合并肌肉减少症患者,随机分为试验组30例和对照组30例,记录患者年龄、性别、体质指数(BMI)、骨骼肌质量指数(SMI)、血糖、血清白蛋白、甘油三酯水平及IL-1β、IL-6、IFN-γ、TNF-α细胞因子水平,通过干预治疗后探讨4项细胞因子与肌肉减少症的相关性。结果:除IL-1β水平以外,试验组与对照组患者的基线指标差异无统计学意义(P>0.05);4项细胞因子的水平下降程度在服药第10天明显高于第10天至第25天,差异具有统计学意义(P<0.05)。通过相关性分析得出,不同测量时间点4项细胞因子水平呈正相关(P<0.05)。甲地孕酮干预后SMI值较基线升高11.8%。结论:肺癌合并肌肉减少症患者口服甲地孕酮后,下调了IL-1β、IL-6、IFN-γ、TNF-α细胞因子的水平,一定程度增加了骨骼肌质量,提示该药可能对改善此类患者的预后和相关临床症状有积极的治疗价值。

六君子汤加味联合甲地孕酮治疗结肠癌手术化疗后厌食症的疗效观察

目的观察六君子汤加味联合甲地孕酮治疗结肠癌手术病人化疗后厌食症的疗效。方法选取2021年1月至2022年4月唐山市中医医院诊治的结肠癌手术化疗后厌食症病人60例作为研究对象。根据信封法随机将病人分为对照组(30例,甲地孕酮治疗)和观察组(30例,六君子汤加味联合甲地孕酮治疗)。比较两组中医症状积分、体质量和厌食评分、营养指标(白蛋白、前白蛋白)、胃肠激素(胃泌素、胃动素)水平、生活质量评分(QOL评分)以及临床疗效。结果观察组总有效率为93.33%,高于对照组的73.33%(P<0.05);治疗后观察组恶心呕吐[(1.02±0.21)分比(1.35±0.28)分]、脘腹胀满[(1.12±0.32)分比(1.47±0.35)分]、嗳气反酸[(0.89±0.22)分比(1.43±0.27)分]、脘腹疼痛[(0.95±0.23)分比(1.52±0.28)分]等中医证候积分和NRS评分均低于对照组(P<0.05);而体质量、血清白蛋白水平、血清前白蛋白水平、胃泌素水平、胃动素水平、QOL评分均高于对照组(P<0.05)。结论六君子汤加味联合甲地孕酮治疗结肠癌手术病人化疗后厌食症可减轻病人临床症状,增加食欲,增强胃肠功能、改善营养状况,提高生活质量,疗效显著。

甲地孕酮乙酸酯合成用钯炭催化剂研究

甲地孕酮乙酸酯属于甾体类化合物,是重要的孕激素类药物。研究以6-亚甲基孕酮乙酸酯作为原料在Pd/C催化剂和助剂等作用下,发生结构B上的环外双键异构化反应生成甲地孕酮乙酸酯。实验主要探究催化剂质量、反应时间、反应温度、反应转速、环己烯质量及乙酸钠质量对合成甲地孕酮乙酸酯的影响,同时在最佳合成反应条件下研究不同盐溶液后处理的催化剂对反应效果的影响。

注射用醋酸亮丙瑞林缓释微球联合甲地孕酮治疗小儿性早熟的临床疗效及不良反应

目的观察注射用醋酸亮丙瑞林缓释微球联合甲地孕酮治疗小儿性早熟的临床疗效及不良反应。方法选择2021年3月—2022年3月于大连市妇女儿童医疗中心(集团)接受治疗的性早熟患儿82例为研究对象,采用随机数字表法分为试验组和对照组,每组41例。对照组采用甲地孕酮治疗,试验组在对照组基础上联合注射用醋酸亮丙瑞林缓释微球治疗,2组均持续治疗1年。比较2组患儿治疗前后性激素水平、影像学指标、生长情况及不良反应。结果治疗1年后,2组卵泡刺激素、雌二醇、黄体生成素水平、卵泡直径、子宫容积、卵巢容积及骨龄均较治疗前下降,身高及体质量均较治疗前升高,且试验组变化幅度大于对照组(P<0.01);试验组与对照组不良反应总发生率比较差异无统计学意义(7.32%vs.9.76%,χ^(2)=0.156,P=0.692)。结论注射用醋酸亮丙瑞林缓释微球联合甲地孕酮治疗小儿性早熟可取得显著的临床疗效,可有效改善患儿性激素水平,促进身体生长发育,抑制第二性征,且安全性高。

左炔诺孕酮宫内节育系统联合醋酸甲地孕酮治疗围绝经期异常子宫出血患者的效果观察

目的观察左炔诺孕酮宫内节育系统(LNG-IUS)联合醋酸甲地孕酮治疗围绝经期异常子宫出血患者的效果。方法122例围绝经期异常子宫出血患者,通过双盲黑白双色球法随机分为常规组(61例)和联合组(61例)。常规组给予宫腔镜电切术治疗,联合组在常规组基础上术后采用LNG-IUS联合醋酸甲地孕酮治疗。比较两组临床疗效、康复情况、性激素水平、并发症发生情况和复发情况。结果联合组的总有效率(96.72%)较常规组(78.69%)更高(P<0.05)。治疗3个月后,两组月经失血图(PBAC)评分、子宫内膜厚度均较术前显著降低,且联合组较常规组更低;月经时间均较术前显著缩短,且联合组较常规组更短;血红蛋白水平均较术前显著提高,且联合组较常规组更高(P<0.05)。治疗3个月后,两组卵泡刺激素(FSH)、雌二醇(E_(2))、黄体生成素(LH)、睾酮(T)水平均较术前显著降低,且联合组较常规组更低(P<0.05)。联合组并发症发生率(3.28%)较常规组(19.67%)更低(P<0.05);随访6个月后,联合组复发率(4.92%)较常规组(22.95%)更低(P<0.05)。结论围绝经期异常子宫出血患者应用LNG-IUS联合醋酸甲地孕酮治疗效果明显,可显著改善患者康复情况、并发症发生情况和复发情况,降低性激素水平。

甲地孕酮通过调节凋亡因子Bcl-2和Bax的表达治疗宫颈癌的研究

目的探讨甲地孕酮通过调节凋亡因子B淋巴细胞瘤-2基因(Bcl-2)和Bcl-2相关X基因(Bax)的表达治疗宫颈癌的作用。方法选取2021年1月至2023年12月皖西卫生职业学院附属医院收治的100例宫颈癌患者作为研究对象,进行前瞻性研究,按照入院后的电子编号分为研究组和对照组,每组50例。对照组采用紫杉醇与顺铂化疗方案治疗,研究组在对照组基础上加用甲地孕酮治疗。比较两组临床疗效、生活质量、Bcl-2和Bax表达水平、不良反应发生情况。结果研究组治疗总有效率高于对照组(P<0.05)。研究组卡氏功能状态评分标准(KPS)评分、食欲改善评分、体重增加及平均能量摄取情况均高于对照组(P<0.05)。治疗前,两组Bcl-2和Bax表达水平比较,差异无统计学意义(P>0.05);治疗后,两组Bcl-2和Bax表达水平均降低,且研究组均低于对照组(P<0.05)。研究组不良反应总发生率低于对照组(P<0.05)。结论宫颈癌患者采用甲地孕酮联合紫杉醇与顺铂化疗方案治疗,可通过下调Bcl-2和Bax表达水平提高患者的治疗效果和生活质量,且不会增加不良反应的发生。

紫杉醇、奈达铂联合甲羟孕酮同步放化疗治疗中晚期宫颈癌的临床研究

目的研究中晚期宫颈癌患者给予紫杉醇、奈达铂联合甲羟孕酮同步放化疗治疗效果。方法 2009年6月～2011年6月于南方医科大学附属南海人民医院住院治疗的中晚期宫颈癌患者共收集89例,将其分为对照组(放化疗)43例和观察组(放化疗+甲羟孕酮)46例。放射治疗:采用体外盆腔照射联合腔内后装照射,盆腔外照射5周,每周5次,总剂量50 Gy,第3周后开始腔内照射,每周1次,每次剂量5～6 Gy,共5～6次。化疗:静脉滴注紫杉醇35 mg/m2+奈达铂20 mg/m2,每周1次,共6次。对照组均给予上述放化疗治疗,观察组在放化疗同时行加入甲羟孕酮1000 mg/d口服。对两组的临床疗效、不良反应、对体重的影响及复发、转移和生存情况进行比较。结果观察组总有效率高于对照组,放化疗化反应有减轻,但差异均无统计学意义(P>0.05);观察组在改善患者体重方面有显著优势,差异有统计学意义(P<0.05);观察组复发及转移率(8.7%)低于对照组(11.6%),差异无统计学意义(P>0.05);观察组1年生存率(100.0%)高于对照组(95.3%),但差异无统计学意义(χ2=2.189,P=0.139)。结论奈达铂、紫杉醇联合甲地孕酮同期放疗治疗中晚期宫颈癌,近期疗效好,不良反应减轻,并且提高了患者远期生存率,在改善患者食欲、增加体重方面有显著优势,明显提高了患者的生活质量,值得临床推广应用。

90例甲地孕酮治疗晚期癌症患者厌食和体重减轻的临床观察

１９９１年６月～１９９３年１２月，我科应用甲地孕酮治疗９０例晚期癌肿患者，包括５９例原发性肝癌，１０例结直肠癌肝转移和２１例其他癌肿，治疗后食欲增加（Ｐ＜０．００５），体重增加和稳定占７６．７％，全身情况改善（Ｐ＜０．０５），同时发现，该药对晚期癌症尚有镇吐作用，其副作用小，因此，该药可作为晚期癌肿治疗中一种有效的辅助治疗药物。

来曲唑对人子宫内膜癌细胞作用的研究

目的:探讨第3代芳香化酶抑制剂来曲唑(letrazole)对子宫内膜癌细胞生长的抑制作用。方法:体外培养人子宫内膜癌细胞株RL-952,培养液中加入来曲唑和(或)丙酸睾酮、醋酸甲地孕酮(MA),用计数法分析细胞的生长,用流式细胞仪检测细胞周期和凋亡细胞,并对药物处理过的细胞进行苏木精-伊红(H-E)染色、光镜下观察细胞形态和凋亡细胞。结果:来曲唑联合丙酸睾酮、MA对RL-952子宫内膜癌细胞周期有影响,使G0/G1期的细胞增加,S期、G2/M期细胞减少;单用丙酸睾酮或来曲唑对RL-952子宫内膜癌细胞周期均无明显影响。结论:芳香化酶抑制剂来曲唑可抑制丙酸睾酮所致RL-952子宫内膜癌细胞株的增殖。

奥氮平联合醋酸甲地孕酮治疗晚期癌症性厌食症的疗效观察

目的:观察奥氮平联合醋酸甲地孕酮治疗晚期癌症性厌食症的疗效。方法:将85例癌性厌食患者随机分至治疗组(奥氮平联合醋酸甲地孕酮组+营养支持)和对照组(醋酸甲地孕酮组+营养支持)及单纯营养支持组,观察各组治疗前后食欲、体重、卡氏评分和免疫功能的变化并评价不良反应。结果:治疗结束后,治疗组食欲、卡氏评分改善率分别为82.8%、69.0%,对照组分别为65.5%、34.4%,空白组分别为40.7%、33.3%,治疗组改善率明显高于对照组和空白组(P<0.05);治疗组在体重、血清白蛋白、免疫功能改善程度方面均优于对照组和空白组(P<0.05)。未见明显不良反应。结论:奥氮平联合醋酸甲地孕酮能有效改善晚期恶性肿瘤患者厌食症状,是治疗晚期恶性肿瘤患者有效辅助药物,药物不良反应小。

一种尼尔雌醇-甲地孕酮周期新疗法

本文报告了应用长效尼尔雌醇和甲地孕酮序贯周期疗法治疗84例闭经患者,其中原发闭经者13例,继发闭经者71例,后者中有47例诊断为高促性腺激素性闭经。结果所有病人在用药后均产生撤退性子宫出血。在用药一年以上的12例病人中,血清中FSH和LH值明显下降,而血清E_2明显上升,其中10例B超检查示有卵泡发育或/和排卵,并有3例获得妊娠。其中一例于妊娠34周时活产一健康婴儿,流产和人工流产各一例,因此本周期疗法具有有效、方便、经济、安全和副作用少等优点。

醋酸甲地孕酮的荧光分析法研究

基于醋酸甲地孕酮与浓 H2 SO4反应后水解产物的荧光性质建立了一种测量醋酸甲地孕酮的荧光光度分析新方法 .系统地研究了不同环境介质和表面活性剂对产物荧光性质的影响 ,提出了醋酸甲地孕酮被氧化及荧光增强的作用机理 .本法检测限为 1.0 4× 10 - 6mol· L- 1 ,荧光强度与醋酸甲地孕酮浓度在 0～ 4.6 8× 10 - 5mol· L- 1 范围内呈良好线性关系 ,方法相对标准偏差为 5 .6 %.

醋酸甲地孕酮改善子宫内膜癌患者食欲和体重的临床研究

目的：探讨醋酸甲地孕酮在子宫内膜癌治疗中改善患者食欲和体重的临床疗效。方法：对38例ER、PR阳性的子宫内膜癌患者术后给予口服醋酸甲地孕酮,160mg/天,连续6-12个月;44例ER、PR阴性者术后不服用醋酸甲地孕酮作对照。结果：醋酸甲地孕酮可显著改善子宫内膜癌患者术后、放化疗后的食欲,明显增加体重,减轻化疗的毒副作用,提高Karnofsky评分,对子宫内膜癌患者的生存率无明显改善。结论：醋酸甲地孕酮可显著改善子宫内膜癌患者的食欲和体重,提高生活质量,但对部分患者可能会过分增加体重,未明显改善子宫内膜癌患者的生存率。