机构地区:[1]浙江中医药大学附属湖州中医院,浙江湖州313000
出 处:《中医药临床杂志》2024年第10期1986-1990,共5页Clinical Journal of Traditional Chinese Medicine
基 金:浙江中医药大学校级科研项目(NO.2021FSYYZY36)。
摘 要:目的:观察艾迪注射液联合内分泌治疗转移性激素敏感性前列腺癌(metastatic Hormone SensitiveProstate Cancer,mHSPC)的临床疗效。方法:采用随机数字表法,将51名mHSPC患者分为研究组26例和对照组25例,2组均行不间断雄激素剥夺治疗(ADT)治疗,研究组加用艾迪注射液,14d为1个疗程,共3个疗程,比较2组血清总前列腺特异性抗原(tPSA)水平、中医症候评分、视觉模拟评分(VAS)、欧洲癌症研究治疗组织制定的生存质量核心量表(EORTC QLQ-C30)评分、国际前列腺症状评分(IPSS)、不良反应发生率。结果:至观察终点,研究组血清tPSA水平为(0.666±1.359)mmol/L,低于对照组的(1.176±1.451)mmol/L;研究组中医症候评分为(1.62±1.47)分,低于对照组的(3.32±1.86)分;研究组VAS评分为(0.81±1.17)分,与对照组(1.76±1.23)分比较,显著降低;研究组QLQ-C30评分(87.92±6.09)分较对照组(78.88±6.69)分高;研究组IPSS评分为(9.08±2.54)分,较对照组(13.72±3.36)分低;研究组不良反应总发生率(15.38%)、贫血发生率(7.69%)低于对照组(总发生率44%、贫血发生率32%),差异均有统计学意义。不良反应潮红、乳房发育及乏力发生率差异无统计学意义。结论:艾迪注射液联合内分泌治疗相对于单纯的内分泌治疗可以提高临床疗效、减轻疼痛、改善症状、并提高生存质量、降低不良反应的发生,值得临床推广应用。Objective:To observe the clinical efficacy of Aidi injection combined with endocrine therapy for metastatic hormone-sensitive prostate cancer(mHSPC).Methods:A total of 51 patients with mHSPC were randomly divided into a study group(n=26)and a control group(n=25).Both groups received uninterrupted androgen deprivation therapy(ADT).The study group was given Aidi injection,with 14 days as one course of treatment,for a total of 3 courses.The serum total prostate-specific antigen(tPSA)level,TCM symptom score,visual analogue scale(VAS),European Organization for Research and Treatment of Cancer(EORTC QLQ-C30)score,International Prostate Symptom Score(IPSS),and the incidence of adverse reactions were compared between the two groups.Results:At the end of observation,the serum tPSA level of the study group was(0.666±1.359)mmol/L,which was lower than that of the control group(1.176±1.451)mmol/L;the TCM symptom score of the study group was(1.62±1.47)points,which was lower than that of the control group(3.32±1.86)points;the VAS score of the study group was(0.81±1.17)points,which was significantly lower than that of the control group(1.76±1.23)points;the QLQ-C30 score of the study group(87.92±6.09)points was higher than that of the control group(78.88±6.69)points;the IPSS score of the study group was(9.08±2.54)points,which was lower than that of the control group(13.72±3.36)points;the total incidence of adverse reactions(15.38%)and anemia(7.69%)in the study group were lower than those in the control group(total incidence 44%,anemia 32%),the differences were statistically significant.There was no statistically significant difference in the incidence of adverse reactions such as hot flashes,breast development and fatigue.Conclusion:Compared with endocrine therapy alone,Aidi injection combined with endocrine therapy can improve clinical efficacy,relieve pain,improve symptoms,improve quality of life,and reduce the occurrence of adverse reactions,which is worthy of clinical promotion and application.
关 键 词:艾迪注射液 转移性激素敏感性前列腺癌 雄激素剥夺
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