益肾化痰方联合伊班膦酸钠治疗前列腺癌骨转移疼痛的临床观察

Clinical Observation of Yishen Huatan Formula Combined with Ibandronate Sodium in Treatment of Bone Metastasis Pain of Prostate Cancer

目的:观察益肾化痰方联合伊班膦酸钠治疗骨转移疼痛的有效性。方法:选择2016年12月—2019年12月河南中医药大学第三附属医院及河南省中医院治疗的男性前列腺癌骨转移疼痛患者50例,分为对照组和治疗组各25例,对照组治疗第1~2日将阿片类镇痛药用量滴定至NRS评分<4分,第4日给予伊班膦酸钠4 mg静滴;治疗组在对照组治疗基础上,第4~14日服用益肾化痰方;统计分析第2~3日、第13~14日等效吗啡日平均口服量,第1、14日NRS评分,第1、15日Karnofsky评分、ALP(血清碱性磷酸酶,Alkaline Phosphatase)指数及不良反应进行评估与比较。结果:(1)两组患者治疗后等效吗啡日平均口服量均较治疗前明显减少(P<0.01),治疗组较对照组减少更加明显(P<0.01);(2)两组患者第14日NRS评分较第1日明显下降(P<0.05),两组患者第14日NRS评分无明显差别(P>0.05);(3)两组患者第15日Karnofsky评分均较第1日明显提高,治疗组Karnofsky评分较对照组提高幅度更大(P<0.01);(4)两组血清ALP指数均明显下降(P<0.01),治疗组血清ALP指数较对照组下降幅度更大(P<0.01);(5)在治疗过程中,对照组患者出现不明原因的发热3例,便秘3例,呕吐2例;治疗组出现腹泻1例,头晕2例,对症处理后均未再出现,余均未见明显不良反应。结论:益肾化痰方联合伊班膦酸钠能明显减轻前列腺癌骨转移患者的疼痛,减少阿片类镇痛药使用量,改善生活质量,降低ALP,且副作用较小。

Objective:To observe the efficacy of Yishen Huatan Formula combined with Ibandronate Sodium in the treatment of bone metastasis pain.Methods:50 male patients of prostate cancer with bone metastasis pain were randomly divided into the control group(n=50)and the treatment group(n=50).The control group was treated with opioid analgesics on the first and second day with the dosage was titrated to NRS score less than 4,and Ibandronate Sodium(4 mg)was given intravenously on the 4 th day;on which basis,the treatment group was also treated with Yishen Huatan Formula during the 4 th-14 th day.The average daily oral dose of equivalent morphine on the 2 th-3 th day,the 13 th-14 th day,NRS score on the 1 st day and 14 th day,Karnofsky score on the 1 st and 15 th day,as well as serum ALP(alkaline phosphatase)index were statistically analyzed,and adverse reactions were evaluated and compared between the two groups.Results:The average daily oral dose of equivalent morphine was significantly reduced in the two groups after the treatment(P<0.01),and the reduction in the treatment group was more significant than that in the control group(P<0.01).On the 14 th day,the NRS score of the two groups was significantly decreased compared to that on the 1 st day(P<0.05);however there was no statistical difference in NRS score between the two groups on the 14 th day(P>0.05).On the 15 th day,the Karnofsky score was significantly increased compared to that on the 1 st day in the two groups(P<0.05,P<0.01),the increase in the treatment group was more significant(P<0.01).The ALP index was significantly decreased on the 15 th day than that on the 1 st day in the two groups(P<0.01),and the decrease in the treatment group was more significant(P<0.01).There were 3 cases of fever,3 cases of constipation and 2 cases of vomiting in the control group;there were 1 case of diarrhea and 2 cases of dizziness in the treatment group.Conclusion:Yishen Huatan Formula combined with Ibandronate Sodium can significantly reduce the pain of prostate cancer in patients with bone metastasis,it can reduce the use of opioid analgesics,improve the quality of life and reduce ALP with less side effects.