摘要
目的:观察加味芪榔方治疗气阴两虚型药物依赖性便秘的临床疗效及对生活质量的影响。方法:采用随机双盲临床试验设计,将160例药物依赖性便秘患者,按照1∶1比例随机分为两组,治疗组和对照组各80例。治疗组予加味芪榔方和乳果糖口服液模拟剂,对照组予乳果糖口服液和加味芪榔方模拟剂,两组疗程均为8周。记录患者治疗前后的便秘主要症状积分、中医证候积分、便秘患者症状自评问卷(PAC-SYM)积分、便秘患者生活质量自评问卷(PAC-QOL)积分;并在停药后第2周、第4周对患者进行随访。结果:两组患者治疗后,全分析集(FAS)分析发现,治疗组总有效率为91.14%(72/79),对照组总有效率为73.33%(55/75),治疗组总有效率高于对照组(Z=-6.62,P<0.01);符合方案集(PPS)分析发现,治疗组总有效率为93.51%(72/77),对照组总有效率为76.39%(55/72),治疗组总有效率高于对照组(Z=-6.77,P<0.01)。与本组治疗前比较,两组患者治疗后,FAS和PPS分析发现便秘主要症状积分较治疗前均降低(P<0.05),且与对照组比较,治疗组除下坠、不尽、胀感方面外,其余症状积分均低于对照组(P<0.05);两组中医证候主证积分较治疗前降低(P<0.05),且治疗组低于对照组(P<0.05);治疗组中医证候次证积分较治疗前均明显降低(P<0.05),且与对照组比较,在腹胀、乏力、心烦少寐方面积分明显降低(P<0.05)。与本组治疗前比较,治疗后两组均能改善患者PAC-SYM量表积分(P<0.05),治疗组在对于改善患者粪便症状、腹部症状方面优于对照组(P<0.05);两组均能改善患者PAC-QOL量表积分,治疗组在改善患者生理功能、社会心理、担忧度、满意度方面优于对照组(P<0.05);在停药后第2周(χ^(2)=5.65,P<0.05)、第4周(χ^(2)=12.37,P<0.01)治疗组复发率更低。结论:加味芪榔方治疗药物依赖性便秘疗效显著,临床疗效优于乳果糖口服液,疗效稳定持久未见明显不良反应。
Objective:To observe the clinical effect of modified Qilang prescription on the treatment of drug-dependent constipation of Qi-Yin deficiency type.Method:In a randomized double-blind clinical trial,160 patients with drug-dependent constipation were randomly divided into two groups,namely,the treatment group(80 cases)and the control group(80 cases).The treatment group was treated with modified Qilang prescription and lactulose oral liquid simulator,while the control group was treated with lactulose oral liquid and the simulator of modified Qilang prescription.The course of treatment of both groups was 8 weeks.The scores of main syndromes of constipation,traditional Chinese medicine(TCM)syndromes,patient assessment of constipation symptom(PAC-SYM)scale,and patient assessment of constipation quality of life(PAC-QOL)scale before and after treatment were recorded.The patients were followed up at the 2^(nd) and 4^(th) week after drug withdrawal.Result:After treatment,the full analysis set(FAS)analysis showed that the total effective rate was 91.14%(72/79)in the treatment group and 73.33%(55/75)in the control group.The treatment group had a higher total effective rate than the control group(Z=-6.62,P<0.01).The per-protocol set(PPS)analysis showed that the total effective rate was 93.51%(72/77)in the treatment group and 76.39%(55/72)in the control group.The treatment group had a higher total effective rate than the control group(Z=-6.77,P<0.05).After treatment,the FAS and PPS analysis showed that the main syndrome scores of constipation were lower in both groups than those before treatment(P<0.05).Except the syndromes of falling,overexertion defecation,and distension,the scores of other syndromes in the treatment group were lower than those in the control group(P<0.05).The scores of TCM primary syndromes in the two groups were lower than those before treatment(P<0.05),and the scores of the treatment group were significantly lower than those of the control group(P<0.05).The scores of TCM secondary syndromes in the treatment group were significantly lower than those before treatment(P<0.05).The syndrome scores of abdominal distension,fatigue,and lack of sleep in the treatment group were significantly lower than those in the control group(P<0.05).The scores of PAC-SYM scale were improved in both groups after treatment(P<0.05),and the treatment group was superior to the control group in improving fecal syndromes and abdominal syndromes.The scores of PAC-QOL scale were improved in both groups after treatment,and the treatment group was superior to the control group in improving patients’physiological function,social psychology,anxiety,and satisfaction.After drug withdrawal,the recurrence rate was lower in the treatment group at the 2^(nd)(χ^(2)=5.65,P<0.05)and 4^(th) week(χ^(2)=12.37,P<0.01).Conclusion:modified Qilang prescription is effective in the treatment of drug-dependent constipation,and its clinical effect is better than that of lactulose oral liquid.The curative effect of modified Qilang prescription is stable and lasting without obvious adverse reactions.
作者
曹梦醒
周蒙恩
李勇
CAO Mengxing;ZHOU Mengen;LI Yong(Shanghai Municipal Hospital of Traditional Chinese Medicine(TCM)Affiliated to Shanghai University of TCM,Shanghai 200071,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2022年第24期145-152,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
上海市科学技术委员会科研计划项目(18401904000)
上海市2022年度“科技创新行动计划”生物医药科技支撑专项项目(22S21901100)。
关键词
加味芪榔方
药物依赖性便秘
乳果糖
生活质量
临床研究
modified Qilang prescription
drug-dependent constipation
lactulose
quality of life
clinical study
