肠胃舒胶囊治疗肿瘤相关腹泻与便秘疗效及调节机制研究

目的观察肠胃舒胶囊治疗肿瘤相关腹泻与便秘的疗效及调节机制。方法采用拆随机信封法、多中心竞争入组的临床试验方法,将2018年7月—2019年10月北京中医药大学东直门医院、河南省肿瘤医院、江西省肿瘤医院、广西中医药大学瑞康医院、广西中医药大学第一附属医院、安徽医科大学第一附属医院、中国中医科学院望京医院7家医院诊治的肿瘤化疗相关腹泻与肿瘤相关便秘患者随机分为治疗组与对照组。①肿瘤化疗相关腹泻:治疗组63例服用肠胃舒胶囊(4粒/次,每日3次),对照组30例服用香连片(5片/次,每日3次)。②肿瘤相关便秘:治疗组33例服用肠胃舒胶囊(4粒/次,每日3次),对照组28例服用麻仁润肠软胶囊(8粒/次,每日2次)。治疗时间均为2周。记录2组治疗前后便秘、腹泻症状积分,统计2组临床疗效,检测2组治疗前后血清胃蛋白酶原(PG)、血管活性肠肽(VIP)、胆囊收缩素(CCK)水平。结果治疗后2组患者便秘、腹泻症状积分均明显降低(P均<0.05),且治疗组患者腹泻症状积分明显低于对照组(P均<0.05)。腹泻和便秘患者治疗组总有效率分别为90.5%(57/63)和87.9%(29/33),对照组分别为76.7%(23/30)和67.8%(19/28),2组比较差异均无统计学意义(P均>0.05)。治疗后2组便秘患者血清PG水平有升高趋势(P均>0.05),对照组腹泻患者血清PG水平明显升高(P<0.05);治疗后治疗组便秘患者血清VIP水平有升高趋势(P>0.05),腹泻患者无明显变化(P>0.05);治疗后对照组便秘患者血清CCK水平明显升高(P<0.05)。结论肠胃舒胶囊对肿瘤相关腹泻、便秘有双向调节效果,其在降低腹泻症状积分方面具有明显优势,调节PG、VIP、CCK水平可能是肠胃舒胶囊治疗便秘、腹泻潜在的效应机制之一。

Effect and regulation mechanism of Changweishu capsule in the treatment of tumor-related diarrhea and constipation

Objective It is to observe the curative effect and regulation mechanism of Changweishu capsule in the treatment of tumor-related diarrhea and constipation.Methods The patients with tumor chemotherapy-related diarrhea and constipation treated in Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Henan Provincial Cancer Hospital,Jiangxi Provincial Cancer Hospital,The First Affiliated Hospital of Anhui Medical University,Wangjing Hospital of China Academy of Chinese Medical Sciences,The First Affiliated Hospital of Guangxi University of Chinese Medicine,Ruikang Hospital of Guangxi University of Traditional Chinese Medicine from July 2018 to October 2019 were randomly divided into treatment group and control group according to the randomized envelope method and multi-center competitive enrollment in clinical trials.①Tumor chemotherapy-related diarrhea:The treatment group(n=63)was treated with Changweishu capsules(4 capsules/time,3 times a day),the control group(n=30)was treated with Xianglian tablets(5 tablets/time,3 times a day).②Tumor-related constipation:the treatment group(n=33)was treated with Changweishu capsules(4 capsules/time,3 times a day),the control group(n=28)was treated with Ma Ren Run Chang soft capsules(8 capsules/time,twice a day).The duration of treatment was two weeks.All the groups were treated for 2 weeks.The scores of constipation and diarrhea symptoms before and after treatment were recorded in the 2 groups,and the clinical effects of the 2 groups were counted.The levels of serum pepsinogen(PG),vasoactive intestinal peptide(VIP)and cholecystokinin(CCK)were detected before and after treatment in the 2 groups.Results After treatment,the scores of constipation and diarrhea symptoms of the two groups were significantly reduced(both P<0.05),and the scores of diarrhea symptoms of the patients in the treatment group were significantly lower than those of the control group(both P<0.05).The total effective rates of diarrhea and constipation patients in the treatment group were 90.5%(57/63)and 87.9%(29/33),respectively,and the control group were 76.7%(23/30)and 67.8%(19/28),the differences were not statistically significant between the 2 groups(both P>0.05).After treatment,the serum PG level of constipation patients in the two groups showed an increasing trend(P both>0.05),and the serum PG level of diarrhea patients in the control group was increased significantly(P<0.05);after treatment,the serum VIP level of constipation patients in the treatment group had an increasing trend(P>0.05),there was no significant change in diarrhea patients(P>0.05);after treatment,the serum CCK level of constipation patients in the control group was significantly increased(P<0.05).Conclusion Changweishu capsule has two-way regulating effect on tumor chemotherapy-related diarrhea and constipation,it has obvious advantages in reducing diarrhea symptom score.Regulating the levels of PG,VIP and CCK may be one of the potential effect mechanisms of Changweishu capsules in the treatment of constipation and diarrhea.