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李蕊白,田同德,郑智,李平,芦殿荣,王宝利,黄伟师,贾梦冉,张稚淳,丁皓,田劭丹,侯丽.肠胃舒胶囊对肿瘤湿热证腹泻与便秘的双向调节[J].湖南中医药大学学报英文版,2021,41(8):1268-1274.[Click to copy
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| 肠胃舒胶囊对肿瘤湿热证腹泻与便秘的双向调节 |
| 李蕊白,田同德,郑智,李平,芦殿荣,王宝利,黄伟师,贾梦冉,张稚淳,丁皓,田劭丹,侯丽 |
| (北京中医药大学东直门医院, 北京 100700;河南省肿瘤医院, 河南 郑州 450008;江西省肿瘤医院, 江西 南昌 330029;安徽医科大学第一附属医院, 安徽 合肥 230022;中国中医科学院望京医院, 北京 100102;广西中医药大学第一附属医院, 广西 南宁 530023;广西中医药大学瑞康医院, 广西 南宁 530011) |
| 摘要: |
| 目的 观察肠胃舒胶囊对肿瘤相关湿热证腹泻与便秘的双向调节治疗效果。方法 采用随机对照（拆随机信封法）、多中心临床试验方法，将肿瘤化疗相关腹泻与肿瘤相关便秘患者随机分为试验组与对照组。肿瘤化疗相关腹泻：试验组服用肠胃舒胶囊（4粒/次，每日3次，早中晚餐后30 min服用）；对照组服用香连片（5片/次，每日3次，早中晚餐后30 min服用）。肿瘤及其治疗相关便秘：试验组服用肠胃舒胶囊（剂量、服法同上）；对照组服用麻仁润肠软胶囊（8粒/次，每日2次，早晚餐后30 min服用）。治疗时间均为14 d。记录治疗前后的中医证候总积分、证候疗效、单项症状积分变化以及治疗中出现的不良反应。结果 （1）腹泻。与治疗前比较，两组治疗后中医证候总积分皆下调，且试验组下降更明显，差异有统计学意义（P<0.05）。治疗后，两组单项症状积分皆下调，组间比较，试验组腹泻、脘腹胀满积分下调更明显，差异有统计学意义（P<0.05）。腹泻证候总疗效试验组为90.48%，对照组为76.67%。（2）便秘。与治疗前比较，两组治疗后中医证候总积分皆下调，差异有统计学意义（P<0.05）。治疗后两组单项症状积分皆下调，与治疗前比较，差异有统计学意义（P<0.05）；治疗后组间比较，试验组食少纳呆单项症状积分下降更明显，差异有统计学意义（P<0.05）。试验组证候总有效率为87.88%，对照组为67.86%。（3）在临床观察过程中，未发现肠胃舒胶囊、香连片、麻仁润肠软胶囊有不良反应。结论 具有"清热燥湿，理气止痛"功效的肠胃舒胶囊对肿瘤化疗相关性腹泻、肿瘤及其治疗相关便秘属脾胃湿热证有双向调节治疗效果，安全有效，值得临床推广应用。 |
| 关键词: 肿瘤 腹泻 便秘 化疗 肠胃舒胶囊 脾胃肠同治 |
| DOI：10.3969/j.issn.1674-070X.2021.08.024 |
| Received:December 29, 2020 |
| 基金项目:国家癌症攀登计划项目（NCC201814B045）；江西省中医药科研课题（2019A057）。 |
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| Changweishu Capsule's Two-way Regulation on Diarrhea and Constipation of Tumor Damp-heat Syndrome |
| LI Ruibai,TIAN Tongde,ZHENG Zhi,LI Ping,LU Dianrong,WANG Baoli,HUANG Weishi,JIA Mengran,ZHANG Zhichun,DING Hao,TIAN Shaodan,HOU Li |
| (Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China;Henan Cancer Hospital, Zhengzhou, Henan 450008, China;Jiangxi Cancer Hospital, Nanchang, Jiangxi 330029, China;The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, China;Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing 100102, China;The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, Guangxi 530023, China;Ruikang Hospital of Guangxi University of Chinese Medicine, Nanning, Guangxi 530011, China) |
| Abstract: |
| Objective To observe the two-way regulating effect of Changweishu Capsule on diarrhea and constipation of tumor-related damp-heat syndrome. Methods Using a randomized controlled (randomized envelope method), multi-center clinical trial method, patients with tumor chemotherapy-related diarrhea and tumor-related constipation were randomly divided into test group and control group. Tumor chemotherapy-related diarrhea:the test group was given Changweishu Capsule (4 capsules/time, 3 times a day, 30 minutes after breakfast, lunch and dinner); the control group was given Xianglian Tablet (5 tablets/time, 3 times a day, 30 minutes after breakfast, lunch and dinner). Tumor and its treatment-related constipation:the test group was given Changweishu Capsule (the dosage and administration were the same as above); the control group was given Maren Runchang Soft Capsule (8 capsules/time, 2 times a day, 30 minutes after breakfast and dinner). The treatment time was 14 days. The total scores of traditional Chinese medicine (TCM) syndromes, the efficacy of syndromes, the changes in individual symptom scores, and the adverse reactions that occurred during the treatment were record before and after treatment. Results (1) Diarrhea. Compared with before treatment, the total scores of TCM syndromes in the two groups were lower than after treatment, and the decrease in the test group was more obvious, and the difference was statistically significant (P<0.05). After treatment, the individual symptom scores of the two groups were all down-regulated, compared between the groups, the scores of diarrhea and abdominal distension in the test group were down-regulated more significantly, and the difference was statistically significant (P<0.05). The total curative effect of diarrhea syndrome was 90.48% in the test group and 76.67% in the control group. (2) Constipation. Compared with before treatment, the total scores of TCM syndromes of the two groups were lower than after treatment, and the difference was statistically significant (P<0.05). After treatment, the individual symptom scores of the two groups were decreased, and the difference was statistically significant compared with before treatment (P<0.05); after treatment, the individual symptom scores in anorexia of the test group decreased significantly, and the difference was statistically significant (P<0.05). The total effective rate of syndromes in the test group was 87.88%, and that in the control group was 67.86%. (3) During the clinical observation, no adverse reactions were found in Changweishu Capsule, Xianglian Tablet and Maren Runchang Soft Capsule. Conclusion Changweishu Capsule with the effects of "clearing heat, eliminating dampness, regulating Qi and relieving pain" has a two-way regulating therapeutic effect on tumor chemotherapy-related diarrhea, tumors and their treatment-related constipation, which belongs to the spleen and stomach damp-heat syndrome. It is safe and effective, and is worthy of clinical application. |
| Key words: tumor diarrhea constipation chemotherapy Changweishu Capsule simultaneous treatment of spleen and stomach |
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