联合应用多种中医适宜技术干预阿片类药物相关性便秘的多中心临床研究

Multicenter Clinical Study on the Combined Intervention with Appropriate TCM Techniques in the Treatment of Opioid-induced Constipation

目的通过多中心临床研究,评价多项中医适宜技术联合干预对阿片类药物相关性便秘的临床疗效。方法2021年7月至2022年10月,在上海中医药大学附属岳阳中西医结合医院肿瘤科病房、利群医院安宁疗护病房、长征社区卫生服务中心安宁疗护病房选取符合阿片类药物相关性便秘诊断标准及便秘津亏肠燥证辨证标准的住院患者为研究对象,采用随机数字法分为对照组(n=164)与观察组(n=164)。两组患者均参照《阿片类药物相关性便秘中西医结合护理方案》开展常规护理工作。对照组在常规护理的基础上,给予乳果糖口服液(每日3次,每次10 mL空腹服用)及相应的用药指导;观察组在常规护理的基础上,采用中药贴敷、中药离子导入、耳穴压豆3项中医适宜技术联合干预。两组患者干预时间均为14 d,比较两组患者干预后的日均排便次数、平均排便间隔时间,干预前后的便秘症状、便秘相关生活质量及疼痛评分。结果观察组患者治疗便秘的显效率(31.71%)高于对照组(8.54%),且两组便秘症状疗效比较,差异有统计学意义(Z=-5.41,P<0.01);治疗后两组患者的日均排便次数及平均排便间隔时间差异均无统计学意义(P>0.05);两组患者治疗后便秘症状及相关生活质量较治疗前均有明显改善和提高,且观察组便秘症状及便秘相关生活质量评分的变化均比对照组更为明显,差异均有统计学意义(P<0.01);两组患者干预后疼痛评分均明显低于干预前,差异有统计学意义(P<0.01),但组间差异无统计学意义(P>0.05)。结论多种中医适宜技术联合干预可改善阿片类药物相关性便秘患者的便秘情况,同时可有效缓解患者的便秘不适症状、提高患者的生活质量,符合晚期肿瘤患者安宁疗护的理念,具有一定临床推广意义。

Objective To evaluate the clinical efficacy of combined intervention with appropriate TCM techniques in the treatment of opioid‐induced constipation through a multicenter clinical study.Methods From July 2021 to October 2022,patients were selected based on the following criteria:fulfilling the diagnostic criteria for opioid‐induced constipation,fulfilling the differentiation criteria for constipation with the pattern of intestinal dryness and fluid consumption,and being hospitalized in either the oncology wards of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,the hospice wards of Shanghai Putuo Liqun Hospital,or the hospice wards of Shanghai Changzheng Community Health Service Center.Eligible patients were divided into the control group(n=164)and the observation group(n=164)by using a random number table.Both groups received routine care with reference to the Protocol of Combined Treatment of Traditional Chinese Medicine and Western Medicine for Opioid⁃induced Constipation.On this basis,the control group additionally received lactulose oral solution(10 mL under fasting conditions,TID)and corresponding medication guidance,while the observation group additionally received combined intervention with appropriate TCM techniques,comprising TCM application,TCM iontophoresis and auricular acupressure therapy.The duration of intervention was 14 days in both groups.The daily average defecation frequency and the average defecation interval after intervention were compared between the two groups;the constipation symptoms,constipation⁃related quality of life scores and pain scores were compared pre⁃and post⁃intervention and between the two groups.Results The markedly effective rate(31.71%)of the observation group was higher than that of the control group(8.54%)and there was a significant difference in the efficacy of constipation symptoms between the two groups(Z=−5.41,P<0.01).There was no significant difference in the average daily defecation frequency and the average defecation interval post⁃intervention between the two groups(P>0.05).The constipation symptoms and constipation⁃related quality of life scores were significantly improved post⁃intervention compared to pre⁃intervention in both groups,and more pronounced and significant improvements were observed in the observation group(P<0.01).The pain scores post⁃intervention were significantly lower than those pre⁃intervention in the two groups(P<0.01),but no significant difference was observed between the groups(P>0.05).Conclusion For patients with opioid⁃induced constipation,the combined intervention with appropriate TCM techniques can relieve their constipation and constipation⁃related discomforts and improve their quality of life.This approach aligns with the concept of hospice care for patients with advanced cancers and holds certain implications for promotion in clinical practice.