癌症疼痛病人伴随阿片类药物导致便秘的中医汤剂标准化治疗：一项多中心前瞻性随机对照试验

Objective： To observe the efficacy and the influence on quality of life （QOL） of syndrome differentiation treatment with Chinese medicine （CM） for opioid-induced constipation as well as the safety and influence on analgesic effect of opioids. Methods： Totally 406 cases enrolled from 53 collaborating medical centers were randomly assigned to a CM group and a control group. The CM group were treated with CM decoction based on syndrome differentiation, and the control group were treated with Phenolphthalein Tablet. Both groups were treated for 14 days. Cleveland constipation score （CCS）, numedcal rating scale （NRS） of pain and Chinese version of European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-C30 V3.0 （EORTC QLQ-C30 V3.0） were used to evaluate the efficacy, pain controlled and QOL status. Results： The comparisons of CCS score reduction and QOL between the two groups after treatment suggested that the improvements of constipation and QOL in the CM group were better than that in the control group （P〈0.05）. The total efficiency of the CM group was better than the control group （93.5% vs. 86.4%, P〈0.05）. There was no significant difference in NRS scores between before and after treatment in both groups. There was no serious drug-related adverse event during the course of study. Conclusion： CM decoction could effectively treat opioid-induced constipation and improve patients＇ QOL at the same time. It is safe and doesnt affect the analgesic effect of opioids when treating constipation.

Standardized Treatment of Chinese Medicine Decoction for Cancer Pain Patients with Opioid-Induced Constipation: A Multi-Center Prospective Randomized Controlled Study

Objective

To observe the efficacy and the influence on quality of life (QOL) of syndrome differentiation treatment with Chinese medicine (CM) for opioid-induced constipation as well as the safety and influence on analgesic effect of opioids.

Methods

Totally 406 cases enrolled from 53 collaborating medical centers were randomly assigned to a CM group and a control group. The CM group were treated with CM decoction based on syndrome differentiation, and the control group were treated with Phenolphthalein Tablet. Both groups were treated for 14 days. Cleveland constipation score (CCS), numerical rating scale (NRS) of pain and Chinese version of European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-C30 V3.0 (EORTC QLQ-C30 V3.0) were used to evaluate the efficacy, pain controlled and QOL status.

Results

The comparisons of CCS score reduction and QOL between the two groups after treatment suggested that the improvements of constipation and QOL in the CM group were better than that in the control group (P<0.05). The total efficiency of the CM group was better than the control group (93.5% vs. 86.4%, P<0.05). There was no significant difference in NRS scores between before and after treatment in both groups. There was no serious drug-related adverse event during the course of study.

Conclusion

CM decoction could effectively treat opioid-induced constipation and improve patients’ QOL at the same time. It is safe and doesn’t affect the analgesic effect of opioids when treating constipation.