消癥止痛凝胶外敷治疗恶性肿瘤骨转移疼痛的随机对照研究

External Application of Xiaozheng Zhitong Gel(消癥止痛凝胶) in the Treatment of Pain from Bone Metastasis:A Randomized Controlled Trial

目的观察消癥止痛凝胶治疗恶性肿瘤骨转移疼痛的临床疗效及安全性。方法采用随机对照试验,将所纳入患者分为治疗组52例和对照组51例。对照组在常规抗肿瘤治疗的基础上,根据患者主观需求规范应用或放弃三阶梯止痛治疗;治疗组在对照组治疗的基础上联合应用消癥止痛凝胶,每个疼痛部位约2 g,每日3次。两组均用药1周。主要疗效指标为最严重疼痛及平均疼痛的有效性,并从是否联合三阶梯止痛、中医证型、骨转移部位、性别、年龄因素进行亚组分析;次要指标包括采用数字疼痛评分系统(NRS)评价治疗前后最严重疼痛、平均疼痛、最轻疼痛的变化,采用简明疼痛评估量表(BPI)评价治疗前后疼痛对患者日常生活功能的影响变化,同时观察三阶梯止痛药的需求变化以及消癥止痛凝胶的局部不良反应。结果治疗组49例、对照组48例纳入分析。治疗组骨转移最严重疼痛疗效总有效率为61.22%(30/52),对照组为4.17%(2/51),治疗组总有效率高于对照组(P<0.05)。治疗组骨转移平均疼痛疗效总有效率为34.69%(17/52),对照组为0(0/51),治疗组总有效率高于对照组(P<0.05)。无论是否联合三阶梯止痛,消癥止痛凝胶对骨转移最严重疼痛、平均疼痛的有效性均明显优于对照组(P<0.05),且治疗组不同中医证型、骨转移部位、性别和年龄最严重疼痛疗效均优于对照组(均P<0.05)。在治疗组中,不同疼痛程度、中医证型、转移部位、性别间差异无统计学意义(均P>0.05),而在不同年龄间显示≥65岁者疗效更佳,差异有统计学意义(P<0.05)。治疗组治疗后最严重疼痛、平均疼痛、最轻疼痛NRS评分及疼痛对日常生活功能影响评分明显低于治疗前(P<0.05);对照组治疗前后各评分差异无统计学意义(P>0.05);治疗组治疗前后各评分差值显著高于对照组(P<0.05)。两组三阶梯止痛药的需求比较差异无统计学意义(P>0.05)。治疗组5例出现轻度刺激性皮炎,未影响治疗,治疗结束即愈。结论消癥止痛凝胶单独应用或联合三阶梯止痛药治疗恶性肿瘤骨转移疼痛具有良好镇痛效果,不受疼痛程度、转移部位、性别、年龄或中医证型的限制,且安全性较好。

Objective To observe the clinical efficacy and safety of Xiaozheng Zhitong Gel(消癥止痛凝胶)in the treatment of pain from bone metastasis.Methods The included patients were randomized into treatment group(52 cases)and control group(51 cases).On the basis of routine anti-tumor treatment,the patients in the control group were administered with standardized or abandoned the three-step analgesic treatment according to the subjective needs of patients.The patients in the treatment group were additionally given Xiaozheng Zhitong Gel,2 g for each pain site,three times daily,on the basis of the treatment given in the control group.Both groups were treated for one week.The primary outcomes were the effectiveness on the most severe pain and the average pain,for which subgroup analyses could be performed regarding whether three-step analgesic treatment is combined or not,traditional Chinese medicine(TCM)syndrome type,site of bone metastases,gender,and age.The secondary outcomes included the changes of the most severe pain,the average pain and the lightest pain measured by the numerical rating scale(NRS),the impact of pain on activities of daily living measured by brief pain inventory(BPI),the changes in the demand for three-step analgesics,and the local adverse reactions of the Xiaozheng Zhitong Gel.Results Totally,49 cases were included in the treatment group and 48 cases in the control group for analysis.The total effective rate of Xiaozheng Zhitong Gel on the most severe pain was 61.22%(30/52)in the treatment group,significantly higher than 4.17%(2/51)of the control group(P<0.05).The total effective rate on average pain of bone metastasis was 34.69%(17/52)in the treatment group,significantly better than 0(0/51)in the control group(P<0.05).Regarding whether three-step analgesic treatment was combined with,the treatment group with Xiaozheng Zhitong Gel had better effects on the most severe pain and average pain than the control group(P<0.05),and the significant advantages on the most severe pain in favor of the treatment group were not associated with different TCM syndromes,site of bone metastases,gender and age(all P<0.05).In the treatment group,there was no significant difference among the subgroups with different pain severity,TCM syndromes,sites of bone metastases and gender(all P>0.05),except for age indicating best effect in people≥65 years old(P<0.05).The NRS scores of the worst pain,average pain,and lightest pain,and the impact score of pain on activities of daily life function in the treatment group were significantly lower after treatment(P<0.05);the scores before and after treatment in the control group were not significantly different(P>0.05);and the changes of the scores were larger in the treatment group than the control group(P<0.05).There was no significant difference between groups in the demand for three-step analgesics(P>0.05).There were five cases of mild irritant dermatitis in the treatment group,which not interrupted the treatment and disappeared after treatment.Conclusion Xiaozheng Zhitong Gel alone or in combination with three-step analgesics has a good analgesic effect in the treatment of bone metastasis pain,which are not associated to the pain severity,the site of bone metastasis,gender,age or TCM syndromes,and is safe.