中医外治化疗性手足痛的随机、双盲、对照、多中心临床研究
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摘要
文献综述共有两篇,分别回顾了近年来国内外对于“化疗药物所致周围神经病变的发病规律与评价方法”和“化疗药物所致周围神经病变的中西医防治”的基础和临床研究进展,主要从临床特点与发病机制、影响因素与预测因子、评价方法与鉴别诊断及中西医防治进展等方面展开了论述。综合分析,多种化疗药物均可引起周围神经病变,包括铂类、紫杉类、长春碱类、蛋白酶抑制剂、沙利度胺及类似物。目前,肿瘤治疗相关的不良反应可严重影响患者的生活质量,并会造成有效治疗的停药或减量,受到了许多学者的广泛关注。目前化疗药物致周围神经病变的发病机理尚不明确,不同种类的化疗药物引起周围神经病变的作用靶点和临床特点均不相同,各有特点；而针对周围神经病变发生、发展以及持续存在过程中的危险因素和预测因子,有多项临床研究进行了相关的探讨和研究,结论却并不一致。发生严重周围神经病变的危险因素或预测因子可能包括：年龄、性别、合并疾病、外周生长因子水平、既往存在的周围神经病变、曾接受过有潜在神经毒性的抗肿瘤药物治疗等。化疗致周围神经病变的评价方法主要通过临床评估完成,应用最为广泛地是美国国家癌症研究所的不良反应分级评价标准,但也存在其局限性；其他还有半定量评估、神经电生理检测、神经影像学、病理学活检、复合性量表等,但多应用于临床研究中,尚未在临床实践中广泛开展。针对化疗性周围神经病变的发病机制,已有一些防治研究,包括钠离子通道拮抗剂、钙镁制剂、B族维生素、中药内服或外用、针灸治疗等,但多属小样本、非盲法的临床观察,尚缺乏大样本、设计严谨的临床研究验证。
临床研究部分观察了中医外治化疗性手足痛的疗效。目的：观察温经通络活血法外用治疗化疗性手足痛的临床疗效和安全性。方法：选取化疗后出现手足痛不良反应者204例,包括奥沙利铂致周围神经毒性和卡培他滨致手足综合征各102例,按2：1随机分为试验组136例与对照组68例,分别给予温经通络活血法或安慰剂外用(洗／浸),温浴(35-40℃),20min／次,每日2次,连用7天为1个观察周期。疗效评价方法为：采用自身对照,参照分级标准比较治疗前、后的症状和体征,用药后降至0级为治愈、较用药前下降1级以上为有效、无改善为无效。结果：试验组与对照组治疗前后的数字评估法(NRS)评分试验组为(5.51±1.99)和(2.20±2.20)分,对照组为(5.57±1.82)和(4.50±2.44)分,组间比较有统计学意义(P<0.05)；疼痛缓解有效率试验组与对照组分别为88.06%、42.65%,比较有统计学意义(P<0.05)。手足痛分级的疗效总有效率试验组与对照组分别为81.34%、26.47%,比较有统计学意义(P<0.01)。试验组治疗起效时间为(4.1±0.22)天。结论：温经通络活血法外用能够减轻化疗性手足痛的疼痛程度,有效降低分级,改善患者的生活质量,且安全性良好。
There are two review articles about chemotherapy induced peripheral neuropathy. The first one reviewed the pre-clinical and clinical research about incidence characteristics and assessment of chemotherapy induced peripheral neuropathy, the second one is about the prevention and treatment for chemotherapy induced peripheral neuropathy. They mainly conclude clinical features, mechanisms, risk factors and predictors, assessment of patients, and the development of management in Traditional Chinese Medicine and Western Medicine. Analysis by synthesis, many different anticancer agents may cause chemotherapy induced peripheral neuropathy, such as platinum salts, taxanes, vinca alkaloids, bortezomib, thalidomide and analogs. Chemotherapy induced peripheral neurotoxicity is a common, potentially severe and dose-limiting adverse effect of cancer treatment. Chemotherapy induced peripheral neurotoxicity can profoundly affect the quality of life, often compelling clinicians to lower the chemotherapy regimen, consequently limiting therapeutic efficacy. The characteristics of chemotherapy induced peripheral neuropathy (type and seriousness) are related to dose intensity, cumulative dose and anticancer drug. Numerous associated factors promote the onset of neuropathy. The toxic mechanisms are not fully understood but are known to vary between anticancer drugs, affecting either dorsal root ganglia or the peripheral nerves of the peripheral nervous system. Several studies have approached the clinically relevant issue of identification of risk factors and/or predictors of the onset, course or long-term persistence of chemotherapy induced peripheral neuropathy, however, the results have been conflicting and, overall, inconclusive. Possible risk factors or predictors for a more severe chemotherapy induced peripheral neuropathy course include age, sex, comorbidities, changes in the levels of circulating growth factors, pre-existing peripheral neuropathy, and previous treatment with potentially neurotoxic antineoplastic drugs. Assessment of patients mainly use the clinical scales, the occurrence and severity of chemotherapy induced peripheral neuropathy is assessed by means of common toxicity criteria scales developed by the US national Cancer institute, which is most widely used. Semiquantitative assessment, neurophysiological investigation, neuroimaging, pathological evaluation and composite scales, are also can be used to evaluate the status of CIPN.
The second part is a clinical study. Objective:The Randomized trial was designed to evaluate the efficacy and safety of the external use of Wenjing Tongluo Huoxue treatment, versus placebo for peripheral neurotoxicity (CIPN) and hand-foot syndrome (HFS) caused by chemotherapy. Methods:Eligible patients (pts) with CIPN/HFS grade≥l (NCI-CTCAE, v3.0) after oxaliplatin/capecitabine therapy. Pts were randomly assigned2:1to receive external compound Chinese herbal extract (Arm1) versus placebo (Arm2). Pts soaked their hands and feet in Chinese herbal extract or placebo lotion for20minutes, twice daily for7days. Results:204pts from3centers were enrolled. Arms were well balanced. In Arm1/Arm2, total response rate for pain was88.06%/42.65%, the mean score of pain measurement ((NRS scale of0-10) before and after treatment were5.51±1.99and2.20±2.20in Arm1,5.57±1.82and4.50±1.44in Arm2. Total response rate for CIPN/HFS Grade was81.34%/26.47%. The average time from therapy beginning to pain relieve in Arm1was4.15±0.23days. Conclusions:The external use of Wenjing Tongluo Huoxue treatment can treat CIPN/HFS, which is especially effective for relieving pain, can improve QoL of pts, easy useand safe.
临床研究部分观察了中医外治化疗性手足痛的疗效。目的：观察温经通络活血法外用治疗化疗性手足痛的临床疗效和安全性。方法：选取化疗后出现手足痛不良反应者204例,包括奥沙利铂致周围神经毒性和卡培他滨致手足综合征各102例,按2：1随机分为试验组136例与对照组68例,分别给予温经通络活血法或安慰剂外用(洗／浸),温浴(35-40℃),20min／次,每日2次,连用7天为1个观察周期。疗效评价方法为：采用自身对照,参照分级标准比较治疗前、后的症状和体征,用药后降至0级为治愈、较用药前下降1级以上为有效、无改善为无效。结果：试验组与对照组治疗前后的数字评估法(NRS)评分试验组为(5.51±1.99)和(2.20±2.20)分,对照组为(5.57±1.82)和(4.50±2.44)分,组间比较有统计学意义(P<0.05)；疼痛缓解有效率试验组与对照组分别为88.06%、42.65%,比较有统计学意义(P<0.05)。手足痛分级的疗效总有效率试验组与对照组分别为81.34%、26.47%,比较有统计学意义(P<0.01)。试验组治疗起效时间为(4.1±0.22)天。结论：温经通络活血法外用能够减轻化疗性手足痛的疼痛程度,有效降低分级,改善患者的生活质量,且安全性良好。
There are two review articles about chemotherapy induced peripheral neuropathy. The first one reviewed the pre-clinical and clinical research about incidence characteristics and assessment of chemotherapy induced peripheral neuropathy, the second one is about the prevention and treatment for chemotherapy induced peripheral neuropathy. They mainly conclude clinical features, mechanisms, risk factors and predictors, assessment of patients, and the development of management in Traditional Chinese Medicine and Western Medicine. Analysis by synthesis, many different anticancer agents may cause chemotherapy induced peripheral neuropathy, such as platinum salts, taxanes, vinca alkaloids, bortezomib, thalidomide and analogs. Chemotherapy induced peripheral neurotoxicity is a common, potentially severe and dose-limiting adverse effect of cancer treatment. Chemotherapy induced peripheral neurotoxicity can profoundly affect the quality of life, often compelling clinicians to lower the chemotherapy regimen, consequently limiting therapeutic efficacy. The characteristics of chemotherapy induced peripheral neuropathy (type and seriousness) are related to dose intensity, cumulative dose and anticancer drug. Numerous associated factors promote the onset of neuropathy. The toxic mechanisms are not fully understood but are known to vary between anticancer drugs, affecting either dorsal root ganglia or the peripheral nerves of the peripheral nervous system. Several studies have approached the clinically relevant issue of identification of risk factors and/or predictors of the onset, course or long-term persistence of chemotherapy induced peripheral neuropathy, however, the results have been conflicting and, overall, inconclusive. Possible risk factors or predictors for a more severe chemotherapy induced peripheral neuropathy course include age, sex, comorbidities, changes in the levels of circulating growth factors, pre-existing peripheral neuropathy, and previous treatment with potentially neurotoxic antineoplastic drugs. Assessment of patients mainly use the clinical scales, the occurrence and severity of chemotherapy induced peripheral neuropathy is assessed by means of common toxicity criteria scales developed by the US national Cancer institute, which is most widely used. Semiquantitative assessment, neurophysiological investigation, neuroimaging, pathological evaluation and composite scales, are also can be used to evaluate the status of CIPN.
The second part is a clinical study. Objective:The Randomized trial was designed to evaluate the efficacy and safety of the external use of Wenjing Tongluo Huoxue treatment, versus placebo for peripheral neurotoxicity (CIPN) and hand-foot syndrome (HFS) caused by chemotherapy. Methods:Eligible patients (pts) with CIPN/HFS grade≥l (NCI-CTCAE, v3.0) after oxaliplatin/capecitabine therapy. Pts were randomly assigned2:1to receive external compound Chinese herbal extract (Arm1) versus placebo (Arm2). Pts soaked their hands and feet in Chinese herbal extract or placebo lotion for20minutes, twice daily for7days. Results:204pts from3centers were enrolled. Arms were well balanced. In Arm1/Arm2, total response rate for pain was88.06%/42.65%, the mean score of pain measurement ((NRS scale of0-10) before and after treatment were5.51±1.99and2.20±2.20in Arm1,5.57±1.82and4.50±1.44in Arm2. Total response rate for CIPN/HFS Grade was81.34%/26.47%. The average time from therapy beginning to pain relieve in Arm1was4.15±0.23days. Conclusions:The external use of Wenjing Tongluo Huoxue treatment can treat CIPN/HFS, which is especially effective for relieving pain, can improve QoL of pts, easy useand safe.
引文
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