Raw Pinelliae Rhizoma (a toxic TCM decoction piece) has demonstrated confirmed therapeutic efficacy in malignant tumor treatment. However, due to its inherent toxicity characteristics, substantial controversies persist regarding its safe dosage range and standardized administration protocols, posing significant clinical challenges in balancing toxicity and efficacy.

This study aimed to investigate the clinical medication characteristics and safety of raw Pinelliae Rhizoma in the outpatient service of the Department of Oncology, Dongfang Hospital, Beijing University of Chinese Medicine, from 2012 to 2023, thereby providing evidence-based references for the standardized application of raw Pinelliae Rhizoma in medical institutions.

A retrospective collection of data from tumor patients who were prescribed formulations containing raw Pinelliae Rhizoma between 2012 and 2023 was conducted. The dataset included demographic characteristics, clinical visit records, prescription details, and liver and kidney function test results. Data integration, statistical analysis, and graphical processing were performed using Microsoft Excel, IBM SPSS Statistics 30.0, R 4.3.2, and Origin Pro 2025b.

A total of 44 066 prescriptions were included, involving 11 971 tumor patients (51.91% male, 48.09% female), predominantly elderly (69.87%, 8 364/11 971). The core syndrome types included Intermingled Phlegm and Blood Stasis Syndrome, Qi-Yin Deficiency Syndrome, and Qi Stagnation-Blood Stasis Syndrome. Out of the prescriptions, 35 349 (80.22%) used a single-dosage range of 10-15 g, exceeding the recommended dosage in the Chinese Pharmacopoeia (3-9 g); meanwhile, 63.10% of patients (7 553 cases) had a treatment course of ≤30 days. The number of prescriptions containing raw Pinelliae Rhizoma showed a decreasing trend over the past decade (r=-0.964, P<0.001). Lung cancer, colorectal cancer, and breast cancer were the primary tumor types for which raw Pinelliae Rhizoma was prescribed. Taking lung cancer as the reference, esophageal cancer, liver cancer, uterine cancer, ovarian cancer, and pancreatic cancer were identified as influencing factors for the dosage of raw Pinelliae Rhizoma (esophageal cancer: B=-145.195, 95%CI=-280.686 to -9.705; liver cancer: B=-253.363, 95%CI=-400.976 to -105.751; uterine cancer: B=-866.593, 95%CI=-1 023.046 to -710.140; ovarian cancer: B=-847.736, 95%CI=-1 008.190 to -687.281; pancreatic cancer: B=-236.043, 95%CI=-423.324 to -48.762, P<0.05). Age and gender were not found to be significant factors affecting the dosage of raw Pinellia (P>0.05). Safety analysis showed that all prescriptions strictly followed the operational standard of 30-minute pre-decoction; 86 prescriptions (0.20%) had incompatibility with Aconitum species, 3 476 prescriptions (7.89%) were combined with ginger-family herbs (fresh ginger/dried ginger) for toxicity reduction, and 15 214 prescriptions (34.53%) were compatible with licorice for detoxification. Statistical analysis of liver and kidney function indicators showed no significant differences before and after treatment in the Chinese medicine monotherapy group (n=71) (P>0.05). In the combined Chinese medicine with chemotherapy/targeted therapy group (n=7), a statistically significant difference was observed in albumin (ALB) (P<0.05). In the Chinese medicine monotherapy group, there was no statistically significant difference between the dose subgroups of ≤9 g (n=21) and 10-15 g (n=48) before and after treatment (P>0.05). After excluding 754 patients who received combined chemotherapy during the treatment period, among 11 217 patients, 289 (2.58%) experienced grade 1 gastrointestinal adverse events. The incidence was 3.22% (60/1 861) in the ≤9 g group and 2.47% (229/9 255) in the 10-15 g group, with no statistically significant difference between the two groups (χ²=3.439, P>0.05). A total of 78 patients (0.70%) reported transient palpitations after medication, with an incidence of 0.75% (14/1 861) in the ≤9 g group and 0.67% (62/9 255) in the 10-15 g group. The difference between the two groups was not statistically significant (χ²=0.155, P>0.05).

In the Department of Oncology of this hospital, raw Pinelliae Rhizoma is commonly used for syndromes complicated by phlegm pathogens, with a typical dosage range of 10-15 g. The administered amount is adjusted based on the severity of phlegm pathogens across different cancer types. Standardized clinical administration, including strict decoction procedures (pre-decocted for 30 minutes) and rational combination with detoxifying agents (such as ginger and licorice), ensures medication safety. In this study, no significant correlation was observed between excessive use of raw Pinelliae Rhizoma or combined medication and definitive organ function impairment.The available data support that, under standardized operations, raw Pinelliae Rhizoma within the dosage range of 10-15 g has reliable safety in tumor patients, providing empirical references for its rational clinical application.

生半夏对恶性肿瘤的疗效确切，但由于生品的毒性特性，其安全剂量范围和合理用药标准存在争议，临床应用面临毒-效平衡的挑战。

分析北京中医药大学东方医院肿瘤科门诊毒性饮片生半夏的临床用药特征及安全性，为医疗机构规范应用生半夏提供参考。

回顾性纳入2012年1月—2023年8月于北京中医药大学东方医院肿瘤科门诊就诊且服用含生半夏处方的肿瘤患者的一般资料、就诊信息、处方数据及肝肾功能检查结果，采用Microsoft Excel、IBM SPSS Statistics 30.0、R 4.3.2、Origin Pro 2025b软件进行数据整合、统计学计算及图像处理。

共纳入44 066张处方，涉及11 971例肿瘤患者（男51.91%，女48.09%），以老年为主（69.87%，8 364/11 971）。处方核心证型包括痰瘀互结证、气阴两虚证及气滞血瘀证。35 349张（80.22%）处方单剂用量为10~15 g，高于《中国药典》的推荐剂量（3~9 g）；63.10%（7 553例）的患者疗程≤30 d。近十年生半夏处方量呈下降趋势（r=-0.964，P<0.001）。使用生半夏人数排名前三位的肿瘤疾病分别为肺癌、结直肠癌、乳腺癌。以肺癌为参照，食管癌、肝癌、子宫癌、卵巢癌、胰腺癌是患者生半夏用量的影响因素（食管癌：B=-145.195，95%CI=-280.686~-9.705；肝癌：B=-253.363，95%CI=-400.976~-105.751；子宫癌：B=-866.593，95%CI=-1 023.046~-710.140；卵巢癌：B=-847.736，95%CI=-1 008.190~-687.281；胰腺癌：B=-236.043，95%CI=-423.324~-48.762；P<0.05），年龄与性别因素不是生半夏用量的影响因素（P>0.05）。安全性分析显示：所有处方严格执行先煎30 min的操作规范，86张处方（0.20%）存在与乌头类药物的配伍禁忌，3 476张处方（7.89%）联合姜类（生姜/干姜）减毒，15 214张处方（34.53%）配伍甘草解毒。中药治疗组（n=71）肝肾功能指标治疗前后差异均无统计学意义（P>0.05），中药与化疗/靶向联合治疗组（n=7）治疗前后白蛋白（ALB）比较，差异有统计学意义（P<0.05），中药治疗组中≤9 g（n=21）与10~15 g（n=48）组间治疗前后差异无统计学意义（P>0.05）。排除治疗期间合并化疗的患者754例，11 217例患者中289例（2.58%）患者出现1级消化道不良反应，其中≤9 g组患者发生率为（3.22%，60/1 861），10~15 g组患者发生率为（2.47%，229/9 255）；两组消化道不良反应发生率比较，差异无统计学意义（χ²=3.439，P>0.05）。共78例（0.70%）患者出现服药后短暂心悸，≤9 g组发生率为（0.75%，14/1 861），10~15 g组发生率为（0.67%，62/9 255），两组间差异无统计学意义（χ²=0.155，P>0.05）。

本中心肿瘤科生半夏普遍应用于痰邪兼夹证型的肿瘤患者，常用剂量为10~15 g，用药剂量随不同癌种的痰邪盛衰而调整。临床给药规范，通过严格煎煮（先煎30 min）和合理配伍（姜类、甘草等减毒药物）可确保用药安全，研究中未发现生半夏的超量使用或合并用药与明确的脏器功能损害存在显著相关性。现有数据支持在规范操作前提下，生半夏10~15 g剂量范围对肿瘤患者具有可靠的安全性，可为临床合理应用提供实证参考。