Introduction With the advancement of the ERAS (Enhanced Recovery After Surgery) concept, minimally invasive heart valve replacement surgery has become widely performed due to its advantages of smaller trauma and fewer adverse reactions. However, postoperative pain management remains complex and traditional opioid analgesia is often associated with adverse side effects. Oxycodone, an opioid agonist, has strong analgesic effects with relatively few side effects. This study aims to explore the efficacy and safety of oxycodone hydrochloride injection in multimodal pain management following minimally invasive heart valve replacement surgery.Methods and analysisThis is a prospective, double-blind, randomised controlled clinical trial designed as a non-inferiority study. The schedule of enrolment, interventions and outcome assessments is summarised in figure 2. The study period is from October 2024 to September 2027, and between 30 April 2026 and 31 October 2026, a total of 130 patients undergoing minimally invasive heart valve replacement surgery will be planned to recruit and randomly assign in a 1:1 ratio to receive either oxycodone hydrochloride injection or sufentanil for postoperative patient-controlled analgesia. The primary outcome is the Numerical Rating Scale pain score during coughing at 24 hours postoperatively. Secondary outcomes include measures of postoperative pain control, analgesic consumption, adverse events and recovery-related indicators. To address the risk of type I error due to multiple secondary outcomes, secondary endpoints are prespecified and categorised into key secondary outcomes and exploratory outcomes with corresponding statistical analysis strategies planned. This protocol is V.2.0, dated 29 December 2025.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2024LSYY-389-04). The study will be conducted in accordance with the Declaration of Helsinki, and informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals, scientific conferences and appropriate public channels.Trial registrationChiCTR2400094930.

Objectives: To evaluate the clinical impact and treatment adaptations during the immediate-release oxycodone hydrochloride shortage. Methods: This retrospective, observational study was conducted during the oxycodone shortage period (May 2024-March 2025) in patients with cancer pain. Pain intensity was assessed using the Numerical Rating Scale (NRS) at baseline (prior to switching, while receiving oxycodone) and at follow-up (after switching to alternative analgesics). Changes in pain intensity were evaluated using within-patient differences (ΔNRS), with clinically meaningful worsening defined as an increase of ≥2 points. Descriptive and inferential statistics were used to summarize patient characteristics and outcomes. Results: Of 300 patients screened, 55 met inclusion criteria (mean age 65.2 ± 11.0 years; 63.6% male). Pain intensity increased significantly following treatment modification during the period of oxycodone unavailability, with mean NRS scores rising from 4.3 ± 1.7 to 5.9 ± 2.5 (p < 0.001). The mean ΔNRS was +1.56 (95% CI 0.79-2.34), with clinically meaningful worsening observed in 36 patients (65.5%). No statistically significant association was observed between substitute analgesic type and clinically meaningful worsening (p = 0.11). Conclusions: The oxycodone shortage was associated with worsened pain control and increased need for treatment modifications in cancer patients, highlighting the importance of uninterrupted access to essential opioids.

Anesthesia option is critical for Percutaneous vertebroplasty (PVP) procedure in terms of its analgesic effect, sedation, adverse reactions and patient satisfaction. Oxycodone and sufentanil are commonly used as analgesic agents for surgeries in clinic. The comparison of clinical effect between oxycodone and sufentanil for pain management in PVP has not been elucidated. In this retrospective study, we investigated the clinical effect of oxycodone injection for pain management in spinal percutaneous vertebroplasty (PVP) surgery in terms of the analgesic effect, sedation, adverse reactions and patient satisfaction. A total of 100 patients who had previously undergone spinal PVP surgery were selected for a retrospective study from December 2022 to June 2024 including the oxycodone group (50 cases) and the sufentanil group (50 cases). The sufentanil group received 1mg/kg propofol + 0.15ug/kg sufentanil as anesthetic, while the oxycodone group received 0.1mg/kg oxycodone + 1mg/kg propofol. The analgesic effects and safety of both groups were compared. The intraoperative additional dose of propofol, MOAA/S score, and number of body movements of the oxycodone group were lower than the sufentanil group (p < 0.05); on postoperative day 1, the changes in SBP, DBP, HR, and SpO2 in the oxycodone group were lower than the sufentanil group (p < 0.05); 1day and 3days after surgery, the oxycodone group had significantly lower VAS scores (p < 0.001); The oxycodone group showed significantly lower postoperative pain intensity compared with the sufentanil group. On postoperative day 1, mean VAS scores were 2.76 ± 0.82 in the oxycodone group and 4.30 ± 0.73 in the sufentanil group (P < 0.05). On postoperative day 3, VAS scores were 1.26 ± 0.44 vs. 2.04 ± 0.70, respectively (P < 0.05). Using oxycodone hydrochloride for intraoperative pain management in patients undergoing percutaneous vertebroplasty can effectively alleviate pain, maintain hemodynamic stability, improve intraoperative and postoperative analgesic effects, and has good safety, making it worth promoting.

Prenatal opioid exposure (POE) can disrupt the development of dopamine and opioid systems, potentially altering behavioral sensitization in adulthood. This study examined the effects of gestational oxycodone (OXY) self-administration on quinpirole-induced locomotor sensitization in adult offspring and on gene expression in the nucleus accumbens (NAc) core, a region specifically involved in the expression phase of behavioral sensitization. Female rats self-administered OXY beginning three weeks prior to conception and continuing throughout pregnancy. All offspring were then reared by drug naïve foster dams. As adults, male and female offspring were assessed for locomotor sensitization following repeated administration of the dopamine D2/D3 receptor agonist quinpirole. Expression of dopamine- and opioid-related genes was measured in the nucleus accumbens (NAc) core. Repeated quinpirole elicited robust locomotor sensitization across all groups. POE did not significantly alter sensitization magnitude; however, sex differences were evident, with males showing reduced locomotor responses compared to females. Despite the absence of behavioral differences, in males, POE was associated with downregulation of OPRM1, OPRD1, DRD1, DRD2, PENK, and PDYN in the NAc core. No significant effects of POE on gene expression changes were observed in females. POE does not impact quinpirole-induced locomotor sensitization but influences sex-specific molecular alterations in NAc core opioid and dopamine pathways, highlighting potential long-term effects of POE on other opioidergic and/or dopaminergic -mediated behaviors.

IntroductionEffective perioperative analgesia in liver cancer patients presents an ongoing clinical challenge. This study investigates oxycodone’s pharmacokinetics in perioperative liver cancer patients with normal liver function to support individualized analgesia.MethodsThis study developed and validated a reliable high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the simultaneous quantification of oxycodone and its metabolite noroxycodone in human plasma. The method was successfully applied to characterize the pharmacokinetics in nine surgical liver cancer patients following intravenous oxycodone administration, using non-compartmental analysis (NCA).ResultsThe developed method showed satisfactory linearity and met validation criteria. In perioperative liver cancer patients, oxycodone exhibited reduced clearance, prolonged half-life, increased volume of distribution, and elevated exposure compared with healthy volunteers. Its metabolite noroxycodone displayed a biphasic profile with consistently higher concentrations in males. Significant sex-related differences were also observed for oxycodone’s area under the plasma concentration-time curve (AUC) and mean residence time (MRT).DiscussionThis study reveals that compared with healthy volunteers, perioperative liver cancer patients with normal liver function exhibit significantly altered oxycodone pharmacokinetics, including reduced clearance, prolonged half-life, increased exposure and volume of distribution, with notable sex differences. These findings support the need for dose reduction, extended monitoring, and individualized analgesic strategies.

745P Real-world, multicenter study of oxycodone hydrochloride and naloxone hydrochloride prolonged-release tablets for severe cancer pain in China: Preliminary results

Introduction: Oxycodone hydrochloride can affect the nervous system, as well as other systems such as the endocrine and reproductive systems. Exposure to oxycodone hydrochloride is not without adverse effects. These adverse effects can lead to infertility. Objective: The aim of the study was to evaluate the effects of oxycodone hydrochloride on reproductive functions in adult female Wistar rats. Materials and methods: Fifteen adult female Wistar rats, weighing between 100 and 300 g, were used. Treatment was administered orally for thirty days. Three batches, each containing five adult female Wistar rats, were formed and treated as follows: (1) a control batch given distilled water at 10 ml/kg; (2) and (3) batches treated with oxycodone hydrochloride at doses of 5 and 10 mg/kg respectively. The variables studied included physiological measurements, hormone assays and histological analysis of the ovaries. Results: Exposure of adult female Wistar rats to oxycodone hydrochloride at doses of 5 mg/kg and 10 mg/kg induced severe morphological alterations such as palpable adnexal masses plus a significant (p&lt;0.05) increase in ovarian weight. A significant decrease (p&lt;0.05) in FSH, LH and progesterone was also observed. Microscopic alterations such as cortical granuloma nodules were observed. Conclusion: Prolonged administration of oxycodone hydrochloride led to a significant increase in ovarian weight, associated with severe morphological alterations, hormone depletion and the appearance of microscopic ovarian alterations. All these disturbances are potentially linked to infertility. Keywords: oxycodone hydrochloride, infertility, hormone, ovary, histology, rats

Abstract Background and Aims The management of medications in hemodialysis (HD) patients with cancer requires meticulous evaluation of the metabolic pathways. Consequently, in practice of palliative care for advanced cancer, HD patients may have difficulty in controlling renal metabolic drugs, leading to suboptimal pain control. Nonetheless, the specific status of palliative care for advanced cancer in HD patients have been documented only through limited case reports and remain insufficiently elucidated. The aim of this study is to elucidate real-world palliative care strategies for advanced cancer in HD patients by comparing with those implemented in non-HD patients. Method In our study, patients diagnosed with stage III or IV cancer were identified from the cancer registry data collected from 69 hospitals in Osaka Prefecture, Japan, between January 2019 and December 2021. To obtain more detailed information on treatment and pharmaceutical intervention, we integrated these data with Japan's Diagnosis Procedure Combination (DPC) data, resulting in the creation of a consolidated dataset. From this dataset, information on maintenance HD, the practice of palliative care, and the use of opioid analgesics—such as morphine sulfate, morphine hydrochloride, hydromorphone, oxycodone, fentanyl, and tramadol hydrochloride—was extracted. The patient characteristics, cancer types, the practice of palliative care, and the use of opioid analgesics were analyzed and compared between patients on maintenance HD and the non-HD. Results Among 57,917 patients diagnosed with stage Ⅲ or Ⅳ cancer, 377 patients (0.7%) were identified as receiving maintenance HD. The median age was 73 years (interquartile range: 68–79) for HD patients and 73 years (66–80) for non-HD patients, with no significant difference (P = 0.411). A higher proportion of HD patients were male compared to non-HD patients (78.8% vs. 61.2%, P &amp;lt; 0.001). There was no significant difference of cancer type between the two groups. HD patients had a higher prevalence of the practice of palliative care compared to non-HD patients (14,3% vs 10.4, P = 0.020). There was no significant difference in use of opioid analgesics (76.1% vs 72.7%, P = 0.462). However, regarding the opioid types, HD patients had a higher prevalence of fentanyl (65.3% vs 59.1%, P = 0.024) and tramadol hydrochloride (23.6% vs 14.2%, P &amp;lt; 0.001) use, and a lower prevalence of morphine hydrochloride (4.2% vs 8.2%, P = 0.004) and hydromorphone (1.9% vs 3.9%, P = 0.043) use compared to non-HD patients. There was no significant difference in use of morphine sulfate (0% vs 0.9%, P = 0.054) and oxycodone (13.3% vs 14.0%, P = 0.766). Conclusion In cancer patients with stage Ⅲ or Ⅳ, HD patients received a greater implementation of palliative care practices compared to non-HD patients. Although the use of opioid was comparable, the selection of drug types differed. Our findings indicate that HD patients received comprehensive palliative care through the use of pharmacological drugs targeting non-renal metabolic pathways.

Introduction: This randomized controlled trial aims to demonstrate the noninferiority of nonsteroidal anti-inflammatory drugs (NSAIDs) compared with narcotics for postoperative pain management after percutaneous nephrolithotomy (PCNL), in an era where opioids are commonly utilized. Methods: After institutional review board approval, 85 patients scheduled for PCNL at our institution between May 2023 and January 2025 were consented and randomized to receive either oxycodone (OXY) or ketorolac (KET) for postoperative pain management at home. Inclusion criteria were unilateral, single-access standard PCNL, whereas exclusion criteria included abnormal anatomy, contraindications to KET/OXY, and preexisting stents or nephrostomy tubes. The primary outcome was the Visual Analog Scale (VAS) pain score from postoperative days (PODs) 1-5. Secondary outcomes were recorded on POD 10 office visit and included VAS score, Patient-Reported Outcomes Measurement Information System questionnaire, pill count, office phone calls because of pain, and drug-related adverse events. Complication outcomes were also included as secondary. Results: The cohort had median age of 65 years (interquartile range [IQR]: 49-70), stone burden of 975 mm³ (IQR: 558-2356), STONE score of 6 (IQR: 5-7), and operative time of 66 minutes (IQR: 53-90). Baseline characteristics, including clinical, stone, and intraoperative variables, were comparable between groups. Maximum and average VAS pain scores over PODs 1-5 were similar across both treatment groups (p = 0.18 and p = 0.17, respectively). Patients in the OXY group consumed fewer pills over the 10-day period (median of 6.5 vs 12, p < 0.01). All other secondary outcomes were not different between the groups. Conclusion: NSAIDs provide comparable postoperative pain relief to opioids following PCNL, with minimal side effects, making them a viable option for patients without contraindications. Our study is the first level 1 evidence on this topic.

Although prescription opioids may be necessary to manage severe and persistent pain, many factors including concern for opioid abuse and misuse have led to restricted availability of these analgesics. Opioid abuse-deterrent formulations (ADFs) were developed to enhance resistance to tampering yet retain analgesic efficacy. US Food and Drug Administration (FDA) approval for the ADF designation is based on prespecified preclinical (category 1), pharmacokinetic (category 2), and/or clinical (category 3) evidence demonstrating abuse-deterrent properties. Currently, 4 opioid formulations carry the ADF designation: XTAMPZA® ER (oxycodone), OXYCONTIN® (oxycodone hydrochloride), HYSINGLA™ ER (hydrocodone bitartrate), and ROXYBOND™ (oxycodone hydrochloride). The FDA requires that ADFs undergo postapproval evaluation to assess their impact on meaningful reductions in abuse, misuse, and related clinical outcomes. An additional designation is available based on FDA assessment of these postmarket studies (category 4). However, none of the 4 opioid ADFs have yet attained this additional category 4 labeling. The impact of opioid ADFs on abuse, misuse, and related clinical outcomes is unclear. The objectives of this narrative review are 1) to describe the benefits of and need for ADFs; 2) to provide an overview of the FDA guidance for ADFs, with a focus on category 4 postmarketing requirements; and 3) to summarize select postmarketing studies of the ADF prescription opioids currently available in the US. We identified key postmarketing publications for these ADFs via PubMed searches and investigation of literature cited in relevant publications. Three opioid ADFs (XTAMPZA ER, OXYCONTIN, and HYSINGLA ER) currently report postmarketing research, generally demonstrating reduced nonoral abuse or misuse compared with non-ADFs or other ADFs. Of note, XTAMPZA ER has shown sustained lower levels of nonoral abuse or misuse compared with other ADFs, despite a substantial increase in dispensed prescriptions since its launch in 2016. Additional postmarketing research is needed, especially for HYSINGLA ER and ROXYBOND.

Pre-clinical characterization of virus-like particles as a platform for nanovaccines against heroin and oxycodone.

The imperative challenges in transdermal iontophoresis (IP) are irritation, skin polarization, and patient discomfort. In this paper, we studied the IP delivery of oxycodone (OXC) using continuous direct current (CDC) and pulse depolarization current (PDC) current protocols. The different current protocols (CDC, PDC1, PDC2, and PDC3) have been employed to investigate the in vitro transdermal IP of OXC through the rat skin. Moreover, other effective factors including the formulation pH, the magnitude of applied current density, and the NaCl concentration were optimized to obtain the best performance of IP. The in vitro permeation experiments demonstrated that the cumulative amount of permeated OXC after 24 h (Q24 h) in the presence of the studied current protocols decreases in the following order: CDC > PDC3 > PDC2 ≈ PDC1. The permeation of OXC in the presence of CDC was evidently enhanced compared to that of the PDC3. Also, the experimental data were fitted using the Peppas-Sahlin model. Finally, in vivo experiments revealed that a statistically significant increase in the permeated OXC in the presence of IP technique (CDC, and PDC3) as compared to the control experiment. The study can pave the way for developing IP delivery systems using PDC.

Pharmacokinetics of oxycodone in rats: Influence of micronized magnesium lactate on oxycodone bioavailability.

Oxytocin attenuates yohimbine-induced responding for oral oxycodone under a progressive ratio schedule in male and female rats.

Much attention has been paid to the public health crisis that has resulted from the opioid epidemic. Given the high number of opioid users that are of childbearing age, the impact of utero exposure is a serious concern. Unfortunately, there is little knowledge regarding the consequences of opioid exposure during early development. While neurobehavioral effects of opioid exposure are well-documented, effects of exposure on embryogenesis remain largely unexplored. To address this gap in knowledge, we investigated the effects of oxycodone and fentanyl exposure on gene expression in zebrafish (Danio rerio) embryos using whole embryo RNA sequencing. Embryos were exposed to environmentally relevant (oxycodone HCl 10.6 ng/L and fentanyl citrate 0.629 ng/L) and therapeutically relevant doses (oxycodone HCl 35.14 μg/L and fentanyl citrate 3.14 μg/L) from 2 to 24 h post-fertilization (hpf), followed by another 24 h of opioid-free development. mRNA profiling at 48 hpf revealed dose- and drug-specific gene expression changes. Lower doses of oxycodone and fentanyl both induced more differentially expressed transcripts (DETs) than higher doses, potentially indicative of opioid receptor desensitization occurring at higher concentrations. In total, 892 DETs (corresponding to 866 genes) were identified across all conditions suggesting continued differential gene expression well after cessation of opioid exposure. Gene ontology analysis revealed changes in gene expression relating to extracellular matrix (ECM) organization, cell adhesion, and visual and nervous system formation. Key pathways include those involved in axon guidance, synapse formation, and ECM biosynthesis/remodeling, all of which have potential implications on neural connectivity and sensory development. These findings demonstrate that very early developmental exposure to opioids induces persistent transcriptomic changes which may have lasting implications for vertebrate cellular functions. Overall, these data provide insights into the molecular mechanisms of opioid-induced alterations during development.

Background: Co-administration of multiple intravenous drugs via the Y-site is common in palliative care. Information on the compatibility of opioid analgesics with intravenous drugs commonly used in palliative care is lacking. Objective: We aimed to determine the physical compatibility of 4 opioid analgesics with 64 drugs during simulated Y-site administration. Design: Four opioid analgesics and intravenous drugs were prepared using 0.9% sodium chloride solution or water for injection, without dilution, according to the manufacturer's recommendations (morphine hydrochloride, oxycodone hydrochloride, fentanyl citrate, and hydromorphone hydrochloride concentrations: 10, 10, 0.05, and 1 mg/mL, respectively). Measurements: In the compatibility tests, the opioid analgesics and target drugs were mixed in an equal volume ratio; the appearance, turbidity, and pH were evaluated immediately, one and four hours after mixing. Incompatibility was defined as change in appearance (turbidity increase ≥0.5 nephelometric turbidity units, Tyndall effect, visual judgment) and pH change ≥10%. Incompatible combinations were retested using dilutions of either opioid analgesics or the target drug. Results: Of the 255 combinations, 26 (10%) were defined as incompatible, including 12 morphine hydrochloride, 11 oxycodone, and 3 hydromorphone combinations involving 15 target drugs. Of the 28 retests conducted by diluting drugs in the combinations determined to be incompatible, the combinations of omeprazole (0.2 mg/mL) and lansoprazole (0.3 mg/mL) with morphine hydrochloride (1 mg/mL) remained incompatible. Conclusions: Utilization of these compatibility data for morphine hydrochloride, oxycodone, fentanyl, and hydromorphone in clinical practice should help guide safer drug administration and influence the selection of IV combinations in palliative care settings.

Sensitivity to the subjective reinforcing properties of opioids has a genetic component and can predict addiction liability of opioid compounds. We previously identified Zhx2 as a candidate gene underlying increased brain concentration of the oxycodone (OXY) metabolite oxymorphone (OMOR) in BALB/cJ (J) versus BALB/cByJ (By) females that could increase OXY state-dependent reward. A large structural intronic variant is associated with a robust reduction of Zhx2 expression in J mice, which we hypothesized enhances OMOR levels and OXY addiction-like behaviors. We tested this hypothesis by restoring the Zhx2 loss-of-function in J mice (mouse endogenous retroviral element knockout) and modeling the loss-of-function variant through knocking out the Zhx2 coding exon (exon 3 knockout [E3KO]) in By mice and assessing brain OXY metabolite levels and behavior. Consistent with our hypothesis, Zhx2 E3KO females showed an increase in brain OMOR levels and OXY-induced locomotor activity. However, contrary to our hypothesis, state-dependent expression of OXY conditioned place preference decreased in E3KO females and increased in E3KO males. We also overexpressed Zhx2 in the livers and brains of J mice and observed Zhx2 overexpression in select brain regions that was associated with reduced OXY state-dependent learning. Integrative transcriptomic and proteomic analysis of E3KO mice identified astrocyte function, cell adhesion, extracellular matrix properties, and endothelial cell functions as pathways influencing brain OXY metabolite concentration and behavior. These results support Zhx2 as a quantitative trait gene underlying brain OMOR concentration that is associated with changes in OXY behavior and implicate potential quantitative trait mechanisms that together inform our overall understanding of Zhx2 in brain function. SIGNIFICANCE STATEMENT: This study validated Zhx2 as a gene whose dysfunction increases brain levels of a highly potent and addictive metabolite of oxycodone, oxymorphone, in a female-specific manner. This result has broad implications for understanding the role of oxycodone metabolism and brain oxymorphone levels in the addiction liability of oxycodone (the active ingredient in OxyContin) and highlights the need for the study of sex differences in opioid metabolism as it relates to the addiction liability of opioids and opioid use disorder.

The design of this study is to compare the effectiveness of two analgesic drugs in the intervention of pain events for patients on mechanical ventilation. 414 patients from three hospitals with respiratory failure requiring mechanical ventilation were randomly assigned to oxycodone hydrochloride or flurbiprofen axetil. The primary endpoints is the difference in the proportion of patients with a Behavioral Pain Scale (BPS) score > 5 within 48 h. The secondary endpoints is to compare the dosage of sedative drugs (midazolam, propofol, dexmedetomidine) and to assess the clinical outcomes such as duration of mechanical ventilation. There was no significant difference in BPS scores between the two groups at enrollment, and BPS scores in oxycodone group were significantly lower than those in flurbiprofen axetil group at 24 and 48 h of enrollment. The proportion of patients with BPS less than 5 points in the Oxycodone hydrochloride group was also significantly lower than that in the flurbiprofen axetil group. For patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 10, subgroup analysis showed that the mechanical ventilation time of oxycodone hydrochloride group was significantly lower than that of flurbiprofen axetil group with statistical significance, and the dosage of midazolam was significantly lower than that of flurbiprofen axetil group. The length of ICU stay was significantly lower than that of flurbiprofen axetil group. Oxycodone hydrochloride was more potent than flurbiprofen axetil for analgesia for patients with respiratory failure requiring mechanical ventilation.

Nasal absorption of oxycodone predicted using a novel computational fluid dynamics-physiologically based pharmacokinetic model.

Postherpetic neuralgia (PHN) is a common complication of herpes zoster, which seriously affects patients' quality of life. This study analysed the synergistic effect of neuromodulation and opioid dilution analgesics in the treatment of PHN. 120 patients with PHN from Affiliated Hospital of Southwest Medical University between December 2020 and December 2023 were categorized into PR and PO groups, both groups were treated with pulsed radiofrequency, PO group was added with Oxycodone hydrochloride. VAS scores, inflammatory factor indexes [tumour necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-2 (IL-2), interleukin-10 (IL-10)], immune indexes [percentage of CD4+ T cells, CD8+ T cells, CD4+ /CD8+] and clinical efficacy were mainly evaluated. Secondary indicators included sleep quality (PSQI) scores, anxiety self-assessment (SAS) scores, disease control time, adverse reactions and recurrence rates. Post-treatment, both groups' indicators were significantly improved. IL-2 and IL-10 levels, CD4+ T cells percentage, CD4+ /CD8+ and clinical efficacy were higher in PO group than PR group. VAS score, TNF-α and IL-1β levels, CD8+ T cells percentage, PSQI score, SAS score, disease control time, adverse reaction and recurrence rate were lower than PR group (P<0.05). The combination treatment efficacy of PHN is remarkable and is worth promoting its use in the clinic.