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방법 논문

항암화학요법으로 유발된 정맥염에 대한 표준 간호와 병행한 국소 호장산황(Huzhang Sanhuang) 적용의 효과: 무작위 대조 연구

90 조회수

⸱

2026년 9월 11일

 ,  ,  ,  ,  , 
1School of Nursing, Nanjing Medical University, 2The Second Affiliated Hospital of Nanjing University of Chinese Medicine

이 논문에서

요약

본 무작위 대조 연구는 표준 간호 케어에 국소 Huzhang Sanhuang 처방을 추가하는 것이 항암 화학요법으로 유발된 정맥염 환자의 증상 완화, 염증 및 안전성 결과에 개선 효과가 있는지 평가합니다.

초록

항암화학요법 유발 정맥염(CIP)은 말초 정맥 항암화학요법의 흔한 합병증으로, 통증, 국소 염증, 치료 중단 및 삶의 질 저하를 유발할 수 있습니다. 본 무작위 대조 시험에서는 표준 간호와 병행한 국소 Huzhang Sanhuang(HZSH) 처방의 CIP 관리 효능과 안전성을 평가하였습니다. CIP(1등급 이상)를 가진 입원 환자 94명을 1:1 비율로 무작위 배정하여 14일 동안 국소 HZSH 처방과 표준 간호를 병행한 군(실험군, n = 47) 또는 50% 황산마그네슘 습포와 표준 간호를 병행한 군(대조군, n = 47)으로 나누었습니다. 사전 설정된 결과 지표에는 정맥염 등급, 시각적 아날로그 척도(VAS) 통증 점수, 고감도 C-반응성 단백질(hs-CRP), 인터루킨-6(IL-6), 증상 소실 시간 및 안전성 지표가 포함되었습니다. 14일째에 실험군 환자들은 대조군보다 정맥염 중증도에서 유의하게 더 큰 개선을 보였습니다(2등급 이상의 위험비, 0.42; 95% 신뢰구간, 0.20–0.87; P = 0.012). 또한 실험군은 VAS 통증 점수, hs-CRP 수치 및 IL-6 농도에서 유의하게 더 큰 감소를 나타냈습니다(모두 P < 0.01). Kaplan–Meier 분석 결과, 실험군에서 다수의 국소 증상이 더 빠르게 소실됨을 확인하였습니다. 치료 순응도는 두 그룹 모두 높았으며, 심각한 이상 반응이나 주요 안전성 문제는 관찰되지 않았습니다. 이러한 결과는 표준 간호와 병행한 국소 HZSH 처방이 임상적 회복을 가속화하고 국소 증상을 완화하며 항암화학요법 유발 정맥염 환자의 염증 부담을 줄여주는 안전하고 효과적인 통합 간호 중재임을 시사합니다.

서론

화학요법 유발 정맥염(CIP)은 말초 정맥 화학요법을 받는 악성 종양 환자에게서 가장 흔하게 발생하는 합병증 중 하나입니다1. 종양학적 치료에서 중심정맥관과 매립형 포트의 사용이 증가하고 있으나, 비용적 제약, 시술상의 편의성 및 환자 개별적인 혈관 상태로 인해 단기 화학요법 및 일차 의료 환경에서는 여전히 말초 정맥 확보가 흔히 이루어집니다. 이러한 환경에서 vincristine, oxaliplatin, docetaxel과 같은 세포독성 제제는 높은 삼투압, pH 불균형 및 직접적인 혈관 독성으로 인해 상당한 내피 세포 손상을 일으킬 수 있으며, 이로 인해 국소 염증 반응이 유발될 수 있습니다2,3. 임상적으로 CIP는 통증, 홍반, 부종 및 경결로 나타날 수 있으며, 심한 경우 국소 조직 괴사로 진행될 수 있습니다. 이러한 합병증은 치료 일정을 중단시키고 항종양 치료를 지연시키며, 반복적인 천자와 혈관 손상으로 인한 환자의 고통을 증가시켜 궁극적으로 삶의 질을 저하시킬 수 있습니다4.

현재 CIP의 간호 관리는 주로 정맥 주입 요법 표준과 사지 거상, 국소 냉압법 또는 온압법, 말초 유치 바늘의 표준화된 관리 등 일상적인 지지 요법을 따릅니다5. 일반적인 국소 중재로는 황산마그네슘 습포, 무코폴리사카라이드 폴리설페이트 연고 및 하이드로콜로이드 드레싱이 포함됩니다6,7. 그러나 이러한 접근 방식에는 실질적인 한계가 있습니다. 황산마그네슘 드레싱은 삼투 효과를 통해 부종을 감소시킬 수 있으나, 빈번한 교체가 필요하며 피부 건조증이나 가려움증을 유발할 수 있습니다. 기존의 국소 제제는 어느 정도 국소 혈액 순환을 개선할 수 있지만, 심한 작열감, 지속적인 경결 또는 더 심각한 염증 반응이 있는 환자에게는 그 효과가 제한적인 경우가 많습니다. 또한 이용 가능한 증거에 따르면, 단일 양식의 간호 조치나 국소 화학 제제만으로는 혈관 내피 회복을 충분히 지원하고 혈전 위험을 포함한 하류 혈관 합병증을 줄이기에 부족할 수 있음을 시사합니다8,9. 따라서 염증을 줄이고 통증을 완화하며 국소 혈관 복구를 지원하기 위한 실용적이고 임상적으로 적용 가능한 통합 간호 전략이 필요합니다10.

전통 중의학(TCM)에서 화학요법 관련 혈관 손상은 열독의 축적과 혈액 정체를 수반하는 상태로 흔히 이해되며, 국소 혈관 손상과 혈액 순환 장애가 주요 병리학적 특징으로 꼽힙니다11,12. 호장삼황(Huzhang Sanhuang) 처방은 Polygonum cuspidatum, Rheum palmatum, Phellodendron amurense, Scutellaria baicalensis와 같은 약재를 포함하며, 전통적으로 청열, 해독, 활혈, 거어, 소종 및 통증 완화에 사용되어 왔습니다. 현대 약리학적 연구들은 이러한 효과에 대한 타당한 생물학적 근거를 제공합니다. Polygonum cuspidatum의 활성 성분(레스베라트롤 관련 화합물 포함)은 염증 신호를 억제하고 산화 스트레스 관련 내피 세포 손상을 줄이는 것으로 보고되었으며, Rheum palmatum은 국소 미세순환과 조직 수복을 지원할 수 있습니다13. 또한, Phellodendron amurense 및 Scutellaria baicalensis에서 유래한 베르베린(berberine) 및 바이칼린(baicalin)과 같은 화합물은 항염증 및 항균 효과가 있는 것으로 기록되어 있습니다. 이 한약 복합 제형을 국소적으로 사용할 경우, 특정 경구용 또는 주사제와 관련된 전신적 부작용을 피하면서 병변 부위에 국소적인 항염증 미세환경을 조성하는 데 도움이 될 수 있습니다14.

이러한 배경에서, 본 무작위 대조 연구는 입원한 CIP 환자를 대상으로 표준 간호 및 국소 호장삼황(Huzhang Sanhuang) 처방 병용 요법의 임상적 유효성과 안전성을 평가하기 위해 설계되었습니다15. 환자들은 표준 간호와 일상적인 국소 치료를 받는 대조군 또는 동일한 표준 간호와 더불어 호장삼황 국소 처방을 받는 실험군으로 무작위 배정되었습니다. 주요 기대 효과는 병용 중재를 통해 정맥염의 중증도를 낮추고 통증, 발적 및 부종의 해소를 가속화하는 것이었습니다. 본 연구는 대조군 설계와 사전 정의된 결과 측정 지표를 사용하여 CIP에 대한 통합적 간호 접근법에 대한 보다 강력한 근거를 제공하고, 현대 종양 지원 간호 실무에서 중의학(TCM) 기반 국소 케어의 표준화된 적용을 뒷받침하는 것을 목표로 합니다.

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프로토콜

Approval was obtained from the Ethics Committee of the Second Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Provincial Second Traditional Chinese Medicine Hospital) before initiating participant recruitment (Approval no. 2025SEZKY-033-02). All study procedures were conducted in accordance with the Declaration of Helsinki. The study purpose, procedures, potential benefits, and possible risks were explained to each eligible participant, and written informed consent was obtained before enrollment.

1. Protect participant confidentiality

  1. Assign study identification codes
    1. Assign a unique study identification code to each participant immediately after enrollment. Use the assigned code throughout the study.
    2. Enter the study identification code on all case report forms, intervention records, laboratory records, and study databases. Do not record participant names in the analysis dataset.
  2. Secure personally identifiable information
    1. Store participant names, contact information, hospital identification numbers, and consent forms separately from coded research data. Link identifiable information to the study identification code only through a secure participant-code list.
    2. Limit access to personally identifiable information to authorized research personnel. Store paper records in locked cabinets and protect electronic records with passwords and access controls.
    3. Do not disclose participant-identifying information in study reports, statistical outputs, presentations, or publications. Use coded or aggregated data when reporting study findings.
  3. Document study events prospectively
    1. Document each protocol deviation when it occurs. Record the date, nature, reason, corrective action, and effect on study participation.
    2. Document each participant's withdrawal prospectively in the case report form and study log. Record the withdrawal date and reason without altering previously collected data.
    3. Record all adverse events in the case report forms and nursing records. Document the onset, severity, duration, management, outcome, and assessed relationship to the study intervention.

2. Study design and participant enrollment

  1. Study design
    1. Conduct a prospective, randomized, controlled, single-center clinical trial at the Second Affiliated Hospital of Nanjing University of Chinese Medicine from January 2025 to December 2025. Compare topical Huzhang Sanhuang formula plus standard nursing care with 50% magnesium sulfate wet dressing plus the same standard nursing care.
    2. Initiate the assigned intervention immediately after confirming chemotherapy-induced phlebitis (CIP) and completing baseline assessment. Continue treatment for 14 consecutive days and perform outcome assessments on Day 0, Day 7, and Day 14.
    3. Identify hospitalized patients who develop CIP after peripheral intravenous chemotherapy during routine chemotherapy infusion rounds and intravenous therapy rounds. Evaluate each patient for study eligibility.
    4. Explain the study objectives, procedures, risks, and benefits to each eligible participant. Obtain written informed consent before enrollment.
    5. Collect demographic information, tumor treatment status, phlebitis grade, visual analog scale (VAS) pain score, and inflammatory biomarker measurements before randomization.
  2. Participant screening
    1. Calculate the sample size using the primary endpoint, defined as the proportion of participants with persistent grade II or higher phlebitis at Day 14. Assume an event rate of 45% in the control group and 15% in the experimental group with a two-sided α of 0.05 and 80% statistical power.
    2. Require at least 36 participants per treatment group based on the sample size calculation. Increase the target sample size by approximately 20% to compensate for anticipated withdrawals or protocol deviations and enroll 94 participants (47 per group).
    3. Include adults aged 18 years or older who develop grade I or higher phlebitis at the peripheral intravenous catheter insertion site during chemotherapy. Confirm that each participant is conscious, capable of reporting symptoms, and able to complete scheduled follow-up assessments.
    4. Obtain written informed consent from each eligible participant before enrollment. Assign each participant a unique study identification number.
    5. Exclude patients with a known allergy to either topical preparation, severe contact dermatitis, skin ulceration or infection at the treatment site, severe eczema, or extensive local skin damage. Exclude patients with severe systemic infection, unstable organ failure, cognitive impairment, communication difficulties, or concurrent topical treatments that could influence study outcomes.
    6. Withdraw participants who revoke consent, miss more than 20% of scheduled topical applications, or receive prohibited topical medications during the study. Withdraw participants who develop severe local skin reactions requiring discontinuation or who cannot complete follow-up because of transfer or hospital discharge.
    7. Record the reason, date, and timing of each withdrawal in the study records. Document all protocol deviations and adverse events before study completion.

3. Randomization, allocation concealment, and blinding

  1. Randomization and allocation concealment
    1. Ask an independent researcher who is not involved in participant recruitment, intervention delivery, or outcome assessment to generate a computer-based random allocation sequence before participant enrollment. Allocate participants to the experimental or control group in a 1:1 ratio.
    2. Place each treatment assignment in a sequentially numbered, opaque, sealed envelope. Seal each envelope securely before participant enrollment begins.
    3. Ask trained research nurses to screen potential participants according to the eligibility criteria. Confirm eligibility and obtain written informed consent before enrollment.
    4. Collect all baseline demographic and clinical data before revealing the treatment allocation. Verify that all required baseline assessments have been completed.
    5. Ask the study coordinator to open the next sequentially numbered envelope only after participant enrollment and completion of the baseline assessment. Record the envelope number and treatment assignment in the study records.
    6. Communicate the assigned treatment to the intervention nurse immediately after opening the allocation envelope. Begin the assigned intervention according to the study schedule.
    7. Record the allocation date, envelope sequence number, assigned treatment group, and responsible study personnel in the study documentation.
  2. Blinding and bias control
    1. Assign different study personnel to deliver the topical interventions and perform outcome assessments. Prevent outcome assessors from participating in treatment administration.
    2. Use identical assessment forms and standardized evaluation procedures for all scheduled study visits. Apply the same assessment criteria to both treatment groups.
    3. Keep outcome assessors unaware of participant treatment allocation whenever feasible. Avoid discussing treatment assignments during outcome assessments.
    4. Replace treatment groups with coded identifiers before statistical analysis. Keep the treatment code concealed until completion of the primary statistical analyses.
    5. Perform all efficacy and safety assessments according to the predefined protocol. Record all observations immediately after each assessment without reference to previous results.
      NOTE: Do not blind participants because the Huzhang Sanhuang formula and 50% magnesium sulfate dressing differ in appearance, texture, and odor. Limit blinding to outcome assessment and statistical analysis whenever feasible.

4. Topical intervention procedures

  1. Overall intervention framework
    1. Provide all participants with the same standard nursing care throughout the study. Vary only the assigned topical treatment between the two groups.
    2. Begin the assigned topical treatment immediately after confirming grade I or higher chemotherapy-induced phlebitis and completing the baseline assessment. Continue treatment for 14 consecutive days.
    3. Administer the assigned topical treatment twice daily, once in the morning and once in the evening, at approximately fixed times each day. Where clinically feasible, maintain an interval of approximately 12 h between the two applications. Perform outcome assessments on Day 0, Day 7, and Day 14 before the morning application.
    4. Standardize treatment delivery across participants by using the same predefined procedures for skin preparation, treatment coverage, dressing retention, documentation, and safety monitoring. Maintain an application thickness of approximately 2 mm for the Huzhang Sanhuang paste, extend both topical treatments approximately 1 cm beyond the visible lesion margin, and leave each dressing in place for 4 h. Record the actual application and removal times after each treatment.
  2. Prepare the Huzhang Sanhuang formula
    1. Obtain 100 g each of Polygonum cuspidatum (Huzhang), Rheum palmatum (Dahuang), Phellodendron amurense (Huangbai), and Scutellaria baicalensis (Huangqin). Verify each herb according to the Chinese Pharmacopeia before preparation.
    2. Record the supplier, batch number, authentication result, and quality certificate for each herbal ingredient before use.
    3. Add 4,000 mL of purified water to the herbal mixture at a crude herb-to-water ratio of 1:10 (w/v). Soak the mixture for 30 min before extraction.
    4. Heat the soaked herbal mixture to gentle boiling (approximately 95–100 °C). Continue decoction for 30 min.
    5. Filter the decoction through an appropriate filter. Concentrate the filtrate at 70–80 °C until a homogeneous, semisolid paste suitable for topical application is obtained.
    6. Inspect the paste for uniform appearance and absence of visible contamination or phase separation. Confirm that the paste has a consistent semisolid consistency suitable for topical application.
    7. Transfer the paste into sterile sealed containers. Store the preparation at 2–8 °C and prepare a fresh batch every 48 h.
    8. Apply approximately 0.20 g/cm2 of herbal paste to achieve a layer approximately 2 mm thick. Extend the application approximately 1 cm beyond the visible lesion margin.
  3. Administer the Huzhang Sanhuang formula (Experimental group)
    1. Inspect the affected skin before each application. Assess erythema, swelling, pain, papules, blistering, exudation, and pruritus.
    2. Clean the treatment site gently with sterile normal saline. Dry the skin using sterile gauze before applying the herbal paste.
    3. Spread the Huzhang Sanhuang paste evenly over the inflamed area to a thickness of approximately 2 mm. Extend the application approximately 1 cm beyond the visible lesion margin.
      NOTE: Do not apply pressure directly over the inflamed vein during application. Ensure complete coverage of the affected area.
    4. Cover the treated area with sterile gauze. Secure the dressing using hypoallergenic tape without applying compression.
    5. Leave the topical preparation in place for 4 h. Remove the dressing at the end of the treatment period.
    6. Remove any remaining herbal paste with sterile normal saline. Dry the skin gently using sterile gauze.
    7. Repeat the application twice daily for 14 consecutive days. Administer treatments at approximately the same time each day.
    8. Record the application time, treatment completion, skin tolerance, and protocol deviations after each application. Report any clinically significant local reactions immediately.
  4. Administer the control treatment
    1. Inspect, clean, and dry the affected area using the same procedure applied to the experimental group.
    2. Soak sterile gauze thoroughly with 50% magnesium sulfate solution. Remove excess solution before application.
    3. Place the soaked gauze over the inflamed area. Extend the dressing approximately 1 cm beyond the lesion margin.
    4. Cover the wet dressing with dry sterile gauze. Secure the dressing using hypoallergenic tape without compression.
    5. Leave the dressing in place for 4 h. Remove the dressing at the end of the scheduled treatment period.
    6. Clean the skin gently with sterile normal saline after dressing removal. Dry the area with sterile gauze.
    7. Repeat the treatment twice daily for 14 consecutive days. Maintain the same treatment schedule used in the experimental group.
    8. Record treatment completion, dressing tolerance, local skin reactions, and protocol deviations after each application. Use identical documentation procedures for both treatment groups.

5. Standard nursing care

  1. Train the nursing staff
    1. Train all participating nurses before enrolling the first participant using the same written protocol and standardized demonstration. Review the phlebitis grading criteria, skin preparation, treatment coverage, dressing application and removal, 4-h retention requirement, safety monitoring, adverse-event reporting, and documentation procedures.
    2. Require each participating nurse to perform the study-related procedures under supervision before independently administering study treatment. Confirm procedural competency using the same predefined treatment checklist and correct any deviations before independent participant care is permitted.
  2. Provide standard nursing care
    1. Inspect the peripheral intravenous catheter insertion site during each nursing shift. Assess pain, erythema, swelling, induration, burning sensation, and catheter patency using the standardized phlebitis grading criteria16.
    2. Monitor participants for worsening phlebitis, suspected extravasation, local infection, or other infusion-related complications. Report clinically significant deterioration promptly to the responsible investigator or treating physician.
    3. Instruct participants to protect the affected limb and avoid pressure, scratching, or unnecessary manipulation of the inflamed area. Advise participants to report worsening pain, swelling, redness, blistering, exudation, or other new symptoms immediately.
    4. Record phlebitis grade, nursing interventions, participant tolerance, and clinically significant findings during each scheduled assessment. Apply identical nursing procedures to both treatment groups throughout the study.

6. Outcome assessment and measurements

  1. Assess all study outcomes at baseline (Day 0), Day 7, and Day 14. Complete each assessment before the morning topical application using standardized assessment forms.
  2. Assess phlebitis severity
    1. Evaluate phlebitis severity using the predefined Grade 0–IV classification. Assess pain, erythema, swelling, burning sensation, induration, and exudation before assigning the phlebitis grade17.
    2. Determine whether participants have persistent Grade II or higher phlebitis on Day 14. Record phlebitis grades at each scheduled assessment.
  3. Ask participants to rate pain using a 10-cm visual analog scale (VAS), where 0 indicates no pain, and 10 indicates the worst imaginable pain. Record the VAS score at each scheduled assessment.
  4. Measure inflammatory biomarkers
    1. Collect fasting venous blood samples between 06:00 and 08:00 at baseline (Day 0) and Day 14 using the same sampling procedure at both time points. Label each specimen with the participant study identification code, collection time, and transport the samples promptly to the central laboratory.
    2. Allow the collected blood samples to clot at room temperature for approximately 30 min. Process all specimens within 2 h of collection. Centrifuge the samples at 1,500 × g for 10 min at 4 °C using a refrigerated benchtop centrifuge.
    3. Separate the serum immediately after centrifugation and inspect each specimen for hemolysis, lipemia, or other visible abnormalities that could interfere with analysis. Analyze the separated serum on the day of collection; do not subject samples to long-term frozen storage or repeated freeze–thaw cycles.
    4. Measure interleukin-6 (IL-6) using an electrochemiluminescence immunoassay according to the manufacturer's instructions. Perform a high-sensitivity C-reactive protein (hs-CRP) measurement using the validated assay routinely employed by the central laboratory.
    5. Use the same sampling, processing, and analytical procedures for baseline and Day 14 specimens. Perform instrument calibration and internal quality control in accordance with the manufacturer's instructions and the central laboratory's standard operating procedures. Record biomarker results only after the corresponding analytical run satisfies the predefined laboratory quality-control criteria.
  5. Calculate the number of days from treatment initiation until pain decreases to a VAS score of ≤1 and redness and swelling remain absent or mild without progression for at least 24 h. Record the time to symptom resolution for each participant.
  6. Evaluate Traditional Chinese Medicine (TCM) syndrome scores at each scheduled assessment using the predefined scoring criteria. Calculate the total score for each participant.
  7. Calculate the efficacy index according to changes in the total TCM syndrome score. Classify treatment responses using the predefined efficacy categories and calculate the total effective rate.
  8. Standardize outcome assessment
    1. Train both outcome evaluators before participant enrollment using the predefined Grade 0-IV phlebitis criteria and TCM syndrome scoring criteria. Review the definitions of pain, erythema, swelling, burning sensation, induration, and exudation to establish a consistent interpretation of each grading category.
    2. Ask the two trained evaluators to independently assess phlebitis grade and TCM syndrome score using identical standardized assessment forms. Whenever feasible, maintain the same evaluator pair across scheduled assessments. Keep the evaluators unaware of treatment allocation whenever possible.
    3. Resolve discrepant assessments by discussion and consensus. If consensus cannot be reached, request adjudication by a senior investigator who is not involved in treatment administration. Record the final adjudicated score in the case report form.

7. Data collection and quality control

  1. Collect study data
    1. Collect baseline demographic and clinical information immediately after enrollment and before randomization. Record participant characteristics, tumor treatment status, phlebitis grade, VAS pain score, inflammatory biomarker levels, TCM syndrome score, and other relevant clinical variables using standardized case report forms.
    2. Complete follow-up assessments on Day 7 and Day 14 according to the study schedule. Record treatment completion, outcome measures, nursing observations, adverse events, and protocol deviations at each assessment.
  2. Manage study data
    1. Enter all study data into the electronic database using independent double-data entry. Compare the two datasets and resolve discrepancies by reviewing the original source documents.
    2. Review completed case report forms for completeness and consistency before database entry. Correct identified errors promptly and document all modifications according to the study data-management procedures.
  3. Maintain data quality
    1. Review study records regularly to identify missing, inconsistent, or implausible data. Verify questionable entries against the original case report forms and nursing records.
    2. Resolve all outstanding data queries before the database lock. Finalize the verified dataset before initiating the statistical analysis.

8. Safety monitoring

  1. Monitor treatment safety
    1. Inspect the treatment area before each topical application and at each scheduled assessment. Evaluate erythema, swelling, blistering, dermatitis, exudation, pruritus, pain, and other local skin reactions.
    2. Document the onset, severity, duration, management, outcome, and relationship of each adverse event to the study intervention. Record all findings in the case report form.
  2. Manage adverse events
    1. Classify adverse events as mild, moderate, or severe according to the predefined study criteria. Refer clinically significant events to an independent investigator for review.
    2. Stop the assigned topical treatment if severe irritation, suspected infection, allergic reaction, or other clinically significant intolerance develops. Provide appropriate medical management and document the reason for treatment discontinuation.
  3. Reassess the treatment site after completion of the 14-day intervention. Document any persistent or delayed adverse reactions before study completion.

9. Statistical analysis

  1. Prepare the study dataset
    1. Perform the primary efficacy analysis according to the intention-to-treat principle. Perform supportive analyses using the per-protocol population and evaluate safety in all participants who receive at least one topical treatment.
    2. Present continuous variables as mean ± standard deviation or median (interquartile range), as appropriate. Present categorical variables as frequencies and percentages.
  2. Compare continuous variables using the independent-samples t-test or Mann–Whitney U test, as appropriate. Compare categorical variables using the chi-square test or Fisher's exact test.
  3. Compare the proportion of participants with persistent grade II or higher phlebitis on Day 14 between treatment groups. Report effect estimates with 95% confidence intervals and corresponding P values.
  4. Compare VAS pain scores, hs-CRP concentrations, IL-6 concentrations, TCM syndrome scores, and clinical efficacy between groups using appropriate parametric or nonparametric statistical tests. Analyze time-to-symptom resolution using Kaplan–Meier survival analysis with the log-rank test.
  5. Perform additional analyses
    1. Adjust for clinically relevant baseline variables when appropriate using multivariable regression models18. Include prespecified variables such as baseline phlebitis grade, puncture site, and chemotherapy-drug irritability when applicable19. Report adjusted effect estimates with 95% confidence intervals.
    2. Compare the results of the intention-to-treat and per-protocol analyses to evaluate the robustness of the study findings.
  6. Handle missing data and statistical significance
    1. Handle missing outcome data using the predefined statistical analysis plan. Perform sensitivity analyses when missing data are present.
    2. Perform all statistical analyses using SPSS Statistics version 26.0. Use two-sided statistical tests and consider P < 0.05 statistically significant.

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결과

A total of 94 participants were randomized equally to the experimental and control groups (47 participants per group). Participant screening, randomization, follow-up, and analysis are summarized in Figure 1. The standardized intervention workflow, including topical treatment, standard nursing care, scheduled assessments, and safety monitoring, is illustrated in Figure 2. Baseline phlebitis grade, visual analog scale (VAS) pain score, high-sensitivity C-reactive...

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토론

본 연구의 주요 방법론적 결과는 국소 Huzhang Sanhuang 처방을 항암 화학요법으로 유발된 정맥염의 표준화된 간호 경로에 재현 가능하게 통합할 수 있다는 것입니다20. 이 방법의 성공적인 구현은 정맥염의 중증도, 통증, 증상 완화, 염증성 바이오마커, 치료 순응도 및 안전성의 일관된 개선을 통해 가장 잘 입증됩니다. 본 연구에서 Huzhang Sanhuang 처방을 받은 참가자들은 기존의 국소 치료를 받은 그룹보다 14일 차에 지속적인 grade ≥II 정맥염 발생률이 낮았고, 증상 완화 속도가 더 빨랐으며, 통증 강도의 감소 폭이 더 컸고, hs-CRP 및 IL-6 농도가 더 낮게 나타났습니다. 이러한 이점은 높은 치료 순응도와 낮은 국소 부작용 발생률을 유지하면서 달성되었습니다.

통계적 유의성 외에도, 관찰된 치료 효과는 임상적으로 의미가 있을 수 있습니다. VAS 통증 점수의 0.8점 감소는 환자의 편안함에 있어 완만하지만...

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공개 사항

원고 작성 과정에서 언어 교정 목적으로만 DeepSeek가 사용되었습니다. 연구 설계, 데이터 분석, 결과 해석 또는 결론 도출에는 사용되지 않았습니다. 모든 과학적 내용은 저자들에 의해 검토 및 승인되었으며, 저자들이 원고에 대한 모든 책임을 집니다.

감사의 글

저자들은 이 무작위 대조 시험에 참여해주신 모든 환자와 그 가족분들께 감사드립니다. 또한 모집, 표준 치료 및 국소 중재의 수행, 추적 관찰, 데이터 수집에 기여해주신 간호 인력분들께 감사를 표합니다. 무작위 배정, 데이터 관리 및 품질 관리를 지원해주신 통계 및 연구 관리 담당자분들의 도움에 감사드립니다.

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재료

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참고문헌

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