当前位置：主页 > 诊疗指南 > 文章内容

2022 中国多学科指南：肌肉骨骼疼痛局部非甾体抗炎药的合理应用

作者：中华医学网发布时间：2026-01-12 08:41浏览：次

Multidisciplinary Guidelines for the Rational Use of Topical Non-Steroidal Anti-Inflammatory Drugs for Musculoskeletal Pain (2022)

Core Title: Multidisciplinary Guidelines for the Rational Use of Topical Non-Steroidal Anti-Inflammatory Drugs for Musculoskeletal Pain (2022)

Released by: Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association

Publication Date: 15 February 2023 (Journal of Clinical Medicine, JCM)

Core Objective: Standardize topical NSAID use for acute/chronic musculoskeletal pain, covering indications, selection, administration, drug interactions, and special populations, balancing efficacy and safety with reduced systemic exposurePMC.

I. Core Recommendations (GRADE 2C/Expert Consensus)

1. Indications for Topical NSAIDs (Conditional Recommendation, Low-Quality Evidence)

Recommendation: Recommend topical NSAIDs for localized acute (e.g., sprains, strains) and chronic (e.g., osteoarthritis, tendinopathy) musculoskeletal pain (mild–moderate intensity)PMC.
Rationale: Efficacy comparable to oral NSAIDs (RR 1.04, 95% CI 0.97–1.12) with lower systemic adverse events (AEs).
Limitations: Not recommended for widespread pain or non-musculoskeletal pain (e.g., visceral pain).

2. Selection of Topical NSAIDs (Expert Consensus)

No sufficient evidence to prioritize specific topical NSAIDs (e.g., diclofenac, ketoprofen, ibuprofen).
Choose based on patient preference, skin tolerance, formulation (gel, cream, patch, spray), and cost.
Formulation Tips: Patches for continuous delivery; gels/creams for flexible application; sprays for hard-to-reach areas.

3. Administration & Duration (Expert Consensus)

Formulation	Application	Frequency	Duration
Gel/Cream	1–4g per site, massage gently	2–4 times daily	2–4 weeks (acute); 4–8 weeks (chronic); reassess if no response
Patch	1 patch per site, apply to intact skin	Once daily	Up to 7 days; rotate sites to avoid skin irritation
Spray	1–2 sprays per site	3–4 times daily	Same as gel/cream

Key Rules: Apply to intact skin only; avoid occlusive dressings (except patches); do not exceed max daily dose.

4. Combination Therapy (Expert Consensus)

With Oral Analgesics: Combine with oral acetaminophen for short-term rescue (moderate–severe pain); avoid routine combination with oral NSAIDs (no added efficacy, increased systemic risk).
With Other Topicals: Avoid concurrent use of multiple topical NSAIDs on the same site.
Anticoagulants: Monitor INR in patients on warfarin (theoretical bleeding risk, no clinical evidence).

5. Special Populations (Expert Consensus)

Population	Recommendations
Pregnancy	Avoid in third trimester; short-term use (≤7 days) may be safe in second trimester; no data for first trimester.
Lactation	Use with caution; monitor infant for skin reactions/fussiness.
Children (≥2 Years)	Recommended for localized pain; use age-appropriate formulations/doses; monitor skin AEs.
Elderly (≥65 Years)	Recommended; higher risk of local irritation (e.g., erythema, pruritus); no increased systemic AEs vs. placebo.
Renal/Hepatic Impairment	Use with caution; monitor liver/renal function (systemic exposure may increase).
GI/CV High Risk	Prefer topical over oral NSAIDs (lower GI/CV risk).

II. Efficacy & Safety Evidence Summary

(1) Efficacy Outcomes

Outcome	Key Findings	Evidence Quality
Pain Relief	Significant reduction vs. placebo; similar to oral NSAIDs for localized pain	Low
Functional Recovery	Improved mobility with better pain control	Low
Patient Satisfaction	Higher adherence vs. oral NSAIDs (lower systemic AEs)	Low

(2) Safety Outcomes (Critical Concerns)

Risk	Association with Topical NSAIDs	Clinical Action
Local Skin Reactions	Most common (5–10%): erythema, pruritus, rash; usually mild/transient	Discontinue if severe; rotate application sites
Systemic AEs	Lower than oral NSAIDs (GI: RR 0.66, 95% CI 0.56–0.77; CV: no significant increase)	Avoid in hypersensitivity; monitor in renal/hepatic impairment
Non-Steroidal Anti-Inflammatory Drug–Exacerbated Respiratory Disease (NERD)	Rare; avoid in patients with history of aspirin/NSAID-induced asthma	—

III. Clinical Implementation Framework

(1) Patient Selection (Indications & Contraindications)

Eligible	Contraindications
Localized mild–moderate musculoskeletal pain; intact skin; preference for topical therapy	Hypersensitivity to NSAIDs/vehicle components; open wounds, infections, or eczema at application site; severe renal/hepatic failure; third-trimester pregnancy

(2) Stepwise Therapy Protocol (Expert Consensus)

First-Line: Topical NSAIDs (e.g., diclofenac gel 1% 4g tid) for localized pain.
Rescue: Add oral acetaminophen (1g q6h) for breakthrough pain; avoid oral NSAIDs unless necessary.
Failure: If no response in 2–4 weeks, switch to alternative topical NSAID or escalate to oral NSAIDs/other analgesics (e.g., tramadol).

(3) Monitoring & Risk Mitigation

Local: Check application site daily for irritation; discontinue if severe rash/blistering occurs.
Systemic: Monitor renal/hepatic function in high-risk patients (e.g., CKD, cirrhosis) at baseline and 4–8 weeks.
Drug Interactions: No significant interactions with ACEIs, ARBs, or diuretics (expert consensus).

IV. Expert Consensus Statements (Key Takeaways)

Topical NSAIDs are preferred over oral NSAIDs in high-risk patients (GI, CV, renal, hepatic) due to lower systemic exposure.
Avoid topical NSAIDs in third-trimester pregnancy; use with caution in lactation.
No evidence to support routine combination of topical NSAIDs with oral NSAIDs; reserve for short-term rescue only.
Rotate patch application sites to prevent skin irritation; do not use patches on broken skin.

V. Limitations & Research Gaps

Evidence Quality: Most comparisons of topical NSAIDs are low/very low quality; no head-to-head trials to support superiority.
Special Populations: Limited data on pregnant/lactating women and patients with severe organ dysfunction.
Long-Term Safety: Data on use beyond 8 weeks is sparse; need more studies on chronic pain managementPMC.

VI. Clinical Takeaways

Topical NSAIDs are conditionally recommended for localized mild–moderate musculoskeletal pain, with efficacy similar to oral NSAIDs and better safetyPMC.
Select formulation based on patient preference, skin tolerance, and pain location; no evidence to prioritize specific agents.
Follow recommended dosing/frequency; avoid occlusive dressings and concurrent oral NSAIDs (except rescue).
Use with caution in special populations (pregnancy, lactation, renal/hepatic impairment) and monitor for local/systemic AEs.